chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood test, Diverticulitis, SARS-CoV-2 test
Clinical narrative: Diverticulitis; This is a solicited report facilitated collect based on the information received by Pfizer from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0161; Expiration date was not reported), intramuscular on 28Apr2021 as dose 2, single for COVID-19 immunization; and adalimumab (HUMIRA), subcutaneous at 80 mg (with frequency and therapy dates unspecified), and then subcutaneous from 27Aug2020 and ongoing, at 40 mg (with frequency unspecified), for ulcerative colitis. Medical history included hypertension; cholesterol abnormal; non-tobacco user; abstained from alcohol; had COVID-19 from Jan2021 to an unspecified date, and was hospitalized for COVID-19 with gastrointestinal symptoms and a little respiratory on 15Jan2021. Concomitant medications included losartan for hypertension; pravastatin; balsalazide; omeprazole (PROTONIX); budesonide, formoterol fumarate (SYMBICORT); and nitrofurantoin. The patient previously took nitrofurantoin for anaphylactic reaction, and had drug allergy. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6204; Expiration date: Jun2021) , intramuscular (IM) on 31Mar2021 (at the age of 72 years old), and had epigastric pain and a little respiratory. In May2021, the patient had diverticulitis. The patient had tested positive for COVID-19 Test Nasal Swab on 15Jan2021, and then had tested negative on 12Mar2021. The patient had a blood work on 12Mar2021 (results were not provided). The action taken in response to the event for adalimumab was unknown. The outcome of the event was unknown. The reporter's causality for the event of DIVERTICULITIS was not provided. The manufacturer's assessment on the causal relationship between the suspect vaccine and the event was 'no reasonable possibility'. AbbVie's opinion was that there was no reasonable possibility that the event, diverticulitis, was related to HUMIRA 40MG/0.4ML(ADALIMUMAB).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable Nurse. This Nurse reported for a 24-year-old female patient that received BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine, Solution for injection, Batch/Lot number EL3247, Expiration date: Not reported), dose 2 intramuscular, administered in Arm Left on 16Feb2021 as DOSE 2, SINGLE and BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number EL3247, Expiration date: Not reported), dose 1 intramuscular, administered in Arm Left on 26Jan2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 11Aug2021 patient experienced positive covid19 PCR test on 11Aug2021. The patient underwent lab tests which included covid-19 positive on 11Aug2021. Positive COVID19 PCR test Nasal Swab. Since the vaccination, has the patient had been tested for COVID-19. The outcome of both events was unknown.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: I have Bell's palsy after receiving my second dose of Pfizer; This is a spontaneous report from a non-contactable consumer (patient). A 23-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date (at the age of 23-years-old) as dose 2, single for covid-19 immunization. The patient medical history included covid-19. Concomitant medications were not reported. The patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 23-years-old) as dose 1, single for covid-19 Immunisation. Patient was not pregnant at time of Vaccination (Prior to vaccination, the patient was diagnosed with COVID-19). Since the vaccination, the patient has not been tested for COVID-19. It was reported that, the patient had bell's palsy after receiving her second dose of Pfizer. The adverse event resulted in emergency room/department or urgent care and hospitalization. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm was just sore with no other side effects; This is a spontaneous report from a contactable consumer or other non hcp. A 14-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 11Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced her arm was just sore with no other side effects on an unspecified date. The outcome of the event pain in extremity was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Chills, Pyrexia
Clinical narrative: his blood pressure is high; my son has had a fever; had chills and the shakes and he is cold (chills); had chills and the shakes and he is cold (chills); This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 11Aug2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced fever, chills and the shakes and he is cold (chills), and he has high blood pressure too on Aug2021. Reporter stated she did not know if it's high because his fever is up or what. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: his blood pressure is high; my son has had a fever; had chills and the shakes and he is cold (chills); had chills and the shakes and he is cold (chills); This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 11Aug2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced fever, chills and the shakes and he is cold (chills), and he has high blood pressure too on Aug2021. Reporter stated she did not know if it's high because his fever is up or what. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Loss of consciousness, Skin laceration
Clinical narrative: loss consciousness; another episode collapsed; loss consciousness; another episode collapsed; cut her head open; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in the left arm on 16Apr2021 12:00 (batch/lot number EP8737 and expiry date unknown) at 48 years of age as dose 2, single for covid-19 immunization. Medical history included Heart murmur, vertigo on left side every year and a half. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included ascorbic acid, ergocalciferol, folic acid, retinol, tocopherol, vitamin b nos (MULTIPLE VITAMINS) taken for an unspecified indication, start and stop date were not reported (received within 2 weeks of vaccination). The patient previously took dose 1 of bnt162b2 administered in the left arm on 26Mar2021 12:00 pm (batch/lot number ER8727) at 48 years of age for Covid-19. The patient informed that day after the first vaccine positional vertigo started bad in both ears; on 06Apr2021, she loss consciousness and had seizure symptoms hit a light pole while driving. The vertigo was just now subsiding since 27Mar2021. The patient informed that after 2nd dose (2021) she had another episode (loss consciousness) collapsed in her brother's kitchen, cut her head open and had 6 staples put in her head. The events were reported serious as hospitalization. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient has not been tested for COVID-19 since the vaccination. The patient received treatment which included IV and Keppra. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: Altered sense of smell and taste; Altered sense of smell and taste; This is a spontaneous report from a contactable consumer (patient's mother). A 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ewo181), via an unspecified route of administration, administered in left arm on 12Jun2021 09:30 (at the age of 13 years old) as dose 2, single for COVID-19 immunization. Medical history included Hashimoto's disease, allergies to cherry, watermelon, pumpkin and tree pollen in spring. The patient was diagnosed with COVID-19 prior to vaccination. There were no concomitant medications. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ewo177) via an unspecified route of administration, administered in the left arm on 22May2021 at 09:30 (at the age of 13 years old) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced altered sense of smell and taste on 14Jun2021. It was reported that the patient has not regained a proper sense of taste since the second vaccine was administered. The patient's mother thought it would resolve on its own but she still is gravely hampered by this side effect. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered. The reporter assessed the events as serious (disability and permanent damage).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Penis disorder, SARS-CoV-2 test
Clinical narrative: When probed if consumer contracted COVID after getting the shot, Consumer (First patient) stated, "Yes, we both got. He is with me on the phone."; When probed if consumer contracted COVID after getting the shot, Consumer (First patient) stated, "Yes, we both got. He is with me on the phone."; My penis shrunk; This is a spontaneous report from a contactable consumer (patient). This was the first case (First patient) out of the two cases. There were two patients over the call. A male patient of an unspecified age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 16May2021 as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, consumer (first patient) added, so him and his colleague, who was also on the phone, we are very concerned because we are vaccinated and his penis had got smaller, considerably smaller and he dont seem to have any sort of protection from COVID he had contracted it. He had been suffering with symptoms, so he was curious, he was very angry with Pfizer. When probed if consumer contracted COVID after getting the shot, consumer (first patient) stated, yes, we both got. He was with him on the phone. When probed if both consumer and the colleague contracted COVID after taking the Pfizer Vaccine, consumer (first patient) stated, correct, exactly. Consumer (First patient) stated, he received his vaccination on 16May. Consumer hung up the call abruptly, hence, product details and other details were unknown. Limited information was available over the call. The patient underwent lab tests and procedures which included sars-cov-2 test: contracted covid on 2021. The outcome of events was unknown.  QR comment: Reporter type was not available over the call as consumer hung up abruptly, hence reporter type was captured as consumer or non-healthcare professional by default.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heavy menstrual bleeding, Inappropriate schedule of product administration, Lethargy, Myalgia
Clinical narrative: The first one on 16 April 2021 and the second one on 07 July 2021; heavy, heavy menstrual cycle bleeding; major bleeding; severe muscle pains; Lethargy; just slept it off; felt completely run down/just felt horrible; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 07Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE (at unspecified age) for covid-19 immunisation.  Patient was unable to provide NDC, Lot, expiry, or dose/strength for either Covid vaccine doses. She does not have card with her since she is at work. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in past. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient had history of heavy, heavy menstrual cycle bleeding; major bleeding, severe muscle pains, lethargy, felt completely run down, felt horrible following the first dose of BNT162B2.  The patient had dose 1 of BNT162B2 for Covid-19 immunization on 16Apr2021, administered to left arm. After the first dose patient experienced heavy, heavy menstrual cycle bleeding; major bleeding, which is very unusual for her, she had severe muscle pains, just slept it off, felt completely run down/just felt horrible for 4-5 days and lethargy that occurred for 3 weeks afterwards. She waited to get the second dose because she had side effects after she took the first dose. Then it happened again after the second dose.  The patient experienced heavy, heavy menstrual cycle bleeding; major bleeding (medically significant) on 2021 with outcome of unknown , severe muscle pains on 2021 with outcome of recovering , lethargy on 2021 with outcome of recovering , just slept it off on 2021 with outcome of recovering , felt completely run down/just felt horrible on 2021 with outcome of recovering, the first dose taken on 16Apr2021 and the second one on 07Jul2021 on an unspecified date with outcome of unknown.  The patient did not seek medical attention or treatments after events.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101042048 same patient/drug, different dose/AE dose 1
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: The first one on 16 April 2021 and the second one on 07 July 2021; heavy, heavy menstrual cycle bleeding; major bleeding; severe muscle pains; Lethargy; just slept it off; felt completely run down/just felt horrible; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 07Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE (at unspecified age) for covid-19 immunisation.  Patient was unable to provide NDC, Lot, expiry, or dose/strength for either Covid vaccine doses. She does not have card with her since she is at work. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in past. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient had history of heavy, heavy menstrual cycle bleeding; major bleeding, severe muscle pains, lethargy, felt completely run down, felt horrible following the first dose of BNT162B2.  The patient had dose 1 of BNT162B2 for Covid-19 immunization on 16Apr2021, administered to left arm. After the first dose patient experienced heavy, heavy menstrual cycle bleeding; major bleeding, which is very unusual for her, she had severe muscle pains, just slept it off, felt completely run down/just felt horrible for 4-5 days and lethargy that occurred for 3 weeks afterwards. She waited to get the second dose because she had side effects after she took the first dose. Then it happened again after the second dose.  The patient experienced heavy, heavy menstrual cycle bleeding; major bleeding (medically significant) on 2021 with outcome of unknown , severe muscle pains on 2021 with outcome of recovering , lethargy on 2021 with outcome of recovering , just slept it off on 2021 with outcome of recovering , felt completely run down/just felt horrible on 2021 with outcome of recovering, the first dose taken on 16Apr2021 and the second one on 07Jul2021 on an unspecified date with outcome of unknown.  The patient did not seek medical attention or treatments after events.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101042048 same patient/drug, different dose/AE dose 1
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased
Clinical narrative: Heartbeat has been in the upper 120; Dizziness; This is a spontaneous report from a contactable consumer (patient's parent). A female patient of unspecified age received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on 10Aug2021 as single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. On 10Aug2021 at 19:00, patient experienced heartbeat has been in the upper 120 and dizziness. Reporter seriousness for both events was unspecified. Lab test included heartbeat was in upper 120 on 10Aug2021. The outcome of events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the second of two reports.   A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 11Aug2021 (at the age of 61-years-old) at dose, 1 single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's husband inquired information regarding treatment for the side effects of Pfizer COVID-19 vaccine. He and the patient received their first dose of the vaccine yesterday (11Aug2021) and within 2 hours, they developed a headache. The patient also developed explosive diarrhea and has no control of it on Aug2021. He asked if IMODIUM can be given or to just let it run its course. The outcome of the event explosive diarrhea was not recovered and unknown for headache.  Follow-up attempts are completed; information about lot/batch number cannot be obtained. No further information is expected. Linked Report(s): US-PFIZER INC-202101041560 same reporter and drug, similar event, different patient.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: He tested positive for Covid; He tested positive for Covid; This is a spontaneous report from a contactable. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date in mid Dec2020 (batch/lot number was not reported) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Saturday he developed a persistent cough. He tested positive for Covid. He was well enough to see his patients virtually but at home.  Event took place after use of product. The outcome of event was unknown.   The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for event "he tested positive for COVID".
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Constipation, Fatigue, Headache, Malaise
Clinical narrative: generally not feeling well; Headache; tiredness; nausea; constipation; chills; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 04Aug2021 19:30 (Batch/Lot number was not reported) (at the age of 52 years old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced generally not feeling well, headache, tiredness, nausea, constipation, and chills on 09Aug2021 at 09:00. The adverse reactions resulted in doctor or other healthcare professional office/clinic visit. The patient received Cortisone shot and Z-pack for the adverse events. The patient underwent Covid-19 test Nasal Swab on 10Aug2021: negative. Outcome of the events was not recovered.    The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test
Clinical narrative: generally not feeling well; Headache; tiredness; nausea; constipation; chills; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 04Aug2021 19:30 (Batch/Lot number was not reported) (at the age of 52 years old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced generally not feeling well, headache, tiredness, nausea, constipation, and chills on 09Aug2021 at 09:00. The adverse reactions resulted in doctor or other healthcare professional office/clinic visit. The patient received Cortisone shot and Z-pack for the adverse events. The patient underwent Covid-19 test Nasal Swab on 10Aug2021: negative. Outcome of the events was not recovered.    The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Dysarthria, Heart rate increased
Clinical narrative: heart pain; Extreme fast heartbeat; slurred speech; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 22Jul2021 14:00 (Batch/Lot number was not reported) at the age of 47 years, as dose 1, single for COVID-19 immunisation. Medical history included fibroids, and known allergies: sulfur, penicillin some antibiotics. Concomitant medications included "vitamins only daily:" cobamamide (VITAMIN B12), and Vitamin D, taken for an unspecified indication within 2 weeks of vaccination, start and stop dates were not reported. The patient did not  receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 23Jul2021 15:45, the patient experienced extreme fast heartbeat, slurred speech, and heart pain during live meeting at work online. The patient stated that "the meeting was recorded I have witnesses my coworkers showed no concern I was terrified it slowed me down." The events were reported as non-serious and resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received. Outcome of the events was unknown. The patient had not been tested for COVID-19 since the vaccination.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Burning sensation, Dizziness, Feeling hot
Clinical narrative: my heart rate went from the 70s to about 150; As soon as I got the shot I got a strong smell of metal in my nose; dizziness; my nose wouldnt stop running; shaking with jumping nerves and tremors; intense burning, on fire sensation in my chest, underarms, and head; trouble walking on my own; balance being off; my tonsils were swelling; weak leg; feeling notably hot; I was switching between very hot and very cold; I felt very flushed and sick; nausea; I felt very flushed and sick; weak; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female (non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 09Aug2021 13:00 (at 40 years old, not pregnant) (Batch/Lot Number: EW0167) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included anaemia from an unknown date (resolved). Concomitant medications included diphenhydramine hydrochloride (BENADRYL); ibuprofen; vitamin d; ascorbic acid, calcium pantothenate, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMIN). On 09Aug2021 13:00, patient got a strong smell of metal in my nose, she felt very flushed and sick, and her heart rate went from the 70s to about 150. She had nausea, dizziness, my nose wouldnt stop running, she was switching between very hot and very cold, was shaking with jumping nerves and tremors, and she had a very intense burning, on fire sensation in my chest, underarms, and head. She was observed and sent home to take Benadryl. She had trouble walking on my own because of the dizziness and balance being off. At home her heart rate kept spiking, her tonsils were swelling, and she had trouble drinking water so she went to the ER. The Benadryl did help quickly,  but she could not leave the ER because of her dizziness and balance. The burning sensation has continued to come and go the last four days. She woke up in the middle of the night shaking very badly, with very weak legs, feeling notably hot, and the burning sensation in my chest. She was still weak and have the burning sensation. All events started on 09Aug2021 13:00. The outcome of the events was unknown. All events was given treatment. The adverse events resulted in visit to Doctor or other healthcare professional office and Emergency room/department or urgent care. Treatment was given, Benedryl, ER gave me Dexamethasone. Since the vaccination, the patient has not been tested for COVID-19. Device Date : 12Aug2021.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Flushing, Gait disturbance, Heart rate, Heart rate increased
Clinical narrative: my heart rate went from the 70s to about 150; As soon as I got the shot I got a strong smell of metal in my nose; dizziness; my nose wouldnt stop running; shaking with jumping nerves and tremors; intense burning, on fire sensation in my chest, underarms, and head; trouble walking on my own; balance being off; my tonsils were swelling; weak leg; feeling notably hot; I was switching between very hot and very cold; I felt very flushed and sick; nausea; I felt very flushed and sick; weak; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female (non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 09Aug2021 13:00 (at 40 years old, not pregnant) (Batch/Lot Number: EW0167) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included anaemia from an unknown date (resolved). Concomitant medications included diphenhydramine hydrochloride (BENADRYL); ibuprofen; vitamin d; ascorbic acid, calcium pantothenate, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMIN). On 09Aug2021 13:00, patient got a strong smell of metal in my nose, she felt very flushed and sick, and her heart rate went from the 70s to about 150. She had nausea, dizziness, my nose wouldnt stop running, she was switching between very hot and very cold, was shaking with jumping nerves and tremors, and she had a very intense burning, on fire sensation in my chest, underarms, and head. She was observed and sent home to take Benadryl. She had trouble walking on my own because of the dizziness and balance being off. At home her heart rate kept spiking, her tonsils were swelling, and she had trouble drinking water so she went to the ER. The Benadryl did help quickly,  but she could not leave the ER because of her dizziness and balance. The burning sensation has continued to come and go the last four days. She woke up in the middle of the night shaking very badly, with very weak legs, feeling notably hot, and the burning sensation in my chest. She was still weak and have the burning sensation. All events started on 09Aug2021 13:00. The outcome of the events was unknown. All events was given treatment. The adverse events resulted in visit to Doctor or other healthcare professional office and Emergency room/department or urgent care. Treatment was given, Benedryl, ER gave me Dexamethasone. Since the vaccination, the patient has not been tested for COVID-19. Device Date : 12Aug2021.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Muscular weakness, Nausea, Parosmia, Rhinorrhoea
Clinical narrative: my heart rate went from the 70s to about 150; As soon as I got the shot I got a strong smell of metal in my nose; dizziness; my nose wouldnt stop running; shaking with jumping nerves and tremors; intense burning, on fire sensation in my chest, underarms, and head; trouble walking on my own; balance being off; my tonsils were swelling; weak leg; feeling notably hot; I was switching between very hot and very cold; I felt very flushed and sick; nausea; I felt very flushed and sick; weak; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female (non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 09Aug2021 13:00 (at 40 years old, not pregnant) (Batch/Lot Number: EW0167) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included anaemia from an unknown date (resolved). Concomitant medications included diphenhydramine hydrochloride (BENADRYL); ibuprofen; vitamin d; ascorbic acid, calcium pantothenate, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMIN). On 09Aug2021 13:00, patient got a strong smell of metal in my nose, she felt very flushed and sick, and her heart rate went from the 70s to about 150. She had nausea, dizziness, my nose wouldnt stop running, she was switching between very hot and very cold, was shaking with jumping nerves and tremors, and she had a very intense burning, on fire sensation in my chest, underarms, and head. She was observed and sent home to take Benadryl. She had trouble walking on my own because of the dizziness and balance being off. At home her heart rate kept spiking, her tonsils were swelling, and she had trouble drinking water so she went to the ER. The Benadryl did help quickly,  but she could not leave the ER because of her dizziness and balance. The burning sensation has continued to come and go the last four days. She woke up in the middle of the night shaking very badly, with very weak legs, feeling notably hot, and the burning sensation in my chest. She was still weak and have the burning sensation. All events started on 09Aug2021 13:00. The outcome of the events was unknown. All events was given treatment. The adverse events resulted in visit to Doctor or other healthcare professional office and Emergency room/department or urgent care. Treatment was given, Benedryl, ER gave me Dexamethasone. Since the vaccination, the patient has not been tested for COVID-19. Device Date : 12Aug2021.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Tonsillar hypertrophy, Tremor
Clinical narrative: my heart rate went from the 70s to about 150; As soon as I got the shot I got a strong smell of metal in my nose; dizziness; my nose wouldnt stop running; shaking with jumping nerves and tremors; intense burning, on fire sensation in my chest, underarms, and head; trouble walking on my own; balance being off; my tonsils were swelling; weak leg; feeling notably hot; I was switching between very hot and very cold; I felt very flushed and sick; nausea; I felt very flushed and sick; weak; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female (non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 09Aug2021 13:00 (at 40 years old, not pregnant) (Batch/Lot Number: EW0167) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included anaemia from an unknown date (resolved). Concomitant medications included diphenhydramine hydrochloride (BENADRYL); ibuprofen; vitamin d; ascorbic acid, calcium pantothenate, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMIN). On 09Aug2021 13:00, patient got a strong smell of metal in my nose, she felt very flushed and sick, and her heart rate went from the 70s to about 150. She had nausea, dizziness, my nose wouldnt stop running, she was switching between very hot and very cold, was shaking with jumping nerves and tremors, and she had a very intense burning, on fire sensation in my chest, underarms, and head. She was observed and sent home to take Benadryl. She had trouble walking on my own because of the dizziness and balance being off. At home her heart rate kept spiking, her tonsils were swelling, and she had trouble drinking water so she went to the ER. The Benadryl did help quickly,  but she could not leave the ER because of her dizziness and balance. The burning sensation has continued to come and go the last four days. She woke up in the middle of the night shaking very badly, with very weak legs, feeling notably hot, and the burning sensation in my chest. She was still weak and have the burning sensation. All events started on 09Aug2021 13:00. The outcome of the events was unknown. All events was given treatment. The adverse events resulted in visit to Doctor or other healthcare professional office and Emergency room/department or urgent care. Treatment was given, Benedryl, ER gave me Dexamethasone. Since the vaccination, the patient has not been tested for COVID-19. Device Date : 12Aug2021.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Felt like throat was closed; This is a spontaneous report from a contactable consumer (patient's mother). A 12-year-old male patient received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration in arm left on 19Jul2021 (Batch/Lot Number: EW0175) as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient felt like throat was closed (medically significant) on 06Aug2021 with outcome of not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101041671 Same patient/product, different dose/events
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Ear discomfort, Hypoacusis, Tinnitus
Clinical narrative: Very little hearing loss in left ear; Tinnitus ongoing; Ear pressure; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 05Mar2021 08:30 (at the age of 63-years-old) (Batch/Lot Number: en6200) as dose 2, single for COVID-19 immunization. Medical history included high blood pressure from 12Oct2020 and ongoing, ankylosing spondylitis from 2018 and ongoing and taking a diuretic. Concomitant medications included lisinopril taken for high blood pressure from 12Oct2020 to 23Feb2021; sulfasalazine taken for ankylosing spondylitis from 2018 and ongoing; and hydrochlorothiazide taken as a diuretic from 14Oct2020 and ongoing. The patient previously took the first dose of BNT162B2 intramuscularly on the upper left arm on 12Feb2021 08:00 (Batch/Lot Number: EL9265) for COVID-19 immunization and experienced tinnitus intermittent: The tinnitus started approximately 7 - 9 days after 1st vaccine. It was intermittent. On 23Mar2021, the patient had ongoing tinnitus and mentioned that she also had ear pressure in both ears since 2021. She saw an ENT on 11Jun2021, and he said it might go away eventually. The patient had a hearing test on 11Jun2021 with very little loss: Very little hearing loss in left ear - probably from age. Tinnitus from vaccine according to ENT. The patient has not recovered from the events.   Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Inappropriate schedule of product administration
Clinical narrative: Fasting glucose was 175 the morning after; first dose: 20Jul2021 second dose: 20Jul2021; This is a spontaneous report from a contactable consumer (patient). A 58-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 20Jul2021 15:30 (Batch/Lot Number: FA6780) (at age 58-years-old) as dose 1, single, then via an unspecified route of administration, administered in arm left on 20Jul2021 (Batch/Lot Number: FA7484) as dose 2, single for covid-19 immunisation. There were no medical history. Concomitant medication(s) included hydrochlorothiazide (HTZ); beta vulgaris, folic acid, malus spp. vinegar extract, punica granatum, vitamin b12 nos (GOLI); and multivitamin (CENTRUM).  There were no ther vaccines received within 4 weeks. The patient experienced fasting glucose was 175 the morning after on 11Aug2021 06:30. Fasting is normally between 125 and 135.  Following morning, results was in range. Outcome of the event of fasting glucose increased was recovered on Aug2021. No treatment was received. Patient had no covid prior to vaccination and had not been tested post vaccination.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Asthenia, Body temperature, COVID-19
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional (Patient).  A 43-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0173; Batch no: not reported), via an unspecified route of administration, administered in Arm Right on 04May2021 (at the age of 43-years-old) 12:00 as dose 2, single for covid-19 immunization. Medical history reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was yes. Covid prior to vaccination was reported as No. Covid tested post vaccination was Yes. Covid test post vaccination tested with Nasal Swab was Rapid/Molecular. No known allergies reported. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient was tested for COVID-19. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8737; bath no: not reported), via an unspecified route of administration, administered in Arm Right on 13Apr2021, 12:00 PM (at the age of 43-years-old) as dose 1, single dose for COVID-19 immunization. The patient stated as he was fully vaccinated and got covid pretty bad, muscle aches on 10Aug2021, along with 9 others from his work. Adverse reactions as follows: Day 1 patient woke up with a sore throat on 07Aug2021. Got a text from her boss in the evening saying 2 people were tested positive for covid. Day 2 patient Woke up with chills (around 4am), headache, Stuffy nose on 08Aug2021. Day 3 patient Ran a 101.6 fever, sore throat, loss of taste and smell, chills/shaking at night, weakness on 09Aug2021. Day 4 same symptoms as the other days Fever of 101.7, weakness, muscle aches, Chills, Microbiology test came back positive for Covid 19. Day 5 same symptoms but fever subsiding. 100.2. Day 6 just starting to feel better, no fever, still no taste or smell, headache, stuffy nose. Therapeutic measures were not taken for the events caused. The patient underwent lab tests and procedures which included body temperature: 101.6 on 09Aug2021, body temperature: 101.7 on 10Aug2021, body temperature: 100.2 on 11Aug2021, sars-cov-2 test: positive on 09Aug2021 with Nasal Swab Rapid/Molecular for Covid-19. The outcome of event Got covid pretty bad, muscle aches, sore throat, chills, headache, Stuffy nose, Ran a 101.6 fever, loss of taste and smell, shaking at night and weakness was recovering. Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nasal congestion, Oropharyngeal pain
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional (Patient).  A 43-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0173; Batch no: not reported), via an unspecified route of administration, administered in Arm Right on 04May2021 (at the age of 43-years-old) 12:00 as dose 2, single for covid-19 immunization. Medical history reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was yes. Covid prior to vaccination was reported as No. Covid tested post vaccination was Yes. Covid test post vaccination tested with Nasal Swab was Rapid/Molecular. No known allergies reported. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient was tested for COVID-19. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8737; bath no: not reported), via an unspecified route of administration, administered in Arm Right on 13Apr2021, 12:00 PM (at the age of 43-years-old) as dose 1, single dose for COVID-19 immunization. The patient stated as he was fully vaccinated and got covid pretty bad, muscle aches on 10Aug2021, along with 9 others from his work. Adverse reactions as follows: Day 1 patient woke up with a sore throat on 07Aug2021. Got a text from her boss in the evening saying 2 people were tested positive for covid. Day 2 patient Woke up with chills (around 4am), headache, Stuffy nose on 08Aug2021. Day 3 patient Ran a 101.6 fever, sore throat, loss of taste and smell, chills/shaking at night, weakness on 09Aug2021. Day 4 same symptoms as the other days Fever of 101.7, weakness, muscle aches, Chills, Microbiology test came back positive for Covid 19. Day 5 same symptoms but fever subsiding. 100.2. Day 6 just starting to feel better, no fever, still no taste or smell, headache, stuffy nose. Therapeutic measures were not taken for the events caused. The patient underwent lab tests and procedures which included body temperature: 101.6 on 09Aug2021, body temperature: 101.7 on 10Aug2021, body temperature: 100.2 on 11Aug2021, sars-cov-2 test: positive on 09Aug2021 with Nasal Swab Rapid/Molecular for Covid-19. The outcome of event Got covid pretty bad, muscle aches, sore throat, chills, headache, Stuffy nose, Ran a 101.6 fever, loss of taste and smell, shaking at night and weakness was recovering. Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Tremor, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional (Patient).  A 43-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0173; Batch no: not reported), via an unspecified route of administration, administered in Arm Right on 04May2021 (at the age of 43-years-old) 12:00 as dose 2, single for covid-19 immunization. Medical history reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was yes. Covid prior to vaccination was reported as No. Covid tested post vaccination was Yes. Covid test post vaccination tested with Nasal Swab was Rapid/Molecular. No known allergies reported. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient was tested for COVID-19. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8737; bath no: not reported), via an unspecified route of administration, administered in Arm Right on 13Apr2021, 12:00 PM (at the age of 43-years-old) as dose 1, single dose for COVID-19 immunization. The patient stated as he was fully vaccinated and got covid pretty bad, muscle aches on 10Aug2021, along with 9 others from his work. Adverse reactions as follows: Day 1 patient woke up with a sore throat on 07Aug2021. Got a text from her boss in the evening saying 2 people were tested positive for covid. Day 2 patient Woke up with chills (around 4am), headache, Stuffy nose on 08Aug2021. Day 3 patient Ran a 101.6 fever, sore throat, loss of taste and smell, chills/shaking at night, weakness on 09Aug2021. Day 4 same symptoms as the other days Fever of 101.7, weakness, muscle aches, Chills, Microbiology test came back positive for Covid 19. Day 5 same symptoms but fever subsiding. 100.2. Day 6 just starting to feel better, no fever, still no taste or smell, headache, stuffy nose. Therapeutic measures were not taken for the events caused. The patient underwent lab tests and procedures which included body temperature: 101.6 on 09Aug2021, body temperature: 101.7 on 10Aug2021, body temperature: 100.2 on 11Aug2021, sars-cov-2 test: positive on 09Aug2021 with Nasal Swab Rapid/Molecular for Covid-19. The outcome of event Got covid pretty bad, muscle aches, sore throat, chills, headache, Stuffy nose, Ran a 101.6 fever, loss of taste and smell, shaking at night and weakness was recovering. Follow-up attempts are completed. No further information is expected.