chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Pulmonary embolism, SARS-CoV-2 test, Thrombosis
Clinical narrative: I suffered a major Saddle Pulmonary Embolism (SPE) that left me needing to airlifted twice,; open heart surgery to remove the clot; needed to relearn walking, gaining all my balance, and all other body functions as well as regaining my strength.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 28Apr2021 as dose 2, single (Lot number: EW0172) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: Other medical history: COPD. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE (Lot No.: EN6027)), administration date: 05Apr2021, when the patient was 62-year-old, for COVID-19 Immunization. The following information was reported: PULMONARY EMBOLISM (hospitalization, disability, intervention required, medically significant, life threatening) with onset 25May2022, outcome "recovered with sequelae", described as "I suffered a major Saddle Pulmonary Embolism (SPE) that left me needing to airlifted twice,"; BALANCE DISORDER (hospitalization, disability, life threatening) with onset 25May2022, outcome "recovered with sequelae", described as "needed to relearn walking, gaining all my balance, and all other body functions as well as regaining my strength."; THROMBOSIS (hospitalization, disability, intervention required, medically significant, life threatening) with onset 25May2022, outcome "recovered with sequelae", described as "open heart surgery to remove the clot". The patient was hospitalized for pulmonary embolism, thrombosis, balance disorder (hospitalization duration: 60 day(s)). The events "i suffered a major saddle pulmonary embolism (spe) that left me needing to airlifted twice,", "open heart surgery to remove the clot" and "needed to relearn walking, gaining all my balance, and all other body functions as well as regaining my strength." required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of pulmonary embolism, thrombosis.  Clinical information: The patient suffered a major Saddle Pulmonary Embolism (SPE) that left the patient needing to airlifted twice, undergone open heart surgery to remove the clot, the patient was on full life support: a ventilator and ECMO machine for 30 days where the patient remained in the ICU. The patient spent another 30 days in the step down ICU before being transferred to a rehab facility for 3 weeks where the patient needed to relearn walking, gaining all the patient balance, and all other body functions as well as regarding the strength. There was No family history of blood clots. The patient recovered with lasting effects. The patient did not had covid prior vaccination. The patient was tested for covid post vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jun2021 as dose 1, single (Lot number: BW0168), in left arm, on 14Aug2021 as dose 2, single (Lot number: EW 0168), in left arm, on 09Dec2021 as dose 3 (booster), single (Lot number: FJ8757), in left arm and on 21Jul2022 as dose 4 (booster), single (Lot number: FN2908) at the age of 53 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: LOSARTAN taken for hypertension, start date: 01Jun2016; VENTOLIN [SALBUTAMOL] taken for inhalation therapy, start date: 01Jun2016. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Lot number: VL-002624736) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, disability, life threatening) with onset 29Apr2021, outcome "recovered with sequelae", described as "stroke". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 4 day(s)). The event "stroke" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of cerebrovascular accident.  Clinical course: patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300026496 same product, patient, and event, different dose;
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage
Clinical narrative: brain bleed after 1st COVID-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 81-year-old female patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6200, Expiration Date: 30Jun2021) at the age of 81 years intramuscular for covid-19 immunisation; apixaban (ELIQUIS), for anticoagulant therapy. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: CEREBRAL HAEMORRHAGE (hospitalization, medically significant) with onset Mar2021, outcome "unknown", described as "brain bleed after 1st COVID-19 Vaccine". The event "brain bleed after 1st covid-19 vaccine" required emergency room visit. The action taken for apixaban was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300026448 Same patient, same product, different dose, different event;US-PFIZER INC-202300026488 Same patient, same product, different dose, different event;
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 2, single (Lot number: VL-002625186) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False, Is bivalent=False, prev dose lot number=VL-002624736, prev dose lot unknown=False, prev dose administration date=11Feb2021, prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 11Feb2021, when the patient was 67-year-old, for Covid-19 immunization, reaction(s): "stroke". The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, disability, medically significant, life threatening) with onset 29Apr2021, outcome "recovered with sequelae", described as "stroke". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 4 day(s)). The event "stroke" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of cerebrovascular accident.  Clinical course: Facility type vaccine: Pharmacy or Drug Store. Other vaccine administrated in four weeks was influenza (high dose, quadrivalent on 27Sep2022), Pneumococcal conjugate PCV20, polysaccharide CRM197 conjugate on 27Sep2022. Other medications received in two weeks. Adverse event: stroke on 29Apr2021, ae resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. 4 days hospitalization, patient recovered with lasting effects, treatment received AE: emergency treatment for stroke. No covid prior vaccination and no covid tested post vaccination. No known allergies and other medical history: rheumatoid arthritis.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300026438 same product, patient, and event, different dose;
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Chest pain, Lung disorder, Postural orthostatic tachycardia syndrome
Clinical narrative: 2 consecutive miscarriage; Posturl Orthostatic Tachycadia Syndrome (POTS); Pulmonary obstruction; Intermittent Chest pain; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2022 as dose 3 (booster), single (Lot number: FM0698) at the age of 38 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EL3248, Prev dose Product=COVID 19, Prev dose Brand=Pfizer,, Prev dose Brand unknown=False,, Is bivalent=False,, Prev dose Lot number=EL3248,, Prev dose Lot unknown=False,, Prev dose Administration date=25Jan2021,, Prev dose Dose number=2), administration date: 25Jan2021, when the patient was 37-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL0142, Prev dose Product=COVID 19, Prev dose Brand=Pfizer,, Prev dose Brand unknown=False,, Prev dose Lot number=EL0142,, Prev dose Lot unknown=False,, Prev dose Administration date=-04Jan2021,, Prev dose Dose number=1), administration date: 04Jan2021, when the patient was 37-year-old, for COVID-19 immunization. The following information was reported: ABORTION SPONTANEOUS (medically significant) with onset 07Apr2022, outcome "not recovered", described as "2 consecutive miscarriage"; CHEST PAIN (non-serious) with onset 07Apr2022, outcome "not recovered", described as "Intermittent Chest pain"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious) with onset 07Apr2022, outcome "not recovered", described as "Posturl Orthostatic Tachycardia Syndrome (POTS)"; LUNG DISORDER (non-serious) with onset 07Apr2022, outcome "not recovered", described as "Pulmonary obstruction". The events "2 consecutive miscarriage", "posturl orthostatic tachycardia syndrome (pots)", "pulmonary obstruction" and "intermittent chest pain" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of abortion spontaneous, postural orthostatic tachycardia syndrome, lung disorder, chest pain. Patient was not taking other vaccine in four weeks and other medication in two weeks and COVID Prior vaccination was no. The allergy was not known.; Sender's Comments: Based on the available information in the case, the causal association between the reported event abortion spontaneous and the 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
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Macule, Nausea
Clinical narrative: Headache; fever; tired; red spot on arm; large bump on arm; nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Jan2023 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 18Jan2023 at 16:00, outcome "recovering"; PYREXIA (non-serious) with onset 18Jan2023 at 16:00, outcome "recovering", described as "fever"; SKIN DISORDER (non-serious) with onset 18Jan2023 at 16:00, outcome "recovering", described as "large bump on arm"; NAUSEA (non-serious) with onset 18Jan2023 at 16:00, outcome "recovering", described as "nauseous"; MACULE (non-serious) with onset 18Jan2023 at 16:00, outcome "recovering", described as "red spot on arm"; FATIGUE (non-serious) with onset 18Jan2023 at 16:00, outcome "recovering", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, pyrexia, fatigue, macule, skin disorder, nausea.  Additional information: No other vaccine patient received in four weeks. Dose received was more than 3. . Headache fever tired red spot on arm large bump on arm nauseous. It was reported that Covid prior vaccination was yes. No Covid tested post vaccination.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin disorder
Clinical narrative: Headache; fever; tired; red spot on arm; large bump on arm; nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Jan2023 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 18Jan2023 at 16:00, outcome "recovering"; PYREXIA (non-serious) with onset 18Jan2023 at 16:00, outcome "recovering", described as "fever"; SKIN DISORDER (non-serious) with onset 18Jan2023 at 16:00, outcome "recovering", described as "large bump on arm"; NAUSEA (non-serious) with onset 18Jan2023 at 16:00, outcome "recovering", described as "nauseous"; MACULE (non-serious) with onset 18Jan2023 at 16:00, outcome "recovering", described as "red spot on arm"; FATIGUE (non-serious) with onset 18Jan2023 at 16:00, outcome "recovering", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, pyrexia, fatigue, macule, skin disorder, nausea.  Additional information: No other vaccine patient received in four weeks. Dose received was more than 3. . Headache fever tired red spot on arm large bump on arm nauseous. It was reported that Covid prior vaccination was yes. No Covid tested post vaccination.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Skin odour abnormal
Clinical narrative: Horrible body odor; Extreme night sweats; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) 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 complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: SKIN ODOUR ABNORMAL (non-serious), outcome "unknown", described as "Horrible body odor"; NIGHT SWEATS (non-serious), outcome "unknown", described as "Extreme night sweats".  Additional information: The reporter wanted to know whether we had any information on how to get rid of the horrible body odor as a side effect of the booster shots. The reporter so far known 12 women with this issue. They also had extreme night sweats. The reporter had read 12 different articles regarding this side effect. A lot of people were having this trouble and this was becoming a major problem.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300006689 Same reporter/drug/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Got one in Jan2021 for the first dose and had a reaction/Clarified he did have the typical sore arm for a few days that then went away.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jan2021, outcome "recovered" (Jan2021), described as "Got one in Jan2021 for the first dose and had a reaction/Clarified he did have the typical sore arm for a few days that then went away.".  Additional Information : The patient got one in Jan2021 for the first dose and had a reaction. Patient wanted to know if the reaction came from the Pfizer COVID-19 vaccine or not. Clarified his first COVID-19 shot was in Jan2021 and since that time he had a booster shot, and after the booster shot had another booster shot. In 2022 had another booster shot and then in Nov2022 had an additional booster shot that would take care of all the viruses up to that point. Out of all the shots he had he never had a bad reaction to any of them. Clarified he did have the typical sore arm for a few days that then went away. After the most recent COVID-19 Vaccine shot he noticed two weeks later he had tinnitus in one ear or ringing in one ear. Wonders if other people have had the same thing?. Clarified he hasn't had a hearing loss but he never had tinnitus and started having it shortly after the COVID-19 Vaccine shot. Have other people reported the same thing?. Declined to complete a report and requested to be transferred to Pfizer Medical Information. Wanted to know if it has to do with the shot and if it will go away?.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300024573 Same patient/vaccine, different dose/event.;
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes with all 3 Pfizer shots. Swollen lymph nodes on collar, neck, groin,bone/ Went to urgent care and side swollen lymph nodes were due to vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient received BNT162b2 (BNT162B2), on 14Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 24Mar2021, when the patient was 49-year-old, for Covid-19 immunization, reaction(s): "swollen lymph nodes". The following information was reported: LYMPHADENOPATHY (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Swollen lymph nodes with all 3 Pfizer shots. Swollen lymph nodes on collar, neck, groin,bone/ Went to urgent care and side swollen lymph nodes were due to vaccine".  Additional information: Swollen lymph nodes with all 3 pfizer shots. Swollen lymph nodes on collar, neck, groin, bone. Went away after a week each time. Went to urgent care and said swollen lymph nodes were due to vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes with all 3 Pfizer shots. Swollen lymph nodes on collar, neck, groin,bone/ Went to urgent care and side swollen lymph nodes were due to vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: unknown), administration date: 24Mar2021, when the patient was 49-year-old, for COVID-19 Immunization, reaction(s): "Swollen lymph nodes"; BNT162b2 (DOSE 2, SINGLE, Lot number: unknown), administration date: 14Apr2021, when the patient was 49-year-old, for COVID-19 Immunization, reaction(s): "Swollen lymph nodes".  The following information was reported: LYMPHADENOPATHY (non-serious) with onset Nov2022, outcome "recovered" (Nov2022), described as "Swollen lymph nodes with all 3 Pfizer shots. Swollen lymph nodes on collar, neck, groin,bone/ Went to urgent care and side swollen lymph nodes were due to vaccine". The events "swollen lymph nodes with all 3 pfizer shots. swollen lymph nodes on collar, neck, groin,bone/ went to urgent care and side swollen lymph nodes were due to vaccine" required emergency room visit.  Additional Information: It was reported swollen lymph nodes with all 3 Pfizer shots. Swollen lymph nodes on collar, neck, groin, bone. Went away after a week each time. Went to urgent care and side swollen lymph nodes were due to vaccine. Stop date was a week after each shot.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, COVID-19, Drug ineffective, Eating disorder, Somnolence
Clinical narrative: had COVID last year after she had the first vaccine for COVID and prior to the timeframe where she could get the second dose of the vaccine. Both times she's had COVID; had COVID last year after she had the first vaccine for COVID and prior to the timeframe where she could get the second dose of the vaccine. Both times she's had COVID; could not wake up for the first 1-2 days; Doesn't eat or drink; bedridden for a while; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2021US222266_OS.  A 57-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EATING DISORDER (non-serious) with onset 2022, outcome "recovering", described as "Doesn't eat or drink"; BEDRIDDEN (non-serious) with onset 2022, outcome "unknown", described as "bedridden for a while"; SOMNOLENCE (non-serious) with onset 2022, outcome "recovering", described as "could not wake up for the first 1-2 days"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "had COVID last year after she had the first vaccine for COVID and prior to the timeframe where she could get the second dose of the vaccine. Both times she's had COVID". Clinical course: The patient reported she had COVID last year after she had the first vaccine for COVID and prior to the timeframe where she could get the second dose of the vaccine. Both times she's had COVID, she reported that she could not wake up for the first 1-2 days and doesn't eat or drink as a result. She was improving, but states she was bedridden for a while.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Skin odour abnormal
Clinical narrative: Horrible body odor; Extreme night sweats; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) 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 complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: SKIN ODOUR ABNORMAL (non-serious), outcome "unknown", described as "Horrible body odor"; NIGHT SWEATS (non-serious), outcome "unknown", described as "Extreme night sweats".  Additional information: The reporter wanted to know whether we had any information on how to get rid of the horrible body odor as a side effect of the booster shots. The reporter so far known 12 women with this issue. They also had extreme night sweats. The reporter had read 12 different articles regarding this side effect. A lot of people were having this trouble and this was becoming a major problem.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Skin odour abnormal
Clinical narrative: Horrible body odor; Extreme night sweats; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) 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 complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: SKIN ODOUR ABNORMAL (non-serious), outcome "unknown", described as "Horrible body odor"; NIGHT SWEATS (non-serious), outcome "unknown", described as "Extreme night sweats".  Additional information: The reporter wanted to know whether we had any information on how to get rid of the horrible body odor as a side effect of the booster shots. The reporter so far known 12 women with this issue. They also had extreme night sweats. The reporter had read 12 different articles regarding this side effect. A lot of people were having this trouble and this was becoming a major problem.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 52-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: COVID 19 Treatment; (17Jan2023) Negative, notes: 2 days after negative test; (19Jan2023) positive, notes: Test strongly positive today. Therapeutic measures were taken as a result of drug ineffective, covid-19, the patient received Paxlovid from 10Jan2023 to 15Jan2023.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162b2, BNT162b2 omi ba.4-5 cannot be excluded. The case will be reassessed once new information is available.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 18:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 41 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EL9267), on 09Mar2021 as dose 2, single (Lot number: EN6205), on 28Sep2021 as dose 3 (booster), single (Lot number: EW0181) and on 06Jun2022 as dose 4 (booster), single (Lot number: FK9896), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type I Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "SVT" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing). Concomitant medication(s) included: NOVOLOG, start date: 01Oct2001; NORTRIPTYLINE, start date: 01Jul2015; LIPITOR, start date: 01Jan2018, stop date: 04Jan2023; PROTONIX [OMEPRAZOLE], start date: 01Feb2007; ASPRIN, start date: 01Jul2010; TOPROL XL, start date: 28Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, the patient received Paxlovid from 05Jan2023 to 10Jan2023.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 at 13:00 as dose 5 (booster), single (Lot number: GJ5665) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Mar2022 at 02:00 as dose 4 (booster), single (Lot number: FK9896), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lymphoma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19, the patient received Paxlovid from 09Jan2023 to 13Jan2023.
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Skin odour abnormal
Clinical narrative: Horrible body odor; Extreme night sweats; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) 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 complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: SKIN ODOUR ABNORMAL (non-serious), outcome "unknown", described as "Horrible body odor"; NIGHT SWEATS (non-serious), outcome "unknown", described as "Extreme night sweats".  Additional information: The reporter wanted to know whether we had any information on how to get rid of the horrible body odor as a side effect of the booster shots. The reporter so far known 12 women with this issue. They also had extreme night sweats. The reporter had read 12 different articles regarding this side effect. A lot of people were having this trouble and this was becoming a major problem.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300026661 Same reporter/drug/event, different patient;US-PFIZER INC-202300028268 Same reporter/drug/event, different patient;US-PFIZER INC-202300028269 Same reporter/drug/event, different patient;US-PFIZER INC-202300028270 Same reporter/drug/event, different patient;US-PFIZER INC-202300028271 Same reporter/drug/event, different patient;US-PFIZER INC-202300028272 Same reporter/drug/event, different patient;US-PFIZER INC-202300028273 Same reporter/drug/event, different patient;US-PFIZER INC-202300028274 Same reporter/drug/event, different patient;US-PFIZER INC-202300028275 Same reporter/drug/event, different patient;US-PFIZER INC-202300028276 Same reporter/drug/event, different patient;US-PFIZER INC-202300028277 Same reporter/drug/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: why he/she did not get his/her period; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AMENORRHOEA (non-serious), outcome "unknown", described as "why he/she did not get his/her period".  Additional information: Patient who had the Pfizer COVID-19 Vaccine, wanted to know if the vaccine was the reason why she did not get her period. . No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: extreme tinnitus in both ears; random incidents of vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset Dec2022, outcome "unknown", described as "extreme tinnitus in both ears"; VERTIGO (non-serious) with onset Dec2022, outcome "unknown", described as "random incidents of vertigo".  Additional Information: Patient stated that, all Covid shots are Pfizer. Patient 4th one 29Nov started without concern. Mid Dec started having extreme tinnitus in both ears. Last week of Dec. Patient started random incidents of vertigo. Yesterday, contacted (facility name withheld), who administered the shot. They said numerous complaints of both symptoms have been reported back to this store. They had no solution said to contact my PCP. Patient did he advised to "wait it out". Can you tell me how long this could be? I'm 72. Awful unwanted side effects.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: UNK
Symptoms: Drug ineffective, Exposure to SARS-CoV-2, Suspected COVID-19
Clinical narrative: exposed to COVID-19 via her boyfriend/her boyfriend had Pfizer vaccine; exposed to COVID-19 via her boyfriend/her boyfriend had Pfizer vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-MO-MOC20230116000216 (Moderna).  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "exposed to COVID-19 via her boyfriend/her boyfriend had Pfizer vaccine".  Clinical course: Calling to report that she had 4 Moderna COVID-19 shots. The last booster was administered on 30Sep2022, and she was exposed to COVID-19 via her boyfriend during Christmas holidays. She would like to compliment Moderna because she did not catch COVID disease after being exposed. She states that the vaccine worked pretty well. She states that her boyfriend had Pfizer vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: he experienced atrial fibrillation; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series immunization complete but manufacturer unknown), for COVID-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "he experienced atrial fibrillation". Clinical course: It was reported that the patient was healthy. After the patient took the Bivalent booster dose he experienced atrial fibrillation.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the reported event atrial fibrillation and the 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.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Periarthritis
Clinical narrative: frozen shoulder; Adhesive capsulitis of left shoulder; decreased range of motion in left shoulder shortly after injection, followed by pain in same shoulder; decreased range of motion in left shoulder shortly after injection, followed by pain in same shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose number unknown (booster), single (Lot number: GJ3275) at the age of 45 years 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 complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: PERIARTHRITIS (non-serious) with onset 11Nov2022, outcome "unknown", described as "Adhesive capsulitis of left shoulder"; JOINT RANGE OF MOTION DECREASED (non-serious), ARTHRALGIA (non-serious) all with onset 11Nov2022, outcome "unknown" and all described as "decreased range of motion in left shoulder shortly after injection, followed by pain in same shoulder"; PERIARTHRITIS (non-serious) with onset 17Jan2023, outcome "unknown", described as "frozen shoulder". The events "adhesive capsulitis of left shoulder", "decreased range of motion in left shoulder shortly after injection, followed by pain in same shoulder" and "frozen shoulder" required physician office visit. Therapeutic measures were taken as a result of periarthritis, joint range of motion decreased, arthralgia, periarthritis.  Additional information: Started experiencing decreased range of motion in left shoulder shortly after injection, followed by pain in same shoulder. After self-treatment for a couple of months, sought treatment by orthopedic surgeon who ordered physical therapy. PT discussed causes which vaccines could be a cause for frozen shoulder and timing matched up. This was discovered on 17Jan2023 around 12pm. Event took place after use of product.
Sex: U
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: had not yet gotten a period; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUATION DELAYED (non-serious), outcome "unknown", described as "had not yet gotten a period". Additional information: The reporter was a transgender and stated that the patient got the covid 19 vaccine and had not gotten a period. The reporter was asking if that was the cause of the covid 19 shot that the patient got. The patient had not yet gotten a period and asked if the patient was pregnant.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cerebellar infarction
Clinical narrative: cerebellar CVA; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient was very healthy and active. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; unknown manufacturer), for Covid-19 immunization. The following information was reported: CEREBELLAR INFARCTION (medically significant), outcome "unknown", described as "cerebellar CVA". The patient had no risk factors other than being 70, very healthy and active. The patient had a cerebellar CVA 2 weeks after the booster.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: FLUX
Symptoms: Influenza B virus test positive
Clinical narrative: got my flu shot in oct tested positive for type b; Initial information received on 13-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves Adult and unknown gender patient who experienced got my flu shot in oct tested positive for type b after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date: not reported) via unknown route in unknown administration site (form, strength: unknown) for prophylactic vaccination.  On an unknown date the patient developed a non-serious event of got my flu shot in oct tested positive for type b (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.