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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 314 out of 7,116

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VAERS ID: 1589407 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Headache, Pruritus, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101005919

Write-up: itching in legs; Hives giant; Headache; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108041742316260-ROJO2, safety report unique identifier is GB-MHRA-ADR 25755436. A 25-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ff3319) via an unspecified route of administration on 01Aug2021 (at the age of 25-years) as single dose for covid-19 immunization. Medical history included lactation decreased from an unknown date and unknown if ongoing and suspected covid-19 from 21Nov2020 to an unknown date (unsure when symptoms stopped). Patient is not pregnant. Patient is not currently breastfeeding. The patient concomitant medications were not reported. On 01Aug2021, the patient experienced headache. On 03Aug2021, the patient experienced itching in legs and hives giant. It was reported that itching in legs started on 03Aug2021. Both legs were now covered in large red hive lumps and itching was all over body. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date (Yes - Positive COVID-19 test). The outcome of event hives giant was not resolved and for rest of events it was resolving. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589412 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-01
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: Axillary pain, 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101005842

Write-up: Armpit pain; Tingling sensation; tingling in finger; 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-202108041810228530-YEGCK. A 28-years-old female patient received bnt162b2 (BNT162B2, Batch/Lot number was not reported), via an unspecified route of administration on 03Aug2021 as DOSE 2, SINGLE for covid-19 immunization. Medical history included suppressed lactation from an unknown date and unknown if ongoing. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on an unspecified date (Lot number: Unknown) as single dose for COVID-19 immunization. The patient''s concomitant medications were not reported. The patient experienced tingling in finger on Aug2021 with outcome of unknown, on 04Aug2021, patient had armpit pain and tingling sensation. Outcome for both events was not recovered. No follow-up attempts are possible. information about lot/batch number cannot be obtained.


VAERS ID: 1589426 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101005670

Write-up: Swollen lymph nodes; My arm pit on my left side ( the side I had the vaccination) is swollen; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108042034273680-ISSMI. Sender''s (Case) Safety Report Unique Identifier: GB-MHRA-ADR 25756545. A 35-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration in arm left on 03Aug2021 (Batch/Lot number was not reported) as single dose 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. Patient was not pregnant. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on an unspecified date for COVID-19 immunisation. The patient experienced swollen lymph nodes (lymphadenopathy) (medically significant) on 04Aug2021 with outcome of not recovered, arm pit on left side ( the side patient had the vaccination) was swollen (medically significant) on an unspecified date in Aug2021 with outcome of unknown. Clinical course reported as follow: Patient''s arm pit on her left side (the side patient had the vaccination) was swollen and has been for the past 14 hours. Paracetamol has not improved the symptoms. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589440 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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: Headache, Lymphadenopathy, Peripheral swelling, Pyrexia, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negetive; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101005872

Write-up: Fever; Headache; Swollen lymph nodes; Swollen arm; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108042248452970-QWUJS, Safety Report Unique Identifier GB-MHRA-ADR 25756901. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 01Aug2021 (at the age of 37-year-old) as dose 2, single for COVID-19 immunisation. Patient received the first dose of BNT162B2 on unknown date. Medical history included suppressed lactation. Patient has not had symptoms associated with COVID-19 Patient is not pregnant, Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced fever, headache, swollen lymph nodes on 02Aug2021, swollen arm on 01Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negetive on unknown date No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of event fever was recovered on 03Aug2021, of headache was recovered on 04Aug2021, of others was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1589445 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Breast pain, Lymph node pain, Pain
SMQs:, Lipodystrophy (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: DULOXETINE; LORATADINE; QVAR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Asthma; Clinical trial participant; Hay fever
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101005665

Write-up: Lymph node pain; pain under arm; pain down the side of her left breast; pain; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency . The regulatory authority report number is GB-MHRA-WEBCOVID-202108042312071150-P3TUQ, Safety Report Unique Identifier GB-MHRA-ADR 25756926. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration in Arm Left on 03Aug2021 (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included clinical trial participant, anxiety, hay fever and asthma, all from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Concomitant medications included duloxetine taken for anxiety from 2019 to an unspecified date; loratadine taken for hay fever from May2021 to an unspecified date; beclometasone dipropionate (QVAR) taken for asthma. Historical vaccine included first dose of BNT162B2 via an unspecified route of administration received for COVID-19 immunisation. The patient experienced pain (medically significant) on an unspecified date in Aug2021 with outcome of unknown, lymph node pain (medically significant) on 04Aug2021 with outcome of not recovered. Clinical course reported as follow: Woke up with a pain under her arm and down the side of her left breast. Pain has carried on throughout the day and patient has never suffered from this before. Her injection was in her left arm. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589518 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Computerised tomogram, Confusional state, Coordination abnormal, Headache, Hemiplegic migraine, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: FROVATRIPTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Common migraine; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: CT Scan; Result Unstructured Data: Test Result:UNKNOWN
CDC Split Type: GBPFIZER INC202101012872

Write-up: Hemiplegic migraine; headache; chest pains; muscle weakness; confusion; loss of speech; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108051956586200-RRY7L. A 39-years-old female patient received first dose of bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 01Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included suppressed lactation and ongoing migraine without aura from an unknown date and unknown if ongoing. Concomitant medications included frovatriptan taken for migraine without aura, start and stop date were not reported. On an unknown date in Aug2021, the patient was collapse, one sided muscle weakness, loss of speech, confusion, headache, chest pains. On 04Aug2021, the patient had hemiplegic migraine. The events were considered as medically significant, and patient was hospitalized. The patient underwent lab tests and procedures which included computerised tomogram: unknown. Patient had not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not pregnant, Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Investigations or tests conducted CT scan, A&E admission. The events were assessed as serious. The outcome of event was Hemiplegic migraine was recovering and other event outcome was unknown.


VAERS ID: 1589527 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Pyrexia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NAPROXEN; SAYANA PRESS
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
CDC Split Type: GBPFIZER INC202101013045

Write-up: Inappropriate schedule of vaccine administered; Fever; Injection site pain; This is a spontaneous report from a contactable consumer received from the Regulatory Authority; report number is GB-MHRA-WEBCOVID-202108052219386460-CYH9L. A 27-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Not Known), dose 2 via an unspecified route of administration on 01Aug2021 (at the age of 27-year-old) as DOSE 2, SINGLE for covid-19 immunization. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Not Known), dose 1 via an unspecified route of administration on 06Jun2021 as DOSE 1, SINGLE for covid-19 immunization. Medical history included suppressed lactation from an unknown date and unknown if ongoing. Concomitant medication(s) included naproxen taken for back pain from Jan2021 to an unspecified stop date; medroxyprogesterone acetate taken for contraception from Nov2020 to an unspecified stop date. On 01Aug2021 the patient experienced fever, injection site pain which were assessed as medically significant, Inappropriate schedule of vaccine administered (non-serious) with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on 04Aug2021. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19 Patient is not pregnant, Patient is not currently breastfeeding. The clinical outcome of the fever, injection site pain was recovered and Inappropriate schedule of vaccine administered was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101026462 same patient, same drug, different dose/event


VAERS ID: 1589535 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   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 FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Movement disorder, Pain, SARS-CoV-2 test
SMQs:, Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Arthritis (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: IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Period pains
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101013063

Write-up: Wrist pain; could not raise arm or clench without shooting pain; Pain radiating along wrist through fingers; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). This is a report received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108060732256050-A2G9A. Safety Report Unique Identifier is GB-MHRA-ADR 25763027. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FE3380), via an unspecified route of administration on 31Jul2021 as dose 2, single for covid-19 immunization. The patient medical history included period pains. Patient has not had symptoms associated with COVID-19. Concomitant medication included ibuprofen taken for period pains. The patient previously received first dose of bnt162b2 (lot number: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. On 05Aug2021, the patient experienced wrist pain. On an unspecified date in Aug2021, the patient had pain radiating along wrist through fingers and could not raise arm or clench without shooting pain. It was reported that the patient had agonising wrist pain in injection site arm from elbow to hand. Pain radiating along wrist through fingers, could not raise arm or clench without shooting pain. Came on suddenly while patient was stationary watching TV. The patient was not injured in any way and not experienced before. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included covid-19 virus test: negative on an unspecified date. The outcome of event wrist pain was not recovered and outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589538 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-01
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: Axillary pain, Lymphadenopathy, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (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
Allergies:
Diagnostic Lab Data: Test Date: 20210806; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014262

Write-up: Swollen glands; Armpit pain; armpit swelling; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108061504583090-IQGXU. Safety Report Unique Identifier (GB-MHRA-ADR 25766062). A 27-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: FF3319) via an unknown route of administration on 05Aug2021 as dose 2, single for covid-19 immunisation. Medical history included suppressed lactation. The patient''s concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. The patient was not currently breastfeeding. The patient previously received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: not reported) via an unknown route of administration on an unknown date as dose 1, single for covid-19 immunisation and experienced no adverse event. On an unknown date in Aug2021, the patient experienced armpit swelling. On 06Aug2021, the patient had swollen glands and armpit pain (medically significant). Clinical course of events includes, about 18 hours after vaccine administration, the patient had begun swelling in the armpit of the arm that received the dose. 28 hours after the dose, the patient experienced armpit swelling which became more pronounced and was the size of half a tennis ball. There was also armpit swelling in the other arm to a lesser extent and glands in neck was also raised. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 06Aug2021. The outcome of the event armpit swelling was unknown while the events swollen glands and armpit pain were reported as not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589543 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-08-01
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Chest pain, Dehydration, Disorientation, Dizziness, Inappropriate schedule of product administration, Muscle twitching, Pyrexia, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: dehydration; first dose 30-MAY-2021) and (second dose 1-AUG-2021); Fainting; Weakness; Disorientated; Twitches; Fever chills; Fever; Dizziness; Chest pain; This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting), DEHYDRATION (dehydration), PYREXIA (Fever chills), PYREXIA (Fever), DIZZINESS (Dizziness), CHEST PAIN (Chest pain), MUSCLE TWITCHING (Twitches), ASTHENIA (Weakness), DISORIENTATION (Disorientated) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 30-MAY-2021) and (second dose 1-AUG-2021)) in a 38-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Clinical trial participant. On 30-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Aug-2021, the patient experienced PYREXIA (Fever chills) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant) and CHEST PAIN (Chest pain) (seriousness criterion medically significant). On 02-Aug-2021, the patient experienced MUSCLE TWITCHING (Twitches) (seriousness criterion medically significant). On 03-Aug-2021, the patient experienced ASTHENIA (Weakness) (seriousness criterion medically significant) and DISORIENTATION (Disorientated) (seriousness criterion medically significant). On 04-Aug-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). On an unknown date, the patient experienced DEHYDRATION (dehydration) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 30-MAY-2021) and (second dose 1-AUG-2021)) (seriousness criterion medically significant). The patient was treated with IBUPROFEN at a dose of 1 dosage form and PARACETAMOL for Adverse event, at an unspecified dose and frequency. At the time of the report, SYNCOPE (Fainting), PYREXIA (Fever chills), PYREXIA (Fever), DIZZINESS (Dizziness), CHEST PAIN (Chest pain), MUSCLE TWITCHING (Twitches), ASTHENIA (Weakness) and DISORIENTATION (Disorientated) had not resolved and DEHYDRATION (dehydration) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 30-MAY-2021) and (second dose 1-AUG-2021)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. Additional treatment included dehydration sachets. Company comment: This case concerns a 38-year-old male with serious unexpected events of syncope, dehydration, pyrexia (fever), pyrexia (fever chills), dizziness, chest pain, muscle twitching, asthenia, disorientation, and inappropriate schedule of vaccine administered. Event onset within 24 hours after second dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This case concerns a 38-year-old male with serious unexpected events of syncope, dehydration, pyrexia (fever), pyrexia (fever chills), dizziness, chest pain, muscle twitching, asthenia, disorientation, and inappropriate schedule of vaccine administered. Event onset within 24 hours after second dose mRNA-1273. Events ongoing. 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: 1589548 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-01
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: Arthralgia, Maternal exposure during breast feeding, Neck pain, Pain, Pain in extremity
SMQs:, Neonatal exposures via breast milk (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Shoulder pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014266

Write-up: Neck pain (with radiation); Maternal exposure during breast feeding; pain in arm; shoulder pain; shoulder pain radiating to arm; This is a spontaneous report from a contactable consumer or other non-health care professional received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108071250443050-6VGNZ. Safety Report Unique Identifier GB-MHRA-ADR 25770432. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration on 02Aug2021 (at the age of 34-year-old) as dose 2, single for COVID-19 immunization. Medical history included arthralgia and breast feeding. The patient''s concomitant medications were not reported. Patient was not pregnant. Patient was not enrolled in clinical trial. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number: Unknown) on an unspecified date for COVID-19 immunization. The patient experienced maternal exposure during breast feeding on 02Aug2021, neck pain (with radiation) on 03Aug2021, pain in arm, shoulder pain and shoulder pain radiating to arm on an unspecified date in Aug2021. It was reported the patient had neck and shoulder pain; and shoulder pain radiating to arm opposite side from injection. Over the counter analgesia was not effective. Pain worsening each day. Contacted NHS 24 and given naproxen for pain. Patient had not tested positive for COVID-19 since having the vaccine. Events considered medically significant. The outcome of the event pain in arm, shoulder pain and shoulder pain radiating to arm and neck pain (with radiation) was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589721 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive
CDC Split Type: ITJNJFOC20210835493

Write-up: SUSPECTED CLINICAL VACCINATION FAILURE; COLD; SUSPECTED COVID-19 INFECTION, HEADACHE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total administered 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. Patient had headache and cold that started on 13-AUG-2021. On the weekend in AUG-2021, she had a swab and was tested positive to covid-19 infection. Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive. On an unspecified date, the patient experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold, suspected covid-19 infection, headache and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210835493- covid-19 vaccine ad26.cov2.s-SUSPECTED CLINICAL VACCINATION FAILURE.This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1589765 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-08-01
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2625 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Chest pain, Panic attack, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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:
CDC Split Type: ITPFIZER INC202101010475

Write-up: chest pain paraesthesia lower limbs anxiety panic attacks; chest pain paraesthesia lower limbs anxiety panic attacks; chest pain paraesthesia lower limbs anxiety panic attacks; chest pain paraesthesia lower limbs anxiety panic attacks; This is a spontaneous report from a contactable physician downloaded from the WEB: IT-MINISAL02-765961. A 26-year-old male patient received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: FE2625, Expiration date: unknown), via intramuscular in arm left (left shoulder) on 30Jun2021 at 13:00 as a dose 1, 0.3 mL, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 01Aug2021, the patient experienced chest pain, paraesthesia lower limbs, anxiety, panic attacks. The patient was hospitalized for the events. The outcome of the events was recovering. No follow-up attempts possible. No further information expected.


VAERS ID: 1589812 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 FF4204 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210801; Test Name: HR; Result Unstructured Data: Test Result:40s
CDC Split Type: JPPFIZER INC202100996988

Write-up: Loss of consciousness; Vasovagal reflex; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21122332. A 36-year and 2-month-old male patient received the first dose of bnt162b2 (COMIRNATY, solution for injection, lot number FF4204, expiration date 31Oct2021) via an unspecified route of administration on 01Aug2021 at 14:10 (at the age of 36-year and 2-month-old) as dose 1, single for COVID-19 immunization. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Medical history and concomitant medications were not reported. Body temperature before vaccination, on 01Aug2021, was 36.7 degrees Centigrade. On 01Aug2021 at 14:20 (ten minutes after vaccination), the patient experienced loss of consciousness and vasovagal reflex. The course of the event was as follows: loss of consciousness attacked. Heart rate (HR) was 40s on 01Aug2021. On 01Aug2021 (the day of vaccination), the outcome of the event was recovered. The reporting physician classified the event as non-serious and assessed the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1589815 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 EY0573 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Anaphylactic reaction, Body temperature, Dyspnoea, Face oedema, Pruritus
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (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: Medical History/Concurrent Conditions: Allergy to nuts; Anaphylaxis (when the patient had bad physical conditioning); Egg allergy; Food allergy; Peanut allergy; Physical deconditioning; Pollinosis
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before the vaccination
CDC Split Type: JPPFIZER INC202100999572

Write-up: Consciousness disturbed; Generalised itching; Face oedema; Dyspnoea; Anaphylaxis; This is a spontaneous report from a contactable other HCP received from the Devices Agency (DA). Regulatory authority report number is v21123130. A 16-year and 05-month-old male patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021) dose 1 via an unspecified route of administration on 01Aug2021 at 10:40 (the day of vaccination), (at the age of 16-year and 05-month-old) as Dose 1, Single for COVID-19 immunization. Body temperature before vaccination was 36.3 degrees Centigrade. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) was anaphylaxis caused by eggs when the patient had had physical conditioning. The causes of the previous allergies were peanuts, nuts, eggs, and shrimp. The patient had pollinosis. The patient''s concomitant medications were not reported. On 01Aug2021 at 10:40 (the same day of vaccination) (as reported), the patient experienced Anaphylaxis. The course of the event was as follows: 40 minutes after the vaccination (as reported), the patient began to have generalised itching. The patient had Face oedema, Dyspnoea, and consciousness disturbed. EPIPEN and SOLU-MEDROL 1g were administered. At 12:00, the symptoms were recovering, and the patient went home. The reporting other HCP classified the event as serious (Medically significant) and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases. On 01Aug2021 (the same day of the vaccination), the outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589825 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100999853

Write-up: Vasovagal reflex; Acute Circulatory failure; Neurally mediated syncope; anaphylaxis; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21122403. A 25-year-old female patient received bnt162b2 (COMIRNATY, Lot number unknown), via an unspecified route of administration on 01Aug2021 16:17 (the day of vaccination, at the age of 25-year-old) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 01Aug2021 at 16:20 (3 minutes after the vaccination), the patient experienced Vasovagal reflex. Clinical course was reported as follows: Acute Circulatory failure developed about 3 minutes after vaccination on 01Aug2021 at 16:20. There were no Dermatologic, respiratory, or gastrointestinal symptoms, with no progression of symptoms. Neurally mediated syncope is also strongly suspected. It is difficult to deny anaphylaxis. The events resulted in emergency room visit. An emergency request was made after Adrenaline 0.3mg intramuscular injection, and the patient was admitted to our hospital. On 01Aug2021 (the day of vaccination), the patient was admitted to our hospital. On 02Aug2021 (1 day after the vaccination), the outcome of the events was recovered. The reporting physician classified the event as serious (hospitalized from 01Aug2021) and the causality between the event and bnt162b2 as unassessable. Other possible cause of the event such as any other diseases included Suspected Neurally mediated syncope. The reporting physician commented as follows: Strongly suspect Neurally mediated syncope rather than drug-induced anaphylaxis. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1589829 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Nausea
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Depression; Diabetes mellitus; Lumbar spinal stenosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101000049

Write-up: Anaphylaxis; queasy; giddiness; dyspnoea; This is a spontaneous report received from a contactable pharmacist via a Pfizer colleague. A 53-year-old male patient received bnt162b2 (COMIRNATY, solution for injection, Lot number and Expiration date was unknown) via intramuscular on 01Aug2021 (the day of vaccination) (at age of 53-years-old) as dose 1, 0.3 ml single for COVID-19 immunisation. Medical history included included asthma, depression, diabetes mellitus and lumbar spinal stenosis. Patient concomitant medications were not reported. The patient previously took alcohol, tetracyclic antidepressant (as reported) and experienced allergies. On 01Aug2021 (the day of vaccination), the patient experienced anaphylaxis. The details was provided as follows: On 01Aug2021, after the vaccination, the patient experienced queasy, giddiness and dyspnoea. After administration of EPIPEN and POLARAMINE, he was transported to hospital by ambulance. On 03Aug2021 (2 days after the vaccination), he was discharged after observation. Seriousness of the events were not provided. Outcome of the events was recovered in 2021. Reporter considered that between the suspect drug and event was definitely related. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of anaphylaxis,queasy, giddiness and dyspnoea . The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate


VAERS ID: 1589859 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 FF0843 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Hyperventilation, Hypoaesthesia, Panic attack
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: body temperature; Result Unstructured Data: Test Result:37.4 Centigrade; Comments: Before vaccination.
CDC Split Type: JPPFIZER INC202101001551

Write-up: numbness on left side of the upper body; Hyperventilation; panic condition; This is a spontaneous report from a contactable nurse received from the regulatory authority. Regulatory authority report number is v21122427. A 29-year and 8-month-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 01Aug2021 09:09 (Batch/Lot Number: FF0843; Expiration Date: 31Oct2021) as dose 2, single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Body temperature before vaccination was 37.4 degrees Centigrade. The event onset date was reported as 01Aug2021 at 09:40 (the same day of vaccination). The course of the event was as follows: After about 30 minutes after the vaccination, the patient complained numbness on left side of the upper body. The patient also had hyperventilation symptom. The patient fell into panic condition. Route keep was administrated. After the administration of STRONGER NEO-MINOPHAGEN and POLARAMINE via intravenous injection, the patient was under observation. The symptoms of hyperventilation and body numbness got improved. On 01Aug2021 (the same day of vaccination), the outcome of the event was recovered. The reporting nurse classified the event as non-serious and assessed that the event was unrelated to bnt162b2.


VAERS ID: 1589864 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 FE8206 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Dyspnoea, Hypersensitivity, Oxygen saturation, Throat irritation, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol allergy; Endometriosis; Rheumatism; Seafood allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: blood pressure; Result Unstructured Data: Test Result:140/45; Comments: normal; Test Date: 20210801; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: before vaccination; Test Date: 20210801; Test Name: SPO2; Test Result: 94 %; Comments: 16:20; Test Date: 20210801; Test Name: SPO2; Test Result: 99 %; Comments: after oxygen therapy
CDC Split Type: JPPFIZER INC202101002001

Write-up: Pharynx itchy sensation; dyspnoea; Wheezing was mild; it was considered to be allergic symptoms caused by the Comirnaty; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21122372. A 50-year-old female patient received BNT162B2 (COMIRNATY, Intramuscular injection, Lot number: FE8206, Expiration date: 31Oct2021), via intramuscular route on 01Aug2021 at 15:50 (the day of vaccination), at the age of 50-years and 6-month-old as dose 1, single for COVID-19 immunization. The patient had rheumatism and endometriosis and an unspecified medications were being taken orally. Patient had food allergies (crab, shrimp and alcohol). Body temperature before vaccination was 37.0 degrees centigrade on 01Aug2021. The event onset date was reported as 01Aug2021 at 16:20 (30 minutes after the vaccination). The course of the events was as follows: On 01Aug2021, the patient received Comirnaty intramuscularly at around 15:20. At about 16:20, the patient complained of pharynx itchy sensation and dyspnea. Oxygen saturation (SpO2) was 94 %. There was no rash and blood pressure (BP) was 140/45 (units not reported) which was normal. Wheezing was mild. Adrenaline 0.3 mg Intramuscular injection was given at 16:23. After starting oxygen with 5 liters/min, SpO2 improved to 99 %. Gradually, the patient''s dyspnea improved. However, the crash cart was called as further progress observation was necessary. On 01Aug2021 (the day of vaccination), the outcome of the event was recovered. The reporting physician classified the events as non-serious and assessed that the events was related to BNT162B2. There was no other possible cause of the events such as any other diseases. The reporting physician commented as follows: According to the time of onset of symptoms, it was considered to be allergic symptoms caused by the Comirnaty. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: According to the time of onset of symptoms, it was considered to be allergic symptoms caused by the Comirnaty.


VAERS ID: 1589866 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 FF0843 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101002261

Write-up: felt queasy; This is a spontaneous report from a contactable nurse received from the Regulatory Authority . The regulatory authority report number is v21122426. The patient was a 50-year and 2-month-old female. On 01Aug2021 at 08:57 (the day of vaccination), the patient received the second dose of BNT162B2 (COMIRNATY, solution for injection, lot number FF0843, expiration date 31Oct2021) via an unspecified route of administration as dose 2, single for COVID-19 immunisation. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient had no medical history. Information on concomitant medication was not reported. Body temperature before vaccination was 37.0 degrees Centigrade on 01Aug2021. The event onset date was reported as 01Aug2021 at 09:17 (20 minutes after the vaccination). The course of the event was as follows: 20 minutes after vaccination, the patient felt queasy. After the patient received bed rest, the symptoms improved, but the queasy recurred. Once the route of administration was determined, Primperan was injected and observation for symptoms was made. About an hour later, the symptoms improved. On 01Aug2021 (the day of vaccination), the outcome of the event was recovering. The reporting nurse classified the event as non-serious and the causality between the event and bnt162b2 as unassessable.


VAERS ID: 1589944 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 FF4204 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Anxiety, Blood pressure decreased, Blood pressure measurement, Body temperature, Chills, Cold sweat, Feeling abnormal, Feeling cold, Heart rate, Hypoaesthesia, Muscular weakness, PO2, Visual impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Hypoglycaemia (broad), Dehydration (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
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: blood pressure; Result Unstructured Data: Test Result:96/57; Comments: at 14:25; Test Date: 20210801; Test Name: blood pressure; Result Unstructured Data: Test Result:110/70; Comments: at 14:40; Test Date: 20210801; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination; Test Date: 20210801; Test Name: heart rate; Result Unstructured Data: Test Result:60; Comments: at 14:25; Test Date: 20210801; Test Name: spo2; Test Result: 99 %; Comments: at 14:25
CDC Split Type: JPPFIZER INC202101023250

Write-up: numbness and Feeling cold in upper extremities; Feeling cold in upper extremities; chills; Blood pressure 96/57; anguished expression; there is a lot of Cold sweat on the face; felt poorly; the patient''s vision became dark; it may correspond to anaphylaxis.; weakness of the upper extremities; This is a spontaneous report from a contactable physician received from the Devices Agency (DA). Regulatory authority report number is v21122651. A 16-year and 6-month-old male patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF4204, Expiration date 31Oct2021) via an unspecified route of administration on 01Aug2021 at 14:09 (the day of vaccination) (at the age of 16-year and 6-month-old) as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.9 degrees centigrade on 01Aug2021. The patient medical history was reported as none. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Concomitant medications were not reported. Event onset date was reported as 01Aug2021 at 14:14 (the day of vaccination). The course of the event was as follows: At 14:14 (about 5 minutes after the above inoculation), the patient felt poorly, the patient''s vision became dark. At 14:23, the patient was moved to the first aid room and observation started. At 14:25, consciousness was clear but had an anguished expression, and there is a lot of Cold sweat on the face. Blood pressure 96/57, spo2 99%, heart rate 60. Around 14:40, the patient had numbness and Feeling cold in upper extremities, and there was chills as well. After that, the blood pressure was maintained at about 110/70, and the cold sweat improved, but the numbness and weakness of the upper extremities continued, so the patient was transferred to a hospital nearby at 16:20. No vomiting, no cutaneous symptom, no wheezing, or oedema. On 01Aug2021 at 18:40 (the day of the vaccination), the outcome of the events was recovering. The reporting physician classified the events as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: It does not improve even 2 hours after inoculation, and especially if the numbness and Feeling cold in upper extremities (even on palpation) was a Circulatory disorder, it might correspond to anaphylaxis. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1590020 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004221 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Gaze palsy, Heart rate, Oxygen saturation, Presyncope, Rash, Respiration abnormal
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Blood pressure measurement; Result Unstructured Data: 100/55 mmHg; Test Date: 2021; Test Name: body temperature; Result Unstructured Data: 36.4? Celsius; Test Date: 20210801; Test Name: body temperature; Result Unstructured Data: 35.8? Celsius; Test Date: 20210801; Test Name: Heart rate; Result Unstructured Data: 58 beats per minute; Test Date: 20210801; Test Name: Oxygen saturation; Result Unstructured Data: 94%
CDC Split Type: JPTAKEDA2021TJP071824

Write-up: Rolling of the eyes; Vasovagal reflex (lightheadedness); Respiratory abnormality; Skin rash; Skin rash on the neck; This case was received via Regulatory Authority (Reference number: 2021TJP071824) on 02-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This case, initially reported to the Regulatory Authority by a physician, was received via the (Ref, v21119551). On an unknown date, body temperature before the vaccination: 36.4 degrees Celsius. On 01-Aug-2021, at 12:26, the patient received the 1st dose of the vaccine. After the vaccination, the patient experienced lightheadedness and skin rash. 35.8 degrees Celsius. At 12:30, lightheadedness and rolling of the eyes developed. Leg elevation was performed. Blood pressure (BP) 100/55, pulse (P) 58, and oxygen saturation (SAT) 94%. Respiratory abnormality developed. The patient received 500 mL of saline. At 12:50, the patient experienced skin rash on the neck and received IA of d-chlorpheniramine maleate intravenously. BP 104/60, P 55, and SAT 99%. The outcome of vasovagal reflex (lightheadedness), skin rash, rolling of the eyes, respiratory abnormality, and skin rash on the neck was reported as ongoing and unchanged. 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: 1590030 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004495 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic 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? 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: JPTAKEDA2021TJP071891

Write-up: Syncope; Vasovagal reflex (dizziness); This case was received via Pharmaceuticals (Reference number: 2021TJP071891) on 03-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This case, initially reported to the Pharmaceuticals and Medical Devices Agency (PMDA) by a (physician), was received via the PMDA (Ref, v21122708). Syncope was assessed as serious. On 01-Aug-2021, at 16:24, the patient received the 1st dose of the vaccine. At 16:39, dizziness and syncope developed. The patient was considered to experience vasovagal reflex. Thereafter, the level of consciousness soon improved while the patient lay in a supine position. HR was 68 with BP of 103/73. No skin, respiratory, or gastrointestinal symptoms developed. The outcome of vasovagal reflex (dizziness) and syncope was reported as recovered. 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 patient was considered to experience vasovagal reflex.; 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: 1590038 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
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: Acute disseminated encephalomyelitis
SMQs:, Noninfectious encephalitis (narrow), Demyelination (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP071927

Write-up: Acute disseminated encephalomyelitis; This case was received via Pharmaceuticals (Reference number: 2021TJP071927) on 10-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This spontaneous case was reported by a pharmacist and describes the occurrence of ACUTE DISSEMINATED ENCEPHALOMYELITIS (Acute disseminated encephalomyelitis) in a 48-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included No adverse event. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. In August 2021, the patient experienced ACUTE DISSEMINATED ENCEPHALOMYELITIS (Acute disseminated encephalomyelitis) (seriousness criteria hospitalization and medically significant). At the time of the report, ACUTE DISSEMINATED ENCEPHALOMYELITIS (Acute disseminated encephalomyelitis) had not resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ACUTE DISSEMINATED ENCEPHALOMYELITIS (Acute disseminated encephalomyelitis) to be possibly related. No concomitant medication was provided by the reporter No treatment medication information was provided by the reporter Action taken was not applicable EU Method of Assessment was given as Reasonable possibility. 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.; Reporter''s Comments: Not reported.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1590047 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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: Arthralgia, Diarrhoea, Headache, Hypophagia, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life 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: JPTAKEDA2021TJP072221

Write-up: Arthralgia; Difficulty in dietary intake and drinking; Pyrexia; Vomiting; Diarrhoea; Headache; This case was received via Takeda Pharmaceuticals (Reference number: 2021TJP072221) on 05-Aug-2021 and was forwarded to Moderna on 16-Aug-2021. This case, initially reported to the Pharmaceuticals and Medical Devices Agency (PMDA) by a (physician), was received via the PMDA (Ref, v21122459). On an unknown date, the patient received the 1st dose of this vaccination. On 01-Aug-2021, the patient received the 2nd dose of this vaccination in the morning. At around 22:00, the patient experienced symptoms of pyrexia, vomiting, diarrhoea, and headache. The patient frequently vomitted. On 02-Aug-2021, at around 10:00, the patient took an over-the-counter anti-inflammatory analgesic, but the symptoms did not improve. The patient also had difficulty in dietary intake and drinking. At around 16:50, the patient requested an ambulance. At 17:14, the patient was accepted to the hospital. The patient was admitted to the hospital on the day, and fluid replacement was performed, and the symptoms improved. On 03-Aug-2021, arthralgia and so on remained in the condition of morning, but it seemed that the patient was able to take meals, so the patient was allowed to go home and was discharged from the hospital. It was considered as various symptoms and side reaction after the vaccination. The outcomes of pyrexia, vomiting, diarrhoea, headache, and arthralgia were 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. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1590065 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
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: Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: JPTAKEDA2021TJP072251

Write-up: Pneumonia (pyrexia, difficulty in breathing, cough); This case was received via agency (Reference number: 2021TJP072251) on 09-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This case, initially reported to the RA by a physician, was received via the RA (Ref, v21122793). Pneumonia was assessed as erious by the agency. On an unknow date, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before the vaccination: 37.1 degrees Celsius. On 31-Jul-2021, the patient received the 2nd dose of this vaccine. On 01-Aug-2021, the patient experienced pyrexia of 39 degrees Celsius, difficulty in breathing, and cough in the morning. On 03-Aug-2021, the patient started medication. On 06-Aug-2021, after that, the patient had no pyrexia, but dyspnoea persisted, and chest CT was performed. The patient was noted to have pneumonia. On an unknown date, the patient was recovering with treatment with antibiotics. The outcome of pneumonia (pyrexia, difficulty in breathing, cough) was reported as resolving. 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.; 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: 1590106 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cellulitis, Chills, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRJNJFOC20210827171

Write-up: CELLULITIS; CHILLS; MUSCLE PAIN; This spontaneous report received from a health care professional via a Regulatory Authority, concerned a 4 decade old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1820095 expiry: 04-JUL-2021) dose was not reported, 1 total, administered at deltoid on 11-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-AUG-2021, the patient experienced cellulitis, chills and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cellulitis, muscle pain and chills was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0-20210827171-Covid-19 vaccine ad26.cov2.S-Cellulitis. 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: 1590148 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210805; Test Name: PCR; Result Unstructured Data: Test Result:14.3; Test Date: 20210808; Test Name: PCR; Result Unstructured Data: Test Result:119
CDC Split Type: MXPFIZER INC202101033672

Write-up: he had a fever, presenting a temperature of 39?C; inflammation in internal organs; This is a spontaneous report from a contactable consumer or other non hcp. A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on 01Aug2021 as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The reporter stated that they want to make known a situation that they were currently going through because their 19-year-old son went to take the vaccine, the first dose, and they applied him from the Pfizer laboratory, on 01Aug2021; the same day that it was applied, he had a fever, presenting a temperature of 39 degrees and he underwent the procedures to decrease and taking acetaminophen, but when the effect of the medication passed, the temperature rose again. According to medical reports, it seemed that the vaccine had an additional effect that was generating inflammation in internal organs causing the PCR that on 05Aug2021 (Thursday) at 14.3 and on 08Aug2021 (Sunday) and they left at 119, so it was quite critical because it generated a very high fever and there was no way to deal with this situation. Right now, their son was in hospital. Further it was reported to tell them if they can communicate with the hospital or with their son or his mother who was there to find out if they provide us with support in terms of the assessment of what he was presenting at this time. The events were considered as serious (Hospitalized) by the reporter. The patient underwent lab tests and procedures which included polymerase chain reaction: 14.3 on 05Aug2021, polymerase chain reaction was 119 on 08Aug2021. Therapeutic measures were taken for both the events. The outcome of all the events was not recovered. Follow-up attempts are required; information about batch number will be obtained.


VAERS ID: 1590581 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
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: Asthenia
SMQs:, Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Hypertension
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210823797

Write-up: R SIDED WEAKNESS; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096492] concerned a 66 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: hypertension, and diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) 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 01-AUG-2021, the patient experienced R (right) sided weakness. The patient was hospitalized (date and duration unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from R sided weakness. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0:20210823797-COVID-19 VACCINE AD26.COV2.S-R sided weakness. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1590653 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INSULIN HUMAN
Current Illness:
Preexisting Conditions: Comments: Dx of Diabetes mellitus type 1, under insulin therapy.
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210831451

Write-up: VASCULITIS LEGS; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-F202108-98] concerned a 25year old male. Initial information was processed along with the additional information received on 16-AUG-2021 The patient''s weight was 75 kilograms, and height was 170 centimeters. The patient''s pre-existing medical conditions included: Dx of Diabetes mellitus type 1, under insulin therapy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 0.5 ml, drug start period 1 week, 1 total administered on 23-JUL-2021 for covid-19 immunisation. The batch number was not reported. Per procedure no follow up will be requested. Concomitant medications included insulin human. On 01-AUG-2021, the patient experienced vasculitis legs for 48 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vasculitis legs. This report was serious (Other Medically Important Condition).; Reporter''s Comments: Other info-25 years-old man. With Dx of Diabetes Mellitus type 1. Under insulin. Janssen vaccine 1 week before onset of vasculitis-like lesions in lower limbs.; Sender''s Comments: V0:20210831451- covid-19 vaccine ad26.cov2.s-VASCULITIS LEGS. 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: 1590756 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XE4223 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Hypersensitivity, Pain in extremity, Paraesthesia, Thrombosis
SMQs:, Angioedema (broad), Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Vascular disorder (The patient had inherited health problem.)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: Blood test; Result Unstructured Data: not reported
CDC Split Type: PTJNJFOC20210832942

Write-up: LITTLE SIGNS OF THROMBOSIS IN LEG (THROMBOSIS STAIN); KNEE, LEG AND FOOT PAIN; NUMBNESS AND TINGLING IN HANDS AND FEET; ALLERGY; This spontaneous report received from a patient concerned a 38 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s concurrent conditions included vascular problems which was an inherited health problem. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE4223, and expiry: UNKNOWN) dose was not reported, 1 total administered on 05-AUG-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced little signs of thrombosis in leg (thrombosis stain), knee, leg and foot pain, numbness and tingling in hands and feet and allergy. On 16-AUG-2021, The patient mentioned she had tingling and pain in her right knee, leg and foot due to blood vessels. After the vaccination she wore elastic compression stockings and raised her legs to improve blood circulation and also mentioned that she was good to work a day after vaccination. On 16-AUG-2021, she had a medical appointment with her physician and did blood test analysis. Laboratory data included: Blood test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness and tingling in hands and feet, and knee, leg and foot pain, and the outcome of little signs of thrombosis in leg (thrombosis stain) and allergy was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210832942-Covid-19 vaccine ad26.cov2.s -Little signs of thrombosis in leg (thrombosis stain). 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: 1590862 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
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: Angina pectoris, Chills, Headache, Hypertension, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Other ischaemic heart disease (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: PROPRANOLOL ACTAVIS; METIZOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LTJNJFOC20210837653

Write-up: CHEST PAIN - CARDIAC; HYPERTENSION; OF THE NAPE; IN THE ARM; CHILLS; NAUSEA; HEADACHE; 39C; This spontaneous report received from a consumer via a Regulatory Authority [Regulatory Authority, LT-SMCA-5448N] concerned a 28 year old female. The patient''s weight was 62 kilograms, and height was 175 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE423 expiry: unknown) dose was not reported, 1 total administered on 01-AUG-2021 for prophylactic vaccination. Concomitant medications included thiamazole for hypothyroidism, and propranolol hydrochloride for tachycardia. On 01-AUG-2021, the patient experienced chest pain ? cardiac, hypertension, of the nape, in the arm, chills, nausea, headache and 39c. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from of the nape, in the arm, chest pain - cardiac, nausea, chills, hypertension, headache, and 39c. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210837653-Covid-19 vaccine ad26.cov2.s-Chest pain-cardiac. 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: 1591057 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-08-01
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Penicillin allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101022348

Write-up: Bell''s Palsy; This is a spontaneous report received from a contactable consumer (Patient). A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via an unspecified route of administration, administered in left arm on 13Jul2021 at 05:00 PM (at the age of 50-years-old) as dose number unknown, single for COVID-19 immunization. The patient medical history included known allergies of Penicilline. Concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. On 01Aug2021 at 06:00 PM, 19-days after the vaccination, the patient experienced Bell''s palsy. The event resulted in medical consultation or other healthcare professional, and emergency room visit. The event was serious (medically significant). Treatment received included unspecified medications. The outcome of the event was not recovered at the time of this report. No follow-up attempts possible. No further information expected.


VAERS ID: 1592212 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-08-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Laboratory test, Physical examination, Thrombocytopenia
SMQs:, Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Laboratory examination; Result Unstructured Data: Test Result:Unknown results; Test Name: Physical examination (personal inspection); Result Unstructured Data: Test Result:Unknown results
CDC Split Type: DEPFIZER INC202101054608

Write-up: Thrombocytopenia; Anemia; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority. WEB, regulatory authority number DE-PEI-202100163963. An 80-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular in Jul2021 (at the age of 80-year-old) (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 01Aug2021 the patient experienced Thrombocytopenia. In Aug2021 the patient experienced Anemia. The patient underwent lab tests and procedures on unspecified date which included Laboratory examination and physical examination (personal inspection), both with Unknown results. Outcome of the events was not recovered. This report is serious with Seriousness Criteria life threatening. Sender Comment: PRIVACY / 1. Comirnaty / Jun2021. Laboratory examination, personal inspection. assessed the causal relationship between bnt162b2 (COMIRNATY) and all events as B. Indeterminate. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1592381 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-08-01
   Days after vaccination:29
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: Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPEI202100162760

Write-up: Myocarditis; This case was received via Regulatory Agency (Reference number: 202100162760) on 16-Aug-2021 and was forwarded to Moderna on 16-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in a 19-year-old male patient who received mRNA-1273 (Spikevax) for Prophylactic vaccination. No Medical History information was reported. On 03-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Jul-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 01-Aug-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown. Concomitant medications were not reported. Treatment history was not reported . Based on the current available information and temporal association between the use of the product and the event, a causal relationship cannot be excluded. Event term, onset date and outcome captured per SD Authority reporting. Event seriousness per assessment by Authority and per IME list; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the event, a causal relationship cannot be excluded. Event term, onset date and outcome captured per SD Authority reporting. Event seriousness per assessment by Authority and per IME list


VAERS ID: 1592408 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-01
   Days after vaccination:3
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: Breast pain, Myocarditis
SMQs:, Cardiomyopathy (broad), Lipodystrophy (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: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: This case was received via Regulatory Authority (Reference number: 202100160092) on 17-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDITIS and BREAST PAIN in a 20-year-old male patient who received mRNA-1273 (Spikevax) for Prophylactic vaccination. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for Prophylactic vaccination. On 29-Jul-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced MYOCARDITIS (seriousness criteria hospitalization and medically significant) and BREAST PAIN (seriousness criterion hospitalization). At the time of the report, MYOCARDITIS and BREAST PAIN was resolving. Concomitant medications were not provided by the reporter. Treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of these 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 these events, a causal relationship cannot be excluded.


VAERS ID: 1592491 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   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 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Tinnitus, Vertigo
SMQs:, Hearing impairment (narrow), Vestibular disorders (narrow)

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

Write-up: Ac?fenos y v?rtigos; Vertigo; This case was received. This regulatory authority case was reported by a consumer and describes the occurrence of TINNITUS in a 43-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 3004672) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced TINNITUS (seriousness criterion medically significant) and VERTIGO (Vertigo). At the time of the report, TINNITUS (Ac?fenos y v?rtigos) and VERTIGO (Vertigo) had not resolved. No relevant concomitant medications were reported. No treatment information was provided. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the 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: 1592520 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7053 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, C-reactive protein, Computerised tomogram, Fall, Platelet count, Procalcitonin, SARS-CoV-2 test, Septic shock, Vomiting
SMQs:, Acute pancreatitis (broad), Toxic-septic shock conditions (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Sepsis (narrow), Opportunistic infections (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: LEVOTHYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Bariatric surgery; Hypothyroidism
Allergies:
Diagnostic Lab Data: Test Date: 20210701; Test Name: Creatinine high; Test Result: 3.61 mg/dl; Comments: high; Test Date: 20210701; Test Name: Chest CT; Result Unstructured Data: Test Result:Pulmonary parenchyma with multiple bilateral areas; Comments: Pulmonary parenchyma with multiple bilateral areas of bronchioalveolar filling, more extensive on the right side, affecting the LSD, LID and LSI, suggestive of an infectious process. Mediastinal lymph nodes increased in number, less than one centimeter on their short axis.; Test Date: 20210701; Test Name: C-reactive protein increased; Result Unstructured Data: Test Result:338 mg/l; Comments: increased; Test Date: 20210701; Test Name: Platelets decreased; Result Unstructured Data: Test Result:99000 /mm3; Comments: decreased; Test Date: 20210701; Test Name: Procalcitonin increased; Result Unstructured Data: Test Result:20.20 ng/ml; Comments: increased; Test Date: 202106; Test Name: covid-19 test anigen; Test Result: Negative ; Test Date: 202106; Test Name: covid-19 test PCR; Test Result: Negative
CDC Split Type: ESPFIZER INC202101068428

Write-up: Septic shock; vomiting; fall; This is a spontaneous case from a contactable physician. The reporter reported two cases of both doses. This is the second case for dose 2. The first case is downloaded from the regulatory authority-WEB, ES-AEMPS-973262). A 35-year-old female patient received her second dose of bnt162b2 (COMIRNATY) intramuscularly on 02Aug2021 (Batch/Lot Number: FE7053) as a single dose for covid-19 immunisation. Medical history included arterial hypertension, bariatric surgery, and hypothyroidism. Concomitant medication included levothyroxine taken for hypothyroidism from 2020 and ongoing. The patient received her first intramuscular dose of BNT162B2 (lot number FC1440) on 28Jun2021 and experienced thrombopenia, septic shock of pulmonary origin due to pneumonia bilateral enterovirus / rhinovirus, multiorgan failure with coagulopathy and acute renal failure. The patient experienced septic shock (hospitalization, life threatening) on 05Aug2021, vomiting (non-serious) in Aug2021, fall (non-serious) in Aug2021. The patient was hospitalized for septic shock from an unknown date to 05Aug2021. The patient underwent lab tests and procedures which included blood creatinine: 3.61 mg/dl on 01Jul2021, computerised tomogram 01Jul2021: Pulmonary parenchyma with multiple bilateral areas of bronchioalveolar filling, more extensive on the right side, affecting the LSD, LID and LSI, suggestive of an infectious process. Mediastinal lymph nodes increased in number, less than one centimeter on their short axis; c-reactive protein: 338 mg/l on 01Jul2021, platelet count: 99000 /mm3 on 01Jul2021, procalcitonin: 20.20 ng/ml on 01Jul2021, sars-cov-2 test: negative in Jun2021, sars-cov-2 test: negative in Jun2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1592791 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-08-01
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2296 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure abnormal, Blood pressure measurement, COVID-19, Chest X-ray, Computerised tomogram, Cough, Crepitations, Diarrhoea, Drug ineffective, Fatigue, Lung disorder, Lung opacity, Microbiology test, Oxygen saturation, SARS-CoV-2 antibody test, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Severe acute respiratory syndrome
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:125 x 170 (instead of 160).; Test Name: Chest x-ray; Result Unstructured Data: Test Result:lung damage at 75%; Comments: and crackles; Test Name: CT scan; Result Unstructured Data: Test Result:lung damage at 75%; Comments: and crackles of the basement; Test Date: 20210803; Test Name: biology test; Result Unstructured Data: Test Result:negative; Test Name: oxygen saturation; Test Result: 93 %; Test Name: COVID-19 serology; Result Unstructured Data: Test Result:not yet disponible; Test Date: 20210802; Test Name: PCR COVID-19 TEST; Result Unstructured Data: Test Result:negative; Test Date: 20210803; Test Name: PCR COVID-19 TEST; Result Unstructured Data: Test Result:negative
CDC Split Type: FRPFIZER INC202101011306

Write-up: vaccination failure; covid-19; lung damage at 75%; Ground-glass opacity; Blood pressure abnormal; crackles; fatigue; diarrhea; Moderate exertion with cough; This is a spontaneous report from a contactable consumer. A 36-year-old male patient received second dose of BNT162B2 (COMIRNATY, formulation: solution for injection, Lot number: FE2296, Expiration date: unknown), via an unspecified route of administration on 15Jul2021 (age at vaccination 36-year-old) as DOSE 2, SINGLE for Covid-19 immunization. Medical history included severe acute respiratory syndrome from 2017 (Sars with undesirable effects: breathing difficulty (which gradually returned), loss of smell and headaches (resolved fairly quickly). Concomitant medications were not reported. After the second injection performed on 15Jul2021, patient presented ten-day adverse events with moderate exertion with cough, diarrhea declared on 01Aug2021. Patient was tired. On the scanner, they discovered patches of ground-glass visible at the lung site and megaly. Emergency physician confirmed COVID-19 despite negative PCR and biology test done on 02Aug2021 and 03Aug2021. Pending with serology. Treatment with ventoline was prescribed for 3 months for the events lung damage at 75 percent and crackles. Patient did not receive any treatment for event Blood pressure abnormal. The patient underwent blood pressure measurement: 125 x 170 (instead of 160) on an unspecified date, chest x-ray: lung damage at 75 percent and crackles on an unspecified date, computerized tomogram: lung damage at 75 percent and crackles of the basement on an unspecified date, microbiology test: negative on 03Aug2021, oxygen saturation: 93 percent on an unspecified date, sars-cov-2 antibody test: not yet disponible on an unspecified date, sars-cov-2 test: negative on 02Aug2021 and 03Aug2021. The outcome of event cough and diarrhea was recovered on an unspecified date in Aug2021, and the outcome of other events was unknown.


VAERS ID: 1592806 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, Pain, SARS-CoV-2 test, Vaccination site discomfort, Vaccination site pain
SMQs:, 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: 20210729; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101012620

Write-up: pain; Lymph nodes enlarged; arm that was injected, causing pain and sensitivity; arm that was injected, causing pain and sensitivity; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-APPCOVID-202108051257574870-AFTPN, Safety Report Unique Identifier GB-MHRA-ADR 25759167. A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number not known; expiration date not provided) via an unspecified route of administration (anatomical location: arm) on 30Jul2021 as DOSE 2, SINGLE for COVID-19 immunization. Patient''s medical history included lactation decreased from an unspecified date an unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient is not pregnant and is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced pain on an unspecified date; ''lymph nodes enlarged'', ''arm that was injected, causing pain and sensitivity'' on 01Aug2021. Patient''s clinical course is as follows: It was reported that patient had enlarged lymph node under the arm that was injected, causing pain and sensitivity. It was also reported that no treatment was sought, painkillers taken for pain (as reported). The events were assessed as serious (medically significant). The patient has not tested positive for COVID-19 since having the vaccine. Outcome of the events pain and ''arm that was injected, causing pain and sensitivity'' was unknown; outcome of the event ''lymph nodes enlarged'' was recovered/resolved with sequel on 04Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1592878 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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: Haemorrhage, 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 INC202101012590

Write-up: Heavy periods; bleeding; This is a spontaneous report from a contactable healthcare professional (patient) received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108051115451010-HA9FI, Safety Report Unique Identifier GB-MHRA-ADR 25758759. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 01Aug2021 (Lot number was not reported) as second dose, single for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not pregnant and not currently breastfeeding (last menstrual period was on 02Aug2021). The patient''s concomitant medications were not reported. The patient experienced bleeding on an unspecified date in Aug2021 with outcome of not recovered. The patient experienced heavy periods on 02Aug2021 with outcome of not recovered. "Finished my period less than a week prior to having my vaccine on 01Aug2021. 24-48post vaccine bleeding started admin and not stopped." 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 unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1592883 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Headache, Inappropriate schedule of product administration, Insomnia, Mental fatigue, Myalgia, Nerve injury, Paraesthesia, Pyrexia, SARS-CoV-2 test, Swelling face, Toothache, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (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: EVRA; NORTRIPTYLINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aura; Blood test; Fatigue; Fever; Headache; Lactation decreased; Menstrual migraine; Mental fatigue; Migraine; Migraine prophylaxis; Mineral deficiency; Nerve damage; Photosensitivity; Sensitivity to weather change; Sleep decreased; Sound sensitivity increased; Stress; Tingling of extremity; Tooth pain; Vitamin deficiency; Wasp sting
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101012524

Write-up: tooth pain; sleeping well ( ~ 8 hours of undisturbed sleep per night/difficulty sleeping; nerve damage; subsides/facial swelling; Mental fatigue; Wrist pain; increasing fatigue; received dose on 06Jun2021/received dose 2 on 01Aug2021; vaccination site (upper left arm) soreness; Muscle soreness; tingling/tingling feet/hands/periodic tingling in fingers on left arm 12 hours after vaccination; Fever; Headache; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). Regulatory authority report number GB-RA-WEBCOVID-202108051131597000-NPCSV, Safety Report Unique Identifier GB-RA-ADR 25758963. A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot Number: FE3380; expiration date not provided), via an unspecified route of administration (anatomical location: arm left) on 01Aug2021 (at the age of 33-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient''s medical history included lactation decreased, paraesthesia, fatigue, stress, aura, nerve damage, tooth pain, headache, fever, photosensitivity, sound sensitivity, blood tests which showed some low vitamins and minerals, ''not enough sleep'', wasp stings, ''changes in weather pressure (usually pre-storm)'', mental fatigue, menstrual migraine, and migraine prophylaxis all from unspecified dates and unknown if ongoing; migraine from 2003. Patient''s medical history was further reported as have been suffering from migraines since 2003. Identified hormones as one of a number of cause a few years ago when changing contraceptives. Other causes include not enough sleep, stress, certain food smells (coffee, beer, raw onions), wasp stings, changes in weather pressure (usually pre-storm). Have never experienced aura (as reported). Sometimes develop light and sound sensitivity with severe migraines. Almost always feel fatigue after a migraine or if I was able to prevent one from developing with medication. Fatigue also occurs without migraines but I have been unable to get a referral for further investigation beyond blood tests which showed some low vitamins and minerals, which I''m taking over the counter supplements for now. It was also reported that patient had periods of mental fatigue of unknown cause, has been present for over 7 years. GP won''t investigate. Sometimes corresponds to migraines, sometimes has no known cause. Patient has not had symptoms associated with COVID-19. Patient is not pregnant and is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medications included ethinylestradiol, norelgestromin (EVRA) from 2020 and unknown if ongoing for menstrual migraine and nortriptyline from Jan2020 and unknown if ongoing for migraine prophylaxis. The patient previously took contraceptives and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot Number: EW3143; expiration date not provided), via an unspecified route of administration on 06Jun2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced ''subsides/facial swelling'', ''tooth pain'', ''sleeping well ( ~ 8 hours of undisturbed sleep per night/Difficulty sleeping'', and nerve damage on unspecified dates; ''tingling/tingling feet/hands/periodic tingling in fingers on left arm 12 hours after vaccination'', fever, headache, muscle soreness, ''vaccination site (upper left arm) soreness'', and ''received dose on 06Jun2021/received dose 2 on 01Aug2021'' on 01Aug2021; ''mental fatigue'', ''wrist pain/getting intense wrist pain'', and ''increasing fatigue'' on 02Aug2021. Patient''s clinical course is as follows: Patient reported that the vaccination site (upper left arm) soreness started a few hours after vaccine. Started experiencing periodic tingling in fingers on left arm 12 hours after vaccination and that is ongoing, usually occurring in evenings when sitting on the sofa or during the day while typing at the desk. Have had previous nerve damage in one of the fingers resulting in reduced feeling. The tingling feels identical in all fingers. Woke up in the night (18 hours after vaccine) with a fever and a headache, took 500 mg paracetamol. 24 hours after vaccine started getting intense wrist pain on the inside of the wrist. Pain is not exacerbated by anything and subsides at random. Has been gradually reducing and now seems to correspond to tingling in fingers (did not to start with). Took 500 mg paracetamol and 200mg ibuprofen twice during the day. Developed increasing fatigue 24-36 hours after vaccination. Feels same as post-migraine fatigue. Took another 500mg paracetamol 40 hours after vaccination for tooth pain (no known cause) and headache stopped after this paracetamol. Muscle soreness in arm was gone by 48h after vaccination. Continuing to experience mental fatigue despite eating well (3 healthy meals a day with small snacks in between) and sleeping well (8 hours of undisturbed sleep per night). Continuing to experience occasional tingling in fingers and slight pain on the inside of her wrist (left arm). The event ''received dose on 06Jun2021/received dose 2 on 01Aug2021'' was assessed as non-serious; the remaining events were assessed as serious (medically significant). The patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test with result of ''negative; No - Negative COVID-19 test'' on an unspecified date. Outcome of the events ''vaccination site (upper left arm) soreness'', ''increasing fatigue'', and ''received dose on 06Jun2021/received dose 2 on 01Aug2021'' was unknown; outcome of the event ''fever'' was recovered on 02Aug2021; outcome of the events ''muscle soreness'' and ''headache'' was recovered on 03Aug2021; outcome of the remaining events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1592913 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-01
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 cold, Headache, Myalgia, Pain in extremity, Rash, SARS-CoV-2 test, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202101012548

Write-up: feeling cold; sore arm; shaking/Shaking of hands/shaking of the body; Headache; body/Rash all over; Muscle soreness; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108051344196250-G9JOR, Safety Report Unique Identifier is GB-MHRA-ADR 25759676. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FF3319), via an unspecified route of administration on 04Aug2021 as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Historical vaccine included dose 1 of BNT162B2 (Lot number: ET8885), received on an unspecified date for COVID-19 immunization, where patient experienced sore shoulder/arm. The patient experienced body/rash all over and muscle soreness, both on Aug2021. The patient experienced feeling cold, sore arm, shaking/shaking of hands/shaking of the body and headache on 05Aug2021. The events were reported as serious per other medically important condition. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The clinical course was reported as follows: The first vaccine was largely fine, the patient just had a sore shoulder/arm. The second time (yesterday), the patient woke up the next day (today) with a headache, shaking of the body, feeling cold, and also had a sore arm. He was starting to feel better but it has lasted the day so far. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event muscle soreness was recovered on Aug2021. The outcome of the remaining events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1592922 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspepsia
SMQs:, Gastrointestinal nonspecific dysfunction (narrow), 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: GBPFIZER INC202101012907

Write-up: Indigestion; Chest pain; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108051505495970-5RYBA and Safety Report Unique Identifier GB-MHRA-ADR 25760094. A 20-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 31Jul2021 as single dose for COVID-19 immunisation. Medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. The patient experienced chest pain on 01Aug2021, indigestion on 03Aug2021. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Case was reported as serious, Other medically important condition. Outcome of events were not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1592925 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-01
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: Axillary pain, Back pain, Chest pain, Hypoaesthesia, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101013024

Write-up: Armpit pain; Nausea; Worse on the same side as vaccination; Some numbness down arm vaccinated; Aches in chest and back; Aches in chest and back; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-RA-WEBCOVID-202108051520421740-RDPAU, Safety Report Unique Identifier GB-RA-ADR 25760299. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm on 03Aug2021 (Lot Number: FF3319) 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 took first dose bnt162b2 for COVID-19 immunisation. The patient experienced armpit pain (medically significant) on 04Aug2021, nausea (medically significant) on 04Aug2021, worse on the same side as vaccination (medically significant) in Aug2021, some numbness down arm vaccinated (medically significant) in Aug2021, aches in chest and back (medically significant) in Aug2021. The outcome of events armpit pain and nausea was not recovered. The outcome of other events was unknown. The clinical course was reported as follows: Armpit pain and feels but does not look swollen. Worse on the same side as vaccination. Some numbness down arm vaccinated. Aches in chest and back. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1592927 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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: Contusion, Headache, Inappropriate schedule of product administration, Lymphadenopathy, Myalgia, Photophobia
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Noninfectious meningitis (narrow), Accidents and injuries (narrow), Glaucoma (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MILLINETTE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101012950

Write-up: Swollen lymph nodes; Dose 1 on 06Jun2021, dose 2 on 01Aug2021; Bruising; Headache; Light sensitivity to eye; Muscle ache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-RA-WEBCOVID-202108051541374200-CWVJY Safety Report Unique Identifier GB-RA-ADR 25760399. A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021(at the age of 25-Year-old) (Lot Number: FF3319) as dose 2, single for COVID-19 immunisation. Medical history included Lactation decreased, suspected covid-19 from 24Dec2019 to an unknown date Unsure when symptoms stopped, contraception. Not had a COVID-19 test. Patient is not pregnant, Patient is not currently breastfeeding. Concomitant medication included ethinylestradiol, gestodene (MILLINETTE) taken for contraception. Patient previously took her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EW3143, Dose 1) on 06Jun2021 at the age of 25-Year-old and experienced bruising. The patient received dose 1 on 06Jun2021, dose 2 on 01Aug2021 and experienced bruising on 01Aug2021 with outcome of recovered on 03Aug2021, headache on 01Aug2021 with outcome of recovered on 04Aug2021, light sensitivity to eye on 01Aug2021 with outcome of recovering , muscle ache on 01Aug2021 with outcome of recovering , swollen lymph nodes on 04Aug2021 with outcome of not recovered. All events were assessed as serious with medically significant. 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.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101022629 Same patient and product/ different dose and similar event


VAERS ID: 1592928 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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: Contusion, Cough, Headache, Inappropriate schedule of product administration, Myalgia, Photophobia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Noninfectious meningitis (narrow), Accidents and injuries (narrow), Glaucoma (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (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: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101012952

Write-up: Light sensitivity to eye; Headache; Muscle ache; Cough; dose 1 on 06Jun2021, dose 2 on 01Aug2021; Bruising; This is a spontaneous report from a contactable consumer received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108051541534240-WPYWI, Safety Report Unique Identifier GB-MHRA-ADR 25760401. A 25-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 (at the age of 25 year-old) (Lot Number: FF3319) as dose 2, single for COVID-19 immunisation. Medical history included suspected covid-19 from 02Aug2021 and ongoing. The patient''s concomitant medications were not reported. Historical Vaccine included first dose BNT162B2 on 06Jun2021 at the age of 25 year-old(lot number: EW3143) and experienced bruising. The patient received dose 1 on 06Jun2021, dose 2 on 01Aug2021 and experienced light sensitivity to eye on 02Aug2021 with outcome of recovered on 05Aug2021 , headache on 02Aug2021 with outcome of recovered on 05Aug2021, bruising on 01Aug2021 with outcome of recovered on 03Aug2021, muscle ache on 02Aug2021 with outcome of recovering , cough on 02Aug2021 with outcome of recovering. All events were assessed as serious with medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 03Aug2021. 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.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101020990 same drug/patient, different dose, similar event.


VAERS ID: 1592950 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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: Blindness, Colour blindness, Magnetic resonance imaging, Ophthalmological examination, SARS-CoV-2 test, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: MRI; Result Unstructured Data: Test Result:unknown results; Test Name: Eye test; Result Unstructured Data: Test Result:unknown results; Test Date: 20210728; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101012614

Write-up: Vision loss; blurry vision; loss of colour vision; This is a spontaneous report from a contactable consumer received from The regulatory authority report number is GB-MHRA-WEBCOVID-202108051748179320-WDOAO, Safety Report Unique Identifier GB-MHRA-ADR 25761092. A 31-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 01Aug2021 (Lot number was not reported) at the age of 31 years old, as second dose, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. On 01Aug2021, the patient experienced vision loss. On unspecified date in Aug2021, the patient experienced blurry vision and loss of colour vision. The patient underwent lab tests and procedures which included magnetic resonance imaging (MRI) and eye test both with unknown results on unspecified date; and covid-19 virus test: no - negative covid-19 test on 28Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the events vision loss was not recovered. Outcome of all 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: 1593015 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLUOXETIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Pregnancy; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: High temperature; Result Unstructured Data: Test Result:High
CDC Split Type: GBPFIZER INC202101012636

Write-up: Glands swollen; Painful joints; Nausea; High temperature; Shivers; This is a spontaneous report from a contactable consumer received from The Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108052221571800-FAHAU, Safety Report Unique Identifier GB-MHRA-ADR 25762363. A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Jul2021 (Lot Number: FF3319) as single dose for COVID-19 immunisation. Medical history included pregnancy from an unknown date, suspected covid-19 from an unknown date to an unknown date (unsure when symptoms started, Unsure when symptoms stopped) and depression from an unknown date. Concomitant medication included fluoxetine hydrochloride (FLUOXETIN) taken for depression from 04May2017 to an unspecified stop date. Patient not had a COVID-19 test. The patient experienced glands swollen, painful joints, nausea, high temperature and shivers 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 recovered from high temperature and shivers on 02Aug2021, nausea on 03Aug2021, painful joints on 04Aug2021 while patient has not recovered from glands swollen. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1593016 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   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 FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Electrocardiogram, Headache, Migraine
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: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pain
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:Normal
CDC Split Type: GBPFIZER INC202101012700

Write-up: Headache; Migraine; Chest pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number [GB-MHRA-WEBCOVID-202108052225159880-CTI7J], Safety Report Unique Identifier [GB-MHRA-ADR 25762380]. A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Jul2021 (lot number: FE1510) at dose 2, single for COVID-19 immunisation. Medical history included pain on an unknown date. Concomitant medications included paracetamol taken for pain from 01Aug2021 to an unspecified stop date. The patient experienced chest pain on 01Aug2021; migraine on 04Aug2021; and headache on an unspecified date. The events were assessed as serious (medically significant). The patient underwent lab tests and procedures which included electrocardiogram: normal on an unspecified date. The outcome of the event ''chest pain'' was recovered with sequelae, event ''migraine'' was not recovered and event ''headache'' was unknown. The clinical course was reported as follows: Patient was told during administration of the vaccination that it may cause chest pain/swelling of the heart. If this happens, call GP. GP didn''t want to know and told him to phone this number. Phoned and was sent paramedics. ECG was ok so didn''t go to hospital. Chest pains have eased but not gone. Migraine has been getting worse. 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. Not had a COVID-19 test. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1593022 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-08-01
   Days after vaccination:19
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: Arthralgia, Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101012637

Write-up: Period came 7 days early; Period came 7 days early Heavier then usual And painful; joint pains; Heavy periods; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108052256449480-PR7OC, Safety Report Unique Identifier GB-MHRA-ADR 25762682. A 22-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not known), via an unspecified route of administration on 13Jul2021 as dose 1, single for COVID-19 immunization. Medical history included lactation decreased. Concomitant medications were not reported. Patient was not currently breastfeeding. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. On 01Aug2021, the patient experienced heavy periods. It was reported that on an unspecified date, the patient period came 7 days early, heavier than usual and painful with joint pains too. The events were serious (medically significant). The patient underwent lab tests which included SARS-CoV-2 test: Negative (No - Negative COVID-19 test) on an unspecified date. Patient was not tested positive for COVID-19 since having the vaccine. The outcome of the event heavy periods was not recovered, while outcome of the other events was unknown. No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1593030 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-01
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: Axillary pain, Chills, Lymphadenopathy, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101012575

Write-up: Swollen lymph nodes; Shivering; Muscle ache; Armpit pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108060004357210-D0ORQ. Safety Report Unique Identifier is GB-MHRA-ADR 25762746. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Fe3380), via an unspecified route of administration on 04Aug2021 as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. On Aug2021, the patient experienced swollen lymph nodes, shivering, muscle ache and armpit pain. The events were reported as serious per other medically important condition. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event shivering was recovering. The outcome of the remaining events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1593037 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Disorientation, Dyspnoea, Epistaxis, Lymphadenopathy, Pain in extremity, Pharyngitis, Pyrexia, Speech disorder, Swelling, Throat irritation, Upper respiratory tract infection
SMQs:, Anaphylactic reaction (narrow), Agranulocytosis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Throat infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101012721

Write-up: Raw throat; ear nose and throat infection; Swollen glands; difficulty speaking; difficulty breathing/shortness of breath; aching arm; Nose bleed; disorientated; fever; throat infection; swollen neck; This is a spontaneous report from a contactable consumer (patient). This report is received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108060416003150-NUUUE and Safety Report Unique Identifier is GB-MHRA-ADR 25762806. A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FD8813), via an unspecified route of administration on 03Aug2021 (at the age of 22 years old) as dose 1, single for COVID-19 immunization. Medical history included lactation decreased and throat infection. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not pregnant and was not currently breastfeeding. The patient''s concomitant medications were not reported. On Aug2021, the patient experienced difficulty breathing/shortness of breath, aching arm, nose bleed, disorientated, fever, throat infection, swollen neck, swollen glands, difficulty speaking and ear nose and throat infection. On 03Aug2021, the patient experienced raw throat. The events were reported as serious per other medically important condition. The clinical course was reported as follows: Fever, aching arm. Worst symptoms are shortness of breath, swollen neck and glands and difficulty breathing speaking. Best way to describe it is it feels like an ear nose and throat infection and she was completely disorientated. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event raw throat was not recovered. The outcome of the remaining events was recovered on Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1593038 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Headache, Pain in extremity, SARS-CoV-2 test
SMQs:, Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMIN B12 [CYANOCOBALAMIN]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pernicious anemia
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101013009

Write-up: Armpit pain; Headache; Painful arm; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108060627216720-OU0F8. Safety Report Unique Identifier GB-MHRA-ADR 25762866. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 05Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included pernicious anemia. Patient has not had symptoms associated with COVID-19. Concomitant medication included cyanocobalamin (VITAMIN B12) taken for pernicious anemia, start and stop date were not reported. The patient experienced armpit pain (medically significant) in Aug2021, headache (medically significant) in Aug2021, painful arm (medically significant) in Aug2021. 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: negative on unknown date (No - Negative COVID-19 test). The outcome of event headache was recovering. The outcome of other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1593061 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Mouth ulceration, Oropharyngeal pain, Ulcer
SMQs:, Severe cutaneous adverse reactions (broad), Systemic lupus erythematosus (broad), Gastrointestinal ulceration (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014394

Write-up: Dose 1 on 08Jun2021/Dose 2 on 03Aug2021; Mouth ulceration; sore throat; ulcer; This is a spontaneous report from a contactable consumer (Patient) received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108060852359270-9ZVNZ. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FF3319), via an unspecified route of administration, administered in left arm on 03Aug2021 as dose 2, single for COVID-19 immunisation. No medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW3143), via an unspecified route of administration on 08Jun2021 as dose 1, single for COVID-19 immunisation and experienced sore throat, ulcer and mouth ulceration. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient received dose 1 on 08Jun2021 and dose 2 on 03Aug2021. On 05Aug2021, after second injection, the patient experienced mouth ulceration and on an unspecified date in Aug2021, the patient experienced sore throat and ulcer. The events were serious (medically significant). The patient thought it was a coincidence that he experienced similar events within 1-2 days of both the vaccine doses. Patient had an ulcer at the back of his throat on the righthand side (my right, body right - jab was in left arm) was located on or near the tonsil. It was a large white ulcer, larger than the first but pain was around the same as sore throat / hurts to swallow - but very manageable and nothing too bad. Patient was not tested positive for COVID-19 since having the vaccine. The outcome of all the events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1593084 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-01
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: Dizziness, Food allergy, Paraesthesia oral, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014703

Write-up: Allergy to nuts; Tingling in mouth; Throat felt tight; dizziness; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108061015152600-P8MQE, Safety Report Unique Identifier GB-MHRA-ADR 25764196. A 32-year-old female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Aug2021 (Lot number was not reported) 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. Patient had not had a COVID-19 test. The patient experienced allergy to nuts on 05Aug2021. The patient had never had a problem with nuts and suddenly had a reaction since having her vaccination. It could be unrelated but thought it could be worth mentioning. The patient experienced tingling in mouth, throat felt tight and dizziness in Aug2021. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient had appointment with gp booked. The outcome of the event allergy to nuts was recovered on 05Aug2021 and the 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: 1593123 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Hot flush, Pain, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210805; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101014583

Write-up: fatigue; ache; Hot flush; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108061335552520-PTX6S, safety report unique identifier is GB-MHRA-ADR 25765627. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Aug2021, at the age of 31 years, as the second single dose, for COVID-19 immunisation. Medical history included lactation decreased and suspected COVID-19 from 01Aug2021 and ongoing. The patient received the first dose of BNT162B2 vaccine on an unknown date. Patient was not pregnant and not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced fatigue on an unspecified date with outcome of unknown and hot flush on 01Aug2021 with outcome of not recovered. The case was reported serious per other medically important condition. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 05Aug2021. Additional Information: on and off hot flushes, fatigue and aches. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Details of any relevant investigations or tests conducted: "Covid-19 teat". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1593126 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chest discomfort, Chest pain, Cough, Decreased appetite, Dyspnoea, Headache, Illness, Malaise, Oropharyngeal pain, Pain in extremity, Paraesthesia, SARS-CoV-2 test, Vision blurred
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CODEINE PHOSPHATE; GABAPENTIN; IBUPROFEN; MIRTAZAPINE; ORAMORPH [MORPHINE SULFATE PENTAHYDRATE]; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis; Fibromyalgia; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); 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
CDC Split Type: GBPFIZER INC202101014880

Write-up: Chest pain; Coughing; Sore throat; Blurry vision; Tight chest; Weakness; Pins and needles; Short of breath; Appetite lost; Pain in arm; Sickness; Feeling sick; Headache; This is a spontaneous report from a contactable consumer, received from the Regulatory Authority. Regulatory authority report number (GB-MHRA-WEBCOVID-202108061345288120-9FGEZ), Safety Report Unique Identifier (GB-MHRA-ADR 25765720) A 34-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 31Jul2021 (Batch/Lot Number: FD8813) as 2nd single dose, for COVID-19 immunisation. Medical history included fibromyalgia, decreased lactation, unspecified illness or condition which reduces the immune response, and endometriosis. Concomitant medications included codeine phosphate for endometritis from Apr2019, gabapentin for endometritis from 09Jun2018, ibuprofen for endometritis from 01Oct2016, mirtazapine (MIRTAZAPINE) for depression from 09Jan2021, morphine sulfate pentahydrate (ORAMORPH) for endometritis from 01Oct2016, and paracetamol for endometritis from 01Oct2016. The patient has not tested positive for COVID-19 since having the vaccine, was not enrolled in clinical trial, and was not pregnant. The patient reporting becoming very sick as first thing on the morning following BNT162b2 administration (on 01Aug2021), then all of the other symptoms came on. She was unable to keep anything down including water, this lead to be feeling weak, when she stood up she got black spots in her eyes and she struggled to stand still for more than a few minutes. Her chest felt like she''d had a weight on it and it was difficult to breath at times. The reported events on 01Aug2021 were sickness, feeling sick, headache, pain in arm, weakness, pins and needles, short of breath, appetite lost. The reported events on 02Aug2021 were chest pain, blurry vision, tight chest, coughing, sore throat. All the reported events were serious due to important medical condition. A SARS-COV-2 test on 04Aug2021 was negative. The patient had not recovered from all the above mentioned events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1593131 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-08-01
   Days after vaccination:10
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: Abdominal discomfort, Abdominal pain upper, Menstruation delayed, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM; PROPRANOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Anxiety depression; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210725; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014856

Write-up: Severe burning; Stomach pains; Menstruation delayed; This is a spontaneous report from a contactable consumer received from The Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108061425043640-CJK8A. Safety Report Unique Identifier: GB-MHRA-ADR 25765794. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 22Jul2021 as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included suppressed lactation, anxiety depression and anxiety. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medications included citalopram taken for anxiety depression from 01Jun2019 to an unspecified stop date; propranolol taken for anxiety from 15Jul2021 to an unspecified stop date. The patient experienced delayed menstruation (premenstrual symptoms but no bleeding and 2 weeks overdue) and severe, burning stomach pains on 01Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 25Jul2021. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of events was not recovered. This is a serious report received with serious criteria other medically important condition from The Regulatory Authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1593138 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cold (just recovered prior to vaccine); Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014571

Write-up: Swollen lymph nodes; Tiredness; Feverish; This is a spontaneous report from a contactable consumer received from a regulatory authority. A 38-year-old female patient received the 2nd dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection, lot number: FE1510), via an unspecified route of administration on 31Jul2021 as single dose for COVID-19 immunisation. Medical history included lactation decreased, cold - just recovered prior to vaccine. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant, Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient concomitant medications were not reported. Historical Vaccine included BNT162B2, on an unspecified date at dose 1, single for COVID-19 immunization. The patient experienced swollen lymph nodes on 02Aug2021 with outcome of recovering, tiredness on 01Aug2021 with outcome of recovered on 05Aug2021, feverish on 01Aug2021 with outcome of recovered on 03Aug2021. Patient has not tested positive for COVID-19 since having the vaccine. Serious criteria for the case was reported as medical significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1593230 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-01
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: Asthenia, Body temperature, Influenza like illness, Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: Pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20210806; Test Name: Temperature; Result Unstructured Data: Test Result:high; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101014665

Write-up: High temperature; Aches & pains in legs; Feel achy; Feel weak; flu like symptoms; This is a spontaneous study report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108062133559900-MVOZI, Safety Report Unique Identifier GB-MHRA-ADR 25768319. A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 05Aug2021 as dose 2, single for COVID-19 immunisation. Medical history included pregnancy. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced flu like symptoms in Aug2021, high temperature and aches and pains in legs on 06Aug2021, feel achy and feel weak in Aug2021. The events were reported as serious as important medical events. The clinical course was reported as follows: taken paracetamol temperature still high, felt achy and weak. Flu like symptoms. The patient underwent lab tests and procedures which included COVID-19 virus test: negative. Therapeutic measures were taken as a result of high temperature and included paracetamol. Patient has not tested positive for COVID-19 since having the vaccine. Adverse reaction did not occur as a result of an exposure during pregnancy. The patient had recovered from aches and pains in legs on 06Aug2021, had not recovered from high temperature, was recovering from flu like symptoms; the 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: 1593243 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Chest pain, Dizziness, Electrocardiogram, Hyperhidrosis, Hypertension, Pain in extremity, Palpitations, SARS-CoV-2 test, Viral pericarditis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (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: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef)); Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:Unknown result; Test Name: Blood tests; Result Unstructured Data: Test Result:Unknown result; Test Name: ecg; Result Unstructured Data: Test Result:Unknown result; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014664

Write-up: chest pain; dizzy; hot sweats; palpitations; high blood pressure; pain in left arm; Viral pericarditis; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number (GB-RA-WEBCOVID-202108062326175000-7UI4H), Safety Report Unique Identifier (GB-RA-ADR 25768875). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration an unspecified date at single dose for COVID-19 immunization. Medical history included suppressed lactation from an unknown date and unknown if ongoing, immunodeficiency from an unknown date and unknown if ongoing Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef). Past drug history included levothyroxine. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced chest pain (chest pain) (hospitalization) on an unspecified date with outcome of unknown, dizzy (dizziness) (hospitalization, medically significant) on an unspecified date with outcome of unknown, hot sweats (hyperhidrosis) (hospitalization) on an unspecified date with outcome of unknown, palpitations (palpitations) (hospitalization) on an unspecified date with outcome of unknown, viral pericarditis (viral pericarditis) (hospitalization) on 01Aug2021 with outcome of not recovered, high blood pressure (hypertension) (hospitalization) on an unspecified date with outcome of unknown, pain in left arm (pain in extremity) (hospitalization) on an unspecified date with outcome of unknown. The patient''s hospitalization was prolonged as a result of chest pain (chest pain). The patient''s hospitalization was prolonged as a result of dizzy (dizziness). The patient''s hospitalization was prolonged as a result of hot sweats (hyperhidrosis). The patient''s hospitalization was prolonged as a result of palpitations (palpitations). The patient''s hospitalization was prolonged as a result of viral pericarditis (viral pericarditis). The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No-Negative COVID-19 test, blood test: unknown result on, electrocardiogram: unknown result on, blood pressure measurement: unknown result on. Patient has not tested positive for COVID-19 since having the vaccine No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected


VAERS ID: 1593247 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-01
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: Dizziness, Dyspepsia, Feeling cold, Inappropriate schedule of product administration, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Wheezing
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014709

Write-up: Wheezing aggravated; received dose 2 on 06Aug2021, dose 1 on 11Jun2021; Feeling cold; Dizziness; Heartburn; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202108062349452530-XZKBV, Safety Report Unique Identifier GB-MHRA-ADR 25768879. A 31-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 06Aug2021 (Batch/Lot number was not reported) (at the age of 31-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included wheezing from an unknown date. The patient''s concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jun2021 for covid-19 immunisation. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient experienced wheezing aggravated on 06Aug2021, feeling cold, dizziness and heartburn in Aug2021. The outcome of the event dizziness was resolving and of the other events wheezing aggravated, feeling cold and heartburn was not resolved. The events were reported as serious due to medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1593251 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-01
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: Heavy menstrual bleeding, SARS-CoV-2 test, Thrombosis, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: Coil (IUCD) (as I have a Mirena coil fitted a year ago.); Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014748

Write-up: Sudden vaginal bleeding an hour after the vaccine; It was a heavy flow of blood/ Bleeding; It was a heavy flow of blood with clots; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108070129208880-2OYGA, Safety Report Unique Identifier is GB-MHRA-ADR 25768909. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Not known), dose 2 via an unspecified route of administration on 03Aug2021 (at the age of 32-years-old) as dose 2, single for COVID-19 immunisation. Medical history included pregnancy unknown if ongoing. Patient had mirena coil fitted a year ago. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. Patient was not enrolled in clinical trial. The patient previously took first dose of BNT162B2 on unknown date for covid-19 immunisation. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on unknown date (No - Negative COVID-19 test). The patient experienced sudden vaginal bleeding an hour after the vaccine on 03Aug2021. It was reported that it was a heavy flow of blood with clots on an unspecified date in Aug2021. This never happens as she had a Mirena coil fitted a year ago. Patient has not tested positive for COVID-19 since having the vaccine. All the events were reported as medically significant. The outcome of all the events was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1593279 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cellulitis, Headache, Inappropriate schedule of product administration, Influenza, Lymphadenopathy, Nausea, Pain, Pain in extremity, Swelling
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EVRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014536

Write-up: swelling; nausea; soreness; flu; pain in arm; headache; swollen lymph nodes; Cellulitis; dose 2 on 01Aug2021/dose 1 on 05Jun2021; This is a spontaneous report from a contactable consumer received from The regulatory authority report number is GB-MHRA-WEBCOVID-202108071006240140-NSDW0, Safety Report Unique Identifier GB-MHRA-ADR 25770190. A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at 31-year-old, via an unspecified route of administration on 01Aug2021 (Lot Number: FE3380) at single dose for COVID-19 immunisation. Medical history included lactation decreased. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medication included ethinylestradiol/norelgestromin (EVRA) for contraception from 01Jan2019. Patient previously received the first dose of BNT162B2, via an unspecified route of administration on 05Jun2021 (Lot Number: EW3143) at single dose for COVID-19 immunisation. The patient experienced swelling, nausea, soreness, flu, pain in arm, and headache; all on an unspecified date, and cellulitis on 06Aug2021. Patient had previous reaction to the jab (reported before) with flu/swollen lymph nodes, headache, nausea etc. This went away after a few days. Then patient felt pain in arm, soreness and swelling. Area became very hot and read. who made an appointment with her doctor. Doctor confirmed cellulitis caused by vaccine. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Cellulitis treatment included doxycycline, 7-day course. Outcome of event cellulitis was not resolved, of event swollen lymph nodes was unknown, and of other events was resolving. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1593303 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-01
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: Dizziness, Fatigue, Headache, Nausea, Pain in extremity, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014375

Write-up: Nausea; Aching in limb; Headache; Tiredness; Dizzy spells; tender arm; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108071212549530-DKQMI. Safety Report Unique Identifier GB-MHRA-ADR 25770386. A 32-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 06Aug2021 as DOSE 2, SINGLE for covid-19 immunization. Medical history included headache, suppressed lactation from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection) for covid-19 immunization. Patient is not enrolled in clinical trial. On an unspecified date in Aug2021, the patient experienced tender arm. On 07Aug2021, the patient had nausea, aching in limb, headache, tiredness and dizzy spells. Events were considered as medical significant. The patient was woken up with a tender arm. She felt sick and dizzy spells was coming and going. She had a headache and her legs were aching. She also felt very tired. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of event tender arm was resolving, and rest all were not resolved. No follow-up attempts are possible, information about lot/batch number cannot be obtained.


VAERS ID: 1593317 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Fatigue, Myalgia, Nausea, Pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210805; Test Name: COVID-19 virus test; Test Result: Negative; Comments: Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101014641

Write-up: Muscle ache; Ache; Weakness; Exhaustion/ Tiredness; Queasy; 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-202108071427044910-D3JHL, Safety Report Unique Identifier is GB-MHRA-ADR 25770541. A 24-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number unknown), via an unspecified route of administration on 06Aug2021 as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. On Aug2021 the patient experienced muscle ache, ache, weakness, exhaustion/ tiredness and queasy, all reported as serious with medically significant criteria. The patient underwent lab tests and procedures which included COVID-19 virus test negative COVID-19 test on 05Aug2021. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the events was not resolved. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1593325 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-07
Onset:2021-08-01
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: Hyperhidrosis, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014712

Write-up: Syncope; sweating; loss of conscious; This is a spontaneous report from a contactable other hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108071547169480-HVQB1, Safety Report GB-MHRA-ADR 25770612. A 24-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 07Aug2021 (Batch/Lot Number: FE3380) (at the age of 24-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient experienced loss of conscious and sweating in Aug2021, syncope on 07Aug2021. The reporter stated the patient had vaccine no signs of anaphylaxis, witnessed syncope, sweating, put on 15L non re-breath (as reported), loss of conscious x 2 responded well to oxygen therapy and handed over to arrest team. Patient was peri-arrest. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Therapeutic measures were taken as a result of the events included oxygen therapy. The outcome of the event syncope was resolved on 07Aug2021 and of the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1593345 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Cough, Dizziness, Dyspnoea, Fatigue, Headache, Inappropriate schedule of product administration, Influenza like illness, Non-cardiac chest pain, SARS-CoV-2 test, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: 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 INC202101014852

Write-up: suddenly felt breathless; headache; fatigue; dizzy; flu like symptoms; chest pain; wheezing; cough; Chest pain (non-cardiac); vaccine is administered outside of the range 19 - 42 days after the first dose; This is a spontaneous report from a contactable consumer received from The regulatory authority report number is GB-MHRA-WEBCOVID-202108071941139950-7IO9C, Safety Report Unique Identifier GB-MHRA-ADR 25770905. A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 (at the age of 35-Year-old) (Lot Number: FD8813) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included lactation decreased. Unsure if patient has had symptoms associated with COVID-19. Patient is not pregnant, Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jun2021 (Lot Number: EW3143) as dose 1, single for COVID-19 immunisation. The patient experienced suddenly felt breathless, wheezing, feeling dizzy, headache, chest pain, flu like symptoms, fatigue and cough, all from unknown date and with unknow outcome. The patient also experienced chest pain (non-cardiac) on 01Aug2021 and not recovered (stop date reported as 01Aug2021). Seriousness criteria was provided as other medically important condition by Regulatory Authority. The patient experienced vaccine is administered outside of the range 19 - 42 days after the first dose on 01Aug2021 with outcome of unknown. The patient underwent lab tests and procedures which included No - Negative COVID-19 test on an unknown date. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1593361 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Disorientation, Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014652

Write-up: lightheaded/ dizziness; disorientation; nausea; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108072143087380-GMU5V, Safety Report Unique Identifier is GB-MHRA-ADR 25771007. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Aug2021 (Lot number unknown) as dose 2, single for COVID-19 immunisation. The patient''s medical history included lactation decreased from unspecified date. Patient had not had symptoms associated with COVID-19. She had not had a COVID-19 test. Patient was not pregnant. Patient was not breastfeeding at the time of this report. The patient''s concomitant medications were not reported. On Aug2021 the patient experienced lightheaded/ dizziness, disorientation, and nausea, all reported as serious with medically significant criteria. It was reported that within 2 hours after the dose (Aug2021) she had the first bout of dizziness and by 3 days after was getting more common bouts of dizziness every couple of hours. At the time of this report (reported as today) on day 4 (Aug2021) she had a permanent feeling of being lightheaded and disorientation, causing nausea. She felt unable to drive and she was concerned about looking after her children on her own so she would be seeking medical advice if this continued the morning of the next day. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1593363 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-01
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: Arthralgia, Asthenia, Dizziness, Fatigue, Feeling abnormal, Feeling hot, Hyperhidrosis, Nausea, Pain, Pain in extremity, Pallor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014685

Write-up: Nausea; Aching joints; Pain in arm; pale; sweaty; dizzy; brain fog; Heavy tired body; Very achy; Weak; Arm/hand of vaccine arm went hot; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108072205286840-URYOA, Safety Report Unique Identifier GB-MHRA-ADR 25771016. A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm at the age of 26-year-old on 06Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included Lactation decreased, suspected COVID-19 from 30Mar2020 to 08Apr2020. 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 experienced nausea (medically significant) on 06Aug2021, aching joints (medically significant) on 06Aug2021, pain in arm (medically significant) on 06Aug2021, pale (medically significant) in Aug2021, sweaty (medically significant) in Aug2021, dizzy (medically significant) in Aug2021, brain fog (medically significant) in Aug2021, heavy tired body (medically significant) on Aug2021, very achy (medically significant) in Aug2021, weak (medically significant) in Aug2021, arm/hand of vaccine arm went hot (medically significant) in Aug2021. The outcome of events nausea, aching joints and pain in arm was recovered on 07Aug2021. The outcome of other events was unknown. The clinical course was reported as follows: Arm/hand of vaccine arm went hot and sweaty. Felt nauseous and dizzy went very pale. Heavy tired body. Very achy. Weak and brain fog. 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; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1593366 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-01
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: Abdominal pain upper, Arthralgia, Cold sweat, Diarrhoea, Headache, Limb discomfort, Pain in extremity, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), 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: MIRTAZAPINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101014584

Write-up: Diarrhea; Arm discomfort; Headache; painful upper arm and shoulder, spread to rest of arm and hand; painful upper arm and shoulder, spread to rest of arm and hand; painful stomach; Felt clammy; This is a spontaneous report from a contactable consumer received from The Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108072214570060-YDSOF. A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Aug2021 (Lot Number: Fe3380), at 41 years old, as the second single dose, for COVID-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Concomitant medication included mirtazapine. The patient experienced diarrhea on 07Aug2021 with outcome of not recovered, arm discomfort on 06Aug2021 with outcome of not recovered and headache on 06Aug2021 with outcome of recovering. The case was reported as serious per other medically important condition. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unknown date. Additional information: started with painful upper arm and shoulder, spread to rest of arm and hand. Diarrhea started approximate 20 hrs after vaccination, lasted 6 hrs so far with painful stomach. Felt clammy. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1593369 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-01
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: Lymphadenopathy, Pain, Pain in extremity, SARS-CoV-2 test
SMQs:, 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: Asthma; Blood pressure high; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101014591

Write-up: pain; Swollen lymph nodes; pain in the arm; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. Regulatory Authority report number GB-MHRA-WEBCOVID-202108072220592550-PXR9W, Safety Report Unique Identifier GB-MHRA-ADR 25771028. A 50-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 04Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included suppressed lactation from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19, was not pregnant, Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced pain (medically significant) in Aug2021 with outcome of recovered in Aug2021, swollen lymph nodes (medically significant) in Aug2021 with outcome of not recovered, pain in the arm (medically significant) in Aug2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on unknown date. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Patient is not enrolled in clinical trial


VAERS ID: 1593388 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   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: Cough, Dyspnoea, Feeling abnormal, Lymphadenopathy, Nasopharyngitis, Nausea, Rhinorrhoea, SARS-CoV-2 test, Wheezing
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (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:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014631

Write-up: runny nose; wheezing; hours; shortness of breath; coughing; Common cold; Nausea; Swollen glands, swollen armpit; The regulatory authority report number is GB-MHRA-WEBCOVID-202108080648594350-IUQF9, Safety Report Unique Identifier GB-MHRA-ADR 25771132. A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm on 31Jul2021 (Batch/Lot Number: FE3380) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. Patient is not enrolled in clinical trial. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, single for Covid-19 immunisation; date was unknown. The patient experienced runny nose (rhinorrhoea) (medically significant) on an unspecified date with outcome of recovered, wheezing (wheezing) (medically significant) on an unspecified date with outcome of recovered, hours (feeling abnormal) (medically significant) on an unspecified date with outcome of recovered , shortness of breath (dyspnoea) (medically significant) on an unspecified date with outcome of recovered, coughing (cough) (medically significant) on an unspecified date with outcome of recovered, swollen glands/ swollen armpit (lymphadenopathy) (medically significant) on 01Aug2021 with outcome of recovered on 03Aug2021, common cold (nasopharyngitis) (medically significant) on 03Aug2021 with outcome of recovering, nausea (nausea) (medically significant) on 03Aug2021 with outcome of recovered on 08Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 03Aug2021 No Negative COVID-19 test. Additional Information: No medication being taken or existing conditions. Patient has not had symptoms associated with COVID-19. Swollen armpit, in jab arm. Soft large lump in inner armpit. Once ended, runny nose for about 12 hours, this turned into a full-on blocked nose and nausea, for another about 12 hours. Then a cough for about 12 hours and bad nausea/feeling awful, then shortness of breath, unable to move very far without needing to stop, cleared some phelm of lungs and felt a bit better, slept overnight and feel a lot better however have been wheezing since I woke up. Body coughing to clear more phelm, guessing after this I should be better. It seems to have gone through all the different stages in about 12 hours each, if it had gotten any worse last night re breathing I would have gone to hospital. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1593392 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101021422

Write-up: Vaginal bleeding; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108081010391300-60CC4.Safety Report Unique Identifier GB-MHRA-ADR 25771234. A 34-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 31Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. Medical history included suppressed lactation from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. Patient has not had symptoms associated with COVID-19. Patient is not pregnant, Patient is not currently breastfeeding .Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient experienced vaginal bleeding (medically significant) on 01Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No - Negative COVID-19 test on an unknown date. The outcome of the event was recovered on 05Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1593451 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Chills, Dizziness, Influenza like illness, Nausea, Pyrexia, 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), 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: AMITRIPTYLINE; BRIMONIDINE; TIMOLOL
Current Illness: Chronic pain; Eye injury
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
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: Feverish; Chills; Nausea; Vomited; Stomach cramps; Vomiting; Fever; Light-headed; Flu-like aching; This case was received via United Kingdom MHRA (Reference number: 25786259) 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 DIZZINESS (Light-headed), INFLUENZA LIKE ILLNESS (Flu-like aching), ABDOMINAL PAIN UPPER (Stomach cramps), PYREXIA (Feverish), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and VOMITING (Vomited) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Chronic pain and Eye injury. Concomitant products included AMITRIPTYLINE from 06-Apr-2018 to an unknown date for Chronic pain, BRIMONIDINE from 21-Jun-2016 to an unknown date and TIMOLOL from 21-Jun-2016 to an unknown date for Eye injury. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like aching) (seriousness criterion medically significant). On 02-Aug-2021, the patient experienced DIZZINESS (Light-headed) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Stomach cramps) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and VOMITING (Vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (Feverish) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and VOMITING (Vomited) (seriousness criterion medically significant). On 02-Aug-2021, ABDOMINAL PAIN UPPER (Stomach cramps) and VOMITING (Vomiting) had resolved. On 03-Aug-2021, DIZZINESS (Light-headed) and PYREXIA (Fever) had resolved. On 04-Aug-2021, INFLUENZA LIKE ILLNESS (Flu-like aching) had resolved. At the time of the report, PYREXIA (Feverish), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomited) was resolving. 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 Route) was unknown. Patient was not currently breastfeeding. Patient started aching the evening of the vaccine and it got worse during the night and patient did sleep well and woke up with stomach cramps, went to the bathroom and nearly fainted while walking and while sitting on the loo. The cramps lasted for a few hours while also vomited from nausea. The aching got worse and started to get chills and had a temperature which then turned into a fever. Patient took paracetamol with codeine and went to sleep for an hour or so. However, continued to feel feverish. After 3 hours took more paracetamol and went to sleep for 6 hours and woke up and felt a little better however was still aching, feeling feverish and had nausea until the next day. Patient''s appetite reduced for a few days after. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. Company Comment: Very limited information regarding this events has been provided at this time. Further information is not expected.; Sender''s Comments: Very limited information regarding this events has been provided at this time. Further information is not expected.


VAERS ID: 1593531 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Pigmentation disorder, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Accidents and injuries (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEJNJFOC20210838100

Write-up: POSSIBLE BLOOD CLOT-ARM BRUISING; POSSIBLE BLOOD CLOT-ARM BRUISING / BLACK SPOT ON MY ARM; POSSIBLE BLOOD CLOT-ARM BRUISING/BLACK SPOT ON MY ARM; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, IE-HPRA-2021-081446] concerned a male of unspecified age, race and ethnicity The patient''s weight was 96 kilograms, and height was 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: XE93 expiry: unknown) dose was not reported, 01 total, administered on 17-JUL-2021 for covid-19 immunisation (drug start period: 2 weeks). No concomitant medications were reported. On 01-AUG-2021, the patient experienced possible blood clot, arm bruising, black spot on arm and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from possible blood clot-arm bruising, black spot on arm. This report was serious (Hospitalization Caused/Prolonged, Other Medically Important Condition, Life Threatening, and Disability Or Permanent Damage).; Sender''s Comments: V0: 20210838100-covid-19 vaccine ad26.cov2.s-possible blood clot- arm bruising, black spot on arm. 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: 1593567 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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: Nausea, Retching, Sensation of foreign body
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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

Write-up: circa 1 ora dopo la inoculazione nausea con conati di vomito, sensazione di ingombro ipofarigeo . Intervento del 118 con trasporto in PS.; circa 1 ora dopo la inoculazione nausea con conati di vomito, sensazione di ingombro ipofarigeo . Intervento del 118 con trasporto in PS.; circa 1 ora dopo la inoculazione nausea con conati di vomito, sensazione di ingombro ipofarigeo . Intervento del 118 con trasporto in PS.; This case was received via regulatory authority (Reference number: 767968) 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 SENSATION OF FOREIGN BODY (circa 1 ora dopo la inoculazione nausea con conati di vomito, sensazione di ingombro ipofarigeo . Intervento del 118 con trasporto in PS.), NAUSEA (circa 1 ora dopo la inoculazione nausea con conati di vomito, sensazione di ingombro ipofarigeo . Intervento del 118 con trasporto in PS.) and RETCHING (circa 1 ora dopo la inoculazione nausea con conati di vomito, sensazione di ingombro ipofarigeo . Intervento del 118 con trasporto in PS.) in a 21-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004498) for COVID-19 immunisation. The patient''s past medical history included Ligament operation on 07-Jun-2021. Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (ETINILESTRADIOLO E LEVONORGESTREL MYLAN) for Contraception. On 01-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced SENSATION OF FOREIGN BODY (circa 1 ora dopo la inoculazione nausea con conati di vomito, sensazione di ingombro ipofarigeo . Intervento del 118 con trasporto in PS.) (seriousness criterion hospitalization), NAUSEA (circa 1 ora dopo la inoculazione nausea con conati di vomito, sensazione di ingombro ipofarigeo . Intervento del 118 con trasporto in PS.) (seriousness criterion hospitalization) and RETCHING (circa 1 ora dopo la inoculazione nausea con conati di vomito, sensazione di ingombro ipofarigeo . Intervento del 118 con trasporto in PS.) (seriousness criterion hospitalization). On 01-Aug-2021, SENSATION OF FOREIGN BODY (circa 1 ora dopo la inoculazione nausea con conati di vomito, sensazione di ingombro ipofarigeo . Intervento del 118 con trasporto in PS.), NAUSEA (circa 1 ora dopo la inoculazione nausea con conati di vomito, sensazione di ingombro ipofarigeo . Intervento del 118 con trasporto in PS.) and RETCHING (circa 1 ora dopo la inoculazione nausea con conati di vomito, sensazione di ingombro ipofarigeo . Intervento del 118 con trasporto in PS.) had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications were reported. Company Comment: Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the serious unexpected events Sensation of foreign body, Nausea and Retching, a causal relationship cannot be excluded. Additional information is expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the serious unexpected events Sensation of foreign body, Nausea and Retching, a causal relationship cannot be excluded. Additional information is expected.


VAERS ID: 1593573 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-08-01
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002186 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Aphasia, Epilepsy, Facial paresis, Ischaemic stroke
SMQs:, Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Immune-mediated/autoimmune disorders (broad)

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

Write-up: This case was received via Agency (Reference number: 768073) 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 ISCHAEMIC STROKE, EPILEPSY, FACIAL PARESIS dx and APHASIA in a 74-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3002186) for COVID-19 vaccination. The patient''s past medical history included Multiple sclerosis. On 20-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter in total. On 01-Aug-2021, the patient experienced ISCHAEMIC STROKE (seriousness criteria hospitalization and medically significant), EPILEPSY (seriousness criteria hospitalization and medically significant), FACIAL PARESIS (seriousness criterion hospitalization) and APHASIA (seriousness criterion hospitalization). At the time of the report, ISCHAEMIC STROKE, EPILEPSY, FACIAL PARESIS and APHASIA had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Lab data : 1-AUG-2021 Angiogram,Computerised tomogram, SARS-CoV-2 test. 2-AUG-2021: Computerised tomogram, 03-AUG-2021: CSF test, Chest x-ray,Magnetic resonance imaging and on 04-AUG-2021: C-reactive protein. Treatment details not provided. concomitant drug details not provided.; Reporter''s Comments: Treatment - Non; 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. Patient''s advance age along with patient''s medical history of Multiple sclerosis may be contributory to the occurrence of the events.


VAERS ID: 1593656 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-08-01
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Ulnar nerve palsy
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: AMARYL; JANUVIA; METGLUCO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101023358

Write-up: s / o ulnar nerve palsy; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21122659. A 53-year-old (reported as a 53-year-and-11-months old) male patient received BNT162B2 (COMIRNATY, solution for injection, lot number: EW0201, expiry date: 30Sep2021), via an unspecified route of administration on 17Jul2021 (at the age of 53 years old) as dose 1, single for COVID-19 immunization. Medical history included diabetes mellitus (DM) from an unknown date and unknown if ongoing. Body temperature before vaccination was 36.4 degrees centigrade. There were 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): DM. Amaryl, Januvia tablets 50mg, Metgluco tablets (all out-of-hospital prescriptions.) Concomitant medications included glimepiride (AMARYL), sitagliptin phosphate (JANUVIA) and metformin hydrochloride (METGLUCO), all taken for unspecified indications, start and stop dates were not reported. The patient experienced s / o ulnar nerve palsy on an unspecified date in Aug2021. The clinical course was as follows: Until then, no pyrexia and no local swelling. It was said that patient had been vaccinated with water or vitamins, but suddenly he had s / o ulnar nerve palsy. Showed fingers. The person himself appeals to the country. The outcome of the event was unknown. The reporting physician classified the event as serious (can lead to disability) and assessed that the causality between the event and bnt162b2 as unassessable. Other possible cause of the event such as any other diseases was unknown. The reporting physician commented as follows: I think there is a possibility of natural healing. Symptomatology should be fixed now. Scheduled to introduce a specialist. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1593675 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Body temperature, Body temperature increased, C-reactive protein, C-reactive protein increased, Computerised tomogram, Fibrin D dimer, Fibrin D dimer increased, Gastrointestinal oedema, Intestinal ischaemia, Limb injury, Malaise, Myalgia, Pain in extremity, White blood cell count, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Angioedema (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Accidents and injuries (narrow), Ischaemic colitis (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CRESTOR; ADALAT CR; ITOROL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary spastic angina
Allergies:
Diagnostic Lab Data: Test Date: 20210806; Test Name: angiogram CT; Result Unstructured Data: Test Result:Swelling of the terminal wall of the ileum; Test Date: 20210802; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination; Test Date: 20210802; Test Name: Body temperature; Result Unstructured Data: Test Result:38.1 Centigrade; Comments: at 13:00; Test Date: 20210805; Test Name: CT; Result Unstructured Data: Test Result:Swelling of the terminal wall of the ileum; Test Date: 20210805; Test Name: CRP; Result Unstructured Data: Test Result:10.5; Comments: high; Test Date: 20210806; Test Name: D-dimer; Result Unstructured Data: Test Result:0.73; Comments: slightly increased; Test Date: 20210805; Test Name: WBC; Result Unstructured Data: Test Result:17100; Comments: high
CDC Split Type: JPPFIZER INC202101023648

Write-up: D-dimer 0.73, slightly increased; white blood cells 17100 (high); CRP 10.5 (high); strong tenderness in right upper arm and with muscular prevention; Swelling of the terminal wall of the ileum; Pain of lower extremities; Limbs were like twisted; body temperature was 38.1 degrees Centigrade; General malaise; Ischaemia/Findings of the terminal ileum based on the image, Ischaemia may be involved; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21122671. A 58-year-old male patient 1st dose of received BNT162B2 (COMIRNATY, Solution for injection, Lot number FD1945, Expiration date 31Oct2021) at single dose on 02Aug2021 10:00 at 58-year-old for COVID-19 immunisation. Medical history included Coronary spastic angina. Concomitant drugs included rosuvastatin calcium (CRESTOR) (5)1 tablet, nifedipine (ADALAT CR ) (20) 1tablet at a time, isosorbide mononitrate (ITOROL) (20) 2 tablets at a time. Body temperature before vaccination was 36.8 degrees Centigrade. On 02Aug2021 at 13:00 (3 hours after the vaccination), body temperature was 38.1 degrees Centigrade, General malaise appeared. On 03Aug2021 at 20:00 (1 day after the vaccination), the patient experienced Pain of lower extremities (Limbs were like twisted). On 05Aug2021 (3 days after the vaccination), the patient visited hospital, white blood cells 17100 (high), CRP 10.5 (high). The patient experienced strong tenderness in right upper arm and with muscular prevention. Swelling of the terminal wall of the ileum on CT. Antibiotic agents were administered. On 06Aug2021 (4 days after the vaccination), the result of angiogram CT was same. Symptoms gradually recovering. D-dimer 0.73, slightly increased. It was also reported patient experienced ischaemia on an unknown date. Further, reported that the event (unspecified) onset date was 02Aug2021 at 10:05. The reporting physician commented as follows: Findings of the terminal ileum based on the image, Ischaemia may be involved, now (as of 07Aug2021) gradually recovering. Outcome of body temperature was 38.1 degrees Centigrade, Limbs were like twisted, white blood cells 17100 (high), CRP 10.5 (high), D-dimer 0.73, slightly increased was unknown. Outcome of the other events was resolving. The reporting physician classified the event as serious (Medically significant). Causality did not provided.


VAERS ID: 1593704 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
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: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: PCR test; Test Result: Positive.
CDC Split Type: JPPFIZER INC202101029813

Write-up: PCR test result was positive; PCR test result was positive; This is a spontaneous report received from a contactable consumer via the Regulatory Authority. A patient of unspecified age and gender received BNT162B2 (COMIRNATY; lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 01Aug2021, PCR test result was positive and patient went for a check-up. At the time of report it had been 10 days, since the patient was diagnosed as positive. The patient has made an appointment for the second dose of vaccination, on 14Aug2021 but It was informed to patient, that infected people cannot be vaccinated. Outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1593729 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-08-01
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Chills, Diarrhoea, Pyrexia, Rash pruritic, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy (Allergy (unknown causative substance))
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Body temperature; Result Unstructured Data: pyrexia in the 37?C
CDC Split Type: JPTAKEDA2021TJP071887

Write-up: Pruritic rash; Diarrhoea; Urticaria on the trunk; Chills; Pyrexia; Anaphylaxis; This case was received via (Reference number: 2021TJP071887) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This spontaneous case was reported by a physician and describes the occurrence of RASH PRURITIC (Pruritic rash), DIARRHOEA (Diarrhoea), URTICARIA (Urticaria on the trunk), CHILLS (Chills), PYREXIA (Pyrexia) and ANAPHYLACTIC REACTION (Anaphylaxis) in a 28-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004229) for COVID-19 vaccination. Concurrent medical conditions included Allergy (Allergy (unknown causative substance)). On 04-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 01-Aug-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 01-Aug-2021, the patient experienced RASH PRURITIC (Pruritic rash) (seriousness criterion hospitalization), DIARRHOEA (Diarrhoea) (seriousness criterion hospitalization), URTICARIA (Urticaria on the trunk) (seriousness criterion hospitalization), CHILLS (Chills) (seriousness criterion hospitalization) and PYREXIA (Pyrexia) (seriousness criterion hospitalization). 01-Aug-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criteria hospitalization and medically significant). The patient was treated with ADRENALINE [EPINEPHRINE] (intramuscular) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Pruritic rash), DIARRHOEA (Diarrhoea), URTICARIA (Urticaria on the trunk), CHILLS (Chills), PYREXIA (Pyrexia) and ANAPHYLACTIC REACTION (Anaphylaxis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, Body temperature: pyrexia (High) pyrexia in the 37?C. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered RASH PRURITIC (Pruritic rash), DIARRHOEA (Diarrhoea), URTICARIA (Urticaria on the trunk), CHILLS (Chills), PYREXIA (Pyrexia) and ANAPHYLACTIC REACTION (Anaphylaxis) to be possibly related. No concomitant product information was provided by the reporter. Reportedly, the patient experienced rash with itching on the back. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Reporter''s comments: Not reported. Sender''s comments : The 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 28-year-old female hospitalized with a serious expected event of anaphylactic reaction, as well as serious unexpected events of rash pruritic, diarrhoea, urticaria, chills, and pyrexia. Event latency 26 minutes after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1593793 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 FE4728 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Adverse reaction, Altered state of consciousness, Anaphylactic reaction, Angioedema, Arthralgia, Blood pressure abnormal, Blood pressure measurement, Body temperature, Body temperature increased, Chest discomfort, Chills, Cough, Dizziness, Dysphonia, Dyspnoea, Fatigue, Headache, Heart rate irregular, Hypogeusia, Malaise, Myalgia, Nausea, Pallor, Rash erythematous, Retching, Throat tightness, Urticaria, Vaccination site erythema, Vaccination site inflammation, Vaccination site swelling, Vaccination site warmth, Wheezing
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drug allergy; Gastric bypass; Lactose intolerant; Penicillin allergy
Allergies:
Diagnostic Lab Data: Test Name: blood pressure measurement; Result Unstructured Data: Test Result:148/78; Test Date: 20210801; Test Name: body temperature measurement; Result Unstructured Data: Test Result:37.5-38 Centigrade; Comments: increased
CDC Split Type: NLPFIZER INC202101016945

Write-up: Anaphylactic reaction; Pallor; Retching; Dyspnoea; cough; chest tightness; wheezing a little; hoarseness; throat tightness; Erythematous rash; Urticaria; Angioedema; Dizziness; symptoms aggravated multiple times; impaired consciousness; Chills; Headache; Nausea; Abdominal discomfort; Myalgia; Malaise; Fatigue; Generalized joint pain; Injection site erythema; Injection site warmth; Injection site swelling; Injection site inflammation; Body temperature increased; Blood pressure was not low; rapid heartbeat; decreased taste; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Agency. Regulatory authority number NL-LRB-00648645. A 34-year-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FE4728) via an unspecified route of administration on 01Aug2021 (at age of 34-years-old) as 0.3 mL single dose for COVID-19 immunisation. Medical history included gastric bypass. Patient had allergy due to penicillin, codeine, non-steroidal anti-inflammatory drugs, opiate and lactose. Patient do not use an epinephrine (EPIPEN) for existing allergies. Concomitant medication was not reported. Patient had previously received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on 26Jun2021 as single dose for COVID-19 immunisation and experienced dizziness, dyspnea (for 5 hours), nausea the next days and facial rash with pruritus also had stress/anxiety for the first vaccination from fear of an allergic reaction, started around 10 minutes after the injection and lasted for at least a couple of weeks. No previous COVID-19 infection. At the first vaccination, I went in quite tense. Because I was afraid of the above. I was stuffy and a little dizzy shortly after the vaccination. A public health department doctor was also with me at the time and after 45 minutes I was allowed to leave. The tightness lasted for 5 hours. In the days that followed, I was very nauseous, had spontaneous bumps and sores on my face and neck, and was itchy. On 01Aug2021 (2-5 minutes after start), patient had anaphylactic reaction with pallor, retching, dyspnea with cough/ chest tightness/ wheezing a little/ hoarseness, throat tightness, erythematous rash on chest, urticaria (on chest, abdomen and upper legs), angioedema of throat, face, tongue, lips, dizziness, the symptoms aggravated multiple times (within 1 day after start) and impaired consciousness; all these events caused hospitalization. On same day (within 1 day after start), she also developed chills, headache, nausea, abdominal discomfort, myalgia, malaise, fatigue, generalized joint pain, injection site erythema, injection site warmth, injection site swelling, injection site inflammation, body temperature increased and blood pressure was not low (148/78 mmHg) rapid heartbeat and decreased taste. Treatment received was the patient went to hospital by ambulance. Anaphylactic reaction was treated with clemastine (TAVEGIL) and dexamethasone; most symptoms resolved but returned in the evening with aggravation of rash to face and legs. No extensive swelling of vaccinated limb. Shortness of breath and breathlessness, red skin rash, hives, tight squeezing in throat. Allergic reaction with analgesic shock and continuous flare-up of the reaction. The symptoms quickly got worse, it started with white out and the feel like had to vomit. But soon throat, lips, mouth, tongue and face started swelling and everything became rigid and felt short of breath, red rash on face, chest, arms and legs, hives on chest, abdomen and thighs, swelling in the face, throat, lips and tongue, whole mouth felt swollen, rapid heartbeat only went away an hour later in the day. Patient also had impaired consciousness, heavy coughing fits with coughing that still hasn''t passed, still stuffy and short of breath. Feel like have a tight band around chest. Because of this can''t talk properly and constantly gasping for breath; also had decreased taste. A lot of things really don''t taste good now by the way, can still taste, but it was like everything was very stiff. As reported, at the moment patient still don''t feel well, well past the 72 hours mentioned for a reaction like this and was given anti-inflammatory medication as well as medication for an allergic reaction but this also has not provided enough of an effect. Patient was not known to have had an allergic reaction like this in the past so it was still being figured out as to what might be causing this. Lab test included blood pressure measurement: 148/78, on an unspecified date and body temperature measurement result was increased: 37.5-38 centigrade on 01Aug2021. The outcome of events chills, nausea, abdominal discomfort, generalized joint pain, body temperature increased was recovering; for injection site erythema, injection site warmth, injection site swelling, injection site inflammation, cough, blood pressure was not low (148/78 mmHg), cough, chest tightness, wheezing a little, hoarseness and chest tightness, impaired consciousness, decreased taste was unknown; rapid heartbeat resolved on 01Aug2021 and for all other events was not resolved. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101063442 Same reporter, patient, product, different dose


VAERS ID: 1593803 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (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: NLPFIZER INC202101055426

Write-up: Heart Attack; This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency (MA) regulatory authority-WEB. The regulatory authority report number is NL-LRB-00657749. A 58-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 01Aug2021 (Batch/Lot Number: Unknown) at the age of 58 years, as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY) on 12May2021 as 1st dose with no adverse reaction. The patient had no previous COVID-19 infection. The patient experienced heart attack (myocardial infarction) (life threatening, caused or prolonged hospitalization) within 1 day after start on 01Aug2021 following administration of covid-19 vaccine. The patient was resuscitated 4 times. Myocardial infarction was treated with resusciation and placing 3 stents and angioplasty was done. The hospital does not investigate side effects of corona vaccination. Outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.


VAERS ID: 1593834 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C 214 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210838744

Write-up: HEADACHE; This spontaneous report received from a pharmacist via a Regulatory Authority [PHIFDA, PH-PHFDA-300099227] concerned a 62 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C214 expiry: UNKNOWN) dose was not reported, 1 total, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-AUG-2021 at 09:00, the patient experienced headache, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210838744-Covid-19 vaccine ad26.cov2.s-Headache. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1593847 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dizziness, Dyspnoea, Muscular weakness, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839272

Write-up: DYSPNEA; DIZZINESS; GENERALIZED WEAKNESS; MUSCLE PAIN; FEVER; COUGH; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300099211] concerned a 79 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 was not reported) dose was not reported, frequency 1 total, administered on 28-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 01-AUG-2021, the patient experienced productive cough, muscle pain and fever. On 08-AUG-2021, the patient experienced dizziness and generalized weakness. On 08-AUG-2021, the patient experienced dyspnea, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cough, fever, muscle pain, and dizziness, and the outcome of generalized weakness and dyspnea was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210839272-covid-19 vaccine ad26.cov2.s-dyspnea. 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: 1593911 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 21C19-2 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Body temperature, Coccydynia, Dyspnoea, Fatigue, Headache, Laboratory test, Malaise, Pyrexia, Syncope, Tremor, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PARACETAMOL; CODEINE
Current Illness: Non-smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Lumbar puncture headache (Only paracetamol for punctual headache); Tremor (Spine due to have been fat when he was a kid.)
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: Lab test; Result Unstructured Data: Unknown; Test Date: 20210804; Test Name: Body temperature; Result Unstructured Data: 41 C
CDC Split Type: PTJNJFOC20210835832

Write-up: FAINTED; SHORTNESS OF BREATH; VOMITED; FEELING UNWELL; FEVER; FEELING TIRED; HEADACHE; COCCYX PAIN; BACK PAIN; TREMOR; This spontaneous report received from a 32 year old male patient of unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s past medical history included: tremor (spine due to had been fat when he was a kid), and concurrent conditions included: non-smoker, and puncture headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 21C19-2 and expiry: Unknown) dose was not reported, 1 total, administered on 04-AUG-2021 at around 11:00 on right arm for prophylactic vaccination. Concomitant medications included paracetamol for puncture headache and codeine for unknown indication. At around 13:00 on 04-AUG-2021, the patient experienced fainted, shortness of breath, vomited, feeling unwell, feeling tired, headache and fever. Laboratory data included: Body temperature (result was 41 Degree Celsius). On the same day, at 21:00 he was carried to the hospital, where he received intravenous (IV) serum as a treatment and had some lab test (result was unknown). After that the health care professional (HCP) told him everything was fine and probably these symptoms happened due to the vaccine administration. He stayed 10 hours in hospital and on 05-AUG-2021 he went to home at 06:42. On an unspecified date in AUG-2021, he experienced coccyx pain, back pain and tremor when he got up. Treatment medications (dates unspecified) included: Reumon gel (etofenamate) for coccyx pain and back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted, fever, shortness of breath, vomited, feeling unwell, and headache on 05-AUG-2021, and had not recovered from feeling tired, back pain, coccyx pain, and tremor. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0-20210835832-COVID-19 VACCINE AD26.COV2.S- Fainted, Shortness of breath. 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). 20210835832-COVID-19 VACCINE AD26.COV2.S- -fever, vomited, feeling unwell, feeling tired ,headache-These events are labelled per RSI and are therefore potentially related.


VAERS ID: 1593991 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pain in extremity, Vaccination site pain
SMQs:, Tendinopathies and ligament disorders (broad)

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

Write-up: This case was received via Agency (Reference number: 069624) 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 VACCINATION SITE PAIN (SM?RTA VID VACCINATIONSST?LLET) and PAIN IN EXTREMITY (ONT I HELA ARMEN) in a 30-year-old female patient who received mRNA-1273 for COVID-19 vaccination. No Medical History information was reported. On 02-Aug-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 02-Aug-2021, after starting mRNA-1273 , the patient experienced VACCINATION SITE PAIN (SM?RTA VID VACCINATIONSST?LLET) (seriousness criterion disability). In August 2021, the patient experienced PAIN IN EXTREMITY (ONT I HELA ARMEN) (seriousness criterion disability). At the time of the report, VACCINATION SITE PAIN (SM?RTA VID VACCINATIONSST?LLET) and PAIN IN EXTREMITY (ONT I HELA ARMEN) had not resolved. The action taken with mRNA-1273 (Unknown) was unknown. Concomitant medications and treatment details were not provided. Batch number was not provided for mRNA-1273 . The reporter causality with mRNA-1273 was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The translation of the source document has been requested.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The translation of the source document has been requested.


VAERS ID: 1593992 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Atrial fibrillation
SMQs:, Supraventricular tachyarrhythmias (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: SEMODERNATX, INC.MOD20212

Write-up: F?RMAKSFLIMMER; This case was received via regulatory authorities Reference number: 069627) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of ATRIAL FIBRILLATION (F?RMAKSFLIMMER) in a 28-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 31-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced ATRIAL FIBRILLATION (F?RMAKSFLIMMER) (seriousness criteria hospitalization and medically significant). At the time of the report, ATRIAL FIBRILLATION (F?RMAKSFLIMMER) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant products were reported. No treatment information provided.; 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: 1594048 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH KK8871 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Vaccination site induration
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Photosensitivity allergic reaction
Allergies:
Diagnostic Lab Data:
CDC Split Type: UAPFIZER INC202100998967

Write-up: Red spot with a slight induration reaching 10 cm in diameter; Red spot with a slight induration reaching 10 cm in diameter; This is a spontaneous report from a contactable consumer. A 45-years-old non-pregnant female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jul2021 02:45 (Batch/Lot Number: KK8871) as a single dose for covid-19 immunisation. Medical history included heat allergy. The patient''s concomitant medications were not reported. On 01Aug2021, the patient had red spot with a slight induration reaching 10 cm in diameter resulting in a physician visit. The patient was given magnesia as treatment. The outcome of the events was not recovered. The patient did not have covid prior to vaccination and has not been tested post vaccination.


VAERS ID: 1622864 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
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: Insomnia, Malaise, Myalgia, Nausea, Vomiting
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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LYNESTRENOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20212

Write-up: This case was received via Regulatory Authority (Reference number: 103515) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INSOMNIA, MALAISE, MYALGIA, NAUSEA and VOMITING in a 23-year-old female patient who received mRNA-1273 for COVID-19 vaccination. Concomitant products included LYNESTRENOL for an unknown indication. On 31-Jul-2021, the patient received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced INSOMNIA (seriousness criterion disability), MALAISE (seriousness criterion disability), MYALGIA (seriousness criterion disability), NAUSEA (seriousness criterion disability) and VOMITING (seriousness criterion disability). At the time of the report, INSOMNIA, MALAISE, MYALGIA, NAUSEA and VOMITING was resolving. No treatment information was reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1622980 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Blood chloride, Blood creatine phosphokinase, Blood gases, Blood lactate dehydrogenase, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature, C-reactive protein, Chills, Clonic convulsion, Coma scale, Creatinine renal clearance, Depressed level of consciousness, Diarrhoea, Dizziness, Dyspnoea, Electroencephalogram, Heart rate, Hyperventilation, Hypoaesthesia, Magnetic resonance imaging head, Malaise, Neutrophil count, Oxygen saturation, Platelet count, Pyrexia, Red blood cell count, Vaccination site pain, White blood cell count
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Febrile convulsion (Febrile convulsion (at the age of 3))
Allergies:
Diagnostic Lab Data: Test Name: ALT; Test Result: Inconclusive ; Result Unstructured Data: 11 u/L; Test Name: AST; Test Result: Inconclusive ; Result Unstructured Data: 14 u/L; Test Name: ALP; Test Result: Inconclusive ; Result Unstructured Data: 67 u/L; Test Name: CL; Test Result: Inconclusive ; Result Unstructured Data: 107 mEq/L; Test Name: CPK; Test Result: Inconclusive ; Result Unstructured Data: 46 u/L; Test Name: Blood Gas; Test Result: Inconclusive ; Result Unstructured Data: At 00:23, arterial blood gas analysis. PH 7.581, PaCO2 17.8 mmHg, PaCO2 106.0 mmHg, HCO3 -16.7 mmol/L, ABE -2.9 mmol/L, Na +137 mEq/L, K +2.8 mEq/L, CI -107 mEq/L, anion gap (AnGap) 13.4 mEq/L, and lactate (Lac) 4.3 mmol/L.; Test Name: LDH; Test Result: Inconclusive ; Result Unstructured Data: 126 u/L; Test Name: K; Test Result: Inconclusive ; Result Unstructured Data: 4.3 mEq/L; Test Name: Blood pressure; Result Unstructured Data: Low; Test Name: Blood pressure; Result Unstructured Data: Low; Test Name: Blood pressure; Result Unstructured Data: Low; Test Name: Blood pressure; Result Unstructured Data: Low; Test Name: NA; Test Result: Inconclusive ; Result Unstructured Data: 137 mEq/L; Test Name: BUN; Test Result: Inconclusive 7.8 mg/dl; Result Unstructured Data: 7.8; Test Name: Body temperature; Result Unstructured Data: 38.9 degree Celsius; Test Name: Body temperature; Result Unstructured Data: high; Test Name: Body temperature; Result Unstructured Data: high; Test Name: Body temperature; Result Unstructured Data: high; Test Name: Body temperature; Result Unstructured Data: high; Test Name: Body temperature; Result Unstructured Data: high; Test Date: 20210802; Test Name: Body temperature; Result Unstructured Data: 38 degree Celsius; Test Name: Glasgow Coma Scale; Test Result: Inconclusive ; Result Unstructured Data: E3V3-4M4-58/2.; Test Name: Japan Coma Scale; Test Result: Inconclusive ; Result Unstructured Data: II-10; Test Name: CRP; Test Result: Inconclusive 1.00 mg/dl; Result Unstructured Data: 1.00; Test Name: clearanceCreatinine renal; Test Result: Inconclusive 0.69 mg/dl; Result Unstructured Data: 0/69; Test Name: Electroencephalogram; Result Unstructured Data: epilepsy wave was not observed; Test Name: Heart rate; Result Unstructured Data: 88; Test Name: Heart rate; Result Unstructured Data: 84; Test Name: Heart rate; Result Unstructured Data: 74; Test Name: Heart rate; Result Unstructured Data: 64; Test Name: MRI Brain; Result Unstructured Data: no obvious organic disease or abnormality; Test Name: Neutrophil count; Test Result: Inconclusive ; Result Unstructured Data: 7000; Test Name: Neutrophil count; Test Result: Inconclusive ; Result Unstructured Data: 10,200; Test Name: Oxygen saturation; Result Unstructured Data: Normal; Test Name: Oxygen saturation; Result Unstructured Data: low; Test Name: Oxygen saturation; Result Unstructured Data: Normal; Test Name: Oxygen saturation; Result Unstructured Data: low; Test Name: Oxygen saturation; Result Unstructured Data: Normal; Test Name: Plt; Test Result: Inconclusive ; Result Unstructured Data: 170 x 10^3; Test Name: RBC; Test Result: Inconclusive ; Result Unstructured Data: 4.04 x 10^6; Test Name: WBC; Test Result: Inconclusive ; Result Unstructured Data: 8,160
CDC Split Type: JPTAKEDA2021TJP072316

Write-up: Numbness in both arms; The state of gait inability with wobble; Hyperventilation syndrome; Chills; Clonic seizure; Depressed level of consciousness; Malaise; Breathlessness; Pyrexia; Diarrhoea; Vaccination site pain; Pyrexia; This case was received via (Reference number: 2021TJP072316) on 11-Aug-2021 and was forwarded to Moderna on 19-Aug-2021. This case, initially reported to the by a pharmacist, was received via the (Ref, v21123385). On an unknown date, the patient received the 1st dose of this vaccine. After the vaccination, the patient developed pyrexia, vaccination site pain, and diarrhoea. The patient took over-the-counter analgesics. On an unknown date, body temperature before vaccination: Unknown. On 01-Aug-2021, at 09:33, the patient received the 2nd dose of this vaccine. At 16:30, malaise developed, and the patient took an analgesic. At 21:30, pyrexia developed, the patient took the analgesic again. At around 23:30, the patient realized breathlessness. On 02-Aug-2021, at 00:15, the patient had a body temperature of 38 degrees Celsius, hyperventilating, and numbness in both arms, and became unable to walk with wobble; thus, an emergency call was made. During the emergency transport, the patient experienced clonic seizures and decreased level of consciousness. When the patient was transported to emergency department, body temperature 38.9 degrees Celsius, blood pressure 116/64, pulse 88 beats per minute, percutaneous oxygen saturation (SpO2) 99% (room air), Coma Scale (CS) II-10, and Glasgow Coma Scale (GCS) E3V3-4M4-58/2. At 00:23, arterial blood gas analysis. PH 7.581, PaCO2 17.8 mmHg, PaCO2 106.0 mmHg, HCO3 -16.7 mmol/L, ABE -2.9 mmol/L, Na +137 mEq/L, K +2.8 mEq/L, CI -107 mEq/L, anion gap (AnGap) 13.4 mEq/L, and lactate (Lac) 4.3 mmol/L. At 00:23, blood sampling. WBC 12,070, neutrophil count 10,200, RBC 3.98 x 10^6, platelet (Plt) 174 x 10^3, AST 16 U/L, ALT 11 U/L, ALP 68 U/L, CPK 50 U/L, LDH 138 U/L, BUN 9.1 mg/dL, creatinine (Cr) 0.69 mg/dL, sodium (Na) 134 mEq/L, potassium (K) 2.9 Eq/L, chloride (Cl) 105 mEq/L, procalcitonin 0.08 ng/mL, and CRP 0.31 mg/dL. At 00:24, fluid replacement was started. Diazepam 5 mg injectable was intravenously administered, and clonic seizures disappeared rapidly, but SpO2 decreased to 78%, and administration of oxygen 3 L was started. At around 02:00, the patient''s level of consciousness improved to the point where the patient could speak ( Coma Scale [CS] I-1). SpO2 increased to 99%, and administration of oxygen was terminated. The patient was able to walk without wobble. The patient was hospitalized for clonic seizure and hyperventilation syndrome. At 02:46, body temperature 38.0 degrees Celsius, blood pressure 90/52, pulse 84 beats per minute, SpO2 97% (room air), and respiratory rate 26 breaths per minute. The patient complained of chills and breathlessness. At 03:34, body temperature was 38.1 degree Celsius, and the patient took 400 mg of acetaminophen. At 08:53, blood sampling. WBC 8,160, neutrophil count 7,000, RBC 4.04 x 10^6, Plt 170 x 10^3, AST 14 U/L, ALT 11 U/L, ALP 67 U/L, CPK 46 U/L, LDH 126 U/L, BUN 7.8 mg/dL, Cr 0.69 mg/dL, Na 137 mEq/L, K 4.3 mEq/L, Cl 107 mEq/L, and CRP 1.00 mg/dL. At 09:36, body temperature 37.4 degree Celsius, blood pressure 98/57, pulse 74 beats per minute, SpO2 98% (room air), and consciousness was clear. No complaints of chills or breathlessness. Head MRI: no obvious organic disease or abnormality. Electroencephalogram: epilepsy wave was not observed. It was confirmed with the patient''s mother that the patient experienced febrile convulsions at the age of 3, but there was no abnormality during her pregnancy or at the time of birth, and the patient did not have childhood trauma or conversion. Clonic seizures were suspected to be adverse reaction to COVID-19 vaccination. On 03-Aug-2021, at 11:17, body temperature 36.6 degree Celsius, blood pressure 104/64, and pulse 64 beats per minute, and consciousness was clear. The patient had no convulsive seizure after admission. The patient was discharged from the hospital. The outcome of pyrexia, vaccination site pain, and diarrhoea at the time of the 1st dose of this vaccine was reported as unknown. The outcome of malaise, pyrexia, breathlessness, numbness in both arms, the state of gait inability with wobble, clonic seizure, depressed level of consciousness, hyperventilation syndrome, and chills at the time of the 2nd dose of this vaccine was reported as recovered. 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: Clonic seizures are suspected to be side effect of COVID-19 vaccination because the patient does not have history of epilepsy, abnormal EEG, or organic brain disease. Hyperventilation syndrome may be caused by hyperventilation resulting from intense anxiety about adverse reactions to COVID-19 vaccine.; 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. Patient?s history of febrile seizures during childhood is a confounder for the event.


VAERS ID: 1623205 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-08-01
   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: Asthenia, Balance disorder, Feeling abnormal, Feeling of body temperature change, Gait inability, Immobile, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AVONEX; OCREVUS; GILENYA
Current Illness: Multiple sclerosis; Walker user
Preexisting Conditions: Medical History/Concurrent Conditions: Activities of daily living impaired (after taking Avonex , he felt like he was not able to do anything); Consciousness loss (Avonex knocked him out)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAMODERNATX, INC.MOD20212

Write-up: super weak; he couldn''t walk properly/ could''nt walk around; balance issue/ had to hold on everything to not fall; felt completely out, was in very bad shape/ very unstable; coulnt lift his leg; he was hot, he was cold; immobilized him/ he wasn''t able to get out of bed/ stayed in the bed the whole day; he was hot he was cold; This spontaneous case was reported by a consumer and describes the occurrence of IMMOBILE (immobilized him/ he wasn''t able to get out of bed/ stayed in the bed the whole day) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Consciousness loss (Avonex knocked him out) and Activities of daily living impaired (after taking Avonex , he felt like he was not able to do anything). Concurrent medical conditions included Multiple sclerosis and Walker user. Concomitant products included INTERFERON BETA-1A (AVONEX), OCRELIZUMAB (OCREVUS) and FINGOLIMOD HYDROCHLORIDE (GILENYA) for Multiple sclerosis. On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced ASTHENIA (super weak), GAIT INABILITY (he couldn''t walk properly/ could''nt walk around), BALANCE DISORDER (balance issue/ had to hold on everything to not fall) and FEELING ABNORMAL (felt completely out, was in very bad shape/ very unstable). In August 2021, the patient experienced IMMOBILE (immobilized him/ he wasn''t able to get out of bed/ stayed in the bed the whole day) (seriousness criterion medically significant), FEELING OF BODY TEMPERATURE CHANGE (he was hot he was cold), MUSCULAR WEAKNESS (coulnt lift his leg) and FEELING OF BODY TEMPERATURE CHANGE (he was hot, he was cold). On 12-Aug-2021, IMMOBILE (immobilized him/ he wasn''t able to get out of bed/ stayed in the bed the whole day), ASTHENIA (super weak), GAIT INABILITY (he couldn''t walk properly/ could''nt walk around), BALANCE DISORDER (balance issue/ had to hold on everything to not fall), FEELING OF BODY TEMPERATURE CHANGE (he was hot he was cold), FEELING ABNORMAL (felt completely out, was in very bad shape/ very unstable), MUSCULAR WEAKNESS (coulnt lift his leg) and FEELING OF BODY TEMPERATURE CHANGE (he was hot, he was cold) had resolved. It was reported that the patient had a similar reaction when he was first started on Avonex. The patient had to use his walker to go to washroom. On 09-Aug-2021, the patient pretty much stayed in bed and the next day, he was in a better state. On 12-Aug-2021, he was totally fine and was back to normal. No treatment information was provided by the reporter. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender''s Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.


VAERS ID: 1624500 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Chest pain, Dyspnoea, Pulmonary embolism
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hormonal contraception; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101017111

Write-up: Pulmonary embolism; had a cardiac arrest; developed shortness of breath and chest pain; developed shortness of breath and chest pain; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority, regulatory authority number DE-PEI-CADR2021154454, and DE-CADRPEI-2021154454. A 34-years-old female patient received bnt162b2 (COMIRNATY), on 30Jul2021 (Batch/Lot Number: Unknown) as DOSE NUMBER UNKNONW, 0.3 ML, SINGLE for covid-19 immunisation. Medical history included Obesity, taking hormonal contraceptives. The patients concomitant medications were not reported. The patient developed shortness of breath and chest pain on the following day of vaccination and finally collapsed and had a cardiac arrest, as part of the resuscitation an Extracorporeal membrane oxygenation had to be implanted and in the imaging pulmonary artery embolism in all lung segments, after administration of drugs for lysis and establishment of an anticoagulation currently already significantly improved condition of the patient, but still with VA-ECMO. The patient experienced pulmonary embolism on 01Aug2021 with outcome of not recovered, and assessed as serious as hospitalization. Outcome of other events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1624694 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-08-01
   Days after vaccination:4
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: Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101016360

Write-up: Myocarditis; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority (regulatory authority number: ES-AEMPS-964702). A 36-year-old male patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 28Jul2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient experienced myocarditis on 01Aug2021. Outcome of the event was recovering. The regulatory authority assessed this report as serious (medically significant). No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1624701 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-08-01
   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 FD7959 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Tinnitus
SMQs:, Hearing impairment (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: FOSFOMICINA ABAMED
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101016387

Write-up: Tinnitus; This is a spontaneous report from a contactable consumer or other non healthcare professional downloaded from the Agency Regulatory Authority-WEB ES-AEMPS-964993. A 28-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 12Jul2021 (Batch/Lot Number: FD7959) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history was not reported. The patient was not pregnant at the administration of the vaccine. Concomitant medication included fosfomycin trometamol (FOSFOMICINA ABAMED) taken for an unspecified indication from 01Aug2021 to 01Aug2021. The patient experienced tinnitus on 01Aug2021. The outcome of the event was unknown. The patient received the second dose of bnt16b2 (COMIRNATY) on 02Aug2021 (batch/lot number: FF2752) intramuscular administered on left arm. No follow-up attempts possible. No further information expected.


VAERS ID: 1624713 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-08-01
   Days after vaccination:102
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6326 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cardiac failure, Chest pain, Computerised tomogram, Cough, Diagnostic procedure, Ejection fraction, Nasal congestion, Oedema, Pulmonary congestion, SARS-CoV-2 test, Vaccination failure, X-ray
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Lack of efficacy/effect (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyspnea
Allergies:
Diagnostic Lab Data: Test Name: Torax CT SCAN; Result Unstructured Data: Test Result:preserved SFC veiled, bibasal infiltrate that impr; Comments: preserved SFC veiled, bibasal infiltrate that impresses more of pulmonary congestion than SARS-COV 2.; Test Name: SoO2; Result Unstructured Data: Test Result:97; Test Name: Left ventricular ejection fraction; Result Unstructured Data: Test Result:Decompensation; Comments: Decompensation of Left ventricular ejection fraction (LVEF) Preserved heart failure.; Test Date: 20210802; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Name: RX; Result Unstructured Data: Test Result:Afebril
CDC Split Type: ESPFIZER INC202101032032

Write-up: pulmonary congestion; edema; heart failure; nasal congestion; sparse dry cough; mild pain in right hemitorax that increases with expiration; Vaccination Failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. This is a report from the Regulatory Authority-WEB [regulatory authority number ES-AEMPS-968312]. A 75-years-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EW6326), via intramuscular route on 21Apr2021 as DOSE 1, SINGLE and dose 2 bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FA5715) via an unspecified route of administration on 13May2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included dyspnoea from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced covid-19 on 01Aug2021, pulmonary congestion, edema on an unspecified date, nasal congestion and, sparse dry cough and was hospitalised on 03Aug2021, mild pain in right hemitorax that increases with expiration, heart failure on an unspecified date. It was reported that, the patient experienced vaccination failure. Infection by COVID-19, accompanied by congestion, pulmonary and edema that improved with diuretic treatment and discharged after 2 days of hospitalization. Date of admission 03Aug2021. The patient tested positive of COVID-19 diagnosed on 02Aug2021, came back to the emergency room for lack of clinical improved after being voluntarily discharged. Last night she went to the emergency room with symptoms compatible with COVD, which began on day 1: Nasal congestion, sparse dry cough, mild pain in right hemithorax that increases with expiration. Increase of the perimetries in lower limbs. Mild cough without expectoration. Pain in right hemithorax same as last night, absence of other symptoms. Afebrile X-ray Thorax, Thorax Computed Tomography (CT) SCAN preserved unknown meaning (CFS) veiled, bibasal infiltrate that impresses more than pulmonary congestion than SARS-COV 2. Evolution, after depletive treatment with iv furosemide with good clear diuretic response clinical improvement soO2 baseline 97% JC. Infection by SARS-COV2. Hypoxemia resolved. Decompensation of Left ventricular ejection fraction (LVEF) Preserved heart failure. The patient underwent lab tests and procedures which included computerised tomogram: preserved sfc veiled, bibasal infiltrate that impr on an unspecified date, preserved SFC veiled, bibasal infiltrate that impresses more of pulmonary congestion than SARS-COV 2 , diagnostic procedure: 97 on an unspecified date , ejection fraction: decompensation on an unspecified date, Decompensation of Left ventricular ejection fraction (LVEF) Preserved heart failure, sars-cov-2 test: positive on 02Aug2021 , x-ray: afebrile on an unspecified date. The outcome of the event of COVID-19 was recovering. The outcome of the rest of the events was unknown. Brief complaint description: Product Complaint Exchange: [Vaccination failure with COMIRNATY]; Reasonably Suggest Device Malfunction; Severity of Harm: N/A; Complaint Class: Product Use Attributes; Complaint Sub-Class: Lack Of Effect. Root Cause: Process Related: No; Final Confirmation Status: Not Confirmed; Vendor Related: No; Lot-Specific Trend Identified: No; Lot Trend Assmt. & Rationale; Lot Trend Actions Taken; Other Trend Identified; Other Trend Assmt. & Rationale; Site Sample Status: Not Received; Summary of Investigation from authority division was Blank; Investigational report conclusion from authority division was: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 6063385 (see File attachment in this investigation record). The complaint for PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FA5715. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. The authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are needed. No further information expected.


VAERS ID: 1624961 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Headache, Inappropriate schedule of product administration, Lymph node pain, Peripheral swelling, Vaccination site pain
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101012671

Write-up: First dose on 07Jun2021/second dose on 03Aug2021; Arm has swollen at the site of first injection/felt swelling and pain in her under arm; pain in her under arm; Headache; Lymph node pain; Injection site pain; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108050911589280-OPAHU, Safety Report Unique Identifier GB-MHRA-ADR 25758135. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Aug2021 (Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included suspected COVD-19 from 26Dec2019 to 10Feb2020 (no longer ongoing). Patient has not had a COVID-19 test. Thus, patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in the arm on 07Jun2021 (Lot number was not reported) for COVID-19 immunization. Arm has swollen at the site of first injection in Aug2021 after the second dose. She cannot lift her arm and felt swelling and pain in her under arm in Aug2021. She has also had a continuous headache in Aug2021 since 6 hours after the jab. The patient also experienced injection site pain and lymph node pain in Aug2021. The outcome of swelling arm was recovering, for the other events was not recovered. The case has been considered serious due to seriousness criterion of other medically important condition. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.


VAERS ID: 1625009 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Chest discomfort, Fatigue, Irritability, Muscle tightness
SMQs:, Anaphylactic reaction (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (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: CITALOPRAM; MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101021451

Write-up: Made anxiety worse; Fatigue; Anxiety attack lasting for hours; tensed muscles; tightened chest; irritability; This is a spontaneous report from a contactable Consumer (patient). This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202108081136376900-AK01K, Safety Report Unique Identifier GB-MHRA-ADR 25771300. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number was not reported), via an unspecified route of administration on 04Aug2021 at dose 2, single for COVID-19 immunization. Medical history included depression 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 was not pregnant and was not enrolled in clinical trial. Concomitant medications included citalopram taken for depression, start and stop date were not reported; ethinylestradiol, levonorgestrel (MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]) taken for oral contraceptive, start and stop date were not reported. The patient experienced tightened chest, irritability in Aug2021; made anxiety worse, fatigue and anxiety attack lasting for hours on 05Aug2021. The events were reported as serious (other medically important condition). The clinical course was reported as follows: anxiety attack lasting for hours, tightened chest, irritability, tensed muscles combined with extreme fatigue. Am not afraid of or anxious about needles or injections so anxiety is not connected to any fear response. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of tightened chest and irritability was not recovered, for the events of made anxiety worse, fatigue and anxiety attack lasting for hours was recovered and unknown for the tensed muscles. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


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