chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Night sweats, Vaccination site pain
Clinical narrative: Night sweats; soreness at injection site; light headed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 at 11:30 as dose 4 (booster), single (Lot number: fl3197) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]; TYLENOL. Vaccination history included: Covid-19 vaccine (Dose 1, primary series immunization completed but manufactured name unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, primary series immunization completed but manufactured name unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, Manufactured name unknown), for COVID-19 Immunization. The following information was reported: NIGHT SWEATS (non-serious) with onset 14Apr2022 at 22:00, outcome "recovering"; DIZZINESS (non-serious) with onset 14Apr2022 at 22:00, outcome "recovering", described as "light headed"; VACCINATION SITE PAIN (non-serious) with onset 14Apr2022 at 22:00, outcome "recovering", described as "soreness at injection site". Therapeutic measures were not taken as a result of night sweats, vaccination site pain, dizziness.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Advil, Tylenol within 2 weeks of vaccination. The patient was not tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no known allergies.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Loss of personal independence in daily activities
Clinical narrative: he developed arthritis in his right wrist; couldn't play guitar for several months; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A male patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported.  The following information was reported: ARTHRITIS (non-serious), outcome "unknown", described as "he developed arthritis in his right wrist"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "couldn't play guitar for several months".  Additional Information: It was reported that on 16Apr2022, at approximately 3:15 a cruise entertainer (musician/comedian) stated during a public musical performance in front of approximately 75 people that he got the first COVID-19 vaccine, second COVID-19 vaccine and third COVID-19 booster (all from Pfizer). He said that he developed arthritis in his right wrist and couldn't play guitar for several months. He stated that he did research (which he suggested that we could do yourselves in the internet) and the vaccine had also caused a similar problem for (name withheld) who was affected for about 9 months. He further started something to the effect of if I mess up the next song you can blame Pfizer.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Neck pain, Pain, Rhinorrhoea
Clinical narrative: Headache; neck pain; minor injection site pain; body aches within 24 hours; runny nose; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 at 11:45 as dose 4 (booster), single (Lot number: FH8041) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing). Concomitant medication(s) included: VERAPAMIL. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FF8841, Location of injection: Arm Left), administration date: 20Oct2021, when the patient was 58-year-old, for COVID-19 immunisation; Covid-19 vaccine (Dose Number:2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose Number:1, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 14Apr2022 at 17:30, outcome "recovering"; PAIN (non-serious) with onset 14Apr2022 at 17:30, outcome "recovering", described as "body aches within 24 hours"; FATIGUE (non-serious) with onset 14Apr2022 at 17:30, outcome "recovering"; VACCINATION SITE PAIN (non-serious) with onset 14Apr2022 at 17:30, outcome "recovering", described as "minor injection site pain"; NECK PAIN (non-serious) with onset 14Apr2022 at 17:30, outcome "recovering"; RHINORRHOEA (non-serious) with onset 14Apr2022 at 17:30, outcome "recovering", described as "runny nose". Therapeutic measures were not taken as a result of headache, neck pain, vaccination site pain, pain, rhinorrhoea, fatigue.  Additional information: facility type vaccine was workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Any other medications the patient received within 2 weeks of vaccination were Ritual multi-vitamin, Verapamil 240 mg daily. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies. Device timestamp was on 15Apr2022.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Headache; neck pain; minor injection site pain; body aches within 24 hours; runny nose; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 at 11:45 as dose 4 (booster), single (Lot number: FH8041) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing). Concomitant medication(s) included: VERAPAMIL. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FF8841, Location of injection: Arm Left), administration date: 20Oct2021, when the patient was 58-year-old, for COVID-19 immunisation; Covid-19 vaccine (Dose Number:2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose Number:1, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 14Apr2022 at 17:30, outcome "recovering"; PAIN (non-serious) with onset 14Apr2022 at 17:30, outcome "recovering", described as "body aches within 24 hours"; FATIGUE (non-serious) with onset 14Apr2022 at 17:30, outcome "recovering"; VACCINATION SITE PAIN (non-serious) with onset 14Apr2022 at 17:30, outcome "recovering", described as "minor injection site pain"; NECK PAIN (non-serious) with onset 14Apr2022 at 17:30, outcome "recovering"; RHINORRHOEA (non-serious) with onset 14Apr2022 at 17:30, outcome "recovering", described as "runny nose". Therapeutic measures were not taken as a result of headache, neck pain, vaccination site pain, pain, rhinorrhoea, fatigue.  Additional information: facility type vaccine was workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Any other medications the patient received within 2 weeks of vaccination were Ritual multi-vitamin, Verapamil 240 mg daily. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies. Device timestamp was on 15Apr2022.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Upper left arm pain (around injection site); mild headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55-year-old female patient received BNT162b2 (BNT162B2), on 14Apr2022 at 11:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD and mild mitral valve prolapse" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM, Route of Administration: Intramuscular), administration date: 18Mar2021, reaction(s): "covid-19 immunization"; BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 01:45 PM, Route of Administration: Intramuscular), administration date: 25Feb2021, reaction(s): "Covid-19 immunization". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 14Apr2022 at 15:00, outcome "not recovered", described as "Upper left arm pain (around injection site)"; HEADACHE (non-serious) with onset 14Apr2022 at 15:00, outcome "not recovered", described as "mild headache". Therapeutic measures were not taken as a result of vaccination site pain, headache.  Additional Information: Patient current age is 55. Gender Female. Dose received 3. Administration date 14Apr2022, route Intramuscular, time 11:30 AM, Vaccine location Left Arm. Previous dose details product COVID 19, administration date 18Mar2021, administration time 02:30 PM, dose number 2, vaccine location Left arm. Previous dose details product COVID 19. dose number 1, administrator route Intramuscular, date 25Feb2021, time 01:45 PM. vaccine location Left arm. No other vaccine in four weeks. Other medications in twoweeks Vitamin D. Adverse event Upper left arm pain (around injection site), mild headache. start date 14Apr2022. start time 03:00 PM. patient not recovered. No treatment ae. Yes Covid-19 prior vaccination. No Covid-19 tested post vaccination. Other medical history GERD and mild mitral valve prolapse.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular, Thrombosis
Clinical narrative: big blood clots; heavy menstrual cycle for two times a month; heavy menstrual cycle for two times a month/ Very heavy bleeding. Much heavier than ever before; Started getting much more severe cramping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jan2022 as dose 3 (booster), single (Lot number: RJ5683) at the age of 17 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Fiber, reaction(s): "Known allergies: Fiber"; Penicillin, reaction(s): "Known allergies: Penicillin". Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0168), administration date: 06May2021, when the patient was 16-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0151), administration date: 15Apr2021, when the patient was 16-year-old, for Covid-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "not recovered", described as "big blood clots"; MENSTRUATION IRREGULAR (non-serious), outcome "not recovered", described as "heavy menstrual cycle for two times a month"; HEAVY MENSTRUAL BLEEDING (non-serious), outcome "not recovered", described as "heavy menstrual cycle for two times a month/ Very heavy bleeding. Much heavier than ever before"; DYSMENORRHOEA (non-serious), outcome "not recovered", described as "Started getting much more severe cramping". The events "big blood clots", "heavy menstrual cycle for two times a month", "heavy menstrual cycle for two times a month/ very heavy bleeding. much heavier than ever before" and "started getting much more severe cramping" required physician office visit. Therapeutic measures were not taken as a result of thrombosis, menstruation irregular, heavy menstrual bleeding, dysmenorrhea. Clinical course: After the first vaccine. Patient Started having heavy menstrual cycle for two times a month. Each lasting 10 days. Only getting 10 days off in between periods. Would start having ovulation symptoms in the middle of period. Nothing was able to be found on lab work and ultrasounds of pelvic and uterus. Everything comes back as normal. Period had never been this bad until first vaccine. Has stayed like this until now (17Apr2022). Very heavy bleeding. Much heavier than ever before. Started getting much more severe cramping and getting big blood clots that would not even dissolve in water. Patient did not tested for covid post vaccination. patient did not experienced covid prior to vaccination. Patient did not get administered with other vaccines in 4 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Illness, Musculoskeletal discomfort
Clinical narrative: I have never been so cold; freezing to death; My neck was killing me; I got sick with my first one; severe chills; ache all over; my whole body hurt; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6200) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma; "Blood pressure" (unspecified if ongoing), notes: Blood pressure. Concomitant medication(s) included: ARFORMOTEROL TARTRATE taken for asthma; AMLODIPINE BENAZEPRIL taken for blood pressure measurement. The following information was reported: FEELING COLD (non-serious), outcome "unknown", described as "I have never been so cold; freezing to death"; CHILLS (non-serious), outcome "recovered", described as "severe chills"; PAIN (non-serious), outcome "recovered", described as "ache all over; my whole body hurt"; HEADACHE (non-serious), outcome "recovered"; MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "My neck was killing me"; ILLNESS (non-serious), outcome "unknown", described as "I got sick with my first one".  Additional Information: The patient received severe chills and headache and ache all over. The patient had it for only 8 hours and then it was gone. The patient stated that she had her whole body hurt. Her neck was killing her and she had never been so cold. She had the chills so bad, she have never been so cold. The patient stated that she did not take anything because she did not run fever. The patient received second booster on 16Apr2022.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: I have never been so cold; freezing to death; My neck was killing me; I got sick with my first one; severe chills; ache all over; my whole body hurt; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6200) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma; "Blood pressure" (unspecified if ongoing), notes: Blood pressure. Concomitant medication(s) included: ARFORMOTEROL TARTRATE taken for asthma; AMLODIPINE BENAZEPRIL taken for blood pressure measurement. The following information was reported: FEELING COLD (non-serious), outcome "unknown", described as "I have never been so cold; freezing to death"; CHILLS (non-serious), outcome "recovered", described as "severe chills"; PAIN (non-serious), outcome "recovered", described as "ache all over; my whole body hurt"; HEADACHE (non-serious), outcome "recovered"; MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "My neck was killing me"; ILLNESS (non-serious), outcome "unknown", described as "I got sick with my first one".  Additional Information: The patient received severe chills and headache and ache all over. The patient had it for only 8 hours and then it was gone. The patient stated that she had her whole body hurt. Her neck was killing her and she had never been so cold. She had the chills so bad, she have never been so cold. The patient stated that she did not take anything because she did not run fever. The patient received second booster on 16Apr2022.
Sex: M
Vaccine: COVID19
Symptoms: Arterial thrombosis, Atrial fibrillation
Clinical narrative: 2 weeks after receiving 4th dose patient was noted to have A Fib and arterial thrombus in leg.; 2 weeks after receiving 4th dose patient was noted to have A Fib and arterial thrombus in leg.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 75-year-old male patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Other medical history: hypertension. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; VALSARTAN. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ATRIAL FIBRILLATION (hospitalization, medically significant), ARTERIAL THROMBOSIS (hospitalization) all with onset Apr2022, outcome "unknown" and all described as "2 weeks after receiving 4th dose patient was noted to have A Fib and arterial thrombus in leg.". The events "2 weeks after receiving 4th dose patient was noted to have a fib and arterial thrombus in leg." required physician office visit and emergency room visit. Therapeutic measures were taken as a result of atrial fibrillation, arterial thrombosis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events atrial fibrillation and arterial thrombosis 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.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 86-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabiates" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Manufacture by-  Pfizer, Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 01Feb2022, outcome "not recovered", described as "shingles". The event "shingles" required physician office visit. Therapeutic measures were taken as a result of herpes zoster.  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, Diabetes mellitus, Immune system disorder
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). A 55-year-old male patient 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: DIABETES MELLITUS (death), outcome "fatal", described as "Cause he's got diabetes and even though he got the vaccine"; IMMUNE SYSTEM DISORDER (death), outcome "fatal", described as "his immune system is done"; COVID-19 (death), outcome "fatal", described as "died of COVID after being vaccinated". The patient date of death was unknown. Reported cause of death: "Cause he's got diabetes and even though he got the vaccine", "his immune system is done". It was not reported if an autopsy was performed. Clinical course: Dr. reports another Patient died of COVID after being vaccinated. We just lost a fifty-five-year-old. A grandpa and I'm a grandpa. Cause he's got diabetes and even though he got the vaccine, his immune system is done because he has to get part of a liver and he didn't make it. Reports his daughter required surgery after taking Celebrex. She became allergic to Tylenol, Motrin, we had to do Celebrex and then she had to have three hundred thousand dollars' worth of sinus surgery. It came out of nowhere. Reports another Patient experienced side effects while taking Eucrisa and it's an oral pill and there can be some stomach, the Dupixent has worked so well I would only use that, and I used it on two college students. They're beautiful girls. But it gets on their face despite Dupixent and their neck. This is a sensitive area. So, and the Eucrisa was burning her all the time. And girls, they like to look good. They don't like to look yucky, right. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on limited information in the case, a possible causal association between  the reported fatal events Diabetes mellitus, Immune system disorder, COVID-19 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. Reported Cause(s) of Death: his immune system is done; Cause he's got diabetes and even though he got the vaccine.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Covid positive on Monday; Covid positive on Monday; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), in Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset Apr2022, outcome "unknown" and all described as "Covid positive on Monday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, sars-cov-2 test positive.  Clinical Course: The patient was treated with PAXLOVID for COVID-19 and started experiencing Tinnitus which led to disability/permanent damage.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Pain, Pruritus
Clinical narrative: She states she felt icky; she felt like the flu so achy and icky and that was all. She states she can tolerate those symptoms; she felt like the flu so achy and icky and that was all. She states she can tolerate those symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 87-year-old female patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 2, single (Lot number: EN6203) at the age of 86 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SULFASALAZINE; FUROSEMIDE; FOLIC ACID; ATORVASTATIN; METOPROLOL taken for blood pressure measurement; PREDNISONE taken for arthritis; RABEPRAZOLE taken for abdominal discomfort. Vaccination history included: BNT162b2 (Dose number:01, Manufacturer: Pfizer, Batch number: EM9810), administration date: 09Feb2021, when the patient was 86-year-old, for Covid-19 immunization. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "She states she felt icky"; PAIN (non-serious), INFLUENZA (non-serious), outcome "unknown" and all described as "she felt like the flu so achy and icky and that was all. She states she can tolerate those symptoms".  Additional information: she has been on Sulfasalazin for a long time. Caller states she doesn't know why she is taking Sulfasalazin but has something to do with the liver or the kidneys. Caller states she was on 4 of those pills but is now only on 2. She clarified the medication was for her kidneys. Metoprolol: Caller stated she used to take 2 but was cut back to 1 tablet because her blood pressure was to high and the medication was to get her blood pressure back down. She stated she had been on Metoprolol for a long time like 10-15 years. Her blood pressure was 140 or 144 but is down to 110 now. She stated the nerve in her neck that has degenerated with old age is causing her balance to be off and she could not drive a car. She stated she fought with this all winter.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Nasal congestion, Oropharyngeal pain
Clinical narrative: Tested positive for COVID-19 on 4/13/2022; Tested positive for COVID-19 on 4/13/2022; sore throat; cough; congestion; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6206), on 03Apr2021 as dose 2, single (Lot number: EP7533) and on 30Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE, COVID-19 all with onset 13Apr2022, outcome "unknown" and all described as "Tested positive for COVID-19 on 4/13/2022"; NASAL CONGESTION (non-serious) with onset 13Apr2022, outcome "unknown", described as "congestion"; COUGH (non-serious) with onset 13Apr2022, outcome "unknown"; FATIGUE (non-serious) with onset 13Apr2022, outcome "unknown"; OROPHARYNGEAL PAIN (non-serious) with onset 13Apr2022, outcome "unknown", described as "sore throat". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Apr2022) Positive.  Clinical courses: No covid prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19 on 4/13/2022; Tested positive for COVID-19 on 4/13/2022; sore throat; cough; congestion; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6206), on 03Apr2021 as dose 2, single (Lot number: EP7533) and on 30Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE, COVID-19 all with onset 13Apr2022, outcome "unknown" and all described as "Tested positive for COVID-19 on 4/13/2022"; NASAL CONGESTION (non-serious) with onset 13Apr2022, outcome "unknown", described as "congestion"; COUGH (non-serious) with onset 13Apr2022, outcome "unknown"; FATIGUE (non-serious) with onset 13Apr2022, outcome "unknown"; OROPHARYNGEAL PAIN (non-serious) with onset 13Apr2022, outcome "unknown", described as "sore throat". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Apr2022) Positive.  Clinical courses: No covid prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Fatigue, Vulvovaginal dryness
Clinical narrative: occasional flare up of ulcerative colitis; Fatigue; Vaginal dryness; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4358047-00.  A 64-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, on 26Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 16Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for colitis ulcerative. The patient's relevant medical history included: "lichen sclerosus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COLITIS ULCERATIVE (medically significant), outcome "unknown", described as "occasional flare up of ulcerative colitis"; FATIGUE (non-serious), outcome "unknown"; VULVOVAGINAL DRYNESS (non-serious), outcome "unknown", described as "Vaginal dryness". The action taken for adalimumab was unknown.  The reporter considered "occasional flare up of ulcerative colitis", "fatigue" and "vaginal dryness" related to BNT162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The events of colitis ulcerative, vulvovaginal dryness, fatigue is assessed as possibly related to the suspect drug "BNT162B2" based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications.  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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, SARS-CoV-2 test
Clinical narrative: Frequent hypoxia began within 1 month of 2nd shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Lot number: EW0164) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing), notes: Other medical history: GERD, IBS, asthma, COPD; "IBS" (unspecified if ongoing), notes: Other medical history: GERD, IBS, asthma, COPD; "asthma" (unspecified if ongoing), notes: Other medical history: GERD, IBS, asthma, COPD; "COPD" (unspecified if ongoing), notes: Other medical history: GERD, IBS, asthma, COPD. The patient took concomitant medications. Past drug history included: Macrodantin, reaction(s): "Known allergies: Macrodantin", notes: Known allergies: Macrodantin, Morphine; Morphine, reaction(s): "Known allergies: Morphine", notes: Known allergies: Macrodantin, Morphine. Vaccination history included: BNT162b2 (Product: COVID 19, Brand: Pfizer, Brand unknown: False, Lot number: ER2613, Lot unknown: False, Administration date: 26Mar2021, Administration time: 05:30 PM, Dose number: 1, Vaccine location: Left arm), administration date: 26Mar2021, when the patient was 59-year-old, for Covid-19 immunization, reaction(s): "Long term memory loss". The following information was reported: HYPOXIA (medically significant) with onset 20May2021, outcome "recovered with sequelae", described as "Frequent hypoxia began within 1 month of 2nd shot". The event "frequent hypoxia began within 1 month of 2nd shot" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of hypoxia.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Indication for use in the case: Treatment of COVID-19; Indication for use in the case: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: F-EP7533) and on 20Apr2021 as dose 2, single (Lot number: FCEW0151) at the age of 51 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Indication for use in the case: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No known allergies and other medical history. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: cancer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. 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: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "cancer".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Therapeutic product effect decreased
Clinical narrative: Broke out in big mass; Drug effect decreased; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4357422-00 (Company).  A 57-year-old female patient received BNT162b2 (BNT162B2), on 05Oct2021 as dose 1, single (Batch/Lot number: unknown) and on 02Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 56 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC PRODUCT EFFECT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "Drug effect decreased"; MASS (medically significant), outcome "unknown", described as "Broke out in big mass". The action taken for adalimumab was unknown.  The reporter considered "broke out in big mass" and "drug effect decreased" related to BNT162b2.  Clinical Course: On an unknown date, the patient experienced broke out in big mass. In 2021, the patient experienced Humira stopped working. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown that if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (Adalimumab), The reporter' s causality for the event (s) of Broke Out in Big Mass and Humira stopped working was not provided. Causality for Pfizer BioNTech Covid-19 Vaccine Drug (Tozinameran), Unknown, Unknown, Causality as per reporter (Drug/Vaccine): Possible  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events mass and therapeutic product effect decreased 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Sporadic dizziness.  Happens without warning.  Only lasts around 10 seconds, but is strong enough that I often must grab onto a table, chair, or wall to feel like I'm stable and will not fall.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), on 18Sep2021 as dose 2, single (Lot number: ff2589) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, lot number: fa7485, Location of injection: Left Arm), administration date: 25Aug2021, when the patient was 48-year-old, for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset Oct2021, outcome "not recovered", described as "Sporadic dizziness.  Happens without warning.  Only lasts around 10 seconds, but is strong enough that I often must grab onto a table, chair, or wall to feel like I'm stable and will not fall.". Therapeutic measures were not taken as a result of dizziness.  Additional information:  Patient was no covid prior to vaccination. Patient was covid tested post vaccination. Sporadic dizziness. Happens without warning. Only lasts around 10 seconds, but is strong enough that I often must grab onto a table, chair, or wall to feel like I'm stable and will not fall.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pityriasis rosea, Pruritus, Rash
Clinical narrative: have developed pityriasis rosea on my entire body; rash started gradually on my face but has been getting worse while spreading down the rest of my body; It is extremely itchy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old male patient received BNT162b2 (BNT162B2), on 14Mar2022 at 19:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 25 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing). 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 unknown: True, prev dose lot unknown reason: Not, available/provided to reporter at the time of report completion, prev dose administration date: 13May2021, prev dose administration time: 12:00 PM prev dose dose number: 2, prev dose vaccine location: Left arm), administration date: 13May2021, when the patient was 24-year-old, for Covid-19 immunization; BNT162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot unknown: True, prev dose lot unknown reason: Not, available/provided to reporter at the time of report completion, prev dose administration date: 13Apr2021, prev dose administration time: 12:00 PM prev dose dose number: 1, prev dose vaccine location: Left arm), administration date: 13Apr2021, when the patient was 24-year-old, for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 03Apr2022 at 12:00, outcome "recovering", described as "It is extremely itchy"; PITYRIASIS ROSEA (non-serious) with onset 03Apr2022 at 12:00, outcome "recovering", described as "have developed pityriasis rosea on my entire body"; RASH (non-serious) with onset 03Apr2022 at 12:00, outcome "recovering", described as "rash started gradually on my face but has been getting worse while spreading down the rest of my body". The events "have developed pityriasis rosea on my entire body", "rash started gradually on my face but has been getting worse while spreading down the rest of my body" and "it is extremely itchy" required physician office visit. Therapeutic measures were taken as a result of pityriasis rosea, rash, pruritus.  Additional information: I have developed pityriasis rosea on my entire body, this has been confirmed by 4 separate doctors. The rash started gradually on my face but has been getting worse while spreading down the rest of my body. It is extremely itchy. Patient has covid prior to vaccination and no covid tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: after 2nd shot, fatigue 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 75 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer", start date: Apr2019 (ongoing), notes: Pertinent details: Mastectomy 2019; "Chronic bronchotis", start date: Oct2021 (ongoing), notes: Pertinent details: Inhaler & Monthly testing. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1st, Date: 04Jan2021, Time: 10:00 AM, Anatomical site of Injection: Right arm, Route of administration: Intramuscular, Batch/Lot number: Not Available), administration date: 04Jan2021, when the patient was 75-year-old, for Covid-19 immunization.  The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "after 2nd shot, fatigue 2 days".  Additional information: The patient had third dose on an unknown date in Octob2021 in right arm. The patient received 1st and 2nd vaccine in assisted living home; 3rd and 4th in an hospital. The patient had no prior vaccinations nor had any concomitant medications. It was unknown if patient had any relevant test for thromboembolic events with thrombocytopenia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 1.25
Sex: M
Vaccine: DT
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 15 month old patient was given DT and not the prescribed Daptacel,with no reported adverse event; Initial information received on 11-Apr-2022 regarding an unsolicited valid  non-serious case received from health professional and Physician.  This case involves a 15 months old male patient who experienced 15 month old patient was given DIPHTHERIA AND TETANUS TOXOIDS (dt) and not the prescribed daptacel,with no reported adverse event.  This case is linked to case 2022SA128715(Companion Case).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination.  On 08-Apr-2022, the patient received a  dose of suspect DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer at dose 0.5 ml once lot C5733AA via intramuscular route in right thigh for Prophylactic vaccination.  On 08-APR-2022, it was reported 15 month old patient was given dt and not the prescribed daptacel,with no reported adverse event (wrong product administered) latency same day following the administration of DIPHTHERIA AND TETANUS TOXOIDS.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TD, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: The vaccines were stored at 18 F for approximately 30 days with no reported adverse event; Initial information received on 11-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 9 patients who experienced the vaccines were stored at 18 f for approximately 30 days with no reported adverse event while receiving vaccines Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [tenivac] and diphtheria-2/tetanus/5 ac pertussis vaccine [adacel] and while treated with tuberculin test [tubersol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient started taking Tubersol (tuberculin test) Solution for injection once (strength, dose :unknown) (lot - C5823BA) for Immunization, Diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (strength, dose : unknown) lot U73068A via unknown route in unknown administration site for immunization, Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult ( (strength, dose :unknown) lot U7189AA via unknown route in unknown administration site for immunization.  On an unknown date the patient 's developed a non-serious the vaccines were stored at 18 f for approximately 30 days with no reported adverse event (product storage error) (unknown latency) following the first dose intake of Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [tenivac] and diphtheria-2/tetanus/5 ac pertussis vaccine and while treated with tuberculin test.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (The vaccines were stored at 18 F for approximately 30 days with no reported adverse event).  At time of reporting, the outcome was Unknown for the event the vaccines were stored at 18 f for approximately 30 days with no reported adverse event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.