chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: received the first dose of the vaccine and 2 weeks later came down with the COVID virus; received the first dose of the vaccine and 2 weeks later came down with the COVID virus; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 17Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the first dose of the vaccine and 2 weeks later came down with the COVID virus. The patient wants to know when he can get the second dose of the vaccine. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Energy increased, Feeling abnormal, Sensory level abnormal
Clinical narrative: Something kicked in like drinking espresso; Everything, all senses seemed like they were amplified/Blues bluer, reds redder, sense of smell enhanced, sense of hearing enhanced.; Seemed like had more energy; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 62-year-old-male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731) administered in left arm on 13Apr2021 09:15 at age of 62-year-old at single dose for COVID-19 immunization. Medical history was not reported. Prior vaccinations: the only one caller can really think of is when caller was 8 or 9 years old, received the DPT vaccine and had rash and fever of 102. Caller cannot provide NDC/lot/expiration. Caller states he has a Vaccination card for all the vaccines received in the last 15-20 years. The last vaccine caller received was the second dose for shingles in Jul2020. There were no prior vaccinations within 4 weeks. There were no additional vaccines administered on same date of the Pfizer suspect. Concomitant medications were not reported. Caller is a consumer reporting he received the first dose of the Pfizer Covid 19 Vaccine took first dose vaccine yesterday, 13Apr2021 at 0915. Reports this is crazy, he hears a lot of people talking about negative effects, caller had the weirdest side effects that are still going on. Caller states all the symptoms began about two hours after receiving the first dose Pfizer Covid 19 Vaccine. Caller received the first dose Pfizer Covid 19 Vaccine at 0915 and on 13Apr2021 at 1115 something kicked in, like drinking espresso. On 13Apr2021, everything, all senses seemed like they were amplified. Blues bluer, reds redder, sense of smell enhanced, sense of hearing enhanced. Everything amplified, everything kicked into overdrive. It was like caller did not have to drink coffee today. Reports it was a good feeling, it was an awakening. It was just like the whole body seems like its amplified. On 13Apr2021, seemed like had more energy, everything, almost like drinking two doses of espresso coffee, enhanced all senses and everything. Caller states it was like the wildest thing ever experienced with a vaccine. Everybody else is talking about negative side effects and mine is like drinking high potency coffee, energy level spiked up. Caller did not know if the Pfizer Covid 19 Vaccine amped up his immune system or whatever. States he has never had any real problems before. The adverse events did not require a visit to Emergency room or Physician office.  Non-serious. Outcome of events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Extreme pain, excruciating at times, in entire upper left arm and shoulder; Extreme pain, excruciating at times, in entire upper left arm and shoulder; This is a spontaneous report from a contactable consumer (patient) reported that a 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration, administered in arm left on 05Jan2021 (at the age of 69-years-old) as a single dose for covid-19 immunisation. The vaccine was administered at the home. The patient medical history included high blood pressure, depression, anxiety, neurodermatitis, GERD and sleep apnea. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications included labetalol; bupropion; amlodipine; and mirtazapine all were taken for an unspecified indication, start and stop date were not reported. On 06Jan2021, the patient experienced extreme pain, excruciating at times, in entire upper left arm and shoulder. The reported events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Therapeutic measures were taken as a result of extreme pain, excruciating at times, in entire upper left arm and shoulder as the patient was told to use heating pad, get P.T. The outcome of the events was recovering. It was also reported that the patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration, administered in arm right on 26Jan2021 as a single dose for covid-19 immunisation.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive to covid-19 virus; tested positive to covid-19 virus; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 30Mar2021 (batch/lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that after she got the first dose last 30Mar2021, and then she was tested positive to COVID-19 virus after all on an unspecified date in 2021. She had the second dose appointment on Tuesday 20Apr2021 and was wondering if she can get it or what. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on an unspecified date in 2021. The outcome of the event was unknown.  Information on batch/lot number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm, left, were the shot was from; Slightly tired; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) at the age of 81-years-old, via an unspecified route of administration in left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included type 2 diabetes from 2004 and high blood pressure from 2000, which were both ongoing. Concomitant medications included unspecified medications including blood pressure medication. She has not started any new medication prior to starting or during the vaccine. There were no additional vaccines administered on the same date and within four weeks prior to the COVID-19 vaccine. The patient previously received flu shots, her last flu shot was in September. The patient received her first dose of COVID-19 vaccine on 20Jan2021 at around at 1:30 to 1:45. On 21Jan2021, the patient experienced sore left arm where the shot was administered, and she was also slightly tired. She mentioned that she experienced the events both times, she received her second dose on 10Feb2021. The outcome of the events was recovered on 22Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a Pfizer- sponsored program  received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive for COVID. The patient wanted to reschedule her appointment for the second dose, because she's been quarantined. The outcome of the event was unknown.  Information about lot/batch has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain
Clinical narrative: Sore the first 24 hours; This is a spontaneous report from a Pfizer ibrance cep from a contactable consumer (patient). This 63-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 31Mar2021 at single dose for COVID-19 immunization; palbociclib (IBRANCE) oral form 13Oct2020 and ongoing at 125 mg once a day (21 days) for breast cancer. Medical history included hair falling out. Concomitant medications included FULVESTRANT (FASLODEX) for hair falling out. The patient received first covid vaccine on 31Mar2021. she was sore the first 24 hours. Second vaccine was schedule next week at the time of reporting. Md aware: yes. Action taken with palbociclib  was unknown. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: he had rashes and redness in the chest stomach.; he had rashes and redness in the chest stomach.; breaking out in a rash with hives; This is a spontaneous report from a Pfizer Sponsored Program  received by a contactable consumer reported for himself. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Mar2021 as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient is scheduled to get the second dose of the COVID 19 vaccine tomorrow 15Apr2021. Last week, he had rashes and redness in the chest stomach on Apr2021. He asks if he can get the second dose appointment tomorrow. The patient had 2 questions regarding the vaccine first would which be possible delayed side effect. So, he received first dose of Pfizer vaccine (Covid-19 Vaccine) on 25Mar2021 and this week probably two or three days ago he started breaking out in a rash with hives. He wanted to know there have been reports of that late of the reaction to the vaccine. The second that was how long, like can he delay getting his second dose of vaccine and how long can he delay for because he was worried about going get to the vaccine while he had this rash that may or may not be part of his reaction to vaccine. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had her 1st vaccine on 15Mar2021(confirmed) , she had a positive test on 29th; had her 1st vaccine on 15Mar2021(confirmed) , she had a positive test on 29th; This is a spontaneous report from a contactable consumer (parent). A 17-years-old female patient (Reporter's daughter) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 15Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received her 1st Pfizer vaccine on 08Mar2021 and ended up getting a positive Covid test on 26Mar2021 and the test came back positive and then it was clarified that she got a positive test (Covid-19 test) on 29th (29Mar2021), she had her 1st vaccine on 15Mar2021(confirmed). The CVC called her and told her that she could have her 2nd vaccine on 09Apr2021 as long as she has no more symptoms, she got her 2nd vaccine on 12Apr2021, after the 1st vaccine she had no reaction. The result was on 31st but she got the test on 29th. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Rash, Urticaria
Clinical narrative: hives and welts along the back; she had rashes and welts on the front upper side; This is a spontaneous report from a contactable consumer (parent). A 17-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Apr2021 at 14:00 as single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Mar2021 as single dose for COVID-19 immunization and getting a positive Covid test on 29Mar2021. On 13Apr2021 about 21:30, so more than 24 hours later second dose , patient developed hives and welts along the back of her body, got the rashes on her back, patient was given diphenhydramine hydrochloride (BENADRYL) at night and then she woke up around 6 o' clock in the morning, she had rashes and welts on the front upper side, the back is gone, rashes are on the front upper side, the reporting consumer asked was that reaction to the vaccine or should they contact Dermatitis. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Electroencephalogram, Seizure
Clinical narrative: Seizure; This is a spontaneous report from a Pfizer sponsored program COVAX US Support from a contactable consumer (patient's grandmother). A 16-year-old female patient received bnt162b2 (Pfizer COVID vaccine), via an unspecified route of administration, administered in arm on 24Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included epilepsy from 2016 to an unknown date. There were no concomitant medications. The patient experienced seizure on 25Mar2021 03:00 with outcome of recovering. It was added that the patient did not have a seizure for 3 years and took her off after 2 years. She had not been on seizure medications for 4-5 years. She had been seizure free and had not been to her neurologist for 4-5 years. Epileptic but never had a seizure for the past 6 years. She is going back to the same doctor. She was diagnosed as being epileptic 5 years prior. Time the vaccination was given: 14:00-14:30. Her neurologist is informed not to get second dose. NO ER required. The patient went to the doctor. Last Friday, she had an EEG and results are unknown now. They have not had follow up appointment yet to get results. The patient underwent lab tests and procedures which included electroencephalogram: results are unknown on an unspecified date.   Information on the lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Body height, Body height decreased, Gastric disorder, Vaccination site pain
Clinical narrative: she's losing height; arm was a little sore where they put the needle in; Balance problems/ has a feeling of unbalance like she'll just strike the floor/ sense of being off-balance; stomach issues; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered on the left arm, first dose on 06Mar2021 (Lot Number: EN6206; Expiration Date: Jun2021) and second dose on 27Mar2021 15:35 (Lot Number: EP6955) at a single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. She had her first dose on 06Mar2021 and her second dose on 27Mar2021. She was calling because she was wondering if anyone was having balance problems or problems with equilibrium. She had a balance problems on an unspecified date. She's not dizzy. She hasn't heard anything on the news about a balance problem. She had no reaction to either COVID 19 vaccine. She thought the balance problems started about 10 days ago. She reported she's losing height. She stated she's never had anything related to balance problems. She just has a feeling of unbalance like she'll just strike the floor and she hasn't heard this on the news. She reported her arm was a little sore where they put the needle in. Other than that, she had no side effects. She had stomach issues for about a day and a half and then it went away. She experienced a sense of being off-balance, emphasizing that she was not dizzy. The patient asked if this was one of the side effects of the COVID vaccine. There were no additional vaccines administered on same date of Pfizer suspect. The events did not require visit to emergency room and physician office. Prior to vaccination, the patient was not diagnosed with COVID-19. No relevant tests done. Outcome of the event arm was a little sore where they put the needle in was unknown, stomach issues recovered on an unspecified date while for the other events was not recovered.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Ear pain, Facial pain, Headache, Tinnitus
Clinical narrative: Right ear was losing hearing sporadically; Pain in surrounding area on face and cranium  on same side; Pain in surrounding area on face and cranium  on same side/Periodic headaches on same side; Feels a bit like swimmer's ear with pain and muffled sounds; Feels a bit like swimmer's ear with pain and muffled sounds; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in arm left on 14Apr2021 14:15 (at the age of 39-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 irritable bowel syndrome (IBS) from an unknown date. The patient had known allergies with lactose (lactose intolerance). The patient had no covid-19 prior vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), administered in arm left on 24Mar2021 02:45 PM (at the age of 39-years-old) for covid-19 immunisation. Concomitant medications included vitamin d3; zinc; magnesium; calcium; and vitamin b6; all were taken for an unspecified indication, start and stop date were not reported. On 15Apr2021 12:00PM, the right ear was losing hearing sporadically. Pain in surrounding area on face and cranium on same side. Periodic headaches on same side. Feels a bit like swimmer's ear with pain and muffled sounds. It was unknown if the patient did received any treatment for the events. The outcome of the events was not recovered. The patient did not covid-19 tested post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: injection site soreness; headache.; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Program. A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 30-years, on 13Apr2021 at 9:00 (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included headache that usually from dehydration, stress, and/or hormone-related fluctuations during menstrual cycle. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation. The patient's concomitant medications were not reported. The patient experienced injection site soreness and a bad headache after the 2nd dose of the COVID-19 vaccine. The headache developed overnight after receiving the vaccine and she woke up with a headache on 14Apr2021. Events outcome was unknown.  Information on the lot/ batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Cellulitis, Migraine, Pain in extremity, Peripheral swelling
Clinical narrative: A Blood clot was found; Cellulitis; Migraine started within 24 hours; left calf pain/Leg increased in swelling and burning pain; severe swelling and burning sensation; severe swelling and burning sensation; Leg increased in swelling and burning pain; Phlebitis; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199/EN5318), via an unspecified route of administration administered in left arm at doctor's office/urgent care facility on 12Mar2021 15:00 as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient was not COVID tested post vaccination. The patient had no other vaccines in four weeks. Medical history included high blood pressure and sleep apnea. Concomitant medications included amoxicillin, valsartan, amlodipine, and vitamin d [vitamin d nos]. The patient previously took doxycycline and experienced allergies. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. On 05Apr2021 at 03:00 PM, the patient experienced a blood clot was found, cellulitis, migraine started within 24 hours, left calf pain/leg increased in swelling and burning pain, severe swelling and burning sensation, leg increased in swelling and burning pain, and phlebitis. It was further reported that migraine started within 24 hours. 48 hour left calf pain that got increasingly worse leading to a severe swelling and burning sensation. The patient went to right time urgent care on Friday, 09Apr2021. The patient was diagnosed with cellulitis. It was also reported that pain increased swelling spread and went to emergency room (ER) on 10Apr2021 for ultrasound of leg. No clots and was advised if worsened to come back. The patient's leg increased in swelling and burning pain. The patient went to urgent care patient first on 11Apr2021 and then the doctor on Monday, 12Apr2021 where she was sent for a STAT ultrasound due to major pain and swelling. A blood clot was found. Phlebitis was diagnosis. The patient was sent to a vascular surgeon on 13Apr2021 and vein specialist on 15Apr2021. The patient was given Xarelto blood thinners and started taking them on 15Apr2021. All of this began 48 hours after taking the second vaccination (pending clarification) and has the patient worried. The events resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of all events. The patient had not yet recovered from all events.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Phlebitis, Swelling, Thrombosis, Ultrasound scan
Clinical narrative: A Blood clot was found; Cellulitis; Migraine started within 24 hours; left calf pain/Leg increased in swelling and burning pain; severe swelling and burning sensation; severe swelling and burning sensation; Leg increased in swelling and burning pain; Phlebitis; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199/EN5318), via an unspecified route of administration administered in left arm at doctor's office/urgent care facility on 12Mar2021 15:00 as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient was not COVID tested post vaccination. The patient had no other vaccines in four weeks. Medical history included high blood pressure and sleep apnea. Concomitant medications included amoxicillin, valsartan, amlodipine, and vitamin d [vitamin d nos]. The patient previously took doxycycline and experienced allergies. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. On 05Apr2021 at 03:00 PM, the patient experienced a blood clot was found, cellulitis, migraine started within 24 hours, left calf pain/leg increased in swelling and burning pain, severe swelling and burning sensation, leg increased in swelling and burning pain, and phlebitis. It was further reported that migraine started within 24 hours. 48 hour left calf pain that got increasingly worse leading to a severe swelling and burning sensation. The patient went to right time urgent care on Friday, 09Apr2021. The patient was diagnosed with cellulitis. It was also reported that pain increased swelling spread and went to emergency room (ER) on 10Apr2021 for ultrasound of leg. No clots and was advised if worsened to come back. The patient's leg increased in swelling and burning pain. The patient went to urgent care patient first on 11Apr2021 and then the doctor on Monday, 12Apr2021 where she was sent for a STAT ultrasound due to major pain and swelling. A blood clot was found. Phlebitis was diagnosis. The patient was sent to a vascular surgeon on 13Apr2021 and vein specialist on 15Apr2021. The patient was given Xarelto blood thinners and started taking them on 15Apr2021. All of this began 48 hours after taking the second vaccination (pending clarification) and has the patient worried. The events resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of all events. The patient had not yet recovered from all events.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Upper gastrointestinal haemorrhage
Clinical narrative: Upper GI bleeding; This is a spontaneous report from a non-contactable consumer (patient). A 50-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Er8729) via an unspecified route of administration into left arm on 09Apr2021 12:30 (at the age of 50-year-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Ep7534) into left arm on 19Mar2021 12:30 PM (at the age of 50-year-old) for COVID-19 immunisation. The patient experienced upper GI (gastrointestinal) bleeding on 11Apr2021 07:00. The patient was  brought to the physician's office and treated with acid blockers and had a scheduled follow-up with the GI doctor. Outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Condition aggravated, Muscular weakness
Clinical narrative: Severe leg weakness; Went from walking with a cane without any assistance to walking with a walker to needing a wheelchair any time we leave the house within 4 weeks immediately following the 2nd dose; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm on 10Mar2021 13:00 as single dose for COVID-19 immunization. Medical history included breast cancer (Breast CA), diabetes, high cholesterol, hypertension (HTN), and known allergies to Sulfa, and Penicillin (PCN) from an unknown date and unknown if ongoing. The patient has no history of covid prior vaccination. Concomitant medications included rosuvastatin calcium (CRESTOR); fulvestrant (FASLODEX); palbociclib (IBRANCE); and metformin, all taken for an unspecified indication. The patient was also reported to be taking BP medication (unspecified) concomitantly. The patient previously took codeine and experienced allergies, and also previously received the first dose of BNT162B2 on 11Feb2021 01:00 PM on right arm, for COVID-19 immunisation. The patient experienced severe leg weakness on 12Mar2021. It was further described that went from walking with a cane without any assistance to walking with a walker to needing a wheelchair any time she leaves the house within 4 weeks immediately following the 2nd dose. As reported, it was a very fast decline. She has trouble ambulating by herself with the walker in the home and cannot be left alone at night. The events resulted in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization for 3 days, and disability or permanent damage. No treatment was received for the events. The patient was COVID tested post vaccination via nasal swab on 11Apr2021with negative results. The outcome of the event was not recovered.  Information on the batch/lot number has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: her arm still hurts; was a little tired; had a little chill; This is a spontaneous report from a contactable consumer reported for herself. An 82-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 10:30 am (Batch/Lot Number: ER8727) as SINGLE DOSE for covid-19 immunization, at the age of vaccination of 82 years old.  Medical history included  she was fine and had the covid too and did not know she had it and was tested for antibodies and gave covid to her husband; stated she had antibody testing but did not remember when the testing was but was maybe in Jan2021; stated she had covid in Nov2020 and one day she did not feel good and had a sore throat thinking she was getting a cold with a scratchy throat and never thought it was covid. Historical vaccine included 1st dose of the Pfizer Vaccine was administered in her left arm on 23Mar2021 with lot EN6208. The patient's concomitant medications were not reported.  None Prior Vaccinations (within 4 weeks). The patient experienced was a little tired (non-serious) on 13Apr2021 with outcome of recovered on 13Apr2021, had a little chill (non-serious) on 13Apr2021 with outcome of recovered on 13Apr2021, her arm still hurts (non-serious) on an unspecified date with outcome of recovering.  The patient underwent lab tests which included sars-cov-2 antibody test: unknown result on Jan2021.  Therapeutic measures were taken as a result of her arm still hurts. Caller stated she got so nervous when he became sick regarding her husband. Caller stated she was a little tired and had a little chill about 1pm in the afternoon; states she had the Pfizer Vaccine 2nd dose at 10:30am on 13Apr2021; stated the chill and tiredness was not ongoing and she was fine and these reported events were resolved as of yesterday afternoon. Stated she put ice on her arm after the Pfizer Vaccine 2nd dose and her arm still hurts and hurt a little bit yesterday. Stated she did not require treatment for the reported events.  Caller stated the tiredness and chills lasted about an hour and she felt them when she was asleep and was tired all of a sudden. AEs not require a visit to ER or MD office.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Myocardial necrosis marker increased
Clinical narrative: had weakness in his arm and went to ER where his cardiac enzymes were high; had weakness in his arm and went to ER where his cardiac enzymes were high; This is a spontaneous report from contactable consumers. A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration in Apr2021 (lot number: ER8729) as single dose for COVID-19 immunisation. Medical history included Covid. Concomitant medications were not reported. The patient who previously had Covid received his first injection of vaccine. A few days after treatment he had weakness in his arm and went to ER where his cardiac enzymes were high (also reported as elevated cardiac enzymes and weakness in arm). He was admitted for observation. His doctor suspects that this may be linked to the vaccine and has reported to Pfizer and CDC. The doctors think the vaccine triggered what happened to put the patient in the hospital. The events required doctor clinic visit, emergency room visit and hospitalization. The patient was hospitalized from 16Apr2021 to an unspecified date. It was unknown if there was treatment given. It was unknown if the patient was tested for covid post vaccination. The patient was fine at the time of the report and was out of the hospital. The patient recovered completely from the event on an unspecified date in Apr2021.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Anal abscess, SARS-CoV-2 test
Clinical narrative: I developed a peri-anal abscess; This is a spontaneous report from a contactable consumer (patient).  A 44-year-old male patient received first dose of BNT162B2 (Lot Number: EN6299), via an unspecified route of administration, administered in the left arm, on 03Mar2021 08:45 as a single dose for COVID-19 immunisation. Medical history included Crohn's Disease and Ileostomy. Concomitant medications included vedolizumab (ENTYVIO); esomeprazole sodium (NEXIUM); loperamide hydrochloride (LOMOTIL); simeticone (GAS-X); calcium carbonate (TUMS), all taken for an unspecified indication, start and stop date were not reported. The patient previously took prochlorperazine maleate (COMPAZINE) and dilaudid and both experienced known allergies. It was reported that the patient has Crohn's Disease but had been in remission for several years. Ten days after his first vaccine on 13Mar2021 08:00, he developed a peri-anal abscess that required treatment via antibiotics. It resolved quickly. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 16Apr2021. The outcome of the event was recovered on an unknown date.
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test
Clinical narrative: received the first dose of the Pfizer-BioNTech COVID-19 vaccine on 27Mar2021 and tested positive'; This is a spontaneous report from a contactable consumer. A 38-year-old male patient received  the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as an single dose for covid-19 immunization. The patient's medical history and  concomitant medications were not reported. The patient experienced received the first dose of the pfizer-biontech covid-19 vaccine on 27Mar2021 and tested positive on 01Apr2021. Patient explained he was symptom free and completed isolation and wanted to know if  okay for him to take his 2nd or he needs to reschedule. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache, on left side of head; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 15Apr2021 (after 10:00 as reported; at the age of 68 years old) at a single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8732), via an unspecified route of administration at the upper right shoulder on 26Mar2021 (after 17:00 as reported; at the age of 68 years old) at a single dose for COVID-19 immunization. The patient experienced headache, on left side of head on 16Apr2021 10:00. The event was reported as serious (disabling). It was reported that the patient decided to take the vaccine because everyone should take the vaccine, and because of the virus. There were no additional vaccines administered on same date of the Pfizer suspect. The AEs did not require a visit to the emergency room and physician office. There were no prior vaccinations (within 4 weeks). There were no AEs following prior vaccinations. The patient had no medical history (including any illness at time of vaccination), no family medical history relevant to AEs and no relevant test. The outcome of the event was not recovered. Relatedness of drug to reaction(s)/event(s): Causality assessment between BNT162B2 and the event headache, on left side of head as per primary source reporter via global introspection was related.  Information on the lot/batch number has been requested.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and the known product profile, the causal relationship between the reported headache , left side head and the BNT162B2 vaccination is possible.  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 agencies as appropriate.
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Cough; This is a spontaneous report from a contactable consumer (patient).  This is the 1st of 2 reports, for the 1st dose.  An 81 years old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, at age of 80 years old,  administered in Arm Left (upper) on 15Feb2021 (Lot Number: EL9267) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were none. The patient experienced cough in about 10 days from the time got the shot. The patient did not had cough before and did not have a cold. Cough medication for the cough took but it did not seem to be working good (Unspecified medication). Outcome of event was unknown.    No follow-up attempts are needed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021427456 Same patient, different dose and event.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blood electrolytes, Blood test, Cerebrovascular accident, Computerised tomogram, Electrocardiogram
Clinical narrative: he was having trouble walking, he would get out of bed and take a couple steps and his legs would give out and he would try to get back up and would walk a few steps and fall again; fall; presuming he had a stroke; This is a spontaneous report from a contactable consumer (reporting for her fiance). A 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6205), via an unspecified route of administration, administered in the right arm (in his right arm up by the shoulder joint) on 06Apr2021 at 14:30 (at the age of 47-years-old) as single dose for COVID-19 immunization (to stay safe and so he doesn't get it). The patient's medical history included diabetic for years, and End stage renal disease. There were no concomitant medications. There were no additional vaccines administered on the same date as BNT162B2. There were no prior vaccinations within 4 weeks. The reporter stated that they were presuming he had a stroke and were doing diagnostics. Everything was pointing to a stroke. The reporter stated it started Monday, 12Apr2021, he was having trouble walking, he would get out of bed and take a couple steps and his legs would give out and he would try to get back up and would walk a few steps and fall again. This started Monday evening. The reporter stated that she called 911 as she couldn't get the patient to the car. He kept falling and there was something clearly wrong. The patient was taken to the ER and was admitted around 1am on Tuesday morning (13Apr2021) and was still hospitalized. The patient has had lots of blood work to include checking electrolytes, thyroid, and vitamin and mineral deficiencies; all with unknown results on an unspecified date. Additional lab tests included Computerized tomogram (CT) scan on 13Apr2021, Electrocardiogram (EKG) on 13Apr2021, and Magnetic resonance imaging (MRI) on 15Apr2021; all with unknown results. The outcome of the events was unknown.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Gait disturbance, Investigation, Magnetic resonance imaging, Thyroid function test
Clinical narrative: he was having trouble walking, he would get out of bed and take a couple steps and his legs would give out and he would try to get back up and would walk a few steps and fall again; fall; presuming he had a stroke; This is a spontaneous report from a contactable consumer (reporting for her fiance). A 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6205), via an unspecified route of administration, administered in the right arm (in his right arm up by the shoulder joint) on 06Apr2021 at 14:30 (at the age of 47-years-old) as single dose for COVID-19 immunization (to stay safe and so he doesn't get it). The patient's medical history included diabetic for years, and End stage renal disease. There were no concomitant medications. There were no additional vaccines administered on the same date as BNT162B2. There were no prior vaccinations within 4 weeks. The reporter stated that they were presuming he had a stroke and were doing diagnostics. Everything was pointing to a stroke. The reporter stated it started Monday, 12Apr2021, he was having trouble walking, he would get out of bed and take a couple steps and his legs would give out and he would try to get back up and would walk a few steps and fall again. This started Monday evening. The reporter stated that she called 911 as she couldn't get the patient to the car. He kept falling and there was something clearly wrong. The patient was taken to the ER and was admitted around 1am on Tuesday morning (13Apr2021) and was still hospitalized. The patient has had lots of blood work to include checking electrolytes, thyroid, and vitamin and mineral deficiencies; all with unknown results on an unspecified date. Additional lab tests included Computerized tomogram (CT) scan on 13Apr2021, Electrocardiogram (EKG) on 13Apr2021, and Magnetic resonance imaging (MRI) on 15Apr2021; all with unknown results. The outcome of the events was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle ache in my arms; This is a spontaneous report received from a contactable consumer (patient) reported for herself. This is the second of two report. A 81-years-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 81-years-old, via an unspecified route of administration, administered in upper left arm on 16Mar2021 (Lot Number: CN6205) as single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. patient received first dose of bnt162b2 (lot number: EL9267) at the age of 80-years-old on 15Feb2021 for covid-19 immunisation. Patient got the second shot and about 10 days later and started having a muscle ache in arms and neither one is gone away yet. Patient was just rubbing some Benadryl on arms because, because it hurts she was thinking about going to doctor make an appointment with the doctor and yet I was hoping it'd go away but so far not. Event outcome was not recovered.  No follow-up attempts are needed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021427428 Same patient, different dose and event.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: breakthrough seizure and frequent seizures; This is a spontaneous report from a contactable consumer. A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 16Apr2021 13:00 (1:00PM) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient is not pregnant at the time of vaccination. Medical history included ongoing epilepsy and known allergies latex, bee stings from an unknown date and unknown if ongoing. No other vaccine in four weeks. The patient had no Covid prior vaccination and not Covid tested post vaccination. The patient was vaccinated at a facility. Concomitant medication included (reported as Other medications in two week): cenobamate (XCOPRI) and zonisamide (ZONISAMIDE); both taken for temporal lobe epilepsy, start and stop date were not reported. The patient previously took bnt162b2 for covid-19 immunisation first dose from 18Mar2021 at 01:00 PM in the left arm. The patient also previously took oxcarbazepine and experienced allergies (reported as Known allergies: Oxcarbazepine). It was reported that the patient has temporal lobe epilepsy well controlled on Xcopri(200mg) and zonisdamide(300mg) and experienced breakthrough seizure and frequent seizures during the last 14 hours (reported as 15Apr2021 at 08:00 PM [20:00]). Previously well controlled for the past 2-3 months, upon titration to current dose of zonisamide/xcopri. The outcome of the event was recovering. No treatment for the reported event.   Information on the lot/batch number has been requested.