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From the 9/10/2021 release of VAERS data:

Found 686,636 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 339 out of 6,867

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VAERS ID: 1526413 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiovascular insufficiency, Circulatory collapse, Dyspnoea, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic asthma; Pollen allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100933151

Write-up: circulatory problems; circulatory collapse; breathing difficulties; severe urtecaria on the trunk and extremities, circulatory problems, circulatory collapse, respiratory problems in several episodes.; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 74547, 74830], license party for Comirnaty. Verbatim as reported by physician for himself: Last Thursday (15Jul2021) I received my second dose of the BioNTech vaccine. About 72 hours later I developed a very pronounced urtecaria on the trunk and extremities, which was also associated with circulatory problems up to and including circulatory collapse today. This was successfully treated with iv administration of antihistamines, but came back quickly and more strongly this time also with breathing difficulties in several episodes, I have no history of vaccination resections of this kind, but I am slightly allergic to pollen and as a child I had allergic asthma that has completely grown together. I also tolerated BioNTech vaccination No. 1 very well. Since my attending physicians at the PRIVACY Clinic are already at the end of their game, I wanted to ask you, as the proven experts, whether you have seen similar cases and are you aware of more promising treatment options? The relevant specialist literature assumes delayed hypersensitivity from systemic mast cell degranulation induced by complement activation. Thank you in advance for your feedback. Kind regards Booster date: 15Jul2021. Reporter is patient: Yes. Patient gender: M. Start date of reaction: 18Jul2021. Outcome information: Unknown The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the temporal relationship, the association between the events "circulatory problem up to and including circulatory collapse" with COMIRNATY use can not be fully 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: 1526429 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100940460

Write-up: anaphylactic shock; whole body skin rash; feels very bad; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 74946], license party for Comirnaty. A male patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Jul2021 (Batch/Lot number was not reported) as DOSE 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient got his 2nd BNT vaccination last Thursday (July 15th), on Sunday afternoon (July 18th) he suddenly got a whole-body rash and feels very bad. On Monday (July 19th) he had an anaphylactic shock and was in mortal danger. The doctors in the hospital have never seen such cases and have registered the case at the institute. The patient is now being treated with very high doses of antihistamine and cortisone. The outcome of the events was not recovered. Information regarding lot/batch number has been requested.


VAERS ID: 1526475 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-18
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and 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: ESJNJFOC20210764201

Write-up: RIGHT CEREBRAL INFARCTION ACM; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, ES-AEMPS-953785] concerned a 48 year old male, unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C14-04 expiry: UNKNOWN) dose was not reported, 1 dose administered on 18-JUN-2021 for covid-19 vaccination. No concomitant medications were reported. On 18-JUL-2021, the patient experienced right cerebral infarction acm, and was hospitalized (date unspecified). Treatment with covid-19 vaccine ad26.cov2.s was withdrawn on 18-JUN-2021. The patient was recovering from right cerebral infarction acm. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0; 20210764201-COVID-19 VACCINE AD26.COV2. S- Right cerebral infarction acm. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1526667 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003187 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angiocardiogram, C-reactive protein, Fibrin D dimer, Glomerular filtration rate, Myocarditis, Myoglobin blood, Troponin T, White blood cell count
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Tobacco user
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: Angiogram coronary; Result Unstructured Data: normale; Test Date: 20210719; Test Name: C-reactive protein; Result Unstructured Data: 19.3 milligram per litre; Test Date: 20210719; Test Name: Fibrin D dimer; Result Unstructured Data: 280 nanogram per millliiter; Test Date: 20210719; Test Name: CKD epi; Result Unstructured Data: 105 millilitre per minute; Test Date: 20210719; Test Name: Myoglobin blood; Result Unstructured Data: 31 nanogram per millliiter; Test Date: 20210619; Test Name: Troponin T; Result Unstructured Data: 64 nanogram per litre; Test Date: 20210719; Test Name: Leucocyte count; Result Unstructured Data: 10150 per cubic millimetre
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Acute myocarditis; This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Acute myocarditis) in a 24-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003187) for COVID-19 vaccination. Concurrent medical conditions included Tobacco user. On 16-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced MYOCARDITIS (Acute myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Acute myocarditis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jun-2021, Troponin T (Unknown-15): 64 (High) 64 nanogram per litre. On 19-Jul-2021, Angiocardiogram: normal (normal) normale. On 19-Jul-2021, C-reactive protein (Unknown-5): 19.3 (High) 19.3 milligram per litre. On 19-Jul-2021, Fibrin D dimer (Unknown-500): 280 (normal) 280 nanogram per millliiter. On 19-Jul-2021, Glomerular filtration rate: 105 (normal) 105 millilitre per minute. On 19-Jul-2021, Myoglobin blood (Unknown-72): 31 (normal) 31 nanogram per millliiter. On 19-Jul-2021, White blood cell count (4000-9000): 10150 (High) 10150 per cubic millimetre. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Laboratory information included cardiac ultrasound, ECG and cardiac MRI. Concomitant product use was not provided by the reporter. No treatment information was provided. France Sender''s Case Safety Report Unique Identifier is FR-AFSSAPS-NY20213100. Company comment Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Case awaiting translation.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.Case awaiting translation.


VAERS ID: 1526802 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Influenza, Maternal exposure during breast feeding, Off label use, Product use issue
SMQs:, Neonatal exposures via breast milk (narrow), Medication errors (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923128

Write-up: Flu symptoms; Maternal exposure during breast feeding; Off label use; Drug use in unapproved population; This is a spontaneous report from a contactable consumer. The is a report received from The regulatory authority report number is GB-MHRA-WEBCOVID-202107191759547630-WFRRD. Safety Report Unique Identifier GB-MHRA-ADR 25674762.This consumer reported information for both mother and fetus/baby. This is the mother case. Only this case is serious. A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Jul2021 at the age of 33 years old (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included ongoing breastfeeding. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. The patient experienced maternal exposure during breast feeding on 18Jul2021, flu symptoms on 19Jul2021, off label use and drug use in unapproved population on 18Jul2021. The events were reported as serious (medically significant). The patient has not recovered from flu symptoms while outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100931957 baby case


VAERS ID: 1526829 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510-L758 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypersensitivity, SARS-CoV-2 test, Seasonal allergy
SMQs:, Angioedema (broad), Conjunctival disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Food intolerance (Cashew and pistachio intolerance had ceased 3 years ago due to a Kambo ceremony); Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100928545

Write-up: Allergy; Hay-fever; This is a spontaneous report from a contactable consumer or other non-HCP. This report is received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107202300404220-NZBKU and Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25683701. A 26-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FE1510-L758) via an unspecified route of administration on 17Jul2021 as dose 1, single for COVID-19 immunization. Patient medical history included suspected COVID-19 from 30Oct2020 to 06Nov2020. The patient concomitant medications were not reported. Patient has not tested positive for COVID-19, since having the vaccine. Patient was not enrolled in clinical trial. Additional information included cashew and pistachio intolerance had ceased 3 years ago due to a Kambo ceremony. On 18Jul2021, the patient experienced allergy and on an unspecified date in 2021 experienced hay fever. After Pfizer they have come back. That was irritating. Hay-fever has also become worse, even though and do not usually get it this time of year. The patient underwent lab tests and procedures which included SARS-COV-2 test with result as negative no-negative COVID-19 test. The outcome of the events allergy was not resolved and hay-fever was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1526874 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Gynaecological examination normal, Heavy menstrual bleeding, Menstruation irregular, Rectal examination, SARS-CoV-2 test, Uterine haemorrhage, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:unknown; Test Name: vaginal exam; Result Unstructured Data: Test Result:unknown; Test Name: rectal exam; Result Unstructured Data: Test Result:unknown; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100934255

Write-up: early periods; bleeding was found to be from the womb; Very heavy bleeding and lots of black discharge; Vaginal bleeding; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107211211585000-BMMJU and Safety Report Unique Identifier GB-MHRA-ADR 25685849. An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 17Jul2021 (Lot Number: FE1510) as dose 1, single for COVID-19 immunization. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. On an unknown date, the patient experienced early periods, bleeding from womb, heavy bleeding and lots of black discharge. On 18Jul2021, the patient had vaginal bleeding. It was reported that the patient had very heavy bleeding and lots of black discharge that required admission. Investigation was done to assess if it was vaginal, rectal or urethra. Her period was not due. She never ever have early periods, and this bleeding was found to be from the womb, but it was 2.5 weeks early to be a period and the patient was always late with her cycle. The patient believed the vaccine induced this unusual bleeding. The outcome of the event vaginal bleeding as recovering. The outcome of the remaining events was recovered on an unknown date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative, andblood test, vaginal exam and rectal exam; all with unknown result. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1526875 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain lower, Chest pain, SARS-CoV-2 test
SMQs:, Retroperitoneal fibrosis (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100934254

Write-up: Chest pain; Cramp in lower abdomen; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority report number is GB-MHRA-WEBCOVID-202107211212354560-VSZCP, Safety Report Unique Identifier GB-MHRA-ADR 25685846. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 17Jul2021 (Lot Number: FD8813) as second dose, single for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. The patient''s medical history and concomitant medications were not reported. On 18Jul2021, the patient experienced chest pain and cramp in lower abdomen. "Short sharp pains in centre of chest which reoccur throughout the day and night. I spoke with the nurse at my GP surgery who said it was nothing to worry about although no checks were carried out." Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included covid-19 virus test: No - Negative COVID-19 test on 08Jul2021. Outcome of the event chest pain was not recovered. Outcome of the event cramp in lower abdomen was recovered on 20Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1526884 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-07-18
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Acne, Anxiety, Inappropriate affect, Lethargy, Menstruation delayed, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Fertility disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acne; Anxiety; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100934394

Write-up: lethargy; anxiety; acne; Bloat; Happiness; Delayed period; This is a spontaneous report from a contactable consumer received from the The regulatory authority report number is GB-MHRA-WEBCOVID-202107211345150300-K5TGT and Safety Report Unique Identifier GB-MHRA-ADR 25686744. A 36-year-old female patient received 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Batch/Lot number: Unknown), via an unspecified route of administration on 15Jun2021 as dose 1, single for COVID-19 immunization. Medical history included lactation decreased, anxiety and ache. Patient has not had symptoms associated with COVID-19. Patient is not pregnant; Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. On 18Jul2021, the patient experienced delayed period. On an unspecified date, the patient experienced lethargy, anxiety, acne, bloat and happiness. The clinical course was reported as follows: Delayed Period - approximately 10 days. Extreme emotions and hormonal symptoms during this time including anxiety, bloat, happiness, lethargy and acne. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The case is serious (medically significant). The patient had COVID-19 test (Unknown date): No - Negative COVID-19 test. The outcome for the event delayed period was recovering; outcome for lethargy, anxiety, acne, bloat and happiness was unknown. No follow-up attempts are possible, Information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1526891 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-07-18
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100934506

Write-up: COVID-19; COVID-19; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107211422037420-EMYJM, Safety Report Unique Identifier is GB-MHRA-ADR 25686840. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Jun2021 (Lot Number: ew3143) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient experienced COVID-19 on 18Jul2021. The event was reported as serious (medically significant). The patient underwent lab tests and procedures which included SARS-COV-2 test with Yes - Positive COVID-19 on 18Jul2021. The patient was recovering from the event.


VAERS ID: 1526909 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-18
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Drug ineffective, Pyrexia, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100934241

Write-up: High temperature; Experience the exact same thing such as symptoms and positive test after the vaccine; Experience the exact same thing such as symptoms and positive test after the vaccine; Loss of taste; Loss of smell; This is a spontaneous report from a contactable consumer received from the Regulatory Agency Safety Report Unique Identifier GB-MHRA-ADR 25687887. A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FE1510) via an unspecified route of administration on 14Jul2021 as dose 1, single for covid-19 immunisation. Medical history included suspected covid-19 from 18Jul2021 and ongoing. The patient concomitant medications was not reported. Patient is not enrolled in clinical trial. The patient always have been a healthy and sporty person without any illness whatsoever. Patient got first vaccine on wednesday, 14Jul2021, and never tested positive for COVID-19. After the vaccine he started having some side effects such as strong headaches, eyes pain, bit of high temperature, on the 3rd day on 18Jul2021 lost taste and smell and until now 21Jul2021 (7 days have passed)a still have the same symptoms. then tested positive for an antigen test of the pharmacy. Furthermore, this has happened to 02Mar2021 more people that took the same vaccine at the same location within the same week, with the same vaccine batch number (FE1510) and they all experience the exact same thing such as symptoms and positive test after the vaccine (covid-19 and drug ineffective). The patient underwent lab tests and procedures which included sars-cov-2 test with positive yes-positive COVID-19 test. The outcome of the events loss of taste, loss of smell were not resolved and highs temperature was resolving and other events were unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1526916 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest pain, Dizziness, Dyspnoea, Feeling abnormal, Headache, Malaise, Myalgia, Pain, SARS-CoV-2 test, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: All blood; Result Unstructured Data: Test Result:ok; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Date: 20210719; Test Name: X-rays; Result Unstructured Data: Test Result:ok
CDC Split Type: GBPFIZER INC202100934294

Write-up: feel poorly; Headache; muscle pains; Chest pain; Breathlessness; Sickness; dizzy; still achey; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107211742380440-2TMDP. Safety Report Unique Identifier GB-MHRA-ADR 25688334. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jul2021 12:00 (at the age of 27 years) (Batch/Lot number was not reported) as DOSE 2 , SINGLE for covid-19 immunisation. Medical history included lactation decreased and suspected COVID-19 (Unsure when symptoms started and Unsure when symptoms stopped). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient is not pregnant, Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient had the vaccine at 12:00 on Sunday afternoon (18Jul2021), she was fine until she woke suddenly with chest pains at 23:30 Sunday evening. Chest pain and breathlessness persisted, the patient was sick, dizzy and achey everywhere. She called 111 the next morning (19Jul2021), experienced headaches and muscle pains and was sent to A&E all test (Blood and X-rays) came back okay and was discharged. Continued to feel poorly the next day (20Jul2021) chest pain eased and breath was better (reported as 2 days on from A&E) I am feeling lots better but still achey, come chest pain, headache and muscle pains. Other lab data includes COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The outcome of the event sickness was recovered on 19Jul2021; breathlessness was recovered on 20Jul2021; chest pain, dizzy, headache, muscle pains was recovering; while unknown for the rest of the events. No follow-up attempts are possible, information about the batch number cannot be obtained.


VAERS ID: 1526961 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Muscle spasms, Musculoskeletal stiffness, Pain, Sleep disorder
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100934341

Write-up: pain; muscle spasm; Neck stiffness; impacting on sleep; This is a spontaneous report from a contactable consumer (patient) received from the The regulatory authority report number is GB-MHRA-WEBCOVID-202107212016196030-OPJV5, Safety Report Unique Identifier GB-MHRA-ADR 25689265. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jul2021 (Lot Number: FE1510) as dose 2, single for COVID-19 immunisation. There were no medical history and concomitant medications. The patient previously took dose 1 of bnt162b2 for COVID-19 immunization. The patient was in perfect health with no history of taking regular medication. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. On 18Jul2021, the patient experienced pain, muscle spasm, neck stiffness, and impacting on sleep. The events were medically significant. Therapeutic measures were taken as a result of pain, muscle spasm, and neck stiffness and included treatment with 6 dose of diazepam 2 mg. Outcome of the impacting on sleep was unknown, of the neck stiffness was not recovered, while of the remaining events was recovering. The clinical course was reported as follows: It''s been a very painful stiffness of the neck which I didn''t experience after the first jab. There are no signs of physical swelling in the affected area which is on my right side but the pain is nonetheless sharp and ever present. I called (withheld) this afternoon and was referred to the Urgent Care. After series of assessment the doctor thinks it''s muscle spasm and prescribed 6 dose of Diazepam 2mg. I''m really hoping this medication brings me much needed relief from the uncomfortable pain which is now impacting on my sleep as I''m constantly tossing and turning trying to find the perfect posture. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1526971 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DESOGESTREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100934494

Write-up: Shivers; Prolonged periods; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number [GB-RA-WEBCOVID-202107211858332300-XHZDS], Safety Report Unique Identifier [GB-RA-ADR 25688853]. A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jul2021 (Lot/Batch Number: FD5613), at the age of 22-years-old, as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased from an unknown date and unknown if ongoing, contraception from an unknown date and unknown if ongoing. Concomitant medications included desogestrel taken for contraception from 27Nov2019 to an unspecified stop date. The previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jun2021 (Lot Number: FA1027) as dose 1, single for COVID -19 immunisation. The patient experienced shivers on 19Jul2021 and prolonged periods on 18Jul2021. The events were assessed as serious (medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The outcome of the event ''shivers'' was recovered on 20Jul2021 and event ''prolonged periods'' was not recovered. Additional information: Patient has not had symptoms associated with COVID-19 Patient is not pregnant. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1526981 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aura, Fatigue, Headache, Migraine, SARS-CoV-2 test
SMQs:, Convulsions (broad), Generalised convulsive seizures following immunisation (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; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100934386

Write-up: aura; fatigue; headaches; Migraine; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. Regulatory authority report number is GB-MHRA- WEBCOVID- 202107212226311180-RJO0Y, and Safety Report Unique Identifier is GB-MHRA-ADR 25689631. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 15Jul2021) as dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation (lactation decreased) and depression from an unknown date and unknown if ongoing. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medication included sertraline taken for depression from 10Oct2020 to an unspecified stop date. Historical vaccine included BNT162B2 dose 1, single via an unspecified route of administration on an unspecified date for COVID-19 immunisation. The patient experienced aura on an unspecified date with outcome of unknown, fatigue on an unspecified date with outcome of unknown, migraine on 18Jul2021 with outcome of recovering, and headaches on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date, No - Negative COVID-19 test. The events were reported as serious, medically significant by the health authority. Narrative case summary and further information: Case narrative: Migraine, headaches, aura and fatigue. 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: 1526986 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
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 vagina, Urine analysis
SMQs:, Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? Yes
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; NASONEX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic sinusitis; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20210720; Test Name: Vaginal U/S; Result Unstructured Data: Test Result:confirmed the probability of miscarriage as there; Comments: confirmed the probability of miscarriage as there was no fetus seen; Test Date: 20210720; Test Name: urine test; Test Result: Positive
CDC Split Type: GBPFIZER INC202100934334

Write-up: Early miscarriage; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202107212245044910-TCJZI. Safety Report Unique Identifier is GB-MHRA-ADR 25689709. This is the maternal report. A 25-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 17Jul2021 as dose 2, single for COVID-19 immunization. Medical history included lactation decreased, and chronic sinusitis. Patient had no previous pregnancy. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Historical vaccine included first dose on BNT162B2, received on 19Jun2021 for COVID-19 immunization. Concomitant medications included folic acid taken for folic acid supplementation; and mometasone furoate (NASONEX) taken for chronic sinusitis. The patient experienced early miscarriage on 18Jul2021. The event was reported as serious per congenital anomaly/birth defect. The clinical course was reported as follows: The patient had her 1st dose on 19Jun2021 and the 2nd on 17Jul2021. She was 5 weeks pregnant when she had her second dose, this meant that she had her 1st dose 1 week before conception. On 18Jul2021 on 24 hours, patient started to bleed. Therefore, she called 111 and they got her a U/S appointment on Tuesday 20Jul2021. There, they confirmed the probability of miscarriage as there was no fetus seen, despite positive urine test. She told the midwives about her concerns regarding the vaccine and they agreed that its worth to mention this on the report. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. They were unsure if the medicine had an adverse effect on any aspect of the pregnancy. Patient was exposed to the medicine first-trimester (1-12 weeks). Patient was no longer pregnant at the time of reporting. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. The patient had only 1 scan (Vaginal U/S) when the bleeding started 2 days after her 2nd dose. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 10Jun2021; urine test: positive and Vaginal U/S: confirmed the probability of miscarriage as there was no fetus seen, both on 20Jul2021. The outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1526987 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Back pain, Ear disorder, Headache, Hypoacusis, Lung disorder, Musculoskeletal chest pain, Tenderness
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100934338

Write-up: Back pain; Stomach pain; Hearing reduced; left lung felt like it was sticking; rib cage is extremely tender to touch; rib cage/pain; right ear feels like it constantly needs to pop; Headache; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-RA-WEBCOVID-202107212251407560-LYSNS, Safety Report Unique Identifier GB-RA-ADR 25689708. A 30-year-old female patient (not pregnant, not currently breastfeeding) received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, lot unknown), via an unspecified route of administration on 18Jul2021 as dose 2, single for COVID-19 immunisation. Medical history included decreased lactation. The patient''s concomitant medications were not reported. The patient experienced headache on 18Jul2021. On 19Jul2021, she felt her left lung felt like it was sticking and took several deep breaths before and breathing was normal (this did not happen again), her left side only at the bottom of her rib cage was extremely tender to touch it does not hurt to breath and she does not feel this pain except if she touch the area, had stomach pain, also her right ear felt like it constantly needs to pop and hearing was reduced. On 21Jul2021, she experienced sporadic extreme lower back pain. The events were reported as serious medically significant. The outcome of backpain, headache was recovering; for other events was not recovered. No follow-up attempts are possible. No further information is expected. Information on lot/batch number cannot be obtained.


VAERS ID: 1527027 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FEIS10 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bone pain, Lymphadenopathy, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Osteonecrosis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100941435

Write-up: Swollen lymph nodes; Slight temperature; Bone pain; This is a spontaneous report from a contactable consumer. This is a report, received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107221256288630-NMXM2, Safety Report Unique Identifier GB-MHRA-ADR 25692415. A 35-year-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on 17Jul2021 (Lot Number: FEIS10) as single dose for COVID-19 immunization. Medical history included suppressed lactation from an unknown date. The patient''s concomitant medications were not reported. The patient was not enrolled in clinical trial. On 18Jul2021 the patient experienced slight temperature and bone pain and on 19Jul2021 she experienced swollen lymph nodes. The patient didn''t receive any treatment except for 2 paracetamol on 18Jul2021 for slight temperature and bone pain. The patient underwent lab tests and procedures which included SARS-CoV-2 test which was negative on an unknown date. The events slight temperature and bone pain resolved on 19Jul2021, whereas the event swollen lymph nodes was resolving at the time of the report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1527305 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-07-18
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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: 20210718; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:positive with L452R mutant virus strain; Comments: found to carry the L452R variant virus, but no N501Y and E484K mutant gene; Test Name: CT value of patient virus samples; Result Unstructured Data: Test Result:low CT value of patient virus samples, only approx; Comments: low CT value of patient virus samples, only approximately 21 to 24, which indicated a high virus load
CDC Split Type: HKPFIZER INC202100967308

Write-up: TESTED POSITIVE WITH L452R MUTANT VIRUS STRAIN; TESTED POSITIVE WITH L452R MUTANT VIRUS STRAIN; This is a spontaneous report from a contactable consumer based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS002811), license party for BNT162b2 (COMIRNATY). A 27-year-old male patient received bnt162b2 (COMIRNATY), via unspecified route of administration, on 26Apr2021 (Lot number was not reported) as first dose, single; and via unspecified route of administration, on 17May2021 (Lot number was not reported) as second dose, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced tested positive with L452R mutant virus strain on 18Jul2021 with outcome of unknown. It was reported that on 04Jul2021, the patient went on a trip and on 18Jul2021, he went back home. The patient was found to carry the L452R variant virus, but no N501Y and E484K mutant gene. Due to the low CT value of patient virus samples, only approximately 21 to 24, which indicated a high virus load, the Regulatory Authority presumed that the patient was likely to be infected while on the trip. BIONTECH SE comment: The medical review comments of RA Department on the reports of Covid-19 and Vaccination failure are as follows: The seriousness of Covid-19 and Vaccination failure was: serious. As with any vaccine, vaccination with COMIRNATY may not protect all vaccine recipients, so the expectedness of covid-19 and vaccination failure is: expected. Vaccination per se does not contribute to the infection of this disease, so it is difficult to attribute covid-19 infection to vaccination, so the causal relationship between covid-19, vaccination failure and COMIRNATY is considered as unlikely. No follow-up attempts are needed, information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1527624 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-18
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100939375

Write-up: Occurrence in right lumbar region of a vesicular eruption accompanied by burning suggestive of Herpes Zooster.; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authorities -WEB. This report was received from Medicines Agency regulatory authority number IT-MINISAL02-759152. A 22-year-old female patient received her first dose BNT162B2 (COMIRNATY), intramuscular, administered in arm left (left shoulder) on 08Jul2021 11:30 (Batch/Lot Number: unknown; Expiration Date: 18Jul2021) as DOSE 1, 0.3 ML, SINGLE for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 18Jul2021, the patient experienced occurrence in right lumbar region of a vesicular eruption accompanied by burning suggestive of herpes zoster (medically significant). Therapeutic measures were taken as a result of of the event which included treatment with acyclovir at appropriate doses. The outcome of the event was not recovered. Sender Comment: Following verification with the reporter, it is clarified that a diagnosis of shingles has been made and therefore a severity upgrade is performed. Appearance after 10 days from the first Pfizer dose of a vesicular eruption URENTE in the right lumbar region suggestive of herpes zoster. Reporter comment: Occurrence in right lumbar region of a vesicular eruption accompanied by burning suggestive of Herpes Zooster. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reporter''s Comments: Occurrence in right lumbar region of a vesicular eruption accompanied by burning suggestive of Herpes Zooster.


VAERS ID: 1527645 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4213 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac monitoring, Electrocardiogram, Flat affect, Micturition disorder, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (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 Name: CARDIAC MONITORING; Result Unstructured Data: Test Result:unknown; Test Name: ECG; Result Unstructured Data: Test Result:unknown
CDC Split Type: ITPFIZER INC202100949239

Write-up: LIPOTIMIA, RESPIRATORY ARREST, LACK OF CONTROL OF URINATION; LIPOTIMIA, RESPIRATORY ARREST, LACK OF CONTROL OF URINATION; LIPOTIMIA, RESPIRATORY ARREST, LACK OF CONTROL OF URINATION; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority -WEB IT-MINISAL02-759904. A 37-year-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, lot/batch number: FE4213, Expiration date: 31Oct2021) intramuscularly in right arm (right shoulder) on 18Jul2021 at 10.34 AM, (age at vaccination: 37 years) as dose 2, 0.3 ml single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced lipotimia, respiratory arrest and lack of control of urination on 18Jul2021. The patient reports that he has always had such episodes, to the staff who rescued him. The patient was hospitalized for the events. The patient underwent lab tests and procedures including cardiac monitoring: unknown and ECG monitoring: unknown. Treatment received included cardiac massage and balloon oxygenation. The outcome of the events was recovered on 19Jul2021.; Reporter''s Comments: the patient reports that he has always had such episodes, to the staff who rescued him.


VAERS ID: 1527708 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9909 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Depressed level of consciousness, Dyspnoea, Oxygen saturation
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: Blood pressure; Result Unstructured Data: Test Result:170/111; Test Date: 20210718; Test Name: SPO2; Test Result: 98 %
CDC Split Type: JPPFIZER INC202100935616

Write-up: Consciousness clouding; Blood pressure was 170/111; Dyspnoea; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21120773. A 46-year and 0-month-old male received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC9909, Expiration date 30Sep2021) via an unspecified route of administration on 18Jul2021 at 15:50 (the day of vaccination) (at the age of 46-year and 0-month-old) at a single dose for COVID-19 immunization. Relevant medical history included asthma, hypertension and dysphoria after the dose 1 of vaccination. Concomitant medications were not reported. After the vaccination and observation for 30 minutes, the patient went tentatively. After that, the patient experienced dyspnoea and consciousness clouding, and did observation again. The symptom was not aggravated, but the patient went to a privacy hospital for treatment just in case. Blood pressure was 170/111, SPO2 98%. Event onset date was 18Jul2021 at 16:30 (the same day of the vaccination). On 18Jul2021 (the same day of the vaccination), the event was not resolved. The reporting physician classified the event as non-serious and assessed that the causality between the event and BNT162b2 was unassessable.


VAERS ID: 1527723 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, Pericarditis, Troponin, White blood cell count
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210718; Test Name: CRP; Result Unstructured Data: Test Result:1.61; Test Date: 20210719; Test Name: CRP; Result Unstructured Data: Test Result:2.67; Test Date: 20210718; Test Name: Cardiac troponin; Result Unstructured Data: Test Result:0.029; Test Date: 20210719; Test Name: Cardiac troponin; Result Unstructured Data: Test Result:0.044; Test Date: 20210718; Test Name: WBC; Result Unstructured Data: Test Result:137000
CDC Split Type: JPPFIZER INC202100935942

Write-up: Acute pericarditis; This is a spontaneous report from a contactable pharmacist received from the Agency Regulatory Authority. Regulatory authority report number is v21120960. A 22-year and 1-month-old male patient received BNT162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 16Jul2021 at 14:20 (Batch/Lot Number: FD0889; Expiration Date: 30Sep2021) as dose 2, single for COVID-19 immunisation. Patient''s history according to 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) included asthma. The patient''s concomitant medications were not reported. On 25Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number FA7338, Expiration date 30Sep2021) as dose 1, single for COVID-19 immunisation. On 18Jul2021 (2 days after the vaccination), the patient experienced acute pericarditis. On 18Jul2021 (2 days after the vaccination), the patient was admitted to the hospital. On 21Jul2021 (5 days after the vaccination), the patient discharged from the hospital. On 21Jul2021 (5 days after the vaccination), the outcome of the event was recovering. The course of the events was as follows: On 16Jul2021 at 14:20 (the day of vaccination), the patient received the second dose of COVID-19 vaccination. On 17Jul2021 (1 day after the vaccination), the patient experienced a pyrexia at 38s centigrade. On 18Jul2021 at 00:00 (2 days after the vaccination), the patient experienced feeling strange on the chest and palpitations. On 18Jul2021 at 04:00 (2 days after the vaccination), the patient experienced chest pain. The patient visited hospital on holiday, since WBC increased was observed, the patient was transferred to our hospital and hospitalized. (WBC 137000, CRP 1.61, Cardiac troponin 0.029). Patient started to take loxoprofen regularly. On 19Jul2021 (3 days after the vaccination), CRP 2.76, Cardiac troponin 0.044, it was peak out. On 21Jul2021 (5 days after the vaccination), the patient was discharged from the hospital because the symptoms were recovering. The reporting pharmacist classified the event as serious (hospitalized from 18Jul2021 to 21Jul2021) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1527726 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0348 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Erythema, Flushing, Heart rate, Oxygen saturation, Pruritus, Respiratory rate, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Hypertension (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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: blood pressure; Result Unstructured Data: Test Result:164/114; Comments: At 10:10; Test Date: 20210718; Test Name: blood pressure; Result Unstructured Data: Test Result:165/82; Comments: At 10:35; Test Date: 20210718; Test Name: Pulse (P); Result Unstructured Data: Test Result:91; Comments: At 10:10; Test Date: 20210718; Test Name: Pulse (P); Result Unstructured Data: Test Result:97; Comments: At 10:35; Test Date: 20210718; Test Name: SO2; Test Result: 98 %; Comments: At 10:10; Test Date: 20210718; Test Name: SO2; Test Result: 98 %; Comments: At 10:35; Test Date: 20210718; Test Name: R; Result Unstructured Data: Test Result:16; Comments: At 10:35
CDC Split Type: JPPFIZER INC202100935972

Write-up: BP 164/114 / BP 165/82; flushing of both hands, itching; flushing of both hands, itching; redness; Urticaria; This is a spontaneous report from a contactable physician received from the Agency . Regulatory authority report number is v21120836. A 51-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 18Jul2021 at 09:45 (Batch/Lot Number: FD0348; Expiration Date: 31Oct2021) (at the age of 51-years-old) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 18Jul2021 at 10:10 (25 minutes after the vaccination), the patient experienced the following events. Clinical course of the events was reported as follows: After the vaccination was performed on 18Jul2021 at 09:45, On 18Jul2021 at 10:10 (25 minutes after the vaccination), the patient complained about flushing of face and both hands, itching. BP 164/114, P91, SO2 98%, Adrenaline 0.3 mg intramuscular injection, Normal Saline 500ml. On 18Jul2021 at 10:35 (50 minutes after the vaccination), BP 165/82, P97, R16, SO2 98%. Delayed reaction. Considering the patient was living alone, the patient was hospitalized at the hospital for one night. On 18Jul2021 (the day of the vaccination), the patient was admitted to the hospital. On 18Jul2021 (the day of the vaccination), the outcome of the event was recovered. The reporter classified the event as non-serious. The causality between the event and BNT162b2 was not provided. The reporter commented as follows: In diagnosis criteria of anaphylaxis, there was only Cutaneous symptom (redness, Urticaria, itching), no respiratory symptom or blood pressure symptom (as reported). It did not meet the level of anaphylaxis. No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: In diagnosis criteria of anaphylaxis, there was only Cutaneous symptom (redness, Urticaria, itching), no respiratory symptom or blood pressure symptom (as reported). It did not meet the level of anaphylaxis.


VAERS ID: 1527931 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Headache, Hyperpyrexia, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EUTHYROX
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: hyperpyrexia; Result Unstructured Data: Test Result:40.5 to 42 Centigrade; Comments: hyperpyrexia / fever: 40.5 to 42 degrees celsius
CDC Split Type: NLPFIZER INC202100936494

Write-up: Hyperpyrexia / Fever: 40.5 to 42 degrees Celsius; Chills; Myalgia; Headache; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00631426. A 41-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration at age of 41 years on 18Jul2021 (Lot Number: FF0688) as single dose (reported as 1DF) for covid-19 immunisation. The patient medical history was not reported. No previous COVID-19 infection. Concomitant medication included levothyroxine sodium (EUTHYROX). Historical vaccine included bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 13Jun2021 as 0.3ml single dose for COVID-19 immunisation and no adverse events. The patient experienced hyperpyrexia / fever: 40.5 to 42 degrees celsius on 19Jul2021 (1 days after vaccination), headache on 18Jul2021 (5 hours after vaccination), chills on 19Jul2021 (1 days after vaccination), myalgia on 18Jul2021 (12 hours after vaccination). Therapeutic measures were taken as a result of all events included Ibuprofen, diclofenac. The outcome of hyperpyrexia, headache was recovering, chills recovered on 19Jul2021 with duration of 1 hour and myalgia recovered on 19Jul2021 with duration of 1 day (as reported). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1527978 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6029 / 2 RA / -

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gilbert''s syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC202100961044

Write-up: Acute myocarditis; This is a spontaneous report from a contactable consumer (patient) received via regulatory authority. An 18-year-old male patient received second dose of bnt162b2 (COMIRNATY,Lot Number: FE6029), via an unspecified route of administration at the age of 18-year-old administered in arm right on 15Jul2021 at single dose for covid-19 immunisation. Medical history included gilbert''s syndrome. Prior to vaccination, the patient wasn''t diagnosed with COVID-19. The patient''s concomitant medications were not reported. The patient didn''t receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 (COMIRNATY, Lot number: FD4342) on 10Jun2021 at arm right for COVID-19 immunisation. The patient experienced acute myocarditis on 18Jul2021 09:00. The adverse event result in Emergency room/department or urgent care. The patient was hospitalized for 5 days. The events were serious for being hospitalization, disability, life threatening. Facility where the most recent COVID-19 vaccine was administered in Hospital. Since the vaccination, the patient hasn''t been tested for COVID-19. Treatment received for the adverse event included Diagnostics and treatment in a cardiology clinic. The outcome of event was recovering.


VAERS ID: 1528355 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse event, Anxiety, Dyspnoea, Headache, Hyperhidrosis, Loss of consciousness, Nausea, Pain in extremity, Pharyngeal oedema, Pharyngeal swelling, Pyrexia, Stress, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: little like difficult with the breathing which is on and off; it is a little swollen in the throat in an exhausting way with the breathing and this has stuck around then for a week; it is a bit thick in the throat but she does not have cold; Worry; Stress; Adverse event; little fever; Headache; felt naseous; totally sweaty; almost blurry in the eyes, later she emphasized the word "blurry"/described that she lost the sight for a little short moment but it did not become black or she did not loose the sight totally; she lost the sight for a little short moment but it did not become black or she did not loose the sight totally; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (she lost the sight for a little short moment but it did not become black or she did not loose the sight totally) in a 24-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL (DIZMINELLE) for an unknown indication. On 18-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Jul-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm). On 19-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (she lost the sight for a little short moment but it did not become black or she did not loose the sight totally) (seriousness criterion medically significant), HYPERHIDROSIS (totally sweaty), VISION BLURRED (almost blurry in the eyes, later she emphasized the word "blurry"/described that she lost the sight for a little short moment but it did not become black or she did not loose the sight totally), ADVERSE EVENT (Adverse event), PYREXIA (little fever), HEADACHE (Headache) and NAUSEA (felt naseous). On an unknown date, the patient experienced DYSPNOEA (little like difficult with the breathing which is on and off), PHARYNGEAL SWELLING (it is a little swollen in the throat in an exhausting way with the breathing and this has stuck around then for a week), PHARYNGEAL OEDEMA (it is a bit thick in the throat but she does not have cold), ANXIETY (Worry) and STRESS (Stress). On 20-Jul-2021, LOSS OF CONSCIOUSNESS (she lost the sight for a little short moment but it did not become black or she did not loose the sight totally), HYPERHIDROSIS (totally sweaty), VISION BLURRED (almost blurry in the eyes, later she emphasized the word "blurry"/described that she lost the sight for a little short moment but it did not become black or she did not loose the sight totally), PAIN IN EXTREMITY (Pain in the arm), ADVERSE EVENT (Adverse event), PYREXIA (little fever), HEADACHE (Headache) and NAUSEA (felt naseous) had resolved. At the time of the report, DYSPNOEA (little like difficult with the breathing which is on and off) and PHARYNGEAL SWELLING (it is a little swollen in the throat in an exhausting way with the breathing and this has stuck around then for a week) had not resolved and PHARYNGEAL OEDEMA (it is a bit thick in the throat but she does not have cold), ANXIETY (Worry) and STRESS (Stress) outcome was unknown. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. Treatment information was not provided. Patient not even recognizing the swelling in the throat it but when it comes suddenly then it is exhausting. Also, nothing is seeable that her throat is swollen it is a feeling. Patient has no appointment for the second dose yet. Company comment: This case concerns a 24-year-old female with serious unexpected events of loss of consciousness, and non-serious hyperhidrosis, vision blurred, dyspnoea, pharyngeal swelling, pharyngeal edema, anxiety, pain in extremity, adverse event, pyrexia, headache, nausea. Event latency within 24 hours after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received 30 JUL 2021. Reporters information Address added. Patients Birth date added. start date of drug, batch number, Route of administration added. Concomitant drug added i.e., DIZMINELLE Events added.Events outcome updated from unknown to not recovered not resolved.; Sender''s Comments: This case concerns a 24-year-old female with serious unexpected events of loss of consciousness, and non-serious hyperhidrosis, vision blurred, dyspnoea, pharyngeal swelling, pharyngeal edema, anxiety, pain in extremity, adverse event, pyrexia, headache, nausea. Event latency within 24 hours after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1528441 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-07-18
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

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: Adipositas; Contraception; Dyspnea; Metabolic syndrome (metabolic state of metabolism); Retrosternal pain; Smoker
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202100973151

Write-up: central pulmonary embolism bilateral; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-38410. A 17-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot number and expiry date not reported), intramuscular on 26Jun2021 as dose 1, single for covid-19 immunisation. Medical history included retrosternal pain and dyspnoea, both ongoing 3 days before vaccination, since 23Jun2021; ongoing contraception (patient was taking pills (until symptoms start)); ongoing adipositas; ongoing metabolic syndrome (metabolic state of metabolism); and ongoing casual smoker. The patient was taking pills as contraception until symptoms reported started. The patient previously took ethinylestradiol norgestimate (LIBERELLE ("Pille")). On 18Jul2021, the patient experienced central pulmonary embolism, 22 days after Covid vaccination. Patient had ongoing retrosternal pain and dyspnoea 1 week before the event, then symptom-free. Treatment of the side effect included intensive care monitoring, heparin and O2 therapy. Pulmonary embolism caused hospitalization on unknown dates and was life threatening. The patient''s outcome was recovered/resolved on an unspecified date in 2021 from pulmonary embolism. Relatedness of drug to reaction/event per source of assessment health care professional and method of assessment as WHO assessment was possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1528496 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-07-18
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Pneumonia, Pulmonary embolism, Pulmonary infarction
SMQs:, Embolic and thrombotic events, venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Non-smoker; Paroxysmal atrial fibrillation; Thermal ablation (succesful)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC202100950392

Write-up: Diagnosis of peripheral pulmonary embolisms on both sides and infarct pneumonias; Diagnosis of peripheral pulmonary embolisms on both sides and infarct pneumonias; infarct pneumonias; Thoracic pain; This is a spontaneous report from a contactable physician. A 48-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 07Jun2021 at 47-year-old (Batch/Lot Number: unknown) as dose 2, single for covid-19 immunisation. Medical history included never smoked (Non-smoker), Covid-19 infection Oct2020, no PCR testing: 2021 paroxysmal atrial fibrillation, successful thermal ablation on 21Mar2021 (transseptal catheterism and electrical isolation of the 4 pulmonary veins). Patient had normal weight, was athletic (jogging, tennis), physiotherapist. The patient''s concomitant medications were not reported. The patient previously took bnt162b2 (COMIRNATY) from 04May2021 for covid-19 immunisation and Xarelto 20Feb2021 to the end of May2021. Patient was on a holiday trip to the sea on 10Jul2021, he returned by car on 17Jul2021 (9 hours by car). He had no leg swelling. Thoracic pain from the evening of 18Jul2021, on 20Jul2021 diagnosis of peripheral pulmonary embolism on both sides and infarct pneumonia/ peripheral infarct pneumonia. Patient went to emergency room. Patient was given Xarelto and co-amoxicillin. It was asked "Is there a known relationship between discontinuation of Xarelto therapy (end of May2021) and increased risk of thromboembolism after Comirnaty vaccinations (2nd vaccination on 07Jun2021)?, Generally increased risk of pulmonary embolism after vaccinations? At what time interval can be expected?, In your opinion, would you consider special laboratory tests to be necessary? (e.g. antibody titer?)". The outcome of the events was unknown. Therapeutic measures were taken as a result of diagnosis of events. The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.; Sender''s Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for events, peripheral pulmonary embolism on both sides and infarct pneumonia. However, the discontinuation of Xarelto indicated for a unknown reason may be confounding. The case will be assessed further upon receipt of additional information. 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: 1529480 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-07-18
   Days after vaccination:170
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Odynophagia, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: 20210719; Test Name: PCR; Test Result: Positive
CDC Split Type: ESPFIZER INC202100948645

Write-up: COVID-19; Vaccination failure; Cough; Odynophagia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number ES-AEMPS-949450. A 43-years-old male patient received bnt162b2 (COMIRNATY, solution for injection), dose 1, via an unspecified route of administration on 08Jan2021 (Batch/Lot Number: EJ6796, Expiration date: 30Apr2021) as DOSE 1, SINGLE, and dose 2 via an unspecified route of administration on 29Jan2021 (Batch/Lot Number: EK9788, Expiration date: 31May2021) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported the symptoms started on 18Jul2021, the patient presented odynophagia and cough, which motivated the performance of the test in addition to being close contact of a positive, patient also reported covid-19 and vaccination failure. The patient underwent lab tests and procedures which included PCR test which was positive on 19Jul2021. Patient confirmed that he received the same vaccine. The events covid-19 and vaccination failure were assessed as medically significant and odynophagia and cough were assessed as non-serious by the regulatory authority. Information from product quality complaint team division regarding consumers complaint which includes: Lot: EK9788, Expiration date: 31May2021. Brief complaint description: Patient tested Covid19 positive after vaccination, potential LOE. Reasonably Suggest Device Malfunction No. Severity of Harm: N/A. Complaint Class: Container . Complaint Sub-Class: Product Use Attributes. Root Cause: Non-assignable (Complaint Not Confirmed). Process Related: No. Final Confirmation Status: Not Confirmed. Vendor Related: No. Lot-Specific Trend Identified: No. Lot Trend Assmt. & Rationale: Blank. Lot Trend Actions Taken: Blank. Site Sample Status: Not Received. Summary of Investigation from division was: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5648370 (see File attachment in this investigation record). The complaint for adverse event/LOE of PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EK9788. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or were identified as the complaint was not confirmed. Investigational report conclusion from Puurs division was: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5648370 (see File attachment in this investigation record). The complaint for adverse event/LOE of PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EK9788. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or were identified as the complaint was not confirmed. Lot: EJ6796, Expiration date: 30Apr2021. Brief complaint description. Reasonably Suggest Device Malfunction No. Severity of Harm: Product Use Attributes. Complaint Class: Container. Complaint Sub-Class: Lack Of Effect. Root Cause: Non-assignable (Complaint Not Confirmed). Process Related: No Final Confirmation Status: Not Confirmed. Vendor Related: No. Lot-Specific Trend Identified: No. Lot Trend Assmt. & Rationale: Blank. Lot Trend Actions Taken: Blank. Site Sample Status: Not Received. Summary of Investigation from divison was: Investigational report conclusion from division was: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5574036 (see File attachment in this investigation record). The complaint for FATAL vaccine case of PFIZER-BIONTECH COVID-19 was investigated. The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, 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 EJ6796. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root cause or were identified as the complaint was not confirmed. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.


VAERS ID: 1529647 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Diplopia, Dizziness, Muscular weakness, Nasal congestion, Oropharyngeal pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Ocular motility disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100941609

Write-up: Fever; sore throat; weakness in the muscles; cough; blocked nose; Double vision; dizzyness; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-EYC 00256722. Safety Report Unique Identifier GB-MHRA-ADR 25682879. A 22-years-old female patient received a single dose of BNT162B2 parenteral on 18Jul2021 (Batch/Lot number was not reported), at the age of 22-years-old, as dose number unknown, single for Covid-19 immunisation. The patient medical history was not reported. Concomitant medication included levothyroxine taken for an unspecified indication, start and stop date were not reported. The patient experienced fever, sore throat, weakness in the muscles, cough, blocked nose, double vision, dizzyness on 18Jul2021. Outcome of the events was not recovered. The events were assessed as serious and medically significant by regulatory authority. Additional information: Seek Advice Details: "We have contacted 111 and have been sent to an urgent care unit." No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1529703 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Headache, Heart rate, Nausea, Palpitations, Presyncope, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PHENYLPROPANOLAMINE HYDROCHLORIDE
Current Illness: Anxiety
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: Blood pressure; Result Unstructured Data: Low; Test Date: 20210718; Test Name: Heart rate; Result Unstructured Data: Low; Test Date: 20210714; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: nauseous; heart racing; Near fainting; Nausea; Headache; This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (nauseous), PALPITATIONS (heart racing), PRESYNCOPE (Near fainting), NAUSEA (Nausea) and HEADACHE (Headache) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Anxiety. Concomitant products included PHENYLPROPANOLAMINE HYDROCHLORIDE for Anxiety. On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 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 18-Jul-2021, the patient experienced PRESYNCOPE (Near fainting) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (nauseous) (seriousness criterion medically significant) and PALPITATIONS (heart racing) (seriousness criterion medically significant). On 18-Jul-2021, PRESYNCOPE (Near fainting), NAUSEA (Nausea) and HEADACHE (Headache) had resolved. At the time of the report, NAUSEA (nauseous) and PALPITATIONS (heart racing) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jul-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. On 18-Jul-2021, Blood pressure measurement: low (Low) Low. On 18-Jul-2021, Heart rate: low (Low) Low. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient reported that Heart rate was slowing right down, feeling incredibly faint and nauseous. Then at other points, heart racing and pounding. This lasted for about 5 hours Patient has not tested positive for COVID-19 since having the vaccine No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness was captured as provided by Regulatory Authority assessment.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness was captured as provided by Regulatory Authority assessment.


VAERS ID: 1529825 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-07-18
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Hair loss; This regulatory authority case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, the patient experienced ALOPECIA (Hair loss) (seriousness criterion medically significant). At the time of the report, ALOPECIA (Hair loss) had not resolved. 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. 2 months after vaccination. The patient started losing his hair-quite a bit. Still losing hair but not quite as dramatically. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. No Concomitant and Treatment medication was provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1529834 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-07-18
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Migraine
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodeficiency)); Lupus erythematosus (skin lupus); Migraine
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Migraine; Headache; This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine) and HEADACHE (Headache) in a 37-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Migraine, Lupus erythematosus (skin lupus) and Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodeficiency)). On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jul-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant). At the time of the report, MIGRAINE (Migraine) and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. On an unspecified date, COVID-19 virus test was done and negative. Treatment included unspecified migraine medication. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events seriousness were captured as per Regulatory Authority assessment in Source Document.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events seriousness were captured as per Regulatory Authority assessment in Source Document.


VAERS ID: 1530224 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood pressure increased, Blood pressure measurement, Body temperature, Malaise, Nausea, Pulse abnormal, Urticaria
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: blood pressure; Result Unstructured Data: Test Result:166~102; Test Date: 20210718; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100944184

Write-up: hazy consciousness; Urticaria; Malaise; pulse tense became weak; blood pressure 166~102; nausea; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21120963. A 59-years and 8-month-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY, Solution for injection), via an unspecified route of administration on 18Jul2021 10:05, at 59 years of age, (Batch/Lot Number: EY0583; Expiration Date: 31Oct2021) as single dose for COVID-19 immunization. Medical history was none. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s concomitant medications were not reported. On 18Jul2021 10:10 (5 minutes after the vaccination) the patient experienced urticaria, malaise and had difficulty maintaining a sitting position on the chair. The patient had hazy consciousness, because the pulse tense became weak, let the patient laid on the floor. Blood pressure was 166~102, and the patient said she felt nausea. An ambulance was requested due to the patient felt suffer. On 18Jul2021 the patient underwent lab tests and procedures which included blood pressure measurement: 166~102 and body temperature: 36.7 centigrade before vaccination. At the time of the report the event urticaria was resolving, whereas all the other reported events recovered on an unknown date. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. The reporting physician commented as follows: The patient was admitted to the hospital and recovered (as reported), but urticaria appeared. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1530243 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-18
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Hemiparesis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100958026

Write-up: Unilateral weakness of limbs continued for 10 minutes and diappeared, and then appeared repeatedly; This is a spontaneous report from a non-contactable physician received. The patient was a non-pregnant 85-year-old female. On 14Jul2021 (the day of vaccination), (at the age of 85-year-old) the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY0583, Expiration date 31Oct2021) via intramuscular route of administration in the arm left as dose 1, single for COVID-19 immunization. Other medical history included hypertension. The patient received bisoprolol within 2 weeks 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. The patient had no allergies to medications, food, or other products. Since the vaccination, the patient has not been tested for COVID-19. On 18Jul2021 (4 days after the vaccination), the patient experienced unilateral weakness of limbs continued for 10 minutes and disappeared, and then appeared repeatedly. The outcome of the event was not recovered without treatment. The reporter did not provide seriousness assessment. No follow up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event of Hemiparesis. 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: 1530405 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-18
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4632 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PULMICORT; Proventil HFA
Current Illness: Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202100967136

Write-up: Acute respiratory distress, difficulty breathing; Acute respiratory distress, difficulty breathing; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority, regulatory authority number SE-MPA-2021-064805. A 43-years-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 29Jun2021 (Lot Number: FA4632) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma from 2020 and ongoing. Concomitant medication(s) included budesonide (PULMICORT) taken for an unspecified indication from 01Jan2020 to an unspecified stop date; Proventil HFA taken for an unspecified indication from 01Jan2020 to an unspecified stop date. The patient experienced acute respiratory distress, difficulty breathing on 18Jul2021. Clinical course reported as: The man experienced difficulty breathing with mild physical exertion which did not resolve with Proventil HFA. Increasing problems despite rest. To emergency department after consultation with medical staff, but ambulance had to be called urgently and met on the way. Breathing difficulties reduced with treatment in emergency room, but continues to be slightly short of breath. Outcome of events was unknown. Case was reported as serious hospitalization, disability, life threatening. No follow-up attempts possible. No further information expected.


VAERS ID: 1531374 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

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

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA, HYPERHIDROSIS, NAUSEA, FATIGUE , PYREXIA, CHILLS, HEADACHE, MALAISE and MYALGIA in a 35-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 17-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Jul-2021, the patient experienced ARTHRALGIA (seriousness criterion disability), HYPERHIDROSIS (seriousness criterion disability), NAUSEA (seriousness criterion disability), FATIGUE (seriousness criterion disability), PYREXIA (seriousness criterion disability), CHILLS (seriousness criterion disability), HEADACHE (seriousness criterion disability), MALAISE (seriousness criterion disability) and MYALGIA (seriousness criterion disability). At the time of the report, ARTHRALGIA, HYPERHIDROSIS, NAUSEA, FATIGUE, PYREXIA, CHILLS, HEADACHE, MALAISE and MYALGIA was resolving. No concomitant medications were reported. Treatment information was not provided. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1531408 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA9099 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Erythema, Flushing, Loss of consciousness, SARS-CoV-2 test, Throat irritation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic to cats (occasional sniffles from cats); Hodgkin''s disease stage II (2 years post treatment)
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: COVID-19; Result Unstructured Data: Test Result:Unknown results; Comments: Nasal Swab
CDC Split Type: CAPFIZER INC202100978578

Write-up: Anaphylactic shock; collapsed; itchy throat; flushed; my legs were bright red; This is a spontaneous report received via COVAES from a contactable consumer (patient). A 39-year-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 12Jul2021 (at the age of 39-year-old) (Batch/Lot Number: FA9099) as single dose for COVID-19 immunisation. Medical history included Hodgkin''s disease stage II 2 years post treatment, allergy to animal (occasional sniffles from cats). The patient''s concomitant medications were not reported. The patient has not received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced anaphylactic shock (hospitalization, medically significant, life threatening) on 18Jul2021 20:00 with outcome of recovered with sequelae, itchy throat (non-serious) on an unspecified date with outcome of unknown, flushed (non-serious) on an unspecified date with outcome of unknown, my legs were bright red (non-serious) on an unspecified date with outcome of unknown, collapsed (non-serious) on an unspecified date with outcome of unknown. The adverse event anaphylactic shock resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was hospitalized for anaphylactic shock for 1 day. The patient underwent lab tests and procedures which included investigation: negative on 31Jul2021. Therapeutic measures were taken as a result of anaphylactic shoc: epinephrine (EpiPen). Since the vaccination, the patient has been tested for COVID-19, results not provided. Patient was playing in the garden with his son after supper when he felt flushed and had an itchy throat, he heooked down and his legs were bright red, it was clear he was having a reaction to something. He rushed inside to grab some Benedryl but collapsed in the kitchen in full anaphylactic shock. Luckily they live close to the hospital, so the paramedics arrived with an EpiPen within a few minutes, which prevented him from dying in front of his 3 year old son. Short of getting the occasional sniffles from cats, he has never been allergic to anything in his life. Today (01Aug2021) he had his second episode, but was able to administer one of his new EpiPens and made it to hospital before passing out. He was not 100% sure the vaccine caused it, but the timing seemed very suspicious. If you''re working on a cure for the cure, he would love to take part in some trials, rather than ending up in hospital every few days. He has been referred to an allergist, but it could be months/years before seeing them.


VAERS ID: 1532309 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH CH. - B 1D017A / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Hypoaesthesia, Pain in extremity, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), COVID-19 (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? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hives; Pollen allergy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 test; Result Unstructured Data: Test Result:result not provided; Comments: after vaccination; Test Date: 20210722; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: DEPFIZER INC202100942585

Write-up: tingling, pain and numbness throughout the left arm/slight tingling in the left arm; Pain and tingling in the left forearm; Pain and tingling in the left forearm; a slight headache from the neck starts with more severe attacks; Dizziness consistently mild with more severe attacks again and again; This is a spontaneous report from a contactable consumer (patient) received via Regulatory Authority. A 48-year-old female patient received bnt162b2 (COMIRNATY, solution for injection), via an unspecified route of administration, administered in right arm on 16Jul2021 17:30 (at the age of 48-years-old) (lot: Ch.-B 1D017A) (at the age of 48-years-old) as dose 1, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included pollen allergy and hives. There were no concomitant medications. On 18Jul2021 the patient experienced from day 3 after the vaccination, a slight headache from the neck starts with more severe attacks, dizziness consistently mild with more severe attacks again and again. On 19Jul2021 day or night 4 after vaccination pain and tingling in the left forearm. On 21Jul2021 day 6 after vaccination, tingling, pain and numbness throughout the left arm. All the events were serious as they led to hospitalization for 2 days. The adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Case narrative: From day 3 after the vaccination, a slight headache from the neck starts with more severe attacks. Dizziness consistently mild with more severe attacks again and again. Both symptoms today (day 9 after vaccination) continue to be present. Day or night 4 after vaccination pain and tingling in the left forearm. Then went away. Day 6 after vaccination, tingling, pain and numbness throughout the left arm. Day 9 after vaccination only slight tingling in the left arm. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included SARS-CoV-2 test (COVID-19 test): result not provided after vaccination on an unspecified date and SARS-CoV-2 test (nasal swab): negative on 22Jul2021. The outcome for the event paraesthesia was recovering; headache and dizziness was not recovered while recovered for the remaining events in Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1532370 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1435 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Anosmia, Axillary pain, Blood immunoglobulin G, Blood immunoglobulin M, Chest pain, Cough, Dyspnoea, Headache, Lymphadenopathy, Nasal congestion, Vaccination site lymphadenopathy
SMQs:, Anaphylactic reaction (broad), Taste and smell disorders (narrow), 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), 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: ENALAPRIL
Current Illness: Blood pressure high; Stress
Preexisting Conditions: Medical History/Concurrent Conditions: Anosmia; Chest pain; Cough; COVID-19; Fever; General body pain; Head pain; Loss of taste; Shortness of breath
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: IgG; Test Result: Positive ; Test Date: 20210718; Test Name: IgM; Test Result: Negative
CDC Split Type: ESPFIZER INC202100948803

Write-up: Ageusia; Vaccination site lymphadenopathy; Anosmia; Headache; Breathing difficult; right armpit ganglion inflamed and with pain; right armpit ganglion inflamed and with pain; nasal congestion; cough; chest pain; shortness of breath; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority, number is ES-AEMPS-951197. A 30-year-old non-pregnant female patient received the first dose of BNT162B2 (COMIRNATY; lot number: FC1435), intramuscular on 18Jul2021 (at an unspecified age) at dose 1, single in the right arm for COVID-19 immunisation. Medical history included COVID-19, fever, cough, body pain, head pain, chest pain, shortness of breath, anosmia, and lack of taste; all from Mar2020 to an unspecified date, high blood pressure and stress; both ongoing from an unspecified date. It was in Mar2020, the beginning of it all and as the health was collapsed, the patient never had PCR. It took the patient two weeks to fully recover. The patient was not pregnant at the time of vaccination. Concomitant medication included enalapril 10 mg tablet for high blood pressure for stress from 09Feb2021 and ongoing. On 18Jul2021, the patient experienced ageusia, vaccination site lymphadenopathy, anosmia, headache, breathing difficult, and right armpit ganglion inflamed and with pain. On an unspecified date in 2021, the patient experienced cough, chest pain, shortness of breath, and nasal congestion. The patient stated that all the events were equal to when she had COVID-19. The patient was not admitted but had a serious time. All the events except for nasal congestion (assessed as non-serious) were assessed as serious, medically significant by the reporter. All the events (except nasal congestion) were treated with paracetamol and ibuprofen, and nasal congestion was treated with acetylcysteine. The patient underwent lab tests on 18Jul2021 which included: IgG: positive, and IgM: negative. Outcome of the event nasal congestion was unknown, and for other events was recovering. No follow up attempts are possible. No further information is expected.


VAERS ID: 1532683 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, Pain, SARS-CoV-2 test
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100949464

Write-up: pain; Swollen lymph nodes; This is a spontaneous report from a contactable consumer via Regulatory Authority, downloaded from the Regulatory authority report number is GB-MHRA-WEBCOVID-202107210017278710-VAACB; safety report unique identifier is GB-MHRA-ADR 25683752. A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Jul2021 (Batch/Lot number unknown) as single dose for COVID-19 immunisation. Medical history included suppressed lactation from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The patient experienced swollen lymph nodes (medically significant) on 18Jul2021 with outcome of not recovered and pain (medically significant) on an unspecified date with outcome of not recovered. Underarm/armpit felt like she had been stung, pain started a few hours after the vaccine. Lump roughly size of an orange appeared the next morning. Very painful to touch and constantly aching. The lump has reduced in size by about half over the past 2 days but pain has not subsided. The patient underwent lab tests and procedures which included COVID-19 virus test, which was negative on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1532737 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac murmur, Chest discomfort, Chest pain, Dyspnoea, Fatigue, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Lower extremity dysfunction; Poor peripheral circulation
Allergies:
Diagnostic Lab Data: Test Date: 20210722; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100941557

Write-up: chest tightness; shortness of breath; Chest pressure; Tiredness; Chest pain; Heart murmur; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107221123441140-SOYK5 and Safety Report Unique Identifier is GB-MHRA-ADR 25691935. A 36-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 VACCINE), dose 2 via an unspecified route of administration on 18Jul2021, at the age of 36 years, (Batch/Lot Number: FD8813) as dose 2, single for covid-19 immunization. Medical history included lactation decreased, problems with circulation to the feet, with toes occasionally turning a bluish colour. Patient has not had symptoms associated with COVID-19. Patient is not pregnant; Patient is not currently breastfeeding. Historical vaccine includes dose 1 of bnt162b2 on 08Jun2021 (Batch/Lot Number: EW3143) for COVID-19 immunization. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced chest tightness and shortness of breath. On 18Jul2021, the patient experienced chest pain, heart murmur. On 19Jul2021, the patient experienced chest pressure and tiredness. The clinical course was reported as follows: Intermittent chest tightness, pressure and pain around the heart area when sitting, drinking, walking and during the night, including slight shortness of breath. General tiredness. Reported to GP, waiting for an appointment. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient had COVID-19 Virus test (22Jul2021): no - negative covid-19 test. The case is serious (medically significant). The outcome for the events chest tightness and shortness of breath was unknown; outcome for the events chest pain, heart murmur and chest pressure was not recovered; outcome for tiredness was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1532739 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Headache, Hypoaesthesia, Peripheral coldness, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Arthritis (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100941836

Write-up: Numbness in feet; Cold feet; Low back pain; Joint pain; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number: GB-MHRA-WEBCOVID-202107221128446950-LU0R0, Safety Report Unique Identifier: GB-MHRA-ADR 25691981. A 31-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), dose 1 via an unspecified route of administration on 17Jul2021 (Lot Number: PF3319) as single dose for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19 Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 30Jun2021. The patient experienced headache on 18Jul2021. The patient reported that lower back started aching slightly several days after vaccine on 20Jul2021. She took painkillers, tried rest, walking, stretching, yoga, sleeping on side with pillow between legs, but getting steadily worse to the point where she can''t sleep and it was difficult to move. Shooting, aching pain in joints especially wrists (onset date: 20Jul2021). The patient experienced cold feet on 21Jul2021, and numbness in feet on 22Jul2021. The events were considered serious: disability and medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1532740 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Formication, Joint range of motion decreased, Pain in extremity, Paraesthesia, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: DULOXETINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100941734

Write-up: Large arm swelling/swollen arm; Painful L arm; Armpit pain; could not move arm much or pick up things; crawling sensation; Tingling; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority, report number is GB-MHRA-WEBCOVID-202107221135185820-WIGAZ, Safety Report Unique Identifier is GB-MHRA-ADR 25691957. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jul2021 (Lot Number: FD5613), at the age of 37 years, as dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation and depression. Concomitant medication included duloxetine taken for depression. The patient experienced tingling and crawling sensation on 18Jul2021; and swollen arm/large arm swelling, painful arm, and armpit pain on 19Jul2021. Additional information was reported as follows: started with tingling in arm after injection. Woke the next morning with swollen arm and armpit extremely painful and could not move her arm much or pick up things, took paracetamol but did not help. Next day GP saw her and said to take ibuprofen 3 times a day, it was getting easier but still swollen and painful, sometimes feeling the tingling/ crawling sensation down the arm. Patient has not tested positive for COVID-19 since having the vaccine. The events were considered medically significant. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative COVID-19 test on an unknown date. The patient was recovering from the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1532752 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Dry throat, Malaise, Pain, Pharyngeal swelling, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: IBD; Irritable bowel syndrome; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100941817

Write-up: Abdominal pain; Throat swelling; Dry throat; Feeling sick; Ache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107221338064920-W7O2F, Safety Report Unique Identifier GB-MHRA-ADR 25692745. A 20-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FE1510), via an unspecified route of administration on 17Jul2021 as dose 1, single for COVID-19 immunisation. Medical history included suspected COVID-19 from 09Jun2021 to 12Jun2021 and was not ongoing, inflammatory bowel disease (IBD), and irritable bowel syndrome (IBS). The patient''s concomitant medications were not reported. The patient experienced ache on 18Jul2021; abdominal pain, throat swelling, dry throat, feeling sick on 21Jul2021. The events was medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test was yes - positive COVID-19 test on 10Jun2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the pain was recovered on 19Jul2021 while of the remaining events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1532806 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-18
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Tooth abscess, Tooth loss, Toothache
SMQs:, Osteonecrosis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Periodontal disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100941686

Write-up: Tooth pain; healthy tooth became so loose it developed an abscess; Tooth loss; 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-202107230030500110-CF8WA], Safety Report Unique Identifier [GB-MHRA-ADR 25696089]. A 39-year-old female patient received BNT162B2, via an unspecified route of administration on 10Jul2021 (Lot/batch number was not known) as dose 2, single for COVID-19 immunization. Medical history included lactation decreased and periodontal disease, both from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced tooth pain and healthy tooth became so loose it developed an abscess on an unspecified date; and tooth loss on 18Jul2021. The events were assessed as serious (medically significant). Therapeutic measures were taken as a result of all the events and included tooth extraction. The outcome of the events was unknown. The clinical course was reported as follows: 1 week after 2nd dose (7wks after 1st) previously healthy tooth became so loose it developed an abscess and had to be extracted. Whilst she has a history of periodontal disease, the tooth in question was fine. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Additional information: Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1532820 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness postural, Fatigue, Myalgia, Pruritus, Sinus headache, Tension headache, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Tension headache
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100943242

Write-up: Dizziness upon standing; Itchy; Blurred vision; Headache sinus; Headache tension; Tiredness; Muscle ache; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107230753565640-L29WB. Safety Report Unique Identifier (GB-MHRA-ADR 25697066). A 39-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jul2021 (Lot Number: FE1510) as single dose (at age of 39-years-old) for COVID-19 immunisation. Medical history included tension headache. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Concomitant medication included acetylsalicylic acid (ASPIRINE) taken for tension headache. On 18Jul2021 patient experienced muscle ache, on 19Jul2021 he experienced headache sinus, headache tension, tiredness and blurred vision, on 20Jul2021 patient experienced itchy and on 22Jul2021 dizziness upon standing. Events considered serious as medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient recovered on 22Jul2021 from headache sinus and blurred vision, recovered on 23Jul2021 from headache tension and itchy, while he was recovering from the other mentioned events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1532913 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Rash pruritic, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202100943072

Write-up: This is a spontaneous report from a contactable consumer received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202107231243075890-QVXOG; safety report unique identifier: GB-MHRA-ADR 25698749). A 32-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FE1510, expiry date not reported), via an unspecified route of administration, on Jul 16, 2021, single dose, for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medications not reported. The patient experienced a very itchy skin rash on Jul 18, 2021; with outcome of recovered on Jul 20, 2021. The patient underwent lab tests and procedures, which included SARS-CoV-2 test: No - Negative COVID-19 test on an unspecified date. The event reported serious (medically significant). Case narrative: Extensive skin rash in the inner thighs (both) also very itchy. Patient has not tested positive for COVID-19 since the vaccination. Patient was not enrolled in a clinical trial. No follow-up attempts possible. No further information expected.


VAERS ID: 1532984 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-18
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Electrocardiogram, Oxygen saturation, Pericarditis, SARS-CoV-2 test
SMQs:, Systemic lupus erythematosus (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:All ok; Test Name: ECG; Result Unstructured Data: Test Result:All ok; Test Name: Oxygen sat; Result Unstructured Data: Test Result:All ok; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100942925

Write-up: Pericarditis; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107232118298320-OO1EL, Safety Report Unique Identification Number: GB-MHRA-ADR 25702020. A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at dose 2, single, on 14Jul2021 (lot number: FD8813) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient is not enrolled in clinical trial. The patient received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient experienced pericarditis on 18Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included blood pressure, electrocardiogram (ECG), and oxygen sat, results were all ok, Covid-19 virus test: no - negative COVID-19 test, all on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. The event was assessed as serious and medically significant by regulatory authority. Additional information: Stabbing pain in the upper left chest Which onsets with no prior symptoms and dissipates after a few seconds. "Called an emergency number, went to hospital. ECG, blood pressure and oxygen sat all ok. Sent home." No follow-up attempts are possible. No further information is expected.


VAERS ID: 1533007 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Brachyolmia, Heart rate, Heart rate decreased, Inappropriate schedule of product administration, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Congenital, familial and genetic disorders (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? No
Previous Vaccinations:
Other Medications: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: Heart rate; Result Unstructured Data: Test Result:47; Comments: having a dangerously low heart rate of 47, my normal resting heart rate is 62; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100943124

Write-up: a dangerously low heart rate of 47; Brachyrachia; First dose on 18May2021/second dose on 18Jul2021; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107240324308670-3IFWZ, Safety Report Unique Identifier GB-MHRA-ADR 25702281. A 28-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine, Lot Number: FF3319), via an unspecified route of administration at the age of 28-year-old on 18Jul2021 at single dose for COVID-19 immunisation. Medical history included lactation decreased and anxiety. Patient has not had symptoms associated with COVID-19 Patient was not pregnant. Patient was not currently breastfeeding. The patient previously received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine, Lot number: EW3143) on 18May2021 for COVID-19 immunisation. Concomitant medications included citalopram taken for anxiety from 01Feb2020 to an unspecified stop date; hepatitis b vaccine taken for an unspecified indication on 30Jun2021.The patient experienced brachyrachia on 24Jul2021. Her smart watch woke she up due to having a dangerously low heart rate of 47, her normal resting heart rate was 62. This has never happened previously. The events were serious for being medical significant. The patient underwent lab tests included Heart rate: 47 on unspecified date, COVID-19 virus test: negative on unspecified date (reported as No - Negative COVID-19 test). Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of event a dangerously low heart rate of 47 was recovered and of event Brachyrachia was not recovered. No follow-up attempts are possible. No further information is expected


VAERS ID: 1533089 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100942991

Write-up: Red rash on legs, arms and coming up the face; This is a spontaneous report from a contactable consumer, received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202107241516495180-ZKK2X, Safety Report Unique Identifier is GB-MHRA-ADR 25703141. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jul2021 (Lot Number: FC9001, Expiry date not reported) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced red rash on legs, arms and coming up the face on 18Jul2021 with outcome of not recovered. Therapeutic measures were taken as a result of red rash on legs, arms and coming up the face that included fexofenadine 120mg tablets and eumovate ointment. The event was reported as serious, medically significant. Additional Information: Red rash on legs, arms and coming up the face. Been given Fexofenadine 120mg tablets and eumovate ointment. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient had not had symptoms associated with COVID-19. Patient had not had a COVID-19 test. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1533127 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal hypokinesia, Maternal exposure during pregnancy, SARS-CoV-2 test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210416; Test Name: Fetal movement counting; Result Unstructured Data: Test Result:Decreased.; Test Date: 20210723; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: Negative
CDC Split Type: GBPFIZER INC202100943037

Write-up: Vaccine giving in the morning (at 28 weeks pregnant); Foetal movements decreased; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107241734180820-KVX7L. Safety Report Unique Identifier (GB-MHRA-ADR 25703270). A fetus patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via transplacental on 18Jul2021 (Lot number was not reported) as dose 1, single for covid-19 immunization. The patient''s mother medical history and concomitant medications were not reported. The patient''s mother has not had symptoms associated with COVID-19.It was reported that on 18Jul2021, vaccine was given in the morning (at 28 weeks pregnant) and experienced reduced foetal movements (foetal movements decreased) for the rest of the day and the next few days. Pattern and sequence of foetal movements has changed since vaccine given. The events were serious (hospitalization, medically significant). The outcome of the events was recovering. The mother had negative covid-19 test on 23Jul2021. Therapeutic measures were taken as a result of the events. The patient''s mother has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. She went to maternity assessment centre on evening of the day vaccine was given for the baby to be monitored. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1533207 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Eye pain, Fatigue, Headache, Pain, Pain in extremity, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210629; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100950179

Write-up: Tingling sensation; Fatigue; Shooting pain; Leg pain; Eye pain; Back pain; Head pain; This is a spontaneous report from a contactable consumer. The regulatory authority report number is GB-MHRA-WEBCOVID-202107260337466690-34RLI, Safety Report Unique Identifier GB-MHRA-ADR 25704487. A 39-year-old (non-pregnant) female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 18Jul2021 (at the age of 39-year-old) as single dose for COVID-19 immunisation. The patient medical history included suppressed lactation. Concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 18Jul2021, the patient experienced head pain and back pain. On 19Jul2021, she experienced eye pain, tingling sensation, fatigue, shooting pain and leg pain. The patient underwent lab tests which showed sars-cov-2 test as negative on 29Jun2021, negative COVID-19 test. Outcome was resolved on 21Jul2021 for event fatigue and resolved on 19Jul2021 for rest of the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1533524 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blindness transient, Body temperature, Colour vision tests, Computerised tomogram, Neurological examination, Ophthalmological examination, Pyrexia, SARS-CoV-2 test, Vaccination site pain, Vision blurred
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal 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? 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: Myopia
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: body temperature; Result Unstructured Data: Test Result:fever; Comments: fever; Test Date: 20210718; Test Name: colorimetric; Result Unstructured Data: Test Result:colorimetric deficit; Comments: colorimetric deficit; Test Name: Cranial-brain computed tomography and Angio-computed tomography of intracranial and neck vessels; Result Unstructured Data: Test Result:normal; Test Name: neurological examination; Result Unstructured Data: Test Result:lower altitudinal field deficit in left eye impro; Comments: lower altitudinal field deficit in left eye improving, neurological physical examination normal; Test Name: Ophthalmology examination; Result Unstructured Data: Test Result:visual field normal, left eye symptoms in regressi; Comments: visual field examination normal, left eye symptoms in almost complete regression; Test Name: Nasopharyngeal swab for Severe acute respiratory syndrome-Cov-2; Test Result: Negative
CDC Split Type: ITPFIZER INC202100948759

Write-up: Temporary loss of vision in the left eye, arm pain, fever; Injection site pain/arm pain; Temporary loss of vision in the left eye, arm pain, fever; Temporary loss of vision in the left eye, arm pain, fever; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Agency Agency-WEB, regulatory authority number IT-MINISAL02-759705. A 40-year-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: FF0688) via an unspecified route, administered in Left arm (left shoulder) on 18Jul2021 at 10:00 (40-year-old at vaccination) as a Dose 2, single for COVID-19 immunization. The patient''s medical history (remote case history:)included myopia. The patient''s concomitant medications were not reported. On 20Jul2021, Local Manager reported from Accident and Emergency report as vaccination at 10:00 on 18Jul2021, the patient was admitted to Accident and Emergency at 1:11 PM, apyretic, symptoms described left eye: conical reduction of visual field with blurred vision and colorimetric deficit, subsequently the field of view returned to its original size. Patient does not take medication at home. Neurological examination outcomes included: lower altitudinal field deficit in left eye improving, neurological physical examination normal. Ophthalmology examination outcome: visual field examination normal, left eye symptoms in almost complete regression. Cranial-brain computed tomography and Angio-computed tomography of intracranial and neck vessels: normal, Nasopharyngeal swab for Severe acute respiratory syndrome-Cov-2: negative, Body temperature: (result was not provided) Fever". Actions taken (Admitted to Accident and Emergency for tests for possible thrombosis). Impact on quality of life (10/10). The outcome of the events was recovered on an unknown date in 2021. Reporter comment: None. Health authority comment: On 19Jul2021 Local Manager: vaccination date, second dose batch number, hospital clinical documentation requested from the reporter. Feedback 19Jul2021, updated fields scsi reported in the description of the case; the Accident and Emergency report would be attached in the Network. No follow-up attempts are possible. No further information was expected.; Reporter''s Comments: None


VAERS ID: 1533601 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Hypoaesthesia, Musculoskeletal discomfort, Neuropathy peripheral, Oropharyngeal discomfort, Palmar erythema
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Immune-mediated/autoimmune disorders (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: Contrast media allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: Body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202100944432

Write-up: Peripheral nerve disorder; Feeling strange around the joints of both hands (stirring restlessly, Numbness); Feeling strange around the joints of both hands (stirring restlessly, Numbness); palms turn red; mild pharynx strange sensation of; This is a spontaneous report from a contactable physician received from the PMDA. Regulatory authority report number is v21120974. The patient was a 68-year-old female. Body temperature before vaccination was 35.8 degrees Centigrade. Family history was not provided. The patient had a history of Contrast media allergy. The patient received BNT162B2 (COMIRNATY; Lot Number: FD0889; Expiration Date: 30Sep2021), via an unspecified route of administration on 18Jul2021 13:13 (at the age of 68-years-old) as dose 2, single for COVID-19 immunization. The patient''s concomitant medications were not reported. On 18Jul2021 at 13:40 (27 minutes after the vaccination), the patient experienced Peripheral nerve disorder. The course of the event was as follows: On 18Jul2021, from about 13:40, feeling strange around the joints of both hands (stirring restlessly, numbness) appeared. Palms also turned red and had mild pharynx strange sensation of. At 14:15, the symptoms above continued but they were improving. Outcome of the events was resolving. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The causal relationship with the coronary vaccine couldn''t be denied.


VAERS ID: 1533607 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0203 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Heart rate, Hypoaesthesia, Neuropathy peripheral, Oxygen saturation
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: BP; Result Unstructured Data: Test Result:144/98; Test Date: 20210718; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210718; Test Name: HR; Result Unstructured Data: Test Result:68; Test Date: 20210718; Test Name: spo2; Test Result: 98 %
CDC Split Type: JPPFIZER INC202100944669

Write-up: peripheral nerve disorder; Numbness in left hand; BP: 144/98; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21120986. The patient was a 50-year 3-month-old male. Body temperature before vaccination was 36.7 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, etc). On 18Jul2021 at 14:10, the patient received the first dose of bnt162b2 (COMIRNATY intramuscular injection, Lot# EW0203, Expiration date 30Sep2021) via an unspecified route of administration as single dose for COVID-19 immunization. On 18Jul2021 at 14:20 (10mins after the vaccination), the patient experienced peripheral nerve disorder. The course of the event was as follows: Around10 minutes after vaccination, Numbness in left hand developed. He complained of numbness when he was about to go home after waiting time. The doctor examined the patient. BP: 144/98, HR 68, SpO2 98%. No muscular weakness, no difficulty breathing, and no nausea were noted. He took ALLEGRA just in case and went home. The reporter classified the events as non-serious and assessed that the event was the causality between the event and bnt162b2 as related. On 18Jul2021 (the day of the vaccination), the outcome of events were recovered. Reporter''s comment: If the event was nerve damage caused by injection needle, it considered to be a transient nerve reflex, that is, numbness may appear at the time of injection. Follow up attempts are completed. No further information is expected.; Reporter''s Comments: If the event was nerve damage caused by injection needle, it considered to be a transient nerve reflex, that is, numbness may appear at the time of injection.


VAERS ID: 1533634 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0203 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Feeling abnormal, Heart rate, Oxygen saturation, Palpitations
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Hypertension (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: BP; Result Unstructured Data: Test Result:163/99; Test Date: 20210718; Test Name: BP; Result Unstructured Data: Test Result:145/96; Test Date: 20210718; Test Name: BP; Result Unstructured Data: Test Result:128/90; Test Date: 20210718; Test Name: BP; Result Unstructured Data: Test Result:127/85; Test Date: 20210718; Test Name: HR; Result Unstructured Data: Test Result:110; Test Date: 20210718; Test Name: HR; Result Unstructured Data: Test Result:99; Test Date: 20210718; Test Name: HR; Result Unstructured Data: Test Result:98; Test Date: 20210718; Test Name: HR; Result Unstructured Data: Test Result:88; Test Date: 20210718; Test Name: Sat; Result Unstructured Data: Test Result:97; Test Date: 20210718; Test Name: Sat; Result Unstructured Data: Test Result:98; Test Date: 20210718; Test Name: Sat; Result Unstructured Data: Test Result:99
CDC Split Type: JPPFIZER INC202100951773

Write-up: Blood pressure increased/BP 163/99; Palpitations/HR 110; Fuzzy head; This is a spontaneous report from the a contactable physician received from the Regulatory Agency. Regulatory authority report number is v21120903. The patient was a 67-year-old female. Body temperature before the vaccinations was not provided. Patient''s history according to 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, etc.) was not provided. On 18Jul2021 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY Intramuscular injection, Lot number: EW0203, expiration date: 30Sep2021). Adverse event onset date and time was on 18Jul2021. Clinical course of the event was reported as follows: After about 5 minutes of vaccination, the patient complained of Palpitations and Fuzzy head; the patient was instructed to take a bed rest. BP 163/99, Sat 97, HR 110. As the patient had no primary physician, she was instructed to keep taking a bed rest, after which she was immediately recovering, and she asked her husband by phone to come over to her bedside. This might have helped her feel much safer, and her vital signs changed from BP 145/96, Sat 98, HR 99 to BP 128/90, HR 98 then to BP 127/85, HR 88, Sat 99. It was explained to her husband that only rest and drug-free course observation was working and that her condition was becoming stable. The patient was instructed to visit an internal medicine clinic once tomorrow. The outcome of event was recovering. The reporter classified the event as non-serious and assessment the causality between the event and the vaccines was not provided. Other possible cause of the event such as any other diseases was not provided. The reporter concluded as follows: Have there been any reports of post-vaccination Blood pressure increased (Maybe not) (?). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1533690 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-18
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: JPTAKEDA2021TJP065330

Write-up: Coronavirus infection; This case was received via Regulatory Authority (Reference number: 2021TJP065330) on 26-Jul-2021 and was forwarded to Moderna on 03-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Coronavirus infection) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jul-2021, the patient experienced COVID-19 (Coronavirus infection) (seriousness criterion medically significant). At the time of the report, COVID-19 (Coronavirus infection) had not resolved. Concomitant medications was not reported. Treatment medications was not reported. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable. Reporter did not allow further contact; Reporter''s Comments: Recuperation at home until 28-Jul-2021.; Sender''s Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.


VAERS ID: 1534597 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-18
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3064 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100964241

Write-up: Shingles; This is a spontaneous report received from a non-contactable consumer or via the Regulatory Authority. The regulatory authority number was ZA-SAHPRA-202107201241205630-YRGR7. A 70-years-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: FE3064), via an unspecified route of administration on 09Jul2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced shingles with disability on 18Jul2021.The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1534605 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2090 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Influenza, Sinus headache
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100970786

Write-up: Headache sinus; Flu symptoms; This is a spontaneous report from a non-contactable consumer received via the Regulatory Authority. The regulatory authority number was ZA-SAHPRA-20210721101252. A 47-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 16Jul2021 (Batch/Lot Number: FE2090) as single dose (at the age of 47-years-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 18Jul2021, the patient experienced headache sinus and flu symptoms. The events were considered serious, disability (disabling/incapacitating) according to the regulatory authority. The patient has not recovered from the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1535819 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-18
Submitted: 0000-00-00
Entered: 2021-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dizziness, Fatigue, Hyperhidrosis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROJNJFOC20210810294

Write-up: EXCESS SWEATING; DIZZINESS TO FAINTING; CHILLS; FATIGUE; FEVER; This spontaneous report received from a consumer via a Regulatory Authority [RO-NMA-2021-SPCOV12075] concerned a 40 year old male, race and ethnicity unknown. The patient''s weight was 88 kilograms, and height was 185 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C13-01 expiry: UNKNOWN) 1 dosage forms, one total administered on 18-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 18-JUL-2021, the patient experienced excess sweating, dizziness to fainting, fatigue, fever and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excess sweating, fatigue, fever, and chills on 22-JUL-2021, and was recovering from dizziness to fainting. This report was serious (Disability Or Permanent Damage).; Sender''s Comments: V0: 20210810294-COVID-19 VACCINE AD26.COV2.S-excess sweating, dizziness to fainting. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210810294-COVID-19 VACCINE AD26.COV2.S-chills, fatigue, fever. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1537772 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA9099 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Influenza like illness, Interchange of vaccine products, Limb discomfort, Movement disorder, Pain in extremity, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Medication errors (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: AMLODIPINE; ATENOLOL; FLUOXETINE; FUROSEMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Congestive heart failure; Depression
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202100957086

Write-up: They are so huge it''s like "popeye the sailor arms" but her whole arm and now both/swollen/arm swelling/left arm swollen/arms are so swollen/Arm girth should not swell overnight; flu like symptoms; Chills; left arm was uncomfortable; Sore/pain/arms are so swollen and painful; it is difficult to exercise, lift them up high; first dose: AstraZeneca vaccine, second second: Pfizer vaccine; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose, via an unspecified route of administration, administered in arm left on 18Jul2021 15:00 (Batch/Lot Number: FA9099) at the age of 62 years old, as dose 2 (initial Pfizer dose), single dose for covid-19 immunization; covid-19 vaccine NRVV AD (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA), via an unspecified route of administration, administered in arm left on 26Apr2021 16:00 (Batch/Lot Number: MT0055), at dose 1, single dose for covid-19 immunization. Medical history included cardiac failure congestive, depression. Known allergies was no. The patient was not pregnant at the time of vaccination. Ongoing concomitant medications included amlodipine; atenolol; fluoxetine; furosemide, and Pantopr (as reported). The patient experienced they are so huge it''s like "popeye the sailor arms" but her whole arm and now both/swollen/arm swelling/left arm swollen/arms are so swollen/arm girth should not swell overnight on 19Jul2021 08:00, flu like symptoms on 19Jul2021 08:00, chills on 19Jul2021 08:00, left arm was uncomfortable on 19Jul2021 08:00, sore/pain/arms are so swollen and painful on 19Jul2021 08:00, it is difficult to exercise, lift them up high on 19Jul2021 08:00. Clinical course: The day after the vaccine the patient had flu like symptoms, ackes and chills no fever, her left arm was uncomfortable, sore and swollen. The flu like symptoms subsided within 24 hours. But her arm swelling and pain has not ,it seems not only was her left arm swollen and massive to the point of not being able to fit in any long sleeve top/blouse etc but now her right arm seems to be playing catch up in size . Her arms were so swollen and painful it was difficult to exercise, lift them up high. Arm girth should not swell overnight, the day of the vaccine the patient could fit into a long sleeve top, now the patient can''t. They were so huge it''s like "popeye the sailor arms" but her whole arm and now both. The patient was a female so this was distressing. The outcome of the event flu like symptoms was recovered in Jul2021, of the other events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.


VAERS ID: 1537900 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-18
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Investigation, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: fluorescence-activated cell sorting analysis and cytomorphology; Result Unstructured Data: Test Result:B-cell lymphoma ruled out
CDC Split Type: DEPFIZER INC202100987671

Write-up: Thrombocytopenia; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, company number DE-PEI-202100149470. A 22-years-old male patient received BNT162B2 (COMIRNATY/ mRNA TOZINAMERAN, formulation: Solution for injection, Lot number was not provided), via intramuscular route, at an unknown dosage on 05Jul2021 as dose number unknown, single (age at vaccination: 22 years), for covid-19 immunization. Medical history and concomitant medications were not reported. It was stated that, on 18Jul2021, the patient was presented with thrombocytopenia. The seriousness criteria were reported as hospitalization and life threatening. The patient underwent lab tests and procedures which included fluorescence-activated cell sorting analysis and cytomorphology: b-cell lymphoma ruled out on an unspecified date. The outcome of the event was not recovered. Sender comment: Vaccine-related thrombocytopeny 1Gpt/L. Backed by blood count control and thrombexact test. B-cell lymphoma ruled out by fluorescence-activated cell sorting analysis and cytomorphology. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1538336 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac flutter
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Tachyarrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CERUMOL [ARACHIS HYPOGAEA OIL;CHLOROBUTANOL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped); The pill
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100950147

Write-up: Heart fluttering; This is a spontaneous report from a contactable consumer and received from the The regulatory authority report number is GB-MHRA-WEBCOVID-202107251038368300-MNC3L Safety Report Unique Identifier GB-MHRA-ADR 25703811. A female patient of an unspecified age received first dose of (COMIRNATY, Solution for injection, Lot Number: Fe1510), via an unspecified route of administration on 17Jul2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included suspected covid-19 from 01Jan2021 to an unknown date Unsure when symptoms stopped and the pill (oral contraception) from an unknown date and unknown if ongoing. Not had a COVID-19 test. Concomitant medications included arachis hypogaea oil, chlorobutanol (CERUMOL [ARACHIS HYPOGAEA OIL, CHLOROBUTANOL]) taken for oral contraception, start and stop date were not reported. It was reported that, on 18Jul2021, after the vaccination, the patient experienced heart fluttering. Patient stated after vaccine most mornings she wake up and her heart was fluttering, it also randomly happened during the day and evening. Patient had her first dose a week ago and woke this morning with her heart fluttering again which was why she was reporting this. If this carry on patient will be seeking medical advice as in the mornings patient just have to stop and wait for her heart to go back to normal which can take a few minutes. Patient was not enrolled in clinical trial. The outcome of event was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1538471 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Epistaxis, Joint stiffness, Musculoskeletal stiffness, Neck pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100949904

Write-up: This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107252218073830-PRMM7 and Safety Report Unique Identifier GB-MHRA-ADR 25704373. A 38-year-old female patient received 2nd dose of bnt162b2 (Pfizer-BioNTech COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 (Batch/Lot Number: FF5613) as dose 2, single for COVID-19 immunization. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant; Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. On 18Jul2021, the patient experienced stiff joint; on 19 Jul2021 patient had nose bleeds; on an unspecified date patient experienced joint pain, pain in upper back & neck and stiffness. Therapeutic measure was given for the events stiff joint, joint pain, pain in upper back & neck and stiffness. The clinical course was reported as follows: Seeking treatment from an osteopath due to stiffness & pain in upper back & neck. Also joint pain in left hip. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The case is serious (medically significant). The outcome for stiff joint and nose bleeds was not recovered; outcome for joint pain, pain in upper back & neck and stiffness was unknown.No follow-up attempts are possible. No further information is expected.


VAERS ID: 1538537 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Chest pain, Dyspnoea, Electrocardiogram, SARS-CoV-2 test, Scan
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Endometriosis
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:Unknown result; Test Name: chest x-ray; Result Unstructured Data: Test Result:Unknown result; Test Name: ECG; Result Unstructured Data: Test Result:Unknown result; Test Date: 20210719; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: Echo scan; Result Unstructured Data: Test Result:Unknown result
CDC Split Type: GBPFIZER INC202100956930

Write-up: Chest pain; Shortness of breath; This is a spontaneous report from a contactable consumer received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202107261105390180-GKPTA, Safety Report Unique Identifier GB-MHRA-ADR 25706084. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FA1027), via an unspecified route of administration at single dose on 17Jul2021 for COVID-19 immunization. Medical history included endometriosis (diagnosed previously & ongoing), lactation decreased. Patient did not have symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced chest pain, shortness of breath on 18Jul2021. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: No-Negative COVID-19 test on 19Jul2021, details of any relevant investigations or tests conducted: ECG, blood tests, chest x-ray. Awaiting Echo scan. The outcome of events was not recovered. This case was reported as serious due to medical significant. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1538538 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ear pain, Headache, Investigation, Myalgia, Nausea, Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GABAPENTIN; NAPROXEN; OMEPRAZOLE; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression mental; Slipped lumbar disc
Allergies:
Diagnostic Lab Data: Test Name: Lateral Flow Test; Test Result: Negative ; Test Date: 20210726; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100956789

Write-up: Fever; Headache; Nausea; Ache; Earache; Muscle pain; Sore throat; 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-202107261122061540-STCGD, Safety Report Unique Identifier GB-MHRA-ADR 25706192. A 44-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Jul2021 (Lot Number: FE1510) as single dose for covid-19 immunisation. Medical history included Slipped lumbar disc and depression mental. Patient had not symptoms associated with COVID-19. Concomitant medications included gabapentin (MILPHARM GABAPENTIN) taken for slipped lumbar disc; naproxen taken for slipped lumbar disc; omeprazole; sertraline taken for depression mental. The patient experienced fever, headache, nausea, ache, earache, muscle pain, sore throat (all reported as serious as medically significant) and all started on 18Jul2021. Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on 26Jul2021; unspecified Lateral Flow Test: Negative on an unknown date. The outcome of event muscle pain was recovered with sequelae; remains events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1538592 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: African trypanosomiasis, Headache, Poor quality sleep, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response); Lactation decreased; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100956689

Write-up: Sleeping sickness; Fever; Sleep unwell; Rash; Headache; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202107261536104970-67TJQ, Safety Report Unique Identifier GB-MHRA-ADR 25708411. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 16Jul2021 for COVID-19 immunisation. Medical history included lactation decreased, suspected COVID-19 (unsure when symptoms started and unsure when symptoms stopped), immunodeficiency (had an illness or condition, not listed above, which reduces the immune response). Patient had not had a COVID-19 test. Patient was not pregnant and was not currently breastfeeding. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced sleeping sickness, fever, sleep unwell, rash and headache on 18Jul2021. The case was reported as serious (medically significant). Outcome of fever was recovered with sequel on 22Jul2021, of sleep unwell was recovered on 22Jul2021, of rash was not recovered, of sleeping sickness and headache was recovered on 24Jul2021. Patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible, Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1538600 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Inappropriate schedule of product administration, Musculoskeletal stiffness, Pain, Pain in extremity, Scan, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Parkinson-like events (broad), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (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: FERROUS SULFATE; MEFENAMIC ACID; SERTRALINE; TRANEXAMIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Anxiety disorder; Dysmenorrhoea
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:Unknown results; Test Name: scan; Result Unstructured Data: Test Result:Unknown results; Comments: injection in tummy given and then appointment to DVT clinic for a scan
CDC Split Type: GBPFIZER INC202100956769

Write-up: pain; Pain in left leg; tightness in back of left leg; Clot blood; first dose of BNT162B2 on 14May2021; second dose on 17Jul2021; This is a spontaneous report from a contactable consumer received from the Regulatory authority report number GB-MHRA-WEBCOVID-202107261615126420-VYABT, Safety Report Unique Identifier GB-MHRA-ADR 25708672. A 37-year-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 17Jul2021 (Batch/Lot Number: FD8813) as dose 2, single for covid-19 immunisation. Patient received first dose of BNT162B2 on 14May2021 with Batch/lot number:EW4109. Medical history included anaemia, dysmenorrhoea, anxiety disorder. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Concomitant medication(s) included ferrous sulfate (FERROUS SULFATE) taken for anaemia from Jun2021; mefenamic acid (MEFENAMIC ACID) taken for dysmenorrhoea from 02Jul2020 to 30Jun2021; sertraline (SERTRALINE) taken for anxiety disorder from 19Feb2014; tranexamic acid (TRANEXAMIC ACID) from 20May2020. The patient experienced pain on an unspecified date, clot blood on 18Jul2021. Clinical course was reported as follows: Pain in left leg, felt pain and tightness in back of left leg. The patient visited from the Rapid Response Team, blood test taken, injection in tummy given and then appointment to DVT clinic for a scan. The outcome of Clot blood was recovered on 22Jul2021, other events outcome was unknown. Case reported as serious due to caused hospitalization. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1538609 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Diarrhoea, Fatigue, Illness, Malaise, Migraine, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fever; Lactation decreased; Sickness
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100957042

Write-up: unwell; sickness; weakness; diarrhea; fatigue; fever; Severe Migraines; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. Regulatory authority report number , Safety Report Unique Identifier. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ff3319), via an unspecified route of administration on 18Jul2021 (at the age of 40 years old) as dose 1, single for COVID-19 immunisation. Medical history included lactation decreased, sickness, and fever. The patient''s concomitant medications were not reported. The patient experienced unwell, sickness, weakness, diarrhea, fatigue, fever all on an unspecified date then severe migraines on 18Jul2021. 1 week and still unwell. The events were medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test was yes - positive COVID-19 test on 21Jan2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the severe migraines was not recovered while of the remaining events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1538714 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acne cystic, Endometriosis, Lymph node pain, Lymphadenopathy, SARS-CoV-2 test, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Endometriosis; Fatigue; Fibromyalgia; Insomnia; Joint pain; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100964330

Write-up: Cystic acne; Enlarged lymph nodes (excl infective); enlarged lymph node in left armpit, very swollen and sore; she had had a lot of pain and bleeding since the vaccine; she had had a lot of pain and bleeding since the vaccine; This is a spontaneous report from a contactable consumer. This is the second of two report. The first report was received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107262301524100-XXYLR. Sender''s (Case) Safety Report Unique Identifier-GB-MHRA-ADR 25711175. A 30-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jul2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient had received first dose of vaccine on 15May2021. Medical history included suppressed lactation, fibromyalgia, arthralgia, endometriosis. Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient is not enrolled in clinical trial. Concomitant medications included amitriptyline taken for insomnia and sertraline taken for depression. The patient reported that second dose of vaccine caused enlarged lymph node in left armpit, very swollen and sore on 18Jul2021. Also on 22Jul202 have come up in large cystic acne spots on her face which she had never had before, and nothing else has changed apart from the vaccine. Very painful. She did not have periods due to being on the pill and have endometriosis, but she had had a lot of pain and bleeding since the vaccine. Seeking gynaecology help on bleeding and doctor on the acne. The events were considered medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of cystic acne was not recovered, the outcome of enlarged lymph nodes armpit, very swollen was recovering and the outcome other other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100956611 same patient different vaccine dose and events


VAERS ID: 1538849 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-18
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7010 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial flutter, Pericarditis, SARS-CoV-2 test
SMQs:, Systemic lupus erythematosus (broad), Supraventricular tachyarrhythmias (narrow), 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NORMIX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diverticulitis
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: swabs for Severe acute respiratory syndrome-Cov-2; Result Unstructured Data: Test Result:three swabs were Negative
CDC Split Type: ITPFIZER INC202100954922

Write-up: Atrial flutter; Acute pericarditis; FARMAVIGITER This is a Non-Interventional report from a contactable physician downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-760777. A 50-years-old male subject received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in right deltoid (also reported as "right shoulder") on 05Jul2021 10:18 (Lot Number: FE7010; Expiration Date: 31Oct2021) as single dose for COVID-19 immunisation. Medical history included diverticulitis. Concomitant medication included rifaximin (NORMIX) taken for diverticulitis, start and stop date were not reported. The subject previously took first dose of Comirnaty vaccine (batch FA8016) in the left deltoid for COVID-19 immunization on 28May2021 at 10:32 a.m. The subject experienced atrial flutter and acute pericarditis on 18Jul2021 with outcome of recovering. The events were reported as serious (hospitalization). The treatment of the events included access to emergency room, electrical cardioversion. The clinical course included on Sunday of 18Jul2021 he began to suffer from posterior radiating chest pain, which in the morning of 20Jul2021 worsened and dyspnea also occurred. He therefore went to the Emergency Room of Hospital where he was diagnosed with acute pericarditis complicated by mid- to late-onset atrial flutter. He underwent External electrical cardioversion with restoration of sinus rhythm. He carried out three swabs for Severe acute respiratory syndrome-Cov-2, all of which were negative. The patient underwent lab tests and procedures which included three swabs for Severe acute respiratory syndrome-Cov-2, all of which were negative on 18Jul2021. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected. ; Sender''s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. 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 RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1538857 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Bradycardia, Headache, Heart rate, Myalgia, Nausea, Presyncope, Pyrexia, Vaccination site pain, Vaccination site swelling
SMQs:, Rhabdomyolysis/myopathy (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), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 07/18/2021; Test Name: Fever; Result Unstructured Data: Test Result: up to 40 Centigrade; Comments: Fever up to 40/body temperature 40; Test Date: 07/18/2021; Test Name: bradycardia; Result Unstructured Data: Test Result:40; Comments: bpm.
CDC Split Type: ITPFIZER INC202100953621

Write-up: This is a spontaneous report from a contactable consumer, downloaded via the regulatory authority (IT-MINISAL02-760818). A 55-years-old female patient received the 2nd dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# FF0688), at the vaccination age of 55, intramuscularly, right arm (right shoulder), on Jul 18, 2021, single dose, for COVID-19 immunization. The patient''s medical history and concomitant medications not reported. The patient experienced fever up to 40, headache, nausea, myalgia, one episode of bradycardia (40 beats) with semi-syncope, injection site pain and swelling on Jul 18, 2021 (after the second dose of vaccine). Impact on quality of life (9/10). The patient underwent lab tests, which included fever up to 40 centigrade (body temperature 40) and bradycardia at 40 bpm on Jul 18, 2021. Therapeutic measures taken: Tachipirina and absolute rest as a result of all the events. The outcome of all the events not recovered. Sender''s comment: Jul 25, 2021 upgraded seriousness as body temperature 40. No follow-up attempts possible. No further information expected. Information on lot number already obtained.


VAERS ID: 1538899 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: Blood pressure; Result Unstructured Data: Test Result:100/50; Test Date: 20210718; Test Name: Blood pressure; Result Unstructured Data: Test Result:140/80; Comments: Lower limb fist on; Test Date: 20210718; Test Name: Blood pressure; Result Unstructured Data: Test Result:120/76; Comments: 1 hour after fell; Test Date: 20210718; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210718; Test Name: Heart rate; Result Unstructured Data: Test Result:50; Test Date: 20210718; Test Name: Heart rate; Result Unstructured Data: Test Result:66; Comments: 1 hour after fell; Test Date: 20210718; Test Name: SaO2; Test Result: 98 %; Test Date: 20210718; Test Name: SaO2; Test Result: 98 %; Comments: 1 hour after fell
CDC Split Type: JPPFIZER INC202100944438

Write-up: temporary vasovagal reflex; fell from chair; Pallor facial; BP 100/50; bruise pain on left head; bruise pain on left head; Heart rate (HR) was 50; This is a spontaneous report from a contactable other health care professional. This is a report received from Agency Regulatory Authority. The regulatory authority report number is v21120988. A 22-year and 3-month-old female patient received BNT162B2 (COMIRNATY; lot number: EW0201 and expiration date: 30Sep2021), via an unspecified route of administration on 18Jul2021 at 14:30 (the day of vaccination), at the age of 22-year and 3-month-old, dose 1, single for COVID-19 immunisation. Body temperature before vaccination was 36.7 Centigrade. The patient had no medical history. The patient''s concomitant medications were not reported. On 18Jul2021 at 14:48 (18 minutes after the vaccination), the patient experienced vasovagal reflex. The clinical course of the event was as follows: 18 minutes later after vaccination, the patient fell from chair. The patient experienced pallor facial and could response to calling her name. The patient''s vitals were blood pressure (BP) 100/50, heart rate (HR) 50, and SaO2 98%. Oxygen giving started and the patient moved to bed. The blood pressure improved to 140/80 for lower limb fist on. Saline 120/h started. There were no queasy and no dyspnoea. The patient had bruise pain on left head, and lay on back for 42 minutes of observation, then symptoms improved. 1 hour later after fell, the patient''s vitals were blood pressure 120/76, heart rate 66, and SaO2 98%. It was determined that symptoms were caused by vasovagal reflex. The patient called family''s car to go home and moved by wheelchair. The outcome of the event was recovering. The reporting public health nurse classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting public health nurse commented as follows: It was considered as temporary vasovagal reflex. No follow-up attempts are possible; No further information is expected.


VAERS ID: 1538903 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-18
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Bradycardia, Myocardial necrosis marker increased, Myocarditis, Shock, Sinus node dysfunction
SMQs:, Anaphylactic reaction (narrow), Myocardial infarction (broad), Arrhythmia related investigations, signs and symptoms (broad), Disorders of sinus node function (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), 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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic; Chronic kidney disease
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: blood test; Result Unstructured Data: Test Result:Elevated cardiac enzymes; Comments: upon hospitalization; Test Date: 20210630; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before the vaccinations
CDC Split Type: JPPFIZER INC202100945732

Write-up: Myocarditis; bradycardia; sick sinus syndrome; shock state; Elevated cardiac enzymes; This is a spontaneous report from a contactable other healthcare professional and physician received from the Regulatory Authority. Regulatory authority report number is v21120898. A 91-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 30Jun2021 (Batch/Lot Number: EW0201; Expiration Date: 30Sep2021) as dose 2, single for COVID-19 immunisation. Medical history included cardiac failure chronic and chronic kidney disease. Body temperature before the vaccinations was 36.2 degrees Centigrade on 30Jun2021. Concomitant medication included unspecified beta-blocker from 2015. The patient previously took the first dose of BNT162B2 (COMIRNATY, Lot number: FA2453, expiration date: 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 18Jul2021 at 14:00 (18 days after the vaccination), the patient experienced Myocarditis. The course of the event was as follows: On 18Jul2021(18 days after the vaccination), the patient experienced bradycardia (sick sinus syndrome) and shock state, she was raced to the hospital, and was hospitalized for treatment. Elevated cardiac enzymes was noted by the blood test performed upon hospitalization, and myocarditis was suspected. For bradycardia, the effect of beta-blocker that the patient was taking was considered, but there was no particular problem as she had been taking it since prior to the vaccination (2015). On 20Jul2021 (20 days after vaccination), the outcome of the events was recovering. The reporter classified the events as serious (hospitalization, from 18Jul2021 to 20Jul2021) and assessed the causality between the event and the vaccines as unassessable. Other possible cause of the event such as any other diseases was cardiac failure chronic and chronic kidney disease. The reporter''s comments: This is a case with suspected myocarditis that appeared on 18 days after the vaccination, and I do not think that the causality between the event and the vaccination could be denied. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1538920 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Computerised tomogram head, Fall, Loss of consciousness, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210718; Test Name: head CT; Result Unstructured Data: Test Result:No abnormalities
CDC Split Type: JPPFIZER INC202100952467

Write-up: Loss of consciousness; vasovagal reflex; fall from a chair; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21121116. A 54-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 18Jul2021 16:22 (Batch/Lot Number: EW0207; Expiration Date: 30Sep2021) (at age 54-years-old) as dose 1, single for covid-19 immunisation. Body temperature before vaccination was 36.6 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status).On 18Jul2021 at 16:22 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY). The event onset date was reported as 18Jul2021 at 16:30 (8 minutes after vaccination).On 18Jul2021 (the day of vaccination), the outcome of the event was recovered.The course of the event was as follows: On 18Jul2021, at 16:22, the patient received the Comirnaty (dose 1). At 16:30, the patient experienced loss of consciousness and fall from a chair. The consciousness returned within 2 to 3 minutes. No abnormalities were found on head CT examination, and the symptom was diagnosed as vasovagal reflex. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1540172 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-18
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Myocarditis
SMQs:, Myocardial infarction (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Coronary heart disease; Hyperlipidemia; Hypertension arterial; Nicotine abuse; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Colon perforation; Sigmoidectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210812387

Write-up: ACUTE CORONARY SYNDROME ON 21.07.21 WITH TROPONIN DEFLECTION, AND CORO WITH 2XDES IN 1ST DIAGONAL BRANCH AND THE LEFT ANTERIOR DESCENDING ARTERY (LAD); FRAGILE MYOCARDITIS; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, AT-BASGAGES-2021-38059] concerned a 72-year-old male of unspecified race and ethnicity. The patient''s weight was 89 kilograms, and height was 172 centimeters. The patient''s past medical history included: colon perforation, and sigmoidectomy, and concurrent conditions included: hypertension arterial, hyperlipidemia, type 2 diabetes mellitus, coronary heart disease, and nicotine abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 21C16-04 expiry: unknown) 1 dosage forms, 1 total, administered on 17-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUL-2021, the patient experienced fragile myocarditis. On 21-JUL-2021, the patient experienced acute coronary syndrome with troponin deflection, and Coro with 2xdes in first diagonal branch and the left anterior descending artery (LAD) and was hospitalized (date unspecified).. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fragile myocarditis, and acute coronary syndrome with troponin deflection, and Coro with 2xdes in first diagonal branch and the left anterior descending artery (LAD). This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210812387-covid-19 vaccine ad26.cov2.s-Acute coronary syndrome with troponin deflection, and Coro with 2xdes in first diagonal branch and the left anterior descending artery (LAD).. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 20210812387-covid-19 vaccine ad26.cov2.s-Fragile myocarditis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1540184 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-18
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100964008

Write-up: Anaphylactic reaction; This is a spontaneous report from a contactable other healthcare professional via regulatory authority. Regulatory authority report number is 590262. A 48-year-old female patient received BNT162B2 (COMIRNATY; lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced anaphylactic reaction on 18Jul2021. Outcome of the event was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1540209 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA9091 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac flutter, Discomfort, Fatigue, Headache, Heavy menstrual bleeding, Inappropriate schedule of product administration, Lymphadenopathy, Menstruation irregular, Musculoskeletal chest pain, Oropharyngeal pain, Palpitations, Rash erythematous, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Fertility disorders (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Insect bite allergy.
Allergies:
Diagnostic Lab Data: Test Date: 20210723; Test Name: PCR; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab
CDC Split Type: CAPFIZER INC202100958266

Write-up: Fluttering palpitations discomfort; tenderness around heart; sore throat; discomfort; Menstrated very heavily; Menstrated very heavily and was 10 days early in my cycle; Felt tired/Tiredness; headached; swollen lymph nodes; white and red rashes on my breast; palpitations; dose 1 on 22May2021 and dose 2 on 18Jul2021; This is a spontaneous report from a contactable consumer (patient) via COVAES. A 31-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Jul2021 10:00 at the age of 31 years old (Lot Number: FA9091) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included insect bite allergy from an unknown date. The patient previously had BNT162B2 on 22-MAY-2021 12:45pm at the age of 31 years old, dose 1 in the left arm (lot number: FA8721) for COVID-19 immunization. The patient was not pregnant at time of vaccination. The patient''s concomitant medications were not reported. Next morning after vaccination, the patient menstrated very heavily and was 10 days early in my cycle. Next 1-2 days, the patient felt tired, headached and developed swollen lymph nodes on my left side. The patient stated, "I experienced white and red rashes on my breast that dissapeared in a few hours. Also sore throat. The next 3-5 days - tiredness continues swollen lymphnodes improved. Development of tenderness around heart. Fluttering palpitations discomfort. Tiredness, sore throat a little continued heart sensations. cannot exert myself." The events started on 19Jul2021 08:00. The events was treated with Tylenol and Aspirin. The patient had PCR nasal swab: negative on 23Jul2021. The facility where the most recent COVID-19 vaccine was administered: School or Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received dose 1 on 22May2021 and dose 2 on 18Jul2021. The patient has not been COVID-9 tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The outcome of felt tired and tenderness around heart was not recovered and the outcome of the rest of events was recovering. Information about lot/batch number has been obtained.


VAERS ID: 1540312 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-18
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Coronary bypass thrombosis, Scan with contrast
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: EZETIMIBE; PRADAXA; SOMAC; PLAVIX; CORDARONE; ATORVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bypass surgery (in several vessels)
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: contrast imaging; Result Unstructured Data: Test Result:occlusion of one graft vein was found
CDC Split Type: FIPFIZER INC202100997219

Write-up: Coronary bypass thrombosis; Chest pain; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Authority WEB FI-FIMEA-20213697. A 73-year-old male patient received BNT162B2 (COMIRANTY; Formulation: Solution for injection; Lot number: Unknown, Expiration date: was not reported) via intramuscular on 30Jun2021 as dose 2, single for COVID-19 immunisation.Medical history included bypass surgery performed on 24May2021 in several vessels. Concomitant medications included ezetimibe, pradaxa (dabigatran etexilate mesylate), somac [pantoprazole sodium sesquihydrate], plavix (clopidogrel bisulfate), cordarone (amiodarone hydrochloride), atorvastatin.Historical vaccine included BNT162B2 on 30Mar2021 as dose 1 for covid-19 immunisation. On 18Jul2021, patient stated Chest pain occurred, when the patient was hospitalized in an ambulance and coronary bypass thrombosis. Lab test included contrast imaging in which occlusion of one graft vein was found on 19Jul2021. Patient also stated at the same time, the patient underwent balloon dilatation into his own bypassed vessel. Doctors said the cause of the blockage was unknown because proper medication was in use and intravenous flows have been good after surgery. The suspicion is a blockage caused by the coronary vaccine. The outcome of event coronary bypass thrombosis was recovering and for event chest pain was unknown. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1541302 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Mastitis, Off label use, Product use issue, SARS-CoV-2 test
SMQs:, Functional lactation disorders (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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100957085

Write-up: Mastitis; breastfeeding; breastfeeding; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107270443462260-KF2EU. Safety Report Unique Identifier GB-MHRA-ADR 25711359. This consumer reported information for both mother and baby. This is the maternal report. Only this case is serious. A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 18Jul2021 (Lot number was not reported), at the age of 34 years old, as first dose, single for covid-19 immunisation. Medical history included ongoing breast feeding. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient was reported to be breastfeeding on 18Jul2021. The patient experienced mastitis on 23Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included covid-19 virus test: No - Negative COVID-19 test on unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100963035 baby case


VAERS ID: 1541409 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-07-18
   Days after vaccination:102
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8289 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Anal incontinence, Diarrhoea, Disease recurrence, Headache, Rectal haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fecal incontinence; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100962132

Write-up: Diarrhea; Fecal incontinence; Fecal incontinence/history of fecal incontinence; Headache; Diarrhoea; Rectal bleeding; Abdominal pain; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202107271125573030-JKTUQ, Safety Report Unique Identifier GB-MHRA-ADR 25713531. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 (Batch/Lot Number: FC8289) as dose 1, single for COVID-19 immunization. Medical history included fecal incontinence and lactation decreased. Patient was fit and reasonably healthy. She did not take any medications. Unsure if patient had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. No concomitant medications. The patient experienced diarrhea on an unspecified date with outcome of recovering, rectal bleeding on 18Jul2021 with outcome of recovered on 21Jul2021, abdominal pain on 18Jul2021 with outcome of recovered on 24Jul2021, fecal incontinence on 22Jul2021 with outcome of recovered on 24Jul2021, headache on 21Jul2021 with outcome of recovered on 24Jul2021, diarrhoea on 21Jul2021 with outcome of recovering. Clinical course was reported as it started with abdominal pain and rectal bleeding, 14 days after the 1st jab (as reported). There was significant blood (more than 1 teaspoon) for 3 days, with each toilet, accompanied by persistent/ ongoing abdominal pain. After the bleeding stopped, this turned into headache and diarrhoea, still accompanied by abdominal pain. There were also 2-3 instances of fecal incontinence/ loss of bowel control, which had never happened to patient before. Major symptoms lasting 8 days in total. Diarrhoea was currently only symptom still persisting slightly, after this time. Patient was particularly concerned by the blood and the incontinence, so will need to seek medical advice before thinking about having the 2nd vaccine. Patient was not enrolled in clinical trial. This case was reported as serious with seriousness criteria-disabling/incapacitating and other medically important condition. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1541440 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Fatigue, Headache, Micturition urgency, Myalgia, Osteoarthritis
SMQs:, Rhabdomyolysis/myopathy (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Osteoarthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100961908

Write-up: Muscular pain/muscle pain; Fatigue/ Tiredness.; Urinary urgency/Urination problems - urgency; No energy; headache; Osteoarthritis; Headache dull; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107271343359460-ZYLFO, Safety Report Unique Identifier GB-MHRA-ADR 25714432. A 74-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Lot number was not reported), the first dose via an unspecified route of administration on 16Jul2021 as single dose for covid-19 immunisation. Medical history included osteoarthritis from an unknown date. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. The patient experienced fatigue/ tiredness on an unspecified date, headache on an unspecified date, headache dull on 18Jul2021, osteoarthritis on 20Jul2021, muscular pain/muscle pain on an unspecified date, Urinary urgency/Urination problems - urgency on an unspecified date. Case narrative: Persistent dull headache. Osteoarthritis and ME worsened. Severe muscle pain. No energy. Tiredness. Fatigue. Urination problems - urgency. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The events were reported as serious due to medically significant. The outcome of the events headache and no energy was unknown, while other events were not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1541506 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-18
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Comments: Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202100962101

Write-up: Rash; persistent itchiness; Itchy rash; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107272045466020-IIAFR and Safety Report Unique Identifier GB-MHRA-ADR 25716905. A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 14Jul2021 as dose 2, single for COVID-19 immunization. Medical history included lactation decreased. Patient had no symptoms associated with COVID-19. Patient was not on breastfeeding. Patient was not enrolled in clinical trial. Concomitant medications were not reported. The patient had previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, (Batch/Lot number was not reported), via unspecified route on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient had experienced rash, persistent itchiness. On 18Jul2021, the patient had experienced itchy rash. The events seriousness was assessed as serious (medically significant). It was reported that rash increasing in size on both sides of left foot. Red raised itchy lumps, persistent itchiness, and growing in area. Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests which included SARS-COV-2 test Negative COVID-19 test on an unspecified date. The outcome of the events was rash, persistent itchiness was unknown and itchy rash was not recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1541740 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-18
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Computerised tomogram, Depressed level of consciousness, Headache, Ruptured cerebral aneurysm, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), 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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: CT; Result Unstructured Data: Test Result:Subarachnoid hemorrhage due to aneurysm rupture; Comments: Subarachnoid hemorrhage due to aneurysm rupture
CDC Split Type: JPPFIZER INC202100958461

Write-up: Subarachnoid hemorrhage aneurysm rupture; Subarachnoid hemorrhage aneurysm rupture; Consciousness disturbed; depressed level of consciousness; Headache; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21121191. An 80-year-old female patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN; lot Number: unknown and expiration date: not reported), via an unspecified route of administration on 11Jul2021 (the day of vaccination), at the age of 80 years old as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) was unknown. On 18Jul2021 (7 days after the vaccination), the patient experienced headache, consciousness disturbed and subarachnoid hemorrhage. On 18Jul2021 (7 days after the vaccination), the patient was admitted to the hospital. The course of the events was as follows: On 11Jul2021, the patient received the second dose of COVID-19 Vaccine. At about 13:00 on 18Jul2021, the patient did not reply soon after saying that she had a headache when talking to her friend. The patient was already in depressed level of consciousness (JCS300) when her friend visited her and she was rushed to the hospital. After computerized tomogram (CT) examination, the patient was diagnosed with subarachnoid hemorrhage aneurysm rupture. After emergency surgery, the patient was currently hospitalized. The outcome of the events was not provided. The reporter classified the events as serious (hospitalized from 18Jul2021 and disability) and assessed the causality between the events and BNT162B2 as unassessable. It was not provided if there was other possible cause of the event such as any other diseases.


VAERS ID: 1541758 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Body temperature, Drug hypersensitivity
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: Body temperature; Result Unstructured Data: Test Result:35.6 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100965287

Write-up: Asthmatic attack; drug allergy; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21121632. A 54-year and 2-month female patient received bnt162b2 (COMIRNATY Solution for injection), dose 1 via an unspecified route of administration on 18Jul2021 14:07 (the day of vaccination) (Batch/Lot Number: EY5422; Expiration Date: 31Aug2021) as single dose for covid-19 immunisation at the age of 54 years old. The patient''s medical history and concomitant medications were not reported. The patient experienced asthmatic attack on 18Jul2021 14:14 with outcome of recovered on 19Jul2021, drug allergy on 18Jul2021 with outcome of recovered on 18Jul2021. Body temperature before vaccination was 35.6 degrees Centigrade. On 18Jul2021 at 14:14 (the day of vaccination), the patient experienced asthmatic attack. On 18Jul2021 (the day of vaccination), the patient was admitted to the hospital. On 19Jul2021(one day after the vaccination), the patient was discharged from hospital. On 19Jul2021 (1 day after the vaccination), the outcome of the event was recovered. The reporting physician classified the event as serious (hospitalized, from 18Jul2021 to 19Jul2021) 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: Although this case did not meet the criteria of anaphylaxis, it was regarded as a drug allergy. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1544773 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-18
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Dysgeusia, Fatigue, Headache, Injection site reaction, Lymphadenopathy, Malaise, Myalgia, Nausea, Pyrexia, Tongue coated, Urine abnormality, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Arthritis (broad), Proteinuria (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210812068

Write-up: FROTHY URINE; REACTION AT THE INJECTION SITE; WHITE-COATED TONGUE; METALLIC TASTE IN MOUTH; BLURRED VISION IN ONE EYE; COLD CHILLS; FEELING UNWELL; SWOLLEN GLAND IN ARMPIT ON SIDE OF INJECTION; JOINT PAIN; NAUSEA; MUSCLE PAIN; FATIGUE; FEVER; HEADACHE; This spontaneous report received from a consumer via a Regulatory Authority [BE-FAMHP-DHH-N2021-101996] concerned a 50 year old female patient of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: XE395 and expiry: unknown) dose was not reported, 1 total, administered on 16-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 18-JUL-2021, the patient experienced frothy urine, reaction at the injection site, white-coated tongue, metallic taste in mouth, blurred vision in one eye, cold chills, felt unwell, had swollen gland in armpit on side of injection, joint pain, nausea, muscle pain, fatigue, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, frothy urine, reaction at the injection site, cold chills, feeling unwell, white-coated tongue, muscle pain, fatigue, metallic taste in mouth, fever, swollen gland in armpit on side of injection, joint pain, headache, and blurred vision in one eye. This report was serious (Disability Or Permanent Damage).; Reporter''s Comments: Treatment - No Evolution of the ADR - Worsening Situations - Other: The vaccine is far too severe for prevention. Governments with motive? ADR description - Swollen gland in armpit on side of injection, metallic taste in the mouth, white swollen tongue, frothy urine, blurred vision in one eye.; Sender''s Comments: V0:20210812068 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- frothy urine, reaction at the injection site, white-coated tongue, metallic taste in mouth, blurred vision in one eye-This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0:20210812068-JANSSEN COVID-19 VACCINE Ad26.COV2.S- cold chills, felt unwell, had swollen gland in armpit on side of injection, joint pain, nausea, muscle pain, fatigue, fever,headache- This event(s) is labeled per RSI and is therefore considered potentially related


VAERS ID: 1544787 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-07-18
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: METHOTREXATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Interstitial lung disease; Rheumatism
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: COVID-19 test; Result Unstructured Data: Test Result:strong positive; Comments: Corona: delta kapa variant 452R.V3 ( B.1.6.17)
CDC Split Type: BEPFIZER INC202100989875

Write-up: patient tested positive for SARS-CoV-2 test /COVID-19 test and experienced COVID-19 and vaccination failure; patient tested positive for SARS-CoV-2 test /COVID-19 test and experienced COVID-19 and vaccination failure; This is a spontaneous report from a contactable physician received via a sales representative. A 68-year-old male patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number and expiration date were unknown), via an unspecified route of administration, on 28Apr2021, as single dose and second dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number and expiration date were unknown), via an unspecified route of administration, on 02Jun2021, as single dose, both for COVID-19 immunization. Medical history included interstitial lung disease from an unknown date and unknown if ongoing and rheuma from an unknown date and unknown if ongoing. Concomitant medication included methotrexate taken for rheumatism. On 18Jul2021, patient tested positive for SARS-CoV-2 test /COVID-19 test and experienced COVID-19 and vaccination failure. The patient was hospitalized for the events on an unknown date in 2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test /COVID-19 test on 18Jul2021. Result was Corona: delta kapa variant 452R.V3 (B.1.6.17) strong positive. Therapeutic measures were taken as a result of COVID-19: patient was put under oxygen and brought to intensive care on 03Aug2021. The outcome of the events was unknown. No follow-up attempt is possible. No further information is expected.; Sender''s Comments: Based on the information given in narrative, the causal relationship between the events vaccination failure, COVID-19 and the suspect vaccine BNT162B2 cannot be excluded.


VAERS ID: 1546045 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Hypomenorrhoea
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100960223

Write-up: Hypomenorrhea / decreasing the duration of the period.; This is a spontaneous report from a contactable consumer downloaded from the EMA EudraVigilance-WEB, regulatory authority number ES-AEMPS-948199. A 34-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in arm right on 16Jul2021 15:52 (Batch/Lot Number: Unknown) as a single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient''s medical history and concomitant medications were not reported. The patient experienced hypomenorrhea/decreasing the duration of the period on 18Jul2021 with outcome of recovered on 18Jul2021 13:00. Beginning of menstruation was Friday 16Jul2021 1:00 hrs. Duration of bleeding was 2 days. Menstruation ended on 18Jul2021 at 13:00 hrs. Normal period is 3-4 days. Therefore she has had alteration decreasing the duration of the period. This case was reported as serious with seriousness criteria: medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1546050 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1435 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100960286

Write-up: Acute pericarditis; This is a spontaneous report from a contactable pharmacist downloaded from theregulatory authority, regulatory authority number ES-AEMPS-950324. A 38-year-old male patient received BNT162b2 (COMIRNATY, solution for injection, Lot Number: FC1435), via an intramuscular route on 12Jul2021 as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. On 18Jul2021, the patient experienced acute pericarditis. The patient was hospitalized for event and was still admitted until report of 23Jul2021. The outcome for the event was resolving. No follow-up attempts are possible. No further information expected.


VAERS ID: 1546227 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-18
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1439 / 2 LA / OT

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: IMETH [METHOTREXATE]; BENEPALI
Current Illness: Arthritis rheumatoid; Lyme borreliosis (Chronic borreliosis)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100967005

Write-up: Shingles; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-MP20215502. A 54-year-old female patient received BNT162B2 (COMIRNATY, lot number: FC1439), intramuscular in left arm on 06Jul2021 at dose 2, single for COVID-19 immunisation. Medical history included arthritis rheumatoid and lyme borreliosis also reported as chronic borreliosis, which were both ongoing. She has no history of COVID-19 infection and was not tested for it. She was considered at risk for developing severe COVID-19 disease because she was on immunomodulators. Concomitant medications included methotrexate (IMETH) and etanercept (BENEPALI) injection, both for rheumatoid arthritis. The patient previously took BENEPALI for rheumatoid arthritis. On 18Jul2021, the patient experienced shingles on the left upper limb (C7 territory) from supraspinatus to the palm of the hand. She self-medicated with prednisone 5mg on 18Jul2021 in the evening, 19Jul2021 in the morning and evening, and 20Jul2021 in the morning. In conclusion, shingles zoster of the left upper limb at day 13 (as reported) post-vaccination of dose 2, COMIRNATY in a 54-year-old patient with rheumatoid arthritis and chronic borreliosis. The outcome of the event was not recovered. The event was reported as serious, medically significant. Note: Accountability done "without prejudice to further investigations that could be carried out as part of legal or amicable compensation procedures." Guide of RA. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1546277 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2296 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Headache, Loss of control of legs, Motor dysfunction, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Pre-diabetic
Allergies:
Diagnostic Lab Data: Test Name: COVID test; Test Result: Positive
CDC Split Type: FRPFIZER INC202100965866

Write-up: Loss of control of legs; Loss of motor skills in the legs; Headache; Myalgia; This is a spontaneous report received from a contactable pharmacist downloaded from the regulatory authority; report number is FR-AFSSAPS-TO20215699. A 26-year-old male patient received BNT162B2 (COMIRNATY; lot number: FE2296), intramuscularly in the left arm on 17Jul2021, dose 1, single for COVID-19 immunisation. Medical history included pre-diabetic and COVID-19. The patient''s concomitant medications were not reported. On 18Jul2021, the patient experienced loss of control of legs, loss of motor skills in the legs, headache and muscle weakness (myalgia). The patient underwent lab tests and procedures which included COVID test: positive on an unspecified date. The outcome of the events was not recovered. No follow-up attempts are possible; No further information is expected.


VAERS ID: 1546684 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, Monoplegia, Pain in extremity, Vaccination site pain
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100988967

Write-up: loss of use of left arm; Shooting pain; in pain with shooting pain throughout arm and hand; Swollen lymph nodes; This is a spontaneous report from a non-contactable Consumer or other non HCP (patient). A 55-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Lot Number: 9001), via an unspecified route of administration, administered in Arm Left on 15Jul2021 11:00 as dose number unknown, single for covid-19 immunisation. Medical history included hypersensitivity. The patient''s concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination, patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19. On 18Jul2021, the patient experienced loss of use of left arm, shooting pain, in pain with shooting pain throughout arm and hand, swollen lymph nodes. The adverse event result in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of loss of use of left arm, shooting pain, in pain with shooting pain throughout arm and hand, swollen lymph nodes. Outcome of arm paralysis, vaccination site pain, painful arm, swollen lymph nodes was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1546961 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Heart rate, Loss of consciousness, Oxygen saturation, Presyncope, Pulse abnormal, Shock
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic 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: Febrile convulsion (in childhood (infant))
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: blood pressure; Result Unstructured Data: Test Result:cannot be measured; Test Date: 20210718; Test Name: blood pressure; Result Unstructured Data: Test Result:gradually recovered; Test Date: 20210718; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before the vaccination; Test Date: 20210718; Test Name: pulse; Result Unstructured Data: Test Result:weakness; Test Date: 20210718; Test Name: pulse; Result Unstructured Data: Test Result:gradually recovered; Test Date: 20210718; Test Name: SPO2; Result Unstructured Data: Test Result:P
CDC Split Type: JPPFIZER INC202100966453

Write-up: Loss of consciousness/suddenly fell forward/No response to the call; Shock circulatory; vasovagal reflex; a sudden drop in blood pressure/blood pressure cannot be measured; pulse weakness; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21121633. A female patient of an unspecified age (age illegible) received BNT162B2 (COMIRNATY; lot number: FC5947, Expiration Date: 30Sep2021) via an unspecified route of administration on 18Jul2021 12:10 as dose 1, single for COVID-19 immunisation. Medical history included febrile convulsion in childhood (infant), but there is no other description in particular. Body temperature before vaccination was 36.4 degrees Centigrade. The patient''s concomitant medications were not reported. On 18Jul2021 at 12:15 (5 minutes after the vaccination), the patient experienced shock circulatory, Loss of consciousness, and Vasovagal reflex. On 18Jul2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: No problem after vaccination. The patient walked to the waiting area and was sitting on a vibe chair, but after a few minutes the patient suddenly fell forward. Immediately, staff and doctors deal with it (blood pressure cannot be measured, SPO2: P, pulse weakness). No response to the call. Recover in minutes: O2 3L / min mask. Blood pressure and pulse gradually recovered. (illegible characters) execution 12:37 Ambulance request, transportation to HP, clearing of consciousness, went home. The reporting physician classified the event as non-serious (recovered in minutes) 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: "Within a few minutes after vaccination, a sudden drop in blood pressure and an unconsciousness attack caused the patient to fall forward from a sitting position and became a state where teeth are also missing, but recovered within a few minutes. Is it a vasovagal reflex?" Outcome of the events was recovered on 18Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1554894 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-18
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: PTJNJFOC20210818894

Write-up: VASO-VAGAL REACTION (SYNCOPE); SWEATING; MALAISE; This spontaneous report received from a health care professional via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-F202107-3662] concerned a 25 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: UNKNOWN) 0.5 ml, 1 total, administered on 18-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 18-JUL-2021, the patient experienced vaso-vagal reaction (syncope), sweating and malaise for 20 minutes duration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaso-vagal reaction (syncope), sweating, and malaise on 18-JUL-2021. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210818894- covid-19 vaccine ad26.cov2.s - vaso-vagal reaction (syncope), sweating. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210818894- covid-19 vaccine ad26.cov2.s -malaise. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1574707 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1440 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiocardiogram, Blood creatine phosphokinase, Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram, Magnetic resonance imaging heart, Myocarditis, N-terminal prohormone brain natriuretic peptide, Troponin T increased
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), 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), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: coronary angiography; Result Unstructured Data: Test Result:Rules rear wall infarct out; Test Date: 20210719; Test Name: Creatinine kinase; Result Unstructured Data: Test Result:1146; Comments: U/l; Test Date: 20210719; Test Name: Echocardiograph; Result Unstructured Data: Test Result:unknown results; Test Date: 20210719; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Rear wall infarct; Test Date: 20210719; Test Name: Magnetic resonance tomography; Result Unstructured Data: Test Result:acute myocarditis; Test Date: 20210719; Test Name: NT-proBNP; Result Unstructured Data: Test Result:1340 pg/mL; Test Date: 20210719; Test Name: Troponin; Result Unstructured Data: Test Result:1680 ng/L; Comments: Was very high
CDC Split Type: DEPFIZER INC202100987773

Write-up: Myocarditis; increased thoracic pain; dyspnoea; The troponin level is very high / Troponin T 1680 {ng/l}; This is a spontaneous report downloaded from a regulatory authority, regulatory authority number DE-PEI-202100146157. A 17-years-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: FC1440, expiration date was not reported) via an unspecified route of administration on 16Jul2021 (at the age of 17-years-old) as dose 2, 0.3 mL, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received COMIRNATY, dose 1, 0.3 mL, single received on 16Jun2021. On 18Jul2021, the patient experienced increased thoracic pain, dyspnoea, the troponin level is very high / troponin t 1680 {ng/l}. The patient experienced myocarditis (hospitalization, life threatening) on 19Jul2021. The patient was hospitalized for myocarditis from 19Jul2021 to an unknown date. The patient underwent lab tests and procedures which included angiocardiogram: rules rear wall infarct out on 19Jul2021, blood creatine phosphokinase: 1146 U/l on 19Jul2021, echocardiogram: unknown results on 19Jul2021, electrocardiogram: rear wall infarct on 19Jul2021, magnetic resonance imaging heart: acute myocarditis on 19Jul2021, n-terminal prohormone brain natriuretic peptide: 1340 pg/ml on 19Jul2021, troponin t increased: 1680 ng/l on 19Jul2021 Was very high. There was no outpatient treatment necessary. The outcome of the event myocarditis was not recovered and for all other events was unknown. Health Authority comment: about 2 days after the second COVID vaccination with the above vaccine, there was increased thoracic pain and dyspnoea. The next day, the patient reported to accident and emergency with an electrocardiogram image of a rear wall infarct. A coronary angiography ruled this out. The magnetic resonance tomography reveals acute myocarditis. The troponin level is very high. The pump function was limited. There are reports on similar previous occurrences following vaccination with mRNA vaccine. Period after vaccination, age and sex conform to the risk profile of the reactions already observed. No follow-up attempts are possible. No further information expected.


VAERS ID: 1583325 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0900 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Electrocardiogram, Myocarditis, Troponin
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CRP; Result Unstructured Data: Test Result:335 mg/ml; Comments: elevation to 335; Test Name: ECG; Result Unstructured Data: Test Result:ST segment elevations V4-V5; Test Name: troponin; Result Unstructured Data: Test Result:elevation more than 1000
CDC Split Type: DEPFIZER INC202100989158

Write-up: Perimyocarditis; This is a spontaneous report from a non-contactable consumer downloaded from a regulatory authority-WEB DE-PEI-202100144862. A 14-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 15Jul2021 (Batch/Lot Number: FF0900) as dose 2, single at the age of 14-year-old for covid-19 immunisation. First vaccination with bnt162b2 on 24Jun2021 with batch/lot number: FD7958. The patient medical history and concomitant medications were not reported. On 18Jul2021 the patient experienced perimyocarditis. Perimyocarditis, supported by ECG (ST segment elevations V4-V5), troponin elevation$g 1000, CRP elevation to 335 mg / mL. Myocardial infarction was excluded. This report is serious due to hospitalization. The patient''s outcome was not recovered. Relatedness of drug to reaction(s)/event(s) assessed by PEI as B. Indeterminate No follow-up attempts possible. No further information expected.


VAERS ID: 1588640 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Hyperhidrosis, Loss of consciousness, Nausea, Somnolence
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), Dementia (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), 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: Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202101003519

Write-up: Loss of consciousness; Nausea; Fatigue; Sweating; Drowsiness; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB [CZ-CZSUKL-21008774]. An 18-year-old male patient received bnt162b2 (COMIRNATY, Lot number was unknown), dose 1 intramuscular on 18Jul2021 (at the age of 18-year-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing asthma. The patient''s concomitant medications were not reported. Five (5) minutes after vaccination on 18Jul2021, the patient experienced loss of consciousness, nausea, fatigue, drowsiness, sweating. Everything came back to normal after 20 minutes. As of the reporting date, the adverse reactions subsided. Therapeutic measures were taken as a result of the reported events which included first aid - feet up, sugar and fluid intake. The patient recovered from the events on 18Jul2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1481370 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0185 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ascorbic acid flexeril
Current Illness: Just having issues with sob and swollen glands- went to allergist this past week Also went to pulm doctor - stated to continue cpap
Preexisting Conditions: obesity Pulm issues
Allergies: Just went to allergist on 7/15/21 waiting for results Her allergist stated that she could take the covid vaccine Ibuprofen - allergy in records
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received vaccine and was observed for 15 minutes. She received Pfixer EW0185 at 8:32 She left the covid center and was in car and stated that she felt a little SOB and that her left gland felt swollen. This was 8:55. Took her back to the observation center 9:05 Allegra 9:15 Vitals 180/102 HR 99 Pulse ox 100% resp 20 Gave Allegra at 9am- vis- 150/94 HR 85 Pulse ox 100% Resp 20 Feeling a little better She did let me know that she met with her private allergist this past Thursday 7/15/21 and he told her she could have vaccine. They also did more testing to foods, environment and medication- results are not all in as of yet 9:30 153/93 HR 75 98% Resp 18 States feeling better - gland not as swollen 9:50- 155/91 states her blood pressure meds were stopped about 6 months ago and she has noticed that it has been going up. Told her to consult her PCP She is feeling better. Instructed to take Allegra at home that her allergist prescribed if needed. Go to ER if she gets SOB or other symptoms get worst. She will also notify her allergist. Was taken to bathroom by nurse and left with her husband. Feeling much better.


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