chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Hypersensitivity, Loss of consciousness
Clinical narrative: Severe allergic reaction unable to breath passed out; Severe allergic reaction unable to breath passed out; Severe allergic reaction unable to breath passed out; Headaches; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), HYPERSENSITIVITY (medically significant), DYSPNOEA (non-serious), outcome "unknown" and all described as "Severe allergic reaction unable to breath passed out"; HEADACHE (non-serious), outcome "not recovered", described as "Headaches". Therapeutic measures were taken as a result of loss of consciousness, hypersensitivity, dyspnoea.  Clinical course: Had to be transported and had medical intervention. Still was having reactions to other environmental reactions. Headaches after the vaccine had persisted. Was immunized before thanksgiving possibly the 10Nov.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and the reported  events Loss of consciousness , Hypersensitivity, Dyspnoea, Headache  cannot be completely 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.
Sex: M
Vaccine: PNC20
Symptoms: Vaccination site pain
Clinical narrative: pain and soreness at the injection site; 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 66 year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) as a single dose for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain and soreness at the injection site".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Iridocyclitis, SARS-CoV-2 test
Clinical narrative: anterior uveitis - dual eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Mar2021 (Lot number: EN6208) at the age of 35 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EN5318,, prev dose lot unknown: False, prev dose administration date: 19Feb2021, prev dose number: 1, prev dose vaccine location: Right arm), administration date: 19Feb2021, when the patient was 36 years old, for COVID-19 immunization.The following information was reported: IRIDOCYCLITIS (non-serious) with onset 17May2021, outcome "not recovered", described as "anterior uveitis - dual eye". The event "anterior uveitis - dual eye" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of iridocyclitis.  Clinical Course: Facility type vaccine was other. There was No other vaccine in four weeks and no other medications in two weeks. Treatment received for AE was steroid eye drops. There was no COVID prior vaccination. COVID tested post vaccination with Nasal Swab and test result was found as negative.  No follow-up attempts are possible; no information is necessary.
Sex: M
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: This is a literature report for the following literature source(s): "Otologic Manifestations After COVID-19 Vaccination: Ear Clinic Experience", 2021; Vol:42, pgs:e1213-e1218, DOI:10.1097/MAO.0000000000003275. A 60 year-old male patient received bnt162b2 (COMIRNATY) (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: Covid-19 vaccine (dose 1), for COVID-19 immunisation. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "Hearing loss". The event "hearing loss" was evaluated at the physician office visit. Information regarding lot/batch number has been requested. Sender's Comments: Based on the information in the case report, a possible causal relationship between the event deafness and suspect drug BNT162B2 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: Omicron; Omicron; illness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Omicron"; ILLNESS (non-serious), outcome "unknown", described as "illness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive for omicron.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "AFib". Clinical course: No prior histories of heart problems. These spike proteins are firing throughout the human body. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes/covid test result=Positive; Since the vaccination, has the patient been tested for COVID-19?:Yes/covid test result=Positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 19 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17May2021 14:00 (Lot number: EW0179) at the age of 19 years as dose 2, single and administered in arm left (Lot number: EW0179) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Jan2022, outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19?:Yes/covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  Clinical Information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any known allergies. The reporter stating events as non serious. The patient was not prolonged hospitalization due to events. Since the vaccination, has the patient been tested for COVID-19 was yes reported. The complaint for lack of effect of the PFIZER-BIONTECH COVID19 VACCINE lot EW0179 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0179, fill lot EP8730, and the bulk formulated drug product lot EP8611. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.This is a spontaneous follow-up report received in response to the mail trail sent regarding the translation of Initial report. This report included that: Reaction/event as reported by primary source: My card's ink got faded and vaccination data are illegible.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Swallow under left arm in armpit area, felt like a golf ball under arm; Swallow under left arm in armpit area, felt like a golf ball under arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2022 15:30 (Lot number: FK9895) at the age of 42 years as dose 3 (booster) single for covid-19 immunisation. Relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, product=COVID 19, lot number=ERV0168, administration date=12Aug2021, administration time=05:00 PM, vaccine location=Left arm), administration date: 12Aug2021, when the patient was 41 years old, for Covid-19 Immunization, reaction(s): "Covid test result=Positive", "Covid test result=Positive"; Bnt162b2 (Dose Number: 2, product=COVID 19, brand=Pfizer, lot number=FD8448 , administration date=02Sep2021, administration time=05:00 PM, vaccine location=Left arm), administration date: 02Sep2021, when the patient was 41 years old, for Covid-19 Immunization, reaction(s): "Covid test result=Positive", "Covid test result=Positive". The following information was reported: AXILLARY MASS (non-serious), LYMPHADENOPATHY (non-serious) all with onset 25Feb2022 08:30, outcome "recovering" and all described as "Swallow under left arm in armpit area, felt like a golf ball under arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of axillary mass, lymphadenopathy. Additional information: The patient did not receive other vaccine in four weeks and any other medications in two weeks.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: His left and right side neck musclefrom up to collarbone up to the back of ears and into jaw line; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacturer unknown), for Covid-19 immunization. The following information was reported: MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "not recovered", described as "His left and right side neck musclefrom up to collarbone up to the back of ears and into jaw line". Therapeutic measures were taken as a result of musculoskeletal discomfort.  Additional information: Caller was a consumer and he already got the booster shot for the Pfizer covid-19 vaccine. He mentioned that he called us several months ago about the side effects of the booster shot. He said that he's been through physical therapy, doctor and chiropractor and still has the same issue with his neck. His left and right side neck muscle from up to collarbone up to the back of ears and into jaw line.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Hypoxia, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: 8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions; positive for Covid-19; positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOXIA (death, medically significant), outcome "fatal", described as "8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive for Covid-19". The patient underwent the following laboratory tests and procedures: oxygen saturation: 60-80%; sars-cov-2 test: positive. The patient date of death was unknown. The reported cause of death was hypoxia. It was not reported if an autopsy was performed. There were 8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions. 5 were long term residents and 3 were short term residents. 5 of them passed within a two week period. One of the above patients were sent to the hospital and was pumped with 20L of oxygen but there was no success. 1 of the above patients tested positive for Covid-19 and 4 tested negative for Covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200377557 same reporter/drug, different patient with similar event;US-PFIZER INC-202200377559 same reporter/drug, different patient with similar event;US-PFIZER INC-202200377560 same reporter/drug, different patient with similar event.;US-PFIZER INC-202200377558 same reporter/drug, different patient with similar event.;US-PFIZER INC-202200377563 same reporter/drug, different patient with similar event;US-PFIZER INC-202200377562 same reporter/drug, different patient with similar event;US-PFIZER INC-202200377561 same reporter/drug, different patient with similar event; Reported Cause(s) of Death: 8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fall, Headache, Illness
Clinical narrative: dizzy; triped fell hard; I brused my whole torso; so sick; vomiting; massive headaches; weakness; vision problems; 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), administration date 19Aug2021 (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, Manufacturer Unknown), for COVID-19 Immunization.  The following information was reported: DIZZINESS (hospitalization) with onset Aug2021, outcome "not recovered", described as "dizzy"; FALL (hospitalization) with onset Aug2021, outcome "unknown", described as "triped fell hard"; INJURY (hospitalization) with onset Aug2021, outcome "unknown", described as "I brused my whole torso"; ILLNESS (non-serious) with onset Aug2021, outcome "not recovered", described as "so sick"; VOMITING (non-serious) with onset Aug2021, outcome "not recovered", described as "vomiting"; HEADACHE (non-serious) with onset Aug2021, outcome "not recovered", described as "massive headaches"; ASTHENIA (non-serious) with onset Aug2021, outcome "not recovered", described as "weakness"; VISUAL IMPAIRMENT (non-serious) with onset Aug2021, outcome "not recovered", described as "vision problems".  The lot number for bnt162b2 was not provided and will be requested during follow up.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Injury, Visual impairment, Vomiting
Clinical narrative: dizzy; triped fell hard; I brused my whole torso; so sick; vomiting; massive headaches; weakness; vision problems; 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), administration date 19Aug2021 (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, Manufacturer Unknown), for COVID-19 Immunization.  The following information was reported: DIZZINESS (hospitalization) with onset Aug2021, outcome "not recovered", described as "dizzy"; FALL (hospitalization) with onset Aug2021, outcome "unknown", described as "triped fell hard"; INJURY (hospitalization) with onset Aug2021, outcome "unknown", described as "I brused my whole torso"; ILLNESS (non-serious) with onset Aug2021, outcome "not recovered", described as "so sick"; VOMITING (non-serious) with onset Aug2021, outcome "not recovered", described as "vomiting"; HEADACHE (non-serious) with onset Aug2021, outcome "not recovered", described as "massive headaches"; ASTHENIA (non-serious) with onset Aug2021, outcome "not recovered", described as "weakness"; VISUAL IMPAIRMENT (non-serious) with onset Aug2021, outcome "not recovered", described as "vision problems".  The lot number for bnt162b2 was not provided and will be requested during follow up.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pancreatic carcinoma
Clinical narrative: pancreatic cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PANCREATIC CARCINOMA (death), outcome "fatal", described as "pancreatic cancer". The patient date of death was Dec2020. The reported cause of death was pancreatic carcinoma. It was not reported if an autopsy was performed. Clinical course: The consumer family members were thankful recipients of the Pfizer Covid Vaccine and were very appreciative of teams diligent work at Pfizer. The consumer's personal journey made even more thankful because of help in lengthening husband's life while battling pancreatic cancer. He lost the battle in Dec2020, obviously missed him dearly.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: pancreatic cancer
Sex: U
Vaccine: COVID19
Symptoms: Hypoxia, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: 8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from medical information team reporting similar events under the same suspect product for 8 patients. This is one of 8 reports.  An elderly patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as single dose for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOXIA (death, medically significant), outcome "fatal", described as "8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions". The patient underwent the following laboratory tests and procedures: oxygen saturation: 60-80 %, notes: Pulse oxygen saturation levels ranged 60-80%; sars-cov-2 test: negative, notes: 4 tested negative for Covid-19. The patient date of death was unknown. The reported cause of death was hypoxia. It was not reported if an autopsy was performed.   The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200376657 same reporter/drug, different patient with similar event; Reported Cause(s) of Death: 8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions
Sex: U
Vaccine: COVID19
Symptoms: Hypoxia, Oxygen saturation
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOXIA (death, medically significant), outcome "fatal", described as "8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions". The patient underwent the following laboratory tests and procedures: oxygen saturation: ranged 60-80%. The patient date of death was unknown. The reported cause of death was hypoxia. It was not reported if an autopsy was performed. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202200376657 same reporter/drug, different event with similar event. Reported Cause(s) of Death: 8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions.
Sex: U
Vaccine: COVID19
Symptoms: Hypoxia, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: 8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOXIA (death, medically significant), outcome "fatal", described as "8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions". The patient underwent the following laboratory tests and procedures: oxygen saturation (60-80): 60-80 %, notes: pulse oxygen saturation levels ranged 60-80%; sars-cov-2 test: negative. The patient date of death was unknown. The reported cause of death was hypoxia. It was not reported if an autopsy was performed. There were 8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions. 5 were long term residents and 3 were short term residents. 5 of them passed within a two week period. One of the above patients were sent to the hospital and was pumped with 20L of oxygen but there was no success. 1 of the above patients tested positive for Covid-19 and 4 tested negative for Covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200376657 same reporter/drug, different event with similar event.; Reported Cause(s) of Death: hypoxic conditions
Sex: U
Vaccine: COVID19
Symptoms: Hypoxia, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic condition; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOXIA (death, medically significant), outcome "fatal", described as "passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic condition". The consumer stated that he works in a long-term facility for elderly people.  This patient is of one the 8 patients at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions. 5 out of the 8 patients were long term residents and 3 were short term residents. 5 of them passed within a two-week period. The above patients' pulse oxygen saturation levels ranged 60-80%. Four of the above patients tested negative for Covid-19. The consumer asked with the Pfizer Covid-19 vaccine, how long the body continues to make the spike protein and how long after the inoculation is signaling set up. The patient underwent the following laboratory tests and procedures: oxygen saturation: 60-80%; sars-cov-2 test: negative. The patient date of death was unknown. The reported cause of death was hypoxia. It was not reported if an autopsy was performed.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200376657 same reporter/drug, different event with similar event; Reported Cause(s) of Death: passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions
Sex: U
Vaccine: COVID19
Symptoms: Hypoxia, Oxygen saturation
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from medical information team reporting similar events under the same suspect product for 8 patients. This is one of 8 reports. An elderly patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as single dose for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOXIA (death, medically significant), outcome "fatal", described as "8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions". The patient underwent the following laboratory test and procedure: oxygen saturation: 60-80 %, notes: Pulse oxygen saturation levels ranged 60-80%. The patient date of death was unknown. The reported cause of death was hypoxia. It was not reported if an autopsy was performed. The lot number for BNT162B2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202200376657 same reporter/drug, different patient with similar event. Reported Cause(s) of Death: 8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions.
Sex: M
Vaccine: COVID19
Symptoms: Cardiomegaly
Clinical narrative: an enlarged heart which made him pass; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: CARDIOMEGALY (death), outcome "fatal", described as "an enlarged heart which made him pass". The event "an enlarged heart which made him pass" was evaluated at the physician office visit. The patient date of death was unknown. The reported cause of death was cardiomegaly. It was not reported if an autopsy was performed. Clinical course: The booster shot was great only thing that gave consumer's father an enlarged heard which made him pass. He had never had a heart condition and he was the best thing in life. Wondering if there's anything could do to sue or even maybe get some help, mean his doctor even said that's only thing that could of caused it. Wish big pharma had a heart because it ruined the life.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: an enlarged heart which made him pass
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: AFib; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 62-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Feb2021 (Lot number: EN6201) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, Batch/lot number: EL3302, Anatomical Location: Left Arm), administration date: 21Jan2021, when the patient was 61 years old, for COVID-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset Jan2022, outcome "not recovered", described as "AFib". The patient never had it before and does not take any medication. She was diagnosed with Afib in Jan2022, diagnosed at her physical appointment in Jan2022. The event "afib" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of atrial fibrillation.
Sex: M
Vaccine: COVID19
Symptoms: Depression, Nasopharyngitis
Clinical narrative: had severe depression and only had colds after the first 2 doses; had severe depression and only had colds after the first 2 doses; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: DEPRESSION (non-serious), NASOPHARYNGITIS (non-serious), outcome "unknown" and all described as "had severe depression and only had colds after the first 2 doses".  Additional Information:when patient had the 3rd dose he no longer had depression.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Insomnia, Mobility decreased, Pain, Swelling
Clinical narrative: My left armpit is extremely swollen and painful.; My left armpit is extremely swollen and painful.; I can barely move my arm because it starts to throbbing and pulsating; I can't sleep because I'm in pain; I can barely move my arm because it starts to throbbing and pulsating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2022 10:15 (Lot number: FM0698) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SPIRONOLACTONE; ZYRTEK; CENTRUM WOMEN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0180, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 10Jun2021, when the patient was 31 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0185, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 19May2021, when the patient was 31 years old, for Covid-19 Immunization. The following information was reported: AXILLARY PAIN (non-serious), SWELLING (non-serious) all with onset 05Mar2022 14:00, outcome "not recovered" and all described as "My left armpit is extremely swollen and painful."; MOBILITY DECREASED (non-serious), PAIN (non-serious) all with onset 05Mar2022 14:00, outcome "not recovered" and all described as "I can barely move my arm because it starts to throbbing and pulsating"; INSOMNIA (non-serious) with onset 05Mar2022 14:00, outcome "not recovered", described as "I can't sleep because I'm in pain". Therapeutic measures were taken as a result of axillary pain, pain. Therapeutic measures were not taken as a result of swelling, mobility decreased, insomnia.  Additional information: Reaction/event as reported by primary source included that the left armpit was extremely swollen and painful. It started the same day as the patient took the third dose of the vaccine. Patient could barely move her arm because it started to throbbing and pulsating. She can not sleep because she was in pain and can not even put on her clothes by herself. It was really scary and she does not know what to do. Was taking Tylenol for pain but can not say it was helping. Was worried about her lymph nodes and if it can get more serious since it was right next to her breast. She cannot wear a bra or do anything, and since she does not have insurance, she can not see a doctor about it. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device date was reported as 07Mar2022.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Haemophagocytic lymphohistiocytosis, Investigation, Serum ferritin
Clinical narrative: Hemophagocytic lymphohistiocytosis; This is a literature report for the following literature source(s): (Privacy).  A 53 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Interstitial lung disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (hospitalization, medically significant), outcome "recovered", described as "Hemophagocytic lymphohistiocytosis". Symptom onset after vaccination was 4 days after 1st vaccination. HLH-2004 diagnostic criteria included: fever (greater than or equals to 38.3 Centigrade); ferritin greater than or equals to 500 ug/L; hemophagocytosis in bone marrow or spleen or lymph nodes. Therapeutic measures were taken as a result of haemophagocytic lymphohistiocytosis, which included Dexamethasone, Anakinra, IVIG, rituximab given as treatment. Patient received ventilatory support for 3 months; discharged to rehab facility. The patient underwent the following laboratory tests and procedures: body temperature: greater than or equals to 38.3 Centigrade; serum ferritin: greater than or equals to 500 ug/L; H-score: 213.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS and BNT162B2. 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.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): NVSC2022US051829_NS (NOVARTIS).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Severe headache".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Hypoglycaemia, Postural orthostatic tachycardia syndrome, SARS-CoV-2 test
Clinical narrative: right sided weakness; Patient also reported severe dizziness with 1st dose of vaccine.prolonged hypoglycemia; developed POTS (diagnosed by clinician); This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: (unspecified if ongoing); "inflammatory bowel disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), outcome "not recovered", described as "right sided weakness"; DIZZINESS (non-serious), outcome "not recovered", described as "Patient also reported severe dizziness with 1st dose of vaccine."; HYPOGLYCAEMIA (non-serious), outcome "not recovered", described as "prolonged hypoglycemia"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "not recovered", described as "developed POTS (diagnosed by clinician)". The events "right sided weakness", "patient also reported severe dizziness with 1st dose of vaccine.", "prolonged hypoglycemia" and "developed pots (diagnosed by clinician)" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of asthenia, dizziness, hypoglycaemia, postural orthostatic tachycardia syndrome.  Additional Information : other vaccine in four weeks: Unknown . Ae resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient did not received covid prior vaccination. Known allergies: unknown  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID infection/test:Positive; COVID infection/test:Positive; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "ehlers danlos" (unspecified if ongoing); "inflammatory bowel disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID infection/test:Positive". The event "covid infection/test:positive" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of covid-19.  Patient had prolonged hypoglycemia, developed POTS (diagnosed by clinician) and also had right sided weakness post -COVID vaccine. However, patient also developed these symptoms after COVID infection all occurring after she received vaccine administration (2 doses and 1 booster). Patient also reported severe dizziness with 1st dose of vaccine.  Patient did not experienced covid prior to vaccination. Patient was tested for covid post vaccination and found positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a causal relationship between reported events drug ineffective, covid-19 and suspect BNT162B2 cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Pain in extremity
Clinical narrative: extremely sore arm after first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 22Jan2021 (Batch/Lot number: unknown) at the age of 71 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 22Jan2021, outcome "recovered" (2021), described as "extremely sore arm after first dose". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She was calling to talk about her side effects, she sick of the news saying no side effects to the vaccine except a sore arm. She had not visited Emergency Room or Physician Office. She was so incoherent she had not know what day it was. Patient had not Family Medical History Relevant to events.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Insomnia, unable to stay asleep for more than 2 hours at a time since receiving booster; This is a spontaneous report from two contactable reporter (Nurse). The reporter is the patient.  A 32-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 07Mar2022 at 17:30 (Lot number: FR9895) at the age of 32 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: FY0584), administration date: 06Aug2021, when the patient was 31 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: FC3184), administration date: 27Aug2021, when the patient was 31 years old, for COVID-19 immunisation.  The following information was reported: INSOMNIA (non-serious) with onset 07Mar2022, outcome "not recovered", described as "Insomnia, unable to stay asleep for more than 2 hours at a time since receiving booster". Therapeutic measures were not taken as a result of insomnia.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden
Clinical narrative: 'the first one put me in the bed'; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2) (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: BEDRIDDEN (non-serious), outcome "unknown", described as "'the first one put me in the bed'".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.