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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 234 out of 8,010

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VAERS ID: 1724708 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NUROFEN (GSL)
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101191568

Write-up: Fever; Pain in arm; Diarrhea; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109111026544920-X2KVO and Safety Report Unique Identifier is GB-MHRA-ADR 25927915. A 24-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: FE8087, Expiry date was not reported), (at the age of 24 years), via an unspecified route of administration on 09Sep2021 as dose 2, single for COVID-19 immunization. Medical history included headache from an unknown date and unknown if ongoing. Concomitant medication(s) included ibuprofen (NUROFEN (GSL) was taken for headache from 10Sep2021 to 10Sep2021. Historical Vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution of injection, Lot number, Expiry date was not reported), via an unspecified route of administration as dose 1, single for COVID-19 immunization. The patient experienced fever on 10Sep2021, diarrhea on 09Sep2021, pain in arm on 10Sep2021. The events caused medically significant. It was reporter that, the day after the jab he was fine that night and in the day he was good. However, the next night he was tired and woke up maybe like every 2 hours, so it was an awful night. However, he would like to mention that he had fast food that day, but he believe they are unrelated. The Patient was not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the events recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724711 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Illness, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191601

Write-up: Sickness; Increased shortness of breath; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109111104148260-QCQEL. [Safety Report Unique Identifier: GB-MHRA-ADR 25927984]. A 25-year-old male patient received 2nd dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 09sep2021 (at the age of 25-year-old) as dose 2, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration as dose 1 single for COVID-19 immunization. Unsure if patient has 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. On 09Sep2021, patient experienced increased shortness of breath (dyspnea), on 10Sep2021 patient experienced sickness. 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 events was recovering. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1724732 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Genital herpes, SARS-CoV-2 test
SMQs:, 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: SERTRALINE
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 INC202101191512

Write-up: Genital herpes; 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-202109111742402360-BKJFM. Safety Report Unique Identifier is GB-MHRA-ADR 25928561. A 32-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 06Sep2021 as dose 1, single for COVID-19 immunisation. Medical history included depression from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not pregnant. Concomitant medication included sertraline taken for depression from 02Jan2016 to an unspecified stop date. On 09Sep2021, 3 days after first dose patient experienced genital herpes. The event were reported as medically significant. Herpes outbreak after 9 years of none. 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) on an unspecified date. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1724740 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CETIRIZINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hay fever; Suspected COVID-19 (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 INC202101191678

Write-up: Headache; Nauseous; Acute chest pain; Tiredness; This is a spontaneous report from a contactable consumer or other non-health care professional received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109112147217870-R5UN6. Safety Report Unique Identifier GB-MHRA-ADR 25928731. A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF2153), first dose via an unspecified route of administration (Age at vaccination 35-year-old) on 09Sep2021 as dose 1, single for COVID-19 immunization. The patient medical history included suspected COVID-19 from 30Mar2020 to an unknown date Unsure when symptoms stopped, hay fever. Concomitant medications included cetirizine (CETIRIZINE) taken for hay fever. On 09Sep2021 the patient experienced Tiredness, on 10Sep2021 he had headache, nauseous, acute chest pain. The patient underwent lab tests and procedures which included covid-19 virus test was negative on an unspecified date No - Negative COVID-19 test. Therapeutic measures were taken as a result of headache (headache). Headache persists but reduces using pain relief (paracetamol). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of event (Tiredness) was recovering, event (Headache) was not recovered yet, event of (Acute chest pain) was recovering, and (Nauseous) was recovered 11Sep2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724790 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Nasal Swab; Result Unstructured Data: Test Result:Unknown
CDC Split Type: GBPFIZER INC202101189692

Write-up: Reporter fainted after having the jab.; This is a spontaneous report from a non-contactable consumer (patient). A 20-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 09Sep2021 as dose number unknown, single (at the age of 20-year-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 09Sep2021, the patient fainted after having the jab. The event was assessed as medically significant by the reporter. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown. On an unspecified date in Sep2021, the patient had recovered from the event. No follow-up attempts are possible: Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724799 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dizziness, Inappropriate schedule of product administration, Magnetic resonance imaging head, Physical examination, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210618; Test Name: Blood pressure; Result Unstructured Data: Test Result:Blood pressure slightly low; Test Date: 2021; Test Name: Head MRI; Result Unstructured Data: Test Result:Nothing found; Test Date: 20210624; Test Name: Physical examination; Result Unstructured Data: Test Result:Confirmed vertigo symptoms; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217046

Write-up: lightheaded; inappropriate schedule of vaccine administered (dose 1 on 18Jun2021 and dose 2 on 09Sep2021); dizzy; This is a spontaneous report from a contactable consumer (the patient). This is a second of 2 reports. The first reported downloaded from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109092217285110-UCRKU, Safety Report Unique Identifier GB-MHRA-ADR 25921256. A 26-year-old male patient received the 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 09Sep2021 (at the age of 26-year-old), as dose 2, single for COVID-19 immunization. The patient''s medical history Scrotal pain, Dizziness, Vertigo, Slowed thinking and concomitant medications were not reported. Historical vaccine included patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: FC9001), via an unspecified route of administration, on 18Jun2021, as dose 1, single for COVID-19 immunization. Less than 1 minute after receiving the vaccine, developed severe dizziness and vertigo. The room started spinning and was unsteady on feet. The doctor lay down, gave some water, biscuits, and a sugary drink, and observed over the next 90 minutes. After approximately 15 minutes, attempted to stand but was not able to keep balance. After approximately 90 minutes, patient''s mother came to pick me up as patient was not in a fit state to drive. Patient spent the following week in bed and spoke to my GP on 21Jun2021 and saw them on 24Jun2021 after being advised to contact them asap by 111 when symptoms did not improve. Patient was eventually prescribed betahistine which patient took 3x per day for the following weeks. Vertigo gradually improved over the weeks following the vaccination and eventually disappeared after 6 weeks - at which point patient stopped taking the medication. During this time, patient was very limited in my work as patient was unable to focus on a computer screen. Patient also experienced brain fog which took a few weeks to completely disappear, even after the vertigo had gone. Patient has not tested positive for COVID-19 since having the vaccine. The patient experienced lightheaded on 09Sep2021, dizzy on an unknown date in 2021 and inappropriate schedule of vaccine administered (dose 1 on 18Jun2021 and dose 2 on 09Sep2021) on 09Sep2021. Despite being nervous about the potential for this to repeat, Patient did attend appointment for second vaccination on 09Sep2021. Patient was given this vaccine lying down and was observed for approximately 30 minutes afterwards. Patient felt slightly lightheaded at times during this period but felt well enough to go after 30 minutes. However, while walking to the car, patient again felt dizzy - although less so than after the first dose and had to sit down outside the vaccination centre. After a few minutes, patient was able to stand and walk the few yards to the car to be driven home. The dizziness has not reappeared since then. The patient underwent lab tests and procedures which included blood pressure measurement: blood pressure slightly low on 18Jun2021, magnetic resonance imaging head: nothing found on an unknow date in 2021, physical examination: confirmed vertigo symptoms on 24Jun2021, SARS-COV-2 test: no - negative covid-19 test on an unspecified date. Therapeutic measures were taken for event lightheaded. Outcome of the event lightheaded was not recovered and outcome of the rest events was unknown. Patient was not enrolled in clinical trial No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101190597 Same patient/drug, different events/doses


VAERS ID: 1724821 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-09
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: covid-19 test; Test Result: Positive
CDC Split Type: ILPFIZER INC202101191367

Write-up: Infected with COVID despite being vaccinated with Pfizer vaccine, two doses/A positive result to COVID was received today; Infected with COVID despite being vaccinated with Pfizer vaccine, two doses/A positive result to COVID was received today; This is a spontaneous report received from a contactable consumer, a Pfizer colleague. It is a second of 2 cases and it refers to a 20-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single and via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced infected with covid despite being vaccinated with pfizer vaccine, two doses/a positive result to covid was received "today". The patient underwent lab tests and procedures which included covid-19 test was positive on 09Sep2021. The outcome of event covid-19 was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.


VAERS ID: 1724970 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9944 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Presyncope
SMQs:, Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101181170

Write-up: vagal reaction; This is a spontaneous report from a contactable physician. The patient was a non-pregnant 30-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history and concomitant medications were unknown. On 09Sep2021 at 14:00 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY), Solution for injection, Lot number FF9944, Expiration date 30Nov2021, intramuscular in the arm left for COVID-19 immunization at the age of 30-year-old. On 09Sep2021 at 14:15 (15 minutes after the vaccination), the patient experienced vagal reaction. The event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was recovered with treatment including intravenous (iv) drip with saline. Since the vaccination, weather the patient has not been tested for COVID-19 or not was unknown.; Sender''s Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the event Presyncope and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 1725164 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Electrocardiogram, Muscle spasms, Pain in extremity, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ECG examination; Result Unstructured Data: Test Result:unremarkable
CDC Split Type: SEPFIZER INC202101223152

Write-up: Chest pain; Cramps; Pain radiating into the left arm and shoulder/shoulder blade; Pain radiating into the left arm and shoulder/shoulder blade; fainted; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-083047. A 36-years-old female patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 09Sep2021 (at the age of 36-years-old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced suspected adverse reactions including chest pain, cramping/cramps, and pain radiating to the left arm and shoulder with onset date on the same day of vaccination on 09Sep2021. It was described that the patient was cooking when she experienced sudden chest pain radiating to her left arm and shoulder blade and she also fainted on 09Sep2021. The patient was taken by ambulance. An ECG (Echocardiogram) examination was performed which was unremarkable. The ambulance staff gave the vaccine as the probable cause of the symptoms. The outcome of the events was not recovered. The report was assessed as serious, life-threatening. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1725846 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia, Asthenia, Headache, Heavy menstrual bleeding, Menstruation irregular, Muscle spasms, Oral herpes, Parosmia, Pyrexia, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Oropharyngeal infections (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Fertility disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Comments: No relevant medical history was provided.
Allergies:
Diagnostic Lab Data: Test Date: 20210910; 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: unusually sore; cramps; felt very weak and then period started a week and a day early; Cold sores; Irregular periods; Heavy periods; Smell alteration/chemical smell; Headache; Fever; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 25930970) on 14-Sep-2021 and was forwarded to Moderna on 14-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARRHYTHMIA (unusually sore), MUSCLE SPASMS (cramps), ASTHENIA (felt very weak and then period started a week and a day early), HEADACHE (Headache), PYREXIA (Fever), MENSTRUATION IRREGULAR (Irregular periods), HEAVY MENSTRUAL BLEEDING (Heavy periods), ORAL HERPES (Cold sores) and PAROSMIA (Smell alteration/chemical smell) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No relevant medical history was provided. Concomitant products included PARACETAMOL from 09-Sep-2021 to an unknown date for Fever. On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced HEADACHE (Headache) (seriousness criteria disability and medically significant), PYREXIA (Fever) (seriousness criteria disability and medically significant) and PAROSMIA (Smell alteration/chemical smell) (seriousness criteria disability and medically significant). On 11-Sep-2021, the patient experienced MENSTRUATION IRREGULAR (Irregular periods) (seriousness criteria disability and medically significant) and HEAVY MENSTRUAL BLEEDING (Heavy periods) (seriousness criteria disability and medically significant). On 12-Sep-2021, the patient experienced ORAL HERPES (Cold sores) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced ARRHYTHMIA (unusually sore) (seriousness criteria disability and medically significant), MUSCLE SPASMS (cramps) (seriousness criteria disability and medically significant) and ASTHENIA (felt very weak and then period started a week and a day early) (seriousness criteria disability and medically significant). On 10-Sep-2021, PYREXIA (Fever) had resolved. On 11-Sep-2021, HEADACHE (Headache) and PAROSMIA (Smell alteration/chemical smell) had resolved. At the time of the report, ARRHYTHMIA (unusually sore), MUSCLE SPASMS (cramps), ASTHENIA (felt very weak and then period started a week and a day early), MENSTRUATION IRREGULAR (Irregular periods) and HEAVY MENSTRUAL BLEEDING (Heavy periods) was resolving and ORAL HERPES (Cold sores) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication reported. The patient had 9 hours after vaccine dose got a headache, felt sick and didn''t like bright lights, progressed to have a shivering fever for 6 hours then hot flushes drenched in sweat for the next 12 hours. Felt very weak and then period started a week and a day early, very sudden with a very heavy bright red flow that stayed extremely heavy for 3 days before gradually easing. Unusually sore, sharp cramps throughout. Just as the flow begins to ease off, my cold sore flares up very aggressively despite none of the usual precursors. Patient was not enrolled in clinical trial. Company Comment: This case concerns a 30-year-old, female patient with no previous relevant medical history, who experienced the unexpected events of arrhythmia, muscle spasms, asthenia, headache, pyrexia, menstruation irregular, heavy menstrual bleeding, oral herpes and parosmia. The events occurred on an unknown day''s day after the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 30-year-old, female patient with no previous relevant medical history, who experienced the unexpected events of arrhythmia, muscle spasms, asthenia, headache, pyrexia, menstruation irregular, heavy menstrual bleeding, oral herpes and parosmia. The events occurred on an unknown day''s day after the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1726098 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7204 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101181697

Write-up: fainted when walking to the bathroom; extremely nauseous; started sweating Profusely; dizzy; was extremely pale in face and lips; This is a spontaneous report from a contactable consumer (patient) through COVAES. A 21-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 08Sep2021 10:45 (Lot Number: FD7204) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 09Sep2021, the patient woke up the night feeling extremely nauseous. On that day, patient fainted when walking to the bathroom, started sweating profusely, feeling dizzy and was extremely pale in face and lips. Outcome of the events was recovered in Sep2021 with sequelae. Since the vaccination, the patient has not been tested for COVID-19.


VAERS ID: 1728918 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-09
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0810 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
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: Shellfish allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101197607

Write-up: Blood clots in the varicose veins on my legs and menstrual spotting.; Blood clots in the varicose veins on my legs and menstrual spotting.; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 39 years old, dose 1 via an unspecified route of administration, administered in arm left on an unspecified date (Batch/Lot Number: FD0810) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included shellfish allergy. None of any other medications the patient received within 2 weeks of vaccination. The patient was not pregnant at time of vaccination. The patient experienced blood clots in the varicose veins on her legs and menstrual spotting on 09Sep2021 with outcome of not recovered. It is unknown treatment was received for both events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1729113 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Sudden hearing loss
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101191828

Write-up: after the vaccine i had a very sudden; Painful periods; Heavy periods; This is a spontaneous report from a contactable consumer (patient) or other non HCP. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109101621092500-YTJE0, Safety Report Unique Identification Number: GB-MHRA-ADR 25924896 A 19-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 08Sep2021 at DOSE 1, SINGLE for COVID-19 immunization. patient was not pregnant. patient was not currently breastfeeding. She had not symptoms associated with COVID-19. No medical history reported. No concomitant medications reported. On an unspecified date patient experienced after the vaccine she had a very sudden. on 09Sep2021, 1 day after first dose patient experienced painful periods and, heavy periods. it was reported that, patient had a period recently as normal, her regular ones are light and short. After the vaccine she had a very sudden, heavy, painful period the next day. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of events she had a very sudden was recovered and outcome of other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected


VAERS ID: 1729148 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-08
Onset:2021-09-09
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram thorax, Fibrin D dimer, Platelet count, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, venous (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Non-smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: CT pulmonary angiogram; Result Unstructured Data: Test Result:CTPA- PE confirmed; Test Date: 20210911; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:not $g4000; Test Date: 20210911; Test Name: Platelet count; Result Unstructured Data: Test Result:Not less than 150, 109/L; Test Name: Platelet count; Result Unstructured Data: Test Result:231; Test Date: 2021; Test Name: Platelet count; Result Unstructured Data: Test Result:256; Test Date: 20210910; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101196453

Write-up: Unprovoked pulmonary embolism; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109121108300770-C4QUA with Safety Report Unique Identifier of GB-MHRA-ADR 25929031. A male patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3380) via an unspecified route of administration on 08Aug2021, as a single dose for COVID-19 immunisation. Medical history included non-smoker, it was reported that the patient was fit, no previous history of venous or arterial thromboses, no history of reactions with medications heparin or anticoagulants, no confirmed or suspected autoimmune or inflammatory disease, including vasculitis. The patient had no history of or current malignancy, intracranial malignancy, intracranial infections and had no other medical history. The patient had no symptoms associated with COVID-19 and not enrolled in clinical trial. Concomitant medications were not reported. The patient previously received heparin (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown date. On an unknown date, the patient underwent lab test platelet count before vaccine and result was 231 (unspecified units) (usual normal range 150-450). On 09Sep2021, the patient experienced unprovoked pulmonary embolism, diagnosed by CTPA (computerised tomogram pulmonary angiogram); reported as serious for causing hospitalization and being medically significant. It was reported that patient requested haematologist outpatient review, the patient was not identified with haemorrhage, no recent surgical or medical interventions to the central nervous system and no recent trauma or head injury. On 11Sep2021, the patient underwent platelet count and the result was not less than 150 (unspecified units), 109/liter, fibrin D dimer was measured on the same day and the result was not greater than 4000 (unspecified units). It was reported that anti- platelet factor 4 antibodies identification was unknown. On an unknown date in 2021, after vaccination the patient underwent lab test platelet count and lowest platelet count measured was 256 (unspecified units) (usual normal range 150-450). The patient was not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event unprovoked pulmonary embolism was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1729188 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-09-09
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002621 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body mass index, Hemiplegia, Hypoaesthesia, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test; Test Name: BMI; Result Unstructured Data: 23.94
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Numbness; Tingling skin; Left sided paralysis; This case was received via the Regulatory Authority(Reference number: GB-MHRA-ADR 25940629) on 15-Sep-2021 and was forwarded to Moderna on 15-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling skin) and HEMIPLEGIA (Left sided paralysis) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002621) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped). On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced HYPOAESTHESIA (Numbness) (seriousness criteria hospitalization and medically significant), PARAESTHESIA (Tingling skin) (seriousness criteria hospitalization and medically significant) and HEMIPLEGIA (Left sided paralysis) (seriousness criteria hospitalization and medically significant). At the time of the report, HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling skin) and HEMIPLEGIA (Left sided paralysis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body mass index: 23.94 (normal) 23.94. 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. Concomitant medications was not reported. Treatment history was not reported. Patient had not tested positive for COVID-19 since having the vaccine. The patient experienced tingling and numbness of the whole left side of the body from foot to half the vagina up to left side of the lip. CT scan done and blood test are fine. ECG done with unknown results. Patient was not enrolled in clinical trial. Company comment: This case concerns a 34-year-old, female subject with no relevant medical history, who experienced the unexpected events of hypoaesthesia, paraesthesia and hemiplegia. The events, which resulted in hospitalization, occurred 17 days after the administration of the first dose. The rechallenge was not applicable as the events occurred after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was assessed as per Regulatory Authority reporting. Of note, there was no mention in the case narrative that the event ''hemiplegia'' occurred; however, the event was retained per Regulatory Authority report.; Sender''s Comments: This case concerns a 34-year-old, female subject with no relevant medical history, who experienced the unexpected events of hypoaesthesia, paraesthesia and hemiplegia. The events, which resulted in hospitalization, occurred 17 days after the administration of the first dose. The rechallenge was not applicable as the events occurred after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was assessed as per Regulatory Authority reporting. Of note, there was no mention in the case narrative that the event ''hemiplegia'' occurred; however, the event was retained per Regulatory Authority report.


VAERS ID: 1729197 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Headache, Pain in extremity, Pain of skin, SARS-CoV-2 test
SMQs:, Arthritis (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: Moderna CoviD-19 Vaccine
Current Illness: Ehlers-Danlos syndrome (suspected)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Scalp tenderness; Headache; Painful arm; Joint pain; This case was received (Reference number: GB-MHRA-ADR 25942221) on 15-Sep-2021 and was forwarded to Moderna on 15-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN OF SKIN (Scalp tenderness), HEADACHE (Headache), PAIN IN EXTREMITY (Painful arm) and ARTHRALGIA (Joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Ehlers-Danlos syndrome (suspected). Concomitant products included mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced PAIN OF SKIN (Scalp tenderness) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant) and ARTHRALGIA (Joint pain) (seriousness criterion medically significant). At the time of the report, PAIN OF SKIN (Scalp tenderness) and HEADACHE (Headache) had not resolved and PAIN IN EXTREMITY (Painful arm) and ARTHRALGIA (Joint pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant products were not provided. Treatment medication were not reported. Company comments:This case concerns a female subject, of unknown age, with relevant medical history of suspected Ehlers-Danlos syndrome, who experienced the unexpected events of pain of skin, pain in extremity, headache and arthralgia. The events occurred on the same day of administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was unknown since no information about the first dose was provided. The events headache and arthralgia are consistent with the current understanding of the mechanism of action of the vaccine. The medical history of suspected Ehlers-Danlos syndrome, which may cause the event arthralgia, remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report. Event seriousness was assessed as per Regulatory Authority reporting; however, there was no information in the source document supporting that the events are medically significant. Of note, another dose of the Moderna COVID-19 Vaccine administered on 23Jun2021 was captured as a concomitant product per Regulatory Authority report.; Sender''s Comments: This case concerns a female subject, of unknown age, with relevant medical history of suspected Ehlers-Danlos syndrome, who experienced the unexpected events of pain of skin, pain in extremity, headache and arthralgia. The events occurred on the same day of administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was unknown since no information about the first dose was provided. The events headache and arthralgia are consistent with the current understanding of the mechanism of action of the vaccine. The medical history of suspected Ehlers-Danlos syndrome, which may cause the event arthralgia, remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report. Event seriousness was assessed as per Regulatory Authority reporting; however, there was no information in the source document supporting that the events are medically significant. Of note, another dose of the Moderna COVID-19 Vaccine administered on 23Jun2021 was captured as a concomitant product per Regulatory Authority report.


VAERS ID: 1729198 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-09-09
   Days after vaccination:78
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Contusion, Fatigue, Hunger, Inappropriate schedule of product administration, Pruritus, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Accidents and injuries (narrow), Hypersensitivity (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fatigue; Itchy skin; Bruising; Hunger; Inappropriate schedule of vaccine administered; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25942222) on 15-Sep-2021 and was forwarded to Moderna on 15-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), PRURITUS (Itchy skin), CONTUSION (Bruising) and HUNGER (Hunger) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant), PRURITUS (Itchy skin) (seriousness criterion medically significant), CONTUSION (Bruising) (seriousness criterion medically significant), HUNGER (Hunger) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 09-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, FATIGUE (Fatigue), PRURITUS (Itchy skin) and CONTUSION (Bruising) was resolving and HUNGER (Hunger) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had not tested positive for COVID-19 since having the vaccine. Concomitant medications was not reported. Treatment history was not reported. Company Comment: This case concerns a female patient of an unknown age with no relevant medical history, who experienced the unexpected events of fatigue, pruritus, contusion and hunger. The events occurred the same day the second dose of COVID-19 vaccine moderna was administered. The rechallenge was unknown since there''s no information about the first dose. The benefit-risk relationship of COVID-19 vaccine moderna in not affected by this report. Despite the unexpected event of inappropriate schedule of product administration not being captured by the RA it was added to the case.; Sender''s Comments: This case concerns a female patient of an unknown age with no relevant medical history, who experienced the unexpected events of fatigue, pruritus, contusion and hunger. The events occurred the same day the second dose of COVID-19 vaccine moderna was administered. The rechallenge was unknown since there''s no information about the first dose. The benefit-risk relationship of COVID-19 vaccine moderna in not affected by this report. Despite the unexpected event of inappropriate schedule of product administration not being captured by the RA it was added to the case.


VAERS ID: 1729208 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-09-09
   Days after vaccination:131
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: Lateral flow Test; Result Unstructured Data: Test Result:Positive; Comments: Nasal Swab
CDC Split Type: GBPFIZER INC202101189648

Write-up: Fully Vaccinated Pfizer colleague contracted Covid-19, positive test via lateral flow; Covid-19; This is a spontaneous report from a contactable consumer. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection intramuscular in left arm, first dose with lot ET3620 in May2021, and second dose with lot ET1831 in May2021 (at the age of 24-years-old) as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history was not reported. Concomitant medications included birth control and vitamin supplements. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The fully vaccinated Pfizer colleague (patient) contracted COVID-19, positive test via lateral flow on the 09Sep2021. Lab test on 09Sep2021 included Lateral flow Test Nasal Swab (SARS-CoV-2 test) was positive. PCR test booked to confirm. No treatment was provided for the event. The outcome of the event was recovering. Conclusion: For this lot Adverse Event Safety Request for Investigation and/or Lack of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID # the complaint for "PFIZERBIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot ''ET1831''. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality.


VAERS ID: 1729212 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cold sweat, Deafness, Electrocardiogram, Heart rate, Heart rate decreased, Inappropriate schedule of product administration, Muscle spasms, Pallor, Palpitations, Paraesthesia, Pyrexia, SARS-CoV-2 test, Syncope, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hearing impairment (narrow), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:tachycardia; Comments: tachycardia with palpations, pyrexia; Test Date: 20210908; Test Name: heart rate; Result Unstructured Data: Test Result:low; Comments: 40, low; Test Date: 20210908; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101199160

Write-up: pyrexia; palpitations; clammy; heart rate: low, 40; tachycardia; Fainting; Hearing loss; Muscle spasms; pallor; Cold sweat; Pins and needles; 1st dose on 28Jun2021 and 2nd on 08Sep2021; This is a spontaneous report from a contactable consumer (parent). This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109101734411030-YPCUK and Safety Report Unique Identifier GB-MHRA-ADR 25925238. This is a second report. A 19-years-old non pregnant female patient received second dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection; Lot Number: FF2153) via an unspecified route of administration on 08Sep2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient had previously received first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection; Lot Number: F05613) via an unspecified route of administration on 28Jun2021 as single dose for COVID-19 immunisation and had chest pains, shortness of breath, tachycardia and felt unwell. This lasted one day. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 09Sep2021 (after 1 day of vaccination), patient experienced muscle spasms, fainting, pallor of skin, cold sweat, pins and needles and hearing loss. On an unspecified date, patient experienced pallor, pyrexia, clammy and palpitations, heart rate: 40, low and tachycardia. All events were medically significant and caused hospitalization. Patient visited to emergency department due to events. After second vaccine patient had a sudden onset of feeling very unwell, she became cold and clammy, white pallor, heart rate was 40, was short of breath, had palpitations, nearly fainted. Her arm and hand went into a stiff spasm that she had the injection in. She lost her hearing temporarily and was admitted to hospital for assessment and monitoring. Lab tests on 08Sep2021, included heart rate: low, 40, and COVID-19 virus test: negative. On unspecified date, ECG had a tachycardia with palpations, pyrexia. This was a very frightening experience. Adverse reaction did not occur as a result of an exposure during pregnancy. Outcome of events muscle spasms, fainting, pallor of skin, pins and needles, hearing loss was resolved on 09Sep2021, cold sweat was resolved on 10Sep2021 and for heart rate: low, 40 and tachycardia was unknown and all other events was resolved on an unspecified date. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1729426 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-09
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: Covid test; Test Result: Positive
CDC Split Type: ILPFIZER INC202101191364

Write-up: Infected with COVID despite being vaccinated with Pfizer vaccine, two doses/A positive result to COVID was received today; Infected with COVID despite being vaccinated with Pfizer vaccine, two doses/A positive result to COVID was received today; This is a spontaneous report received from a contactable consumer, a Pfizer colleague. It is a first of 2 cases. A 14-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single and first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was infected with covid despite being vaccinated with pfizer vaccine, two doses/a positive result to covid was received today on 09Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Sep2021. Outcome of events was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.


VAERS ID: 1729627 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9942 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Body temperature
SMQs:, Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: body temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Comments: before the vaccination
CDC Split Type: JPPFIZER INC202101185253

Write-up: Arrhythmia; This is a spontaneous report from a contactable physician received from The Regulatory Authority report number is v21126341. The patient was a 60-year and 7-month-old male (age at second dose of vaccination). Body temperature before vaccination was 35.9 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 08Sep2021 at 14:20 (the day of vaccination), the patient received the second dose of bnt162b2 (Comirnaty, solution for injection, Lot number FF9942, Expiration date30Nov2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. The patient experienced arrhythmia on 09Sep2021 at 12:00 (one day after the vaccination). On 09Sep2021 (one day after the vaccination), the outcome of the event was recovered. The course of the event was as follows: After immunisation the patient felt arrhythmia and at the time of examination (on next day 12:00), no arrhythmia. The reporter classified the event as non-serious and the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporter commented as follows: Considering it was irrelevant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1729654 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF5357 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Dysphoria, Oxygen saturation, 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? 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: Fall (Even the injection for drawing blood caused the patient to collapse before.); Haemophobia (Even the injection for drawing blood caused the patient to collapse before.); Pollinosis
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: BP; Result Unstructured Data: Test Result:dropped to 60; Test Date: 20210909; Test Name: BP; Result Unstructured Data: Test Result:100s; Comments: Before that, BP was in the 100 range; Test Date: 20210909; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination; Test Date: 20210909; Test Name: SpO2; Test Result: 98 %
CDC Split Type: JPPFIZER INC202101191975

Write-up: Vagal reflex; Dysphoria; BP dropped to 60; This is a spontaneous report from a contactable physician received from the regulatory authority). Regulatory authority report number is v21126377. The patient was a 35-year and 2-month old female (age at vaccination). Body temperature before vaccination was 36.0 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). The patient had pollinosis, haemophobia. Even the injection for drawing blood caused the patient to collapse before. The patient''s concomitant drug was not reported. On 09Sep2021 at 12:38 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF5357, Expiration date 30Nov2021) via an unspecified route of administration at the age of 35-year-old as a single dose for COVID-19 immunization. Event onset date reported as 09Sep2021 at 12:40 (the day of vaccination). The course of the event was as follows: Dysphoria occurred 10-15 minutes after the vaccination. When the patient stands up, BP (Blood pressure) dropped to 60. Before that, BP was in the 100s. Consciousness level was OK. SpO2 was 98%. epinephrine (BOSMIN) (0.2 mg) and 100 mL saline, hydroxyzine (ATARAX-P) were received, blood pressure was improved. Date was not provided; the outcome of the events was resolved. The reporting physician classified the events as non-serious and did not assess that the causality between the event and bnt162b2. Other possible cause of the event such as any other diseases was vagotony is suspected. The reporting physician commented as follows: Even the injection for drawing blood caused the patient to collapse before. Vagal reflex is a possibility.; Reporter''s Comments: Even the injection for drawing blood caused the patient to collapse before. Vagal reflex is a possibility.


VAERS ID: 1729655 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9942 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure increased, Blood pressure measurement, Body temperature, Heart rate, Heart rate increased, Palpitations, Paraesthesia oral, Pruritus, Rhinorrhoea
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TALION [BEPOTASTINE BESILATE]
Current Illness: Rhinitis allergic (under periodical administration of TALION.)
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (in the patient 30s.); Urticaria (in childhood)
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: BP; Result Unstructured Data: Test Result:174/110; Comments: 14:50; Test Date: 20210909; Test Name: BP; Result Unstructured Data: Test Result:158/101; Comments: 17:00; Test Date: 20210909; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination; Test Date: 20210909; Test Name: pulse; Result Unstructured Data: Test Result:109; Comments: /minute 14:50; Test Date: 20210909; Test Name: pulse; Result Unstructured Data: Test Result:98; Comments: /minute 17:00
CDC Split Type: JPPFIZER INC202101191982

Write-up: Anaphylaxis; palpitations; blood pressure increased/BP: 174/110; pulse: 109/minute; Itching of the neck; nasal discharge; tingling sensation of the tongue; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126395. The patient was a 64-year and 6-month old female (age at vaccination). Body temperature before vaccination on 09Sep2021 was 36.8 degrees Centigrade. There were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient has a history of beef and urticaria in childhood and asthma in the patient 30s.The patient currently has rhinitis allergic and under periodical administration of bepotastine besilate (TALION). Concomitant medication included ongoing TALION for rhinitis allergic. On 09Sep2021 at 14:21 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FF9942, Expiration date 30Nov2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 09Sep2021 at around 14:50 (the day of vaccination), the patient experienced anaphylaxis. On 09Sep2021 (the day of vaccination), the outcome of the event was recovering. The course of the event was as follows: At around 14:50, the patient experienced palpitations and blood pressure increased. BP: 174/110, and pulse: 109/minute. Itching of the neck, nasal discharge and tingling sensation of the tongue appeared. Drip infusion of saline 250 ml, and administration of fexofenadine hydrochloride (ALLEGRA). At 17:00, when the clinic was closed, palpitations and tingling sensation of the tongue disappeared. BP: 158/101, and pulse: 98/minute. The reporting physician classified the events as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: No dyspnoea. No urticaria. The patient''s symptoms are considered as Grade 1 in anaphylaxis guidelines. Outcome of the events palpitations and tingling sensation of the tongue was recovered/resolved on 09Sep2021 17:00 while of remain was recovering/resolving.


VAERS ID: 1729662 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG0978 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Body temperature, Disease recurrence
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchial asthma
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade
CDC Split Type: JPPFIZER INC202101192073

Write-up: Asthmatic attack/cough/dyspnoea; Asthmatic attack/cough/dyspnoea; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126408. A 21-years-old (21-year and 1month-old) female patient received BNT162b2 (COMIRNATY), first dose 1 via an unspecified route of administration on 09Sep2021 16:02 (Lot Number: FG0978; Expiration Date: 30Nov2021) at the age of 21 years old, as single dose for covid-19 immunisation. 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) was reported as asthma bronchial. The patient''s concomitant medications were not reported. Body temperature before vaccination on 09Sep2021 was 36.9 degrees Centigrade. On 09Sep2021 at 16:02 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY) via an unspecified route of administration as a single dose for COVID-19 immunization. On 09Sep2021 at 16:08 (6 minutes after the vaccination), the patient experienced asthmatic attack. The course of the event was as follows: 6 minutes after receiving vaccination, the symptoms of dry cough and dyspnoea occurred. The symptoms subsided by meptin air inhalation and solumedrol 40mg intravenous injection. On 09Sep2021 ((the day of vaccination), the outcome of the event was recovered on 09Sep2021. The reporting physician classified the event as non-serious and assessed the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was Asthma bronchial. The reporting physician commented as follows: The patient had symptom of asthma originally, the degree of association with today''s vaccination was unknown.


VAERS ID: 1729667 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9944 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Cerebral infarction, Loss of consciousness, Polymerase chain reaction, Unresponsive to stimuli
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), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BAYASPIRIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210909; Test Name: PCR; Result Unstructured Data: Test Result:covid-19 positve
CDC Split Type: JPPFIZER INC202101192319

Write-up: Cerebral infarction; consciousness disappeared; no reaction when being called; PCR test showed covid-19 positive; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21126439. The patient was a 63-year and 7-month-old male. Body temperature before vaccination was 36.5 degrees Centigrade. 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) was reported as oral drug being taken was Bayaspirin and anti- pressure agent. On 07Sep2021 at 13:40 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF9944, Expiration date 30Nov2021), at the age of 63-year-old, via an unspecified route of administration as a single dose for COVID-19 immunization. Event onset date was reported as on 09Sep2021 at 10:42 (2 day after vaccination). The course of the event was as follows: On 09Sep2021, consciousness disappeared, no reaction when being called, then transported by ambulance. Cerebral infarction was confirmed, but PCR test showed covid-19 positive, so transported to other hospital. On 09Sep2021 ( 2 days after the vaccination), the patient was admitted to the hospital. The outcome of the event was unknown. The reporting physician classified the event as serious (hospitalized) and the causality between the event and bnt162b2 as unassessable.


VAERS ID: 1729668 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: blood pressure; Result Unstructured Data: Test Result:122/82; Test Date: 20210909; Test Name: body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: Before vaccination; Test Date: 20210909; Test Name: Pulse; Result Unstructured Data: Test Result:56/minutes; Test Date: 20210909; Test Name: SpO2; Test Result: 98 %; Test Date: 20210909; Test Name: RR; Result Unstructured Data: Test Result:18
CDC Split Type: JPPFIZER INC202101192402

Write-up: transient loss of consciousness; Vagal reflex; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126409. The patient was a 17-year-old female. On 09Sep2021 at 14:03 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF3620, Expiration date 30Nov2021) via an unspecified route of administration as a single dose at age of 17-year-old for COVID-19 immunization. Body temperature before vaccination was 36.0 degrees Centigrade. The family history of the patient was unknown. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Concomitant medications were not reported. Event onset date was reported as on 09Sep2021 at 14:35 (32 minutes after vaccination). The course of the event was as follows: After vaccination, the patient experienced transient loss of consciousness while waiting on a chair. The patient was guided to bed, and was placed under observation with her legs elevated. Blood pressure 122/82, SpO2 98%, pulse 56/minute, respiratory rate 18. After the observation for 30 minutes, the patient returned home. (Vagal reflex was suspected.) On 09Sep2021 ( the day of the vaccination), the outcome of the events was recovered. 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. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1729695 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG0978 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Anaphylactic shock (3times (hospitalized 3times)); Loss of consciousness (3times (hospitalized 3times)); Sleeplessness
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:upper 90s/lower 50s Centigrade; Test Date: 20210909; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101198458

Write-up: feeling of difficulty breathing down her throat/difficult to breathe with big deep breaths; Anaphylaxis; headache; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126574. A 45-years and 6-months-old female patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FG0978, Expiration date 30Nov2021) via an unspecified route of administration on 09Sep2021 at 15:00 (the day of vaccination, at the age of 45-years-old) as dose 2, single for COVID-19 immunization. The patient had a medical history of loss of consciousness due to anaphylactic shock 3times (hospitalized 3times), sleeplessness. The patient previously took medication of EPIPEN, ferric medicine and unspecified medicine to prevent motion sickness and eye lotion. Concomitant medications were not reported. Body temperature before vaccination, on 09Sep2021, was 36.6 degrees Centigrade. On 09Sep2021 at 15:10 (10minutes after the vaccination), the patient experienced anaphylaxis. On 09Sep2021, the patient experienced headache. On 09Sep2021 at 15:30, the patient experienced feeling of difficulty breathing down her throat/difficult to breathe with big deep breaths. The course of the event was as follows: after the patient waited for 30 minutes following the injection, the patient felt that it was difficult to inhale a breath into her throat. As the patient was wearing 2 masks, the patient was made to wear only one mask, and the symptom slightly recovering, it was difficult to breathe with big deep breaths. In the meantime, the patient had some symptoms such as headache, so the patient was given 0.3mg BOSMIN injection. The symptom of headache was recovering soon, and she went home with her family. The reporting physician classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable. Other possible causes of the event such as any other diseases was sleeplessness. On 09Sep2021 (the day of the vaccination), the outcome of the event was recovering. The reporting physician commented as follows: the patient only slept 4hours on the previous day night, and patient blood pressure was originally in the upper 90s/lower 50s, so it was hard to considered as shock. A possibility of anaphylaxis could not be ruled out. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1729703 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Coronary artery surgery; Myocardial infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101219060

Write-up: Cardio-respiratory arrest; This is a spontaneous report received from a contactable physician via medical information team and via a sales representative. The patient information was not provided. The patient had medical history of angina pectoris, myocardial infarction and bypass surgery. Concomitant medications included unspecified blood coagulation drugs. On 06Sep2021 (the day of vaccination), the patient received the second single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown, Dosage was 0.3 ML single (also as reported Daily)) via an unspecified route of administration for COVID-19 immunization. On 09Sep2021(3 days after the vaccination), the patient experienced cardio-respiratory arrest. The clinical course was reported as follows: The patient had a medical history of coronary artery bypass surgery, and it was the second vaccination. Dr. thought that the blood vessels have become clogged was related to blood coagulation drugs instead of vaccines. Since the patient was transported to Privacy Hospital by emergency, the patient was hospitalized and was extubated within a few days after being transported due to cardio-respiratory arrest. The patient didn''t know any other information in addition to hospital name. The reporter classified the event as serious (Hospitalization or extension of hospital stay, life-threatening). The reporter stated that the events possibly related to the BNT162B2. The outcome of event was unknown. The outcome of event(s) was not provided. The reporter classified the event as serious.(Hospitalization or extension of hospital stay) The reporter stated that the events possibly related to the BNT162B2.; Sender''s Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event Cardio respiratory arrest and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1729906 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-09
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (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: PTJNJFOC20210942720

Write-up: PULMONARY THROMBOEMBOLISM; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-J202109-1561) on 22-SEP-2021 and concerned a 58 year old female of unknown race and ethnicity. The patient''s height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: Unknown) 0.5 ml, 1 total, administered on 13-MAY-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 09-SEP-2021, the patient experienced pulmonary thromboembolism and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pulmonary thromboembolism. This report was serious (Hospitalization Caused / Prolonged).; Reporter''s Comments: Reaction description - Pulmonary thromboembolism, Causation - Possible


VAERS ID: 1732449 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Dysphagia, Dyspnoea, Presyncope, Rash
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Milk protein allergy; Seizures cerebral (without EEG findings-after antidepressants due to dietary change (attending neurology, epileptology))
Preexisting Conditions: Medical History/Concurrent Conditions: Eating disorder symptom; Esophageal reflux
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: Blood pressure; Result Unstructured Data: Test Result:103/66 mmHg; Test Date: 20210909; Test Name: Blood pressure; Result Unstructured Data: Test Result:108/57 mmHg
CDC Split Type: CZPFIZER INC202101239101

Write-up: Anaphylactic reaction; Dyspnoea; dysaphia; pre-collapse; Blood pressure decreased; Rash; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number CZ-CZSUKL-21010702. This is the first report for this patient and refers to events after second vaccination. An 18-year-old female patient received BNT162B2 (COMIRNATY) dose 2 intramuscular on 09Sep2021 (at the age of 18 years old) (Lot Number: FD6840) as dose 2, single for covid-19 immunisation. Medical history included Seizures cerebral from 2019 and ongoing without EEG findings appeared after antidepressants due to dietary change (attending neurology, epileptology), eating disorder symptom from 2019 to an unknown date, ongoing allergy to milk protein, esophageal reflux all already fixed. The patient''s concomitant medications were not reported. The patient previously received Comirnaty (1st dose, intramuscular, batch/LOT number unknown) on 19Aug2021 and experienced influenza-like illness, fever, joint pain, overall exhaustion. The patient experienced anaphylactic reaction and dyspnoea 10 minutes after vaccination on 09Sep2021 with outcome of recovered on 09Sep2021, blood pressure decreased (blood pressure decreased) on 09Sep2021 with outcome of unknown, rash 10 minutes after vaccination on 09Sep2021 with outcome of unknown. Dyspnea, rash on the face, forehead, neck, chest appeared 10-15 minutes after the administration of the vaccine. The rash spread throughout the body. Ventolin and after that adrenaline was applied due to dysaphia, difficulty breathing and pre-collapse. An ambulance was called then application of Dithiaden and Dexamed 8 mg i.v. Temporarily lower blood pressure was measured (108/57 mmHg, 103/66 mmHg). The outcome of events dysaphia and pre-collapse was unknown. The events anaphylactic reaction and dyspnoea were reported as serious as Life threatening and hospitalization. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1732929 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Cardiac flutter, Chest pain, Electrocardiogram
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CERELLE; SPATONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood iron decreased; Contraception
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:fine
CDC Split Type: GBPFIZER INC202101191593

Write-up: Armpit pain; Heart fluttering; Chest pain; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Authority (RA). Regulatory authority report number RA-WEBCOVID-202109111021596250-FCDTK. Safety Report Unique Identifier RA-ADR 25927891. A 27-years-old non-pregnant female patient 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 09Sep2021 (at the age of 27-years-old) as single dose for COVID-19 immunisation. Medical history included contraception and blood iron decreased from an unknown date. Concomitant medication(s) included desogestrel (CERELLE) taken for contraception from 01Apr2019 to an unspecified stop date; iron (SPATONE) taken for blood iron decreased from 29Aug2021 to an unspecified stop date. Patient has not had symptoms associated with covid-19 and not had a covid-19 test. Patient was not currently breastfeeding. The patient experienced armpit pain, heart fluttering and chest pain on 09Sep2021. Patient had severe pain under armpit and side of chest. Heart fluttering and palpitations and episodes of feeing faint. Patient went to hospital after speaking with NHS 111, ECG was fine but discharged herself due to extreme waiting times. 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 electrocardiogram: fine on an unspecified date. The outcome of event heart fluttering was recovering and not recovered for other events. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1732949 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Headache, Hot flush, Influenza like illness, SARS-CoV-2 test
SMQs:, Arthritis (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: PANADOL EXTRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Joint ache
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101196498

Write-up: tiredness; headache; flu like symptoms; hot waves; Joint ache; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109120936514440-2J3UG, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25928979. The 28-year-old male patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Lot number was not reported) via an unspecified route of administration on 09Sep2021 (at the age of 28 years old) as dose 2, single for COVID-19 immunisation. The medical history included arthralgia. The concomitant medication(s) included caffeine, paracetamol (PANADOL EXTRA) taken for arthralgia from 09Sep2021. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Lot number was not reported) via an unspecified route of administration on an unknown date as single for COVID-19 immunisation. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient did not have symptoms associated with COVID-19. On an unspecified date the patient experienced tiredness, headache, flu like symptoms and hot waves, on 09Sep2021 joint ache. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 23Aug2021 No - Negative COVID-19 test. Therapeutic measures were taken as a result of joint ache. All events considered as medically significant. The outcome of the event tiredness, headache, flu like symptoms and hot waves was unknown and joint ache was recovered on 12Sep2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1732954 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Nausea, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: LANSOPRAZOLE; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid reflux (esophageal)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101196385

Write-up: Headache; Feverish; Nausea; Fatigue; Ache; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109121138305690-ZMF1D, Safety Report Unique Identifier GB-MHRA-ADR 25929047. A 24-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 09Sep2021 (at the age of 24-year-old), as a single dose for COVID-19 immunisation. Medical history included acid reflux (esophageal). The patient had no symptoms associated with COVID-19. The patient was not enrolled in clinical trial. The patient was not pregnant at the time of vaccination and was not currently breastfeeding. Concomitant medications included lansoprazole for acid reflux (esophageal) from an unknown date in 2016; and paracetamol for covid-19 vaccination from 09Sep2021 to 11Sep2021. On 09Sep2021, the patient experienced headache, feverish, nausea, fatigue and ache; all events were reported as serious for being medically significant. The patient had not tested positive for COVID-19 since having the vaccine. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. The clinical outcome of the events fatigue and ache was resolved on 10Sep2021, after the duration of 1 day, and that of headache, feverish and nausea was resolved on 11Sep2021, after the duration of 2 days. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1733024 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Hyperhidrosis, Insomnia, Myalgia, Pain in extremity, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101196499

Write-up: Insomnia; Leg pain; Generalised muscle aches; Chills; Sweating; Headache; Pain injection site; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109130537209470-3LV6R, Safety Report Unique Identifier GB-MHRA-ADR 25929686. A 34-years-old non-pregnant female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 09Sep2021 (at the age of 34-Years-old) as dose 1, single for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant and not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient medical history concomitant medications were not reported. The patient experienced pain injection site on 09Sep2021, chills, sweating, headache and generalized muscle aches on 10Sep2021, insomnia and leg pain on 11Sep2021. The adverse events were considered as serious with seriousness criteria of medically significant. The outcome of the events chills and injection site pain was resolving and not resolved for events sweating, headache, generalized muscle aches, insomnia and leg pain. No follow-up attempts are needed; information about lot number cannot be obtained. No further information is expected.


VAERS ID: 1733038 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8081 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Diarrhoea, Headache, Inappropriate schedule of product administration, Maternal exposure during pregnancy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Noninfectious diarrhoea (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101205409

Write-up: Fever; Diarrhoea; Chills; Headache; Dose 1:15Jul2021; dose 2: 09Sep2021; Maternal exposure during pregnancy; This is a spontaneous report from a contactable consumer. This is a report received from a regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109130926580720-PIM1L, Safety Report Unique Identifier GB-MHRA-ADR 25930794. A 28-year-old pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE8081), via an unspecified route of administration on 09Sep2021 (at the age of 28-year-old) at single dose for COVID-19 immunisation. Medical history included ongoing pregnancy. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medication included folic acid as folic acid supplementation. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF3319) via an unspecified route of administration on 15Jul2021 at single dose for COVID-19 immunisation. On 11Sep2021, the patient experienced fever, diarrhoea, chills and headache; all events were reported as serious for being medically significant. The pregnant patient was exposed to the medicine first-trimester (1-12 weeks) on 09Sep2021. Patient has not tested positive for COVID-19 since having the vaccine. The clinical outcome of event chills was recovered in Sep2021; headache was recovering; outcome of fever and diarrhoea was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1733083 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MIRTAZAPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101205512

Write-up: chest pain; got worse over the next few days; Pericarditis; 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-202109131938077300-OLN4K, Safety Report Unique Identifier GB-MHRA-ADR 25933940. A 30-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: FF8222), via an unspecified route of administration on 09Sep2021 (age at vaccination was 30-year-old), as dose 2, single for COVID-19 immunisation. The patient''s 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) on an unspecified date as dose 1, single for COVID-19 immunisation. Concomitant medication(s) included mirtazapine (MIRTAZAPINE) taken for depression (start and stop date were not reported). On an unspecified date, the patient experienced chest pain, got worse over the next few days. On 09Sep2021, the patient had pericarditis. All the events were serious (hospitalization, medically significant). The patient stated that he developed chest pain after the vaccine. Gradually got worse over the next few days following the vaccine. Went to A&E who diagnosed pericarditis. The patient''s hospitalization was prolonged as a result of chest pain, pericarditis and got worse over the next few days. The patient underwent lab tests and procedures which included electrocardiogram as unknown results and sars-cov-2 test as negative on an unspecified date, No - Negative COVID-19 test. The outcome of the event got worse over the next few days was unknown, pericarditis was not recovered, and chest pain was recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1733086 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Headache, Lymph node pain, Lymphadenopathy
SMQs:, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101205394

Write-up: Swollen lymph nodes; lymph nodes pain; Headache; Aching joints; 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-202109132050353450-FLJCW with Safety Report Unique Identifier GB-MHRA-ADR 25934413. A 31-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Sep2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant and was not breastfeeding at the time of this report. The patient did not have symptoms associated with COVID-19 and did not undergo a COVID-19 test. The patient was not enrolled in the clinical trial. On 09Sep2021, the following day of vaccination, the patient experienced aching joints which worsened during the night. On 10Sep2021, 2 days after the vaccination, the patient experienced swollen lymph nodes which took over 24 hours to appear and were less painful at the time of this report. On the same day 10Sep2021, the patient experienced a headache. The events aching joints, swollen lymph nodes and headache were reported as serious for being medically significant. The patient had not been tested positive for COVID-19 since having the vaccine. The clinical outcome of the events aching joints, swollen lymph nodes, lymph node pain and headache was recovering at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1733111 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-09-09
   Days after vaccination:126
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, 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: ASPIRIN [ACETYLSALICYLIC ACID]; HYDROCORTISONE; LEVOTHYROXINE; OMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pituitary tumour; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101225463

Write-up: Shingles; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161216444540-FBXIC, Safety Report Unique Identifier GB-MHRA-ADR 25952257. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 06May2021 as single dose for COVID-19 immunization. Medical history included pituitary tumour from an unknown date and unknown if ongoing (panhypopituitary following transphenoidal resection of pituitary tumour), steroid therapy from an unknown date and unknown if ongoing (Taking regular steroid treatment (e.g. orally or rectally)). Concomitant medication(s) included aspirin [acetylsalicylic acid] taken for an unspecified indication, start and stop date were not reported; hydrocortisone taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported; omeprazole taken for an unspecified indication, start and stop date were not reported. Historical vaccine included 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 an unspecified date as single dose for COVID-19 immunization. The patient has not had symptoms associated with COVID-19, not had a COVID-19 test. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. It was reported that the patient experienced shingles on 09Sep2021. Outcome of the event was reported as not recovered at this time of the report. Narrative case summary and further information: taking antiviral tablets provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1733429 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Anaphylactic shock, Blood pressure decreased, Blood pressure measurement, Body temperature, Heart rate, Heart rate decreased, Hypoaesthesia, Tachycardia
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Dehydration (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to chemicals; Cosmetic allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210909; Test Name: blood pressure; Result Unstructured Data: Test Result:77/48; Test Date: 20210909; Test Name: blood pressure; Result Unstructured Data: Test Result:102/69; Test Date: 20210909; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination.; Test Date: 20210909; Test Name: P; Result Unstructured Data: Test Result:63 (with tachycardia); Test Date: 20210909; Test Name: P; Result Unstructured Data: Test Result:57
CDC Split Type: JPPFIZER INC202101185833

Write-up: Anaphylaxis; Anaphylactic Shock; blood pressure decreased (77/48); numbness in hand; P 63 (with tachycardia); P 57; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126396. A 27-year-old female patient received first dose of BNT162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 09Sep2021 at 11:50 (Lot Number: FA5765; Expiration Date: 30Sep2021) (at the age of 27-year-old) as single for COVID-19 immunisation. Medical history included allergy to polyethylene glycol (cosmetics) from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.6 degrees Centigrade. On 09Sep2021 at 11:50 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY). On 09Sep2021 at 12:00 (10 minutes after the vaccination), the patient experienced anaphylactic shock and anaphylaxis. The course of the event was as follows: 10 minutes after the vaccination, the patient experienced blood pressure decreased and numbness in hand. BP (blood pressure) 77/48, P (pulse) 63 (with tachycardia). Normal saline and POLARAMIN 1A were administered and the symptoms recovered to BP 102/69, P 57. The consciousness was clear. No respiratory symptoms. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162b2. Other possible cause of the event such as any other diseases was not provided. On unspecific date, the outcome of the event was not provided.


VAERS ID: 1733454 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9944 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Pyrexia, X-ray
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Persistent chest pain; Test Date: 2021; Test Name: x-ray; Result Unstructured Data: Test Result:Persistent chest pain
CDC Split Type: JPPFIZER INC202101193127

Write-up: Chest pain/Chest pain became stronger; Dyspnoea; Pyrexia; This is a spontaneous report from a physician via the regulatory authority, regulatory authority report number v21126546 and a contactable other healthcare professional via the Medical Information Team. The patient was a 20-year and 8-month-old male (Age at Vaccination). On 19Aug2021, the patient previously received the first dose of bnt162b2 (COMIRNATY intramuscular injection, lot number: FF4204, expiration date 31Oct2021). The patient''s medical history and concomitant medications were not reported. On 09Sep2021 at 10:30 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY intramuscular injection, lot number: FF9944, expiration date: 30Nov2021) via an unspecified route of administration as single dose for COVID-19 immunisation. On 09Sep2021, the patient received the second dose of vaccination. At night, pyrexia appeared. On 11Sep2021, 2 days after vaccination, in the morning, it was considered as chest pain and dyspnoea. Chest pain became stronger. The patient was referred to the hospital. Persistent chest pain was confirmed through Electrocardiogram and X-ray, and the patient was introduced to another hospital and then hospitalized on unspecified date in 2021. The patient had an underlying disease. The outcome of the events was unknown. The physician classified the events as serious and assessed that causality between the events and bnt162b2 as unassessable. There was no other possible cause such as any other diseases. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1733469 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Body temperature, Depressed level of consciousness
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Peanut allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: Systolic pressure; Result Unstructured Data: Test Result:78 mmHg; Test Date: 20210909; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101201163

Write-up: anaphylaxis; Depressed level of consciousness; blood pressure decreased with systolic pressure decreased to 78mmHg; This is a spontaneous report from a contactable physician received from the Regulatory authority number is v21126688. A 16-year and 8-month-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Number FC8736, Expiration date 30Sep2021), intramuscular on 09Sep2021 16:30 (the day of vaccination, at the age of 16-year and 8-month-old) as dose 2, 0.3 ml single for COVID-19 immunisation. Body temperature before vaccination was 36.9 centigrade on 09Sep2021. The patient had a history of peanuts allergy. The patient''s concomitant medications were not reported. The event onset time was reported as 09Sep2021 at 16:35. The course of the event was as follow: After vaccination, the patient experienced blood pressure decreased with systolic pressure decreased to 78mmHg and depressed level of consciousness. The patient recovered (as reported) after receiving adrenaline injection. From 3-4 hours after the onset of the events, the patient finally was on her feet and relieving so that could back home. On 09Sep2021, outcome of the event was recovered. The reporting physician classified the event as non-serious and assessed that the event was related to the bnt162b2. There was no other possible cause of the event such as other diseases. The reporting physician commented as follows: It''s possible that it was anaphylaxis. No Follow-up attempts are needed. No further information is expected.


VAERS ID: 1736630 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0810 / 1 LA / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Pruritus, Swelling, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Oral allergy syndrome (Specific fruits (Oral Allergy Syndrome))
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101198199

Write-up: Extreme pain at injection site approximately 18 hours after injection. This occured after accidental light physical contact with injection site. Constant pain persisted for about a day and improved th; Redness; swelling; itching below injection site; This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FD0810), dose 1 via an unspecified route of administration, administered in Arm Left on 08Sep2021 17:30 (at the age of 25-year-old) as dose 1, single for covid-19 immunisation; ethinylestradiol, norgestimate (TRICIRA LO), via an unspecified route of administration from an unspecified date and ongoing, at unspecified dose and frequency for an unspecified indication. Medical history included specific fruits (Oral Allergy Syndrome). The patient was not pregnancy at time of Vaccination. The patient''s concomitant medications were not reported. Extreme pain at injection site approximately 18 hours after injection (09Sep2021 13:00). This occurred after accidental light physical contact with injection site. Constant pain persisted for about a day and improved the following day. Redness, swelling, and itching below injection site appeared 2 days after injection which persisted for 2 more days (09Sep2021 13:00). The event did not prolong hospitalization. The patient did not receive treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was resolving. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1737896 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-09-09
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Bell's palsy
SMQs:, Hearing impairment (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101213881

Write-up: Bell''s palsy; Arthralgia; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 622248. A 39-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 22Aug2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced Bell''s palsy and arthralgia on 09Sep2021 (18 days after the vaccination). The patient has not yet recovered from the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1738692 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101205535

Write-up: Swollen lymph nodes in armpit; Headache; Fatigue; Muscle ache; Fever; Pain at injection site; Taste metallic; 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-EYC 00260376. Safety Report Unique Identifier: GB-MHRA-ADR 25928317. A 43-year-old (age at vaccination) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number was not reported), parenteral on 09Sep2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication, start and stop date were not reported. On 09Sep2021, the patient experienced headache, fatigue, muscle ache, fever, pain at injection site and taste metallic, the patient had swollen lymph nodes in armpit on 10Sep2021. The outcome of event headache, fatigue, pyrexia, Dysgeusia was recovered on 11Sep2021, myalgia, vaccination site pain was recovering and lymphadenopathy was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1738717 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenopia, Dizziness, Headache, Musculoskeletal stiffness, Nausea, Pain, SARS-CoV-2 test, Vaccination site reaction, Vaccination site swelling
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Corneal disorders (broad), Vestibular disorders (broad), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appetite lost; Insomnia; Migraine
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101196495

Write-up: Light-headed/ Dizzy; Eyes heavy feeling of/ Tired eyes; Ache; Stiff neck; Injection site reaction/ the injection site swelled up; Injection site reaction/ the injection site swelled up; Headache; Nauseous; This is a spontaneous report from a contactable consumer (Patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109121328469540-KU8BG. Safety Report Unique Identifier GB-MHRA-ADR 25929115. A 37-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection, Batch/Lot number: FE3380), via an unspecified route of administration on 08Sep2021 as dose 2, single for COVID-19 immunisation. Medical history included appetite lost, insomnia and migraine from an unknown date. Patient suffered with Migraines and have medication for this as and when needed. Patient was prescribed Fresubin 2kcal drinks for lack of appetite at times. Concomitant medication(s) included zolpidem tartrate (MANUFACTURER UNKNOWN) taken for insomnia, start and stop date were not reported. Unsure if patient has had symptoms associated with COVID-19. Patient was not currently breastfeeding. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On 09Sep2021, the patient experienced light-headed/ dizzy, eyes heavy feeling of/ tired eyes, ache, stiff neck, injection site reaction/ the injection site swelled up, headache and nauseous. It was reported that the patient had to finish work early, had to go to bed and sleep, couldn''t keep her eyes open no matter she did. Patient had no control over what was happening to her. Patient took some paracetamol, which did not help one bit. every 2 minutes her eyes would close and her body just wanted to rest. Patient felt very dizzy, and weak all over, it felt as though she had just come out of anesthetic from an operation where you could not stay awake and your body just wanted to sleep, the injection site swelled up and was aching. The events were assessed as serious (medically significant). Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests which included SARS-COV-2 test: Negative (No - negative COVID-19 test) on an unspecified date. Therapeutic measures were taken as a result of events. The outcome of event injection site reaction/the injection site swelled up was recovering, and all other events were recovered on 10Sep2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1738875 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Ear pain, Influenza like illness, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217768

Write-up: Dizzy spells; Earache; Flu-like aching; This is a spontaneous report from a contactable consumer (the patient), This report is received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109150908032090-MUKZU and Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25944295. A 32-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FE8087), via an unspecified route of administration, on 08Sep2021, as DOSE 2, SINGLE for COVID-19 immunization; ibuprofen via an unspecified route of administration, start and stop date, lot number and dose were not reported for an unspecified indication. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not pregnant at the time of vaccination. Patient was not currently breastfeeding. The patient experienced flu-like aching on 09Sep2021; dizzy spells and earache on 10Sep2021. 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/ COVID-19 virus test: negative on an unspecified date (No - Negative COVID-19 test). Therapeutic measures were taken as a result of dizzy spells, flu-like aching and earache. Patient was not enrolled in clinical trial. Outcome of the event flu like aching was recovered on 11Sep2021 and events dizzy spells and earache was recovering. Case Narrative: My whole body was aching the next day I was drained and my body aching and I was having dizzy spells then I had earache. I was taking paracetamol and ibuprofen. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1738897 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-09
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: Ultrasound; Result Unstructured Data: Test Result:Unknown; Comments: Unknown
CDC Split Type: GBPFIZER INC202101217706

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109151348523710-FYNKP. Safety Report Unique Identifier GB-MHRA-ADR 25945573. This consumer reported information for both mother and fetus/baby. This is a maternal report. A pregnant female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not known), via an unspecified route of administration, on an unspecified date, as dose 2, single for COVID-19 immunization. The patient''s medical history included pregnancy. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not known), via an unspecified route of administration, on an unspecified date, as dose 1, single for COVID-19 immunization. The patient experienced miscarriage on 09Sep2021. The mother reported she became pregnant while taking bnt162b2. Patient has not had symptoms associated with COVID-19. Miscarriage 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/ COVID-19 virus test was negative on 10Sep2021 (No - Negative COVID-19 test) and ultrasound scan result was unknown on an unspecified date. The event was serious (hospitalization, medically significant, congenital anomaly). Patient was not enrolled in clinical trial. Outcome of the event miscarriage was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1738908 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FPL513 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Fatigue, Insomnia, Limb discomfort, Lymphadenopathy, Nausea, Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test, Somnolence
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210911; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: Negative
CDC Split Type: GBPFIZER INC202101217698

Write-up: my whole side felt bruised; feverish; Swollen lymph nodes; Fatigue; Nausea; Fever/feverish; pain in my arm; drowsy; my arm felt heavier; so painful; I struggled to sleep; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109151908124640-KRZ2V, Safety Report Unique Identifier GB-MHRA-ADR 25947552. A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Sep2021 (Lot Number: FPL513) (at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported and concomitant medications included daily contraceptive pill. The patient previously took BNT162B2 on an unknown date for covid-19 immunisation. On 09Sep2021, the patient experienced swollen lymph nodes, fatigue, nausea, fever, drowsy, her arm felt heavier, so painful, she struggled to sleep and on 08Sep2021, experienced pain in her arm. Feverish and experienced her whole side felt bruised on an unknown date. Patient had no symptoms associated with COVID-19. Patient was not pregnant and was not currently breastfeeding. The patient had a pain in my arm a few hours after the jab was administered and then the day after felt especially drowsy and queasy. She struggled to keep cool and definitely felt feverish.The day after my jab, her arm felt heavier than expected and that night it was so painful, and she struggled to sleep at all due to the pain. Below her armpit and her whole side felt bruised and swollen. She had not heard of this particular reaction, so she was quite worried, after talking to colleagues she had heard that a few others had similar affects which made her feel more reassured. 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 resulted negative on 11Sep2021. The outcome of the event lymphadenopathy recovered on 13Sep2021, the events fatigue, nausea, fever recovered on 11Sep2021 and all other events outcome was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1739478 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005693 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Depressed level of consciousness, Fall, Presyncope
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Decreased consciousness; Fall; Vagal reflex; This case was received via regulatory authority (Reference number: 2021TJP094356) on 14-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This case, reported by a physician, was received via Moderna''s adverse reaction reporting site (TASK0021723), and reported to the regulatory authority by a physician, was received via the RA (Ref, v21126699). Decreased consciousness was assessed as serious by the RA. On an unknown date, body temperature before the vaccination: 36.1 degrees Celsius. On 09-Sep-2021, at 18:20, the patient received the 1st dose of the vaccine. At 18:25, the patient fell after the vaccination and regained consciousness in about 5 minutes. At 18:30, vagal reflex developed. Thereafter, symptoms were resolving. The outcome of fall, decreased consciousness, and vagal reflex was reported as resolving. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 24 year-old male patient with no relevant medical history, who experienced the unexpected serious event of Depressed level of consciousness. The event occurred on the same day as the first dose of mRNA-1273 vaccine. Seriousness criteria of Medially significant maintained for consistency with RA report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1740489 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005693 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Febrile convulsion, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Febrile convulsion; Loss of consciousness; This case was reported by a physician via a medical representative. On an unknown date, the patient received the 1st dose of this vaccine. On 08-Sep-2021, the patient received the 2nd dose of this vaccine. Around 22:00, the patient had pyrexia. On 09-Sep-2021, at 12:30, the patient was transported by ambulance because pyrexia, convulsion in the hand, and loss of consciousness for about 1 minute. Blood test, CT, and X-ray revealed no abnormalities. Febrile convulsion was considered. Thereafter, the patient returned home because the symptoms were alleviated. At that time, acetaminophen PO, betahistine mesylate PO, and metoclopramide hydrochloride PO were prescribed. On 10-Sep-2021, the symptoms disappeared, and the patient recovered from the events. The outcome of febrile convulsion and loss of consciousness was reported as recovered. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Company Comment: This case refers to a 20-year-old female patient with no known medical history who experienced the unexpected events of Febrile Convulsion and Loss of Consciousness 1 day after the second dose of Moderna COVID-19 Vaccine. The events were assessed as possibly related by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Reporter''s Comments: The events were judged to be serious because the patient lost consciousness before the transport to the hospital.; Sender''s Comments: This case refers to a 20-year-old female patient with no known medical history who experienced the unexpected events of Febrile Convulsion and Loss of Consciousness 1 day after the second dose of Moderna COVID-19 Vaccine. The events were assessed as possibly related by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1740632 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Headache, Lymphadenopathy
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101209513

Write-up: Axilar swelling and pain of the lymph node; Diarrhoea; Headache; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number AT-BASGAGES-2021-044163. A 40-year-old male patient received bnt162b2 (COMIRNATY Formulation: Solution for injection), intramuscularly on 08Sep2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient did not have relevant medical history. There were no concomitant medications. The patient experienced headache and diarrhoea on 09Sep2021. The patient experienced axilar swelling and pain of the lymph node on 10Sep2021. The headache had been difficult to treat with ibuprofen for two days and diarrhea several times a day for two days. Therapeutic measures were taken as a result of diarrhoea and headache. The outcome events was not recovered. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1742490 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Off label use, Postpartum haemorrhage, Product use issue, SARS-CoV-2 test, Uterine haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Medication errors (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: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 virus test positive; Pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101211321

Write-up: Uterine bleeding/period like bleeding; Off-label use; Drug use in unapproved population; post partum bleeding; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202109141528356680-NDOVA, Safety Report Unique Identifier GB-MHRA-ADR 25939657. This consumer reported information for both mother and baby. This is the maternal report, first of two reports. Only this case is serious. A female patient of unknown age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 09Sep2021 as a single dose for COVID-19 immunisation. Medical history included pregnancy from unknown date to 04Aug2021 and breastfeeding which was ongoing. On 04Aug2021, the patient underwent COVID-19 virus test and the result was positive. The patient had no symptoms associated with COVID-19 and was not enrolled in the clinical trial. Concomitant medications were not reported. On an unknown date in 2021, the patient experienced post partum bleeding; uterine bleeding/period like bleeding on 13Sep2021; both were reported as serious for being medically significant. The clinical course was reported as follows: The patient gave birth on 04Aug2021 and had the usual post-partum bleeding for 4 weeks. This stopped a week or so before her first covid vaccination, but then she had bleeding again, which is like a period, however she was exclusively breastfeeding. This was her second child and with first child she breastfed exclusively for 8 months and had no bleeding during that time. It was reported that the bleeding was due to the vaccine. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the events postpartum bleeding was resolved, on an unknown date in 2021 and uterine bleeding was not resolved. 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-202101231248 baby case


VAERS ID: 1742557 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Uveitis anterior (long term sufferer of chronic anterior uveitis, had not had a flare up for many years)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217899

Write-up: uveitis; Uveitis flare up; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109151627393260-CZS7C, safety report unique identifier is GB-MHRA-ADR 25946445. The 24-year-old male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number was not reported) via an unspecified route of administration on 07Sep2021 as DOSE 1, SINGLE for COVID-19 immunization. The medical history included steroid therapy, taking regular steroid treatment (e.g. orally or rectally), iridocyclitis, patient had been a long term sufferer of chronic anterior uveitis however had not had a flare up for many years. The patient concomitant medications were not reported. Patient did not have symptoms associated with COVID-19. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. on an unspecified date the patient experienced uveitis and on 09Sep2021 uveitis flare up. Patient had her vaccine Tuesday and had been in ae in moor fields eye hospital twice in the last week with a uveitis flare. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date, No-Negative COVID-19 test. The outcome of the event uveitis recovered on an unspecified date in 2021, uveitis flare up was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1742674 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-09-09
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ear pain, Fatigue, Hyperaesthesia, Inappropriate schedule of product administration, Libido decreased, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Medication errors (narrow), Hypoglycaemia (broad), 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: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101224771

Write-up: Ear pain; Tired all the time; very sensitive skin on the left side of my face when the ear pain started; struggling to stay awake during the afternoon and in the evening; First dose on 14Jun2021 and second dose on 21Aug2021; I am tired while driving; tiredness; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number {GB-MHRA-WEBCOVID- 202109162100588630-CNTDL} Safety Report Unique Identifier {GB-MHRA-ADR 25955504}. A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FF3319) via an unspecified route of administration on 21Aug2021 as dose 2, single for COVID-19 immunisation. Medical history included suspected covid-19 from 06Nov2019 to an unknown date, unsure when symptoms stopped. Concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 on 14Jun2021 for COVID-19 immunisation. 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. On 09Sep2021, the patient had Ear pain was very painful shooting pains in left ear. On an unspecified date in 2021, the patient reported tiredness is very unlike me and I am struggling to stay awake during the afternoon and in the evening. I am tired while driving, while working, just always. I also had very sensitive skin on the left side of my face when the ear pain started, lasted a few days but seems to have gone now. Seriousness was reported as medically significant. Outcome of not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1742709 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Back pain, Dehydration, Dizziness, Fatigue, Feeling hot, Gastrooesophageal reflux disease, Groin pain, Headache, Hypoaesthesia, Musculoskeletal chest pain, Musculoskeletal pain, Nausea, Neck pain, Pain in extremity, Peripheral swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Osteonecrosis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Dehydration (narrow), Sexual dysfunction (broad)

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

Write-up: Rib pain; Buttock pain; Dehydration; Shoulder pain; Groin pain; Swollen arm; Pain in arm; Dizzy; Nausea; Fatigue; Acid reflux (oesophageal); Aching pain in hands, forearms, elbows; Numbness in hand; Headache dull; Leg pain; Low back pain; Neck pain; Feeling of warmth facial; This case was received via Regulatory Authority (RA) (Reference number: GB-MHRA-ADR 25966140) on 20-Sep-2021 and was forwarded to Moderna on 20-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Pain in arm), DIZZINESS (Dizzy), NAUSEA (Nausea), FATIGUE (Fatigue), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (oesophageal)), PAIN IN EXTREMITY (Aching pain in hands, forearms, elbows), HYPOAESTHESIA (Numbness in hand), HEADACHE (Headache dull), PAIN IN EXTREMITY (Leg pain), BACK PAIN (Low back pain), NECK PAIN (Neck pain), FEELING HOT (Feeling of warmth facial), DEHYDRATION (Dehydration), ARTHRALGIA (Shoulder pain), GROIN PAIN (Groin pain), MUSCULOSKELETAL PAIN (Buttock pain) and MUSCULOSKELETAL CHEST PAIN (Rib pain) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No medical history was reported. Concomitant products included CYCLIZINE for Nausea. On 09-Sep-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 09-Sep-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant), DIZZINESS (Dizzy) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (oesophageal)) (seriousness criterion medically significant), PAIN IN EXTREMITY (Aching pain in hands, forearms, elbows) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness in hand) (seriousness criterion medically significant), HEADACHE (Headache dull) (seriousness criterion medically significant), PAIN IN EXTREMITY (Leg pain) (seriousness criterion medically significant), BACK PAIN (Low back pain) (seriousness criterion medically significant), NECK PAIN (Neck pain) (seriousness criterion medically significant), FEELING HOT (Feeling of warmth facial) (seriousness criterion medically significant) and GROIN PAIN (Groin pain) (seriousness criterion medically significant). On 10-Sep-2021, the patient experienced DEHYDRATION (Dehydration) (seriousness criterion medically significant), ARTHRALGIA (Shoulder pain) (seriousness criterion medically significant) and MUSCULOSKELETAL PAIN (Buttock pain) (seriousness criterion medically significant). On 11-Sep-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (Rib pain) (seriousness criterion medically significant). On 09-Sep-2021, PAIN IN EXTREMITY (Aching pain in hands, forearms, elbows), HYPOAESTHESIA (Numbness in hand), HEADACHE (Headache dull), BACK PAIN (Low back pain), NECK PAIN (Neck pain), FEELING HOT (Feeling of warmth facial) and GROIN PAIN (Groin pain) had resolved. On 10-Sep-2021, DIZZINESS (Dizzy), NAUSEA (Nausea), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (oesophageal)), DEHYDRATION (Dehydration) and ARTHRALGIA (Shoulder pain) had resolved. On 11-Sep-2021, FATIGUE (Fatigue), PAIN IN EXTREMITY (Leg pain), MUSCULOSKELETAL PAIN (Buttock pain) and MUSCULOSKELETAL CHEST PAIN (Rib pain) had resolved. On 13-Sep-2021, PERIPHERAL SWELLING (Swollen arm) and PAIN IN EXTREMITY (Pain in arm) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medication were not reported. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: This case concerns a 25-year-old, female patient with no relevant medical history, who experienced the unexpected events of Swollen arm, Pain in arm, Dizzy, Nausea, Fatigue, Gastroesophageal Reflux Disease, Pain in extremity, Hypoaesthesia, Headache, Leg pain, Back pain, Neck pain, Feeling hot, Groin pain, dehydration, Athralgia, Musculoskeletal pain. The events occurred approximately 1 day after the second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed. The event was considered related to the study drug, per the reporter''s assessment was unknown. The benefit-risk relationship of Moderna Covid -19 vaccine, is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 25-year-old, female patient with no relevant medical history, who experienced the unexpected events of Swollen arm, Pain in arm, Dizzy, Nausea, Fatigue, Gastroesophageal Reflux Disease, Pain in extremity, Hypoaesthesia, Headache, Leg pain, Back pain, Neck pain, Feeling hot, Groin pain, dehydration, Athralgia, Musculoskeletal pain. The events occurred approximately 1 day after the second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed. The event was considered related to the study drug, per the reporter''s assessment was unknown. The benefit-risk relationship of Moderna Covid -19 vaccine, is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1743067 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9942 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Decreased appetite, Dysphoria, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol allergy; Allergy to grains; Diabetes mellitus.
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination.; Test Date: 20210909; Test Name: body temperature; Result Unstructured Data: Test Result:from 37.0 to 38.0 Centigrade; Test Date: 20210913; Test Name: body temperature; Result Unstructured Data: Test Result:39.1 Centigrade; Comments: from the morning; Test Date: 20210913; Test Name: body temperature; Result Unstructured Data: Test Result:37.6 Centigrade; Comments: at the time of diagnosis
CDC Split Type: JPPFIZER INC202101206995

Write-up: queasy; Inappetence; Dysphoria; Pyrexia (KT: from 37.0 to 38.0); This is a spontaneous report from a contactable other health professional received from the Regulatory Authority. Regulatory authority report number is v21126772. A 57-year and 0-month-old male patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: FF9942 Expiration date: 30Nov2021) via an unspecified route of administration on 09Sep2021 at 14:00 (the day of vaccination, at the age of 57-year-old), as dose 2, single for COVID-19 immunization. Body temperature before vaccination was 36.6 degrees centigrade on 09Sep2021. The patient history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received, or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) as follows: Soba, Alcohol, Diabetes mellitus. Concomitant medications were not reported. On 09Sep2021 (the day of vaccination), the patient experienced pyrexia (KT: from 37.0 to 38.0). On 13Sep2021 (4 days after vaccination), the patient experienced queasy, inappetence and dysphoria. Clinical course of the event was reported as follows: On 09Sep2021, after the second dose of the vaccination, the patient had pyrexia, KT: from 37.0 to 38.0. On 13Sep2021 from the morning, queasy occurred, the patient had inappetence and dysphoria. KT: 39.1. At the time of diagnosis, pyrexia of 37.6. Perform SOLDEM 3A 500ml infusion. Events resulted in physician office visit. On 14Sep2021 (5 days after the vaccination), the outcome of the events was not recovered. The reporting other health professional 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. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1743202 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bell's palsy, Facial paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

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

Write-up: Facial palsy; Bell''s palsy; This case was received via Pharmaceutical Company (Reference number: JP-TAKEDA-2021TJP091297) on 15-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case was reported by a nurse via a medical representative. On 07-Sep-2021, the patient received the 1st dose of this vaccination. On 09-Sep-2021, the patient is aware of facial palsy and visited in nearby hospital. Thereafter, the symptom did not improve. On 13-Sep-2021, the patient visited another hospital. The patient was diagnosed with facial palsy and was admitted to the hospital for treatment. The outcome of facial palsy and bells palsy was reported as ongoing and unchanged. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 42-year-old, male patient with no relevant medical history, who experienced the unexpected events of facial paralysis and Bell''s palsy. The events occurred approximately 2 days after the first dose of Moderna COVID-19 Vaccine. The patient was hospitalized due to the events. The rechallenge was unknown since no information about the second dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1743203 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005293 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia, Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

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

Write-up: Arrhythmia; Chest pain; This case was received via Pharmaceutical Company(Reference number: 2021TJP093041) on 16-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case was reported by a public health nurse via a medical representative. Arrhythmia was assessed as serious by the Regulatory Authority. On 08-Sep-2021, around 13:30, the patient received the 1st dose of this vaccine. In the middle of the night, the patient became aware of chest pain. On 09-Sep-2021, the patient visited a medical institution. An electrocardiogram showed arrhythmia. According to the physician''s opinion, there is no possible myocarditis. On 15-Sep-2021, a week after the vaccination, the patient still felt kind of sick. On 16-Sep-2021, at this time, the patient was still complaining of mild chest pain. The outcome of chest pain and arrhythmia was reported as ongoing and unchanged. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Not reported.; Sender''s Comments: This case concerns a 41-year-old male patient with no reported medical history who experienced Arrhythmia and chest pain 2 days after first dose of Spikevax. The reporter did not provide causality assessment. Patient experienced AEs after the first dose, which is ongoing at the time of report no information about second dose rechallenge is not applicable. The benefit-risk relationship of Spikevax in not affected by this report.


VAERS ID: 1743209 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005288 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Throat irritation
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: JPMODERNATX, INC.MOD20213

Write-up: Itching in the throat; Cough; This case was received via Pharmaceutical Company(Reference number: 2021TJP094156) on 14-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This case, initially reported to the Regulatory Authority by a nurse, was received via the Regulatory Authority(Ref, v21126685). The patient had a history of queasy and vomiting after receiving influenza vaccination. On an unknown date, body temperature before the vaccination: 36.8 degrees Celsius. On 09-Sep-2021, at 15:59, the patient received the 1st dose of the vaccine. At 16:15, itching in the throat and cough developed. Generalized rash and redness were not noted. At 16:26, adrenaline 0.5 mg was intramuscularly injected. At 16:28, the route was secured with 500 mL of saline. At 16:31, 1 ampule (A) of d-chlorpheniramine maleate was intravenously administered via a side tube. At 16:39, cough persisted. Adrenalin 0.5 mg was intramuscularly injected. At 16:42, the symptoms persisted. The patient was emergently transported. The outcome of itching in the throat and cough was unknown. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Not reported.; Sender''s Comments: This case concerns a 24-year-old, female patient with no relevant medical history, who experienced the unexpected events of throat irritation, cough, generalised rash and erythema. The events occurred approximately 16 minutes after the first dose of Moderna COVID-19 Vaccine. The patient was treated with adrenaline but symptoms persisted. Chlorpheniramine maleate was intravenously administered and another ampule of adrenaline but due to persistence of symptoms patient was emergently transported. The rechallenge was unknown since no information about the second dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1743237 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fall, Loss of consciousness, Presyncope, Skin abrasion, Wound haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: Loss of consciousness; Vasovagal reflex; Collapse from a chair; Abrasion of the right side of the head; Abrasion of the right auricle with bleeding; Abrasion of the right auricle with bleeding; This case was received via the regulatory authority (Reference number: 2021TJP096425) on 17-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case, reported by a physician, via Moderna''s adverse reaction reporting site (TASK0021767), and this case, initially reported by a physician, was received via the PMDA (Ref, v21127115). Loss of consciousness was assessed as serious by the MAH. On an unknown date, body temperature before the vaccination: 36.4 degrees Celsius. On 09-Sep-2021, at 10:48, the patient received the 1st dose of this vaccine. During follow-up after the vaccination, vasovagal reflex developed. The patient collapsed from a chair, but at once the patient got up by him/herself and sat again. Loss of consciousness for a short time was noted. Abrasion of the right side of the head and abrasion of the right auricle with bleeding were noted. The patient had facial pallor, which rapidly improved by bed rest. Blood pressure: 94/50 mmHg, heart rate: 58/min, and SpO2: 97%. Afterwards, the recovery of the symptom was observed. The outcome of vasovagal reflex, collapse from a chair, loss of consciousness, abrasion of the right side of the head, and abrasion of the right auricle with bleeding was reported as recovered. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 23-year-old male patient with reported medical history of Vasovagal reaction who experienced Loss of consciousness, presyncope, fall, skin abrasion skin abrasion and wound hemorrhage 1 day after second dose of Spikevax. The reporter did not provide causality assessment. Rechallenge is not applicable. The benefit-risk relationship of Spikevax in not affected by this report.


VAERS ID: 1746526 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101190685

Write-up: had vaccine lying down lost consciousness after having vaccine; clammy; sweating; Syncope; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109091853321960-CEGAQ, Safety Report GB-MHRA-ADR 25919705. A 24-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: FE8087 and Expiry date was not reported), dose 2 via an unspecified route of administration on 09Sep2021 (age at vaccination was 24-year-old) as dose 2, single dose for COVID-19 immunisation. The patient was not pregnant at time of vaccination. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient had not a COVID-19 test. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The 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. Patient had vaccine lying down lost consciousness after having vaccine, was noticed to be sweating, cold and clammy. legs raised and regained consciousness after a few seconds. Allow to recover and encouraged to drink orally, observed for over 30mins and post syncopal advice given. On an unspecified date patient experienced had vaccine lying down lost consciousness after having vaccine, clammy, sweating, on 09Sep2021 the patient experienced syncope. Reaction: asking does report relate to possible blood clots or low platelet counts. If yes, will ask additional questions at the end of this report: No. Outcome of the event syncope was recovered on 09Sep2021, and rest of the events was recovered on an unspecified date. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1746539 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-09-09
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder, Menstruation delayed
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ISOTRETINOIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acne
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101191548

Write-up: Menstrual disorder; a week late and much heavier/more painful than usual; a week late and much heavier/more painful than usual; a week late and much heavier/more painful than usual; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109111556549840-4TOP5, Safety Report Unique Identifier GB-MHRA-ADR 25928402. A 25-year-old female non pregnant patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FE8087, expiry date: not reported) dose 2 via an unspecified route of administration on 11Aug2021 as single dose for COVID-19 immunisation. Medical history included acne. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not currently breastfeeding. Concomitant medication included isotretinoin taken for acne from 17Jan2021 to an unspecified stop date. On 09Sep2021, the patient experienced menstrual disorder, a week late and much heavier/more painful than usual. Case narrative as reported: Changes to menstrual cycle - a week late and much heavier/more painful than usual. 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 unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1746541 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia; Anxiety; Depression; Fibromyalgia; Gastritis; Intracranial hypertension; Irritable bowel syndrome; Mood disorder; Polycystic ovaries
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101191532

Write-up: Dizziness; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109112353081380-HYEJC, safety report unique identifier is GB-MHRA-ADR 25928778. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 09Sep2021 as a Single dose for Covid-19 immunization (at the age of 25-years). 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. Medical history included intracranial pressure increased, polycystic ovaries, affective disorder, fibromyalgia, depression, gastritis, anxiety, anaemia, and IBS (irritable bowel syndrome). The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and did not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient experienced dizziness on 09Sep2021. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1746691 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-09-09
   Days after vaccination:66
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: pregnancy test; Result Unstructured Data: Test Result:negative
CDC Split Type: GBPFIZER INC202101225135

Write-up: Delayed period; This is a spontaneous report from a contactable consumer or other non hcp received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161127586880-B2VTK. Safety Report Unique Identifier: GB-MHRA-ADR 25951919. A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection, Lot number: Ew3143), via an unspecified route of administration on 05Jul2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with covid-19, not had a covid-19 test. On 09Sep2021, the patient experienced delayed period/missed period and still had not started. Patient had not tested positive for covid-19 since having the vaccine. Patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. The patient underwent lab tests and procedures which included pregnancy test: negative on an unspecified date. The outcome of event was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1746734 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-09-09
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Intermenstrual bleeding, Menstrual discomfort, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101225211

Write-up: discomfort during period; Extreme cramping; Spotting 2-3 days before period actually started; Extremely heavy periods with clots; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202109161404227360-VRAYG, Safety Report Unique Identifier is GB-MHRA-ADR 25953090. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Aug2021 as dose 1, single for COVID-19 immunisation. Medical history and 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 discomfort during period on an unspecified date with outcome of recovering, extremely heavy periods with clots on 09Sep2021 with outcome of recovered on 16Sep2021, extreme cramping on an unspecified date with outcome of unknown, and spotting 2-3 days before period actually started with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. The events were reported as serious, medically significant. Narrative case summary and further information: Case narrative: Extremely heavy periods with clots. Never ever experienced clots during my period since they started (19 years ago). Extreme cramping and discomfort during period. Spotting 2-3 days before period actually started. I have never experienced any kind of spotting before my period before. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1746769 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ear pain, Fatigue, Hypoaesthesia, Inappropriate schedule of product administration, Oropharyngeal pain, Pain, Paraesthesia, Pyrexia, Sinus headache, Sinusitis
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperthyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101225006

Write-up: Tingling sensation; Numbness; Fatigue; Sore throat; Headache sinus; Sinusitis; Earache; General body pain; Feverish; Patient received BNT162B2 Vaccine Dose 1 on 21Jun2021, Dose 2 on 09Sep2021; This is a spontaneous report from a contactable consumer (Patient). This is the first of two reports. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161734388250-6GSN4. Safety Report Unique Identifier GB-MHRA-ADR 25954477. A 37-year-old 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 09Sep2021 (at the age of 37-year-old) as dose 2, single for COVID-19 immunization. Medical history included suspected COVID-19 from 09Sep2021 and ongoing, hyperthyroidism. The patient previously took first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Lot number was not reported), on 21Jun2021 for COVID-19 Immunisation and experienced tingling sensation in hand and arm on the site of vaccine, then became numb and went to left side of face (same reaction on the 1st dose) started with fever, sinusitis followed by headaches and earache and other symptoms still here after day 6. Not had a COVID-19 test, patient had not tested positive for COVID-19 since having the vaccine, patient was not enrolled in clinical trial, Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for hyperthyroidism, start and stop date were not reported. The patient experienced tingling sensation, numbness, fatigue, sore throat, headache sinus, sinusitis, earache, general body pain, feverish, patient received BNT162B2 vaccine dose 1 on 21Jun2021, dose 2 on 09Sep2021 (inappropriate schedule of product administration) on 09Sep2021. The clinical outcome of event tingling sensation, numbness was recovered on 11Sep2021. Fatigue, sore throat, headache sinus, sinusitis, general body pain was not recovered and earache was recovering and Feverish was recovered on 12Sep2021. No follow-up attempts are possible; information about lot/batch number cannot be requested. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101240628 Same Patient, Same product, different dose and different Event.


VAERS ID: 1747011 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-09-09
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthritis bacterial, Blood fibrinogen, C-reactive protein, Chest pain, Deep vein thrombosis, Fibrin D dimer, Pain in extremity, Pruritus, Pulmonary embolism, Pyrexia, Thrombocytopenia
SMQs:, Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: 20210909; Test Name: Fibrinogen; Result Unstructured Data: Fibrinogen increased; Test Date: 20210909; Test Name: High-sensitivity C-reactive protein; Result Unstructured Data: 205.9; Test Date: 20210909; Test Name: Fibrin D dimer; Result Unstructured Data: 1861
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-785103) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEEP VEIN THROMBOSIS, THROMBOCYTOPENIA, PAIN IN EXTREMITY, PULMONARY EMBOLISM, PRURITUS, ARTHRITIS BACTERIAL, CHEST PAIN and PYREXIA in a 21-year-old female patient who received mRNA-1273 (Spikevax) for SARS-CoV-2 vaccination. No Medical History information was reported. On 23-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter in total. On 09-Sep-2021, the patient experienced DEEP VEIN THROMBOSIS (seriousness criteria hospitalization and medically significant), THROMBOCYTOPENIA (seriousness criteria hospitalization and medically significant), PAIN IN EXTREMITY (seriousness criterion hospitalization), PULMONARY EMBOLISM (seriousness criteria hospitalization and medically significant), PRURITUS (seriousness criterion hospitalization), ARTHRITIS BACTERIAL (seriousness criteria hospitalization and medically significant), CHEST PAIN (seriousness criterion hospitalization) and PYREXIA (seriousness criterion hospitalization). At the time of the report, DEEP VEIN THROMBOSIS, THROMBOCYTOPENIA, PAIN IN EXTREMITY, PULMONARY EMBOLISM, PRURITUS, ARTHRITIS BACTERIAL, CHEST PAIN and PYREXIA outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, Blood fibrinogen: high (High) Fibrinogen increased. On 09-Sep-2021, C-reactive protein: high (High) 205.9. On 09-Sep-2021, Fibrin D dimer: high (High) 1861. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Company Comment: This case concerns a 21-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of deep vein thrombosis, thrombocytopenia and pulmonary embolism. The events occurred approximately 17 days after an unknown number of doses of mRNA-1273. The rechallenge was unknown. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 in not affected by this report.; Sender''s Comments: This case concerns a 21-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of deep vein thrombosis, thrombocytopenia and pulmonary embolism. The events occurred approximately 17 days after an unknown number of doses of mRNA-1273. The rechallenge was unknown. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 in not affected by this report.


VAERS ID: 1747083 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Cough, Pruritus
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? 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 INC202101191980

Write-up: Anaphylaxis; Generalised itching; Cough gradually appeared; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory authority report number is v21127788. A 41-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 09Sep2021 14:30 (Batch/Lot number was not reported) at the age of 41-years-old as DOSE 2, SINGLE for covid-19 immunisation. Medical history was none. The patient''s concomitant medications were not reported. The patient experienced anaphylaxis, generalised itching, cough gradually appeared since on 09Sep2021 14:45 with outcome of recovering. The detail information was reported as On 09Sep2021 at 14:30 (the day of vaccination), the patient received the second dose of bnt162b2. On 09Sep2021 at 14:51 (the day of vaccination), the patient experienced anaphylaxis. On 09Sep2021 (the day of vaccination), the outcome of the event was recovering. The course of the event was as follows: About 15 minutes after vaccination, the patient experienced generalised itching. Cough gradually appeared and did not stop. Adrenaline was intramuscularly injected as diagnostic therapy. After that, the symptoms remarkably improved. So, the reporter judged the events as anaphylaxis. The reporting physician classified the events 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: Considering the time course until onset of the events from vaccination, the reporter judged that the event was anaphylaxis due to the vaccine. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1747084 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9942 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Hypoaesthesia, Vaccination site pain
SMQs:, Peripheral neuropathy (broad), Guillain-Barre 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:
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade
CDC Split Type: JPPFIZER INC202101192054

Write-up: numbness at the left fingertip /numbness occurred on the 5 roots in the first joint of the fingertip; pain at the injection site; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory authority report number is v21126410. A 55-year and 10-month-old female patient received BNT162B2 (COMIRNATY) dose 2 via an unspecified route of administration, administered in arm left on 09Sep2021 10:41 (Lot Number: FF9942; Expiration Date: 30Nov2021) as dose 2, single (at the age of 55 years old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Body temperature before vaccination was 36.5 degrees Centigrade. Event onset date was reported as on 09Sep2021 about 10:56 (as reported) (the day of vaccination) The outcome of the event was not provided. The course of the event was as follows: At 10:41, the patient received vaccination at the left upper arm. The patient called up in the waiting room. At 10:56 (after waiting 15 minutes), the patient complained symptom of numbness at the left fingertip. The numbness occurred on the 5 roots in the first joint of the fingertip. No discoloration or swelling were observed. discoloration and swelling had not occurred at the injection site. Other symptom was the pain at the injection site only. After 30 minutes the symptoms subsided and the patient went home. The reporting physician classified the event as serious (can lead to disability). The outcome of events was unknown.


VAERS ID: 1747088 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? 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: 20210909; Test Name: blood pressure; Result Unstructured Data: Test Result:140/100; Test Date: 20210909; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination.; Test Date: 20210909; Test Name: heart rate; Result Unstructured Data: Test Result:80
CDC Split Type: JPPFIZER INC202101192780

Write-up: Loss of consciousness; fell; BP (blood pressure): 140/100; This is a spontaneous report from a contactable physician received from the Agency (A). Regulatory authority report number is v21126416. A 43-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 09Sep2021 14:05 (Lot Number: FF3620; Expiration Date: 30Nov2021) (at age of 43-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none. The patient''s concomitant medications were not reported. The patient experienced loss of consciousness (medically significant) on 09Sep2021 14:22 with outcome of recovered on 09Sep2021, fell (non-serious) on 09Sep2021 14:22 with outcome of recovered on 09Sep2021, bp (blood pressure): 140/100 (non-serious) on 09Sep2021 14:22 with outcome of recovered on 09Sep2021. At 14:22, the patient fell and experienced loss of consciousness. Blood pressure (BP): 140/100, heart rate (HR): 80. At 14:25, EPIQUICK 0.3 mg was intramuscularly administered. A route was secured, and the patient was followed up. At 16:00, the patient went home. Body temperature before vaccination was 36.5 degrees Centigrade. The reporting physician classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable. Other possible causes of the event such as any other diseases was Painful reflex, psychological. The reporting physician commented: The possibility of Neurally mediated reflex and psychological stress reflex was high.; Reporter''s Comments: The possibility of Neurally mediated reflex and psychological stress reflex was high.


VAERS ID: 1747203 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005289 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: Blood pressure; Result Unstructured Data: 87/43; Test Date: 20210909; Test Name: Body temperature; Result Unstructured Data: 36.1; Test Date: 20210909; Test Name: SpO2; Result Unstructured Data: 98%.
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Loss of consciousness; Vasovagal reflex; This case was received via The Regulatory Authority (Reference number: JP-TAKEDA-2021TJP095717) on 15-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case, reported by a physician, was received by the Regulatory Authority via Moderna''s adverse reaction reporting site (TASK0021740), and reported to the Regulatory Authority by a physician, was received via the RA (Ref, v21126973). On 09-Sep-2021, at 15:25, the patient received the 1st dose of this vaccination. At 15:36, vasovagal reflex developed when the patient is waiting for follow-up observation in a chair. The patient complained of poor physical condition with unknown details. After that, the patient lost consciousness for about one minute. Carotid artery was not easily palpated, so the lower legs are elevated while lying in bed. At 15:37, level of consciousness recovered. Carotid and radial arteries were palpated, and vital BP 87/43, P46, SpO2 98%, body temperature 36.1 degrees Celsius. The patient made an emergency request just in case, and the patient was transported by ambulance. Blood pressure was stabilized without treatment, and symptom recovery was confirmed. The patient went home without hospitalization. The outcome of loss of consciousness and, vasovagal reflex was reported as recovered. Follow-up investigation will be made. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. This case concerns a 39-year-old male patient with no details on previous relevant medical history, who experienced the serious unexpected events of Loss of consciousness and Presyncope after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The events occurred on the X days after the first dose of Spikevax. The rechallenge is unknown since only information about the first dose was disclosed. The benefit-risk relationship of Spikevax vaccine is not affected by this report. The seriousness criteria of the events was assessed as per regulatory authority report. As per narrative, the patient was not Hospitalized and there is insufficient evidence to support the seriousness assessment from a clinical or regulatory standpoint.


VAERS ID: 1747324 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA FE7053 / UNK LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 immunisation, Fatigue, Heart rate, Heart rate increased, Interchange of vaccine products, Myocarditis, Pyrexia, Troponin I
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202109; Test Name: HEART RATE; Result Unstructured Data: Heart rate increased; Test Date: 202109; Test Name: Troponin I; Result Unstructured Data: Maximum 22000
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: MYOCARDITIS; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; Heart rate increased; Interchange of vaccine products; FATIGUE; FEVER; This case was received via regulatory authority (Reference number: NO-NOMAADVRE-E2B_00050386) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (MYOCARDITIS) in an 18-year-old male patient who received mRNA-1273 (Spikevax) (batch no. FE7053) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Vaccination: Comirnaty. On 09-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 2 dosage form. On 09-Sep-2021, the patient experienced PYREXIA (FEVER). On an unknown date, the patient experienced MYOCARDITIS (MYOCARDITIS) (seriousness criteria hospitalization and medically significant), COVID-19 IMMUNISATION (REVACCINATION WITH DIFFERENT COVID-19 VACCINE), HEART RATE INCREASED (Heart rate increased), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and FATIGUE (FATIGUE). On 10-Sep-2021, PYREXIA (FEVER) had resolved. At the time of the report, MYOCARDITIS (MYOCARDITIS), COVID-19 IMMUNISATION (REVACCINATION WITH DIFFERENT COVID-19 VACCINE), HEART RATE INCREASED (Heart rate increased) and FATIGUE (FATIGUE) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Heart rate: increased (High) Heart rate increased. In September 2021, Troponin I: 22000 (High) Maximum 22000. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered MYOCARDITIS (MYOCARDITIS), FATIGUE (FATIGUE) and PYREXIA (FEVER) to be possibly related and COVID-19 IMMUNISATION (REVACCINATION WITH DIFFERENT COVID-19 VACCINE) to have an unknown relationship. No further causality assessments were provided for HEART RATE INCREASED (Heart rate increased) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). Concomitant medications was not provided by the reporter Treatment information was not provided. Company Comment: This case concerns an 18 year old male with no reported history who experienced the listed, serious event of Myocarditis along with other listed and unlisted non-serious events. The events occurred one day after the second dose of Spikevax. Re-challenge is unknown as no information about the first dose is reported. Causality is reported as possible. Benefit-risk relationship of Spikevax is not affected by this report.; Reporter''s Comments: * High fever (unspecified) the first day after vaccination with COVID-19 vaccine Spikevax. * Fatigued and hospitalized due to fast heart action and diagnosed with probable myocarditis. * Troponin I was increased to a maximum of 22000.; Sender''s Comments: This case concerns an 18 year old male with no reported history who experienced the listed, serious event of Myocarditis along with other listed and unlisted non-serious events. The events occurred one day after the second dose of Spikevax. Re-challenge is unknown as no information about the first dose is reported. Causality is reported as possible. Benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1747373 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8871 / 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: 20210909; Test Name: blood pressure; Result Unstructured Data: Test Result:191/100 mmHg; Test Date: 20210909; Test Name: blood pressure; Result Unstructured Data: Test Result:160/100 mmHg; Test Date: 20210909; Test Name: blood pressure; Result Unstructured Data: Test Result:150/100 mmHg
CDC Split Type: PHPFIZER INC202101219817

Write-up: Elevated BP/ 191/100 mmhg; This is a spontaneous report from a contactable other healthcare professional received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300105291. A 57-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 09Sep2021 (lot number: FF8871; expiry date: unknown) at the age of 57-years-old, as dose number unknown, single for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 09Sep2021 at 13:50, the patient experienced elevated blood pressure (BP). The clinical course was reported as follows: At 13:50, elevated BP at 191/100 mmhg. At 14:10, patient was given Captopril 25 mg, 1 tab sublingual (SL) now. At 14:25, BP was 160/100 mmhg. At 14:52, BP was 150/100 mmhg. Patient may go home (MGH). To start Losartan 50 mg 1 tab once daily (OD). The patient recovered from the event on unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1747440 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005242 / 2 - / -

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

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

Write-up: ; This case was received via Agency Regulatory Authority (Reference number: SE-MPA-2021-083068) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of HYPERSENSITIVITY in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005242) for COVID-19 vaccination. The patient''s past medical history included Adverse drug reaction NOS. On 09-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced HYPERSENSITIVITY (seriousness criterion medically significant). At the time of the report, HYPERSENSITIVITY was resolving. For mRNA-1273 (Spikevax) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Company Comment: This case concerns a 30 year-old, female patient with a history of Adverse drug reaction, who experienced the unexpected serious event of Hypersensitivity. The event occurred approximately the same day after the second dose of Spikevax. The rechallenge was not applicable, as the event was reported exclusively after the second dose. The medical history, of Adverse drug reaction, remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 30 year-old, female patient with a history of Adverse drug reaction, who experienced the unexpected serious event of Hypersensitivity. The event occurred approximately the same day after the second dose of Spikevax. The rechallenge was not applicable, as the event was reported exclusively after the second dose. The medical history, of Adverse drug reaction, remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1749251 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-09-09
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Asthenia, Blood pressure abnormal, Chest pain, Computerised tomogram, Fall, Fatigue, Myocarditis, Pain in extremity, Specialist consultation, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ct scan of thorax; Result Unstructured Data: Test Result:without findings; Test Name: cardiologist consultation; Result Unstructured Data: Test Result:confirmed myocarditis
CDC Split Type: DEPFIZER INC202101240421

Write-up: There she was diagnosed with myocarditis; she had experienced severe, burning pain in the chest; she had experienced severe, burning pain in the heart area; pain spread over the left shoulder and arm.; tired and exhausted; had weak knees and was very weak; collapsed on her way to work; blood pressure still makes caprioles; she collapsed again and crashed herself against a door; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Biontech [manufacturer control number: 87648]. A 41-year-old female patient received second dose of BNT162b2, via an unspecified route of administration on 10Jul2021 (Batch/Lot Number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2, via an unspecified route of administration on 05Jun2021 (Batch/Lot Number was not reported) as single dose for COVID-19 immunisation. The clinical course was reported as follows: on 09Sep2021 the patient had experienced severe, burning pain in the chest and heart area in the morning. The pain spread down her left shoulder and arm. She had weak knees and was very weak, tired and exhausted and collapsed on her way to work. Therefore, instead of going to work, she went to see her family doctor. She was immediately admitted to the hospital. There she was diagnosed with myocarditis and then prescribed for her blood pressure inhibitors and an antibiotic and was told to take it easy. In the following days, a CT scan of her thorax was performed without any findings. A visit to the cardiologist confirmed the initial diagnosis and he gave her a referral for cardio MRI. The prescribed medicines show so far unfortunately no resounding effect. Her blood pressure still makes caprioles, she feels ill and is very weak and exhausted. This morning she collapsed again and crashed herself against a door. She has been unable to work since 09Sep2021. Until 09Sep2021 she was a very healthy person. The patient outcome of the events was not recovered. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.


VAERS ID: 1749268 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4721 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood pressure measurement, Echocardiogram, Electrocardiogram, Full blood count, Headache, Heart rate, Increased upper airway secretion, Mitral valve incompetence, Mitral valve prolapse, Myocarditis, Oxygen saturation, Rhinorrhoea, SARS-CoV-2 test negative, Troponin
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chickenpox (at one month old); Cranioencephalic trauma (with lineal occipital fracture, small, without complications.)
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:rhythmic to 70x without murmurs; Comments: no pericardial rub. Preserved vesicular murmur without any added noises. No lower limbs edema; Test Date: 20210909; Test Name: Arterial tension; Result Unstructured Data: Test Result:119/80; Test Date: 20210909; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Mild anterior leaflet prolapse of mitral valve; Comments: Left ventricle not dilated with normal wall thickness. Preserved global systolic function, without alterations in segmental contractility. Left atrium slightly dilated (anteroposterior diameter 41 mm). Undilated right chambers with normal right ventricular function. Mild anterior leaflet prolapse of mitral valve. Mild mitral regurgitation. Non-dilated inferior vena cava. No pericardial effusion. CONCLUSION: mild mitral regurgitation. Normal left ventricle systolic function. Mild anterior leaflet prolapse of mitral valve.; Test Date: 20210909; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:In RS with short and lowered PR; Comments: In RS with short and lowered PR. Diffuse ST elevation; Test Date: 20210909; Test Name: Hemogram; Result Unstructured Data: Test Result:normal; Test Date: 20210909; Test Name: Hemogram; Result Unstructured Data: Test Result:normal; Test Date: 20210909; Test Name: Hemogram; Result Unstructured Data: Test Result:normal; Test Date: 20210909; Test Name: Heart rate; Result Unstructured Data: Test Result:72; Test Date: 20210909; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:99%; Test Date: 20210909; Test Name: COVID-19 antigen test negative; Test Result: Negative ; Test Date: 20210909; Test Name: Troponin; Result Unstructured Data: Test Result:655; Test Date: 20210909; Test Name: Troponin; Result Unstructured Data: Test Result:799; Test Date: 20210909; Test Name: Troponin; Result Unstructured Data: Test Result:1613; Test Date: 20210909; Test Name: Troponin; Result Unstructured Data: Test Result:1523
CDC Split Type: ESPFIZER INC202101222655

Write-up: Myopericarditis; mitral valve prolapse; Mild mitral valve insufficiency; Headache; Rhinopharyngeal mucus; Rhinopharyngeal mucus; This is a spontaneous report from a contactable other health professional downloaded from the regulatory authority number ES-AEMPS-1000751. A 15-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 06Sep2021 (Lot Number: FE4721) as single dose for COVID-19 immunization. Medical history included no known adverse reaction to drugs. No toxic habits. He had chickenpox at one month old. Admitted in 2007 with cranioencephalic trauma with lineal occipital fracture, small, without complications. No important relevant medical history. House treatment: "non." The patient''s concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 17Aug2021 (Lot Number: unknown) as single dose for COVID-19 immunization. Goes to the emergency room on 09Sep2021 with oppressive chest pain in the middle or the chest irradiating to the whole chest, about 5 hours of duration. The pain woke the patient, accompanied with headache and rhinopharyngeal mucus. No nausea or vomit, no abdominal pain, no fever, dyspnea or cough, no voiding symptoms. Refers episodes of pain but with less intensity and duration, that sometimes matches or not with exertion. After performing analysis, the troponin was increased, patient is translated to cardiology, and they perform an echocardiogram. Arterial tension: 119/80, Heart rate: 72, Oxygen saturation: 99%. Good general wellbeing. Eupneic. Properly hydrated and perfused. Pulmonary auscultation: rhythmic to 70x without murmurs, no pericardial rub. Preserved vesicular murmur without any added noises. No lower limbs edema. Clinical assessment: Acute myopericarditis (probably related to the SARS COV2 vaccine), Systolic function of the left ventricle preserved. Mitral valve prolapse. Mild mitral insufficiency. Action plan: Telemetry. Watch evolution. More analyses are requested. Control echocardiogram requested. The patient underwent lab tests and procedures on 09Sep2021 which included auscultation: rhythmic to 70x without murmurs (no pericardial rub. Preserved vesicular murmur without any added noises. No lower limbs edema), blood pressure measurement: 119/80, echocardiogram: mild anterior leaflet prolapse of mitral valve (Left ventricle not dilated with normal wall thickness. Preserved global systolic function, without alterations in segmental contractility. Left atrium slightly dilated (anteroposterior diameter 41 mm). Undilated right chambers with normal right ventricular function. Mild anterior leaflet prolapse of mitral valve. Mild mitral regurgitation. Non-dilated inferior vena cava. No pericardial effusion. CONCLUSION: mild mitral regurgitation. Normal left ventricle systolic function. Mild anterior leaflet prolapse of mitral valve), electrocardiogram: in RS with short and lowered PR (In RS with short and lowered PR. Diffuse ST elevation), full blood count: normal, full blood count: normal, full blood count: normal, heart rate: 72, oxygen saturation: 99%, SARS-CoV-2 test negative: negative, troponin: 655, troponin: 799, troponin: 1613, troponin: 1523. The events required Emergency Room Visit. The patient was hospitalized for the events. The outcome of the event myopericarditis was recovering while for the rest of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1750707 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA J07BX03 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Malaise
SMQs:, Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylactic shock (anaphylactic shock during surgery); Surgery.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Agency (Reference number: FR-AFSSAPS-CN20212956) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ASTHENIA and MALAISE in a 53-year-old female patient who received mRNA-1273 (Spikevax) (batch no. J07BX03) for COVID-19 vaccination. The patient''s past medical history included Anaphylactic shock (anaphylactic shock during surgery) and Surgery. Concurrent medical conditions included Allergy. On 08-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 09-Sep-2021, the patient experienced ASTHENIA (seriousness criterion medically significant) and MALAISE (seriousness criterion medically significant). At the time of the report, ASTHENIA and MALAISE was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. Patient experienced Dizziness. Company Comment: This case concerns a 53-year-old female patient with relevant medical history of previous anaphylactic shock and multiples allergies who experienced the unexpected serious events of asthenia and malaise. The events occurred 1 day after the first dose of COVID-19 Vaccine Moderna (mRNA-1273). The rechallenge was not applicable, as the events happened after the first dose of the vaccine. The history of anaphylactic shock and multiple allergies remain confounders as they are risk factors for future reactions to the vaccine. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. Events seriousness was assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events seemed to be serious by medical judgement and from a clinical or regulatory standpoint. Further information (translation) is expected. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Translation received on 28-Sep-2021, added other relevant history.; Sender''s Comments: This case concerns a 53-year-old female patient with relevant medical history of previous anaphylactic shock and multiples allergies who experienced the unexpected serious events of asthenia and malaise. The events occurred 1 day after the first dose of COVID-19 Vaccine Moderna (mRNA-1273). The rechallenge was not applicable, as the events happened after the first dose of the vaccine. The history of anaphylactic shock and multiple allergies remain confounders as they are risk factors for future reactions to the vaccine. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. Events seriousness was assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events seemed to be serious by medical judgement and from a clinical or regulatory standpoint. Further information (translation) is expected.


VAERS ID: 1751000 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Abdominal pain upper, Diarrhoea, Discomfort, Myalgia, Overdose, Paraesthesia oral, SARS-CoV-2 test, Tongue ulceration, Ulcer
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Pseudomembranous colitis (broad), Drug abuse and dependence (broad), Gastrointestinal ulceration (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101226723

Write-up: muscle aches; dose; tingling tongue; ulcer; very uncomfortable; Stomach cramps; Diarrhea; Felt bloated 4 days after the jab; Tongue ulceration; This is a spontaneous report from a contactable consumer or other non hcp (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109171232193820-2KAQZ. Safety Report Unique Identifier GB-MHRA-ADR 25958770. A 26-year-old (non-pregnant and not currently breastfeeding) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FF2153), dose 2 via an unspecified route of administration on 08Sep2021 as single dose for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Patient was not pregnant, Patient was not currently breastfeeding. The patient''s medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported) on an unspecified date for COVID-19 immunisation. It was reported that on an unspecified date, the patient experienced muscle aches, dose, tingling tongue, ulcer. On 13Sep2021, stomach cramps, diarrhea. On 09Sep2021, tongue ulceration. On 12Sep2021, felt bloated 4 days after the jab. On an unspecified date, very uncomfortable. Tingling tongue 1 hour after 2nd dose. Next day patient had an ulcer on tip of patient tongue which took a few days to go. patient also had muscle aches. Felt bloated 4 days after the jab and then on the 5th day patient had bad stomach cramps and diarrhoea which has so far lasted 5 more days and has been very uncomfortable. 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 underwent lab tests and procedures which included SARS-CoV-2 test was negative (No-Negative COVID-19 test). The outcome of event for tongue ulceration was recovered on 12Sep2021. For event muscle aches, dose, tingling tongue, Ulcer, Stomach cramps, Diarrhea was Recovered/Resolved and for event very uncomfortable, felt bloated 4 days after the jab was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1751066 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Malaise, Migraine, Polymerase chain reaction, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: PCR; Test Result: Negative ; Comments: Two negative PCR tests; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101226753

Write-up: feeling unwell; Persistent migraine like headache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109171952594880-T1LXB, Safety Report Unique Identifier GB-MHRA-ADR 25961062. A 16-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Batch/Lot Number were not reported), dose 1 via an unspecified route of administration on 08Sep2021 as dose 1, single for COVID-19 immunisation. Medical history included suspected covid-19 from 09Sep2021 and ongoing. The patient concomitant medications were not reported. On 09Sep2021, the patient experienced persistent migraine like headache and on an unspecified date the patient experienced feeling unwell. The patient underwent lab tests and procedures which included sars-cov-2 test was negative (No - Negative COVID-19 test), polymerase chain reaction was negative (Two negative PCR tests) on an unspecified date. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The outcome of the event migraine like headache was not recovered and feeling unwell was unknown. No follow-up at tempts are possible, information about Lot/Batch number cannot be obtained. No further information is expected.


VAERS ID: 1751075 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-09
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Confusional state, Dysmenorrhoea, Fatigue, Headache, Limb discomfort, Pain in extremity, Resting tremor, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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:
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101227087

Write-up: Period pains; Chest discomfort; Exhaustion; Heaviness in leg; Headache; Resting tremor; Confusion; Leg pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109172031554900-5QJM6. [Safety Report Unique Identifier: GB-MHRA-ADR 25961271] A 41-year-old female patient received first dose of BNT162B2 (PFIZER COVID-19 MRNA VACCINE BIONTECH, Solution for injection, lot number: FE3380), via an unspecified route of administration on 04Sep2021 as single dose for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19, was not pregnant and was not currently breastfeeding. The patient''s medical history and concomitant medications were not reported. The patient experienced chest discomfort on 12Sep2021 with outcome of not recovered , exhaustion on 12Sep2021 with outcome of not recovered , headache on 10Sep2021 with outcome of not recovered , heaviness in leg on 12Sep2021 with outcome of not recovered , period pains on 13Sep2021 with outcome of not recovered , resting tremor on 10Sep2021 with outcome of recovered on 17Sep2021, confusion on 09Sep2021 with outcome of recovering , leg pain on 09Sep2021 with outcome of not recovered. Reported events were assessed serious as medically significant. The patient underwent sars-cov-2 test which was negative on 15Sep2021. It was also informed that patient was not enrolled in clinical trial No follow-up attempts are possible. No further information is expected.


VAERS ID: 1751168 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Antinuclear antibody, Bacterial test, Body temperature, C-reactive protein, Chest X-ray, Computerised tomogram abdomen, Echocardiogram, Haemoglobin, Inflammation, Lymphadenopathy, Myalgia, Neutrophil count, Platelet count, Polymerase chain reaction, Pyrexia, Rash maculo-papular, SARS-CoV-2 test, Serum ferritin, Ultrasound scan
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Depression
Allergies:
Diagnostic Lab Data: Test Name: ANA; Result Unstructured Data: Test Result:negative; Test Name: bacterial cultures; Result Unstructured Data: Test Result:negative; Test Name: Body temperature; Result Unstructured Data: Test Result:$g 39 degrees; Test Name: CXR; Result Unstructured Data: Test Result:neg; Test Name: CT abdomen; Result Unstructured Data: Test Result:widespread lymphadenopathy; Test Name: CRP; Result Unstructured Data: Test Result:263; Test Name: echocardiograms; Result Unstructured Data: Test Result:NAD; Test Name: echocardiograms; Result Unstructured Data: Test Result:NAD; Test Name: HB; Result Unstructured Data: Test Result:stable; Test Name: neutrophil count; Result Unstructured Data: Test Result:high; Test Name: Platelet count; Result Unstructured Data: Test Result:normal; Test Name: Viral PCRs and cultures; Result Unstructured Data: Test Result:negative; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: ferritin; Result Unstructured Data: Test Result:raised (to over 30 000); Test Name: US neck; Result Unstructured Data: Test Result:cervical lymphadenopathy
CDC Split Type: GBPFIZER INC202101226956

Write-up: fever; maculopapular rash; myalgia; lymphadenopathy; Inflammation; This is a spontaneous report from a contactable physician received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109181619048120-YUWNB, Safety Report GB-MHRA-ADR 25964921.A 17-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Sep2021 as a single dose for COVID-19 immunization. Medical history included depression. The patient was not pregnant at the time of vaccination. The patient had not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient was recently treated for depression from May (on sertraline). On an unspecified date the patient experienced fever, maculopapular rash, myalgia, and lymphadenopathy. On 09Sep2021 the patient experienced inflammation. The patient was hospitalized as a result of the events. The clinical course was: the patient developed significant inflammatory response post vaccine that started 3 days post vaccination. She had 10 days of fevers $g 39 degrees, and raised inflammatory markers, including high neutrophil count, C-reactive protein (CRP) 263, ferritin raised (to over 30 000), D-dimer raised to over 9000. Apart from fever, she had widespread maculopapular rash, myalgia, and significant and widespread lymphadenopathy. The patient''s platelet count was normal throughout and hemoglobin (HB) was stable. The patient underwent lab tests and procedures on unspecified dates which included sars-cov-2 test with result of negative, two echocardiograms with results "NAD," chest x-ray (CXR) with result of negative, all bacterial cultures were negative, viral PCRs and cultures were negative, rheumatology bloods (including Rh factor, antinuclear antibody [ANA] negative), computerized tomogram (CT) abdomen which showed widespread lymphadenopathy, and ultrasound (US) neck which showed cervical lymphadenopathy. The outcomes of fever, maculopapular rash, and myalgia were recovered. The outcome of inflammation was recovering. The outcome of lymphadenopathy was unknown. It was also reported that since the vaccination the patient had not tested positive for COVID-19. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1751172 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Epistaxis, Haematochezia, Headache, Nausea, Palpitations, Vision blurred, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), 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: Pfizer, Inc. EUA 027034
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101226578

Write-up: Blood in stool; Nose bleeds; Blurred vision; Heart racing; Headache; Vomiting; Nausea; This is a spontaneous report from a contactable consumer or other non-HCP (Patient). This is a report received from the regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109181655153450-MRXX7, Safety Report Unique Identifier GB-MHRA-ADR 25964941. A 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: ff8222; Expiration Date: not reported) via an unspecified route of administration on 09Sep2021 (age at vaccination 43-year-old) as DOSE 2, SINGLE for Covid-19 immunization. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: not reported; Expiration date: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for Covid-19 immunization. The patients medical history included suspected covid-19 from 13Jul2021 and ongoing. The patients concomitant medications included ramipril taken for an unspecified indication, start and stop date were not reported. Patient had not tested positive for Covid-19 since having the vaccine. Patient was not enrolled in clinical trial. On 09Sep2021, patient experienced blood in stool, nose bleeds, blurred vision, heart racing, headache, vomiting and nausea. The patient reported that I could not see my doctor (they only see urgent cases - maybe I can get an appointment in few weeks), 111 said that if I think it''s bad enough I should go to hospital. The adverse events considered serious under medically significant and disability. The outcome of event blurred vision was recovered on 14Sep2021. The outcome of event vomiting was recovering at the time of reporting and the outcome of all other events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1751174 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-09
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ear infection, Menstruation delayed
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101227101

Write-up: Ear infection; Late period; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109181704379170-MKAP7, Safety Report Unique Identifier GB-MHRA-ADR 25964955. A 16-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), on 05Sep2021via an unspecified route of administration as single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. It was unsure if patient has had symptoms associated with COVID-19. She had not a COVID-19 test. The patient experienced late period (it was normally regular) on 09Sep2021 with outcome of not recovered and ear infection left middle ear and outer ear on right side on 10Sep2021 with outcome of not recovered. It was also reported that patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1751265 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blindness, Haemorrhage, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Retinal disorders (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:
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: faint; Blind; Bleeding; This case was received via RA (Reference number: GB-MHRA-ADR 25977436) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (faint), BLINDNESS (Blind) and HAEMORRHAGE (Bleeding) in a 33-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced BLINDNESS (Blind) (seriousness criterion medically significant) and HAEMORRHAGE (Bleeding) (seriousness criterion medically significant). On an unknown date, the patient experienced SYNCOPE (faint) (seriousness criterion medically significant). On 09-Sep-2021, BLINDNESS (Blind) had resolved with sequelae. On 10-Sep-2021, HAEMORRHAGE (Bleeding) had resolved with sequelae. At the time of the report, SYNCOPE (faint) outcome was unknown. 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. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided by the reporter. Treatment medications was not provided by the reporter. Patient had temporary blindness in left eye for 6 hours also bled from the nose for a consecutive 2 hours and felt light headed and faint as a result. Company Comment: This case concerns a 33 year-old male patient with no reported medical history who experienced the unexpected events of syncope, blindness and hemorrhage. The event of blindness and hemorrhage occurred approximately 2 days after the first dose of mRNA-1273. The event of syncope occurred on an unknown date. The rechallenge was not applicable as the events occurred after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 33 year-old male patient with no reported medical history who experienced the unexpected events of syncope, blindness and hemorrhage. The event of blindness and hemorrhage occurred approximately 2 days after the first dose of mRNA-1273. The event of syncope occurred on an unknown date. The rechallenge was not applicable as the events occurred after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1751361 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005687 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Loss of consciousness, Nausea, Pyrexia
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), Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: This case was received via Regulatory Authority (Reference number: IT-MINISAL02-785839) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS in a 22-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005687) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 09-Sep-2021, the patient experienced LOSS OF CONSCIOUSNESS (seriousness criterion medically significant), ABDOMINAL PAIN , NAUSEA and PYREXIA . At the time of the report, LOSS OF CONSCIOUSNESS , ABDOMINAL PAIN , NAUSEA and PYREXIA had resolved with sequelae. No relevant concomitant medication information provided. No relevant treatment medication information provided. It was reported that the patient had fever, abdominal pain, nausea and fainted for about 3 seconds, regained consciousness straight away but the patient hit his head. Company comment: This case concerns a 22-year-old male patient with no relevant medical history, who experienced the serious unexpected event of Loss of consciousness. The event occurred approximately 02 days after the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Translation document received on 27-SEP-2021 and Reaction/event as reported by primary source updated and updated Narrative On 24-Sep-2021: Follow-up received included which updated dosage date and batch number.; Sender''s Comments: 17.09.21 LOTTO 3005687. This case concerns a 22-year-old male patient with no relevant medical history, who experienced the serious unexpected event of Loss of consciousness. The event occurred approximately 02 days after the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1751618 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300528 / 1 - / OT

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

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

Write-up: Angiooedema; This case was received via regulatory authority on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of ANGIOEDEMA (Angiooedema) in a 28-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 300528) for COVID-19 vaccination. No Medical History information was reported. On 08-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced ANGIOEDEMA (Angiooedema) (seriousness criterion medically significant). On 10-Sep-2021, ANGIOEDEMA (Angiooedema) had resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided. Company comment: This case concerns a 28-year-old female patient, with no reported medical history who experienced the unexpected event of angioedema. The event occurred 1 day after the first dose of Spikevax. The rechallenge was not applicable as based o vaccine administration date, patient was not due for second dose at the time of the report. Causality for the reported event was not provided by the reporter. The benefit-risk relationship of the vaccine in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting as this is noted as an important medical event Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Translated Document received on 27-Sep-2021, containing no new information; Sender''s Comments: This case concerns a 28-year-old female patient, with no reported medical history who experienced the unexpected event of angioedema. The event occurred 1 day after the first dose of Spikevax. The rechallenge was not applicable as based o vaccine administration date, patient was not due for second dose at the time of the report. Causality for the reported event was not provided by the reporter. The benefit-risk relationship of the vaccine in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting as this is noted as an important medical event


VAERS ID: 1752972 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-09-09
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005784 / UNK - / OT

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

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

Write-up: BODY MALAISE, COLDS, COUGH, DIARRHEA,FATIGUE, FEVER, HEADACHE, SORE THROAT,CHILLS, DIFFICULTY OF BREATHING, LOSS OF TASTE AND SMELL; This regulatory authority case was reported by an other health care professional and describes the occurrence of COVID-19 (BODY MALAISE, COLDS, COUGH, DIARRHEA,FATIGUE, FEVER, HEADACHE, SORE THROAT,CHILLS, DIFFICULTY OF BREATHING, LOSS OF TASTE AND SMELL) in a 52-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3005784) for COVID-19 vaccination. No Medical History information was reported. On 31-Aug-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 09-Sep-2021 at 10:00 AM, the patient experienced COVID-19 (BODY MALAISE, COLDS, COUGH, DIARRHEA,FATIGUE, FEVER, HEADACHE, SORE THROAT,CHILLS, DIFFICULTY OF BREATHING, LOSS OF TASTE AND SMELL) (seriousness criterion hospitalization prolonged). At the time of the report, COVID-19 (BODY MALAISE, COLDS, COUGH, DIARRHEA,FATIGUE, FEVER, HEADACHE, SORE THROAT,CHILLS, DIFFICULTY OF BREATHING, LOSS OF TASTE AND SMELL) was resolving. 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. No concomitant medication were reported. The treatment information were unknown. Company Comment: This case concerns a 52-year-old female patient with no previous relevant medical history, who experienced the unexpected serious events of COVID-19 after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred approximately 9 days after the Spikevax, dose number unknown. The rechallenge is not applicable since only information about one dose was disclosed and dose number is unknown. The benefit-risk relationship of Spikevax vaccine is not affected by this report. Regulatory authority subsumed the events of body malaise, cold, cough, diahrrea, fatigue, fever, sore throat, chills, difficulty breathing, loss of taste and smell under the final diagnosis of COVID-19. However, SARS-CoV-test was not reported. The information is retained as reported.; Sender''s Comments: This case concerns a 52-year-old female patient with no previous relevant medical history, who experienced the unexpected serious events of COVID-19 after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred approximately 9 days after the Spikevax, dose number unknown. The rechallenge is not applicable since only information about one dose was disclosed and dose number is unknown. The benefit-risk relationship of Spikevax vaccine is not affected by this report. Regulatory authority subsumed the events of body malaise, cold, cough, diahrrea, fatigue, fever, sore throat, chills, difficulty breathing, loss of taste and smell under the final diagnosis of COVID-19. However, SARS-CoV-test was not reported. The information is retained as reported.


VAERS ID: 1754455 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-09-09
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCP17 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Platelet count, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (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: Immune thrombocytopenia
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: platelet count; Result Unstructured Data: Test Result:reduced
CDC Split Type: DEPFIZER INC202101228918

Write-up: Reduced platelet count; This is a spontaneous report from a non-contactable physician, downloaded from the regulatory authority. The regulatory authority number is DE-PEI-202100190541. A 35-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, strength: 0.3 mL), via an unspecified route of administration on 11Aug2021 at the age of 35 years old (Batch/Lot Number: SCP17, Expiration date: unknown) as dose 2, single for COVID-19 immunization. Relevant medical history included immune thrombocytopenia from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY, Solution for injection) on 14Jul2021 (Batch/Lot number and Expiration date were unknown) as dose 1, 0.3 mL single for COVID-19 immunization. On 09Sep2021, the patient experienced reduced platelet count. This report was considered serious as other medically important event. The clinical outcome of reduced platelet count was unknown. The result of assessment of the relatedness of drug, Comirnaty, to the reaction/event, Reduced platelet count, by the source of assessment: RA, was "D. Unclassifiable."


VAERS ID: 1755161 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Inappropriate schedule of product administration, Investigation, SARS-CoV-2 test
SMQs:, Termination of pregnancy and risk of abortion (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: scans or investigations; Result Unstructured Data: Test Result:I went into labour the same night I got my vaccine; Comments: baby was 17+4 weeks gestation; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101266221

Write-up: Late miscarriage; first dose on 15-JUL-2021/second dose on 9-SEP-2021; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109250819407140-L79AG, Safety Report Unique Identifier GB-MHRA-ADR 25994306. A pregnant 29-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 09Sep2021 (Batch/Lot Number: Not known) as single dose for COVID-19 immunization. Medical history included pregnancy. The patient was no longer pregnant at the time of reporting. The patient has not had symptoms associated with COVID-19 and was not currently breastfeeding. The patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Concomitant medication included folic acid taken for folic acid supplementation. On 09Sep2021 the patient experienced late miscarriage, assessed as medically significant and requiring patient''s hospitalization, moreover an inappropriate schedule of vaccine was administered. The patient reported that later in the night of the second vaccine dose her body started the process of labour. Her mucus plug came away at around 10pm, she then began having bleeding, cramping/contractions, intense pain in my lower back. These symptoms continued until 4pm on Sunday 12Sep2021 when she delivered her baby at just 17+4 weeks gestation. The baby was delivered premature. The fetal outcome was neonatal death. Her baby did not survive. Her placenta then wouldn''t deliver itself so the patient had to go to theatre for a procedure to remove it. The previous 2 pregnancy''s were both successful, both full term healthy babies. The patient took folic acid and all vitamins prescribed by doctors throughout pregnancy, with no problems.. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: the patient went into labour the same night she got her vaccine, baby was 17+4 weeks gestation. Post-mortem is being done on baby and results will be submitted once this is complete. On an unknown date the patient underwent SARS-CoV-2 test which was negative. The event outcome was unknown at the time of the report. 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-202101275895 Same patient, different dose drug/event.


VAERS ID: 1755214 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-09
Onset:2021-09-09
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: COVID-19 virus test; Test Result: Negative ; Comments; Test Date: 20210909; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: HKPFIZER INC202101287490

Write-up: This is a spontaneous report from a non-contactable healthcare professional via Regulatory Authority (Regulatory authority report number: not applicable), based on information received by Pfizer (manufacturer control number: HK-Fosun-2021FOS003630), license party for bnt162b2. The Regulatory Authority announced that as of 0.00 am, 17-Sep-2021, the RA was investigating a positive imported case of COVID-19 and two cases of COVID-19. This case was split for 1 of 2 cases of COVID-19. A 16-year-old female patient started to receive first dose of BNT162B2 (Formulation: solution for injection, Batch/Lot number: unknown), via an unknown route of administration on 19Jul2021 as dose 1, single and second dose via an unknown route of administration on 09Aug2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history, concomitant medication(s) and past product were not reported. The patient travelled on 06Sep2021 by flight and tested negative on 04Sep2021. Her specimen collected on 09Sep2021 tested positive. The patient remained asymptomatic. The RA is following up on the case with the regulatory authority. The event was considered as Important Medical Event. At the time of the report, the outcome of the event was unknown. Initial report was received on 20Sep2021. It was reported that, the follow-up (24Sep2021): Non-significant follow-up. No new safety information was received. It was reported that, the causality assessment of asymptomatic covid-19 and vaccination failure were assessed as possible as per reporter. Follow-up attempts are closed, no further information is possible.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101275902 same reporter/drug/event, different patient


VAERS ID: 1755309 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / UNK RA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Electrocardiogram, Investigation, 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: the competitive sports medical examination; Result Unstructured Data: Test Result:all checks in the norm; Test Name: regular blood tests; Result Unstructured Data: Test Result:not provided; Test Name: Electrocardiography; Result Unstructured Data: Test Result:not provided
CDC Split Type: ITPFIZER INC202101231283

Write-up: syncope at 8 pm, first COVID Pfizer vaccine dose at 4 pm; This is a spontaneous report from a contactable physician from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-785929 A 13-year-old male patient received BNT162B2 (COMIRNATY; solution for injection, Batch/Lot Number: FG7387 and expiry date: 30Nov2021), via unspecified route of administration, in right arm on 09Sep2021 16:00 (at the age of 13-year-old) as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On 09Sep2021 the patient experienced syncope of probable vasovagal origin, 4 hours after administration of first dose of Pfizer COVID vaccine. The patient underwent laboratory tests and procedures which included regular blood test and electrocardiography on unspecified date and competitive sports medical examination on 15Sep2021. Patient also had emergency room visit. The outcome of the reported event was recovered on 09Sep2021. Health authority comment: 15Sep2021, regulatory authority: This report sheet was updated from NON-SERIOUS to SERIOUS as the suspected adverse reaction described is a clinically relevant event on the important medical events list. 15Sep2021 regulatory authority: requested follow-up information from the reporter regarding clinical documentation and suspected vaccine batch number. 16Sep2021 regulatory authority: the form is updated with the additional information provided by the reporter/attaching clinical report provided by the reporter. 16Sep2021 regulatory authority follow-up information, the reporter reports: The boy was fine, he has performed yesterday the competitive sports medical examination, all checks in the norm. The vaccination batch is Pfizer Biotech FG738730112021. The Emergency Room report was attached. No follow-up attempts possible. No further information expected. Information about batch number has been obtained.; Reporter''s Comments: syncope of probable vasovagal origin, 4 hours after administration of first dose of Pfizer COVID vaccine


VAERS ID: 1755457 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-09-09
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004496 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fall, Loss of consciousness, Musculoskeletal stiffness, Presyncope, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (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), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal pain; Loss of consciousness
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Loss of consciousness; Vagal reflex; Fall; Stiffness of the body; Pyrexia; This case was received via regulatory authority (Reference number: 2021TJP094066) on 13-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This case, initially reported to regulatory authority by a physician, was received via Moderna''s adverse reaction reporting site (TASK0021720). On an unknown date, body temperature before the vaccination: 36.4 degrees Celsius. On 11-Aug-2021, the patient received the 1st dose of this vaccine. On 08-Sep-2021, at 14:50, the patient received the 2nd dose of this vaccine. On 09-Sep-2021, pyrexia of 37.5-37.9 degrees Celsius developed. At 08:30, aspirin was taken. At 12:00, vagal reflex developed. The patient had nausea and lost consciousness for about 30 seconds. The patient fell from a chair, and the body became stiff even after the patient regained consciousness. The patient was raced to a hospital. PCR test was negative with body temperature of 38.3 degrees Celsius on arrival. Electrocardiogram, electroencephalogram, and MRI showed no abnormalities. The patient was hospitalized. On 10-Sep-2021, there was nothing unusual. The recovery of symptoms was confirmed, and the patient was discharged from the hospital. The outcome of pyrexia, vagal reflex, loss of consciousness, fall, and stiffness of the body was reported as resolved. Follow-up investigation will be made. Reporter comments continuation: Based on the above, it is presumed that decreased blood pressure and loss of consciousness were due to vagal reflex, but the possibility that the patient had seizure cannot be ruled out based on stiffness of the body or other symtpoms. Although pyrexia as adverse reaction is highly likely to have triggered the event, this case was reported because there is a risk of severe events associated with loss of consciousness. Loss of consciousness after pyrexia and rigidity of the body may be other factors. Company Comment: This case concerns a patient with no previous relevant medical history, who experienced the unexpected events of loss of consciousness, presyncope, fall, musculoskeletal stiffness, and pyrexia. The events occurred 1 day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since events occurred after second dose. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Reporter''s Comments: When the medical history was confirmed in detail later, the patient had a history of abdominal pain and loss of consciousness in May-2021. See "narrative" section; Sender''s Comments: This case concerns a patient with no previous relevant medical history, who experienced the unexpected events of loss of consciousness, presyncope, fall, musculoskeletal stiffness, and pyrexia. The events occurred 1 day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since events occurred after second dose. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.


VAERS ID: 1755458 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005692 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Genital haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

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

Write-up: Metrorrhagia; This case was received via Regulatory Authority (Reference number: 2021TJP095125) on 14-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This case, reported by an office worker, was received by Regulatory Authority Company Limited via Moderna''s adverse reaction reporting site(TASK0021731). Metrorrhagia was assessed as serious by the MAH. On an unknown date, body temperature before vaccination: 36.3 degrees Celsius. On 07-Sep-2021, at 13:30, the patient received the 1st dose of this vaccine. On 09-Sep-2021, metrorrhagia developed and persisted for 5 days. Only 2 weeks had passed since the last menstrual period. On 13-Sep-2021, the symptom was stable at this time. The outcome of metrorrhagia was reported as unknown. No follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: According to a physician at this clinic, the effect of this vaccine is small, but it is recommended to consult a gynecologist as a precaution. There is a possibility of abnormal vaginal bleeding as other factors.; Sender''s Comments: This case concerns a 47-year-old, female patient with no reported medical history. The patient experienced serious event of Genital haemorrhage 3 days after the first dose of Spikevax . The outcome of events was unknown. The reporter assessed the event as related. Patient experienced AE after the first dose with unknown outcome and probably has not received second dose. Rechallenge is unknown. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1755466 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005693 / 1 - / OT

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

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

Write-up: Bell''s palsy; This case was received via Takeda Pharmaceuticals (Reference number: 2021TJP098252) on 17-Sep-2021 and was forwarded to Moderna on 30-Sep-2021. This case, reported by a physician, was received by Takeda via Moderna''s adverse reaction reporting site (TASK0021770), and reported to the Pharmaceuticals and Medical Devices Agency (PMDA) by a physician, was received via the PMDA (Ref, v21127162). Bell''s palsy was assessed as serious by the MAH. On an unknown date, body temperature before the vaccination: 36.6 degrees Celsius. On 07-Sep-2021, at 16:01, the patient received the 1st dose of this vaccine. On 09-Sep-2021, around 22:30, facial palsy developed. The patient was aware of burning sensation on the tip of tongue. On 11-Sep-2021, when the patient brushed the teeth, water leaked from the corner of the right mouth. The patient was aware of numbness on the right side of the tongue and dull movement in the right side of the face. On 13-Sep-2021, the patient visited a local physician in the early evening. Head CT showed no abnormality. The patient was explained that virus might have been in the food the patient ate. On 15-Sep-2021, the symptoms did not improve, and the patient visited a hospital. The patient visited an otolaryngology and an ophthalmology and was diagnosed with Bell''s palsy. On 16-Sep-2021, the symptoms were resolving. On an unknown date, the patient had received treatment appropriately. The outcome of bell''s palsy was reported as resolving. Follow-up investigation will be impossible due to non-cooperation of the reporter. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The patient hopefully will recover as soon as possible because the symptoms seem to be improving with steroid therapy. Other factors are unknown in detail, and it is a matter of possibility.; Sender''s Comments: This case concerns a 42-year-old, male patient with a no relevant medical history, who experienced the serious, expected event of Bell''s Palsy. The event occurred two days after the first dose of mRNA-1273. The rechallenge is unknown as only the first dose was received. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1755542 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-09-09
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7053 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101229222

Write-up: Chest pain: probable but not detected pericarditis; Chest pain: probable but not detected pericarditis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-Uz8y79. A 18-years-old male patient received bnt162b2 (COMIRNATY), intramuscular on 12Aug2021 (Batch/Lot Number: FE7053) as Dose 2, single for covid-19 immunisation. The patient medical history included allergy. Concomitant medication(s) included phleum pratense pollen (GRAZAX) taken for allergy from 03Sep2021 to an unspecified stop date. On 09Sep2021, the patient developed chest pain. It was concluded with probable pericarditis, but the diagnosis has not been confirmed by any investigations. No relevant laboratory findings or investigations was included in the report. The patient experienced chest pain: probable but not detected pericarditis (hospitalization) on 09Sep2021 with outcome of unknown. The case was considered to be Serious. The Regional Pharmacovigilance Center assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1757698 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004498 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: C-reactive protein, COVID-19 immunisation, Echocardiogram, Electrocardiogram, Magnetic resonance imaging heart, Myocarditis, Pain assessment, Troponin T, White blood cell count
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Childhood asthma
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: Leucocyte count; Result Unstructured Data: Slight leucopenia, monocytopenia and neutropenia.; Test Date: 20210911; Test Name: C-reactive protein; Test Result: Inconclusive ; Result Unstructured Data: 100; Test Date: 20210915; Test Name: C-reactive protein; Test Result: Inconclusive ; Result Unstructured Data: 18; Test Date: 20210911; Test Name: Cardiac ultrasound; Result Unstructured Data: Small amount of pericardial fluid; Test Date: 20210912; Test Name: Echocardiogram; Test Result: Inconclusive ; Result Unstructured Data: Done by cardiologist. No pericardial fluid. Fine contractility.; Test Date: 20210911; Test Name: ECG; Result Unstructured Data: No distinct abnormality; Test Date: 20210916; Test Name: ECG; Result Unstructured Data: Normal at first, but development of global ST-elevations during one of the episodes with chest pain.(New reporter, duplicate report); Test Date: 20210915; Test Name: Cardiac MRI; Result Unstructured Data: Sparse perimyocarditis changes basal inferolateral.; Test Date: 20210916; Test Name: Cardiac MRI; Result Unstructured Data: Perimyocarditis changes detected as well as reduced contractility in affected myocardium (New reporter, duplicate report); Test Date: 20210911; Test Name: Pain scale; Test Result: Inconclusive ; Result Unstructured Data: NRS 3; Test Date: 20210911; Test Name: Troponin T; Test Result: Inconclusive ; Result Unstructured Data: 620; Test Date: 20210914; Test Name: Troponin T; Result Unstructured Data: 709 (highest value); Test Date: 20210915; Test Name: Troponin T; Result Unstructured Data: 498 (lowest value)
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: Perimyocarditis; Revaccination with different COVID-19 vaccine; This case was received via a regulatory authority (Reference number: NO-NOMAADVRE-E2B_00050963) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Perimyocarditis) in a 24-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004498) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Childhood asthma. Previously administered products included for Vaccination: COMIRNATY. On 09-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 09-Sep-2021, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). On 11-Sep-2021, the patient experienced MYOCARDITIS (Perimyocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Perimyocarditis) was resolving and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Sep-2021, C-reactive protein: 100 (Inconclusive) 100. On 11-Sep-2021, Echocardiogram: small amount of pericardial fluid (abnormal) Small amount of pericardial fluid. On 11-Sep-2021, Electrocardiogram: no distinct abnormality (normal) No distinct abnormality. On 11-Sep-2021, Pain assessment: nrs 3 (Inconclusive) NRS 3. On 11-Sep-2021, Troponin T: 620 (Inconclusive) 620. On 12-Sep-2021, Echocardiogram: no pericardial fluid (Inconclusive) Done by cardiologist. No pericardial fluid. Fine contractility.. On 12-Sep-2021, White blood cell count: slight leucopenia, monocytopenia and neutropenia. (abnormal) Slight leucopenia, monocytopenia and neutropenia.. On 14-Sep-2021, Troponin T: 709 (High) 709 (highest value). On 15-Sep-2021, C-reactive protein: 18 (Inconclusive) 18. On 15-Sep-2021, Magnetic resonance imaging heart: sparse perimyocarditis changes basal inferolateral (abnormal) Sparse perimyocarditis changes basal inferolateral.. On 15-Sep-2021, Troponin T: 498 (Low) 498 (lowest value). On 16-Sep-2021, Electrocardiogram: global st-elevations during on of the episodes (abnormal) Normal at first, but development of global ST-elevations during one of the episodes with chest pain.(New reporter, duplicate report). On 16-Sep-2021, Magnetic resonance imaging heart: perimyocarditis changes; reduced contractility (abnormal) Perimyocarditis changes detected as well as reduced contractility in affected myocardium (New reporter, duplicate report). For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered MYOCARDITIS (Perimyocarditis) to be possibly related. No further causality assessment was provided for COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. This is a case of revaccination with different Covid-19 vaccine for this 24-year-old, male patient with no relevant medical history, who experienced the expected event of myocarditis. The event myocarditis occurred 2 days after the administration of labeled dose number two of mRNA-1273 vaccine. The rechallenge was not applicable because the patient previously received other brand of Covid-19 vaccine (Comirnaty). The patient''s age, gender and vaccine history of receiving of other brand of Covid-19 vaccine (Comirnaty) remains confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The RA SD captured the onset latency of the event myocarditis as 3 days instead of 2 days, RA SD coding was captured and maintained. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Translation received on 30-Sep-2021 for initial; Sender''s comments translated. On 24-Sep-2021: Follow-up received on 24-SEP-2021 contained significant information: additional lab/diagnostic studies. On 24-Sep-2021: Translation received for FU on 30-Sep-2021 contained no new information.; Sender''s Comments: This is a case of revaccination with different Covid-19 vaccine for this 24-year-old, male patient with no relevant medical history, who experienced the expected event of myocarditis. The event myocarditis occurred 2 days after the administration of labeled dose number two of mRNA-1273 vaccine. The rechallenge was not applicable because the patient previously received other brand of Covid-19 vaccine (Comirnaty). The patient''s age, gender and vaccine history of receiving of other brand of Covid-19 vaccine (Comirnaty) remains confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The RA SD captured the onset latency of the event myocarditis as 3 days instead of 2 days, RA SD coding was captured and maintained.


VAERS ID: 1757798 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005687 / 2 - / 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: ITMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-787384) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of SYNCOPE in a 12-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005687) for COVID-19 vaccination. No Medical History information was reported. On 08-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .3 milliliter in total. On 09-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced SYNCOPE (seriousness criterion medically significant). On 10-Sep-2021, SYNCOPE had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Loss of consciousness while seated with eye rolling and rapid recovery after around one minute. No concomitant medications were provided. No treatment information was provided. Company comment: This case concerns a 12-year-old, female patient with no relevant medical history, who experienced the unexpected event of Syncope. The event occurred approximately 2 day after the second dose of Spikevax. The rechallenge was not applicable as event occurred after the second dose. The benefit-risk relationship of Spikevax in not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation received on 30-sep-2021. dose number were updated, event description were added in narrative.; Sender''s Comments: This case concerns a 12-year-old, female patient with no relevant medical history, who experienced the unexpected event of Syncope. The event occurred approximately 2 day after the second dose of Spikevax. The rechallenge was not applicable as event occurred after the second dose. The benefit-risk relationship of Spikevax in not affected by this report.


VAERS ID: 1758331 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, Chest pain, Echocardiogram, Electrocardiogram, Fatigue, Headache, Myocarditis, Pyrexia, Troponin T
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cold induced asthma
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210911; Test Name: CRP; Result Unstructured Data: Test Result:23 mg/l; Test Date: 20210915; Test Name: CRP; Result Unstructured Data: Test Result:4 mg/l; Test Date: 20210911; Test Name: Echocardiography (UKG); Result Unstructured Data: Test Result:no changes; Test Date: 20210911; Test Name: ECG; Result Unstructured Data: Test Result:no changes; Test Date: 20210911; Test Name: Troponin T; Result Unstructured Data: Test Result:650 ng/L; Test Date: 20210915; Test Name: Troponin T; Result Unstructured Data: Test Result:26 ng/L; Comments: drops steadily to 26 ng / L
CDC Split Type: SEPFIZER INC202101229130

Write-up: Myocarditis; tired; headache; fever of 38 degrees; chest pain on the upper left side; This is a spontaneous report from two contactable physicians from a regulatory authority, regulatory authority number SE-MPA-2021-084141. A 16-year-old male patient received second dose of BNT162B2 (COMIRNATY) on 08Sep2021 at single dose for COVID-19 immunisation. Medical history included Cold induced asthma. Concomitant medication was not reported. The patient experienced myocarditis one day after the second dose (09Sep2021). The day after the vaccination (09Sep2021) the man felt tired, had a headache and he had a fever of 38 degrees. During the evening the same day he experienced a chest pain on the upper left side and the pain increased during the night. He went to the pediatric emergency department three days after the vaccination (11Sep2021). Troponin T 650 ng / L, no changes on ECG or Echocardiography (UKG). He was admitted to the hospital for monitoring. Daily sampling of Troponin T and CRP, daily ECG. Troponin T drops steadily to 26 ng / L on the seventh day after the vaccination (15Sep2021). Three days after the vaccination (11Sep2021) the CRP was 23 mg / L and four days later (15Sep2021) it drops to 4 mg / L. Another physician reported that the man had recovered. The outcome of all events was resolved in Sep2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1758403 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-09
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Erythema multiforme, Headache
SMQs:, Severe cutaneous adverse reactions (narrow), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101242637

Write-up: Erythema multiforme; dizziness; headache; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 623266. A 46-year-old female patient received bnt162b2 (COMIRNATY, lot unknown), via an unspecified route of administration on an unspecified date at unknow dose number, single for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced erythema multiforme, dizziness, headache on 09Sep2021. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1758588 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-09-09
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA9094 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Bone pain, Chest pain, Dizziness, Dyspnoea, Hypoaesthesia, Mobility decreased, Palpitations, Paraesthesia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Osteonecrosis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

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

Write-up: the day of the vaccine and up to 3 days after I had severe bone and joint pain. One month after getting the vaccine I started to get heart palpitations all day long which lasted 7 days. for 2 weeks I felt fine again. then On September 28, 2021 I had a sudden onset of SEVERE chest pain, heart palpitations, extreme difficulty breathing and increased work of breathing. I was extremely lightheaded and if I laid down everything got worse. The next day I was the same. Then the Thursday Sept 30th I felt ok up until Friday evening when all of the symptoms came back except this time my left should all the way down to my fingers were numb and tingling, which I was also experiencing in the left side of my jaw. As of today (October 4, 2021) my symptoms have remained the same and I am basically bedridden.


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