chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Skin lesion, Thrombocytopenia, Troponin increased, Vomiting
Clinical narrative: Patient developed symptoms of MISC on 9/11/21; fevers began on 9/12/21.  Over the course of illness, symptoms included fevers, AKI, hypotension, cough, shortness of breath, abdominal pain, vomiting/diarrhea, rash, mucocutaneous lesions including conjunctival injection, headache, and myalgias. Abnormal labs included elevated troponin, elevated NT-ProBNP, elevated creatinine, elevated liver enzymes, thrombocytopenia, elevated CRP, elevated ferritin, and elevated D-dimers. ECHO studies showed pericardial and pleural effusions. Patient was admitted to the hospital on 9/18/21 and treated with LFNC oxygen, IVIG, infliximab, and aspirin. He was discharged on 9/23/2021.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Nodule, X-ray
Clinical narrative: knot on arm
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Fatigue, Nausea, Pain
Clinical narrative: left breast swelled up horribly for weeks after on the left side; Tiredness; Nausea; Normal Soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 47-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Aug2021 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BREAST SWELLING (non-serious) with onset 28Aug2021, outcome "recovered" (2021), described as "left breast swelled up horribly for weeks after on the left side"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Tiredness"; NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Nausea"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Normal Soreness".  Additional information: No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks). Medical history, Family history and relevant tests were none. The patient got the shot in her left arm and the first shot was 28Aug2021 (Lot: FC3184 or FL3184). after that her left breast swelled up horribly for weeks after on the left side in addition to the normal soreness tiredness and nausea.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Illness, Immunisation, SARS-CoV-2 test
Clinical narrative: began feeling cold like illness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 27 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 21Dec2021, outcome "unknown", described as "began feeling cold like illness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient experienced, began feeling cold like illness 21Dec2021. Took at-home COVID-19 rapid test which was negative on 21Dec2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: began feeling cold like illness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 27 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 21Dec2021, outcome "unknown", described as "began feeling cold like illness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient experienced, began feeling cold like illness 21Dec2021. Took at-home COVID-19 rapid test which was negative on 21Dec2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Limb discomfort, Vision blurred
Clinical narrative: blurry vision; legs felt really heavy above his ankles; sore arm; red at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17 year-old male patient received bnt162b2 (BNT162B2), administration date 14Jan2022 (Lot number: FF2589) at the age of 17 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1,, Time: Approx 10:30 am, Anatomical Site of injection: Left arm, Lot number: ER8731), administration date: 16Jul2021, for COVID-19 immunisation; Bnt162b2 (Dose 2,, Time: Approx 11:00am, Anatomical Site of injection: Left arm, Lot number: EW0171), administration date: 06Aug2021, for COVID-19 immunisation. The following information was reported: VISION BLURRED (non-serious) with onset 14Jan2022, outcome "recovered" (15Jan2022), described as "blurry vision"; VACCINATION SITE ERYTHEMA (non-serious) with onset Jan2022, outcome "unknown", described as "red at the injection site"; LIMB DISCOMFORT (non-serious) with onset 14Jan2022, outcome "recovered", described as "legs felt really heavy above his ankles"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "not recovered", described as "sore arm".  Additional Information: This was the first case out of 2 cases in which reporter was reporting for herself (Consumer). Consumer stated, She was calling to report side effects that her son has had from the third, the booster shot from the Pfizer vaccine and herself (Hence split made). Her Son had booster shots yesterday and her son was 17 years old and then hour after he got his booster shot he said that his legs felt really heavy above his ankles, and about 20 minutes later his vision became blurry and finally his vision was clear again. And then they had it about 10:15 yesterday morning, finally up in the evening the heaviness did go away. And then of course his arm was sore and was still sore and red at the injection site. Pfizer/Biontech Covid-19 Vaccine details: Dose: 1 anatomical site of injection: upper left arm; and right arm. Dose: 2 anatomical site of injection: Upper Left arm; and right arm. Dose: 3 Anatomical Site of injection: Upper Left arm; And Right Arm. Consumer was unwilling to take the contact details for Pfizer medical information.  Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Limb discomfort, Vaccination site erythema, Vaccination site pain, Vision blurred
Clinical narrative: blurry vision; legs felt really heavy above his ankles; sore arm; red at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17 year-old male patient received bnt162b2 (BNT162B2), administration date 14Jan2022 (Lot number: FF2589) at the age of 17 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1,, Time: Approx 10:30 am, Anatomical Site of injection: Left arm, Lot number: ER8731), administration date: 16Jul2021, for COVID-19 immunisation; Bnt162b2 (Dose 2,, Time: Approx 11:00am, Anatomical Site of injection: Left arm, Lot number: EW0171), administration date: 06Aug2021, for COVID-19 immunisation. The following information was reported: VISION BLURRED (non-serious) with onset 14Jan2022, outcome "recovered" (15Jan2022), described as "blurry vision"; VACCINATION SITE ERYTHEMA (non-serious) with onset Jan2022, outcome "unknown", described as "red at the injection site"; LIMB DISCOMFORT (non-serious) with onset 14Jan2022, outcome "recovered", described as "legs felt really heavy above his ankles"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "not recovered", described as "sore arm".  Additional Information: This was the first case out of 2 cases in which reporter was reporting for herself (Consumer). Consumer stated, She was calling to report side effects that her son has had from the third, the booster shot from the Pfizer vaccine and herself (Hence split made). Her Son had booster shots yesterday and her son was 17 years old and then hour after he got his booster shot he said that his legs felt really heavy above his ankles, and about 20 minutes later his vision became blurry and finally his vision was clear again. And then they had it about 10:15 yesterday morning, finally up in the evening the heaviness did go away. And then of course his arm was sore and was still sore and red at the injection site. Pfizer/Biontech Covid-19 Vaccine details: Dose: 1 anatomical site of injection: upper left arm; and right arm. Dose: 2 anatomical site of injection: Upper Left arm; and right arm. Dose: 3 Anatomical Site of injection: Upper Left arm; And Right Arm. Consumer was unwilling to take the contact details for Pfizer medical information.  Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Limb discomfort, Pain in extremity, Vaccination site erythema, Vision blurred
Clinical narrative: blurry vision; legs felt really heavy above his ankles; sore arm; red at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17 year-old male patient received bnt162b2 (BNT162B2), administration date 14Jan2022 (Lot number: FF2589) at the age of 17 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1,, Time: Approx 10:30 am, Anatomical Site of injection: Left arm, Lot number: ER8731), administration date: 16Jul2021, for COVID-19 immunisation; Bnt162b2 (Dose 2,, Time: Approx 11:00am, Anatomical Site of injection: Left arm, Lot number: EW0171), administration date: 06Aug2021, for COVID-19 immunisation. The following information was reported: VISION BLURRED (non-serious) with onset 14Jan2022, outcome "recovered" (15Jan2022), described as "blurry vision"; VACCINATION SITE ERYTHEMA (non-serious) with onset Jan2022, outcome "unknown", described as "red at the injection site"; LIMB DISCOMFORT (non-serious) with onset 14Jan2022, outcome "recovered", described as "legs felt really heavy above his ankles"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "not recovered", described as "sore arm".  Additional Information: This was the first case out of 2 cases in which reporter was reporting for herself (Consumer). Consumer stated, She was calling to report side effects that her son has had from the third, the booster shot from the Pfizer vaccine and herself (Hence split made). Her Son had booster shots yesterday and her son was 17 years old and then hour after he got his booster shot he said that his legs felt really heavy above his ankles, and about 20 minutes later his vision became blurry and finally his vision was clear again. And then they had it about 10:15 yesterday morning, finally up in the evening the heaviness did go away. And then of course his arm was sore and was still sore and red at the injection site. Pfizer/Biontech Covid-19 Vaccine details: Dose: 1 anatomical site of injection: upper left arm; and right arm. Dose: 2 anatomical site of injection: Upper Left arm; and right arm. Dose: 3 Anatomical Site of injection: Upper Left arm; And Right Arm. Consumer was unwilling to take the contact details for Pfizer medical information.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Hives, pruritis, constant for first 2 weeks then every few days continuing to present day.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives, pruritis, constant for first 2 weeks then every few days continuing to present day.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Paraesthesia oral
Clinical narrative: 10min after her pfizer covid 'booster' vaccine was given her lips started tingling; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 19 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2022 (Lot number: FK9896) at the age of 19 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 041B21A), administration date: 23Apr2021, when the patient was 19 years old, for Covid-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: 016B21A), administration date: 24Mar2021, when the patient was 18 years old, for Covid-19 immunization. The following information was reported: PARAESTHESIA ORAL (non-serious) with onset 28Jan2022, outcome "recovered" (Jan2022), described as "10min after her pfizer covid 'booster' vaccine was given her lips started tingling". Therapeutic measures were taken as a result of paraesthesia oral.  Additional Information: Patient stated that she did fine w/ her 1st 2 moderna covid vaccines. Approximately 10min after her Pfizer covid 'booster' vaccine was given her lips started tingling. She took 2 benadryl tabs and symptoms improved after 15min or so and cleared/resolved after 30min -- she was symptom free when dismissed at 1hr post vaccine. Treatment was benadryl 50mgs (pt had these on hand since is currently being evaluated for allergies. It was unknown if patient had covid prior vaccination and tested post vaccination. Patient had known allergy but not sure to what all yet  she was evaluated/allergy tested by specialist  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral
Clinical narrative: 10min after her pfizer covid 'booster' vaccine was given her lips started tingling; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 19 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2022 (Lot number: FK9896) at the age of 19 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 041B21A), administration date: 23Apr2021, when the patient was 19 years old, for Covid-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: 016B21A), administration date: 24Mar2021, when the patient was 18 years old, for Covid-19 immunization. The following information was reported: PARAESTHESIA ORAL (non-serious) with onset 28Jan2022, outcome "recovered" (Jan2022), described as "10min after her pfizer covid 'booster' vaccine was given her lips started tingling". Therapeutic measures were taken as a result of paraesthesia oral.  Additional Information: Patient stated that she did fine w/ her 1st 2 moderna covid vaccines. Approximately 10min after her Pfizer covid 'booster' vaccine was given her lips started tingling. She took 2 benadryl tabs and symptoms improved after 15min or so and cleared/resolved after 30min -- she was symptom free when dismissed at 1hr post vaccine. Treatment was benadryl 50mgs (pt had these on hand since is currently being evaluated for allergies. It was unknown if patient had covid prior vaccination and tested post vaccination. Patient had known allergy but not sure to what all yet  she was evaluated/allergy tested by specialist  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia
Clinical narrative: hair started falling out; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Dec2021 09:25 (Lot number: 3313BA) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Note: Dose 1, Vaccination site: Left arm, Lot number : EN6205), administration date: 02Mar2021, when the patient was 70 years old, for Covid-19 immunization; Bnt162b2 (Note: Dose 2, Vaccination site: Left arm, Lot number: EP7534), administration date: 21Mar2021, when the patient was 70 years old, for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "hair started falling out".  Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After 3 days of vaccine her hair started falling out.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: pt was diagnosed 12/29/21 with a positive COVID test, received monoclonal antibodies; to ED via EMS due to increasing SOB, confusion, diarrhea; O2 sats 80% on RA per EMS; started on O2 supplementation; admitted to hospital; red chest rash since positive COVID test; transferred to ICU; ABX; intubated with mechanical ventilation; pt's condition declined; kidney failure; pt transitioned to DNR; condition continued to deteriorate; placed on comfort measures only; extubated and he passed away in the hospital
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Confusional state, Death, Diarrhoea, Dyspnoea
Clinical narrative: pt was diagnosed 12/29/21 with a positive COVID test, received monoclonal antibodies; to ED via EMS due to increasing SOB, confusion, diarrhea; O2 sats 80% on RA per EMS; started on O2 supplementation; admitted to hospital; red chest rash since positive COVID test; transferred to ICU; ABX; intubated with mechanical ventilation; pt's condition declined; kidney failure; pt transitioned to DNR; condition continued to deteriorate; placed on comfort measures only; extubated and he passed away in the hospital
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Endotracheal intubation, General physical health deterioration, Intensive care, Mechanical ventilation, Rash
Clinical narrative: pt was diagnosed 12/29/21 with a positive COVID test, received monoclonal antibodies; to ED via EMS due to increasing SOB, confusion, diarrhea; O2 sats 80% on RA per EMS; started on O2 supplementation; admitted to hospital; red chest rash since positive COVID test; transferred to ICU; ABX; intubated with mechanical ventilation; pt's condition declined; kidney failure; pt transitioned to DNR; condition continued to deteriorate; placed on comfort measures only; extubated and he passed away in the hospital
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Renal failure, SARS-CoV-2 test positive
Clinical narrative: pt was diagnosed 12/29/21 with a positive COVID test, received monoclonal antibodies; to ED via EMS due to increasing SOB, confusion, diarrhea; O2 sats 80% on RA per EMS; started on O2 supplementation; admitted to hospital; red chest rash since positive COVID test; transferred to ICU; ABX; intubated with mechanical ventilation; pt's condition declined; kidney failure; pt transitioned to DNR; condition continued to deteriorate; placed on comfort measures only; extubated and he passed away in the hospital
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Dosage administered was after expiration date/they gave him an expired dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202200205035 (Pfizer).  A 5 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 28Jan2022 15:30 (Lot number: FK5127) at the age of 5 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5127, Vaccine Administration Time: 10:30 AM, Route of Administration: Intramuscular), administration date: 05Jan2022. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 28Jan2022, outcome "recovered" (2022), described as "Dosage administered was after expiration date/they gave him an expired dose". Therapeutic measures were not taken as a result of expired product administered.  Additional information: Reporter stated his pediatrician called yesterday and they gave him an expired dose. 8-10 kids in the practice were effected by this. She stated it is supposed to be in the fridge for 10 weeks and there is a 2 day grace period and he received it after the 2 day grace period but it was only one day. The pediatrician said he spoke with someone in 'ID' and they said one day would not make a difference in efficacy. She also asked her family member who is a pharmacist who said the same thing. She stated he is only 5 years old. RA- the caller declined being warm transferred to RA but she agreed to be contacted but said it would have to be after business hours, after 4 pm today; e-transmitting potential duplicate AE details. No other medications in two weeks. No covid prior vaccination. Not tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Asthma, Bronchitis, Pain, Therapeutic response unexpected
Clinical narrative: Within hours all my symptoms gone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (initial pfizer dose), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: J & j (Dose:01), for COVID-19 Immunization, reaction(s): "Asthma", "Bronchitis", "body aches"; J & j (Dose: 01), for COVID-19 Immunization, reaction(s): "no energy". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Within hours all my symptoms gone".  Customer Verbatim: Just wanted to thank you for her Pfizer booster. She got the J & J first and had a rough health year. Bronchitis, asthma, body aches, no energy. Fast forward to 2022. One week ago she chose the Pfizer booster because of her kids and grandchildren who all had Pfizer vaccine. Within hours all her symptoms gone! She told her husband and son both doctors who each had a different opinion. All she know was for the first time in her life she now have a pink looking tongue. She feel so great. Not sick anymore.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Within hours all my symptoms gone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (initial pfizer dose), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: J & j (Dose:01), for COVID-19 Immunization, reaction(s): "Asthma", "Bronchitis", "body aches"; J & j (Dose: 01), for COVID-19 Immunization, reaction(s): "no energy". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Within hours all my symptoms gone".  Customer Verbatim: Just wanted to thank you for her Pfizer booster. She got the J & J first and had a rough health year. Bronchitis, asthma, body aches, no energy. Fast forward to 2022. One week ago she chose the Pfizer booster because of her kids and grandchildren who all had Pfizer vaccine. Within hours all her symptoms gone! She told her husband and son both doctors who each had a different opinion. All she know was for the first time in her life she now have a pink looking tongue. She feel so great. Not sick anymore.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: has been experiencing ongoing tinnitus; it is causing her to have trouble sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "has been experiencing ongoing tinnitus"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "it is causing her to have trouble sleeping".  Additional Information: Patient wanted to get a booster dose of Comirnaty but was apprehensive due to the tinnitus that arose after her second dose. Patient was asking if Pfizer had any information that would indicate tinnitus could get worse after a booster dose. This report was related to a study or programme. Patient did not have the lot number. Patient mentioned that she experienced side effects of the covid-19 vaccine.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Tinnitus
Clinical narrative: has been experiencing ongoing tinnitus; it is causing her to have trouble sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "has been experiencing ongoing tinnitus"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "it is causing her to have trouble sleeping".  Additional Information: Patient wanted to get a booster dose of Comirnaty but was apprehensive due to the tinnitus that arose after her second dose. Patient was asking if Pfizer had any information that would indicate tinnitus could get worse after a booster dose. This report was related to a study or programme. Patient did not have the lot number. Patient mentioned that she experienced side effects of the covid-19 vaccine.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: My platelets were 129 on 29Dec2021. They have never been below the normal range starting at 150 in years past. I take no chronic medications; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 16:00 (Lot number: FGJ527) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6208, Location of injection: Arm Left, Vaccine Administration Time: 11:30 AM), administration date: 01Apr2021, when the patient was 60 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6201, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 11Mar2021, when the patient was 59 years old, for Covid-19 immunization. The following information was reported: PLATELET COUNT DECREASED (non-serious) with onset 02Dec2021 16:00, outcome "recovered", described as "My platelets were 129 on 29Dec2021. They have never been below the normal range starting at 150 in years past. I take no chronic medications". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of platelet count decreased.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Platelet count, Platelet count decreased, SARS-CoV-2 test
Clinical narrative: My platelets were 129 on 29Dec2021. They have never been below the normal range starting at 150 in years past. I take no chronic medications; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 16:00 (Lot number: FGJ527) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6208, Location of injection: Arm Left, Vaccine Administration Time: 11:30 AM), administration date: 01Apr2021, when the patient was 60 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6201, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 11Mar2021, when the patient was 59 years old, for Covid-19 immunization. The following information was reported: PLATELET COUNT DECREASED (non-serious) with onset 02Dec2021 16:00, outcome "recovered", described as "My platelets were 129 on 29Dec2021. They have never been below the normal range starting at 150 in years past. I take no chronic medications". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of platelet count decreased.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received undiluted Pfizer Covid vaccine.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Corneal reflex test, Fluorescence angiogram, Metamorphopsia, Optical coherence tomography
Clinical narrative: blurred and distorted vision; blurred and distorted vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 16:00 (Lot number: EN6205) at the age of 48 years as dose 1, single and administered in arm left, administration date 24Mar2021 16:00 (Lot number: ER8727) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Vitrectomy" (unspecified if ongoing), notes: in the left eye; "PVD" (unspecified if ongoing), notes: in right eye. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The following information was reported: VISION BLURRED (disability), METAMORPHOPSIA (disability) all with onset 05Mar2021, outcome "not recovered" and all described as "blurred and distorted vision". The event "blurred and distorted vision" and "blurred and distorted vision" was evaluated at the physician office visit and emergency room visit. Patient saw several ophthalmologist, retina specialists, cornea specialist and they cant figure out what was wrong. Her vision continued to deteriorate since last year after the vaccine. She did not relate her vision problem to the vaccines because she was dealing with PVD in her right eye and had a vitrectomy in the left eye but it recovered very well. She had no issues until right after the vaccines in 2021. She had also been in the emergency room and they can't figure it out. Thet patient had been tested for COVID-19 since the vaccination: (08Dec2021) negative, notes: Nasal Swab. This year, her vision changed drastically after the booster, and that's when she realized and she was sure it was related to the vaccine. Therapeutic measures were not taken as a result of vision blurred, metamorphopsia. No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: blurred and distorted vision; blurred and distorted vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 16:00 (Lot number: EN6205) at the age of 48 years as dose 1, single and administered in arm left, administration date 24Mar2021 16:00 (Lot number: ER8727) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Vitrectomy" (unspecified if ongoing), notes: in the left eye; "PVD" (unspecified if ongoing), notes: in right eye. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The following information was reported: VISION BLURRED (disability), METAMORPHOPSIA (disability) all with onset 05Mar2021, outcome "not recovered" and all described as "blurred and distorted vision". The event "blurred and distorted vision" and "blurred and distorted vision" was evaluated at the physician office visit and emergency room visit. Patient saw several ophthalmologist, retina specialists, cornea specialist and they cant figure out what was wrong. Her vision continued to deteriorate since last year after the vaccine. She did not relate her vision problem to the vaccines because she was dealing with PVD in her right eye and had a vitrectomy in the left eye but it recovered very well. She had no issues until right after the vaccines in 2021. She had also been in the emergency room and they can't figure it out. Thet patient had been tested for COVID-19 since the vaccination: (08Dec2021) negative, notes: Nasal Swab. This year, her vision changed drastically after the booster, and that's when she realized and she was sure it was related to the vaccine. Therapeutic measures were not taken as a result of vision blurred, metamorphopsia. No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Metamorphopsia, SARS-CoV-2 test, Vision blurred
Clinical narrative: blurred and distorted vision; blurred and distorted vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 16:00 (Lot number: EN6205) at the age of 48 years as dose 1, single and administered in arm left, administration date 24Mar2021 16:00 (Lot number: ER8727) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Vitrectomy" (unspecified if ongoing), notes: in the left eye; "PVD" (unspecified if ongoing), notes: in right eye. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The following information was reported: VISION BLURRED (disability), METAMORPHOPSIA (disability) all with onset 05Mar2021, outcome "not recovered" and all described as "blurred and distorted vision". The event "blurred and distorted vision" and "blurred and distorted vision" was evaluated at the physician office visit and emergency room visit. Patient saw several ophthalmologist, retina specialists, cornea specialist and they cant figure out what was wrong. Her vision continued to deteriorate since last year after the vaccine. She did not relate her vision problem to the vaccines because she was dealing with PVD in her right eye and had a vitrectomy in the left eye but it recovered very well. She had no issues until right after the vaccines in 2021. She had also been in the emergency room and they can't figure it out. Thet patient had been tested for COVID-19 since the vaccination: (08Dec2021) negative, notes: Nasal Swab. This year, her vision changed drastically after the booster, and that's when she realized and she was sure it was related to the vaccine. Therapeutic measures were not taken as a result of vision blurred, metamorphopsia. No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: inflammatory destructive arthritis in right SI joint; This is a spontaneous report received from a contactable reporter (Physician). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 28Sep2021 15:00 (Lot number: 30155BA) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (lot number= EL1283; Administrator route=Intramuscular (left arm); dose 2), administration date: 19Jan2021, when the patient was 39 years old, for covid-19 immunization, reaction: "Covid test date=30Dec2021,Covid test result=Positive", "Covid test date=30Dec2021,Covid test result=Positive"; Bnt162b2 (lot number= EK5370; Administrator route=Intramuscular (left arm); dose 1), administration date: 23Dec2020, when the patient was 39 years old, for Covid-19 Immunization, reaction(s): "Covid test date=30Dec2021,Covid test result=Positive", "Covid test date=30Dec2021,Covid test result=Positive". The following information was reported: ARTHRITIS (medically significant) with onset Oct2021, outcome "not recovered", described as "inflammatory destructive arthritis in right SI joint". The event "inflammatory destructive arthritis in right si joint" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) all negative; imaging procedure: (Oct2021) inflammatory destructive arthritis right SI joint; sars-cov-2 test: (30Dec2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of arthritis which included SI joint steroid injections and oral steroids. There was no other vaccine in four weeks. In Oct2021, the patient developed inflammatory destructive arthritis in right SI joint, confirmed on imaging. The patient had no family history of autoimmune disease, no personal history of autoimmune disease and blood work for another etiology all negative. Will require Humira. The patient had no known allergies.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Blood test, Imaging procedure, SARS-CoV-2 test
Clinical narrative: inflammatory destructive arthritis in right SI joint; This is a spontaneous report received from a contactable reporter (Physician). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 28Sep2021 15:00 (Lot number: 30155BA) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (lot number= EL1283; Administrator route=Intramuscular (left arm); dose 2), administration date: 19Jan2021, when the patient was 39 years old, for covid-19 immunization, reaction: "Covid test date=30Dec2021,Covid test result=Positive", "Covid test date=30Dec2021,Covid test result=Positive"; Bnt162b2 (lot number= EK5370; Administrator route=Intramuscular (left arm); dose 1), administration date: 23Dec2020, when the patient was 39 years old, for Covid-19 Immunization, reaction(s): "Covid test date=30Dec2021,Covid test result=Positive", "Covid test date=30Dec2021,Covid test result=Positive". The following information was reported: ARTHRITIS (medically significant) with onset Oct2021, outcome "not recovered", described as "inflammatory destructive arthritis in right SI joint". The event "inflammatory destructive arthritis in right si joint" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) all negative; imaging procedure: (Oct2021) inflammatory destructive arthritis right SI joint; sars-cov-2 test: (30Dec2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of arthritis which included SI joint steroid injections and oral steroids. There was no other vaccine in four weeks. In Oct2021, the patient developed inflammatory destructive arthritis in right SI joint, confirmed on imaging. The patient had no family history of autoimmune disease, no personal history of autoimmune disease and blood work for another etiology all negative. Will require Humira. The patient had no known allergies.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: She broke out in hives- 1st outbreak; This case was reported by a consumer via call center representative and described the occurrence of hives in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd February 2022, the patient received the 1st dose of Shingrix. On 23rd February 2022, less than a day after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The patient received Shingrix dose and the same day, she broke out with hives. She stated the hives lasted about 3 days and then went away. On 12th March 2022, she began to break out again and it was still not resolved. The patient declined to provide healthcare professional's information. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR048247:same patient
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging head, Neurological examination, Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 (Lot number: FF2590) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Not Known allergies. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3246, Location of injection: Arm Left), administration date: 08Jan2021, for COVID-19 immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: EK5730, Location of injection: Arm Left), administration date: 15Dec2020, for COVID-19 immunisation. The following information was reported: TINNITUS (disability) with onset 28Oct2021, outcome "not recovered", described as "Tinnitus". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Feb2022) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of tinnitus.; Sender's Comments: Based on the information provided in the narrative , a possible contributory role of the suspect vaccine BNT162B2 to reported event of  Tinnitus cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.