chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Small fibre neuropathy
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.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: Fatigue began 2 weeks after the second dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 (Lot number: EY0584) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (My once normal Menstrual Cycle is erratic and coming every two weeks or less accompanied with cramping.), administration date: 05Aug2021, for COVID-19 immunisation, reaction(s): "My once normal Menstrual Cycle is erratic and coming every two weeks or less accompanied with cramping.", "My once normal Menstrual Cycle is erratic and coming every two weeks or less accompanied with cramping.", "lethargic".  The following information was reported: FATIGUE (non-serious) with onset 10Sep2021, outcome "not recovered", described as "Fatigue began 2 weeks after the second dose.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue.  Additional information: The patient was not pregnant at time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no list of any other medications the patient received within 2 weeks of vaccination. Her once normal Menstrual Cycle was erratic and coming every two weeks or less accompanied with cramping. Feeling fatigued, lethargic. Fatigue began 2 weeks after the second dose. Date of start of reaction/event was 19Aug2021. The patient did not received treatment. The patient had Covid test post vaccination. The Covid test type post vaccination was nasal Swab. Covid test name post vaccination was Pcr and covid test date was 16Sep2021, covid test result was negative. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.  Follow-Up (22Sep2021):Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Product preparation error
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Pharmacist and Consumer or other non HCP) from medical information team.  A 12 year-old male patient received bnt162b2 (BNT162B2), administration date 20Sep2021 (Batch/Lot number: unknown) at the age of 12 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), administration date: 2021, when the patient was 12 years old, for Covid-19 immunization. The following information was reported: OVERDOSE (non-serious) with onset 20Sep2021, outcome "unknown", described as "received 6x the dose of the Pfizer COVID 19 vaccine"; PRODUCT PREPARATION ERROR (non-serious) with onset 20Sep2021, outcome "unknown", described as "got an undiluted vaccine due to pharmacist's error".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Functional gastrointestinal disorder
Clinical narrative: someone else who had recovered after 3 months / the intestines and they are not working properly; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FUNCTIONAL GASTROINTESTINAL DISORDER (non-serious), outcome "recovered", described as "someone else who had recovered after 3 months / the intestines and they are not working properly".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Feels like vertigo; the screen is moving back and forth from dizziness; 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 right, administration date 02Sep2021 (Lot number: FC3180) at the age of 48 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Cipro, reaction(s): "Drug allergy", notes: known allergy: Cipro. Vaccination history included: Bnt162b2 (product: COVID 19, brand Pfizer, lot unknown False, administration date 10Aug2021, dose number 1, vaccine location is Right arm), administration date: 10Aug2021, when the patient was 48 years old, for Covid-19 immunization. The following information was reported: VERTIGO (non-serious), outcome "not recovered", described as "Feels like vertigo"; DIZZINESS (non-serious), outcome "not recovered", described as "the screen is moving back and forth from dizziness". The events "feels like vertigo" and "the screen is moving back and forth from dizziness" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vertigo, dizziness.  Additional Information: No other vaccine in four weeks. No other medications in two weeks. Adverse event: Just wanted to share my experience: In August, I started my last 2 semesters in graduate school. For my internship, I was mandated to get the Covid vaccine. If I didn't, then I would of had to drop out of college. Mid August I received my first shot - In less than a week later I started experiencing dizziness, and reported this to my doctor, and she assured me it wasn't from the vaccine, and it would go away. 3 weeks later - got my 2nd vaccine and before I got it, I told the nurse my symptoms since the 1st vaccine. She called my doctor before she gave it to me and my doctor told her to still give it to me few days later after vaccine - driving and getting dizzy, attending classes online, and the screen is moving back and forth from dizziness. At internship and when seeing patients I feel like I'm on an elevator and the floor is moving up and down. Symptoms much worse. Feels like vertigo. Going back to my doctor. Dropped out of college. Ae resulted in: [Doctor or other healthcare Professional office/clinic visit] If patient recovered: Not recovered, If treatment ae: No. No covid prior vaccination. No covid tested post vaccination. Known allergies: Cipro.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Inappropriate schedule of product administration
Clinical narrative: Unilateral numbness on left side; First dose was administered on 17Apr2021, second dose was administered on 27Sep2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Sep2021 09:45 (Lot number: FF2589) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "yellow jacket (bees)" (unspecified if ongoing), notes: yellow jacket (bees); "gluten (intolerance)" (unspecified if ongoing), notes: gluten (intolerance). Concomitant medication(s) included: IBUPROFEN; TYLENOL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (Lot Number: EW0164; first dose; Left arm; administration time: 01:00 PM), administration date: 17Apr2021, when the patient was 31 years old, for COVID-19 immunization, reaction(s): "Unilateral numbness", "migraine", "headaches", "pressure behind eyes", "pressure in one ear", "pounding heart", "pain in left chest", "cramps (legs, feet, side noted well hydration)", "short/sharp pain in side", "forgetfulness", "pressure in chest with deep breaths", "tired", "rash". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 27Sep2021 09:45, outcome "unknown", described as "First dose was administered on 17Apr2021, second dose was administered on 27Sep2021"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "Unilateral numbness on left side". The event "unilateral numbness on left side" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of hypoaesthesia.  No follow-up attempts are possible. No further information is expected.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Doctors office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient received ibuprofen, tylenol, Zyrtec as other medications within 2 weeks of vaccination. The adverse event result in Doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received prednisone as treatment for the adverse event. Patient was not diagnosed with COVID-19 prior vaccination. Patient has not been tested for COVID-19 since vaccination.  Follow-Up (29Sep2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort, Fatigue, Feeling abnormal, Head discomfort
Clinical narrative: arm soreness; feels like she can put her head down and sleep at any time of the day; dizzy; her peripheral vision doesn't seem right and she sees spots; her peripheral vision doesn't seem right and she sees spots; When she turns her head it feels full; there is something in her ear; felt heavy/felt horrible; tiredness; not able to sleep; muscle pain/tightness from back of neck going to bra strap level at the back of her spine; muscle pain/tightness from back of neck going to bra strap level at the back of her spine; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administration date 30Aug2021 (Lot number: EC0178) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset Aug2021, outcome "not recovered", described as "dizzy"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tiredness"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "not able to sleep"; MYALGIA (non-serious) with onset 2021, outcome "unknown", MUSCLE TIGHTNESS (non-serious) with onset 2021, outcome "not recovered" and all described as "muscle pain/tightness from back of neck going to bra strap level at the back of her spine"; VISUAL FIELD DEFECT (non-serious), VISUAL IMPAIRMENT (non-serious) all with onset Aug2021, outcome "not recovered" and all described as "her peripheral vision doesn't seem right and she sees spots"; HEAD DISCOMFORT (non-serious) with onset Aug2021, outcome "unknown", described as "When she turns her head it feels full"; EAR DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "there is something in her ear"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "felt heavy/felt horrible"; SOMNOLENCE (non-serious) with onset Aug2021, outcome "not recovered", described as "feels like she can put her head down and sleep at any time of the day"; PAIN IN EXTREMITY (non-serious) with onset 30Aug2021, outcome "recovered" (31Aug2021), described as "arm soreness".  Additional information: Patient had all of these side effects every single day, it makes no sense. She was on no medications and has no co-morbidities, she was not on anything. The only medications that she takes is only once a month and it was two Advil for cramps and that was it. Patient was going for blood work at the end of this week.  Relatedness of all the events with COVID-19 Vaccine (BNT162B2) - Related.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Muscle tightness, Myalgia, Pain in extremity, Somnolence
Clinical narrative: arm soreness; feels like she can put her head down and sleep at any time of the day; dizzy; her peripheral vision doesn't seem right and she sees spots; her peripheral vision doesn't seem right and she sees spots; When she turns her head it feels full; there is something in her ear; felt heavy/felt horrible; tiredness; not able to sleep; muscle pain/tightness from back of neck going to bra strap level at the back of her spine; muscle pain/tightness from back of neck going to bra strap level at the back of her spine; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administration date 30Aug2021 (Lot number: EC0178) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset Aug2021, outcome "not recovered", described as "dizzy"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tiredness"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "not able to sleep"; MYALGIA (non-serious) with onset 2021, outcome "unknown", MUSCLE TIGHTNESS (non-serious) with onset 2021, outcome "not recovered" and all described as "muscle pain/tightness from back of neck going to bra strap level at the back of her spine"; VISUAL FIELD DEFECT (non-serious), VISUAL IMPAIRMENT (non-serious) all with onset Aug2021, outcome "not recovered" and all described as "her peripheral vision doesn't seem right and she sees spots"; HEAD DISCOMFORT (non-serious) with onset Aug2021, outcome "unknown", described as "When she turns her head it feels full"; EAR DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "there is something in her ear"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "felt heavy/felt horrible"; SOMNOLENCE (non-serious) with onset Aug2021, outcome "not recovered", described as "feels like she can put her head down and sleep at any time of the day"; PAIN IN EXTREMITY (non-serious) with onset 30Aug2021, outcome "recovered" (31Aug2021), described as "arm soreness".  Additional information: Patient had all of these side effects every single day, it makes no sense. She was on no medications and has no co-morbidities, she was not on anything. The only medications that she takes is only once a month and it was two Advil for cramps and that was it. Patient was going for blood work at the end of this week.  Relatedness of all the events with COVID-19 Vaccine (BNT162B2) - Related.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Visual field defect, Visual impairment
Clinical narrative: arm soreness; feels like she can put her head down and sleep at any time of the day; dizzy; her peripheral vision doesn't seem right and she sees spots; her peripheral vision doesn't seem right and she sees spots; When she turns her head it feels full; there is something in her ear; felt heavy/felt horrible; tiredness; not able to sleep; muscle pain/tightness from back of neck going to bra strap level at the back of her spine; muscle pain/tightness from back of neck going to bra strap level at the back of her spine; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administration date 30Aug2021 (Lot number: EC0178) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset Aug2021, outcome "not recovered", described as "dizzy"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tiredness"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "not able to sleep"; MYALGIA (non-serious) with onset 2021, outcome "unknown", MUSCLE TIGHTNESS (non-serious) with onset 2021, outcome "not recovered" and all described as "muscle pain/tightness from back of neck going to bra strap level at the back of her spine"; VISUAL FIELD DEFECT (non-serious), VISUAL IMPAIRMENT (non-serious) all with onset Aug2021, outcome "not recovered" and all described as "her peripheral vision doesn't seem right and she sees spots"; HEAD DISCOMFORT (non-serious) with onset Aug2021, outcome "unknown", described as "When she turns her head it feels full"; EAR DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "there is something in her ear"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "felt heavy/felt horrible"; SOMNOLENCE (non-serious) with onset Aug2021, outcome "not recovered", described as "feels like she can put her head down and sleep at any time of the day"; PAIN IN EXTREMITY (non-serious) with onset 30Aug2021, outcome "recovered" (31Aug2021), described as "arm soreness".  Additional information: Patient had all of these side effects every single day, it makes no sense. She was on no medications and has no co-morbidities, she was not on anything. The only medications that she takes is only once a month and it was two Advil for cramps and that was it. Patient was going for blood work at the end of this week.  Relatedness of all the events with COVID-19 Vaccine (BNT162B2) - Related.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: lymph node swollen on left collar bone with the 2nd dose and booster shot; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Aug2021 11:00 (Batch/Lot number: unknown) at the age of 36 years as dose 2, single and administration date 30Aug2021 11:00 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, vaccine location: left arm), administration date: 23Mar2021, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 31Aug2021, outcome "not recovered", described as "lymph node swollen on left collar bone with the 2nd dose and booster shot"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 30Aug2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. List of any other medications the patient received within 2 weeks of vaccination: too many. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Diarrhoea, Dizziness, Fatigue, Inappropriate schedule of product administration
Clinical narrative: Diarrhea; queasy stomach; fatigue; migraine headache; confusion; dizzying; Inappropriate schedule of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Sep2021 10:15 (Lot number: 30155BA) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; BLACK SEED [ELWENDIA PERSICA OIL]; ELDERBERRY [SAMBUCUS NIGRA]. Vaccination history included: Bnt162b2 (lot number=Ew0217, Administration time=03:15 PM,, Dose number=1, Vaccine location=left arm), administration date: 16Aug2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 30Sep2021 12:00, outcome "not recovered", described as "Diarrhea"; NAUSEA (non-serious) with onset 30Sep2021 12:00, outcome "not recovered", described as "queasy stomach"; FATIGUE (non-serious) with onset 30Sep2021 12:00, outcome "not recovered", described as "fatigue"; MIGRAINE (non-serious) with onset 30Sep2021 12:00, outcome "not recovered", described as "migraine headache"; CONFUSIONAL STATE (non-serious) with onset 30Sep2021 12:00, outcome "not recovered", described as "confusion"; DIZZINESS (non-serious) with onset 30Sep2021 12:00, outcome "not recovered", described as "dizzying"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 30Sep2021 12:00, outcome "unknown", described as "Inappropriate schedule of vaccine administered". Therapeutic measures were not taken as a result of diarrhoea, nausea, fatigue, migraine, confusional state, dizziness.  Additional information: Patient had no known allergies. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Post vaccination, patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea
Clinical narrative: Diarrhea; queasy stomach; fatigue; migraine headache; confusion; dizzying; Inappropriate schedule of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Sep2021 10:15 (Lot number: 30155BA) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; BLACK SEED [ELWENDIA PERSICA OIL]; ELDERBERRY [SAMBUCUS NIGRA]. Vaccination history included: Bnt162b2 (lot number=Ew0217, Administration time=03:15 PM,, Dose number=1, Vaccine location=left arm), administration date: 16Aug2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 30Sep2021 12:00, outcome "not recovered", described as "Diarrhea"; NAUSEA (non-serious) with onset 30Sep2021 12:00, outcome "not recovered", described as "queasy stomach"; FATIGUE (non-serious) with onset 30Sep2021 12:00, outcome "not recovered", described as "fatigue"; MIGRAINE (non-serious) with onset 30Sep2021 12:00, outcome "not recovered", described as "migraine headache"; CONFUSIONAL STATE (non-serious) with onset 30Sep2021 12:00, outcome "not recovered", described as "confusion"; DIZZINESS (non-serious) with onset 30Sep2021 12:00, outcome "not recovered", described as "dizzying"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 30Sep2021 12:00, outcome "unknown", described as "Inappropriate schedule of vaccine administered". Therapeutic measures were not taken as a result of diarrhoea, nausea, fatigue, migraine, confusional state, dizziness.  Additional information: Patient had no known allergies. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Post vaccination, patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus - previously unexperienced high pitched ringing in right ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 (Lot number: ER8732) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing); "HPV-11" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: FLONASE ALLERGY RELIEF; LANSOPRAZOLE. Vaccination history included: Bnt162b2 (Dose Number: 1, Start date:10Mar2021, Stop date:10Mar2021, Batch/Lot No: EN6202, Location of injection: Arm Left), administration date: 10Mar2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 01Jul2021, outcome "not recovered", described as "Tinnitus - previously unexperienced high pitched ringing in right ear". The event "tinnitus - previously unexperienced high pitched ringing in right ear" was evaluated at the physician office visit.  Additional information: The patient received past drug and patient had experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device Date: 04Oct2021.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Computerised tomogram, Ear discomfort, Magnetic resonance imaging, Tinnitus
Clinical narrative: clogged ears; tinnitus; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Sep2021 (Lot number: 30135BA) at the age of 51 years as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EK5730, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 21Dec2020, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248 , Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 11Jan2021, for COVID-19 immunization. The following information was reported: EAR DISCOMFORT (non-serious), outcome "not recovered", described as "clogged ears"; TINNITUS (non-serious), outcome "not recovered", described as "tinnitus". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of ear discomfort, tinnitus.  Additional Information: The Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient said that after the second dose I developed clogged ears and severe vertigo that would occur every week or so for several months, gradually getting better and less severe.  It finally resolved and then I received the third shot and in less than a week had severely clogged ears and now tinnitus which has lasted for a full week now. The treatment received for the adverse event was Magnetic resonance imaging (MRI), Computed tomography (CT) SCAN, Hearing Test. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: I can taste somewhat on the sides, but the top of my tongue there is no taste only texture; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 01Oct2021 (Lot number: FF8839) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergy-Sulfa" (unspecified if ongoing); "Known allergy- Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; ZYRTEC ALLERGY; WELLBUTRIN; LEXAPRO. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: 30135BA), administration date: 10Sep2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: TASTE DISORDER (non-serious) with onset 01Oct2021 18:00, outcome "not recovered", described as "I can taste somewhat on the sides, but the top of my tongue there is no taste only texture". Therapeutic measures were not taken as a result of taste disorder.  Additional Information:If other vaccine in four weeks: No.The date of the second injection I started experiencing changes in my taste. Things are still no better but at the same time not worse. I can taste somewhat on the sides, but the top of my tongue there is no taste, only texture.ae resulted in: None of the above.if Covid prior vaccination: No.if Covid tested post vaccination: No.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Headache; The caller had a headache and became dizzy; This is a spontaneous report received from a 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 right, administration date 03Sep2021 10:45 (Lot number: FC3184) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose: lot FC3184, NDC and expiration date unknown.), administration date: 18Aug2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "The caller had a headache and became dizzy"; HEADACHE (non-serious) with onset 03Sep2021, outcome "not recovered", described as "Headache".  Additional information: It was reported that the caller is calling about the Pfizer covid vaccine. The caller got her second dose on Friday and has had headaches since the vaccine, now its worse. Should the caller go to the emergency room? Is this from the vaccine? The caller cannot handle walking around the hospital like that. No History of all previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. Doctor or other healthcare professional office/clinic visit is not required for events. No Prior Vaccinations within 4 weeks. No AE's following prior vaccinations. Patient has no Medical History (including any illness at time of vaccination). No Family Medical History Relevant to AE.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypoaesthesia, Paraesthesia, Sensory loss
Clinical narrative: no feeling in her pinky on her right hand and her ring finger on her right hand; no feeling and are numb; no feeling in her pinky on her right hand and her ring finger on her right hand; no feeling and are numb; right arm got hot and tingling as if it had fallen asleep; right arm got hot and tingling as if it had fallen asleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Sep2021 13:30 (Lot number: FE3592) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Vaccine Name: Pfizer Covid Vaccine First Dose, Lot Number / Expiry Date: EW0191, Route, Anatomical Location: Left Arm , No. of Previous Doses: 1, Date: 11Aug2021), for COVID-19 immunization. The following information was reported: SENSORY LOSS (non-serious), HYPOAESTHESIA (non-serious) all with onset 01Sep2021, outcome "not recovered" and all described as "no feeling in her pinky on her right hand and her ring finger on her right hand; no feeling and are numb"; FEELING HOT (non-serious), PARAESTHESIA (non-serious) all with onset 01Sep2021, outcome "recovered" (02Sep2021) and all described as "right arm got hot and tingling as if it had fallen asleep".  Additional information: No additional vaccines administered on same date of the Pfizer suspect. Evening is reported as Adverse Event onset time. No Emergency Room and Physician Office visit was reported. Patient dose not had Prior Vaccinations (within 4 weeks) and no AEs was reported following prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain, Pleurisy, Sleep disorder
Clinical narrative: very hard pain; I am sick; vaccine made me sick; my doctor said I have to pleurisy it's some summation; I can not sleep well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Sep2021 (Lot number: FC3186) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "breast feed my baby", start date: 2021, stop date: 2021. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE , Lot # EY0584, Route of administration: Intramuscular, Anatomical site: Left arm), administration date: 13Aug2021. The following information was reported: PAIN (non-serious), outcome "unknown", described as "very hard pain"; ILLNESS (non-serious), outcome "unknown", described as "I am sick; vaccine made me sick"; PLEURISY (non-serious), outcome "unknown", described as "my doctor said I have to pleurisy it's some summation"; SLEEP DISORDER (non-serious), outcome "unknown", described as "I can not sleep well". The events "very hard pain" and "my doctor said i have to pleurisy it's some summation" were evaluated at the emergency room visit.  Additional information: The patient stated that I was in the emergency room. I'm sorry my language is not so well, I'm trying to explain. I had a very hard pain. I was checking with my doctor and my doctor said I have the, this like I am sick. The vaccine made me sick so now my doctor said I have to pleurisy it's some summation, the line that is going around my lungs (Further Not Clarified). It's the line going around the lungs and my doctor say it because it is for that second dosage of the COVID-19. Now I take Ibuprofen (Treatment) for the pain because I have a baby, I'm breast feed my baby. So I can't take any other medication. That's what I'm taking now for the pain. Yeah that's what my doctor recommended to take Ibuprofen. There was no other Prior vaccination (4 weeks).   No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: Went for their flu shot but instead got the Pfizer Covid vaccine; arm pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). This consumer reported for a 29-year-old female patient (Reporter's Wife) that:  A 29 year-old female patient received bnt162b2 (BNT162B2), administration date 04Oct2021 (Batch/Lot number: UNKNOWN) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU) (Batch/Lot number: unknown) as unk unk, single for immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (First dose), administration date: 02Apr2021, when the patient was 29 years old, for Covid-19 immunization; Bnt162b2 (Second dose), administration date: 30Apr2021, when the patient was 29 years old, for Covid-19 immunization. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 04Oct2021, outcome "unknown", described as "Went for their flu shot but instead got the Pfizer Covid vaccine"; PAIN IN EXTREMITY (non-serious) with onset 04Oct2021, outcome "unknown", described as "arm pain".  Additional Information: It was reported that patient went to (Pharmacy Name Withheld) yesterday for their flu shot but instead got the Pfizer Covid vaccine mistakenly a week ago at their local pharmacy. She had two doses last Apr.  About 90 minutes later the pharmacist called saying they had made a mistake. The entire family had been injected with adult doses of the COVID-19 vaccine. "When they called and told that they had made a mistake and had given us the wrong shot. She received third dose of the Pfizer Covid 19 Vaccine on 04Oct2021 and experienced arm pain since receiving the vaccine on same day. Caller stated his wife was on a lot of medications for anxiety, he did not know any information about these medications.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Covid Arm:  swelling and redness at site of injection spread approximately 3 1/2 inches down my left arm; Covid Arm:  swelling and redness at site of injection spread approximately 3 1/2 inches down my left arm; Covid Arm/Felt sore and hot to the touch; Covid Arm/Felt sore and hot to the touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Oct2021 11:00 (Lot number: 301308a) at the age of 76 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW6203, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 25Feb2021, when the patient was 76 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EM9809, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 04Feb2021, when the patient was 76 years old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 07Oct2021 12:00, outcome "recovering" and all described as "Covid Arm:  swelling and redness at site of injection spread approximately 3 1/2 inches down my left arm"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 07Oct2021 12:00, outcome "recovering" and all described as "Covid Arm/Felt sore and hot to the touch". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site erythema, vaccination site pain, vaccination site warmth.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 41-year-old female patient (not pregnant) received the 1st dose of  BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FC3182), at the age of 41, in right arm, on Sep 30, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced dizziness, onset Oct 6, 2021, with outcome of not recovered. No therapeutic measures taken as a result of dizziness. Follow-up (Oct 13, 2021): Follow-up attempts completed. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Menstruation irregular, Muscle spasms
Clinical narrative: Cramps; I should've been ovulating. I have never been irregular; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 (Lot number: 301588A) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0217 , Location of injection: Arm Left), administration date: 01Jun2021, when the patient was 39 years old, for COVID-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious) with onset 10Oct2021, outcome "unknown", described as "Cramps"; MENSTRUATION IRREGULAR (non-serious) with onset 10Oct2021, outcome "unknown", described as "I should've been ovulating. I have never been irregular"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 04Oct2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The events "cramps" and "i should've been ovulating. i have never been irregular" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of muscle spasms, menstruation irregular. Additional information: The patient had got a second period and cramps after her second dose 14 days after her period was already done and she should have been ovulating instead. She had never been irregular. She did not take any medication or birth control pills. She had cramps for days. She never experienced anything like this before the vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.