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

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



Case Details (Reverse Sorted by Onset Date)

This is page 399 out of 8,010

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VAERS ID: 1687068 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE HYDROCHLORIDE; FOSTAIR; SALBUTAMOL; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101117564

Write-up: Acute anaphylactic reaction; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). The regulatory authority report number GB-MHRA-TPP7525476C7556955YC1629893476242, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25854883. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Aug2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient was 42-years-old at the time of vaccination. Medical history included ill-defined disorder. Concomitant medications included amitriptyline hydrochloride from 11Jun2021, FOSTAIR from 04Dec2020, salbutamol from 04Dec2020, and sertraline from 30Mar2021, all taken for ill-defined disorder. The patient experienced acute anaphylactic reaction with hospital attendance on 25Aug2021. The event was reported as non-serious. The patient recovered on 25Aug2021. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1687247 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319-L797 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101111671

Write-up: regained consciousness; Faint; This is a spontaneous report from a contactable pharmacist. This report is received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108251034534570-ALSN2. Safety Report Unique Identifier GB-MHRA-ADR 25846268. A 17-year-old non-pregnant female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection, Batch/Lot Number: FF3319-L797) via an unspecified route of administration on 25Aug2021 (at the age of 17-years-old) as dose 1, single for COVID-19 immunization. Medical history included lactation decreased from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient is not currently breastfeeding. Concomitant medication(s) included sertraline taken for an unspecified indication, start and stop date were not reported. The patient experienced regained consciousness on an unspecified date and faint on 25Aug2021. Additional Information: Patient had vaccination. Advised pharmacist administering vaccination that she was prone to fainting, vaccine administered to patient while lying on bed. As felt OK, patient went to wait in supervision area and fainted approx five minutes after vaccine given. Regained consciousness within 10 seconds, spent 10 minutes lying down before sitting for further 10 minutes. Left with mother after this, fully recovered. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No reaction report was related to possible blood clots or low platelet counts. The outcome of regained consciousness was not recovered. The outcome of faint was recovered on 25Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687264 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye movement disorder, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Ocular motility disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LUCETTE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acne
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101111630

Write-up: contacted help now waiting for dr to phone; Swelling face; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The Regulatory Authority report number is GB-MHRA-WEBCOVID-202108251154325530-0JWOS. Safety Report Unique Identifier GB-MHRA-ADR 25846863. A 16-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration on 24Aug2021 (Batch/Lot Number: FE8087) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included acne from an unknown date and unknown if ongoing. Patient was not pregnant and was not pregnant at time of vaccination. Patient was not enrolled in clinical trial. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Concomitant medication included drospirenone, ethinylestradiol (LUCETTE) taken for acne from Apr2020 to an unspecified stop date. The patient experienced contacted help now waiting for dr to phone (eye movement disorder) (medically significant) on an unspecified date with outcome of not recovered, swelling face (swelling face) (medically significant) on 25Aug2021 with outcome of not recovered. 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: 1687268 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cold sweat, Dizziness, Loss of consciousness, Nausea, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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 Date: 20210824; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101111622

Write-up: passed out; feeling light headed; Fainting; Nausea; Cold sweat; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108251209325540-ZDIPH, safety report unique identifier is GB-MHRA-ADR 25846950. A 16-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Aug2021 at age of 16-year-old as dose 1, 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. The patient experienced passed out on an unspecified date, fainting on 25Aug2021, nausea on 25Aug2021, cold sweat on 25Aug2021, feeling light headed on an unspecified date. 2 minutes after receiving the jab he started feeling light headed. He then passed out of about half a minute. He woke up with a cold sweat and felt like he was going to be sick for a minute or two. 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: negative on 24Aug2021 (No - Negative COVID-19 test). The outcome of the event passed out was recovering, of event feeling light headed was unknown, of other events was recovered on 25Aug2021. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1687273 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, SARS-CoV-2 test
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: 20201120; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101111378

Write-up: Enlarged lymph nodes (excl infective); This is a spontaneous report from a contactable consumer received from the Regulatory Authority; report number is GB-MHRA-WEBCOVID-202108251237547820-N8NMY. Safety Report Unique Identifier GB-MHRA-ADR 25847298. A 19-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: FE8087), via an unspecified route of administration on 23Aug2021, as dose 2, single for COVID-19 immunization. The patient''s medical history included suppressed lactation (from an unknown date and unknown if ongoing). The patient''s concomitant medications were not reported. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 25Aug2021, the patient experienced enlarged lymph nodes (excl infective). Swollen, red and sore lump under armpit occurred two days after getting pfizer vaccine. All the events were serious (medically significant). Therapeutic measures was taken ibuprofen was taken after vaccine so didn''t notice this side effect before now. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 20Nov2020 Yes - Positive COVID-19 test. The outcome of the events swollen and red and sore lump under armpit was unknown and enlarged lymph nodes (excl infective) was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687274 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blindness, Feeling abnormal, Hypoacusis, Tunnel vision, Vomiting
SMQs:, Acute pancreatitis (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (narrow), Hearing impairment (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: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101111380

Write-up: Tunnel vision; Around 25 mins after vaccine, sight went dark from edges till I couldn''t see anything.; fuzzy; Hearing also went fuzzy and I felt like I might throw up.; Hearing also went fuzzy and I felt like I might throw up.; 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-202108251240453250-FBCN6, Safety Report Unique Identifier is GB-MHRA-ADR 25847229. A 22-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Not known), via an unspecified route of administration at the age of 22-year-old on 25Aug2021 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 was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced tunnel vision and fuzzy on 25Aug2021. Around 25 mins after vaccine (on 25Aug2021), sight went dark from edges till she couldn''t see anything. Hearing also went fuzzy and she felt like she might throw up. Lasted for around 1 minute before sight/hearing returned fully and she had felt fine since. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of events was recovered on 25Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687279 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Vertigo
SMQs:, 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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101111501

Write-up: Vertigo; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108251308432160-EGBFO, Safety Report Unique Identifier GB-MHRA-ADR 25847336. A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Aug2021 (Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced vertigo (medically significant) on 25Aug2021 with outcome of not recovered. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687285 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fall, Head injury, Loss of consciousness, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fall; Migraine; Pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101111664

Write-up: This is a spontaneous report from a contactable consumer. This is a report received from the Agency. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FE3380), via an unspecified route of administration on 25Aug2021 as dose 1, single for COVID-19 immunisation. Medical history included pregnancy, fall and migraine. The patient had had migraine in the past but not in the last two years. That was all. Nothing else wrong. Patient had not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced unconsciousness and fainted on 25Aug2021 which were considered serious due to other medically important condition by MHRA. It was reported faint occurred within 15 minutes of having the vaccine and lasted for 2 minutes. The faint caused a fall to the floor with consequent bang to the head. The patient had not been unduly stressed or overheated. The patient had eaten well and had never fainted before. The faint was definitely due to the vaccination. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 22Aug2021. The outcome of the event "unconsciousness" was recovered with sequel on 25Aug2021, of the event "Fainted" was recovered on 25Aug2021, of the other events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1687303 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Uveitis
SMQs:, Ocular infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unsure if patient has had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101111577

Write-up: Uveitis; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108251628568510-S2BOU. A 34-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: FE3380 and Expiration date: unknown), dose 2 via an unspecified route of administration on 21Aug2021 as single dose and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got Uveitus 3 days after the first dose. Been taking Pred Forte for 8 weeks. Patient had the second dose and Uveitus has flared up after 4 days on 25Aug2021. Patient had not tested positive for covid-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: No - Negative COVID-19 test. Therapeutic measures were taken as a result of uveitis. The outcome of event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687307 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyskinesia, Fall, Seizure
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101111571

Write-up: Seizure; After about 5min he was reaching for his phone and fell on floor; jerky movements; This is a spontaneous report from a contactable pharmacist. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108251704202890-USZV9, Safety Report Unique Identifier GB-MHRA-ADR 25848738. A 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number fe3380), via an unspecified route of administration on 25Aug2021, at the age of 21-years-old, as dose 1, single for COVID-19 immunisation. Medical history included patient had not had a seizure or seizure like reaction before and he is not a known to had fainted before. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. On 25Aug2021, the patient experienced after about 5min he was reaching for his phone and fell on the floor, jerky movements, and seizure. Outcome of the events was recovered on 25Aug2021. Patient has not tested positive for COVID-19 since having the vaccine. The events were assessed as non-serious by regulatory authority. The clinical course was reported as follows: Patient received first dose of vaccine and was asked to take a seat and wait 15min. After about 5min he was reaching for his phone and fell on floor. He had his fist clenched and eyes were wide open. on the floor his body went all stiff and after few seconds he started having jerky movements of all his limbs. Reaction: Does your report relate to possible blood clots or low platelet counts? If yes, we will ask you additional questions at the end of this report: "No". Relevant investigations or tests conducted: "patient recovered after about 30 seconds" No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687312 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blindness, Eye pain, Muscle twitching, SARS-CoV-2 test
SMQs:, Dyskinesia (broad), Dystonia (broad), Glaucoma (broad), Optic nerve disorders (broad), Retinal 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: 20210825; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101111628

Write-up: twitching of right eye; momentary loss of vision; Eye pain; This is a spontaneous report from a contactable consumer. This is a report received from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108251738510510-SPW7K, Safety Report Unique Identifier (GB-MHRA-ADR 25848928). A 25-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 24Aug2021 for COVID-19 immunization. Patient has not had symptoms associated with COVID-19. The patient medical history and concomitant medications were not reported. Eye pain and twitching of right eye causing momentary loss of vision. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient experienced eye pain on 25Aug2021 with outcome of not recovered, twitching of right eye on an unspecified date with outcome of unknown, momentary loss of vision on an unspecified date with outcome of unknown. All the events were assessed serious as medically significant. The lab tests included no - negative COVID-19 test on 25Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687313 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CODEINE; PARACETAMOL; VENLAFAXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety state; Headache; Lactation decreased; Migraine; Suspected COVID-19 (The patient has been tested for COVID-19 on 20Jul2021 and resulted positive)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Has not tested positive for COVID-19; Comments: Patient has not tested positive for COVID-19 since having the vaccine; Test Date: 20210720; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101111758

Write-up: Headache; Nauseous / Nauseated; Diarrhea; Stomach cramps; Heavy feeling in arms + leg; Eye ache; headache got worse; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202108251750361200-FQMTH, Safety Report Unique Identifier GB-MHRA-ADR 25849002. A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 24Aug2021 at 16:30, at single dose, for COVID-19 immunisation. Relevant medical history included lactation decreased from an unknown date, suspected covid-19 from an unknown date, migraine from an unknown date, headache from an unknown date and anxiety state from an unknown date. Patient is not pregnant and is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medications included codeine taken for migraine, start and stop date were not reported; paracetamol taken for headache, start and stop date were not reported; venlafaxine taken for anxiety, start and stop date were not reported. The patient experienced headache (medically significant) on 25Aug2021 with outcome of recovering, nauseous (medically significant) on 25Aug2021 with outcome of not recovered, diarrhea (medically significant) on 25Aug2021 with outcome of recovering, stomach cramps (medically significant) on 25Aug2021 with outcome of recovering, heavy feeling in arms + leg (medically significant) on 25Aug2021 with outcome of not recovered, eye ache (medically significant) on 25Aug2021 with outcome of not recovered, headache got worse (medically significant) on 25Aug2021 with outcome of unknown. The events were described as "patient had the vaccine around 16.30 pm on 24Aug2021. Felt fine the night of. Woke up on 25Aug2021 with a headache. As day progressed eye ache occurred and headache got worse. Stomach cramps and diarrhoea in the afternoon. Then from about 4pm onwards feeling extremely nauseated, but no vomiting has happened. The patient has been tested for COVID-19 on 20Jul2021 and resulted positive. 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: 1687314 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Malaise, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), 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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101111551

Write-up: Tiredness; Headache; Muscle pain; Feeling unwell; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number: GB-MHRA-WEBCOVID-202108251808093160-8Z4NW; Safety Report Unique Identifier: GB-MHRA-ADR 25849205. A 16-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) at 16-year-old, via an unspecified route of administration on 25Aug2021 (Batch/Lot Number: FE8087) at single dose for COVID-19 immunisation. Medical history included lactation decreased, and lactation decreased. The patient''s concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The patient experienced tiredness, headache, muscle pain, and feeling unwell on 25Aug2021. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: No - negative COVID-19 test on 24Aug2021. The events were assessed as medically significant. Patient had not recovered from all the events. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1687317 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Gastric antral vascular ectasia, Pain in extremity
SMQs:, Gastrointestinal haemorrhage (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:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101111356

Write-up: GAVE; joint pain; arm; Generalized joint pain; shoulder/Joint pain in opposite shoulder to the arm the vaccine was given in; This is a spontaneous report from a contactable consumer. This report is received from the . The regulatory authority report number is GB-MHRA-WEBCOVID-202108251842202540-SLOMY and Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25849315. A 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Aug2021 (Lot Number: Not known) as single dose for COVID-19 immunisation. Patient age at vaccination was 13-year-old. Medical history included pregnancy. The patient''s concomitant medications were not reported. Joint pain in opposite shoulder to the arm the vaccine was given in. Started about 90 mins after injection with outcome of resolved. It was also reported joint pain, GAVE (gastric antral vascular ectasia), arm (pain in extremity), all on an unspecified date with outcome of recovered, generalized joint pain on 25Aug2021 with outcome of recovering. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.


VAERS ID: 1687343 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Headache, Myalgia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Guillain-Barre syndrome (broad), 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: VENLAFAXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101111567

Write-up: Muscle ache; Headache; Injection site pain; Weakness; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108252100235220-JSZ7Q Safety Report Unique Identifier GB-MHRA-ADR 25850163. A 29-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FE8087), via an unspecified route of administration on 24Aug2021 as single dose for COVID-19 immunization. Medical history included anxiety. Unsure if patient had symptoms associated with COVID-19. Patient was not pregnant. Concomitant medications included venlafaxine taken for anxiety. The patient experienced muscle ache, headache, injection site pain, weakness on 25Aug2021. This case was reported as serious due to medically significant. Felt ok this morning but symptoms worsened as the day went on. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1687370 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysphonia, Fatigue, Headache, Oropharyngeal pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cilique
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hormonal imbalance; Lactation decreased.
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: COVID-19 virus test; Test Result: Negative; Comments: Negative.
CDC Split Type: GBPFIZER INC202101111544

Write-up: headache; sore throat; fatigue; Heavy, sore arm; Hoarse voice; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108260544324770-NPI0V, Safety Report GB-MHRA-ADR 25851340. A 35-year-old female (not pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 23Aug2021 as dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation from an unknown date and unknown if ongoing, hormone level abnormal from an unknown date and unknown if ongoing. The patient Historical vaccine include BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 for COVID-19 Immunization from Unknown dates to Unknown dates. Concomitant medication(s) included ethinylestradiol, norgestimate (CILIQUE) taken for hormone level abnormal from 01Aug2019 to an unspecified stop date. Patient has not had symptoms associated with COVID-19. Patient is not pregnant, Patient is not currently breastfeeding. The patient experienced headache (headache) (medically significant) on an unspecified date with outcome of recovering, sore throat (oropharyngeal pain) (medically significant) on an unspecified date with outcome of recovering, hoarse voice (dysphonia) (medically significant) on 25Aug2021 with outcome of not recovered, fatigue (fatigue) (medically significant) on an unspecified date with outcome of unknown, heavy, sore arm (pain in extremity) (medically significant) on an unspecified date with outcome of unknown. The patient underwent COVID-19 virus test with negative result on 26Aug2021. The patient had heavy, sore arm that has lessened by day 4 but still sore. Headache and fatigue day 2. Sore throat day 3 in evening. Woke up with hoarse voice and sore throat day 4. 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.


VAERS ID: 1687375 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-25
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Heavy menstrual bleeding
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101111721

Write-up: This is a spontaneous report from a contactable consumer (patient) received from the Agency. A 48-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration on 11Aug2021 (Batch/Lot Number: FF3319) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included suppressed lactation from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19, did not have a COVID-19 test, was not pregnant and was not pregnant at time of vaccination, was not currently breastfeeding. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced stomach cramps (medically significant) on an unspecified date with outcome of not recovered, heavy periods (medically significant) on 25Aug2021 with outcome of not recovered. Patient reported that her period arrived exactly on time (28 day cycle). Patient had unusual bad stomach cramps and went to bed with an ultra size tampon in at 10:45 PM. At 3:30 AM she awoke and realised she was leaking. She put another ultra tampon in and also put an old towel down to sleep on. She was awake at 6:45 AM with blood literally running down her legs. The tampon when removed was soaked and had small clots on it. 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: 1687386 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Extrasystoles, Insomnia, SARS-CoV-2 test
SMQs:, Tachyarrhythmia terms, nonspecific (narrow), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101117713

Write-up: Insomnia; Heartbeats coupled; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number is -MHRA-WEBCOVID-202108260939161310-LSNAM. Safety Report Unique Identifier: -MHRA-ADR 25852629. A 33-year-old male patient received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot number was not reported) via an unspecified route of administration on 24Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient experienced insomnia and heartbeats coupled on 25Aug2021. The events were medically significant. On an unspecified date the patient underwent lab tests and procedures which included COVID-19 virus test: negative (No - Negative COVID-19 test). The outcome of the events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1687421 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lethargy, Lymphadenopathy, Pain, SARS-CoV-2 test
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: CETIRIZINE HYDROCHLORIDE; SERTRALINE.
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression (Active Drug substance SERTRALINE); Hay fever (Active Drug substance CETIRIZINE HYDROCHLORIDE.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101117737

Write-up: Swollen lymph nodes; Ache; Lethargy; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108261351338860-ZR41F. Safety Report Unique Identifier GB-MHRA-ADR 25853759. A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), DOSE 2 via an unspecified route of administration on 24Aug2021 as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included depression, hay fever from an unknown date and unknown if ongoing. Historical vaccine included first dose. Concomitant medications included cetirizine hydrochloride taken for seasonal allergy and sertraline taken for depression (start and stop date were not reported for both medications). The patient experienced ache (medically significant), lethargy (medically significant) on 25Aug2021 and swollen lymph nodes (medically significant) on 26Aug2021. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on no (negative COVID-19 test). Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient had not had symptoms associated with COVID-19. The clinical outcome of events ache and lethargy was recovering. The clinical outcome of event swollen lymph nodes was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687426 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Cold sweat, Headache, Impaired work ability, Malaise, Nausea, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: None
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101117720

Write-up: cold sweats; inability to work or do much physically; nauseous; Feeling sick; Nausea; Fainting; Shivering; Headache; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108261443412300-M5D5C, Safety Report Unique Identifier GB-MHRA-ADR 25854171. A patient of unspecified age and gender received second dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number and Expiration date was not reported) via an unspecified route of administration on 25Aug2021 as DOSE 2, SINGLE for covid-19 immunization. Patient had historical vaccine of first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number and Expiration date was unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. No medical history included. There were no concomitant medications. On 26Aug2021 the patient experienced fainting, feeling sick, nausea on an unspecified date experienced cold sweats, inability to work or do much physically, nauseous, on 25Aug2021 experienced shivering, headache. Symptoms began during sleep following the vaccine and appeared to be worst upon wake. Horrendous bodily shivers in the nigh with cold sweats. Fainted in the morning upon wake, feeling extremely nauseous. Entire body sweating terribly. Symptoms have lessened during the day with maximum rest however inability to work or do much physically. They appear to be worsened by the fact I was on my menstrual cycle. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. No - Negative COVID-19 test. The outcome of events cold sweats, nauseous, inability to work or do much physically were unknown, for events nausea, shivering, headache, feeling sick were recovering and for event fainting was recovered on 26Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687440 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101117847

Write-up: Swollen glands on neck and underarm; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108261719505290-06FT5. Safety Report Unique Identifier GB-MHRA-ADR 25855234. A 26-year-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot Number: FE3380), via an unspecified route of administration on 23Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection), via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization. On 25Aug2021, the patient experienced swollen glands on neck and underarm. It was reported as Physically visible swollen glands on neck and underarm. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687442 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Hot flush, Lymphadenopathy, SARS-CoV-2 test
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; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101117866

Write-up: Swollen lymph nodes; Hot flush; Shivers; This is a spontaneous report from a contactable consumer.This is a report received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108261744418390-HSELK, Safety Report Unique Identifier GB-MHRA-ADR 25855340. A 20-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 24Aug2021 as a single dose for COVID-19 immunization. Medical history included lactation decreased, suspected covid-19 from 30Mar2020 to an unknown date Unsure when symptoms stopped. The patient''s concomitant medications were not reported. The patient''s historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient experienced swollen lymph nodes on 26Aug2021, hot flush and shivers (chills) on 25Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: no-negative COVID-19 test on an unspecified date. The outcome of the events hot flush and shivers was recovered on 26Aug2021. The outcome of the event swollen lymph nodes was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1687450 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Fatigue, Hypoaesthesia, Lymphadenopathy, Pain, Rash
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101117774

Write-up: Swollen glands; Back pain; Ache; Fatigue; Rash; Body numbness; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority re-port number is GB-MHRA-WEBCOVID-202108261859264710-AJ2IM. Safety Report Unique Identifier GB-MHRA-ADR 25855816. A 22-year-old female patient (Non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number, Expiry date was not reported), (at the age of 22-year-old) via an unspecified route of administration on 25Aug2021 as dose 2, single for COVID-19 immunization. Medical history included Lactation decreased from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number, Expiration date was not reported), via an unspecified route of administration on unknown date as dose 1, single for COVID-19 immunization. On 25Aug2021 patient experienced body numbness and on 26Aug2021, swollen glands, back pain, ache, fatigue, rash. The events caused medically significant. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the events was swollen glands, back pain, ache, fatigue is not recovered. Rash was recovered on 26Aug2021, body numbness recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687452 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-08-25
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Retinal degeneration, Vision blurred, Visual field defect
SMQs:, Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Retinal degeneration; Retinitis pigmentosa.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101117597

Write-up: blurred vision; retinal degeneration; I have noticed a reduction in visual field; Blurry vision; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108261912327380-C8BCB, Safety Report Unique Identifier GB-MHRA-ADR 25855936. A 24-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 24Jun2021, as dose 2, single for COVID-19 immunization. Medical history included retinal degeneration, retinitis pigmentosa, suppressed lactation from an unknown date and unknown if ongoing. Diagnosed with Retinitis pigmentosa 5 years ago. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as dose 1, single for Covid-19 immunization. Patient has not had symptoms associated with COVID-19; Not had a COVID-19 test. Patient was not pregnant; Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced blurred vision in her right eye, retinal degeneration and she noticed a reduction in visual field. On 25Aug2021, the patient experienced blurry vision (vision blurred). Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the events vision blurred vision resolved within 4-5 days, retinal degeneration was not recovered; outcome of event blurry vision was recovered/resolved with Sequel; outcome of the event visual field defect was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687467 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Allodynia, Arthralgia, Muscular weakness, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101117879

Write-up: muscle weakness; mild temperature; Allodynia; Joint pain; 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-202108262131240380-VXU6R, safety report unique identifier is GB-MHRA-ADR 25856751. A 22-years-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Not reported) via an unspecified route of administration, administered on 25Aug2021 as single dose for COVID-19 immunisation. Medical history included depression from an unknown date and unknown if ongoing. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Not reported) via an unspecified route of administration, administered on an unspecified date as a single dose for COVID-19 Immunisation. Concomitant medication included sertraline taken for depression, start and stop date were not reported. It was reported that on 25Aug2021 around 6 hours after the vaccine dose the patient developed a mild temperature, joint pain, and the surface of my skin became very sensitive to touch. Lightly brushing against my skin is painful (dynamic mechanical allodynia) as it was touching cold objects/running my skin under cool/cold water. Patient also had mild moderate pain in all joints, but especially limbs, and some muscle weakness on an unspecified date, but no muscle pain. Patient did not had symptoms associated with covid-19 Not had a covid-19 test. Patient did not test positive for covid-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the events muscle weakness, mild temperature was unknown at the time of report. The patient was not recovered from the events of allodynia, joint pain. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1687478 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Epididymitis, Heart rate increased, Inappropriate schedule of product administration, Memory impairment, SARS-CoV-2 test, Sinus headache, Testicular pain
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Medication errors (narrow), Dehydration (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CETIRIZINE.
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Seasonal allergy.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101117700

Write-up: epididymitis; inappropriate schedule of vaccination administered; Headache sinus; Memory impairment; Heart rate increased; Testicular pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108262314196510-P7KEI, Safety Report Unique Identifier (GB-MHRA-ADR 25857086). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration dates were not reported), dose 2 via an unspecified route of administration on 25Aug2021 as single dose (at the age of 25 years) for COVID-19 immunisation. Medical history included seasonal allergy. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since had the vaccine. Patient was not enrolled in clinical trial. Patient had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration dates were not reported), dose 1 via an unspecified route of administration on 25Jun2021 as single dose for COVID-19 immunisation and experienced epididymitis and testicular pain. Concomitant medications included cetirizine (Manufacture Unknown) for seasonal allergy. On an unspecified date, the patient experienced epididymitis and was inappropriate schedule of vaccination administered, on 25Aug2021, she had heart rate increased, testicular pain, memory impairment and on 26Aug2021, she had headache sinus. She had testicular pain similar to epididymitis came on shortly after both doses but went away naturally, worse with walking/getting up/sitting down i.e., things that would increase blood pressure in the testis. The case classified as serious (medically significant). On unspecified date, the patient underwent lab tests and procedures which included sars-cov-2 test: negative (No-Negative COVID-19 test) and other relevant investigations or tests included GP inspection. The outcome of the events epididymitis and inappropriate schedule of vaccination administered was unknown and events heart rate increased, testicular pain was resolving, event headache sinus was not resolved on an unspecified date and event memory impairment was resolved 26Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101127659 Same patient/Drug/Reporter, different dose number and event.


VAERS ID: 1687505 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-25
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BEDRANOL; CETIRIZINE HYDROCHLORIDE; VENLAFAXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Generalised anxiety disorder; Hay fever
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101118744

Write-up: received first dose on 25Jun2021 and second dose on 20Aug2021/inappropriate schedule of vaccine administered; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Authority; report number is GB-MHRA-WEBCOVID-202108270935180620-KGLKK. Safety Report Unique Identifier GB-MHRA-ADR 25858614. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number and Expiration date: unknown), via an unspecified route of administration on 20Aug2021 as dose 2, single for covid-19 immunization. Medical history included generalized anxiety disorder and hay fever from an unknown date. Concomitant medication(s) included propranolol hydrochloride (BEDRANOL) taken for generalized anxiety disorder from Oct2020 to an unspecified stop date; cetirizine hydrochloride (CETIRIZINE HYDROCHLORIDE) taken for seasonal allergy from Mar2021 to an unspecified stop date; venlafaxine taken for generalized anxiety disorder from Apr2021 to an unspecified stop date. The patient previously took first dose of bnt162b2 on 25Jun2021 as dose 1, single for covid-19 immunization. Patient has not had symptoms associated with covid-19 and not had a covid-19 test. The patient experienced headache on 25Aug2021. The patient received first dose on 25Jun2021 and second dose on 20Aug2021/inappropriate schedule of vaccine administered on an unspecified date. The case was assessed as serious (medically significant). Patient has not tested positive for covid-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of event headache was not recovered and unknown for the other event. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1687515 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-08-25
   Days after vaccination:113
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2Z45 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Fatigue, Headache, Inappropriate schedule of product administration, Lymph node pain, Lymphadenopathy, Pain, SARS-CoV-2 test
SMQs:, Arthritis (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: AMOXICILLIN; PARACETAMOL.
Current Illness: Suspected COVID-19.
Preexisting Conditions: Medical History/Concurrent Conditions: Astigmatism; Cataracts (Mild); Detached retina; Fibromyalgia (Possible); Gastrooesophageal reflux (Silent reflux); Gum infection; Hearing loss; Meniere''s disease; Myopia; Pregnancy.
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: Covid PCR test; Test Result: Negative ; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101118830

Write-up: Lymph node pain; left arm pit pain; headache; painful joints; Date of start of drug: 04May2021; Swollen glands; Generalized aching; Fatigue; This is a spontaneous report from a contactable Consumer. This is a report received from the Regulatory Authority (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202108271055404850-7HTN3, Safety Report Unique Identifier GB-MHRA-ADR 25858828. A female patient of an unspecified age received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, Lot number EW2Z45) via an unspecified route of administration on 04May2021 at single dose for COVID-19 immunization. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ6790) via an unspecified route of administration on 18Feb2021 at single dose for COVID-19 immunisation. Relevant medical history included moderate to severe hearing loss, Meniere''s disease, myopia with astigmatism, previous detached retina, mild cataracts, silent reflux, possible fibromyalgia, pregnancy, gum infection and suspected COVID-19 from 26Aug2021 and ongoing (as reported). Concomitant medications included amoxicillin from 15Jul2021 to 18Jul2021 and paracetamol, both taken for gingivitis. The patient experienced lymph node pain on an unspecified date, left arm pit pain on an unspecified date, headache on an unspecified date, painful joints on an unspecified date, swollen glands on 25Aug2021, generalized aching on 25Aug2021 and fatigue on 25Aug2021. These events were serious as medically significant. In addition, second dose of BNT162b2 was received with inappropriate schedule of product administration (non-serious). The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 26Aug2021 No - Negative COVID-19 test. Clinical course was provided as follows. Symptoms started with left arm pit pain same as after both vaccines. Then progressed to swollen glands, painful joints and full body aching. Left arm pit pain very noticeably worse than other glands, same as post vaccination. No other viral symptoms present apart from mild headache. COVID PCR test negative. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. Swollen glands, generalized aching and fatigue were not resolved, outcome for inappropriate schedule of product administration was unknown, other events were resolving. No follow-up attempts are possible. No further information is expected. Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101181840 Same patient, different dose.


VAERS ID: 1687534 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Hyperhidrosis, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (Steroid inhaler); Lactation decreased; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101118848

Write-up: Swelling arm; Sweating; Tiredness; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority report number GB-MHRA-WEBCOVID-202108271340383120-P7RAR, Safety Report Unique Identifier GB-MHRA-ADR 25859526. A 18-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 25Aug2021 (at the age of 18-year-old) at single dose for COVID-19 immunisation. Relevant medical history included suppressed lactation, asthma and steroid therapy (asthma steroid inhaler, taking regular steroid treatment e.g. orally or rectally). 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 has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Concomitant medications were not reported. The patient experienced tiredness on 25Aug2021, swelling arm on 26Aug2021 and sweating on 26Aug2021. The events were serious as medically significant. Clinical course was provided as follows. Fatigue and swelling arm were not resolved, sweating was resolving at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1687549 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Migraine, Neck pain, Photophobia
SMQs:, Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SUSTANON [TESTOSTERONE CAPRINOYLACETATE;TESTOSTERONE ISOCAPROATE;TESTOSTERONE PHENYLPROPIONATE;TESTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: HRT
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101118486

Write-up: Neck pain; Migraine; Fatigue; Light sensitivity to eye; This is a spontaneous report from a contactable consumer received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108271526062510-72DBL. Safety Report Unique Identifier GB-MHRA-ADR 25860235. A 22-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Aug2021 as dose 2, single for COVID-19 immunization. Medical history included hormone replacement therapy from an unknown date and unknown if ongoing. Sustanon taken 3-weekly, most recent dose on 25Aug2021. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Concomitant medication included (SUSTANON [TESTOSTERONE CAPRINOYLACETATE; TESTOSTERONE ISOCAPROATE; TESTOSTERONE PHENYLPROPIONATE; TESTOSTERONE PROPIONATE]) taken for hormone replacement therapy from 01Feb2019 to an unspecified stop date. The patient previously took first dose of bnt162b2 via an unspecified route of administration, on unspecified date (Batch/Lot Number: not reported) as dose 1, single for COVID-19 immunization. Patient is not enrolled in clinical trial. On 25Aug2021, the patient experienced light sensitivity to eye and fatigue. On 26Aug2021, patient experienced migraine. On 27Aug2021, patient experienced neck pain. Painkillers not touching pain caused by light sensitivity. Sleep/rest not relieving fatigue. Patient has not tested positive for COVID-19 since having the vaccine. Therapeutic measures were taken as a result of light sensitivity to eye. All the events were considered as serious- medically significant. The outcome of events Light sensitivity to eye, Neck pain, Fatigue was not recovered. The outcome of Migraine was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687577 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Chills, Insomnia, Myalgia, Pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101118572

Write-up: Ache/Pain; Painful L arm; Joint ache; Muscle ache; Chest ache; Chills; Insomnia; 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-202108271927236880-4SMMR], Safety Report Unique Identifier [GB-MHRA-ADR 25861772 An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot Number: FE3380) dose 2 via an unspecified route of administration on 25Aug2021 (Lot Number: FE3380) as Dose 2, Single for COVID-19 immunisation. Medical history included suppressed lactation from an unknown date and unknown if ongoing. The patient past drug therapy included BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Batch/lot number: EW3143, Dose 1, start date:30-JUN-2021) for Covid-19 immunisation and the reaction was Painful L arm start and stop date on 30Jun2021. The patient''s concomitant medications were not reported. The patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant, Patient is not currently breastfeeding. The patient experienced insomnia on 25Aug2021, ache/pain, on an unspecified date, chest ache, chills, painful l arm, joint ache, muscle ache on 26Aug2021. The patient struggled to fall asleep the night of receiving my second vaccine and woke up at 5am the next morning with chills, aching in the joints of my hands and feet, and in the muscles of my neck and behind my eyes. I also had a lot of pain in my left arm, so much, so that I had to stay in bed all morning with it resting on a pillow because it hurt too much to move. The chills did not last for long and went away by 10am the day after the vaccine dose. The aches in my muscles and joints went away by the morning of the second day after the vaccine dose and so did the pain in my left arm. The left side of my chest further started to ache on and off throughout the day after my vaccine dose. It was a very minor ache but enough to notice. Today is the second day after my vaccine dose and the aching in the left side of my chest has improved a lot but she had felt it a couple of times today. she had not taken any medications in response to the reactions. The patient has not tested positive for COVID-19 since having the vaccine. The patient is not enrolled in clinical trial. The outcome of the events painful l arm, joint ache, muscle ache was recovered on 27Aug2021, Insomnia and chills was recovered on 26Aug2021, ache/pain, chest ache was recovering. No follow up attempts are possible. No further information is expected.


VAERS ID: 1687587 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-25
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210826; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101118876

Write-up: Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108272117503250-FR7EY, Safety Report Unique Identifier GB-MHRA-ADR 25862171. A 24-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on 16Aug2021 at single dose for COVID-19 immunisation. Historical vaccine includes first dose of BNT162B2 via an unspecified route of administration, received on an unspecified date for COVID-19 immunisation. Relevant medical history was not reported. Patient has not had symptoms associated with COVID-19. Concomitant medications were not reported. The patient experienced vomiting and diarrhea on 25Aug2021. The events were medically significant. Clinical course was provided as follows: lots of vomiting, for half a day. 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 26Aug2021, No - Negative COVID-19 test. The events resolved on 27Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687610 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Burning sensation, Lymphadenopathy, Myalgia, Nausea, Pain, Pain in extremity, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101118835

Write-up: pain; muscle ache; tender when touching the muscle around injection site; burning sensation; Nausea; Swollen lymph nodes; Muscle pain; Painful arm; This is a spontaneous report from a contactable consumer (patient). This is a report received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108280753251620-BMFZB, Safety Report Unique Identifier GB-MHRA-ADR 25863272. A 37-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 24Aug2021 at 19:00 (Batch/Lot number was not reported) as dose 2, single 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 was not pregnant, and she was not currently breastfeeding. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced pain on an unspecified date, muscle ache on an unspecified date, nausea on 25Aug2021, swollen lymph nodes on 25Aug2021, muscle pain on 25Aug2021, painful arm on 25Aug2021, tender when touching the muscle around injection site on an unspecified date and burning sensation on an unspecified date. The patient reported that she received jab roughly 7pm on 24Aug2021. Woke up with the symptoms the next morning. Nausea lasted roughly 36 hours including keeping me up all night. Muscle ache was gone mid-morning the following day. Swollen lymph glands under left arm the size of roughly a tennis ball. Very painful and continued to be very swollen and painful four days later. Muscle and top half of arm down to elbow on the arm with injection was tender and burning for two days. Most pain and burning sensation now gone but still tender when touching the muscle around injection site. Patient has not tested positive for COVID-19 since having the vaccine. Nausea and muscle pain were resolved on 26Aug2021, swollen lymph nodes and tender when touching the muscle around injection site were not resolved, and the other events were resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687664 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Adjustment disorder with depressed mood, Heavy menstrual bleeding, Muscle spasms, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Depression (excl suicide and self injury) (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: Eating disorder; Lactation decreased
Allergies:
Diagnostic Lab Data: 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 INC202101118955

Write-up: Heavy periods; cramps; mood adjustment; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108282013338900-DZO6S. Safety Report Unique Identifier GB-MHRA-ADR 25865162. A 33-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported) dose 2 via an unspecified route of administration on an unspecified date in 2021 as dose 2, single dose for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Patient was not currently breastfeeding. Medical history included eating disorder, lactation decreased from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported) dose 1 via an unspecified route of administration on an unspecified date as dose 1, single dose for COVID-19 immunisation. On an unspecified date of 2021, the patient experienced cramps, mood adjustment, on 25Aug2021 patient experienced heavy periods. It was reported that, the night she had the jab, she had cramps and mood adjustment and she was having a really heavy period when she doesn''t normally have one at all. The patient underwent lab tests and procedures which included COVID-19 virus test: no, negative covid-19 test on an unspecified date. Outcome of the event heavy periods was recovering, and rest of the events was unknown. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1687680 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Pain, Pain in extremity, SARS-CoV-2 test, Toothache
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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210828; Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101118740

Write-up: Period pains; Toothache; Generalized aching; 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-202108290227209200-ZTUGN, Safety Report Unique Identifier GB-MHRA-ADR 25865295. A 23-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 25Aug2021 (age at vaccination was 23 years old) as dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation from an unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: unknown), dose 1 via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for COVID-19 immunisation. The patient concomitant medications were not reported. Patient did not had symptoms associated with COVID-19, patient was not pregnant, Patient was not currently breastfeeding. On 25Aug2021, the patient experienced painful arm. On 26Aug2021 the patient experienced generalized aching. On 28Aug2021, the patient experienced toothache. On 29Aug2021 the patient had period pains. The events are considered as medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Aug2021. The outcome of the event generalized aching was recovered on 27Aug2021, painful arm was recovered on 29Aug2021, period pains was not recovered, and toothache was recovering. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687682 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cough, Dyspnoea, Headache, Hyperhidrosis, Influenza, Influenza like illness, Loss of personal independence in daily activities, Lymphadenopathy, Malaise, Pain in extremity, Pyrexia, Rhinorrhoea, SARS-CoV-2 test, Sinus pain
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cough; 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 INC202101118707

Write-up: flu; pain in arm; unwell; very weak; breathless; unable to function at all and stayed in bed for the last 4 days; Swollen glands; sweaty/ Heavy sweating; Feverish; Flu like symptoms; Cough; Runny nose/ nose started to run; Sinus pain; Headache; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108290724197740-WZF4H, Safety Report Unique Identifier GB-MHRA-ADR 25865338. A 43-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on 22Aug2021 as dose 2, single for COVID-19 immunisation. Patient was not currently breastfeeding (at the time of report). Medical history included lactation decreased and cough. Patient had no symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation and was experienced pain in arm. After third day of second vaccination, patient had sinuses became very painful and her nose started to run. She soon developed very severe headache that was worsened when she lay day or bent forward. She was able to continue normal duties that day but was feverish and sweaty throughout that night and the next day felt as if she had full blown flu. She was feverish, sweating a lot, very weak and in pain. She also developed a cough. She was unable to function at all and stayed in bed for the last 4 days and still feel unwell today. She became extremely breathless and congested feeling and actually felt like she was drowning so she became very panicked. She was unable to use phone but did go on to NHS 111 site. The case was assessed as serious (medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test: negative. Outcome of the event swollen glands, runny nose, flu like symptoms, headache, sinus pain was not resolved; cough, feverish, unwell, sweaty, pain in arm and flu were resolving; and rest of the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101127261 Same patient and product, different event/dose.


VAERS ID: 1687690 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Lymphadenitis, Maternal exposure during pregnancy, Myofascial pain syndrome, Neck pain, Pain of skin, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Maternal exposure during pregnancy; Swollen glads; Glands swollen; Myofascial neck pain; Skin pain; Neck pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25873880) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021. This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), MYOFASCIAL PAIN SYNDROME (Myofascial neck pain), PAIN OF SKIN (Skin pain), NECK PAIN (Neck pain), PERIPHERAL SWELLING (Swollen glads) and LYMPHADENITIS (Glands swollen) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. Concomitant products included FOLIC ACID for Folic acid supplementation. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 25-Aug-2021, the patient experienced MYOFASCIAL PAIN SYNDROME (Myofascial neck pain) (seriousness criterion medically significant), PAIN OF SKIN (Skin pain) (seriousness criterion medically significant) and LYMPHADENITIS (Glands swollen) (seriousness criterion medically significant). 25-Aug-2021, the patient experienced NECK PAIN (Neck pain) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Swollen glads) (seriousness criterion medically significant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved, MYOFASCIAL PAIN SYNDROME (Myofascial neck pain), PAIN OF SKIN (Skin pain), NECK PAIN (Neck pain) and LYMPHADENITIS (Glands swollen) had not resolved and PERIPHERAL SWELLING (Swollen glads) outcome was unknown. The patient was exposed to the medicine first-trimester (1-12 weeks). She had not been tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The patient experienced painful neck preventing turning head left or right, painful skin on neck and shoulder. She was also unable to touch or wear clothes and had swollen glands in armpit. Company comment: This is a case of Maternal exposure during pregnancy (first trimester) with associated AEs of myofascial pain syndrome, pain of skin, neck pain, peripheral swelling and lymphadenitis. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is not expected. Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Additional information received on 3-SEP-2021 that contains updated Event Medra LLT term for Glands swollen, new event Neck pain added and action taken updated; Sender''s Comments: This is a case of Maternal exposure during pregnancy (first trimester) with associated AEs of myofascial pain syndrome, pain of skin, neck pain, peripheral swelling and lymphadenitis. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is not expected.


VAERS ID: 1687747 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Inappropriate schedule of product administration
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101127380

Write-up: Mushy diarrhea; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer. This is the second of two reports. The first report is a report downloaded from the Regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108261338495200-ZB9BS., Safety Report Unique Identifier GB-MHRA-ADR 25853734. A 22-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Aug2021 (at the age of 22-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patients medical history and concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 29Jun2021 (at the age of 22-years-old) as dose 1, single for COVID-19 immunisation. On 25Aug2021, inappropriate schedule of vaccine administered. On 26Aug2021, the patient experienced mushy diarrhea. Patient is not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event diarrhoea was not recovered No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101117723 Same patient, Same drug, Different dose, Different event.


VAERS ID: 1687890 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK RA / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Anosmia, Arthralgia, Asthenia, COVID-19, Cough, Drug ineffective, Dyspnoea, Lymph node pain, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Inconclusive; Test Date: 20210827; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Positive
CDC Split Type: ILPFIZER INC202101118377

Write-up: COVID test type post vaccination: nasal swab on 27Aug2021, positive result; COVID test type post vaccination: nasal swab on 27Aug2021, positive result; fever; joint pain; muscle pain; difficulty breathing; general weakness; lack of sense of taste and smell; lack of sense of taste and smell; lymph node pain; cough; This is a spontaneous report from a contactable consumer or other non hcp (patient himself) via COVAES. A 44-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 23Aug2021 13:15 (Batch/Lot Number: Unknown) as DOSE NUMBER UNKNOWN, single (age at vaccination was 44 years old) for covid-19 immunisation. The COVID-19 vaccine was administered at Clinic/facility. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history and concomitant medications were not reported. No known allergies. On 25Aug2021, patient experienced fever, joint and muscle pain, difficulty breathing, general weakness, lack of sense of taste and smell, joint and lymph node pain and cough. Since the vaccination, the patient tested for COVID-19. COVID test type post vaccination was nasal swab on 25Aug2021, with inconclusive result. On 27Aug2021, patient undertook COVID test type post vaccination (nasal swab) with positive result. COVID-19 and drug ineffective were reported for the patient. The patient underwent lab tests and procedures which included sars-cov-2 test: inconclusive on 25Aug2021, SARS-cov-2 test: positive on 27Aug2021. Therapeutic measures were taken as a result of fever (pyrexia), joint pain (arthralgia), muscle pain (myalgia). Treatment was pills against pain and fever reducers. The outcome of fever, joint and muscle pain, difficulty breathing, general weakness, lack of sense of taste and smell, joint and lymph node pain and cough was not recovered. The outcome of COVID-19 and drug ineffective was unknown. The lot number for the vaccine bnt162b2 was requested during follow up.


VAERS ID: 1687967 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101149967

Write-up: Tachycardia; Fainting; Persistent vomiting; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority number IT-MINISAL02-777770. A 58-years-old female patient received bnt162b2 (COMIRNATY, Formulation:Solution for injection, Batch/Lot Number: Unknown), via an intramuscular route, administered in left shoulder on 25Aug2021 as dose 1, 0.3 mL single for covid-19 immunisation. Medical history and concomitant medications were not reported. On 25Aug2021, the patient experienced fainting, tachycardia, persistent vomiting. All events were assessed as life-threatening. Outcome of the events was not recovered. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.; Reporter''s Comments: nothing, so far very good health


VAERS ID: 1687992 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Blood pressure decreased, Blood pressure measurement, Body temperature, Depressed level of consciousness, Fall, Oxygen saturation immeasurable, Pallor, Presyncope
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? 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: 20210825; Test Name: B.P; Result Unstructured Data: Test Result:72 mmHg; Comments: At 10:50; Test Date: 20210825; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101103863

Write-up: Anaphylactic shock; fallen down due to consciousness stunned; B.P 72mmHg; SPO2 was unmeasurable; Vasovagal reflex; pallor facial; fallen down due to consciousness stunned; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21124716. The patient was a 36-year-old male (age at vaccination). Body temperature before vaccination was 36.2 degrees Centigrade on 25Aug2021 (the day of vaccination). 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 medical history was none. The concomitant medications were not reported. On 25Aug2021 at 10:35 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF0843, Expiration date 31Oct2021) via an unspecified route of administration as 0.3ml single dose for COVID-19 immunization. Event onset date reported as 25Aug2021 at 10:50 (the day of vaccination). The course of the event was as follows: On 25Aug2021 (the day of vaccination), at 10:35, COVID-19 vaccine 0.3 ml was vaccinated. At 10:50, pallor facial and fallen down due to consciousness stunned developed. B.P 72mmHg and SPO2 was unmeasurable. At 10:53, BOSMIN 0.3ml IM. At 11:00, the patient was transported by ambulance to the medical center. On an unspecified date, the outcome of the event was not provided. The outcome of events was unknown. The reporting physician did not classify the events seriousness and assessed that the event was related to bnt162b2. The reporting physician commented as follows: Vasovagal reflex or anaphylactic shock.


VAERS ID: 1688033 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4204 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Heart rate, Hyperventilation, Loss of consciousness, Nausea, Oxygen saturation, Presyncope, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral ischaemia; Hyperpnoea
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Blood Pressure; Result Unstructured Data: Test Result:98/47; Test Date: 20210825; Test Name: body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: Before vaccination; Test Date: 20210825; Test Name: pulse; Result Unstructured Data: Test Result:48; Test Date: 20210825; Test Name: spo2; Test Result: 98 %
CDC Split Type: JPPFIZER INC202101106029

Write-up: Transient loss of consciousness; Convulsion; Vasovagal reflex/Blood Pressure:98/47, pulse:48; queasy; Hyperpnoea; This is a spontaneous report from a contactable other health professional received from the regulatory authority. Regulatory authority report number is v21124729. A 31-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 25Aug2021 09:40 (Lot Number: FF4204; Expiration Date: 31Oct2021) as dose 1, single for COVID-19 immunisation. Medical history included Hyperpnoea and Cerebral ischaemia both on unknown dates. The patient''s concomitant medications were not reported. Body temperature before vaccination was 37.1 degrees Centigrade. On 25Aug2021 at 09:50 (10 minutes after the vaccination), the patient experienced vasovagal reflex. The course of the event was as follows: after sitting for vaccination, in the process of observation (within 10 minutes), the patient experienced transient loss of consciousness, and the same action as convulsion occurred. The patient lay down and recovered consciousness. Blood Pressure:98/47, pulse:48, spo2:98%. The patient reported queasy, the patient experienced hyperpnoea. Intravenous injection of 0.3mg Adrenaline for rehydration. After resting, the patient''s symptoms were stable and went home 2 hours later. The reporting other health professional commented as follows: the patient had the history of hyperpnoea and cerebral ischaemia. When the patient receives the second dose of vaccine, the patient should lie down and be observed after vaccination. The events recovered on 25Aug2021. The reporting other health professional classified the event as non-serious and assessed that the event was unrelated to bnt162b2. There was no other possible cause of the event such as any other diseases. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: As per available information,the events are assessed as not related to BNT162B2, and more likely due to past medical history of cerebral ischemia, although the temporal association cannot be excluded. 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: 1688042 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3622 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Body temperature, Dizziness, Dyspnoea, Heart rate, Oxygen saturation
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), 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? 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: 20210825; Test Name: Blood pressure; Result Unstructured Data: Test Result:80/50; Test Date: 20210825; Test Name: Blood pressure; Result Unstructured Data: Test Result:74/40; Test Date: 20210825; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7; Comments: Before vaccination; Test Date: 20210825; Test Name: HR; Result Unstructured Data: Test Result:70; Test Date: 20210825; Test Name: SpO2; Test Result: 97 %; Comments: after vaccination
CDC Split Type: JPPFIZER INC202101106768

Write-up: Anaphylaxis suspected; Giddiness; Dyspnoea; BP 85/50 / blood pressure decreased to 74/40; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21124837. A 20-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: FF3622; Expiration Date: 30Nov2021), dose 1 via an unspecified route of administration on 25Aug2021 12:10 (at the age of 20years) as DOSE 1, SINGLE for Covid-19 immunization. There was no medical history. The patient''s concomitant medications were not reported. The patient was a 20-year and 9-month-old female (age at vaccination). Body temperature before vaccination was 36.7 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 25Aug2021 at 12:20 (10 minutes after the vaccination), the patient experienced anaphylaxis suspected. The course of the event was as follows: after vaccination, the patient complained of giddiness and then dyspnoea appeared. Oxygen saturation (SpO2) 97%, blood pressure (BP) 85/50, heart rate (HR) 70, however, the daily BP was unknown, then received Solu-Cortef 250mg drip. Due to blood pressure decreased to 74/40, Adrenaline was injected intramuscularly, and BP increased, but just in case, the patient was transferred by ambulance. The outcome of the events was unknown. The reporting physician classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: consciousness of the patient was clear and not to be hospitalized, but just in case, the patient was transferred by ambulance. Follow-up attempts are completed. No further information is expected.; Reporter''s Comments: consciousness of the patient was clear and not to be hospitalized, but just in case, the patient was transferred by ambulance.


VAERS ID: 1688043 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: blood pressure; Result Unstructured Data: Test Result:122/76; Test Date: 20210825; Test Name: blood pressure; Result Unstructured Data: Test Result:131/87; Test Date: 20210825; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination; Test Date: 20210825; Test Name: pulse rate; Result Unstructured Data: Test Result:66; Test Date: 20210825; Test Name: pulse rate; Result Unstructured Data: Test Result:77; Test Date: 20210825; Test Name: SpO2; Test Result: 97 %
CDC Split Type: JPPFIZER INC202101106788

Write-up: convulsion; lost consciousness; in a state of Epileptic seizure; in a state of Epileptic seizure; fell from the chair; BP (Blood pressure) 122/76/ last blood pressure 131/87; This is a spontaneous report from a contactable physician received from the Regulatory authority; report number is v21124823. A 52-year-old female patient received the second dose of BNT162B2 (COMIRNATY,Solution for injection), via an unspecified route of administration on 25Aug2021 12:08 (Batch/Lot Number: FF3620; Expiration Date: 30Nov2021) (at the age of 52-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included epilepsy/epileptic seizure from an unknown date and unknown if ongoing. Body temperature before vaccination was 36.1 degrees Centigrade. The patient''s concomitant medications were not reported. On 25Aug2021 at 12:20 (12 minutes after the vaccination), the patient experienced convulsion (medically significant). On unspecified date, the outcome of the event convulsion was recovering. The course of the event was as follows: After vaccination, the patient was observed while sitting in a chair, but fell from the chair (medically significant), lost consciousness (medically significant), and was found to be in a state of epileptic seizure (medically significant). BP (Blood pressure) 122/76, pulse rate 66, SpO2 97%. When the physician arrived, the patient with a clear level of consciousness, responded okay, no other symptoms, it appeared to be a past history of epileptic seizure, and then the patient went home without further seizures on subsequent observation. The last blood pressure and pulse rate were 131/87 and 77. The reporting physician classified the event convulsion as non-serious. The outcome of the event BP (Blood pressure) 122/76/ blood pressure 131/87 was unknown, while outcome of the rest of the events was recovering.


VAERS ID: 1688071 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4204 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Blood pressure systolic, Cough, Diarrhoea, Flushing, Heart rate, Oxygen saturation, Pruritus, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic to cats; Allergic to dogs; Asthma; Pollinosis
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: BP; Result Unstructured Data: Test Result:131/99 mmHg; Comments: 15:26; Test Date: 20210825; Test Name: BP; Result Unstructured Data: Test Result:140/88 mmHg; Comments: 15:52; Test Date: 20210825; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:112 mmHg; Comments: 14:59; Test Date: 20210825; Test Name: P; Result Unstructured Data: Test Result:105; Comments: 15:52 times/min; Test Date: 20210825; Test Name: SPO2; Test Result: 99 %; Comments: 14:59; Test Date: 20210825; Test Name: SPO2; Test Result: 100 %; Comments: 15:26; Test Date: 20210825; Test Name: SPO2; Test Result: 100 %; Comments: 15:52
CDC Split Type: JPPFIZER INC202101110804

Write-up: Diarrhoea; Wheezing; Anaphylaxis; Pruritus facial; Flushed face; Cough/Cough aggravated/dry Cough; This is a spontaneous report from a contactable pharmacist received from the Regulatory authority report number is v21114912. A 12-year and 4-month-old female patient received the first dose of bnt162b2 (COMIRNATY Solution of injection, Lot number FF4204, Expiration date 31Oct2021) intramuscular on 25Aug2021 at 14:30 (at the age of 12-year -old) as a single dose 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). The patient had a medical history of Asthma, Pollinosis, Allergic to cats, Allergic to dogs and no history of Anaphylaxis. Concomitant drugs were unknown. On 25Aug2021 at 14:56 (the day of the vaccination), the patient experienced Anaphylaxis. The course of the event was as follows: On 25Aug 2021 at 14:30, the patient received the vaccination of COMIRNATY intramuscular injection. At 14:55, Pruritus facial, Flushed face, Cough occurred. At 14:59, anaphylaxis was diagnosed and 0.3 mg of Adrenaline injection was intramuscularly injected. Blood pressure systolic was 112mmHg, SpO2 was 99%. After that, OLOPATADINE HYDROCHLORIDE of 5mg was took orally. Methylprednisolone 20 mg was given by drip. Apply for Emergency ambulance car. At 15:26, from the current place, wheezing appeared and Cough aggravated slowly . The Adrenaline injection 0.3 mg was intramuscularly injected again in the ambulance. BP 131/99mmHg, SpO2 100% (oxygen 15 L/min) At 15:52, arriving at the hospital (oxygen 10 L/min). BP 140/88, P 105 times/min, SpO2 100%. (Oxygen 5 L/min) Sometimes dry cough occurred. The symptoms of anaphylaxis improved slightly. There were no rales, no prolonged breathing, no abnormal heart beats and could be heard, and no Urticaria . At 16:41, the patient was given Methylprednisolone 20 mg by drip. After observation and hospitalization the patient was given the treatment of inhaling Sodium Cromoglicate, Procaterol. On 26Aug2021, the patient had diarrhoea twice at night and could eat in the morning, after which he had no symptoms, no abdominal pain, no fever, no itching or redness, clear breath sounds, soft abdomen, and no tenderness, etc. The patient recovered well and was discharged. The reporter classified the event as serious (hospitalization from 24Aug2021 to 26Aug2021) and assessed that the event was related to bnt162b2. The reporter commented as follows: The symptoms appeared after this vaccination, so there is a causal relationship.


VAERS ID: 1688082 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Dizziness, Dyspnoea, Feeling abnormal, Heart rate decreased
SMQs:, Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101111034

Write-up: Anaphylactic shock; Heart rate decreased; Dyspnoea; Feels poorly; Giddiness; This is a spontaneous report from a contactable physician. A 19-year-old male patient received BNT162B2 (COMIRNATY; lot number: FA5765 and expiration date: 30Sep2021), intramuscularly in the left arm on 25Aug2021 at 09:45 (at the age of 19-year-old), dose 1, single for COVID-19 immunisation. The patient had no medical history and the concomitant medications were not reported. The patient had no allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. On 25Aug2021 at 09:45 (after the vaccination), the patient experienced anaphylactic shock, heart rate decreased, dyspnoea, feels poorly and giddiness. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received bosmin subcutaneous injection, physio drip and oxygen. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was recovered. No follow-up attempts are possible; No further information is expected.; Sender''s Comments: Considering the temporal association, a causal association between administration of bnt162b2 and the onset of anaphylactic shock, heart rate decreased, dyspnoea, feels poorly and giddiness cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1688093 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-08-25
   Days after vaccination:68
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (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: JPPFIZER INC202101111902

Write-up: Cerebral haemorrhage/subcortical hemorrhage; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is v21124883. An 88-year-old male patient received dose 2 of BNT162B2 (COMIRNATY, solution for injection) via an unspecified route of administration on 18Jun2021 (at the age of 88-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on 02May2021 as a single dose for COVID-19 immunization. On 25Aug2021 at 01:40 (2 months after the vaccination), the patient experienced cerebral haemorrhage. On 25Aug2021 (68 days after the vaccination), the patient was admitted to the hospital. The course of the event was as follows: At 01:40, the patient experienced consciousness disturbed, and the patient was transferred to the hospital. The patient was diagnosed with subcortical hemorrhage. The outcome of cerebral hemorrhage was unknown. The reporting physician classified the event as serious (hospitalized from 25Aug2021) and assessed that the event was unrelated to BNT162B2. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender''s Comments: Based on the information provided in the narrative, Cerebral Hemorrhage is considered unrelated to the suspect drug.


VAERS ID: 1688104 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Cough, Oropharyngeal discomfort, Swelling of eyelid, Vital signs measurement, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Oral allergy syndrome (due to Cucurbitaceae (melon etc))
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Vital Sign; Result Unstructured Data: Test Result:No aggravation
CDC Split Type: JPPFIZER INC202101112227

Write-up: Concerned about anaphylaxis progression; Pharynx strange sensation of; Tendency to Swelling around the eyelid; Cough; Wheezing; This is a spontaneous report from a contactable physician received from the Regulatory Agency. The regulatory authority report number is v21124846. A 44-year-old female patient received bnt162b2 (COMIRNATY; Batch/Lot Number: EY0572; Expiration Date: 31Oct2021), via an unspecified route of administration, on 25Aug2021 at 14:55 (at the age of 44 years old) as dose 1, single for COVID-19 immunisation. Medical history included asthma and allergy [OAS symptoms due to Cucurbitaceae (melon etc)]. The patient''s concomitant medications were not reported. The event onset date/time were reported as 25Aug2021 at 15:20 (the day of the vaccination). On 25Aug2021 (the day of the vaccination), the outcome of the event was recovering. The course of the event was as follows: The patient received the COVID-19 Vaccine (first dose, Manufacturer: Pfizer). In the about 25 minutes'' observation, the patient had experienced Pharynx strange sensation of, Tendency to Swelling around the eyelid, Cough and Wheezing (medically significant) were admitted. There was no aggravation in Vital Sign. Concerned about anaphylaxis progression, the reporter let the patient visit the nearby hospital (the reporter''s hospital). Only the Pharynx strange sensation of was remained, the other symptoms had tendency of improvement when the patient came to the hospital. Nebulizer with Meptin was conducted to the patient. The patient went back home for the symptoms improvement. The outcome of the events was recovering. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. Reporter''s comment: It could be considered that there was high possibility of the transient allergic reaction was caused by the components of the vaccine.; Reporter''s Comments: It could be considered that there was high possibility of the transient allergic reaction was caused by the components of the vaccine.


VAERS ID: 1688154 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Anaphylactic reaction, Body temperature, Cough, Tachycardia, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to chemicals (to iodine agents); Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: body temperature; Result Unstructured Data: Test Result: 36.4 Centigrade; Comments: before vaccination.
CDC Split Type: JPPFIZER INC202101119352

Write-up: tachycardia; Anaphylaxis; pharynx itchy sensation of; cough; abdominal pain; This is a spontaneous report from a contactable other HCP received from the Regulatory Authority. The Regulatory authority report number is v21125084. A 48-year and 5-month-old female patient received the first dose of bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 25Aug2021 14:00 (Lot Number: FF3620; Expiration Date: 30Nov2021) as single dose (at the age of 48) for covid-19 immunisation. Body temperature before vaccination was 36.4 degrees Centigrade. Medical history included hypertension from an unknown date and unknown if ongoing, allergy to iodine agents from an unknown date and unknown if ongoing to iodine agents. The patient''s concomitant medications were not reported. On 25Aug2021 at 15:00 (1 hour after the vaccination), the patient experienced anaphylaxis. On 25Aug2021 at 14:00, the patient was vaccinated. Since about 15:00, the patient had been aware of pharynx itchy sensation of. At 19:00, as there was no improvement, the patient visited the emergency room. Pharynx itchy sensation of and frequent cough appeared. No apparent sounds of stenosis. The patient experienced abdominal pain on 25Aug2021 15:00. There was no shock, but the patient experienced tachycardia. No obvious skin eruption. The patient said the same symptoms appeared at that time. The patient was diagnosed as anaphylaxis, and the symptom on the throat improved promptly with intravenous POLARAMINE. On 25Aug2021 (the day of the vaccination), the outcome of the events was recovering, except for tachycardia which was unknown. The reporting other HCP classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting other HCP commented the diagnosis of anaphylaxis was considered as reasonable based on the patient''s clinical course, medical history, and response to the treatment. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1688171 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2782 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Dysphoria, Heart rate, Oxygen saturation, Pallor, Presyncope
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: BP; Result Unstructured Data: Test Result:63/- mmHg; Comments: at 13:04; Test Date: 20210825; Test Name: BP; Result Unstructured Data: Test Result:98/60 mmHg; Comments: at 13:20; Test Date: 20210825; Test Name: BP; Result Unstructured Data: Test Result:102/56 mmHg; Comments: at 13:50; Test Date: 20210825; Test Name: HR; Result Unstructured Data: Test Result:60-70; Comments: bpm at 13:04; Test Date: 20210825; Test Name: SpO2; Test Result: 98 %; Comments: at 13:04
CDC Split Type: JPPFIZER INC202101119883

Write-up: vasovagal reflex; BP 63/- mmHg; dysphoria; Complexion ill; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21124942. A 28-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on 25Aug2021 12:50 (Batch/Lot Number: FF2782; Expiration Date: 30Nov2021) (at the age of 28-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history was None. Body temperature before vaccination was not provided. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s concomitant medications were not reported. On 25Aug2021 at 12:50 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY). On 25Aug2021 at 13:04 (12 minutes after the vaccination as reported), the patient experienced vasovagal reflex. The course of the event was as follows: 12 minutes after the vaccination, the patient experienced dysphoria and complexion ill on 25Aug2021 at 13:04. The patient laid down on bed (radial pulse impalpable at this time). BP 63/- mmHg, Spo2 98%, HR 60~70 bpm. With the legs raised, the drip infusion 500 ml was performed. After 20 minutes, BP increased to 98/60 mmHg. After 1 hour and a half, the patient''s BP was 102/56 mmHg. Complexion ill was recovered. There was no blood pressure decreased either in a sitting position or in a standing position, and the patient went home. Therapeutic measures were taken as a result of the events included drip infusion 500 ml was performed. The outcome of the event Complexion ill was resolved in Aug2021 while of the other events was resolving. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented was not provided. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1688213 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-25
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Duodenal ulcer haemorrhage, Haematochezia, Laboratory test, Shock haemorrhagic, Upper gastrointestinal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypovolaemic shock conditions (narrow), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Precise examination; Result Unstructured Data: Test Result:Duodenal ulcer haemorrhage
CDC Split Type: JPPFIZER INC202101134551

Write-up: This is a spontaneous report from a contactable physician received from the Agency. A 71-year-old male patient received BNT162B2 (PFIZER COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on Aug2021 (at the age of 71-year-old) (Lot number and expiration date was not reported) as dose 2, 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). The patient medical history was unknown and concomitant medications were not reported. On 25Aug2021 12:00, the patient was hospitalized because of shock due to discharge blood. Duodenal ulcer haemorrhage as a result of precise examination. The patient had upper gastrointestinal haemorrhage. The patient was treated by clipping and blood transfusion. The outcome of the events was unknown. The reporting physician classified the event as serious (hospitalization), and the causality between the event and BNT162B2 as unassessable. The physician reported that other possible cause of the event such as any other diseases was gastric ulcer. Information on lot/ batch number has been requested.


VAERS ID: 1688278 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004220 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: JPMODERNATX, INC.MOD20213

Write-up: Neuropathy peripheral; This case was received via Pharmaceuticals (Reference number: JP-TAKEDA-2021TJP085736) on 26-Aug-2021 and was forwarded to Moderna on 06-Sep-2021. This case, initially reported to the Agency (A) by a (physician), was received via the A (Ref, v21124815). Peripheral nerve disorder was assessed as serious by the MAH. On an unknown date, body temperature before the vaccination: 36.3 degrees Celsius. On 25-Aug-2021, at 13:50, the patient received the 1st dose of this vaccine. At 14:00, 10 minutes after the vaccination, sensory aberrations developed in the 1st finger of the vaccinated side. There was no movement disorder. Peripheral nerve disorder was suspected. The outcome of peripheral nerve disorder 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. 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: 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: 1688426 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3430 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: blood pressure; Result Unstructured Data: Test Result:170/100
CDC Split Type: PHPFIZER INC202101146323

Write-up: Elevated BP; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300102373. A 28-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection; lot number FE3430 and expiry date not reported), via intramuscular, on 25Aug2021 (at the age of 28-year-old), as dose number unknown, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced elevated BP (blood pressure) on 25Aug2021 11:05. The patient underwent lab tests and procedures which included blood pressure: 170/100 on 25Aug2021. Patient recovered from the event on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1690011 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-08-25
   Days after vaccination:128
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Influenza, SARS-CoV-2 test, SARS-CoV-2 test positive, 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN CALCIUM
Current Illness: Hypercholesterolaemia (Taking atorvastatin regularly)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210828; Test Name: COVID test; Test Result: Positive ; Comments: test done on 27Aug2021, results received on 28Aug2021
CDC Split Type: BEPFIZER INC202101122541

Write-up: COVID-19 PCR test positive; Vaccination failure; Flu symptoms; This is a spontaneous report from a contactable physician. A 49-year-old male patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: EL1484), via intramuscular route of administration, administered in Arm Left on 19Apr2021 as dose 2, single for COVID-19 immunisation. Medical history included hypercholesterolaemia from 2010 and ongoing (Taking atorvastatin regularly). Concomitant medication(s) included Atorvastatin Calcium (Atorvastatin Calcium) taken for hypercholesterolaemia from an unspecified start date and ongoing. The patient had earlier received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot number: EL0725), via an intramuscular route of administration, administered on 29Mar2021 as dose 1, single for COVID-19 immunisation. The patient experienced flu symptoms (loss of smell/taste, cough, joint/back pain, asthenia, headache) on 25Aug2021; COVID-19 PCR test positive, vaccination failure on 28Aug2021. The patient underwent lab tests and procedures which included COVID test (sars-cov-2 test: positive on 28Aug2021 (test done on 27Aug2021, results received on 28Aug2021). Therapeutic measures were taken with paracetamol prn as a result of flu symptoms. The outcome of event Flu symptoms and other events was Recovered on 30Aug2021. Follow-up attempts are completed. No further information is expected. ; Sender''s Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events


VAERS ID: 1690013 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure immeasurable, Blood pressure measurement, Dizziness, Dyspnoea, Hyperhidrosis, Presyncope
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: blood pressure; Result Unstructured Data: Test Result: 8/4; Comments: sudden blood pressure drop.
CDC Split Type: BRPFIZER INC202101127972

Write-up: Sudden blood pressure drop / blood pressure 8/4; could not measure my blood pressure at the first attempt; sights have darken, almost lost the senses; shortness of breath; sweated a lot; dizziness; This is a spontaneous report from a contactable consumer (patient) via the Regulatory Authority. A 29-year-old male patient received bnt162b2 (COMIRNATY), dose 1 at the age of 29-years-old via an unspecified route of administration, administered in Arm Left on 25Aug2021 00:00 (12AM) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took ketoconazole and experienced allergy. The patient did not receive any other vaccines within 4 weeks PRIOR to the COVID-19 vaccine and was not taking any other medications/products within 2 weeks of vaccination. Prior to vaccination he was not diagnosed with COVID-19. The patient reported that on 25Aug2021 00:15 (as reported), he experienced sudden blood pressure drop and shortness of breath approximately 5 minutes (as reported) after taking the vaccine, it started a dizziness which worsened quickly and the sights have darken, he almost lost the senses. Soon he was rescued by the nurse, who could not measure his blood pressure at the first attempt, in the second one they measured, and it was 8/4. He sweated a lot, but after being lying with legs up he started improving. He did not have other symptoms later, just right after taking the vaccine. He is 29 years old, good health, do exercises, and has never had blood pressure drop. The events were considered life-threatening. Therapeutic measures were taken as a result of the events which included lying with legs up. Since the vaccination, the patient was not tested for COVID-19. The patient recovered from the events on an unspecified date. The lot number for bnt162b2 was not provided and has been requested during follow-up.


VAERS ID: 1690248 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-25
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004731 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema induratum, SARS-CoV-2 test
SMQs:, Vasculitis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Induration erythema; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-TO20217328) on 03-Sep-2021 and was forwarded to Moderna on 03-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of ERYTHEMA INDURATUM (Induration erythema) in a 48-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004731) for COVID-19 vaccination. No Medical History information was reported. On 17-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 25-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced ERYTHEMA INDURATUM (Induration erythema) (seriousness criterion medically significant). At the time of the report, ERYTHEMA INDURATUM (Induration erythema) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications was not reported . Treatment history was not reported. Company Comment: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Of note, this event as assessed as serious by the Regulatory Authority. However, the lack of evidence of seriousness from a clinical or regulatory standpoint, none are considered serious. Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Translated doc received on 07-Sep-2021 includes no new information.; Sender''s Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Of note, this event as assessed as serious by the Regulatory Authority. However, the lack of evidence of seriousness from a clinical or regulatory standpoint, none are considered serious.


VAERS ID: 1690266 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia
SMQs:, Arthritis (broad)

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

Write-up: Wrist pain; This case was received (Reference number: GB-MHRA-ADR 25881114) on 02-Sep-2021 and was forwarded to Moderna on 02-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (Wrist pain) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for Corona virus infection. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced ARTHRALGIA (Wrist pain) (seriousness criterion medically significant). At the time of the report, ARTHRALGIA (Wrist pain) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication information was provided by the reporter. No treatment information was provided by the reporter. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the 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: 1690287 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Migraine, 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:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Migraine; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210710; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101111620

Write-up: Migraine; Ache/ Body aches; This is a spontaneous report from a contactable consumer. This report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108251028135520-DLX6B. Safety Report Unique Identifier GB-MHRA-ADR 25846262. A 24-year-old non-pregnant female patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included Lactation decreased, migraine, both from an unspecified date and unknown if ongoing; suspected COVID-19 from 08Jul2021 to an unspecified date and unsure when symptoms stopped. Concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding at the time of report. The patient received first dose of BNT162B2 (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunization. On 25Aug2021, after second vaccination, the patient experienced migraine and aches or body aches. It was reported patient woke up the following morning in the middle of a migraine. Took Advil. Trying to sleep it off. Body aches was the same. Reporter stated that, patient knows what migraines feel like as she had them in the past so she did not need a doctor to confirm. The patient underwent lab tests and procedures which included sars-cov-2 test (COVID-19 virus test) resulted as positive on 10Jul2021. Therapeutic measures were taken as a result of migraine and treatment included Advil. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the events was recovering at the time of report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1690293 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Headache, Myalgia, Oropharyngeal pain, Pyrexia, Suspected COVID-19
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101117685

Write-up: Cough; Sore throat; Muscle ache; Fever; Headache; Suspected COVID-19; This is a spontaneous report from a contactable consumer and non-hcp. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108260822503110-EQCBT. Safety Report Unique Identifier: GB-MHRA-ADR 25852127. A 17-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Batch/Lot number was not reported) via an unspecified route of administration on 24Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at time of vaccination.The Patient was not currently breastfeeding. Medical history included suppressed lactation from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On an unspecified date,The patient experienced cough, sore throat, muscle ache, fever and headache. On 25Aug2021, The patient experienced suspected COVID-19. The patient had not COVID-19 test. The Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. The outcome of the events (Cough, Sore throat, Muscle ache, Fever, Headache and Suspected COVID-19) was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1690301 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EF3308 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Diarrhoea, Hypotension, Loss of consciousness, Oxygen saturation, Respiratory rate, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Blood pressure; Result Unstructured Data: Test Result:91/49; Test Date: 20210825; Test Name: Spo2; Result Unstructured Data: Test Result:98; Test Date: 20210825; Test Name: Resp rate; Result Unstructured Data: Test Result:17
CDC Split Type: GBPFIZER INC202101117872

Write-up: Loose stools; Syncope vasovagal; loose consciousness; Blood pressure 91/49; This is a spontaneous report from a contactable other HCP. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202108261315382800-IYUJI, Safety Report Unique Identifier GB-MHRA-ADR 25853707. A 20-years-old non-pregnant female patient received the second dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, Formulation: Solution for injection, Lot number: EF3308), via an unspecified route of administration, administered in left deltoid on 25Aug2021 (Age at vaccination: 20-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included lactation decreased from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. On 25Aug2021, the patient experienced syncope vasovagal, loss of consciousness, blood pressure 91/49. On an unspecified date, the patient experienced loose stools. The patient had just been given her vaccine in her left deltoid, she immediately started to lock up and loose consciousness, raised her legs and lowered her head, she was out for approximately 30 seconds with no memory of events prior. The patient underwent lab tests and procedures which included blood pressure: 91/49 on 25Aug2021, Spo2: 98 on 25Aug2021, Resp. rate: 17 on 25Aug2021. The outcome of the events syncope vasovagal, loss of consciousness, blood pressure 91/49 was recovered on 25Aug2021 and outcome of the event loose stools was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1690305 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Malaise, Oropharyngeal pain, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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: FOLIC ACID
Current Illness:
Preexisting Conditions: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Sore throat; General malaise; Heart racing; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25856385) on 27-Aug-2021 and was forwarded to Moderna on 27-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart racing), OROPHARYNGEAL PAIN (Sore throat) and MALAISE (General malaise) in a 37-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No medical history was reported. Concomitant products included FOLIC ACID for an unknown indication. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced PALPITATIONS (Heart racing) (seriousness criterion medically significant). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant) and MALAISE (General malaise) (seriousness criterion medically significant). At the time of the report, PALPITATIONS (Heart racing), OROPHARYNGEAL PAIN (Sore throat) and MALAISE (General malaise) had not resolved. Treatment information was not provided. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of 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 events, a causal relationship cannot be excluded.


VAERS ID: 1690306 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Lymphadenopathy, Peripheral swelling, SARS-CoV-2 test, Vaccination site pain, Vaccination site swelling
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:
Allergies:
Diagnostic Lab Data: Test Date: 20201025; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101117762

Write-up: Arm at injection site is very sore and swollen; Arm at injection site is very sore and swollen; Armpit pain; Swollen lymph nodes; Swollen arm; This is a spontaneous report from a contactable consumer or other non HCP. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108262127432690-HSHET. A 18-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: FE3380), dose 1 via an unspecified route of administration on 25Aug2021 as a single dose for COVID-19 immunization. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient experienced swollen lymph nodes, armpit pain on 26Aug2021, and swollen arm on 25Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: yes - positive covid-19 test on 25Oct2020. Glands in armpit on the side the vaccine was administered are very swollen and painful. Arm at injection site is very sore and swollen. The outcome of the event arm at injection site was very sore and swollen was unknown and the outcome of the event other events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1690331 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Headache, Influenza, Limb discomfort
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: CITALOPRAM HYDROBROMIDE
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Arm discomfort, stomach cramps, flu symptoms, headache; Arm discomfort, stomach cramps, flu symptoms, headache; Arm discomfort, stomach cramps, flu symptoms, headache; Arm discomfort, stomach cramps, flu symptoms, headache; This case was received via Regulatory Authorities MHRA (Reference number: GB-MHRA-ADR 25853088) on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm discomfort, stomach cramps, flu symptoms, headache), ABDOMINAL PAIN UPPER (Arm discomfort, stomach cramps, flu symptoms, headache), INFLUENZA (Arm discomfort, stomach cramps, flu symptoms, headache) and HEADACHE (Arm discomfort, stomach cramps, flu symptoms, headache) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included CITALOPRAM HYDROBROMIDE for an unknown indication. On 24-Aug-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) 1 dosage form. On 25-Aug-2021, the patient experienced LIMB DISCOMFORT (Arm discomfort, stomach cramps, flu symptoms, headache) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Arm discomfort, stomach cramps, flu symptoms, headache) (seriousness criterion medically significant), INFLUENZA (Arm discomfort, stomach cramps, flu symptoms, headache) (seriousness criterion medically significant) and HEADACHE (Arm discomfort, stomach cramps, flu symptoms, headache) (seriousness criterion medically significant). At the time of the report, LIMB DISCOMFORT (Arm discomfort, stomach cramps, flu symptoms, headache), ABDOMINAL PAIN UPPER (Arm discomfort, stomach cramps, flu symptoms, headache), INFLUENZA (Arm discomfort, stomach cramps, flu symptoms, headache) and HEADACHE (Arm discomfort, stomach cramps, flu symptoms, headache) had not resolved. 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 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 events, a causal relationship cannot be excluded.


VAERS ID: 1690336 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dehydration, Fatigue, Headache, Pyrexia, SARS-CoV-2 test, Skin warm, Sleep disorder, Tension headache
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: headache; boiling hot to touch; sleep slot; tiredness; shivering; Fever; Tension headache; Dehydration; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25858383) on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (headache), SKIN WARM (boiling hot to touch), SLEEP DISORDER (sleep slot), FATIGUE (tiredness), CHILLS (shivering), PYREXIA (Fever), TENSION HEADACHE (Tension headache) and DEHYDRATION (Dehydration) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Headache. Concomitant products included PARACETAMOL from 25-Aug-2021 to 27-Aug-2021 for Pain relief. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), TENSION HEADACHE (Tension headache) (seriousness criterion medically significant) and DEHYDRATION (Dehydration) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant), SKIN WARM (boiling hot to touch) (seriousness criterion medically significant), SLEEP DISORDER (sleep slot) (seriousness criterion medically significant), FATIGUE (tiredness) (seriousness criterion medically significant) and CHILLS (shivering) (seriousness criterion medically significant). On 27-Aug-2021, PYREXIA (Fever), TENSION HEADACHE (Tension headache) and DEHYDRATION (Dehydration) had resolved. At the time of the report, HEADACHE (headache), SKIN WARM (boiling hot to touch), SLEEP DISORDER (sleep slot), FATIGUE (tiredness) and CHILLS (shivering) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided The patient experienced Fever started approx 12 hrs after, Boiling hot to touch , felt freezing cold and shivering. Approx 12-14hrs in pressure headache and front of the skull above the eyes. 14hrs plus, very thirsty, Woke up every 2 hrs. Approx 24-36hrs fever gone, now just cold sweats. Tiredness through. Needed to sleep slot within the first 36hrs. Patient is not enrolled in clinical trial Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1690343 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Hyperhidrosis, Myalgia, Nausea, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101118971

Write-up: Nausea; Myalgia; Sweating; Shivers; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108271133301030-KLKJL.Safety Report Unique Identifier GB-MHRA-ADR 25858916. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Aug2021 as DOSE 2, SINGLE for COVID-19 immunization. Medical history included suspected COVID-19 from 09Jul2021 to 30Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunization. The patient''s concomitant medications were not reported. On 25Aug2021, the patient experienced nausea, myalgia, sweating, shivers and headache; all (medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 09Jul2021 (Yes - Positive COVID-19 test). The outcome of the events myalgia and shivers was recovering and for the remaining events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1690348 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Infection, Myalgia, Peripheral swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101118698

Write-up: localised infection to arm; small circular red patch; sore muscles in under arm and in collarbone; Infection; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108271302559760-KFIVE, safety report unique identifier is GB-MHRA-ADR 25859397. A 20-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), via an unspecified route of administration on 25Aug2021 (at the age of 20-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history included suppressed lactation, suspected covid-19; Unsure when symptoms started Unsure when symptoms stopped. The patient took the historical vaccine of first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and Expiration date was unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient''s concomitant medications were not reported. Not had a COVID-19 test. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19, since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date the patient experienced localized infection to arm, small circular red patch, sore muscles in under arm and in collarbone; on 25Aug2021, the patient experienced infection. The clinical outcome of the events localized infection to arm, small circular red patch, sore muscles in under arm and in collarbone was unknown; Infection was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1690352 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Pain in extremity, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (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: AMLODIPINE
Current Illness: Blood pressure high
Preexisting Conditions: Comments: Currently on Amlodipine (blood Pressure Tabs) Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Swelling; Sore arm; Dizzy spells; Light headedness; Dizziness; This case was received via regulatory authority (Reference number: ADR 25859554) on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SWELLING (Swelling), PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizzy spells), DIZZINESS (Light headedness) and DIZZINESS (Dizziness) in a 41-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. Currently on Amlodipine (blood Pressure Tabs) Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE for Blood pressure. On 22-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant). On an unknown date, the patient experienced SWELLING (Swelling) (seriousness criterion medically significant), PAIN IN EXTREMITY (Sore arm) (seriousness criterion medically significant), DIZZINESS (Dizzy spells) (seriousness criterion medically significant) and DIZZINESS (Light headedness) (seriousness criterion medically significant). At the time of the report, SWELLING (Swelling), PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizzy spells) and DIZZINESS (Light headedness) outcome was unknown and DIZZINESS (Dizziness) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. It was reported that after first vaccination, patient was fine and only had sore arm for a day. After second vaccination, on 23-Aug-2021 patient experienced events struggled to wake from bed, headache, swelling away from the injection area. On 24-Aug-2021 patient experienced dizzy spells and light headedness. 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: 1690370 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dry mouth, Headache, Hyperhidrosis, Piloerection, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypoglycaemia (broad), Dehydration (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: CETIRIZINE HYDROCHLORIDE; FEXOFENADINE HYDROCHLORIDE; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Sweating; Goose bumps; Headache; Dry mouth; Chills; This case was received via a Regulatory Authority (Reference number: GB-MHRA-ADR 25862745) on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PILOERECTION (Goose bumps), HEADACHE (Headache), DRY MOUTH (Dry mouth), CHILLS (Chills) and HYPERHIDROSIS (Sweating) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not known) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included CETIRIZINE HYDROCHLORIDE and FEXOFENADINE HYDROCHLORIDE for Allergy, PARACETAMOL from 26-Aug-2021 to an unknown date for Headache. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced DRY MOUTH (Dry mouth) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 26-Aug-2021, the patient experienced PILOERECTION (Goose bumps) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 27-Aug-2021, the patient experienced HYPERHIDROSIS (Sweating) (seriousness criterion medically significant). On 27-Aug-2021, CHILLS (Chills) had resolved. At the time of the report, PILOERECTION (Goose bumps), HEADACHE (Headache), DRY MOUTH (Dry mouth) and HYPERHIDROSIS (Sweating) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. 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 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. However, underlying medical history of headache and use of concomitant medication could probably be contributory factors to the events.; 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. However, underlying medical history of headache and use of concomitant medication could probably be contributory factors to the events.


VAERS ID: 1690376 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cold burn, Diarrhoea, Extrapyramidal disorder, Headache, Hypoaesthesia, Nausea, Pain in extremity, Platelet count, Pyrexia, SARS-CoV-2 test, White blood cell count
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Irritable bowel syndrome (probable); Lactose intolerance; Platelets abnormal ((150 with lower limit 150)); WBC abnormal (low WBC (3.5 with lower limit 4.5))
Preexisting Conditions: Medical History/Concurrent Conditions: T3 decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 2021; Test Name: WBC; Result Unstructured Data: 3.5 with lower limit 4.5; Test Date: 2021; Test Name: Platelets; Result Unstructured Data: 150 with lower limit 150
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Headache; Fever; Nausea; Cold burn; Numbness in toes; Numbness facial; Body numbness; Diarrhea; Unilateral leg pain; Benign shuddering attacks; This case was received via Regulatory Authority (Reference number: 25862995) on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), HEADACHE (Headache), PYREXIA (Fever), COLD BURN (Cold burn), HYPOAESTHESIA (Numbness in toes), HYPOAESTHESIA (Numbness facial), HYPOAESTHESIA (Body numbness), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Unilateral leg pain) and EXTRAPYRAMIDAL DISORDER (Benign shuddering attacks) in a 45-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included T3 decreased. Concurrent medical conditions included Lactose intolerance, Irritable bowel syndrome (probable), WBC abnormal (low WBC (3.5 with lower limit 4.5)) and Platelets abnormal ((150 with lower limit 150)). On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced COLD BURN (Cold burn) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness in toes) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness facial) (seriousness criterion medically significant), HYPOAESTHESIA (Body numbness) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) (seriousness criterion medically significant), PAIN IN EXTREMITY (Unilateral leg pain) (seriousness criterion medically significant) and EXTRAPYRAMIDAL DISORDER (Benign shuddering attacks) (seriousness criterion medically significant). On 26-Aug-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 27-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 25-Aug-2021, HYPOAESTHESIA (Numbness facial) and PAIN IN EXTREMITY (Unilateral leg pain) had resolved. On 27-Aug-2021, PYREXIA (Fever) and EXTRAPYRAMIDAL DISORDER (Benign shuddering attacks) had resolved. On 28-Aug-2021, HEADACHE (Headache) and HYPOAESTHESIA (Numbness in toes) had resolved. At the time of the report, NAUSEA (Nausea) was resolving and COLD BURN (Cold burn), HYPOAESTHESIA (Body numbness) and DIARRHOEA (Diarrhea) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Platelet count: 150 (Low) 150 with lower limit 150. In 2021, White blood cell count: 3.5 (Low) 3.5 with lower limit 4.5. On 25-Aug-2021, SARS-CoV-2 test: negative negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Treatment information was not provided. Company Comment: This case concerns a 45-year-old female with serious unexpected events of headache, nausea, diarrhoea, cold burn, hypoaesthesia, pain in extremity, pyrexia, and extrapyramidal disorder (shuddering). Event latency within 24 hours after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This case concerns a 45-year-old female with serious unexpected events of headache, nausea, diarrhoea, cold burn, hypoaesthesia, pain in extremity, pyrexia, and extrapyramidal disorder (shuddering). Event latency within 24 hours after 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: 1690377 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Migraine, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: headache; Shivering; Migraine; This case was received via Regulatory Authority (RA) (Reference number: GB-MHRA-ADR 25863584) on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (Shivering) and MIGRAINE (Migraine) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). At the time of the report, HEADACHE (headache) and CHILLS (Shivering) had resolved and MIGRAINE (Migraine) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. Concomitant medications was not reported. Patient had not tested positive for COVID-19 since having the vaccine. Patient''s temperature was normal. Treatment drug included Paracetamol. Company comment: Based on the current available information and temporal association between the use of the product and the start date of 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 events, a causal relationship cannot be excluded.


VAERS ID: 1690409 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chest pain, Dyspnoea, Nausea, Pyrexia, Rash, Rash macular, Rash pruritic, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Peanut allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: temperature; Result Unstructured Data: Test Result:high
CDC Split Type: GBPFIZER INC202101126401

Write-up: my face neck and upper shoulders went purple with a blotchy; Facial rash; Vomiting; itchy rash; Chest pain; Breathlessness; nauseous; High temperature; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202108290751498070-YWKS1. Safety Report Unique Identifier: GB-MHRA-ADR 25865356. A 23-year-old male patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection, Lot Number: Fe3380), via an unspecified route of administration on 25Aug2021 (at the age of 23-year-old)) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included food allergy, Peanut allergy, asthma from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and not had a Covid-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient previously received first dose of bnt162b2 for COVID-19 immunization. The Patient started feeling nauseous about an hour after the injection the next day Patient started feeling breathless and still nauseated. on Friday it continued and on the evening his heart felt sore on Saturday at around 3 pm his face neck and upper shoulders went purple with a blotchy none itchy rash Patient vomited could not get through to 111 went to bed. Today Sunday still feeling breathless and nauseous will contact GP tomorrow. The patient got facial rash on 28Aug2021, high temperature on 25Aug2021. Outcome of Event rash was recovered in Aug2021, itchy rash was recovering, and other events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1690413 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autoimmune disorder, Back pain, Chills, Depression, Fatigue, Headache, Pyrexia, SARS-CoV-2 test, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test; Comments: Patient has not tested positive for COVID-19 since having the vaccine
CDC Split Type: GBPFIZER INC202101126379

Write-up: The patient main concern was that it was not known what caused autoimmune disease however it was thought an abnormal response from the immune system was one.; Depression; slept all of next morning; Fatigue; Fever; Chills; Headache; Back ache; This is a spontaneous report from Regulatory Authority. This is a report received from the Regulatory Authority. Regulatory authority report number [GB-MHRA-WEBCOVID-202108290939480640-J7XAY], Safety Report Unique Identifier [GB-MHRA-ADR 25865423]. A 27-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 25Aug2021 (age at the time of vaccination was 27-year-old) as dose 1, single for COVID-19 immunization. Medical history included suppressed lactation from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, suspected covid-19 from 30Jun2021 to an unknown date (Unsure when symptoms stopped). The patient''s concomitant medications were not reported. The patient was not enrolled in clinical trial. The patient was not currently breastfeeding. It was reported that the patient experienced fever, chills, headache, back ache, fatigue on 25Aug2021 and depression on 27Aug2021. The patient reported that the fever was very acute for a few hours at night before settling a little but lasted until the next day. The patient slept all of next morning (26Aug2021). The patient was concerned about this strong immune response without active virus for the body to attack. The patient main concern was that it was not known what caused autoimmune disease however it was thought an abnormal response from the immune system was one. That was exactly what the vaccine ilicits, as the virus does not exist in the first place for the body to fight. A lot of info can be found online saying ''no evidence'' of this. However, with no explanation of why or any evidence provided to say that this was definitely not an effect of the vaccine. The patient felt concerned about the next one until then she had more answers. The vaccine had also made the patient feel very depressed which the patient does not understand. The patient had no reason to feel so sad, but the patient does and cannot understand where it had come from. This was new to the patient and the patient do not suffer from depression or felt sad without reasons but felt considerably out of sorts since having it, which was making the patient question, why. The patient underwent lab tests and procedures which included COVID-19 virus test yes (positive covid-19 test) on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. The case was reported as serious with seriousness criteria disability. Outcome of the event chills was reported as recovered with sequel on 26Aug2021, fever was reported as recovered with sequel on 27Aug2021, headache was reported as recovered on an unspecified date in 2021, back ache, depression and fatigue was reported as not recovered and unknown for slept all of next morning and autoimmune disorder at this time of the report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1690418 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-25
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; Comments: No other relevant history. Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: Multiple blood tests; Result Unstructured Data: Test Result:Unknown; Test Date: 20210827; Test Name: ecg; Result Unstructured Data: Test Result:Unknown; Test Date: 20210827; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101126350

Write-up: bleeding; loose stools; stomach pains; Diarrhea; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108291127375100-DORCH. Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25865519. A patient of 26-year-old age of an unspecified gender received second dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was FF3319), second dose via an unspecified route of administration on 15Aug2021 at unknown DOSE 2, SINGLE for COVID-19 immunization. Medical history included clinical trial participant. No other relevant history. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced bleeding on an unspecified date, loose stools (diarrhoea) on an unspecified date, stomach pains on an unspecified date, diarrhoea on 25Aug2021. 10 days after receiving vaccine began loose stools which worsened over the next 4 days, watery, stomach pains and unable to hold any food. By day four bleeding from back passage and taken to Hospital. Most checks seem ok but symptoms ongoing. For this to be viral there would need to have been contact but I am shielding from CV19 extensively and so is the one person patient live with. Patient have never had bleeding like this before. Bloods do not show patient fighting an infection and we have both eaten the same foods. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 27Aug2021 No - Negative COVID-19 test, blood test: unknown on 27Aug2021, electrocardiogram: unknown on 27Aug2021. The outcome of Event for diarrhea was not recovered and for others was recovering. Narrative case summary and further information: 10 days after receiving vaccine began loose stools which worsened over the next 4 days, watery, stomach pains and unable to hold any food. By day four bleeding from back passage and taken to Hospital. Most checks seem ok but symptoms ongoing. For this to be viral there would need to have been contact but I am shielding from CV19 extensively and so is the one person patient live with. Patient have never had bleeding like this before. Bloods do not show patient fighting an infection and we have both eaten the same foods. Patient has not tested positive for COVID-19 since having the vaccine No follow-up attempts possible. No further information expected.


VAERS ID: 1690429 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Illness, Influenza like illness, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101126465

Write-up: Tiredness; Flu-like aching; Sickness; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108291309552420-ALVSC, safety report unique identifier is GB-MHRA-ADR 25865605. A 31-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: solution for injection, Lot number was not reported) via an unspecified route of administration on 25Aug2021 as dose 2, single (at the age of 31-year-old) for COVID-19 immunization. Medical history included lactation decreased, suspected COVID-19 (unsure when symptoms started and unsure when symptoms stopped). Patient is not pregnant and is not currently breastfeeding. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient''s concomitant medications were not reported. The patient experienced headache; sickness on 25Aug2021; tiredness, flu-like aching on 26Aug2021. The events were assessed as serious medically significant. The patient underwent lab test which included COVID-19 virus test which showed negative (No-Negative COVID-19 test) on an unknown date. Patient is not enrolled in clinical trial. The outcome of the event sickness was recovered on 29Aug2021 and rest all recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1690437 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Headache, Illness, Limb discomfort
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy; Raynauds
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101126328

Write-up: Headache; Sickness; Breathing difficult; Heavy feeling in arms + leg; Tiredness; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108291915219520-OOBWB, Safety Report Unique Identifier GB-MHRA-ADR 25865871. A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on 24Aug2021 as dose 1, single for COVID-19 immunization. Medical history included pregnancy and raynauds. Patient had not symptoms associated with COVID-19. The patient''s concomitant medications were not reported. Patient did not have a COVID-19 test. On 25Aug2021, experienced headache, sickness, breathing difficult, heavy feeling in arms + leg, tiredness. The symptoms extreme to the point of almost phoning an ambulance. Day 4 the events were unresolved and contacted 111. The case was assessed as serious (disability, medically significant). Patient was not enrolled in clinical trial. Outcome of the event sickness, breathing difficult and tiredness was not resolved, and events headache and Heavy feeling in arms + leg were resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1690478 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Migraine, Myalgia, Nerve injury, Pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
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.MOD20213

Write-up: Dizziness; Pain; Nerve damage; Migraine headache; Muscle pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25878925) on 02-Sep-2021 and was forwarded to Moderna on 02-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN (Pain), NERVE INJURY (Nerve damage), MIGRAINE (Migraine headache) and MYALGIA (Muscle pain) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced NERVE INJURY (Nerve damage) (seriousness criteria hospitalization, disability and medically significant), MIGRAINE (Migraine headache) (seriousness criteria hospitalization, disability and medically significant) and MYALGIA (Muscle pain) (seriousness criteria hospitalization, disability and medically significant). On an unknown date, the patient experienced DIZZINESS (Dizziness) (seriousness criteria hospitalization, disability and medically significant) and PAIN (Pain) (seriousness criteria hospitalization, disability and medically significant). At the time of the report, DIZZINESS (Dizziness) and PAIN (Pain) had resolved and NERVE INJURY (Nerve damage), MIGRAINE (Migraine headache) and MYALGIA (Muscle pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. 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: 1690490 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

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

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

Write-up: Faint; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25880360) on 02-Sep-2021 and was forwarded to Moderna on 02-Sep-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of SYNCOPE (Faint) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant). On 25-Aug-2021, SYNCOPE (Faint) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Company comment Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1690514 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Cluster headache, Organic erectile dysfunction, Pyrexia, Rhinalgia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow), Sexual dysfunction (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CERELLE; SERTRALINE
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Had my vaccine early morning; Nasal pain; SARS-CoV-2 infection; Cluster headache; Fever; This case was received via regulatory authority (Reference number: 25886125) on 03-Sep-2021 and was forwarded to Moderna on 03-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of COVID-19 (SARS-CoV-2 infection), CLUSTER HEADACHE (Cluster headache), RHINALGIA (Nasal pain), PYREXIA (Fever) and ORGANIC ERECTILE DYSFUNCTION (Had my vaccine early morning) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Suspected COVID-19 since 25-Aug-2021. Concomitant products included SERTRALINE for Antidepressant therapy, DESOGESTREL (CERELLE) for Contraception. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced CLUSTER HEADACHE (Cluster headache) (seriousness criteria disability and medically significant) and PYREXIA (Fever) (seriousness criteria disability and medically significant). On 26-Aug-2021, the patient experienced COVID-19 (SARS-CoV-2 infection) (seriousness criteria disability and medically significant). On 27-Aug-2021, the patient experienced RHINALGIA (Nasal pain) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced ORGANIC ERECTILE DYSFUNCTION (Had my vaccine early morning) (seriousness criteria disability and medically significant). At the time of the report, COVID-19 (SARS-CoV-2 infection), CLUSTER HEADACHE (Cluster headache), RHINALGIA (Nasal pain) and PYREXIA (Fever) had not resolved and ORGANIC ERECTILE DYSFUNCTION (Had my vaccine early morning) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Patient is was not enrolled in clinical trial. company comment:Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of COVID 19 is assessed as not applicable. Based on the current available information and temporal association between the use of the product and other reported events, a causal relationship cannot be excluded. Coding, seriousness, and dates of events were captured as per Regulatory Authority assessment provided in Source Document. No further information is expected.; Sender''s Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of COVID 19 is assessed as not applicable. Based on the current available information and temporal association between the use of the product and other reported events, a causal relationship cannot be excluded. Coding, seriousness, and dates of events were captured as per Regulatory Authority assessment provided in Source Document. No further information is expected.


VAERS ID: 1690522 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Burning sensation, Cough, Dizziness
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), 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? No
Previous Vaccinations:
Other Medications:
Current Illness: Burning sensation; Coughing; Oral ulceration.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: burning sensation; coughing; dizzy; Acute anaphylaxis; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25887711) on 03-Sep-2021 and was forwarded to Moderna on 03-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Acute anaphylaxis), BURNING SENSATION (burning sensation), COUGH (coughing) and DIZZINESS (dizzy) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. Concurrent medical conditions included Burning sensation, Coughing and Oral ulceration. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced ANAPHYLACTIC REACTION (Acute anaphylaxis) (seriousness criterion medically significant). On an unknown date, the patient experienced BURNING SENSATION (burning sensation) (seriousness criterion medically significant), COUGH (coughing) (seriousness criterion medically significant) and DIZZINESS (dizzy) (seriousness criterion medically significant). On 25-Aug-2021, ANAPHYLACTIC REACTION (Acute anaphylaxis) had resolved. At the time of the report, BURNING SENSATION (burning sensation), COUGH (coughing) and DIZZINESS (dizzy) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. After 15 minutes, patient began to get an uncomfortable feeling from her throat to her stomach. This was shortly followed with a burning sensation on all of her skin, her face became tight and numb, throat began to close and immediately started coughing. She became dizzy. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious. No further information is expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious. No further information is expected.


VAERS ID: 1690553 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-08-25
   Days after vaccination:210
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER PV46662 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Dyspnoea, Hypersensitivity, Illness, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACICLOVIR
Current Illness: Allergic reaction; Allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201119; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: allergic reaction; allergy; after 5 hours waiting; Shivering; Difficulty breathing; Sickness; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 25888785) on 03-Sep-2021 and was forwarded to Moderna on 03-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction), HYPERSENSITIVITY (allergy), DYSPNOEA (Difficulty breathing), ILLNESS (Sickness), ARTHRALGIA (after 5 hours waiting) and CHILLS (Shivering) in a 61-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 19-Nov-2020 to 25-Nov-2020. Concurrent medical conditions included Allergic reaction and Allergy. Concomitant products included ACICLOVIR from 14-Jul-2021 to 19-Jul-2021 for Shingles. On 27-Jan-2021, the patient received first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced DYSPNOEA (Difficulty breathing) (seriousness criterion medically significant), ILLNESS (Sickness) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction) (seriousness criterion medically significant), HYPERSENSITIVITY (allergy) (seriousness criterion medically significant) and ARTHRALGIA (after 5 hours waiting) (seriousness criterion medically significant). On 25-Aug-2021, DYSPNOEA (Difficulty breathing), ILLNESS (Sickness) and CHILLS (Shivering) had resolved. At the time of the report, HYPERSENSITIVITY (allergic reaction), HYPERSENSITIVITY (allergy) and ARTHRALGIA (after 5 hours waiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Nov-2020, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient had allergic reaction to Astra Zeneca in January 2021. The patient received dose of Moderna by Allergy clinic at a local hospital, following allergy tests for Astra Zeneca and Moderna. Allergy tests showed reaction to AZ but not Moderna. Due to that, on the day at the clinic, Moderna vaccine given as second dose. Reaction occurred 9 hours after the vaccination and at 9pm that evening, arm marks from injections became vivid on both test sites (only AZ site showed a reaction in the clinic). Due to that, the patient went to Accident and Emergency (A&E) and after 5 hours of waiting, reaction had ceased. A&E doctor gave anti-histamines as a precaution. Blood pressure and blood test of the patient were ok. 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. However, underlying medical history of suspected COVID-19, allergic reaction and allergy. are cofounder.; 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. However, underlying medical history of suspected COVID-19, allergic reaction and allergy. are cofounder.


VAERS ID: 1690577 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Diarrhoea, Headache, Nausea, Rhinorrhoea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (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: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101118845

Write-up: Headache; Nausea; Joint pain; Diarrhea; Runny nose; This is a solicited report from the Regulatory Authority from a contactable consumer. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-YCVM-202108270845112920-0YLOB. Safety Report Unique Identifier [GB-MHRA-ADR 25858398]. A 22-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 25Aug2021(Age at vaccination: 22-year-old) as DOSE 2 SINGLE for covid-19 immunisation. Medical history included depression from an unknown date and unknown if ongoing. Concomitant medication(s) included citalopram taken for depression from 01Dec2019 to an unspecified stop date. Historical Vaccine received bnt162b2 (BNT162B2, Batch/Lot number was not reported) via an unspecified route of administration on un specified date as DOSE 1,SINGLE for covid-19 immunisation. On 25Aug2021, The patient experienced runny nose. On 26Aug2021, the patient experienced headache, nausea, joint pain and diarrhoea.The Patient had not symptoms associated with COVID-19. The Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No - Negative COVID-19 test. The outcome of the events (headache, runny nose, nausea, joint pain and diarrhoea) was recovered on 27Aug2021. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.; Sender''s Comments: The events of Headache, Nausea, Rhinorrhoea, Diarrhoea, Arthralgia are assessed as possibly related to the suspect drug bnt162b2 based on strong temporal association, but consider also possible contributory effects from patient''s medical history and/or concomitant medications. 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: 1690998 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004222 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Blood Pressure; Result Unstructured Data: High
CDC Split Type: PHMODERNATX, INC.MOD20213

Write-up: Elevated Blood Pressure 190/110; This regulatory authority case was reported by an other health care professional and describes the occurrence of BLOOD PRESSURE INCREASED (Elevated Blood Pressure 190/110) in a 52-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3004222) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced BLOOD PRESSURE INCREASED (Elevated Blood Pressure 190/110) (seriousness criterion hospitalization). At the time of the report, BLOOD PRESSURE INCREASED (Elevated Blood Pressure 190/110) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2021, Blood pressure measurement: 190/110 (High) High. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Company Comment: Very limited information regarding this event had been provided at this time. No further information is expected at this time.; Sender''s Comments: Very limited information regarding this event had been provided at this time. No further information is expected at this time.


VAERS ID: 1694041 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FEXOFENADINE; SALBUTAMOL; VENTOLINE [SALBUTAMOL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Faint; Feeling unwell; Floppy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: dizzy; Dizziness; Shivering; Tenseness; Fainting; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25894023) on 05-Sep-2021 and was forwarded to Moderna on 05-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting), DIZZINESS (dizzy), DIZZINESS (Dizziness), CHILLS (Shivering) and TENSION (Tenseness) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Feeling unwell, Faint and Floppy. Concomitant products included SALBUTAMOL and SALBUTAMOL (VENTOLINE [SALBUTAMOL]) for Asthma, FEXOFENADINE for Hay fever. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant) and TENSION (Tenseness) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (dizzy) (seriousness criterion medically significant). On 25-Aug-2021, SYNCOPE (Fainting) had resolved. On 26-Aug-2021, CHILLS (Shivering) had resolved. On 28-Aug-2021, DIZZINESS (Dizziness) had resolved. At the time of the report, DIZZINESS (dizzy) and TENSION (Tenseness) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient stated she was feeling dizzy about 8 hours after having the vaccine. She got up in the middle of the night to use the toilet was feeling extremely dizzy and shivery and fainted, waking up a bit later on the bathroom floor and a graze on her forehead. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. No treatment medication 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. Seriousness of the events are based on the Regulatory Report received. As per medical judgement the events for this case are non-serious. As this a RA, reported events seriousness is kept as per RA assessment.; 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.Seriousness of the events are based on the Regulatory Report received. As per medical judgement the events for this case are non-serious. As this a RA, reported events seriousness is kept as per RA assessment.


VAERS ID: 1697176 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7053 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Hypotension, Paraesthesia, Pharyngeal swelling, Respiratory arrest, Respiratory disorder, Tachycardia
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101142537

Write-up: Facial paresthesia; Respiratory problems; Swelling of the throat; Tachycardia; Anaphylaxis; Hypotension; Respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the BE-FAMHP-DHH-N2021-105767. A 14-year-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: FE7053) dose 2 via an unspecified route of administration on 25Aug2021 (at the age of 14 years old) as dose 2, single for COVID-19 immunisation. Patient had no known allergies. The patient medical history was not reported. Historical vaccine includes Comirnaty on an unspecified date as dose 1 for COVID-19 immunisation. Concomitant medication was not reported. On 25Aug2021, the patient experienced facial paraesthesia, respiratory problems, swelling of the throat, tachycardia, anaphylaxis, hypotension, respiratory arrest. Therapeutic measures were taken as a result of facial paraesthesia, respiratory problems, swelling of the throat, tachycardia, anaphylaxis, hypotension, respiratory arrest and included with treatment Epipen evolution of the ADR which gives immediate reaction after injecting Epipen after 3 minutes. The clinical outcome of the events was recovering. Heath Authority Comments: Treatment: Epipen Evolution of the ADR: Improving Reporter''s comment: Immediate reaction after injection of Epipen after 3 minutes. No follow-up attempts possible. No further information expected.


VAERS ID: 1697289 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-08-25
   Days after vaccination:198
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK5788 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: PCR test; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: BEPFIZER INC202101150008

Write-up: Despite vaccination still tested positive and still became sick; Despite vaccination still tested positive and still became sick; still became sick; This is a spontaneous report from a non-contactable consumer. A 36-year-old male patient received bnt162b2 (COMIRNATY, Lot Number: EK5788), dose 2 via an unspecified route of administration, administered in Arm Left on 08Feb2021 13:30 (at the age of 36-years-old) as a single dose for covid-19 immunization and received bnt162b2 (COMIRNATY, Lot Number: EM0477), dose 1 via an unspecified route of administration, administered in Arm Left on 18Jan2021 (at the age of 36-years-old) as a single dose for covid-19 immunization. The patient reported that he has no medical history. The patient''s concomitant medications were not reported. It was reported that despite vaccination the patient still tested positive and still became sick on 25Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on 25Aug2021 Nasal Swab. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1697295 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Hypersensitivity, Hypoaesthesia oral, Pain, Paraesthesia, Pruritus, Swelling, Swelling face, Throat tightness, Vaccination site pain
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202101126510

Write-up: swelling; tingling/my spine was tingling; itching; face swelling; tongue numbness; throat closing; a lot of pain in the body; tiredness; felt pain at the injection site; allergic reaction; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 34-year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number was not reported), via an unspecified route of administration on 25Aug2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient received the Pfizer vaccine on Wednesday and had been feeling an allergic reaction and doesn''t know what to do. She went to an emergency care unit and received an antiallergic but the symptoms continue. The patient received the vaccine on 25Aug2021 and felt pain at the injection site that day. On 26Aug2021, the patient experienced a lot of pain in the body and tiredness. On 27Aug2021, the patient felt swelling, tingling, itching, face swelling, tongue numbness, throat closing and spine was tingling. Therapeutic measures taken included Phenergan, Dipyrone and loratadine. Clinical outcome of the events was resolving. The batch number has been requested in follow-up activities.


VAERS ID: 1697726 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCKX7 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101131244

Write-up: Syncope; Pyrexia; Nausea; Vomiting; This is a spontaneous report from a non-contactable physician downloaded from a regulatory authority. regulatory authority number DE-PEI-202100177424. A 13-year-old male patient received second dose of bnt162b2 (COMIRNATY, Strength 0.3 mL), via an unspecified route of administration on 24Aug2021 (Lot Number: SCKX7) as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Historical Vaccine included first dose of Comirnaty on 28Jul2021 (Strength 0.3 mL) for COVID-19 immunization. The patient experienced vomiting on 25Aug2021, syncope on 26Aug2021, pyrexia on 25Aug2021, nausea on 25Aug2021. Serious criteria was reported as medically significant. The outcome of the events were not resolved. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1698112 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2832 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Hypotension, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Vitiligo
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101131359

Write-up: Faint/postprandial vasovagal syncope; postprandial hypotension; loss of consciousness; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority number ES-AEMPS-985624. A 28-years-old male patient received second dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 24Aug2021 (Batch/Lot Number: FF2832) as 0.3 ml single dose, for covid-19 immunisation. Medical history included vitiligo. Patient did not have history of Covid-19. The patient''s concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (COMIRNATY, lot number: FG4442 and expiration date not provided), via intramuscular, on 03Aug2021, at 0.3 mL single dose, for COVID-19 immunization. The patient experienced faint (medically significant) on 25Aug2021. It was reported patient had syncope/ loss of consciousness for 5 seconds. That never happened to patient before. The doctor of vaccination site stated patient was recovered in the context of postprandial vasovagal syncope/ postprandial hypotension. The outcome of events was recovered on 25Aug2021 for 5 seconds. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1698486 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood pressure measurement, Body temperature, Electrocardiogram, Heart rate, Loss of consciousness, Malaise, Nausea, Neurological examination, Oxygen saturation, Physical examination, Presyncope, Syncope, Vaccination complication, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: CABERGOLINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 respiratory infection; Pituitary macroadenoma; Surgery
Allergies:
Diagnostic Lab Data: Test Name: capillary glycemia; Result Unstructured Data: Test Result:5.1 mmol/L; Test Name: blood pressure; Result Unstructured Data: Test Result:104/84 mmHg; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Test Name: ECG; Result Unstructured Data: Test Result:regular sinus rhytm; Comments: regular sinus rhytm (RSR), HR 60 bpm, atrioventricular block (BAV) 1 limit PR (190-200), normal axis fine QRS, negative T waves in V1.; Test Name: heart rate; Result Unstructured Data: Test Result:67; Comments: beats per minute 60 bpm; Test Name: neurological examination; Result Unstructured Data: Test Result:no focal deficit; Comments: no focal deficit, symmetrical and reactive pupils, no abnormalities of the cranial pairs, symmetrical ROT (osteotendinous reflex), indifferent RCP. No craniofacial stigmata of PC. No gait disorder, Romberg negative; Test Name: oxygen saturation; Test Result: 97 %; Test Name: physical examination; Result Unstructured Data: Test Result:Regular heart sounds without murmur; Comments: Regular heart sounds without murmur, symmetrical peripheral pulses, no DT, no palpitation, no signs of right or left heart failure. Soft, painless calves. Eupneic on room air, bilateral vesicular murmur, no cough, no sputum. Regular heart sounds without murmur, symmetrical peripheral pulses, no DT, no palpitation, no signs of right or left heart failure. Soft, painless calves. Eupneic on room air, bilateral vesicular murmur, no cough, no sputum. Abdomen soft, depressed and painless, no defensiveness, no contracture. BHA (hydro-air noises) +. No nausea, no recurrence of vomiting. No SFU (functional urinary signs), no lumbar pain
CDC Split Type: FRPFIZER INC202101130311

Write-up: Syncope vasovagal; loss of consciousness; Vaccination related malaise; nausea; vomiting; Vagal malaise/vagal-like malaise; malaise; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. The regulatory authority report number FR-AFSSAPS-PV20212548. A 32-years-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm on 25Aug2021 (Batch/Lot Number: Unknown) as dose number unknown, 0.3ml single (at age of 32-years-old) for covid-19 immunisation. Medical history included Pituitary macroadenoma (not continuing), COVID-19 respiratory infection from Apr2020 (not continuing), mixed macroadenoma operated. Concomitant medication included cabergoline. On 25Aug2021, the patient experienced syncope vasovagal, vaccination related malaise, nausea, vomiting. On 25Aug2021, occurrence 2 minutes after COMIRNATY injection of malaise accompanied by nausea and vomiting, and loss of consciousness (painful) for 10 seconds. No convulsions. No DT, no palpitation, no urine loss, no tongue biting, no post-critical deficit. Patient referred to the emergency room for control: Clinical examination at the entrance to the emergency room: Patient conscious, oriented, normotensive blood pressure 104/84 mmHg. capillary glycemia: 5.1 mmol/L. HR 67 bpm. body temperature 36.5 centigrade. SpO2 = 97%. Physical examination: Regular heart sounds without murmur, symmetrical peripheral pulses, no DT, no palpitation, no signs of right or left heart failure. Soft, painless calves. Eupneic on room air, bilateral vesicular murmur, no cough, no sputum. Abdomen soft, depressed and painless, no defensiveness, no contracture. BHA (hydro-air noises) +. No nausea, no recurrence of vomiting. No SFU (functional urinary signs), no lumbar pain. Neurologically: no focal deficits, symmetrical and reactive pupils, no cranial pair abnormalities, symmetrical ROT (osteotendinous reflex), indifferent RCP. No craniofacial stigmata of PC. No gait disorder, Romberg negative. ECG: Regular sinus rhytm (RSR), HR 60 bpm, BAV 1 (atrioventricular block) borderline PR (190-200), normal axis fine QRS, negative T waves in V1. In total, no arguments for a neurological or cardiological cause. Vagal malaise/vagal-like malaise 2 minutes after an injection of COMIRNATY vaccine against Covid-19. Outcome of the events was recovered on 25Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1698624 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Inappropriate schedule of product administration, Neck pain, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (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 Date: 20210819; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101126198

Write-up: Vomiting; Neck pain; Chills; received first dose on 30Jun2021/received second dose on 25Aug2021; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-APPCOVID-20210829165959. Safety Report Unique Identifier GB-MHRA-ADR 25865783. A 19-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 on 25Aug2021 (at the age of 19-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient''s Medical history included lactation decreased from an unknown date and 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 previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number not known; expiration date not provided), via an unspecified route of administration on 30Jun2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced vomiting, neck pain, chills, and ''received first dose on 30Jun2021/received second dose on 25Aug2021'' all on 25Aug2021. The events vomiting, neck pain, and chills were assessed as serious (medically significant), the event ''received first dose on 30Jun2021/received second dose on 25Aug2021'' was assessed as non-serious. The patient underwent lab tests and procedures which included COVID-19 virus test with result of ''negative; No - Negative COVID-19 test'' on 19Aug2021. Outcome of the events vomiting and chills was recovered on 26Aug2021; outcome of the event neck pain was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1698641 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Pain, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INTRAUTERINE CONTRACEPTIVE DEVICE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coil (IUCD)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101118996

Write-up: Vomiting; Headache; Achey, fatigue; Achey, fatigue; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-EYC 00259323. Safety Report Unique Identifier GB-MHRA-ADR 25856852. A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported) via parenteral route of administration on 24Aug2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history included coil from an unknown date and unknown if ongoing. Concomitant medication included intrauterine contraceptive device taken for an unspecified indication, start and stop date were not reported. The patient experienced achey, fatigue on 25Aug2021 and vomiting on an unspecified date. Headache on 26Aug2021. The adverse events were considered as serious with seriousness criteria of medically significant. Patient stated that headache was so severe it made patient feel sick. Coil was fitted approximately 3 months ago (not sure if it would have any impact on these side effects). The outcome of the events achey, fatigue, headache was recovered on 26Aug2021 and outcome for event vomiting was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information was expected.


VAERS ID: 1698711 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Headache, Lethargy, Malaise, SARS-CoV-2 test
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (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: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101126230

Write-up: Felt ill; Frontal headache; Aching joints; Lethargic; 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-202108291028432980-IN7CM and Safety Report Unique Identifier GB-MHRA-ADR 25865463. A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 25Aug2021 (at age of 37-years-old) as dose 1, single (at age of 37-year-old) for COVID-19 immunisation. Medical history included Lactation decreased, suspected covid-19 from 25Aug2021 and ongoing, COVID. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced frontal headache on 26Aug2021, aching joints on 25Aug2021, lethargic on 25Aug2021, felt ill on an unspecified date. The patient felt ill since having the vaccine, more ill than when she had COVID. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. This report was serious with seriousness criteria of medically significant. Outcome of the events frontal headache, aching joints, lethargic was not recovered; of the event felt ill was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1698716 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-25
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Gastrointestinal haemorrhage, Laboratory test, Rectal haemorrhage, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant (ONS Covid survey)
Allergies:
Diagnostic Lab Data: Test Name: multiple tests; Result Unstructured Data: Test Result:Unknown; Test Date: 20210826; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101126312

Write-up: loose stools; rectal bleeding; GI bleed; 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-202108291151154970-0J9YD. Safety Report Unique Identifier GB-MHRA-ADR 25865527. A 26-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Aug2021 (Batch/Lot Number: FF3319) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included clinical trial participant (ONS Covid survey). Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced loose stools and then rectal bleeding on an unspecified date, and GI bleed on 25Aug2021 which led to hospital attendance on 27Aug2021. The events were also assessed as medically significant. Lab data includes COVID-19 virus test: No - Negative COVID-19 test on 26Aug2021 and multiple tests with unknown results on an unspecified date. The outcome of the event GI bleed was not recovered, while unknown for the rest of the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1698794 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: 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? 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: Suppressed lactation
Allergies:
Diagnostic Lab Data: 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 INC202101126191

Write-up: bleeding; Prolonged heavy periods; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108300714354330-4H6ON. Safety Report Unique Identifier GB-MHRA-ADR 25866469. A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 24Aug2021 (age at vaccination 30) as dose 2, single for COVID-19 immunization. Medical history included suppressed lactation. She was previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration as dose 1, single for COVID-19 immunization. Patient has not tested positive for COVID-19 since had the vaccine. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Patient was not pregnant at time of vaccination. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced bleeding and on 25Aug2021, she had prolonged heavy periods. She had first period since giving birth however had vaccine day before so unsure of cause. Was given medication to reduce bleeding. The case classified as serious (medically significant). The patient underwent lab tests and procedures which included SARS-COV-2 test: negative (no-negative COVID-19 test). The outcome of the event bleeding was unknown, and event prolonged heavy periods was resolved on 29Aug2021. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1698799 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004222 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Immunisation, Organic erectile dysfunction, Tinnitus, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Sexual dysfunction (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Vaccination
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: started; vaccination; morning; shivering; Vomiting; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25866819) on 31-Aug-2021 and was forwarded to Moderna on 31-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TINNITUS (started), ORGANIC ERECTILE DYSFUNCTION (morning), CHILLS (shivering) and VOMITING (Vomiting) in a 19-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004222) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased and Vaccination. On 24-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 25-Aug-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced TINNITUS (started) (seriousness criterion medically significant), IMMUNISATION (vaccination), ORGANIC ERECTILE DYSFUNCTION (morning) (seriousness criterion medically significant) and CHILLS (shivering) (seriousness criterion medically significant). On 25-Aug-2021, VOMITING (Vomiting) had resolved. At the time of the report, TINNITUS (started), IMMUNISATION (vaccination), ORGANIC ERECTILE DYSFUNCTION (morning) and CHILLS (shivering) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications are not reported. Patient started vomiting at 5AM in the morning after vaccination. Two separate bouts next lot being at 10am. Patient was shivering and very tired. A day later, reaction occurred on arm. Antibiotics were prescribed as patient had a bad reaction on arm after first vaccination. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial.; 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: 1698844 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dry throat, Feeling of body temperature change, Headache, Hyperhidrosis, Interchange of vaccine products, Myalgia, Off label use, Rhinorrhoea
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (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 INC202101133072

Write-up: Runny nose; Feeling hot and cold; Headache; Muscle ache; Dry throat; Sweating; Off Label use; Interchange of vaccine products; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108301339142440-XVB7A.Safety Report Unique Identifier GB-MHRA-ADR 25868725. A 30-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 25Aug2021 (age at vaccination 30-year-old) as Dose 2, Single for COVID-19 immunization. Medical history included Lactation decreased.The patient''s concomitant medications were not reported. Historical vaccine included the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown) on 30-JUN-2021 as Dose 1, Single for COVID-19 immunization. On 30Jun2021, the patient experienced Arm discomfort. On 25Aug2021, the patient experienced dry throat, sweating, off label use, interchange of vaccine products, On 26Aug2021,the patient experienced feeling hot and cold, headache, muscle ache, On 27Aug2021,the patient experienced runny nose. The patient has not had symptoms associated with COVID-19. The patient not had a COVID-19 test.The patient had not tested positive for COVID-19 since having the vaccine. The patient was not currently breastfeeding.The patient was not enrolled in clinical trial. The outcome of events Feeling hot and cold, Muscle ache were recovered on 27Aug2021 while the outcome of the events Sweating was recovered on 28Aug2021 and the outcome of the events Runny nose was recovered on 29Aug2021 and the outcome of the events dry throat, headache was recovering and the outcome of the other events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1698854 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Adnexa uteri pain, Heavy menstrual bleeding, SARS-CoV-2 test, Uterine pain
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:
Allergies:
Diagnostic Lab Data: Test Date: 20210829; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101133057

Write-up: pain in my uterus and left ovary; pain in my uterus and left ovary; Prolonged periods; This is a spontaneous report from a contactable consumer. This is a report received from a regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202108301418229620-UMZFZ, Safety Report Unique Identifier GB-MHRA-ADR 25868832. A 22-years-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot Number: FE8087, Expiry date not reported), via an unspecified route of administration on 24Aug2021 as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 Vaccine, solution for injection) via an unspecified route of administration, on unspecified date as dose 1, single for covid-19 immunization. On 25Aug2021, the patient experienced prolonged periods and on unspecified date, the patient experienced pain in uterus and left ovary. It was reported that patient had heavy and prolonged bleeding, pain in her uterus and left ovary. The patient underwent lab tests which included SARS-Cov-2 test: negative on 29Aug2021.The patient had not yet recovered from Prolonged periods and outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1698873 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8007 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101133143

Write-up: Stomach cramps; Headache; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number [GB-MHRA-WEBCOVID-202108301602581500-2OHOD], Safety Report Unique Identifier [GB-MHRA-ADR 25869662]. A 16-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 24Aug2021 (Lot Number: FE8007) as dose 1, single for COVID-19 immunization. Medical history included pregnancy from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 25Aug2021, the patient experienced stomach cramps and headache. The events were assessed as serious (medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on an unknown date. Therapeutic measures were taken as a result of stomach cramps and headache. The outcome of the event ''stomach cramps'' was recovered on 29Aug2021 and event ''headache'' recovered on 27Aug2021. Case narrative: The headache started first and several hours after acute stomach cramps. She was doubled over and no medication could help. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Additional information: Patient has not had symptoms associated with COVID-19. No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1698897 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Intermenstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101138303

Write-up: Spotting menstrual; 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-202108301908503520-QSAAF.Safety Report Unique Identifier GB-MHRA-ADR 25870844. A 24-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,), via an unspecified route of administration on 23Aug2021 (Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included immunodeficiency (taking other treatments or medicines, not listed above, known to lower the immune response and i). Concomitant medication included ethinylestradiol, levonorgestrel (RIGEVIDON) taken for an unspecified indication from May2015. On 25Aug2021, the pa tient experienced spotting menstrual. Patient had no symptoms associated with COVID-19 and not had a COVID-19 test. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be re-quested. No further information is expected.


VAERS ID: 1698925 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101133049

Write-up: Swollen lymph nodes; Sore throat; This is a spontaneous report from a contactable. This is a report received from the Regulatory Authority The regulatory authority report number is GB-MHRA-WEBCOVID-202108302238349320-SOOFJ, safety report unique identifier is GB-MHRA-ADR 25871643. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FF3319), dose 2 via an unspecified route of administration on 25Aug2021 () as DOSE 2, SINGLE for COVID-19 immunization. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), as DOSE 1, SINGLE for COVID-19 immunization. The patient''s concomitant medications were not reported. On 25Aug2021 the patient experienced swollen lymph nodes (lymphadenopathy), sore throat. The events were assessed as medically significant. Patient had 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 No - Negative COVID-19 test. The clinical outcome of swollen lymph was not recovered, sore throat was recovered on 29Aug2021. No follow-up attempts are possible. No further information is expected.


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