chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Vaccination site pain
Clinical narrative: Headache; soreness around injection site; Dose received: 3, product: COVID 19, brand: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 09Dec2021 (Lot number: FF8839) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021, outcome "unknown", described as "Dose received: 3, product: COVID 19, brand: Pfizer"; HEADACHE (non-serious) with onset 10Dec2021, outcome "recovered" (2021), described as "Headache"; VACCINATION SITE PAIN (non-serious) with onset 10Dec2021, outcome "recovered" (2021), described as "soreness around injection site". Therapeutic measures were not taken as a result of headache, vaccination site pain.  Additional 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. Since the vaccination, the patient had not been tested for COVID-19. The reporter classified the events as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Cough, Headache, Immunisation
Clinical narrative: Mild chest pain/ Moderate chest pain; headache; body ache; chills; fever; lingering cough; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 16:30 (Lot number: FJ8757) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GABAPENTIN; DEPAKOTE. Vaccination history included: Bnt162b2 (Dose 2, on Left arm, Lot No: EW0182 ), administration date: 05May2021, when the patient was 43 years old, for COVID-19 immunization; Bnt162b2 (Dose 2, on Left arm, Lot No: EW0164, ), administration date: 15Apr2021, when the patient was 43 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 16:30, outcome "unknown", described as "Booster "; CHEST PAIN (non-serious) with onset 09Dec2021 16:45, outcome "recovering", described as "Mild chest pain/ Moderate chest pain"; HEADACHE (non-serious) with onset 09Dec2021 16:45, outcome "recovering", described as "headache"; PAIN (non-serious) with onset 09Dec2021 16:45, outcome "recovering", described as "body ache"; CHILLS (non-serious) with onset 09Dec2021 16:45, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 09Dec2021 16:45, outcome "recovered" (11Dec2021 04:45), described as "fever"; COUGH (non-serious) with onset 09Dec2021 16:45, outcome "recovering", described as "lingering cough". Therapeutic measures were not taken as a result of chest pain, headache, pain, chills, pyrexia, cough.  Additional information: No known allergies were reported.  The patient had not received any other vaccine in four weeks prior to vaccination. The patient had mild chest pain immediately after, headache, body ache, chills, fever for 36 hrs then moderate chest pain and lingering cough and headache. It was reported that the patient was not diagnosed with SARS-CoV-2 infection before or after vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Mild chest pain/ Moderate chest pain; headache; body ache; chills; fever; lingering cough; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 16:30 (Lot number: FJ8757) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GABAPENTIN; DEPAKOTE. Vaccination history included: Bnt162b2 (Dose 2, on Left arm, Lot No: EW0182 ), administration date: 05May2021, when the patient was 43 years old, for COVID-19 immunization; Bnt162b2 (Dose 2, on Left arm, Lot No: EW0164, ), administration date: 15Apr2021, when the patient was 43 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 16:30, outcome "unknown", described as "Booster "; CHEST PAIN (non-serious) with onset 09Dec2021 16:45, outcome "recovering", described as "Mild chest pain/ Moderate chest pain"; HEADACHE (non-serious) with onset 09Dec2021 16:45, outcome "recovering", described as "headache"; PAIN (non-serious) with onset 09Dec2021 16:45, outcome "recovering", described as "body ache"; CHILLS (non-serious) with onset 09Dec2021 16:45, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 09Dec2021 16:45, outcome "recovered" (11Dec2021 04:45), described as "fever"; COUGH (non-serious) with onset 09Dec2021 16:45, outcome "recovering", described as "lingering cough". Therapeutic measures were not taken as a result of chest pain, headache, pain, chills, pyrexia, cough.  Additional information: No known allergies were reported.  The patient had not received any other vaccine in four weeks prior to vaccination. The patient had mild chest pain immediately after, headache, body ache, chills, fever for 36 hrs then moderate chest pain and lingering cough and headache. It was reported that the patient was not diagnosed with SARS-CoV-2 infection before or after vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Immunisation, SARS-CoV-2 test
Clinical narrative: My booster shot was on the 25Oct2021. The 26th I had my period for 5 weeks.; dose_number=3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Oct2021 11:00 (Lot number: UNKNOWN) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimotos" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID. Past drug history included: Amoxicillan, reaction(s): "Known allergy: Amoxicillan". Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 26Jan2021, when the patient was 50 years old, for COVID-19 immunization, reaction(s): "Immediately after first 2 doses, periods skipped every other month"; Bnt162b2 (Dose 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location:Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 05Jan2021, when the patient was 50 years old, for COVID-19 immunization, reaction(s): "Immediately after first 2 doses, periods skipped every other month". The following information was reported: IMMUNISATION (non-serious) with onset 25Oct2021 11:00, outcome "unknown", described as "dose_number=3"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 26Oct2021, outcome "recovered" (29Nov2021), described as "My booster shot was on the 25Oct2021. The 26th I had my period for 5 weeks.". The event "my booster shot was on the 25oct2021. the 26th i had my period for 5 weeks." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of heavy menstrual bleeding.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received treatment with estrogen and progesterone. Prior to vaccination, patient was not diagnosed with COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Booster; Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 63 year-old 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: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) tested positive for covid. Clinical course: Patient had his booster dose, he had the 3 series of Pfizer BioNTech Covid 19 vaccine. He had a cold right now that started with a runny nose and sore throat and he got a quick test and he tested positive for Covid. The patient wanted to know if there was anything else he could take for the Omicron variant. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Swelling
Clinical narrative: Swelling and pain in the left armpit radiating down the arm to the elbow.; Swelling and pain in the left armpit radiating down the arm to the elbow.; booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 14:30 (Lot number: FJ8762) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU; VALTREX; SPIRONOLACTONE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3249, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 19Jan2021, when the patient was 27 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EK9231, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 31Dec2020, when the patient was 27 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 14:30, outcome "unknown", described as "booster"; SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset 08Dec2021, outcome "not recovered" and all described as "Swelling and pain in the left armpit radiating down the arm to the elbow.". The event "swelling and pain in the left armpit radiating down the arm to the elbow." and "swelling and pain in the left armpit radiating down the arm to the elbow." was evaluated at the emergency room visit. Therapeutic measures were taken as a result of swelling, axillary pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Other medications in two weeks: Valtrex, oral birth control, spironolactone.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Immunisation, Lymph node pain, Pyrexia
Clinical narrative: This is a spontaneous report received from contactable reporter. The reporter is the patient. A 44-year-old female patient (not pregnant) received bnt162b2, administered in arm left, administration date 08Dec2021 16:30 (Batch/Lot number: unknown) at the age of 44 years as dose 3, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2, Location of injection: Arm Left, Vaccine Administration Time: 10:15 AM), administration date: 04May2021, when the patient was 43 years old, for Covid-19 immunization; Bnt162b2 (Dose 1, Location of injection: Arm Left, Vaccine Administration Time: 10:15 AM), administration date: 13Apr2021, when the patient was 43 years old, for Covid-19 immunization. The following information was reported: immunization, pyrexia, chills and lymph node pain. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, lymph node pain. Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. seriousness was no. It was reported that Seriousness criteria- results in death, life threatening, caused/ prolonged hospitalization, disabling/Incapacitating and congenital anomaly/birth defect was no. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Menstruation irregular, Pregnancy test
Clinical narrative: Missed period after booster dose.; booster; This is a spontaneous report received from a contactable reporter(s).   A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 08:00 (Lot number: FD0809) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included Hyperlipidaemia (unspecified if ongoing). Concomitant medication(s) included ATORVASTATIN; WELLBUTRIN. Vaccination history included Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3302, Location of injection: Arm Left), administration date: 28Jan2021, when the patient was 34 years old, for COVID-19 immunization, reaction(s) Lighter periods after first two doses; Bnt162b2 (Dose Number: 1, Batch/Lot No: EJ1686, Location of injection: Arm Left), administration date: 07Jan2021, when the patient was 34 years old, for COVID-19 immunization, reaction(s) Lighter periods after first two doses. The following information was reported IMMUNISATION (non-serious) with onset 24Nov2021 08:00, outcome unknown; MENSTRUATION IRREGULAR (non-serious) with onset 01Dec2021, outcome unknown. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation irregular. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination was birth Control. Prior to the vaccination, patient not had COVID-19. The patient was not tested positive for COVID-19 post vaccination. The patient had no known allergies. The patient was not prolonged hospitalization. Previously always regular periods on schedule. Two pregnancy tests taken and both negative on an unspecified date in Dec2021.  Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cardiac discomfort, Chest discomfort, Drug ineffective, Headache
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Nov2021 19:00 (Lot number: 3203080) at the age of 32 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; B12 [CYANOCOBALAMIN]. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "unknown", described as "Drug ineffective"; COVID-19 (medically significant) with onset 2021, outcome "unknown", described as "Diagnosed with Covid after first dose"; CARDIAC DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "feeling like heart is being squeezed"; CHEST DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "chest discomfort"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "numbness in face"; PARAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "pricking sensation all over body including face"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache". Therapeutic measures were not taken as a result of cardiac discomfort, chest discomfort, hypoaesthesia, paraesthesia, headache.  Additional information included: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. the patient received Vitamin D, B12, multivitamin within 2 weeks of vaccination. The feeling like heart is being squeezed happened twice after first dose.  No follow-up attempts needed. No further information expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Nov2021 19:00 (Lot number: 3203080) at the age of 32 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; B12 [CYANOCOBALAMIN]. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "unknown", described as "Drug ineffective"; COVID-19 (medically significant) with onset 2021, outcome "unknown", described as "Diagnosed with Covid after first dose"; CARDIAC DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "feeling like heart is being squeezed"; CHEST DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "chest discomfort"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "numbness in face"; PARAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "pricking sensation all over body including face"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache". Therapeutic measures were not taken as a result of cardiac discomfort, chest discomfort, hypoaesthesia, paraesthesia, headache.  Additional information included: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. the patient received Vitamin D, B12, multivitamin within 2 weeks of vaccination. The feeling like heart is being squeezed happened twice after first dose.  No follow-up attempts needed. No further information expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Pain
Clinical narrative: patient received Pfizer COVID booster; Mild headache; body aches for 12 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 43 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 43 years 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), when the patient was 43 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "patient received Pfizer COVID booster"; HEADACHE (non-serious), outcome "unknown", described as "Mild headache"; PAIN (non-serious), outcome "unknown", described as "body aches for 12 hours".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: experiencing Covid/ experiencing symptoms after getting her Covid Pfizer shot; experiencing Covid/ experiencing symptoms after getting her Covid Pfizer shot; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 06Dec2021 (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. 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) all with onset Dec2021, outcome "unknown" and all described as "experiencing Covid/ experiencing symptoms after getting her Covid Pfizer shot". The reporter stated that, "My wife is experiencing Covid, I mean, Well, experiencing symptoms after getting her Covid Pfizer shot."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Eye discharge, Headache, Immunisation, Myalgia
Clinical narrative: Lots of discharge from eyes; Fever; Severe headache; Muscle aches; Joint pain; dose number=3; This is a spontaneous report received from non-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 left, administration date 10Dec2021 15:45 (Batch/Lot number: unknown) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE; VIT C; VIT D [COLECALCIFEROL]; ZINC; MG [MAGNESIUM SULFATE]; CA [CALCIUM]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Pcp has record, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 19Jun2021, when the patient was 35 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Pcp has info, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 27May2021, when the patient was 35 years old, for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021 15:45, outcome "unknown", described as "dose number=3"; PYREXIA (non-serious) with onset 11Dec2021 02:00, outcome "recovering", described as "Fever"; HEADACHE (non-serious) with onset 11Dec2021 02:00, outcome "recovering", described as "Severe headache"; MYALGIA (non-serious) with onset 11Dec2021 02:00, outcome "recovering", described as "Muscle aches"; EYE DISCHARGE (non-serious) with onset 11Dec2021 02:00, outcome "recovering", described as "Lots of discharge from eyes"; ARTHRALGIA (non-serious) with onset 11Dec2021 02:00, outcome "recovering", described as "Joint pain". Therapeutic measures were not taken as a result of pyrexia, headache, myalgia, eye discharge, arthralgia.  Additional information: Patient had no known allergies. Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination,the patient was not tested for COVID-19.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Lots of discharge from eyes; Fever; Severe headache; Muscle aches; Joint pain; dose number=3; This is a spontaneous report received from non-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 left, administration date 10Dec2021 15:45 (Batch/Lot number: unknown) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE; VIT C; VIT D [COLECALCIFEROL]; ZINC; MG [MAGNESIUM SULFATE]; CA [CALCIUM]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Pcp has record, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 19Jun2021, when the patient was 35 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Pcp has info, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 27May2021, when the patient was 35 years old, for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021 15:45, outcome "unknown", described as "dose number=3"; PYREXIA (non-serious) with onset 11Dec2021 02:00, outcome "recovering", described as "Fever"; HEADACHE (non-serious) with onset 11Dec2021 02:00, outcome "recovering", described as "Severe headache"; MYALGIA (non-serious) with onset 11Dec2021 02:00, outcome "recovering", described as "Muscle aches"; EYE DISCHARGE (non-serious) with onset 11Dec2021 02:00, outcome "recovering", described as "Lots of discharge from eyes"; ARTHRALGIA (non-serious) with onset 11Dec2021 02:00, outcome "recovering", described as "Joint pain". Therapeutic measures were not taken as a result of pyrexia, headache, myalgia, eye discharge, arthralgia.  Additional information: Patient had no known allergies. Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination,the patient was not tested for COVID-19.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Urticaria
Clinical narrative: Hives over entire body.; dose_number=3; prev dose brand=Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Dec2021 09:30 (Lot number: FJ1620) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: if covid prior vaccination Yes. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, administration date 18Nov2021. Vaccination history included: Moderna (Dose Number: 1, Batch/Lot No: 039K20A), administration date: 29Dec2020, when the patient was 25 years old, for COVID-19 Immunization; Moderna (Dose Number: 2, Batch/Lot No: 027L20A), administration date: 28Jan2021, when the patient was 25 years old, for COVID-19 Immunization.  The following information was reported: URTICARIA (medically significant) with onset 12Dec2021 12:00, outcome "not recovered", described as "Hives over entire body."; IMMUNISATION (non-serious) with onset 10Dec2021 09:30, outcome "unknown", described as "dose_number=3"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 10Dec2021 09:30, outcome "unknown", described as "prev dose brand=Moderna". The event "hives over entire body." was evaluated at the emergency room visit. Therapeutic measures were taken as a result of urticaria.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events 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.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Cataract, Inappropriate schedule of product administration
Clinical narrative: Advanced cataracts; dose 1 02Aug2021/dose 2 on 16Aug2021 13:00; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Aug2021 13:00 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. No COVID prior to vaccination and not tested post vaccination. Patient have no known allergies. The patient took blood pressure medicine. Patient have no vaccine in four weeks. Vaccination history included: Bnt162b2 (dose 1, 13:00), administration date: 02Aug2021, when the patient was 52 years old, for COVID-19 Immunization. The following information was reported: CATARACT (disability) with onset 15Sep2021 12:00, outcome "not recovered", described as "Advanced cataracts"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 16Aug2021 13:00, outcome "unknown", described as "dose 1 02Aug2021/dose 2 on 16Aug2021 13:00". The event "advanced cataracts" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of cataract.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dehydration, Immunisation, Pyrexia, Syncope
Clinical narrative: fainted; fever of 102; dehydrated; booster; This is a spontaneous report received from contactable reporter consumer or other non HCP . The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 08Dec2021 15:00 (batch/lot number: FTJ1620) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. The facility where the most recent COVID-19 vaccine was administered was in a pharmacy or drug store. Relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included: lisinopril; cetirizine hydrochloride (ZYRTEC ALLERGY). Vaccination history included: bnt162b2 (dose 1, batch/lot no: En6198, arm left, at 15:00 PM), administration date: 22Feb2021, when the patient was 51 years old, for Covid-19 immunization; bnt162b2 (dose 2, batch/lot no: EN 6206, arm left, at 15:00 PM), administration date: 15Mar2021, when the patient was 51 years old, for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: IMMUNISATION (medically significant) with onset 08Dec2021 15:00, outcome "unknown", described as "booster"; SYNCOPE (medically significant) with onset 10Dec2021 12:00, outcome "recovered" (Dec2021), described as "fainted"; PYREXIA (non-serious) with onset 10Dec2021 12:00, outcome "recovered" (Dec2021), described as "fever of 102"; DEHYDRATION (non-serious) with onset 10Dec2021 12:00, outcome "recovered" (Dec2021), described as "dehydrated". The events "fainted", "fever of 102" and "dehydrated" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: body temperature: 102. The patient has not been tested for COVID-19 since the vaccination. Therapeutic measures were taken as a result of syncope, pyrexia, dehydration which included IV fluids.  Additional information: The patient informed that 2 days after receiving the booster, she fainted on the street. The patient had a fever of 102 for 2 days and despite attempts was really dehydrated. The patient informed that this was far worse experience than the previous 2 doses.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Fall, Headache, Immunisation
Clinical narrative: Passed out/Collapse; Really cold; Clammy; Headache; fall; feeling dizzy; Pale; booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 11Dec2021 (Lot number: FE3594) at the age of 16 years as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, dose 1, single), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 11Dec2021, outcome "unknown", described as "booster"; LOSS OF CONSCIOUSNESS (medically significant) with onset 12Dec2021 07:00, outcome "recovered" (12Dec2021), described as "Passed out/Collapse"; NASOPHARYNGITIS (non-serious) with onset 12Dec2021 07:00, outcome "recovered" (12Dec2021), described as "Really cold"; COLD SWEAT (non-serious) with onset 12Dec2021 07:00, outcome "recovered" (12Dec2021), described as "Clammy"; HEADACHE (non-serious) with onset 12Dec2021 07:00, outcome "recovered" (12Dec2021), described as "Headache"; FALL (non-serious) with onset 12Dec2021 07:00, outcome "unknown", described as "fall"; DIZZINESS (non-serious) with onset 12Dec2021 07:00, outcome "unknown", described as "feeling dizzy"; PALLOR (non-serious) with onset 12Dec2021 07:00, outcome "unknown", described as "Pale". Clinical course: There were no prior vaccinations within 4 weeks. The patient did not even get her flu shot yet. The patient received the booster yesterday around noon and this morning, she just, out of the blue, she just collapsed, she passed out and she was really cold and clammy. Also, she had a headache. This has never happened before. The mother made sure that she gets her fluids. She was really cold and clammy. She just had her lie down in bed actually for like half an hour and just monitored her. The patient was cold, clammy and pale and she was dizzy and she has never had that. She passed out. They were upstairs in our bedroom and she hit the floor, we heard her, we heard her fall, it was a big bang and it was her on the ground.; Sender's Comments: Based on known temporal association, there is reasonable possibility of causal association between the event Immunisation, Loss of consciousness, Nasopharyngitis, Cold sweat, Headache, fall, Dizziness, Pallor and the suspect drug 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.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Nasopharyngitis, Pallor
Clinical narrative: Passed out/Collapse; Really cold; Clammy; Headache; fall; feeling dizzy; Pale; booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 11Dec2021 (Lot number: FE3594) at the age of 16 years as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, dose 1, single), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 11Dec2021, outcome "unknown", described as "booster"; LOSS OF CONSCIOUSNESS (medically significant) with onset 12Dec2021 07:00, outcome "recovered" (12Dec2021), described as "Passed out/Collapse"; NASOPHARYNGITIS (non-serious) with onset 12Dec2021 07:00, outcome "recovered" (12Dec2021), described as "Really cold"; COLD SWEAT (non-serious) with onset 12Dec2021 07:00, outcome "recovered" (12Dec2021), described as "Clammy"; HEADACHE (non-serious) with onset 12Dec2021 07:00, outcome "recovered" (12Dec2021), described as "Headache"; FALL (non-serious) with onset 12Dec2021 07:00, outcome "unknown", described as "fall"; DIZZINESS (non-serious) with onset 12Dec2021 07:00, outcome "unknown", described as "feeling dizzy"; PALLOR (non-serious) with onset 12Dec2021 07:00, outcome "unknown", described as "Pale". Clinical course: There were no prior vaccinations within 4 weeks. The patient did not even get her flu shot yet. The patient received the booster yesterday around noon and this morning, she just, out of the blue, she just collapsed, she passed out and she was really cold and clammy. Also, she had a headache. This has never happened before. The mother made sure that she gets her fluids. She was really cold and clammy. She just had her lie down in bed actually for like half an hour and just monitored her. The patient was cold, clammy and pale and she was dizzy and she has never had that. She passed out. They were upstairs in our bedroom and she hit the floor, we heard her, we heard her fall, it was a big bang and it was her on the ground.; Sender's Comments: Based on known temporal association, there is reasonable possibility of causal association between the event Immunisation, Loss of consciousness, Nasopharyngitis, Cold sweat, Headache, fall, Dizziness, Pallor and the suspect drug 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: Chills, Fatigue, Headache, Immunisation, Malaise
Clinical narrative: This is a spontaneous report received from a contactable reporter. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 Immunization; Bnt162b2 (DOSE:2), for Covid-19 Immunization. The following information was reported: immunization, malaise, fatigue and headache.  Additional information: The expiry date, NDC and UPC number of BNT162B2 was unknown. The patient was unwilling to complete the report when asked for no lot number. The patient got booster dose Wednesday afternoon and by Thursday evening was really wasn't feeling good, and started having chills really bad, and was just really tired, so went to bed. On Friday, the patient did not go to work but worked from home and was feeling quite a bit better although still got a headache every once in a while, and was just kind of a little more tired than normal and needed to go to work next week 'quite' every day. So just wanted to make sure that it's safe to go to work. The patient was informed about the role of the Pfizer Drug Safety and also informed that Pfizer Medical Information is the concerned department to answer the question that patient had regarding the vaccine and offered the number. The patient was provided with the number of Pfizer Medical Information number and was requested to select option 3, timings as and 8 am to 8 pm Monday to Fridays as per (EST). When requested to probe to file a safety report, patient was getting text on cell phone after the first and second vaccine and told that it was okay and don't think it's safety report and thought the events were more of a reaction and they were very mild and wanted to make sure that it was okay to be around people. Further probing could not be done as the patient was unwilling to share any further information. Hence limited information available over the call. QR Comment: Reporter type could not be probed as the consumer was unwilling to share any further information, hence limited information available over the call. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Immunisation, Myalgia
Clinical narrative: muscle and joint aches; muscle and joint aches; headache; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 10Dec2021 11:00 (Lot number: FF2589) as dose 3, (booster) single for covid-19 immunisation. Relevant medical history included: "birth control pill" (unspecified if ongoing). Concomitant medication(s) included: TDAP, administration date 15Nov2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Vaccine Administration Time: 12:00 PM, Route of Administration: Intramuscular), administration date: 22Mar2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Vaccine Administration Time: 02:15 PM, Route of Administration: Intramuscular), administration date: 01Mar2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021 11:00, outcome "unknown", described as "Booster"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 10Dec2021 20:00, outcome "recovered" (2021) and all described as "muscle and joint aches"; HEADACHE (non-serious) with onset 10Dec2021 20:00, outcome "recovered" (2021), described as "headache". Therapeutic measures were taken as a result of myalgia, arthralgia, headache.   Additional information: AE treatment - Ibuprofen. If covid prior vaccination - No. If covid tested post vaccination - No. known allergies -no. Other medications in two weeks - birth control pill.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Swelling
Clinical narrative: I got a Pfizer booster a couple; Armpit on that side is all swollen like it is full of fluid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3, (booster) single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1st), for COVID-19 immunization; Bnt162b2 (DOSE: 2nd), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "I got a Pfizer booster a couple"; SWELLING (non-serious), outcome "unknown", described as "Armpit on that side is all swollen like it is full of fluid".  Additional Information: Patient got a Pfizer booster a couple of days ago and armpit on that side was all swollen like it was full of fluid and asked if that was normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Fatigue, Feeling abnormal, Immunisation
Clinical narrative: Recurring Fever; chills; nausea; severe body aches; severe exhaustion; not clear headed; chest pressure; almost fainted right after the infections 2 & 3; respiratory issues; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Dec2021 10:00 (Lot number: Fj8762) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "covid", start date: 10Dec2020 (unspecified if ongoing), notes: Had covid 10Dec2020. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: Er2613, prev dose lot unknown: False, prev dose administration date: 15Apr2021, prev dose administration time: 04:00 PM, prev dose number: 2, prev dose vaccine location: Left arm), administration date: 15Apr2021, when the patient was 49 years old, for Covid-19 Immunization, reaction(s): "Exhausted"; Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: Er2613, prev dose lot unknown: False, prev dose administration date: 18Mar2021, prev dose administration time: 09:00 PM, prev dose number: 1), administration date: 18Mar2021, when the patient was 49 years old, for Covid-19 Immunization, reaction(s): "Exhausted".  The following information was reported: IMMUNISATION (non-serious) with onset 11Dec2021 10:00, outcome "unknown", described as "Booster"; PYREXIA (non-serious), outcome "recovering", described as "Recurring Fever"; CHILLS (non-serious), outcome "recovering", described as "chills"; NAUSEA (non-serious), outcome "recovering", described as "nausea"; PAIN (non-serious), outcome "recovering", described as "severe body aches"; FATIGUE (non-serious), outcome "recovering", described as "severe exhaustion"; FEELING ABNORMAL (non-serious), outcome "recovering", described as "not clear headed"; CHEST DISCOMFORT (non-serious), outcome "recovering", described as "chest pressure"; PRESYNCOPE (non-serious), outcome "recovering", described as "almost fainted right after the infections 2 & 3"; RESPIRATORY DISORDER (non-serious), outcome "recovering", described as "respiratory issues". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, nausea, pain, fatigue, feeling abnormal, chest discomfort, presyncope. Therapeutic measures were taken as a result of respiratory disorder.  No follow-up attempts are possible. No further information is expected.