chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Blood pressure measurement, Cold sweat, Heart rate
Clinical narrative: blood sugar was 140 this am; I don't feel right; don't feel right and I am breaking out in a sweat; clammy and lethargic; clammy and lethargic; respiratory rate was 8; This is a spontaneous report from a contactable nurse (husband). A 65-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EW0153), intramuscular, administered in Arm Right on 08Apr2021 12:30 (received at 65-years-old) as SINGLE DOSE for COVID-19 immunization. The vaccine was administered at Administration facility. The patient did not receive any other vaccines within 4 weeks prior to receiving bnt162b2. Medical history included diabetes, hypertension, depression, and known allergy to sulfa. The patient was not pregnant. Concomitant medication included insulin (INSULIN) taken for an unspecified indication, start and stop date were not reported; and BP (blood pressure) meds, ECT therapy. The reporter stated that he and his wife came around at 12:30 (08Apr2021) and got her first dose of COVID vaccine. They waited in observation for 15 minutes. They went to go eat after the shot and he stopped to get gas and his wife stated "I don't feel right and I am breaking out in a sweat." So, he just came back over here to the vaccine site. When nurse approached the car, the patient in the passenger seat appeared diaphoretic, clammy and lethargic. She was responsive oriented to four spheres and denied pain. She said "I just don't feel right." Pulse rate was 63, respiratory rate was 8, BP was 120/60 O2 saturation 97%. The patient stated "I am a diabetic and blood sugar was 140 this am." She is on insulin and BP meds her spouse stated, Advanced EMT on site checking vitals. Epi 0.3 was given in right thigh per EMT and patient was transported to ER via ambulance. All adverse events started on 08Apr2021 01:15 PM. The adverse events resulted in Emergency room/department or urgent care. The patient received corrective treatment for the reported adverse events. Outcome of the events was recovering. The patient had no COVID prior to administration of bnt162b2 and was not tested for COVID post vaccination.; Sender's Comments: Based on the available information, a possible contribution of the drug to the events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Lethargy, Malaise, Oxygen saturation, Respiratory rate
Clinical narrative: blood sugar was 140 this am; I don't feel right; don't feel right and I am breaking out in a sweat; clammy and lethargic; clammy and lethargic; respiratory rate was 8; This is a spontaneous report from a contactable nurse (husband). A 65-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EW0153), intramuscular, administered in Arm Right on 08Apr2021 12:30 (received at 65-years-old) as SINGLE DOSE for COVID-19 immunization. The vaccine was administered at Administration facility. The patient did not receive any other vaccines within 4 weeks prior to receiving bnt162b2. Medical history included diabetes, hypertension, depression, and known allergy to sulfa. The patient was not pregnant. Concomitant medication included insulin (INSULIN) taken for an unspecified indication, start and stop date were not reported; and BP (blood pressure) meds, ECT therapy. The reporter stated that he and his wife came around at 12:30 (08Apr2021) and got her first dose of COVID vaccine. They waited in observation for 15 minutes. They went to go eat after the shot and he stopped to get gas and his wife stated "I don't feel right and I am breaking out in a sweat." So, he just came back over here to the vaccine site. When nurse approached the car, the patient in the passenger seat appeared diaphoretic, clammy and lethargic. She was responsive oriented to four spheres and denied pain. She said "I just don't feel right." Pulse rate was 63, respiratory rate was 8, BP was 120/60 O2 saturation 97%. The patient stated "I am a diabetic and blood sugar was 140 this am." She is on insulin and BP meds her spouse stated, Advanced EMT on site checking vitals. Epi 0.3 was given in right thigh per EMT and patient was transported to ER via ambulance. All adverse events started on 08Apr2021 01:15 PM. The adverse events resulted in Emergency room/department or urgent care. The patient received corrective treatment for the reported adverse events. Outcome of the events was recovering. The patient had no COVID prior to administration of bnt162b2 and was not tested for COVID post vaccination.; Sender's Comments: Based on the available information, a possible contribution of the drug to the events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory rate decreased
Clinical narrative: blood sugar was 140 this am; I don't feel right; don't feel right and I am breaking out in a sweat; clammy and lethargic; clammy and lethargic; respiratory rate was 8; This is a spontaneous report from a contactable nurse (husband). A 65-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EW0153), intramuscular, administered in Arm Right on 08Apr2021 12:30 (received at 65-years-old) as SINGLE DOSE for COVID-19 immunization. The vaccine was administered at Administration facility. The patient did not receive any other vaccines within 4 weeks prior to receiving bnt162b2. Medical history included diabetes, hypertension, depression, and known allergy to sulfa. The patient was not pregnant. Concomitant medication included insulin (INSULIN) taken for an unspecified indication, start and stop date were not reported; and BP (blood pressure) meds, ECT therapy. The reporter stated that he and his wife came around at 12:30 (08Apr2021) and got her first dose of COVID vaccine. They waited in observation for 15 minutes. They went to go eat after the shot and he stopped to get gas and his wife stated "I don't feel right and I am breaking out in a sweat." So, he just came back over here to the vaccine site. When nurse approached the car, the patient in the passenger seat appeared diaphoretic, clammy and lethargic. She was responsive oriented to four spheres and denied pain. She said "I just don't feel right." Pulse rate was 63, respiratory rate was 8, BP was 120/60 O2 saturation 97%. The patient stated "I am a diabetic and blood sugar was 140 this am." She is on insulin and BP meds her spouse stated, Advanced EMT on site checking vitals. Epi 0.3 was given in right thigh per EMT and patient was transported to ER via ambulance. All adverse events started on 08Apr2021 01:15 PM. The adverse events resulted in Emergency room/department or urgent care. The patient received corrective treatment for the reported adverse events. Outcome of the events was recovering. The patient had no COVID prior to administration of bnt162b2 and was not tested for COVID post vaccination.; Sender's Comments: Based on the available information, a possible contribution of the drug to the events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cell marker decreased, Condition aggravated, HLA-B*27 assay, Iritis
Clinical narrative: I am HLA-27 deficient; iritis flared up; iritis flared up; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6204), via an unspecified route of administration administered in left arm on 19Mar2021 at 11:15 AM (at the age of 59-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Medical history included known allergies to some flours, depending on processing and iritis (significant period of stability). Concomitant medication included brimonidine tartrate. The patient stated, "It may be coincidental, but my iritis flared up 48 hrs after Vaccination, following a significant period of stability. It only lasted 4 days, so a relatively short episode. No visit to doctor was required. I am HLA-27 deficient." The events started on 21Mar2021. The reporter considered the event "I am HLA-27 deficient" as serious medically significant. There was no treatment received for the events. On an unspecified date, the patient recovered from all events.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she tested positive for COVID-19 with symptoms (side effects); she tested positive for COVID-19 with symptoms (side effects); This is a spontaneous report received from contactable consumer (patient) via Pfizer Sponsored Program. A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: UNKNOWN) via an unspecified route of administration on 22Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Two days after getting the vaccine, patient developed symptoms (side effects) and a week later, she tested positive for COVID-19. Patient second dose was scheduled on April 12. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Feeling abnormal, Heart rate
Clinical narrative: fatigue; a racing heartbeat; light headedness; sharp pain in her elbows; felt terrible; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 21Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Caller is asking if she can receive her 2nd dose a day earlier than the scheduled 21 days due to potential bad weather on the date of her appointment. She received the 1st dose on 21Mar2021 and scheduled for her 2nd dose this sunday, 11Apr2021. Caller mentioned that upon receiving her 1st dose of the Pfizer COVID Vaccine on 21Mar2021 she was out it and felt terrible. She experienced fatigue, a racing heartbeat, and light headedness. She also mentioned that she has noticed a sharp pain in her elbows. When she called her doctor's office, the nurse told that the doctor was also out for 3 days after getting vaccinated with a COVID vaccine and that they had several patients calling in for palpitations, fatigue, and fast heartbeats after getting vaccinated. She mentioned that even vitamins make her dizzy and that her body does not take well to anything foreign. She is asking if she maybe expecting the same thing with the 2nd dose. The patient underwent lab tests and procedures which included heart rate: a racing heartbeat on unknown date. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: fatigue; a racing heartbeat; light headedness; sharp pain in her elbows; felt terrible; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 21Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Caller is asking if she can receive her 2nd dose a day earlier than the scheduled 21 days due to potential bad weather on the date of her appointment. She received the 1st dose on 21Mar2021 and scheduled for her 2nd dose this sunday, 11Apr2021. Caller mentioned that upon receiving her 1st dose of the Pfizer COVID Vaccine on 21Mar2021 she was out it and felt terrible. She experienced fatigue, a racing heartbeat, and light headedness. She also mentioned that she has noticed a sharp pain in her elbows. When she called her doctor's office, the nurse told that the doctor was also out for 3 days after getting vaccinated with a COVID vaccine and that they had several patients calling in for palpitations, fatigue, and fast heartbeats after getting vaccinated. She mentioned that even vitamins make her dizzy and that her body does not take well to anything foreign. She is asking if she maybe expecting the same thing with the 2nd dose. The patient underwent lab tests and procedures which included heart rate: a racing heartbeat on unknown date. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: runny/stuffy; runny/stuffy; sore throat; This is a spontaneous report from a contactable consumer reported for herself.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Apr2021 (Batch/Lot number was not reported) at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Upon woke up on Monday, 05Apr21, the patient experienced runny/stuffy and sore throat.  Outcome for events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Pain in extremity, Pruritus, Vaccination site swelling
Clinical narrative: nose bleeds after first vaccine; Itching at first on arm then on body, after first vaccine; Soreness of arm after first vaccine; swelling at the injection site; This is a spontaneous report received from a contactable consumer reported for herself. A 56 years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17Mar2021 12:00 (Batch/Lot Number: EN6201) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller stated that she did not have any side effects noticeable, but reported soreness in her arm lasted for 3 to 4 days, swelling at the injection site lasted for 3 to 4 days, which went away in a few days. Caller stated she did experience itching on her arm, but it was nothing she couldn't deal with. Caller reported that within a couple of weeks, on 01Apr2021, she started having nosebleeds. Caller stated she had a second nosebleed on 04Apr2021, and a third nosebleed on 06Apr2021. Caller added that she had one more, nosebleed, at 3 o'clock on 05Apr2021. Caller then reported she was experiencing the itching on her arm but then it became body itching, she cannot explain, it is hard for her to put into words. Caller stated it was not a rash but it feels like she had to scratch. Outcome of event pruritus was unknown, of others was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hyperhidrosis, Pain in extremity, Poor quality product administered, Wrong technique in product usage process
Clinical narrative: My arm was not sure it just felt like something kind of pinched me; I was sweating in the face. My cloth masked was full of sweat inside out. The back of my neck and forehead was also wet in sweat.; soreness in her arm; She said she prepare them overnight and keeps them in the fridge.; She said she prepare them overnight and keeps them in the fridge. /lady just came out of the back with the syringe prefilled already; This is a spontaneous report received from Pfizer sponsored program from  a contactable consumer (patient) reported for herself. This is the 2nd of 2 reports, for the 2nd dose.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunisation, and had a sore arm with the first dose which lasted a day and the next day everything was fine. Reported that I received my second shot of the Pfizer vaccine. My arm was not sure it just felt like something kind of pinched me. I was sweating in the face. My cloth masked was full of sweat inside out. The back of my neck and forehead was also wet in sweat, a good deal of sweating. She has experienced some soreness in her arm the next date after she had her second shot, She took a couple of aspirins for her soreness. Stated doesn't feel sick though. Also reported that "When I received the first dose the syringe contained a cloudy solution whereas the second dose was clear. The girl didn't even prepare the second shot in front of me. She said she prepare them overnight and keeps them in the fridge. The guy who gave me the first dose prepared it in front of me. I don't know what the young lady gave me. They could've  administered anything. Pharmacy should really set a protocol to draw the vaccine from the vial in front of patients." For her second shot, the lady just came out of the back with the syringe prefilled already. Said she doesn't trust, or know what she got, since the lady is going back and forth to a back room. Outcome for events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021395376 same report/patient, different dose/AE.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with COVID 19 with symptoms; diagnosed with COVID 19 with symptoms; This is a spontaneous report from a contactable physician. A 28-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 05Jan2021 as a single dose for COVID-19 immunisation. Medical history included seronegative rheumatoid and CPPD arthritis (Calcium pyrophosphate dihydrate deposition). Concomitant medication included prednisone for arthritis 10 mg daily and again restated with 5-10 mg. Patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration in mid Dec2020 as a single dose for COVID-19 immunisation. Patient previously received etanercept (ENBREL) and tocilizumab (ACTEMRA) both for arthritis and had failed prior to immunization. On an unspecified date in 2021 (reported as 2 weeks ago), patient developed a fever and sore throat and was diagnosed with COVID 19. Patient was now feeling better and outcome for the events were recovering. Reporter does not wish to be contacted for follow-up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  Further information like confirmative virus genome /nucleic acid detection, specific dates for onset of covid symptoms are needed for meaningful medical assessment.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Hyperhidrosis, Hypoaesthesia
Clinical narrative: passed out two times; Left arm shoulder and neck completely numb; Left lower section of my head severe pain; dizziness; vertigo; nauseous; heavy sweats; my head feels very foggy; Having spots of memory issues; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 30Mar2021 11:30 (Batch/Lot Number: EM9810) as single dose for covid-19 immunization. Medical history included asthma, neuropathy, high cholesterol, and several allergies from an unknown date. The patient has no history of COVID prior vaccination. She was not COVID tested post vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (Lot number=EN6200) on 09Mar2021 12:15, on left arm for COVID-19 immunization. The patient experienced having left arm, shoulder and neck completely numb for four days since 30Mar2021, 19:00. Left lower section of her head with severe pain; she had dizziness, vertigo and was nauseous. She started having heavy sweats and passed out two times. She reported it has been a week since she had the shot and she was still dizzy and her head feels very foggy. She was also having spots of memory issues. The events were experienced on 30Mar2021, 19:00. No treatment was received for the events. The outcome of the events was not recovered from dizziness, and recovered with sequela from "Left arm shoulder and neck completely numb" on 03Ape2021, and recovered with sequelae on an unspecified date for other events..
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Memory impairment, Nausea, Vertigo
Clinical narrative: passed out two times; Left arm shoulder and neck completely numb; Left lower section of my head severe pain; dizziness; vertigo; nauseous; heavy sweats; my head feels very foggy; Having spots of memory issues; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 30Mar2021 11:30 (Batch/Lot Number: EM9810) as single dose for covid-19 immunization. Medical history included asthma, neuropathy, high cholesterol, and several allergies from an unknown date. The patient has no history of COVID prior vaccination. She was not COVID tested post vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (Lot number=EN6200) on 09Mar2021 12:15, on left arm for COVID-19 immunization. The patient experienced having left arm, shoulder and neck completely numb for four days since 30Mar2021, 19:00. Left lower section of her head with severe pain; she had dizziness, vertigo and was nauseous. She started having heavy sweats and passed out two times. She reported it has been a week since she had the shot and she was still dizzy and her head feels very foggy. She was also having spots of memory issues. The events were experienced on 30Mar2021, 19:00. No treatment was received for the events. The outcome of the events was not recovered from dizziness, and recovered with sequela from "Left arm shoulder and neck completely numb" on 03Ape2021, and recovered with sequelae on an unspecified date for other events..
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Developed Tinnitus after 48 hours from receiving the vaccine.; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Right on 22Mar2021 17:30 (5:30 PM) (Batch/Lot Number: EP7534) as SINGLE DOSE for covid-19 immunisation. Medical history included diabetes, high blood pressure, obese all from an unknown date and unknown if ongoing. The patient had no known allergies. The patient had no covid prior vaccination and not covid tested post vaccination. The patient was vaccinated at a Public Health Clinic/Veterans Administration facility. There were no other vaccine in four weeks and there are other medications in two weeks (unspecified). It was reported that the patient developed Tinnitus after (reported as 48 hours from) receiving the vaccine on 24Mar2021 at 5:00 pm. Continuing to have tinnitus. The event was considered serious due to disability. The outcome of the event was not recovered. There was no treatment for the reported event. The event resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia
Clinical narrative: chills; fatigue; sore joints and muscles; sore joints and muscles; This is a spontaneous report received from a contactable consumer (patient's wife). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 07Apr2021 11:30 (Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. Patient took the first dose of vaccine in Arm Right on 17Mar2021 11:30 AM (Lot Number: EP6955) for covid-19 immunization. Medical history included hypertension. Concomitant medication included amlodipine taken for hypertension, start and stop date were not reported. The patient experienced chills, fatigue, sore joints and muscles on 08Apr2021 08:00 with outcome of recovering. Patient didn't receive treatment for the adverse events. Patient was not diagnosed with COVID-19 prior vaccination nor tested COVID-19 post vaccination. No known allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The case was reported as non-serious.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Dysmenorrhoea, Fatigue, Gastric disorder, Postmenopausal haemorrhage
Clinical narrative: Day 6 I started having post menopausal vaginal bleeding; Day 4&5 I was exhausted; had stomach issues; menstrual cramps; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included High Blood Pressure, colitis, irritable bowel syndrome, penicillin allergy, and iodine allergy from an unknown date. Patient is not pregnant. No COVID prior vaccination and not tested for COVID post vaccination. Concomitant medication included losartan; metoprolol; and bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported. No other vaccinations in four weeks. The patient previously took sudafed [xylometazoline hydrochloride] and experienced allergies. On Mar2021 (reported as 19Mar2021 03:30 PM and 25Mar2021) patient had her first COVID-19 vaccine shot. First 3 days she felt fine. On unspecified dates in Mar2021, day 4 and 5 she was exhausted and had stomach issues, Day 6 she started having post-menopausal vaginal bleeding. It stopped on 27Mar then started again on 30Mar2021 to 04Apr2021 along with menstrual cramps. Patient commented that this might all sound normal except she has been post-menopausal for 15 years and she does not believe that is by coincidence. The patient underwent lab tests and procedures which included biopsy: unknown results on an unspecified date, ultrasound scan: unknown results on an unspecified date. Therapeutic measures were taken as a result of post-menopausal vaginal bleeding, was exhausted, had stomach issues, and menstrual cramps. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Day 6 I started having post menopausal vaginal bleeding; Day 4&5 I was exhausted; had stomach issues; menstrual cramps; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included High Blood Pressure, colitis, irritable bowel syndrome, penicillin allergy, and iodine allergy from an unknown date. Patient is not pregnant. No COVID prior vaccination and not tested for COVID post vaccination. Concomitant medication included losartan; metoprolol; and bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported. No other vaccinations in four weeks. The patient previously took sudafed [xylometazoline hydrochloride] and experienced allergies. On Mar2021 (reported as 19Mar2021 03:30 PM and 25Mar2021) patient had her first COVID-19 vaccine shot. First 3 days she felt fine. On unspecified dates in Mar2021, day 4 and 5 she was exhausted and had stomach issues, Day 6 she started having post-menopausal vaginal bleeding. It stopped on 27Mar then started again on 30Mar2021 to 04Apr2021 along with menstrual cramps. Patient commented that this might all sound normal except she has been post-menopausal for 15 years and she does not believe that is by coincidence. The patient underwent lab tests and procedures which included biopsy: unknown results on an unspecified date, ultrasound scan: unknown results on an unspecified date. Therapeutic measures were taken as a result of post-menopausal vaginal bleeding, was exhausted, had stomach issues, and menstrual cramps. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea, Vomiting
Clinical narrative: diarrhea; nausea; vomiting; headaches; This is a Spontaneous report received from a contactable physician. A male patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. the reporter has a patient who is supposed to come for his 2nd dose of the COVID19 Vaccine but has diarrhea, nausea and vomiting, and headaches. She is asking if she should delay the dose for the patient. She mentioned that he got tested and has shown no symptoms of COVID. Events outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer.  A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Apr2021 (Lot Number: ER8734) (at age of 43-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient received the vaccine the first day of this month (01Apr2021). She felt bad Thursday (01Apr2021), and bad Friday. Saturday and Sunday (4Apr2021) she was not able to smell. She was still unable to smell. She only got one dose of the vaccine. Today (6Apr2021) she went to get a COVID test, and she tested positive. She has a little cough. She didn't take any other medications. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on 06Apr2021.  The event outcome was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dizziness, Eye contusion, Eye swelling
Clinical narrative: passed out; dizzy; nauseous; hit her head/huge bump on head; My left eye is half swollen shut; eyelid and under eye are black; very swollen all over head and eye; in lots of pain; breastfeeding; breastfeeding; This is a spontaneous report received from a contactable consumer (who is also the patient). This consumer reported events for mother (self) and child. This is the maternal report.   A 35-year-old female patient received the first dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8733), via an unspecified route of administration in the left arm, on 06Apr2021 12:15, as single dose, for COVID-19 immunisation, at a drug store. The patient medical history was not reported. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient had no prior COVID-19 and was not tested for COVID-19 post vaccination. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS). The patient did not received other vaccines in four weeks. On 07Apr2021 at 03:00, the patient went to the bathroom and felt fine. She sat on the toilet and all of a sudden felt dizzy and nauseous. Next thing she knew, she woke up on the floor and had a huge bump on her head near her left eye. She passed out and hit her head on the tile in the bathroom. Her left eye was half swollen shut, her eyelid and under eye were black, was very swollen all over her head and eye and was in lots of pain. She went to the emergency room around 04:30. All tests, CT scan and blood work came back normal. She was told that it was most likely caused by the vaccine. Treatment for the events included "CT scan, bloodwork, IV fluids" (as reported). She was hoping that Pfizer will pay for her ER visit since the events were vaccine reactions. She reported that she was still in lots of pain and was not taking pain meds because she was breastfeeding. The events resulted to emergency room and physician office visits. The outcome of pain was not recovered. The patient was recovering from the remaining events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021442302 Baby case
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Head injury, Laboratory test, Loss of consciousness, Nausea, Off label use
Clinical narrative: passed out; dizzy; nauseous; hit her head/huge bump on head; My left eye is half swollen shut; eyelid and under eye are black; very swollen all over head and eye; in lots of pain; breastfeeding; breastfeeding; This is a spontaneous report received from a contactable consumer (who is also the patient). This consumer reported events for mother (self) and child. This is the maternal report.   A 35-year-old female patient received the first dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8733), via an unspecified route of administration in the left arm, on 06Apr2021 12:15, as single dose, for COVID-19 immunisation, at a drug store. The patient medical history was not reported. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient had no prior COVID-19 and was not tested for COVID-19 post vaccination. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS). The patient did not received other vaccines in four weeks. On 07Apr2021 at 03:00, the patient went to the bathroom and felt fine. She sat on the toilet and all of a sudden felt dizzy and nauseous. Next thing she knew, she woke up on the floor and had a huge bump on her head near her left eye. She passed out and hit her head on the tile in the bathroom. Her left eye was half swollen shut, her eyelid and under eye were black, was very swollen all over her head and eye and was in lots of pain. She went to the emergency room around 04:30. All tests, CT scan and blood work came back normal. She was told that it was most likely caused by the vaccine. Treatment for the events included "CT scan, bloodwork, IV fluids" (as reported). She was hoping that Pfizer will pay for her ER visit since the events were vaccine reactions. She reported that she was still in lots of pain and was not taking pain meds because she was breastfeeding. The events resulted to emergency room and physician office visits. The outcome of pain was not recovered. The patient was recovering from the remaining events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021442302 Baby case
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Product use issue, Swelling
Clinical narrative: passed out; dizzy; nauseous; hit her head/huge bump on head; My left eye is half swollen shut; eyelid and under eye are black; very swollen all over head and eye; in lots of pain; breastfeeding; breastfeeding; This is a spontaneous report received from a contactable consumer (who is also the patient). This consumer reported events for mother (self) and child. This is the maternal report.   A 35-year-old female patient received the first dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8733), via an unspecified route of administration in the left arm, on 06Apr2021 12:15, as single dose, for COVID-19 immunisation, at a drug store. The patient medical history was not reported. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient had no prior COVID-19 and was not tested for COVID-19 post vaccination. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS). The patient did not received other vaccines in four weeks. On 07Apr2021 at 03:00, the patient went to the bathroom and felt fine. She sat on the toilet and all of a sudden felt dizzy and nauseous. Next thing she knew, she woke up on the floor and had a huge bump on her head near her left eye. She passed out and hit her head on the tile in the bathroom. Her left eye was half swollen shut, her eyelid and under eye were black, was very swollen all over her head and eye and was in lots of pain. She went to the emergency room around 04:30. All tests, CT scan and blood work came back normal. She was told that it was most likely caused by the vaccine. Treatment for the events included "CT scan, bloodwork, IV fluids" (as reported). She was hoping that Pfizer will pay for her ER visit since the events were vaccine reactions. She reported that she was still in lots of pain and was not taking pain meds because she was breastfeeding. The events resulted to emergency room and physician office visits. The outcome of pain was not recovered. The patient was recovering from the remaining events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021442302 Baby case
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell abnormality, Red blood cell analysis abnormal, Thrombocytopenia
Clinical narrative: thrombocytopenia; she is not producing red blood cells; This is a spontaneous report from a contactable consumer. A female 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 single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was in the hospital for thrombocytopenia. The reporter stated that she was not producing red blood cells and they were saying that it was because of the vaccine. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Nasal congestion, Oropharyngeal pain, Pulmonary congestion
Clinical narrative: Chest pains with terrible congestions; Worst sore throat; Terrible coughing; Stuffy and runny nose; Stuffy and runny nose; Chest pains with terrible congestions; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on 20Mar2021, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 26Mar2021, she tested negative for covid-19. Still on 26Mar2021, 4 hours later, she had the worst sore throat, terrible coughing, stuffy and runny nose, and chest pains with terrible congestions. She took Benadryl to treat the symptoms. Her doctor prescribed her with Azithromycin to treat the symptoms. After taking the medication, she felt better. She is scheduled to receive the 2nd dose on 10Apr2021. On 26Mar2021, she had a Covid test results in the negative. However, four hours later she experienced a sore throat, a stuffy nose and a terrible cough. Caller took Benadryl and Azithromycin. The outcome of the events was recovering. She got tested for Covid again and are still waiting for the results to come back  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Chest pains with terrible congestions; Worst sore throat; Terrible coughing; Stuffy and runny nose; Stuffy and runny nose; Chest pains with terrible congestions; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on 20Mar2021, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 26Mar2021, she tested negative for covid-19. Still on 26Mar2021, 4 hours later, she had the worst sore throat, terrible coughing, stuffy and runny nose, and chest pains with terrible congestions. She took Benadryl to treat the symptoms. Her doctor prescribed her with Azithromycin to treat the symptoms. After taking the medication, she felt better. She is scheduled to receive the 2nd dose on 10Apr2021. On 26Mar2021, she had a Covid test results in the negative. However, four hours later she experienced a sore throat, a stuffy nose and a terrible cough. Caller took Benadryl and Azithromycin. The outcome of the events was recovering. She got tested for Covid again and are still waiting for the results to come back  Information on the lot/batch number has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: mini stroke; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm, on 30Mar2021 at 09:00, as a single dose, for COVID -19 immunisation. The patient's medical history included slight issues with cholesterol and pre diabetic, but the patient has been healthy. The patient has no known allergies and other medical histories. Concomitant medication was not reported. On 03Apr2021, 4 days after the patient received the vaccine shot, he was diagnosed with a mini stroke. The patient was shocked as he was too young and have had no medical issues in his entire life, only change was the shot. The patient also experienced numbness in his right arm and hand which subsided but he still has some numbness on the right side of this face. The patient was hospitalized for 1.5 days and treatment included taking low dose aspirin and Lipidore (as reported). The patient had no COVID prior vaccination and no COVID tested post-vaccination, the patient also had no other vaccine in four weeks and other medications in two weeks. Outcome of the event was recovering. Event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, and disability or permanent damage.  Information on the Lot/Batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Cannot hear out of it at all; have tinnitus in my left ear; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 16:45 (Batch/Lot Number: EN6208) as SINGLE DOSE for covid-19 immunisation, at 42 years old. Medical history included blood clot from an unknown date. Patient is not pregnant. Patient did not have COVID prior vaccination. Patient was not tested for COVID post vaccination. No other vaccine in four weeks. Concomitant medication included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported. The patient experienced cannot hear out of it at all and have tinnitus in her left ear on Mar2021 (reported as 02:30), 24 hours after the first dose. Took 2 weeks to return after the first dose. Outcome of cannot hear out of it all was recovered on an unspecified date while unknown for tinnitus.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Post menopausal bleeding; This is a spontaneous report from a contactable consumer (patient) reported that a 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8737), via an unspecified route of administration, administered in arm left on 03Apr2021 10:00 (at the age of 54-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included IBS (irritable bowel syndrome) and gallbladder removal both from an unknown date. The patient had known allergies to sulfa medicines. No covid prior vaccination. Not tested for covid post vaccination. No other vaccines in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207), via an unspecified route of administration, administered in arm left on 13Mar2021 10:00 (at the age of 54-years-old) as a single dose for covid-19 immunisation. The patient's concomitant medications were not reported. On 03Apr2021 12:00 PM, the patient experienced post menopausal bleeding. No treatment was provided for the event. The event was resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of the event was recovered.