chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypertension, SARS-CoV-2 antibody test
Clinical narrative: next day i fell extreme fatigue and sweats; next day i fell extreme fatigue and sweats; 10 minutes after the shot my blood pressure went very high; my face turned beat red; This is a spontaneous report from a contactable consumer (patient) via Covid-19 Adverse Event Self-Reporting Solution.  A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 19Oct2021 12:00 (Lot Number: 30135BA; expiry date: unknown) at the age of 51-years-old, as dose 1, single, for Covid-19 immunization. Medical history included fruit -anaphylaxis and Covid-19 from Nov2020 to an unknown date. The patient had no other health issues. There were no concomitant medications. The patient previously took certain antibiotics and experienced drug hypersensitivity. The patient was not tested for Covid-19 post vaccination. The vaccine was administered in the hospital. The patient did not receive other vaccines in four weeks. The patient did not receive other medications in two weeks. On 19Oct2021 at 12:10 (10 minutes after the shot), patient's blood pressure went very high, and his face turned beat red. The nurse took his pressure, and it was 167 over 101. It remained at that level only fluctuating 5 points within a time period of 1hr. They kept him onsite for monitoring. They sent him home with the same high blood pressure level. Next day, (20Oct2021) patient felt extreme fatigue and sweats. He called his doctor, and they took him in immediately. That next afternoon pressure was still at 158 over 101. They sent him to the emergency room for further blood work and tests for the heart; both with unknown results. His pressure was still the same today (21Oct2021) at 157 over 93. They told him to call cardiologist and he was waiting for an appointment. He does not have high blood pressure it's always been 120 over 80 at last. Dr physical in Jun2021 - no family history either. Patient stated that the shot caused this new health issue. Patient stated that he had Covid in Nov2020 and to this day, he had very high antibodies as he had been tested in Aug2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and disability or permanent damage. The events were not treated. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Facial paralysis, Limb injury, Peripheral swelling, Speech disorder
Clinical narrative: right eye lower than left; Arm swollen; could not close hand; confusion; Problem/difficulty speaking; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: fh8020), via an unspecified route of administration, administered in right arm on 14Oct2021 (at the age of 40-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient previously took ibuprofen and experienced allergy. Historical vaccine included BNT162B2 (Lot number: fe3592), via an unspecified route of administration, administered in right arm on 23Sep2021 (at the age of 40-years-old) at dose 1, single for COVID-19 immunization. Prior to vaccination, the patient did not have COVID-19 infection and did not receive any other vaccine in four weeks. The patient reported that next day at 6 pm, her arm was swollen, could not close hand, had confusion, problem/difficulty speaking, and right eye was lower than left. No treatment was received for the events. The patient was not COVID tested post-vaccination. Outcome of the events was unknown.    Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; This is a spontaneous report received from a contactable consumer (parent; patient's father). A 19-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included sports induced asthma and family history of allergic reactions to several products and vaccinations, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced anaphylactic reaction on an unspecified date. It was reported that the patient experienced an anaphylactic reaction after her first dose and her doctor advised her not to get the 2nd shot. She has a history of sports induced asthma and used to have an inhaler for when she was active playing sports, but now, she was using an inhaler at all time after her reaction to the Pfizer Covid-19 vaccine. The outcome of the event was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood pressure increased, Blood pressure measurement, Eye irritation, Heart rate
Clinical narrative: Anaphylaxis; Blood pressure 167/132; resting heart rate 131; swelling of the throat; irritation of the eyes; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiry date unknown), via an unspecified route of administration administered in arm left on 13Oct2021 17:00 as dose 2, single for covid-19 immunization. Medical history included allergies: PCN (penicillin). The patient was previously vaccinated with the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, lot number unknown) on 22Sep2021 17:00 in the left arm for covid-19 immunization at the age of 32 years old. The patient previously received cefalexin (KEFLEX), ciprofloxacin (CIPRO) and, azithromycin - all on unspecified dates for unknown indications and experienced allergies. The patient's concomitant medications were not reported. The vaccine was given in a pharmacy or drug store. There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination. On 14Oct2021 17:00 the patient experienced anaphylaxis, blood pressure 167/132, resting heart rate 131, swelling of the throat, and irritation of the eyes. Treatment received included IV antihistamine, fluids, and prednisone. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was recovering from all the adverse events at the time of the report. The patient was not tested for covid-19 post-vaccination.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Pharyngeal swelling
Clinical narrative: Anaphylaxis; Blood pressure 167/132; resting heart rate 131; swelling of the throat; irritation of the eyes; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiry date unknown), via an unspecified route of administration administered in arm left on 13Oct2021 17:00 as dose 2, single for covid-19 immunization. Medical history included allergies: PCN (penicillin). The patient was previously vaccinated with the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, lot number unknown) on 22Sep2021 17:00 in the left arm for covid-19 immunization at the age of 32 years old. The patient previously received cefalexin (KEFLEX), ciprofloxacin (CIPRO) and, azithromycin - all on unspecified dates for unknown indications and experienced allergies. The patient's concomitant medications were not reported. The vaccine was given in a pharmacy or drug store. There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination. On 14Oct2021 17:00 the patient experienced anaphylaxis, blood pressure 167/132, resting heart rate 131, swelling of the throat, and irritation of the eyes. Treatment received included IV antihistamine, fluids, and prednisone. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was recovering from all the adverse events at the time of the report. The patient was not tested for covid-19 post-vaccination.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Rhabdomyolysis
Clinical narrative: dose received: 3; Rhabdomyolysis; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at dose 3 (booster), single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at dose 1, single and via an unspecified route of administration on an unspecified date at dose 2, single for COVID-19 immunisation. The patient received the third dose of BNT162B2 on an unspecified date. On Oct2021, the patient experienced rhabdomyolysis which required emergency room visit and caused hospitalization from Oct2021. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Dry eye, Headache, Hypoaesthesia oral, Lacrimation increased
Clinical narrative: Bell''s palsy; Mouth paralysis; Eye is running and tearing; Dry eye; Funny taste in mouth; Headache; Numbness lips; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Arm Right on 11Oct2021 14:30 (at the age of 68-years-old)  (Batch/Lot Number: FE2590) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included ongoing atrial fibrillation Verbatim: heart condition with a-fib, stroke from Feb2021 to an unknown date Wife had a stroke in Feb2021. There were no concomitant medications. The patient previously took Dose number: 1, LOT: EL9267 of bnt162b2 on 10Feb2021, and Dose number: 2, LOT: EN6198, EXP: 30Jun2021 on 03Mar2021, penicillin [benzylpenicillin] and experienced Allergic to penicillin. On 13Oct2021, the patient experienced headache, Was behind his right ear. Put ice on it. Then was using a heating pad. Wasn't really bad, felt more like a toothache throb. On 14Oct2021, the patient experienced funny taste in mouth. Was like salivation gland was going (withheld). Was like he had something sweet in his mouth. Was the whole mouth. On 17Oct2021, the patient experienced eye is running and tearing Right eye is droopy, and right corner of his mouth is sagging. It is obvious, Now is more like a dry eye. Doctor prescribed him artificial tears to make sure eye stays hydrated. Right eye doesn't cooperate. Has to struggle to close his right eye and blink. Right eye will close when he is closing both eyes at the same time. Right eye won't cooperate when he tries to close it by itself. He can blink his left eye, and mouth paralysis (medically significant) started coming on really slow. He really noticed it on the 17Oct2021. On 20Oct2021, the patient experienced Bell's Palsy. In Oct2021, the patient experienced numbness lips, can't tell if the numbness is also on his tongue. Mostly can tell on the lips. When tries to smile, the right side of the mouth doesn't respond. Difficulty drinking: Clarified he doesn't have difficulty swallowing. When he eats, tends to bite that lip. When he takes a drink out of a bottle, it dribbles out. States it's a lot easier to drink from a straw than a bottle. The outcome of the event headache was recovered, Mouth paralysis was not recovered, Funny taste in mouth was recovering, while unknown for the other events.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Paralysis, Taste disorder
Clinical narrative: Bell''s palsy; Mouth paralysis; Eye is running and tearing; Dry eye; Funny taste in mouth; Headache; Numbness lips; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Arm Right on 11Oct2021 14:30 (at the age of 68-years-old)  (Batch/Lot Number: FE2590) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included ongoing atrial fibrillation Verbatim: heart condition with a-fib, stroke from Feb2021 to an unknown date Wife had a stroke in Feb2021. There were no concomitant medications. The patient previously took Dose number: 1, LOT: EL9267 of bnt162b2 on 10Feb2021, and Dose number: 2, LOT: EN6198, EXP: 30Jun2021 on 03Mar2021, penicillin [benzylpenicillin] and experienced Allergic to penicillin. On 13Oct2021, the patient experienced headache, Was behind his right ear. Put ice on it. Then was using a heating pad. Wasn't really bad, felt more like a toothache throb. On 14Oct2021, the patient experienced funny taste in mouth. Was like salivation gland was going (withheld). Was like he had something sweet in his mouth. Was the whole mouth. On 17Oct2021, the patient experienced eye is running and tearing Right eye is droopy, and right corner of his mouth is sagging. It is obvious, Now is more like a dry eye. Doctor prescribed him artificial tears to make sure eye stays hydrated. Right eye doesn't cooperate. Has to struggle to close his right eye and blink. Right eye will close when he is closing both eyes at the same time. Right eye won't cooperate when he tries to close it by itself. He can blink his left eye, and mouth paralysis (medically significant) started coming on really slow. He really noticed it on the 17Oct2021. On 20Oct2021, the patient experienced Bell's Palsy. In Oct2021, the patient experienced numbness lips, can't tell if the numbness is also on his tongue. Mostly can tell on the lips. When tries to smile, the right side of the mouth doesn't respond. Difficulty drinking: Clarified he doesn't have difficulty swallowing. When he eats, tends to bite that lip. When he takes a drink out of a bottle, it dribbles out. States it's a lot easier to drink from a straw than a bottle. The outcome of the event headache was recovered, Mouth paralysis was not recovered, Funny taste in mouth was recovering, while unknown for the other events.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Erythema, Feeling abnormal, Hypoaesthesia, Pruritus
Clinical narrative: sharp heart pain; Full body rash; red and itchy; red and itchy; numbing of hands; a funny sensation has continued; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via unspecified route in left arm on 17Sep2021 at 12:15 at patient age of 57-year-old as single dose (lot number FC3182) for COVID-19 immunisation. The patient medical history included known allergies: penicillin. The patient did not have COVID prior vaccination.  The patient concomitant medication included estradiol, norethisterone acetate (ESTRADIOL AND NORETHINDRONE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced full body rash, red and itchy, numbing of hands, sharp heart pain from 17Sep2021 at 12:30. Heart pain and a funny sensation had continued although the sharp heart pain isn't noticeable unless exercise like running. The event resulted in emergency room/department or urgent care.  The patient did not receive treatment. The patient has not been tested for COVID-19 post vaccination. The patient recovered with lasting effects in 2021.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: sharp heart pain; Full body rash; red and itchy; red and itchy; numbing of hands; a funny sensation has continued; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via unspecified route in left arm on 17Sep2021 at 12:15 at patient age of 57-year-old as single dose (lot number FC3182) for COVID-19 immunisation. The patient medical history included known allergies: penicillin. The patient did not have COVID prior vaccination.  The patient concomitant medication included estradiol, norethisterone acetate (ESTRADIOL AND NORETHINDRONE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced full body rash, red and itchy, numbing of hands, sharp heart pain from 17Sep2021 at 12:30. Heart pain and a funny sensation had continued although the sharp heart pain isn't noticeable unless exercise like running. The event resulted in emergency room/department or urgent care.  The patient did not receive treatment. The patient has not been tested for COVID-19 post vaccination. The patient recovered with lasting effects in 2021.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Dyspnoea
Clinical narrative: got the Covid-19 virus; got the Covid-19 virus; breathing issues; This is a spontaneous report from a contactable consumer (patient's husband).  A 50-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  Historical vaccine includes dose 1 of Comirnaty (at the age of 50-years-old). On an unspecified date, the patient got the covid-19 virus with breathing issues. The outcome of the events was unknown. Therapeutic measures were taken as a result of breathing issues which includes inhaler.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Chest pain, SARS-CoV-2 test
Clinical narrative: Chest pain; Atrial Fibrillation; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 02Oct2021 at 15:30 (Lot Number: 30155BA, unknown expiration) as dose 1, single at the age of 50 years old for COVID-19 immunization.  Medical history included COVID (If COVID prior vaccination: Yes). No known allergies. No other medical history. No other vaccine in four weeks. Concomitant medication included omeprazole. On 04Oct2021 at 22:00, the patient experienced chest pain and atrial fibrillation. The patient was tested for COVID-19 post vaccination via nasal swab on 07Oct2021 with negative result. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. The patient received treatment for chest pain and atrial fibrillation. The patient has not yet recovered from the events. The events were assessed as serious (hospitalization for 1 day).   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Thrombocytopenia
Clinical narrative: thrombocytopenia; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced thrombocytopenia. Reporter stated she already called before and just want to know if we had additional information now regarding thrombocytopenia. At the time of this report, the outcome of event was unknown.  The lot number for (BNT162B2), was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable physician (patient). A male patient, of an unspecified age, received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient previously received the first dose of BNT162B2, on an unspecified date; and experienced ineffective drug/COVID-19 and arm soreness. On an unspecified date, patient reported arm soreness. Patient reported first dose caused no side effects other than arm soreness. Second dose happened within weeks of having positive COVID-19 test and caused similar side effects. He is still happy and feels the reaction meant his body has a robust response to vaccine. The outcome of the events: unknown. No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): INC-202101425758 same patient and product; different events and dose; INC-202101425760 same patient and product; different events and dose.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Ear pain, Immunisation, Insomnia
Clinical narrative: pricking, zap/jab feeling starts in primarily the bilateral feet and ankles neuropathy; stabbing pain across lower back-area of sacrum, across upper back-area between the shoulders, bilateral feet, ankles, hands & ear dum area; stabbing pain across lower back-area of sacrum, across upper back-area between the shoulders, bilateral feet, ankles, hands & ear dum area; stabbing pain across lower back-area of sacrum, across upper back-area between the shoulders, bilateral feet, ankles, hands & ear dum area; stabbing pain across lower back-area of sacrum, across upper back-area between the shoulders, bilateral feet, ankles, hands & ear dum area; stabbing pain across lower back-area of sacrum, across upper back-area between the shoulders, bilateral feet, ankles, hands & ear dum area; the amount of sleep had decreased to no sleep; dose number: 3; This is a spontaneous report from a contactable consumer. This 64-year-old female consumer (patient) reported for herself that she received 3rd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot FC3181) single dose on 11Oct2021 at 11:00 AM at right arm for COVID-19 immunization at the age of 64 years old. Medical history included history of mild Asthma, allergies: Penicillin, cefaclor (CECLOR), levofloxacin (LEVAQUIN), erythromycin ethylsuccinate (EES), Steroids, Sulfa, cefixime (CITROEN), Cephalosporins, montelukast sodium (SINGULAIR), paracetamol (TYLENOL), ibuprofen (MOTRIN), citrus. Concomitant drugs included estradiol (YUVAFEM), estradiol, Vitamin D3, calcium, magnesium. Historical vaccine included 1st dose of BNT162B2 (lot EN 6207) on 10Mar2021 at 12:00 PM, 2nd dose of BNT162B2 (lot ER 8737) on 31Mar2021 at 12:00 PM, both at right arm for Covid-19 Immunization at the age of 64 years old. The patient reported that on 11Oct2021 at 10pm after the injection stabbing pain across lower back-area of sacrum, across upper back-area between the shoulders, bilateral feet, ankles, hands & ear dum area. She felt like a voodoo doll being stabbed at and flopping back & forth like a fish out of water moaning & groaning. This level of intensity lasted 24 hours. Since that, at night, lying in bed-trying to go to sleep the pricking, zap/jab feeling starts in primarily the bilateral feet and ankles neuropathy (she was not diabetic) until she can take enough over the counter meds to fall asleep. During the day just occasional zaps and jabs. Another problem during the first 7 days the amount of sleep had decreased to no sleep & therefore no relief from the zaps/jabs. She finally had to consume alcohol x2 nights and smoke marijuana the last 2 nights. The marijuana seems to be the trick finally the number of daytime hours has been reduced to just a few and it also put her to sleep and enabled her sleep. The events resulted in doctor office visit. The outcome of the events was resolving.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pain in extremity
Clinical narrative: pricking, zap/jab feeling starts in primarily the bilateral feet and ankles neuropathy; stabbing pain across lower back-area of sacrum, across upper back-area between the shoulders, bilateral feet, ankles, hands & ear dum area; stabbing pain across lower back-area of sacrum, across upper back-area between the shoulders, bilateral feet, ankles, hands & ear dum area; stabbing pain across lower back-area of sacrum, across upper back-area between the shoulders, bilateral feet, ankles, hands & ear dum area; stabbing pain across lower back-area of sacrum, across upper back-area between the shoulders, bilateral feet, ankles, hands & ear dum area; stabbing pain across lower back-area of sacrum, across upper back-area between the shoulders, bilateral feet, ankles, hands & ear dum area; the amount of sleep had decreased to no sleep; dose number: 3; This is a spontaneous report from a contactable consumer. This 64-year-old female consumer (patient) reported for herself that she received 3rd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot FC3181) single dose on 11Oct2021 at 11:00 AM at right arm for COVID-19 immunization at the age of 64 years old. Medical history included history of mild Asthma, allergies: Penicillin, cefaclor (CECLOR), levofloxacin (LEVAQUIN), erythromycin ethylsuccinate (EES), Steroids, Sulfa, cefixime (CITROEN), Cephalosporins, montelukast sodium (SINGULAIR), paracetamol (TYLENOL), ibuprofen (MOTRIN), citrus. Concomitant drugs included estradiol (YUVAFEM), estradiol, Vitamin D3, calcium, magnesium. Historical vaccine included 1st dose of BNT162B2 (lot EN 6207) on 10Mar2021 at 12:00 PM, 2nd dose of BNT162B2 (lot ER 8737) on 31Mar2021 at 12:00 PM, both at right arm for Covid-19 Immunization at the age of 64 years old. The patient reported that on 11Oct2021 at 10pm after the injection stabbing pain across lower back-area of sacrum, across upper back-area between the shoulders, bilateral feet, ankles, hands & ear dum area. She felt like a voodoo doll being stabbed at and flopping back & forth like a fish out of water moaning & groaning. This level of intensity lasted 24 hours. Since that, at night, lying in bed-trying to go to sleep the pricking, zap/jab feeling starts in primarily the bilateral feet and ankles neuropathy (she was not diabetic) until she can take enough over the counter meds to fall asleep. During the day just occasional zaps and jabs. Another problem during the first 7 days the amount of sleep had decreased to no sleep & therefore no relief from the zaps/jabs. She finally had to consume alcohol x2 nights and smoke marijuana the last 2 nights. The marijuana seems to be the trick finally the number of daytime hours has been reduced to just a few and it also put her to sleep and enabled her sleep. The events resulted in doctor office visit. The outcome of the events was resolving.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram thorax, Rheumatoid arthritis
Clinical narrative: had severe rheumatoid arthritis; This is a spontaneous report from a contactable Nurse who reported for her husband.    A 77-year-old male patient received second dose of bnt162b2 (COMIRNATY; Lot Number: EP7534) via an unspecified route of administration in Arm on 23Mar2021 at 11:00 (at 77 years) as single dose for covid-19 immunisation.  The patient medical history included obesity , high blood pressure. Concomitant medications were not reported. Previously patient received the first dose of bnt162b2 (COMIRNATY; lot: EN6198) in Arm on 02Mar2021 (at 77 years) as single dose for covid-19 immunisation. On an unspecified date in Mar2021, after the second dose, within a week, his wrist and hand were all deformed, he didn't have this before. He went to a Rheumatologist for blood test in 2021 and he diagnosed him with severe Rheumatoid arthritis. The doctor said he has never seen anything blow up like this. His hands were twisted, and it happened within a week. She was very surprised and called his rheumatologist immediately. The Rheumatologist was the one that asked if he had the vaccine .Patient was on an anti inflammatory. He took Enbrel (Lot number 1134801; and expiration May 2023). He took it once a week. He was a little better , but still not better. His hands were deformed and the bones were still deformed.Patient can hardly hold anything. After the doctor mentioned it, it made since that the Vaccine caused this. He was also getting a Chest CT in 2021, results unknown.Event did not required Emergency Room, but required Physician Office visit.Event Rheumatoid arthritis was serious due to Disability.The final outcome of the event was reported as recovering.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of severe Rheumatoid arthritis . The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: a few weeks ago we both contracted the virus; a few weeks ago we both contracted the virus; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single and via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose 2, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that both him and his wife received Pfizer covid vaccines. The second dose was administered this past Mar2021. A few weeks ago "we both contracted the virus" in 2021. It was not much fun, to say the least. Sometimes he wonder if they really received a true vaccine or just a placebo. He have heard the spin that that taking the vaccine saved them from a more severe case that might have required hospitalization. He suspected that they will never know. He was not aware he had the virus and infected his friend. He could of infected other people. Luckily, he got out the alarm and they were all self isolated. He doesn't remember ever hearing the virus could be disseminated by a vaccinated person. Outcome of the events was unknown.  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-202101426770 same reporter, drug and event, different patient
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report from a contactable nurse (patient). A non-pregnant 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 24Feb2021 at 17:30 (Lot Number: EK9231, unknown expiration) as dose 2, single at the age of 67 years old for COVID-19 immunisation.  The patient medical history was not reported. No COVID prior vaccination and has not been tested for COVID post vaccination.  No other medications in two/four weeks. There were no concomitant medications.  The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot No: EK9231) on 26Jan2021 at 18:00 in left arm at the age of 67 years old for COVID-19 immunization. The patient previously took codeine and experienced drug allergy. The patient experienced tinnitus in Mar2021, approximately 2 weeks following vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. The physician examined the patient's ears with no signs and symptoms of infection or other cause. The patient received treatment for the event. The patient has not yet recovered from the event. The event was assessed as serious (disability or permanent damage).   Information on the lot/batch number has been requested.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the event "tinnitus" and the suspect drug "BNT162B2" cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heavy menstrual bleeding, SARS-CoV-2 test
Clinical narrative: Patient had first vaccine in series in early Aug.  After this has heavy menses.; Developed fatigue; This is a spontaneous report from a contactable physician.   A 13-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number unknown), via an unspecified route of administration, in Aug2021 (at the age of 13-year-old) at single dose for COVID-19 immunisation.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have a COVID-19 before the vaccination. No relevant medical history and concomitant medications were provided. In Aug2021, after vaccination, the patient had heavy menses and fatigue. The patient was hospitalized due to the events for 7 days. The course of the events was reported as follows: patient had first vaccine in series in early Aug.  After this has heavy menses. She developed fatigue. The events required physician office visit and emergency room visit. In Aug2021, Nasal swab was done and resulted negative. 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.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Heavy Menstrual Bleeding and Fatigue and the suspect drug cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-202101427281 same patient/drug, different vaccine dose (second dose)/event
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Fatigue, Nausea, Syncope
Clinical narrative: Faintness; Fatigue; Minor chest pain; dizziness; nausea; This a spontaneous report from a contactable consumer (patient).  This 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number 301308A), via an unknown route administered in the left arm, on 18Oct2021 at 17:15 (at the age of 39-year-old) at single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. No relevant medical history and concomitant medications were provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 before the vaccination. On 20Oct2021, the patient developed faintness, fatigue, minor chest pain, dizziness, and nausea. No seriousness criteria were provided.  The patient was not treated for the events. Post-vaccination COVID-19 test was not done. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Menstrual period arrived 9 days early, have been bleeding for 17 days straight; Menstrual period arrived 9 days early; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 22Sep2021 (Batch/Lot Number: FF2589) as dose 1, single for COVID-19 immunization in a hospital. Medical history included COVID-19 from an unknown date (COVID prior vaccination: Yes). There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took guaifenesin and experienced drug allergy. Since the vaccination, the patient has not been tested for COVID-19. On 06Oct2021, it was reported that the patient experienced menstrual period arrived 9 days early, have been bleeding for 17 days straight with no signs of it letting up. No treatment was received. The reporter considered the events as non-serious. The events did not result in death or life threatening condition, caused/prolonged hospitalization, disability or congenital anomaly/birth defect. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Mastitis
Clinical narrative: Clogged duct/mastitis in left breast; This is a spontaneous report from a non-contactable consumer (patient). A 24-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 19Oct2021 09:15 (Batch/Lot Number: Ff2587) as single dose for Covid-19 immunisation. Medical history included known allergies to amoxicillin and shellfish. The patient was not pregnant at the time of vaccination. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 13Sep2021 at 12pm (Batch/Lot No: Ff2587) in left arm for Covid-19 immunisation. Concomitant medications included pre-natal (as reported); sertraline; loratadine (CLARITINE); paracetamol (TYLENOL); all taken for an unspecified indication, start and stop date were not reported. After the second dose, the patient experienced clogged duct/mastitis in left breast on 21Oct2021. It was treated with antibiotics. The event resulted in doctor/other healthcare professional office/clinic visit. Patient was not diagnosed with Covid-19 prior to vaccination. The patient was not tested for Covid-19 post vaccination. Outcome of the event was recovering.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Tested positive for Covid and they were vaccinated; Tested positive for Covid and they were vaccinated; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 5 patients. This is 2 of 5 reports.  A consumer reported for her daughter of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) on an unknown date at a single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The daughter and son-law were tested positive for Covid the week before reporting and they were vaccinated, except for the kids. The kids can't be vaccinated yet and hopefully this will get approved pretty quickly for the kids. The outcome of the event was unknown.  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-202101427488 same reporter, differet patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: son-law are also tested positive for Covid last week; son-law are also tested positive for Covid last week; This is a spontaneous report from a contactable consumer.   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced tested positive for covid last week The patient underwent lab tests and procedures which included sars-cov-2 test: positive   on unknown date    .  The clinical course was reported as follows: Caller mentioned they were all in quarantine right now for Covid because her grandkids had Covid. So, her daughter and son-law were also tested positive for Covid last week and they were vaccinated, except for the kids. The kids can't be vaccinated yet and hopefully this will get approved pretty quickly for the kids.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a solicited report from a Pfizer sponsored program via Regulatory Authority based on information received by Pfizer from the Regulatory Authority, MFR Control No. 21K-163-4077901-00.   A contactable 58-year-old female consumer (patient) reported that she received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) the first dose on 22Jan2021 as single dose via intramuscular route and second dose on 12Feb2021 as single dose via intramuscular route for COVID-19 immunization at the age of 57-years-old. The patient's medical history included Crohn's disease. Concomitant medication included ADALIMUMAB (HUMIRA, Solution for injection in pre-filled pen via subcutaneous for moderate to severe adult Crohn's disease. In Jul2021 the patient experienced COVID-19. The outcome of the event was reported as recovered. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Quadriceps on both legs are in a lot of pain/generalize muscle soleness in arms and legs; Both thighs feel swollen and tender; Both thighs feel swollen and tender; This is a spontaneous report from a contactable consumer.     A 25-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 14Oct2021 17:00 (Batch/Lot Number: Ff2590) as single dose for covid-19 immunisation  .  Medical history included covid-19.     There were no concomitant medications.  The patient experienced quadriceps on both legs are in a lot of pain/generalize muscle soleness in arms and legs  (disability, medically significant) on 15Oct2021 15:00 with outcome of not recovered , both thighs feel swollen and tender (disability, medically significant) on 15Oct2021 15:00 with outcome of not recovered.  Follow-Up (27Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Postpartum haemorrhage, SARS-CoV-2 test
Clinical narrative: increased postpartum bleeding; This is a spontaneous report from a non-contactable consumer (patient).   A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 14Apr2021, at the age of 30-years-old (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included mental disorder, Clotting disorder and allergy to amoxicillin.  The patient gave a birth 9 days before 1st vaccine dose. The patient previously took first dose of bnt162b2 for covid-19 immunisation on 24Mar2021.  The patient experienced increased postpartum bleeding on Apr2021 with outcome of recovered with sequelae.  The patient underwent lab test included sars-cov-2 test via nasal swab: negative on 20Oct2021. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Investigation, SARS-CoV-2 test
Clinical narrative: stroke; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female non-pregnant patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left on 16Apr2021 12:00 (batch/lot number: ER8737) at 58 years of age as dose 2, single for covid-19 immunisation at a public health clinic/veterans administration facility. Medical history included hypothyroidism, cervical spine fusion, PFO (patent foramen ovale), allergy. The patient, prior to vaccination, was not diagnosed with COVID-19. Concomitant medications included unspecified medications. The patient received other medications within 2 weeks of vaccination. The patient previously took dose 1 of BNT162B2 administered in the left arm on 26Mar2021 13:30 (batch/lot number EP7534) at 58 years of age for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Jul2021 08:00, the patient experienced stroke. The reporter informed that the event was serious - hospitalization for 4 days. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient, since the vaccination, has been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): negative   on 17Sep2021, testing with unknown results on unspecified date. The patient received unspecified medications as treatment for the event. The outcome of the event was recovered on unspecified date in 2021.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis, Pericarditis
Clinical narrative: Myocarditis; Pericarditis; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer-sponsored program with Regulatory Authority Support.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced myocarditis, pericarditis with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.