chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Altered visual depth perception, Dyschromatopsia, Headache, Lacrimation increased, Limb injury
Clinical narrative: left index finger hurting and swollen under side of index finger hurts to move finger; left index finger hurting and swollen under side of index finger hurts to move finger; Side to side fast vision is floaties for about hour/Grey boxes floating sideways; white tear drops floating left side down to up; ears ringing; sometimes when I am outside the color is dimmer like a filter is put over my eye; headache after the side to side; have in spots like a magnifying effect top left and lower right side lately; when I blink I have a Vaseline effect but goes away; depth perception is off more than usual, vision blurry up close when close up was clearer to read that's with glasses; depth perception is off more than usual, vision blurry up close when close up was clearer to read that's with glasses; This is a spontaneous report from a contactable consumer (patient).  This 56-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number unknown), via an unspecified route administered in the left arm, on 09Jun2021 11:00 (at the age of 56-year-old) at single dose (dose number unknown) for COVID-19 immunisation, administered at Pharmacy/Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Relevant medical history included Hepatitis C, coconut allergy, 'daladas' (as reported) allergy, and lactose intolerance. The patient was in menopause. The patient did not have COVID-19 before vaccination. Past drug history included sulfanilamide (SULFA) allergy. The patient did not have concomitant medications. The patient verbally reported as follows: on 11Jun2021, side to side fast vision is floaties for about hour, grey boxes floating sideways, white tear drops floating left side down to up, ears ringing, sometimes when I am outside the color is dimmer like a filter is put over my eye, headache after the side to side but ibuprofen and darkness help, sometimes I have in spots like a magnifying effect top left and lower right side lately, if I wear my sunglasses when outside eye doesn't bother me when I could be without. Sometimes when I blink I have a Vaseline effect but goes away, depth perception is off more than usual, vision blurry up close when close up was clearer to read that's with glasses. On 20Sep2021, the patient woke up with left index finger hurting and swollen under side of index finger hurts to move finger. No seriousness criterion was provided. The patient was treated for 'headache', 'sometimes when I am outside the color is dimmer like a filter is put over my eye' and 'have in spots like a magnifying effect top left and lower right side lately'. No treatments were given for the remaining events. Post vaccination COVID-19 test was not done. The patient had not recovered from the events.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Tinnitus, Vision blurred, Visual impairment, Vitreous floaters
Clinical narrative: left index finger hurting and swollen under side of index finger hurts to move finger; left index finger hurting and swollen under side of index finger hurts to move finger; Side to side fast vision is floaties for about hour/Grey boxes floating sideways; white tear drops floating left side down to up; ears ringing; sometimes when I am outside the color is dimmer like a filter is put over my eye; headache after the side to side; have in spots like a magnifying effect top left and lower right side lately; when I blink I have a Vaseline effect but goes away; depth perception is off more than usual, vision blurry up close when close up was clearer to read that's with glasses; depth perception is off more than usual, vision blurry up close when close up was clearer to read that's with glasses; This is a spontaneous report from a contactable consumer (patient).  This 56-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number unknown), via an unspecified route administered in the left arm, on 09Jun2021 11:00 (at the age of 56-year-old) at single dose (dose number unknown) for COVID-19 immunisation, administered at Pharmacy/Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Relevant medical history included Hepatitis C, coconut allergy, 'daladas' (as reported) allergy, and lactose intolerance. The patient was in menopause. The patient did not have COVID-19 before vaccination. Past drug history included sulfanilamide (SULFA) allergy. The patient did not have concomitant medications. The patient verbally reported as follows: on 11Jun2021, side to side fast vision is floaties for about hour, grey boxes floating sideways, white tear drops floating left side down to up, ears ringing, sometimes when I am outside the color is dimmer like a filter is put over my eye, headache after the side to side but ibuprofen and darkness help, sometimes I have in spots like a magnifying effect top left and lower right side lately, if I wear my sunglasses when outside eye doesn't bother me when I could be without. Sometimes when I blink I have a Vaseline effect but goes away, depth perception is off more than usual, vision blurry up close when close up was clearer to read that's with glasses. On 20Sep2021, the patient woke up with left index finger hurting and swollen under side of index finger hurts to move finger. No seriousness criterion was provided. The patient was treated for 'headache', 'sometimes when I am outside the color is dimmer like a filter is put over my eye' and 'have in spots like a magnifying effect top left and lower right side lately'. No treatments were given for the remaining events. Post vaccination COVID-19 test was not done. The patient had not recovered from the events.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer (patient).   A 32-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 22Sep2021 10:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE, vaccinated at the age of 32 years old, for covid-19 immunisation. Medical history included penicillin allergy, covid-19. There were no concomitant medications. Patient received the first dose of bnt162b2 on 01Sep2021 10:00, at the age of 32 years old for covid-19 immunisation. The patient experienced bell's palsy on 24Sep2021 with outcome of not recovered. The event was reported as serious with criteria medically significant. Event resulted in Doctor or other healthcare professional office/clinic visit and treatment included Steroid  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Dizziness, Dysstasia, Headache
Clinical narrative: Dizzy; Nausea; Fever; Rapid heart beat; Slow breath; Chest pain; Sweats; Unable to stand; Headache with Tylenol; This is a spontaneous report from a contactable consumer (patient).  A 40-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm, on 14Sep2021 at 13:00, at the age of 40 years old, as 1st single dose, for COVID-19 immunisation, and paracetamol (TYLENOL) at an unspecified dose and frequency, in Sep2021, for an unspecified indication. Medical history included autoimmune hepatitis. Past drug history included drug hypersensitivity with clarithromycin (BIAXIN) and clindamycin. There were no other vaccines administered in the four weeks prior to the BNT162b2 administration. The patient was not pregnant at the time of the reporting and vaccination. Regarding concomitant medications, it was reported the patient had took or was taking unspecified other medications in the two weeks prior to BNT162b2. The patient had not had COVID-19 prior to vaccination with BNT162b2 and was not tested for COVID-19 post vaccination. On 14Sep2021, at 16:00, the patient felt dizzy, had nausea, fever, rapid heart beat, slow breath, cheat pain, sweats, was unable to stand, had headache with Tylenol, she was scared and though she was close to death. No treatment was required for the above mentioned events. The patient was recovering from the above mentioned events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Dizzy; Nausea; Fever; Rapid heart beat; Slow breath; Chest pain; Sweats; Unable to stand; Headache with Tylenol; This is a spontaneous report from a contactable consumer (patient).  A 40-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm, on 14Sep2021 at 13:00, at the age of 40 years old, as 1st single dose, for COVID-19 immunisation, and paracetamol (TYLENOL) at an unspecified dose and frequency, in Sep2021, for an unspecified indication. Medical history included autoimmune hepatitis. Past drug history included drug hypersensitivity with clarithromycin (BIAXIN) and clindamycin. There were no other vaccines administered in the four weeks prior to the BNT162b2 administration. The patient was not pregnant at the time of the reporting and vaccination. Regarding concomitant medications, it was reported the patient had took or was taking unspecified other medications in the two weeks prior to BNT162b2. The patient had not had COVID-19 prior to vaccination with BNT162b2 and was not tested for COVID-19 post vaccination. On 14Sep2021, at 16:00, the patient felt dizzy, had nausea, fever, rapid heart beat, slow breath, cheat pain, sweats, was unable to stand, had headache with Tylenol, she was scared and though she was close to death. No treatment was required for the above mentioned events. The patient was recovering from the above mentioned events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory rate, Respiratory rate decreased
Clinical narrative: Dizzy; Nausea; Fever; Rapid heart beat; Slow breath; Chest pain; Sweats; Unable to stand; Headache with Tylenol; This is a spontaneous report from a contactable consumer (patient).  A 40-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm, on 14Sep2021 at 13:00, at the age of 40 years old, as 1st single dose, for COVID-19 immunisation, and paracetamol (TYLENOL) at an unspecified dose and frequency, in Sep2021, for an unspecified indication. Medical history included autoimmune hepatitis. Past drug history included drug hypersensitivity with clarithromycin (BIAXIN) and clindamycin. There were no other vaccines administered in the four weeks prior to the BNT162b2 administration. The patient was not pregnant at the time of the reporting and vaccination. Regarding concomitant medications, it was reported the patient had took or was taking unspecified other medications in the two weeks prior to BNT162b2. The patient had not had COVID-19 prior to vaccination with BNT162b2 and was not tested for COVID-19 post vaccination. On 14Sep2021, at 16:00, the patient felt dizzy, had nausea, fever, rapid heart beat, slow breath, cheat pain, sweats, was unable to stand, had headache with Tylenol, she was scared and though she was close to death. No treatment was required for the above mentioned events. The patient was recovering from the above mentioned events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Headache, Malaise
Clinical narrative: Fever (low grade, then 103 to 104 F); Feeling kind of ill; Arm was really sore; Sluggish; Body aches; Nausea; Vomiting; Diarrhea; Hurting chills; Muscle aches; headache; This is a spontaneous report from a contactable consumer (patient's mother).  A 17-year-old male patient received BNT162b2 (COMIRNATY), via an unspecified route of administration, on 21Aug2021, at the age of 17 years old, as 1st single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. The patient woke up the following morning, on 22Aug2021, and started feeling kind of ill, his arm was really sore, he was just sluggish, with low grade fever, body aches, and as the days progressed the symptoms kept getting worse, he had nausea, vomiting, diarrhea, hurting chills, body aches, muscle aches, headache, and for 2 or 3 days he started running fever like a 103 F to 104 F and then fever 100-101F. According to the patient, no treatment was needed for the events. The outcome of the events was not specified.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101281780 similar report from same reporter
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever (low grade, then 103 to 104 F); Feeling kind of ill; Arm was really sore; Sluggish; Body aches; Nausea; Vomiting; Diarrhea; Hurting chills; Muscle aches; headache; This is a spontaneous report from a contactable consumer (patient's mother).  A 17-year-old male patient received BNT162b2 (COMIRNATY), via an unspecified route of administration, on 21Aug2021, at the age of 17 years old, as 1st single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. The patient woke up the following morning, on 22Aug2021, and started feeling kind of ill, his arm was really sore, he was just sluggish, with low grade fever, body aches, and as the days progressed the symptoms kept getting worse, he had nausea, vomiting, diarrhea, hurting chills, body aches, muscle aches, headache, and for 2 or 3 days he started running fever like a 103 F to 104 F and then fever 100-101F. According to the patient, no treatment was needed for the events. The outcome of the events was not specified.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101281780 similar report from same reporter
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Sluggishness, Vomiting
Clinical narrative: Fever (low grade, then 103 to 104 F); Feeling kind of ill; Arm was really sore; Sluggish; Body aches; Nausea; Vomiting; Diarrhea; Hurting chills; Muscle aches; headache; This is a spontaneous report from a contactable consumer (patient's mother).  A 17-year-old male patient received BNT162b2 (COMIRNATY), via an unspecified route of administration, on 21Aug2021, at the age of 17 years old, as 1st single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. The patient woke up the following morning, on 22Aug2021, and started feeling kind of ill, his arm was really sore, he was just sluggish, with low grade fever, body aches, and as the days progressed the symptoms kept getting worse, he had nausea, vomiting, diarrhea, hurting chills, body aches, muscle aches, headache, and for 2 or 3 days he started running fever like a 103 F to 104 F and then fever 100-101F. According to the patient, no treatment was needed for the events. The outcome of the events was not specified.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101281780 similar report from same reporter
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dyspnoea, Hypoaesthesia, Musculoskeletal discomfort, Palpitations
Clinical narrative: Burning in the left side of my neck; Burning in the left side of my neck; My arm was also tingling and numb.; My arm was also tingling and numb.; Heart was pounding out of my chest; Extreme shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: FF2588), via an unspecified route of administration, administered in left arm on 31Aug2021 10:30 (age at vaccination 46 years) as single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccine within four weeks. No List of any other medications the patient received within 2 weeks of vaccination. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. It was reported that on 09Sep2021 05:00, the patient woke up with a burning in the left side of her neck; her arm was also tingling and numb, left arm. Her heart was pounding out of her chest. Got up to walk around. That day had extreme shortness of breath. It was ended up going to the ER the next day for shortness of breath. Ended up in the ER again less than a week later and have been seeing a doctor. Shortness of breath was not getting better. The patient underwent lab tests and procedures which included Bio Nova test: negative on 13Sep2021. Patient was not tested positive for COVID-19 since the vaccination. The patient was not received any treatment for the events. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test
Clinical narrative: Burning in the left side of my neck; Burning in the left side of my neck; My arm was also tingling and numb.; My arm was also tingling and numb.; Heart was pounding out of my chest; Extreme shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: FF2588), via an unspecified route of administration, administered in left arm on 31Aug2021 10:30 (age at vaccination 46 years) as single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccine within four weeks. No List of any other medications the patient received within 2 weeks of vaccination. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. It was reported that on 09Sep2021 05:00, the patient woke up with a burning in the left side of her neck; her arm was also tingling and numb, left arm. Her heart was pounding out of her chest. Got up to walk around. That day had extreme shortness of breath. It was ended up going to the ER the next day for shortness of breath. Ended up in the ER again less than a week later and have been seeing a doctor. Shortness of breath was not getting better. The patient underwent lab tests and procedures which included Bio Nova test: negative on 13Sep2021. Patient was not tested positive for COVID-19 since the vaccination. The patient was not received any treatment for the events. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19, TDAP, UNK, COVID19, TDAP, UNK
Symptoms: Product use issue, Pruritus
Clinical narrative: Severe itching both sides of both hands, plus both elbows; BNT162B2 co-administered with other vaccines; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 at the age of 74-years-old via an unspecified route of administration, administered in Arm Right on 27Sep2021 11:45 (Batch/Lot Number: FF2587) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX), via an unspecified route of administration administered in arm left on 27Sep2021 11:45 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for immunisation; influenza vaccine (FLUZONE), via an unspecified route of administration administered in arm left on 27Sep2021 11:45 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for immunization. Medical history included known allergies: Penicillin (Penicillin Allergy). Concomitant medication included an unspecified medication. The patient received the first and second doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified dates for covid-19 immunisation. The patient experienced severe itching both sides of both hands, plus both elbows on 27Sep2021 21:00 and BNT162B2 was co-administered with other vaccines on 27Sep2021 11:45. Therapeutic measures were taken as a result of severe itching both sides of both hands, plus both elbows which included Zyrtec and Benadryl. The patient did not recover from Severe itching both sides of both hands, plus both elbows. Prior to the vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination.
Age: 74.0
Sex: F
Vaccine: COVID19, TDAP, UNK, COVID19, TDAP, UNK
Symptoms: Pruritus
Clinical narrative: Severe itching both sides of both hands, plus both elbows; BNT162B2 co-administered with other vaccines; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 at the age of 74-years-old via an unspecified route of administration, administered in Arm Right on 27Sep2021 11:45 (Batch/Lot Number: FF2587) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX), via an unspecified route of administration administered in arm left on 27Sep2021 11:45 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for immunisation; influenza vaccine (FLUZONE), via an unspecified route of administration administered in arm left on 27Sep2021 11:45 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for immunization. Medical history included known allergies: Penicillin (Penicillin Allergy). Concomitant medication included an unspecified medication. The patient received the first and second doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified dates for covid-19 immunisation. The patient experienced severe itching both sides of both hands, plus both elbows on 27Sep2021 21:00 and BNT162B2 was co-administered with other vaccines on 27Sep2021 11:45. Therapeutic measures were taken as a result of severe itching both sides of both hands, plus both elbows which included Zyrtec and Benadryl. The patient did not recover from Severe itching both sides of both hands, plus both elbows. Prior to the vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Brain neoplasm, Feeling abnormal, Lethargy, Magnetic resonance imaging head
Clinical narrative: Dr, suggested MRI of the brain and they noticed tumor; extreme lethargy; brain fog; imbalance; This is a spontaneous report from a contactable consumer. A 52-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 13Apr2021 (Batch/Lot number was not reported) at age of 52-year-old as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced extreme lethargy; brain fog, imbalance etc. for days after 2nd dose in 2021. Dr, suggested MRI of the brain and they noticed tumor. The events resulted in doctor or other healthcare professional office/clinic visit. No hospitalization prolonged.  The outcome of events was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had Covid; had Covid; This is a spontaneous report from a Regulatory Authority. A non-contactable consumer reported that a male patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated she knew a gentleman in withheld who, along with his wife, had Covid. He got the Pfizer vaccine and now needs quadruple bypass. The patient underwent lab tests and procedures which included Covid: positive on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Disorientation, Disturbance in attention, Dizziness, Feeling abnormal
Clinical narrative: pretty bad headaches/headache was consistent; disorientation; brain fog; dizziness; I can no longer concentrate; episodes of fainting; bad memory/memory issues; some hand tremor in both hands; She cannot drive. She had fainted a couple of time/I can no longer drive or exercise since that makes it more likely for me to black out; problems have been escalating more at the cognitive level; This is a spontaneous report from a contactable consumer (patient) and another contactable consumer (patient's mother). A 29-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration as a single dose, in her left arm, on 31Mar2021 11:00 (lot number ER8737), at age of 29-year-old of vaccination, for Covid-19 immunization, in a pharmacy or drug store. The patient had no medical history or known allergies. The patient did not have Covid-19 before vaccination and did not test post vaccination. The patient did not receive other vaccines in four weeks and she received vitamins in two weeks. Started with pretty bad headaches/ consistent headaches, and then the patient started to present memory issues, brain fog, disorientation, dizziness, and overall the problems had been escalating more at the cognitive level. She could no longer concentrate, she had episodes of fainting, bad memory, some hand tremor in both hands. She could no longer drive or exercise since that made it more likely for her to black out. Her family kept her under constant supervision to avoid any accidents from happening. After the vaccine not only the patient but her parents as well experienced some of these issues but in their case the side effects had been disappearing while in her case had been getting worse. The events occurred on 16Apr2021 08:00. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Disability or permanent damage. Patient received doctors' appointments, tests, referrals to special (including neurologist), and received unspecified treatment. The patient did tests and everything but the doctors could not find anything wrong but the symptoms started worsening. The patient had her second dose of vaccine on 22Apr2021. The outcome of the events was not resolved at the time of reporting.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101289277 Same reporter/ drug, different patients/ events;US-PFIZER INC-202101289278 Same reporter/ drug, different patients/ events
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Laboratory test, Loss of personal independence in daily activities, Memory impairment, Syncope
Clinical narrative: pretty bad headaches/headache was consistent; disorientation; brain fog; dizziness; I can no longer concentrate; episodes of fainting; bad memory/memory issues; some hand tremor in both hands; She cannot drive. She had fainted a couple of time/I can no longer drive or exercise since that makes it more likely for me to black out; problems have been escalating more at the cognitive level; This is a spontaneous report from a contactable consumer (patient) and another contactable consumer (patient's mother). A 29-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration as a single dose, in her left arm, on 31Mar2021 11:00 (lot number ER8737), at age of 29-year-old of vaccination, for Covid-19 immunization, in a pharmacy or drug store. The patient had no medical history or known allergies. The patient did not have Covid-19 before vaccination and did not test post vaccination. The patient did not receive other vaccines in four weeks and she received vitamins in two weeks. Started with pretty bad headaches/ consistent headaches, and then the patient started to present memory issues, brain fog, disorientation, dizziness, and overall the problems had been escalating more at the cognitive level. She could no longer concentrate, she had episodes of fainting, bad memory, some hand tremor in both hands. She could no longer drive or exercise since that made it more likely for her to black out. Her family kept her under constant supervision to avoid any accidents from happening. After the vaccine not only the patient but her parents as well experienced some of these issues but in their case the side effects had been disappearing while in her case had been getting worse. The events occurred on 16Apr2021 08:00. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Disability or permanent damage. Patient received doctors' appointments, tests, referrals to special (including neurologist), and received unspecified treatment. The patient did tests and everything but the doctors could not find anything wrong but the symptoms started worsening. The patient had her second dose of vaccine on 22Apr2021. The outcome of the events was not resolved at the time of reporting.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101289277 Same reporter/ drug, different patients/ events;US-PFIZER INC-202101289278 Same reporter/ drug, different patients/ events
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: pretty bad headaches/headache was consistent; disorientation; brain fog; dizziness; I can no longer concentrate; episodes of fainting; bad memory/memory issues; some hand tremor in both hands; She cannot drive. She had fainted a couple of time/I can no longer drive or exercise since that makes it more likely for me to black out; problems have been escalating more at the cognitive level; This is a spontaneous report from a contactable consumer (patient) and another contactable consumer (patient's mother). A 29-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration as a single dose, in her left arm, on 31Mar2021 11:00 (lot number ER8737), at age of 29-year-old of vaccination, for Covid-19 immunization, in a pharmacy or drug store. The patient had no medical history or known allergies. The patient did not have Covid-19 before vaccination and did not test post vaccination. The patient did not receive other vaccines in four weeks and she received vitamins in two weeks. Started with pretty bad headaches/ consistent headaches, and then the patient started to present memory issues, brain fog, disorientation, dizziness, and overall the problems had been escalating more at the cognitive level. She could no longer concentrate, she had episodes of fainting, bad memory, some hand tremor in both hands. She could no longer drive or exercise since that made it more likely for her to black out. Her family kept her under constant supervision to avoid any accidents from happening. After the vaccine not only the patient but her parents as well experienced some of these issues but in their case the side effects had been disappearing while in her case had been getting worse. The events occurred on 16Apr2021 08:00. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Disability or permanent damage. Patient received doctors' appointments, tests, referrals to special (including neurologist), and received unspecified treatment. The patient did tests and everything but the doctors could not find anything wrong but the symptoms started worsening. The patient had her second dose of vaccine on 22Apr2021. The outcome of the events was not resolved at the time of reporting.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101289277 Same reporter/ drug, different patients/ events;US-PFIZER INC-202101289278 Same reporter/ drug, different patients/ events
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Heart rate increased, Inappropriate schedule of product administration
Clinical narrative: spontaneous bleeding from nose; rapid heartbeat upon awakening; dose 1 on 13Jan2021 and dose 2 on 27Jan2021; This is a spontaneous report from a contactable other health professional (patient). A non-pregnant 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 27Jan2021 (Batch/Lot number was not reported) as dose 2, single at the age of 51 years old for COVID-19 immunisation. Medical history and concomitant medications reported as none. No known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 in left arm at the age of 51 years old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 29Jan2021, (2 days after the vaccination) the patient experienced rapid heartbeat upon awakening. The patient also experienced spontaneous bleeding from nose in the middle of the night on 30Jan2021 (3 days after 2nd shot). The patient has no history of nose bleeds. The patient did not receive treatment for the events. The patient recovered from the events in 2021. The events were assessed as non-serious.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Illness, Malaise, Nausea
Clinical narrative: Diarrhea; very sick/very ill; just not feeling well/feel very ill; Very weak; feel like she want to throw up; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in Arm Left on 26Sep2021 (at the age of 72-year-old) (Lot Number: FF8334) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2, on Sep2021 (at the age of 72-year-old) (Lot Number: FF2588) as single dose for covid-19 immunization and no adverse event. The patient experienced diarrhea, very sick/very ill, just not feeling well/feel very ill, very weak on 28Sep2021 07:30; feel like she want to throw up on 28Sep2021. She has a reaction from the shot she had Sunday. She was having a reaction to it. She was having diarrhea. She was very sick, very weak, very ill. She had not been this ill in a long time. She just got her shot Sunday afternoon. She had got diarrhoea, she was very ill. She was just not feeling well. She had been ill since 7:30 the morning. She had diarrhoea all morning and she felt very ill. She felt like she was going to throw up right now. She felt like she want to throw up. This was really bad diarrhoea this morning that's how bad the diarrhoea is. She chew some Pepto Bismol tablet (Treatment). She had diarrhoea. It's not working exactly because she was just in near about 10 minutes ago. The outcome of the events was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Hypoaesthesia, Paraesthesia
Clinical narrative: Facial numbness; tingling on the right side of her face; This is a spontaneous report from a contactable other HCP. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Deltoid Right on 09Jul2021 15:00 (Lot Number: EW0161; Expiration Date: 31Jul2021, NDC number of Pfizer Covid shot: 5926710001) at the age of 41-year-old as 0.3 ML single for covid-19 immunisation. Medical history included penicillin allergy (Just to penicillin. It looks like it is on her allergies. It could have been when she was a child, she did not know). Patient's other medical history (including any illness at time of vaccination) reported as none. Family medical history Relevant to AE(s) reported as no. The patient's concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect reported as no. Additional Vaccines Administered on Same Date of the Pfizer Suspect reported as no. Prior vaccinations (within 4 weeks) reported as no. On 09Jul2021, 6 hours after receiving the vaccine, the patient had facial numbness and tingling on the right side of her face, which resolved after 14 hours. She had no other symptoms. She was a healthy 41 year old. The patient ended up in the emergency room(ER) and they did a CT scan at the hospital and everything was clean. She was not admitted to the hospital, it was just to the emergency room. The numbness went away after 14 hours. Caller stated she guesses it was somewhat serious, it was facial numbness. Events required a visit to emergency room and physician office. The outcome of the events was completely recovered on 10Jul2021 11:00. Causality reported as "they think so, that is what they are trying to figure out". Patient was greater than 42 days past her first dose. Caller was asking if it was okay for her to receive the second dose after having some side effects from the first dose, so addressed timing as well.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event hypoaesthesia, paraesthesia and the suspect drug BNT162B2.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Bone pain, Decreased appetite, Gait disturbance
Clinical narrative: Loss of appetite; Fever 101F; muscle, bone, joint, nerve pain.; muscle, bone, joint, nerve pain; muscle, bone, joint, nerve pain.; muscle, bone, joint, nerve pain.; Difficulty walking; Severe Headache; Patient received booster dose; Patient received booster dose; This is a spontaneous report from a non-contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: FF8839) via an unspecified route of administration, administered on the left arm on 27Sep2021 10:00 (at the age of 67-year-old) as dose 3 (booster), single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose on an unspecified date and second dose in 2021 of BNT162B2 for COVID-19 immunisation and experienced being sick. The booster was given 7 months after dose 2. On 27Sep2021 22:00, the patient experienced Fever 101F, muscle, bone, joint, nerve pain; difficulty walking, severe headache, loss of appetite. Duration continuing. "Was the sickest I ever felt. Much worse than the two prior doses. Even worse than any illness I have ever had". No treatment was received for the events. Events were considered non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Myalgia, Neuralgia, Off label use
Clinical narrative: Loss of appetite; Fever 101F; muscle, bone, joint, nerve pain.; muscle, bone, joint, nerve pain; muscle, bone, joint, nerve pain.; muscle, bone, joint, nerve pain.; Difficulty walking; Severe Headache; Patient received booster dose; Patient received booster dose; This is a spontaneous report from a non-contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: FF8839) via an unspecified route of administration, administered on the left arm on 27Sep2021 10:00 (at the age of 67-year-old) as dose 3 (booster), single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose on an unspecified date and second dose in 2021 of BNT162B2 for COVID-19 immunisation and experienced being sick. The booster was given 7 months after dose 2. On 27Sep2021 22:00, the patient experienced Fever 101F, muscle, bone, joint, nerve pain; difficulty walking, severe headache, loss of appetite. Duration continuing. "Was the sickest I ever felt. Much worse than the two prior doses. Even worse than any illness I have ever had". No treatment was received for the events. Events were considered non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Loss of appetite; Fever 101F; muscle, bone, joint, nerve pain.; muscle, bone, joint, nerve pain; muscle, bone, joint, nerve pain.; muscle, bone, joint, nerve pain.; Difficulty walking; Severe Headache; Patient received booster dose; Patient received booster dose; This is a spontaneous report from a non-contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: FF8839) via an unspecified route of administration, administered on the left arm on 27Sep2021 10:00 (at the age of 67-year-old) as dose 3 (booster), single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose on an unspecified date and second dose in 2021 of BNT162B2 for COVID-19 immunisation and experienced being sick. The booster was given 7 months after dose 2. On 27Sep2021 22:00, the patient experienced Fever 101F, muscle, bone, joint, nerve pain; difficulty walking, severe headache, loss of appetite. Duration continuing. "Was the sickest I ever felt. Much worse than the two prior doses. Even worse than any illness I have ever had". No treatment was received for the events. Events were considered non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypomenorrhoea, Joint swelling, Menstruation irregular, Pruritus
Clinical narrative: Five hours after injection I broke out into hives on my wrists/forearms, ankles, inner thighs, and armpit. I went to urgent care the next morning and got steroids and the rash subsided after a few days. The itchiness lingered until September 13, (vaccine was given 6/4) when I broke out in the same rash but this time my ankles became very red and very very swollen. The rash was both painful and itchy. I returned to urgent care to revive steroids and again after several days (4-5) the rash subsided bit itchiness lingering. I broke out a third time the first week of October but this time a home rememdy of 2000 IUs of Vitamin D and garlic pills both taken twice daily were able to help the rash subside. Benedryl and hydrocortisone did not do much to help. Hydrocortisone helped somewhat soothe the intensity but didn?t help a whole lot and if I took more than two benedryl it would also soothe symptoms mildly but if only taken one or two benedryl, the rash seemed to worsen. The rashes when present would appear in the evening, get less intense over night, and progressively grow in intensity until fully flared before bedtime. This pattern would repeat until treated.   Also during this time, beginning after my first rash, I was on my period for THREE MONTHS. It was very light for the most part but I am 30 years old and have never had an irregular period in my adult life. Things resolved the second week of October but it is a October 16th and I?m sure issues will continue.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Five hours after injection I broke out into hives on my wrists/forearms, ankles, inner thighs, and armpit. I went to urgent care the next morning and got steroids and the rash subsided after a few days. The itchiness lingered until September 13, (vaccine was given 6/4) when I broke out in the same rash but this time my ankles became very red and very very swollen. The rash was both painful and itchy. I returned to urgent care to revive steroids and again after several days (4-5) the rash subsided bit itchiness lingering. I broke out a third time the first week of October but this time a home rememdy of 2000 IUs of Vitamin D and garlic pills both taken twice daily were able to help the rash subside. Benedryl and hydrocortisone did not do much to help. Hydrocortisone helped somewhat soothe the intensity but didn?t help a whole lot and if I took more than two benedryl it would also soothe symptoms mildly but if only taken one or two benedryl, the rash seemed to worsen. The rashes when present would appear in the evening, get less intense over night, and progressively grow in intensity until fully flared before bedtime. This pattern would repeat until treated.   Also during this time, beginning after my first rash, I was on my period for THREE MONTHS. It was very light for the most part but I am 30 years old and have never had an irregular period in my adult life. Things resolved the second week of October but it is a October 16th and I?m sure issues will continue.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Headache, Heart rate increased
Clinical narrative: Started with mild headache that got progressively worse. As the headache worsened body temperature and heart rate rose. Body temp spiked at 103° and resting heartrate rose to 98bpm. Headache began to relieve within 12hrs of onset and heartrate is lower but still elevated.