chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Computerised tomogram, Depression, Insomnia, Quality of life decreased
Clinical narrative: has not been sleeping well/ does not think she slept at all and has not had deep sleep in a while; depression; anxiety; affecting her quality of life; humming or hissing sound, on and off/heard a loud noise in her ear, was a loud, distracting noise and turned into high pitch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101064933 (Pfizer).  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 24May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Flu" (not ongoing), notes: When she was 11, she got the flu and since then, she never got the flu again. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset May2021, outcome "not recovered", described as "humming or hissing sound, on and off/heard a loud noise in her ear, was a loud, distracting noise and turned into high pitch"; INSOMNIA (non-serious), outcome "unknown", described as "has not been sleeping well/ does not think she slept at all and has not had deep sleep in a while"; DEPRESSION (non-serious), outcome "unknown", described as "depression"; ANXIETY (non-serious), outcome "unknown", described as "anxiety"; QUALITY OF LIFE DECREASED (non-serious), outcome "unknown", described as "affecting her quality of life". The event "humming or hissing sound, on and off/heard a loud noise in her ear, was a loud, distracting noise and turned into high pitch" 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 insomnia, depression. Therapeutic measures were not taken as a result of anxiety.  Additional information: Almost immediately after vaccination, sometime in May2021, she noticed a humming or hissing sound, on and off until the week of 12Jul2021. She turned off the sound, as she was watching TV, when she heard a loud noise in her ear. She went out had her ears cleaned out, but the ringing was still there. It has been chronic since Jul2021 and has not gone away. One morning she woke up at 4 am and it was like a buzzing in the back of her head. She has not been sleeping well since the chronic tinnitus and ringing in her ear. She took Xanax to help her sleep and it was not working anymore. She was now taking Lexapro 10mg for depression and anxiety. She saw an ENT and the hearing in her left ear was fine. The right ear was fine.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: has not been sleeping well/ does not think she slept at all and has not had deep sleep in a while; depression; anxiety; affecting her quality of life; humming or hissing sound, on and off/heard a loud noise in her ear, was a loud, distracting noise and turned into high pitch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101064933 (Pfizer).  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 24May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Flu" (not ongoing), notes: When she was 11, she got the flu and since then, she never got the flu again. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset May2021, outcome "not recovered", described as "humming or hissing sound, on and off/heard a loud noise in her ear, was a loud, distracting noise and turned into high pitch"; INSOMNIA (non-serious), outcome "unknown", described as "has not been sleeping well/ does not think she slept at all and has not had deep sleep in a while"; DEPRESSION (non-serious), outcome "unknown", described as "depression"; ANXIETY (non-serious), outcome "unknown", described as "anxiety"; QUALITY OF LIFE DECREASED (non-serious), outcome "unknown", described as "affecting her quality of life". The event "humming or hissing sound, on and off/heard a loud noise in her ear, was a loud, distracting noise and turned into high pitch" 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 insomnia, depression. Therapeutic measures were not taken as a result of anxiety.  Additional information: Almost immediately after vaccination, sometime in May2021, she noticed a humming or hissing sound, on and off until the week of 12Jul2021. She turned off the sound, as she was watching TV, when she heard a loud noise in her ear. She went out had her ears cleaned out, but the ringing was still there. It has been chronic since Jul2021 and has not gone away. One morning she woke up at 4 am and it was like a buzzing in the back of her head. She has not been sleeping well since the chronic tinnitus and ringing in her ear. She took Xanax to help her sleep and it was not working anymore. She was now taking Lexapro 10mg for depression and anxiety. She saw an ENT and the hearing in her left ear was fine. The right ear was fine.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Electrolyte imbalance, Heart rate irregular, SARS-CoV-2 antibody test
Clinical narrative: Developed erratic heart rate and irregular heart rate; Developed severe electrolyte imbalance; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Feb2021 09:00 (Lot number: EL9263) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Penicillin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/lot number: EL3247, Administration time: 09:00 AM.), administration date: 29Jan2021, when the patient was 39 years old, for Covid-19 immunisation. The following information was reported: HEART RATE IRREGULAR (non-serious) with onset 20Feb2021 18:00, outcome "recovered" (2021), described as "Developed erratic heart rate and irregular heart rate"; ELECTROLYTE IMBALANCE (non-serious) with onset 20Feb2021 18:00, outcome "recovered" (2021), described as "Developed severe electrolyte imbalance". The events "developed erratic heart rate and irregular heart rate" and "developed severe electrolyte imbalance" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of heart rate irregular, electrolyte imbalance.  Additional information: Patient developed erratic heart rate and irregular heart rate with 48 hours. No history of rate problems. Developed severe electrolyte imbalance within 48 hours of vaccine. Patient evaluated by Emergency Room staff at hospital, primary care physician and cardiologist. Patient received numerous medications for adverse events. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19 and since the vaccination, patient was tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Coordination abnormal, Dizziness, Fatigue, Gait disturbance, Headache
Clinical narrative: Loss of coordination; Dizzy; Headaches; Difficulty walking; Muscle weakness; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Aug2021 (Lot number: Ew0172) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; MARIJUANA. Past drug history included: Known allergies: codeine, reaction(s): "Known allergies: Codeine"; Known allergies: lortab, reaction(s): "Known allergies: lortab". The following information was reported: COORDINATION ABNORMAL (non-serious) with onset 18Aug2021, outcome "not recovered", described as "Loss of coordination"; DIZZINESS (non-serious) with onset 18Aug2021, outcome "not recovered", described as "Dizzy"; HEADACHE (non-serious) with onset 18Aug2021, outcome "not recovered", described as "Headaches"; GAIT DISTURBANCE (non-serious) with onset 18Aug2021, outcome "not recovered", described as "Difficulty walking"; MUSCULAR WEAKNESS (non-serious) with onset 18Aug2021, outcome "not recovered", described as "Muscle weakness"; FATIGUE (non-serious) with onset 18Aug2021, outcome "not recovered", described as "Fatigue". The events "loss of coordination", "dizzy", "headaches", "difficulty walking", "muscle weakness" and "fatigue" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of coordination abnormal, dizziness, headache, gait disturbance, muscular weakness, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment received for the adverse event are Physical therapy, iv, Topamax shot. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient not has been tested for COVID-19.Device Date mentioned as 29Sep2021 No follow-up attempts are possible. No further information is expected
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: Loss of coordination; Dizzy; Headaches; Difficulty walking; Muscle weakness; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Aug2021 (Lot number: Ew0172) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; MARIJUANA. Past drug history included: Known allergies: codeine, reaction(s): "Known allergies: Codeine"; Known allergies: lortab, reaction(s): "Known allergies: lortab". The following information was reported: COORDINATION ABNORMAL (non-serious) with onset 18Aug2021, outcome "not recovered", described as "Loss of coordination"; DIZZINESS (non-serious) with onset 18Aug2021, outcome "not recovered", described as "Dizzy"; HEADACHE (non-serious) with onset 18Aug2021, outcome "not recovered", described as "Headaches"; GAIT DISTURBANCE (non-serious) with onset 18Aug2021, outcome "not recovered", described as "Difficulty walking"; MUSCULAR WEAKNESS (non-serious) with onset 18Aug2021, outcome "not recovered", described as "Muscle weakness"; FATIGUE (non-serious) with onset 18Aug2021, outcome "not recovered", described as "Fatigue". The events "loss of coordination", "dizzy", "headaches", "difficulty walking", "muscle weakness" and "fatigue" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of coordination abnormal, dizziness, headache, gait disturbance, muscular weakness, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment received for the adverse event are Physical therapy, iv, Topamax shot. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient not has been tested for COVID-19.Device Date mentioned as 29Sep2021 No follow-up attempts are possible. No further information is expected
Age: 86.0
Sex: U
Vaccine: COVID19
Symptoms: Full blood count, Full blood count abnormal
Clinical narrative: CBC abnormal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 86-year-old patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 05Feb2021 13:00 (Lot number: EL9269) at the age of 86 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Irregular beats", start date: 2000 (ongoing); "pacemaker installed", start date: 10Mar2021, stop date: 10Mar2021; "macular degeneration", start date: 2006 (ongoing); "High blood pressure", start date: 1970 (ongoing); "High cholesterol" (ongoing), notes: Onset date: before 2017. Concomitant medication(s) included: PRESERVISION taken for macular degeneration, start date: 2001 (ongoing); VIT D [COLECALCIFEROL], start date: 2010 (ongoing); OMEPRAZOLE taken for gastrooesophageal reflux disease, start date: 2021 (ongoing).  The following information was reported: FULL BLOOD COUNT ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "CBC abnormal". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Investigation, Pain, Pyrexia, Urine analysis
Clinical narrative: Pain and Fever; Pain and Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 (Lot number: EN6205, Expiration Date: Jun2021) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hemochromatosis" (ongoing), notes: Illness/AE: Hemochromatosis, Onset date: genetic, Stop date: ongoing checked, Pertinent details: Phlebotomy, 3 times per year., 12Feb2021, 11Jun2021; "Phlebotomy" (unspecified if ongoing), notes: Onset date: genetic, Stop date: ongoing checked, Pertinent details: Phlebotomy, 3 times per year., 12Feb2021, 11Jun2021; "Swollen lymph node, left clavicle", start date: 01Mar2021, stop date: 08Apr2021, notes: Illness/AE: Swollen lymph node, left clavicle, Onset date: noticed on 01Mar2021, Stop date: 08Apr2021, Pertinent details: Monitored closely by my GP and Hematologist/oncologist, whom I see regularly for Hemochromatosis. Concomitant medication(s) included: IBUPROFEN taken for pain, pyrexia, start date: 15Mar2021, stop date: 17Mar2021. Vaccination history included: Bnt162b2 (Dose: 1st, Date: 22Feb2021, Anatomical Site of injection: L Arm, Batch/Lot number: EN6201), for Covid-19 immunization, reaction(s): "Swollen lymph node". The following information was reported: PAIN (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "Pain and Fever". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Swollen lymph nodes with onset 01Mar2021, outcome "recovered" (08Apr2021), described as "swollen lymph nodes left clavicle. Comments/Narrative: Therapeutic measures were not taken as a result of lymphadenopathy. The patient was monitored closely by his GP and Hematologist/oncologist, whom he see regularly for Hemochromatosis. Unfortunately, he was among the few people who experienced swollen lymph nodes as a side effect. The patient noticed a pea-sized swollen lymph node under his left clavicle about one week after the first dose. The patient and his doctor monitored it closely, and it disappeared several weeks after the second dose. The patient received Ibuprofen (Start date: 15Mar2021, Stop date: 17Mar2021) for the treatment of Pain and fever which were occurred post 2nd dose.  No follow-up attempts are possible. No further information is expected.  Follow-up (04Mar2022): Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Sciatica
Clinical narrative: mild/moderate lower back; sciatic pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Aug2021 14:00 (Lot number: EW0175) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "History of herniating and protruding discs", start date: 2018 (unspecified if ongoing), notes: Patient never had this much pain from the disc issues.; "History of herniating and protruding discs", start date: 2018 (unspecified if ongoing). There were no concomitant medications. The following information was reported: BACK PAIN (non-serious) with onset 06Aug2021 21:00, outcome "not recovered", described as "mild/moderate lower back"; SCIATICA (non-serious) with onset 06Aug2021 21:00, outcome "not recovered", described as "sciatic pain". The events "mild/moderate lower back" and "sciatic pain" were evaluated at the physician office visit. Therapeutic measures were taken as a result of back pain, sciatica.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not take any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no known allergies. Patient reported that the night of the first injection he started having mild/moderate lower back/sciatic pain. Assumed it was related to previous disc issues. Therapeutic measures were taken as a result of the events and patient had meds, steroid shot, and physical therapy. Awaiting MRI. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Dizzy and nauseous everyday since day after vaccine, going on for a week now.; Dizzy and nauseous everyday since day after vaccine, going on for a week now.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Aug2021 09:30 (Lot number: FC3182) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE; CIALIS; CRESTOR; COQ10 [UBIDECARENONE]. The following information was reported: DIZZINESS (non-serious), NAUSEA (non-serious) all with onset 27Aug2021 05:30, outcome "not recovered" and all described as "Dizzy and nauseous everyday since day after vaccine, going on for a week now.". Therapeutic measures were not taken as a result of dizziness, nausea.  Additional information: The patient did not received any other vaccine was taken in four weeks. Other medications in two weeks was Tumeric. He had covid prior vaccination and no covid was tested post vaccination. He had no known allergies.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Poor quality product administered, Product quality issue
Clinical narrative: informed Caller that "301308A" is not a valid lot number for the Pfizer-BioNTech COVID-19 Vaccine; informed Caller that "301308A" is not a valid lot number for the Pfizer-BioNTech COVID-19 Vaccine; heart burn; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Aug2021 13:15 (Lot number: 30130BA, Expiration Date: 30Nov2021) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT QUALITY ISSUE (non-serious), outcome "unknown" and all described as "informed Caller that "301308A" is not a valid lot number for the Pfizer-BioNTech COVID-19 Vaccine"; DYSPEPSIA (non-serious) with onset 2021, outcome "unknown", described as "heart burn". Therapeutic measures were not taken as a result of poor quality product administered, product quality issue, dyspepsia.   Additional information: It was reported that received first dose of the Pfizer vaccine with the lot number was 301308A and was wondering what the expiration date is for this particular one. No other vaccines in four weeks and other medications in two weeks were reported. No prior vaccination and patient not tested covid post vaccination. No known allergies and other medical history was reported. It was stated that concerned about the lot number, the Pfizer medical information and they said that lot number does not exist. they told me to go back to pharmacy to confirm that was correct number on my card. The pharmacist was still using the same lot number on friday September 3rd because she showed me the vial and it said Pfizer with the same lot number that I have given. He worried about what he received,.Since Pfizer medical information has no record of this lot number. When he went on Friday there was at least 20 walk ins getting the same batch that I received. In other words who knows how many people received this shot. The medical information the lot number is not in the system. Now he clarified that the actual LOT number was 30130B-A. The LOT number 30130BA is in fact a valid LOT number for the Pfizer BioNTech Covid-19 Vaccine. NDC number and UPC number of Covid-19 vaccine was unknown.  Follow-up (04Sep2021): No follow-up attempts are possible. No further information is expected.  Follow-up (07Sep2021) (09Sep2021) (17Sep2021): New follow-up report received from same reporter. Updated lot number (301308A to 30130B-A), new event added dyspepsia and added additional information.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia eye, Hypoaesthesia oral, Paraesthesia, SARS-CoV-2 test
Clinical narrative: tingling in the face arm and neck of side of body where shot was administered; Numbness spread from shot location, down to arm, but neck and across jaw lips and up to eye; Numbness spread from shot location, down to arm, but neck and across jaw lips and up to eye; Numbness spread from shot location, down to arm, but neck and across jaw lips and up to eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 12:00 (Lot number: ER8734) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: pineapple" (unspecified if ongoing), notes: Known allergies: pineapple. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Drug allergy", notes: Known allergies: Codeine; Augmentin, reaction(s): "Drug allergy", notes: Known allergies: Augmentin; Breo ellipta, reaction(s): "Drug allergy", notes: Known allergies: Breo. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: UNKNOWN; Administration  time: 12:00, Vaccine location: left arm), administration date: 20Mar2021, when the patient was 37 years old, for COVID-19 immunization. The following information was reported: PARAESTHESIA (non-serious) with onset 10Apr2021 12:00, outcome "recovered with sequelae" (2021), described as "tingling in the face arm and neck of side of body where shot was administered"; HYPOAESTHESIA (non-serious), HYPOAESTHESIA ORAL (non-serious), HYPOAESTHESIA EYE (non-serious) all with onset 10Apr2021 12:00, outcome "recovered with sequelae" (10Apr2021 13:30) and all described as "Numbness spread from shot location, down to arm, but neck and across jaw lips and up to eye". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of paraesthesia, hypoaesthesia, hypoaesthesia oral, hypoaesthesia eye. No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears two days after vaccine; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 14:30 (Lot number: EW0176) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 25Aug2021 07:00, outcome "not recovered", described as "Ringing in ears two days after vaccine". The event "ringing in ears two days after vaccine" was evaluated at the physician office visit.  Additional information: If other vaccine in four weeks, if covid prior vaccination and if covid tested post vaccination were reported as no.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Blood test, Magnetic resonance imaging, Nervousness, Tinnitus
Clinical narrative: tinnitus in both ears; internal shaking; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 10:30 (Lot number: EN 6207) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Back pain" (unspecified if ongoing). There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 12Mar2021 06:00, outcome "recovered", described as "tinnitus in both ears"; NERVOUSNESS (non-serious) with onset 12Mar2021 06:00, outcome "not recovered", described as "internal shaking". The events "tinnitus in both ears" and "internal shaking" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus, nervousness.  Additional information: No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. Patient had no known allergy. Within 24 hours of the initial Pfizer vaccine, extreme tinnitus in both ears occurred. Within 48 hours of vaccine, internal shaking has occurred. The tinnitus calmed down after about 30 days after the vaccine. the internal Shaking continues and there has been no improvement after 6 months.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Investigation, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Aug2021 (Lot number: FC3183) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPOAESTHESIA (non-serious) with onset Aug2021, outcome "not recovered", described as "numbness in his leg. This numbness has not improved or resolved/I have pain and numbness in my leg for 3 weeks now"; PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "not recovered", described as "the side effects, the day after I got the shot I have pain and numbness in my leg for 3 weeks now". The events "numbness in his leg. this numbness has not improved or resolved/i have pain and numbness in my leg for 3 weeks now" and "the side effects, the day after i got the shot i have pain and numbness in my leg for 3 weeks now" were 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 hypoaesthesia, pain in extremity. Additional information: The day after got the shot had pain and numbness in leg for 3 weeks now. Three weeks after got the shot and still having. The patient was supposed to get the second shot tomorrow but don't wanna get now. The patient went to doctor, where he gave some medicines. Had circulation test on 30Aug2021, don't know whether the doctor checked the blood flow of legs.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cortisol, Chest discomfort, Chest pain, Cortisol increased, Hypertension
Clinical narrative: After second dose hypertension; chest pain pressure; chest pain pressure; elevated cortisol; Migraines; numbness in feet and hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 12:00 (Lot number: ER9262) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Low T" (unspecified if ongoing). Concomitant medication(s) included: TESTOSTERONE [TESTOSTERONE CIPIONATE] taken for blood testosterone decreased. Vaccination history included: Bnt162b2 (Dose 1, dose administration time: 12:00 PM, dose lot number: ER2613, Location: Left arm), administration date: 22Feb2021, when the patient was 43 years old, for COVID-19 Immunization, reaction(s): "After first dose heartburn", "severe bloating". The following information was reported: HYPERTENSION (non-serious) with onset 2021, outcome "not recovered", described as "After second dose hypertension"; CHEST PAIN (non-serious), CHEST DISCOMFORT (non-serious) all with onset 2021, outcome "not recovered" and all described as "chest pain pressure"; CORTISOL INCREASED (non-serious) with onset 2021, outcome "not recovered", described as "elevated cortisol"; MIGRAINE (non-serious) with onset 2021, outcome "not recovered", described as "Migraines"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "numbness in feet and hands". The events "after second dose hypertension", "chest pain pressure", "chest pain pressure", "elevated cortisol", "migraines" and "numbness in feet and hands" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of hypertension, chest pain, chest discomfort, cortisol increased, migraine, hypoaesthesia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other vaccine in four weeks. No Known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Migraine, SARS-CoV-2 test
Clinical narrative: After second dose hypertension; chest pain pressure; chest pain pressure; elevated cortisol; Migraines; numbness in feet and hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 12:00 (Lot number: ER9262) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Low T" (unspecified if ongoing). Concomitant medication(s) included: TESTOSTERONE [TESTOSTERONE CIPIONATE] taken for blood testosterone decreased. Vaccination history included: Bnt162b2 (Dose 1, dose administration time: 12:00 PM, dose lot number: ER2613, Location: Left arm), administration date: 22Feb2021, when the patient was 43 years old, for COVID-19 Immunization, reaction(s): "After first dose heartburn", "severe bloating". The following information was reported: HYPERTENSION (non-serious) with onset 2021, outcome "not recovered", described as "After second dose hypertension"; CHEST PAIN (non-serious), CHEST DISCOMFORT (non-serious) all with onset 2021, outcome "not recovered" and all described as "chest pain pressure"; CORTISOL INCREASED (non-serious) with onset 2021, outcome "not recovered", described as "elevated cortisol"; MIGRAINE (non-serious) with onset 2021, outcome "not recovered", described as "Migraines"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "numbness in feet and hands". The events "after second dose hypertension", "chest pain pressure", "chest pain pressure", "elevated cortisol", "migraines" and "numbness in feet and hands" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of hypertension, chest pain, chest discomfort, cortisol increased, migraine, hypoaesthesia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other vaccine in four weeks. No Known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Tinnitus, Vaccination site pain
Clinical narrative: Tinnitus; Metallic taste in mouth; Pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Sep2021 13:30 (Lot number: FC3181) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroidectomy" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: allergies; "asthma" (unspecified if ongoing), notes: asthma; "psoriatic arthritis" (unspecified if ongoing), notes: psoriatic arthritis; "osteoarthritis" (unspecified if ongoing), notes: osteoarthritis; "Allergies: eggs" (unspecified if ongoing), notes: Allergies: eggs; "sulfa drugs" (unspecified if ongoing), notes: sulfa drugs; "Allergies: onions" (unspecified if ongoing), notes: Allergies: onions. The patient took concomitant medications. Past drug history included: Allergies: doxycycline, reaction(s): "Allergies: doxycycline", notes: Allergies: doxycycline. Vaccination history included: Bnt162b2 (Dose: 01, Anatomical location: Left Arm, Administration Time: 01:30 PM, Lot number: FC3182), administration date: 26Aug2021, when the patient was 47 years old, for COVID-19 Immunization, reaction(s): "tinnitus", "metallic taste in mouth", "pain at injection site", "Pain, decreased range of motion in left shoulder joint"; Bnt162b2 (Dose: 01, Anatomical location: Left Arm, Administration Time: 01:30 PM, Lot number: FC3182), administration date: 26Aug2021, when the patient was 48 years old, for COVID-19 immunization, reaction(s): "Pain/left shoulder joint". The following information was reported: TINNITUS (non-serious) with onset Sep2021, outcome "not recovered", described as "Tinnitus"; DYSGEUSIA (non-serious) with onset Sep2021, outcome "not recovered", described as "Metallic taste in mouth"; VACCINATION SITE PAIN (non-serious) with onset Sep2021, outcome "not recovered", described as "Pain at injection site". Therapeutic measures were not taken as a result of tinnitus, dysgeusia, vaccination site pain. Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was  not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Drug hypersensitivity, Dysphagia, Headache, Heart rate increased
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 29 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Sep2021 11:05 (Lot number: 301308A) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gallbladder removal" (unspecified if ongoing), notes: Verbatim: Gallbladder removal, A few years ago. Concomitant medication(s) included: TYLENOL. Past drug history included: Cephazolin iv, reaction(s): "Reaction". The following information was reported: DRUG HYPERSENSITIVITY (non-serious) with onset 17Sep2021, outcome "unknown", described as "allergic reaction"; HEADACHE (non-serious) with onset 17Sep2021, outcome "not recovered", described as "Headache"; ABDOMINAL DISCOMFORT (non-serious) with onset 17Sep2021, outcome "not recovered", described as "Upset stomach"; HEART RATE INCREASED (non-serious) with onset 17Sep2021, outcome "recovering", described as "The caller's heart was beating out of her chest, she had a racing heart"; PARAESTHESIA (non-serious) with onset 17Sep2021, outcome "recovering", described as "mouth, nose, and throat was tingling. Then it went numb"; HYPOAESTHESIA (non-serious) with onset 17Sep2021, outcome "recovering", described as "mouth, nose, and throat was tingling. Then it went numb, face was numb"; DYSPHAGIA (non-serious), outcome "unknown", described as "difficulty swallowing". Patient received the 1st dose of the Pfizer Covid vaccine on 17Sep2021, and reported an allergic reaction 15 minutes after she got it, her mouth, nose, and throat was tingling. Then it went numb and the caller has difficulty swallowing. The face was numb. The tingling and everything in her nose and throat came in waves for the next hour or so. The caller felt fine other than a headache and upset stomach, but she expected that after a normal vaccine. The heart was beating out of her chest, she had a racing heart. The Patient thinks this was an allergic reaction and wants to know what is in the vaccine that may have caused this. The patient had the rogam shot when she was pregnant and was told to wait. When the caller had a C-section she had an antibiotic and had a reaction. The patient was given the same medication with her first two kids but this didn't happen until she had her third kid. The antibiotic was liquid cephazolin IV. Are there similar ingredients in the Cefazolin and the vaccine. The patient knows that there aren't any antibiotics in the vaccine but didn't know if there was a common ingredient. No prior vaccinations within 4 weeks and no AE(s) following prior vaccinations. No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 29 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Sep2021 11:05 (Lot number: 301308A) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gallbladder removal" (unspecified if ongoing), notes: Verbatim: Gallbladder removal, A few years ago. Concomitant medication(s) included: TYLENOL. Past drug history included: Cephazolin iv, reaction(s): "Reaction". The following information was reported: DRUG HYPERSENSITIVITY (non-serious) with onset 17Sep2021, outcome "unknown", described as "allergic reaction"; HEADACHE (non-serious) with onset 17Sep2021, outcome "not recovered", described as "Headache"; ABDOMINAL DISCOMFORT (non-serious) with onset 17Sep2021, outcome "not recovered", described as "Upset stomach"; HEART RATE INCREASED (non-serious) with onset 17Sep2021, outcome "recovering", described as "The caller's heart was beating out of her chest, she had a racing heart"; PARAESTHESIA (non-serious) with onset 17Sep2021, outcome "recovering", described as "mouth, nose, and throat was tingling. Then it went numb"; HYPOAESTHESIA (non-serious) with onset 17Sep2021, outcome "recovering", described as "mouth, nose, and throat was tingling. Then it went numb, face was numb"; DYSPHAGIA (non-serious), outcome "unknown", described as "difficulty swallowing". Patient received the 1st dose of the Pfizer Covid vaccine on 17Sep2021, and reported an allergic reaction 15 minutes after she got it, her mouth, nose, and throat was tingling. Then it went numb and the caller has difficulty swallowing. The face was numb. The tingling and everything in her nose and throat came in waves for the next hour or so. The caller felt fine other than a headache and upset stomach, but she expected that after a normal vaccine. The heart was beating out of her chest, she had a racing heart. The Patient thinks this was an allergic reaction and wants to know what is in the vaccine that may have caused this. The patient had the rogam shot when she was pregnant and was told to wait. When the caller had a C-section she had an antibiotic and had a reaction. The patient was given the same medication with her first two kids but this didn't happen until she had her third kid. The antibiotic was liquid cephazolin IV. Are there similar ingredients in the Cefazolin and the vaccine. The patient knows that there aren't any antibiotics in the vaccine but didn't know if there was a common ingredient. No prior vaccinations within 4 weeks and no AE(s) following prior vaccinations. No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Had a strong reaction to the second vaccine. Couldn't get out of bed for about 12 hours; 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), administered in arm right, administration date 18Aug2021 13:10 (Lot number: EW0217) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "achilles tendonitis", start date: 15Aug2021, stop date: 23Aug2021, notes: problem caused by wearing flip-flops.; "reduce the inflammation of achilles" (unspecified if ongoing). Concomitant medication(s) included: ADVIL taken for inflammation, stop date: 18Aug2021. Vaccination history included: Bnt162b2 (First dose-, Name of product-COVID-19 Vaccine , Lot/batch no. -EW0217, administration date=28Jul2021, administration time=13:30, vaccine_location=upper right arm), administration date: 28Jul2021, when the patient was 73 years old, for COVID-19 immunisation, reaction(s): "achilles swelled". The following information was reported: Feeling abnormal(non-serious), outcome "unknown", described as "Had a strong reaction to the second vaccine. Couldn't get out of bed for about 12 hours".  Follow-Up (10Sep2021): Follow-up attempts are completed. No further information is expected.  Additional Information:The reason I contacted Phone number listed for information regarding fizer vaccine, was that I had questions about using Advil, when my second my vaccine Achilles swelled up prior to 16Aug I took 4 advil, Aug17 Advil and 18Aug I didn't take any. I also had a strong reaction to 2nd vaccine about 8 hours after, and I couldn't get out of bed for about 12 hours, only to get water. But I was not worried about that. I am happy I am vaccinated.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Blood test, Electromyogram, Magnetic resonance imaging, Pain
Clinical narrative: Acute burning pains in both hands and feet occurring two weeks after my second dose; small fiber neuropathy; Burning pain has gotten worse and spread to my face and eyes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Apr2021 13:00 (Lot number: ER9735) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Peyronies Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Possible allergetic to doxycycline, notes: Possible allergetic to doxycycline. Vaccination history included: Bnt162b2 (product=COVID 19, lot_number=EP7534, lot_unknown=False, administration_date=16/Mar/2021, administration_time=02:15 PM, dose_number=1, vaccine_location=Left arm), administration date: 16Mar2021, when the patient was 43 years old, for Covid-19 immunisation. The following information was reported: PAIN (non-serious) with onset 22Apr2021 01:00, outcome "not recovered", described as "Acute burning pains in both hands and feet occurring two weeks after my second dose"; SMALL FIBRE NEUROPATHY (non-serious) with onset 22Apr2021 01:00, outcome "not recovered", described as "small fiber neuropathy"; PAIN (non-serious) with onset 22Apr2021 01:00, outcome "not recovered", described as "Burning pain has gotten worse and spread to my face and eyes". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, small fibre neuropathy, pain.  Additional information: It was reported that, Facility Pharmacy or Drug Store where the most recent COVID-19 vaccine was administered. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Acute burning pains in both hands and feet occurring two weeks after his second dose. Full bloodwork, MRI, and EMG did not show abnormality. Punch Biopsy was performed in August and the results are a positive diagnosis for "small fiber neuropathy" going to see a neurologist about possible treatment with IVIg. Burning pain has gotten worse and spread to my face and eyes. Additionally, He get random zaps of pain throughout his body. Gabapentin treatment received for the adverse event. Possible allergies to doxycycline. Other medical history reported as Anxiety and Peyronies Disease. Prior to vaccination, he was not diagnosed with COVID-19. Since the vaccination, he has not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.