chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Skin wound, Ultrasound scan normal, Vomiting
Clinical narrative: I woke up the following morning (March 5) having chills, vomiting, and very very weak-----but no fever.   On Saturday I was better but still weak and that is when cellulitis started in my left leg.  On March 7, 2021, I was seen in the ER.  I was given a shot and antibiotics and told to return if not better.  So on Monday, March 8, I returned to ER and then was admitted to the hospital.  I was allowed to go home on Saturday, March 13.  Since then I had two sores to develop on my left leg.  I had to have wound surgery on them on March 25.  I am a lot better but still not completely well.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Rash
Clinical narrative: light rash on my chest,sides and neck.  i had chills ON AND OFF ALL DAY and joint aches. THE rash was going away by evening after taking benadryl. chills and joint pain last 2 or 3 days after second shot..
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: COVID Arm.  Itching at injection site beginning the morning after the shot was given. By 2nd day, 4" red circle of swelling around injection site, soreness only at injection site but with continued itching. Persisted through 3rd day with redness diminishing but continued swelling which is when I am reporting.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: The patient did not have an adverse event. The problem was during administration. The needle became detached from the syringe causing the dose to be low and spill on on the patient's sweater. We did give the patient another dose.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis, Pallor
Clinical narrative: Reaction occurred 2 minutes after the injection. Patient felt warm, sweating and looked pale. Patient was awake and alert. No difficulty breathing noted.  3 L of oxygen given via nasal cannula, ice pack given.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Pyrexia, Sneezing
Clinical narrative: Fever/hot flash, sneezing
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Rash papular
Clinical narrative: I got a bright red raised rash on my inner thighs
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is adolescent/juvenile of age 17 years. Symptoms: none; Signs: none; Time Course: none
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Approximately 4 days after receiving my second dose, I started to experience stomach issues, including pain/cramps, loose stools/diarrhea.  The symptoms finally started to ease on 3/29/21 but I visited my doctor on March 30, 2021 who gave me a Zpack in case it was stomach virus but also told me to report my experience.  At first, I did not think anything of it because I have had stomach issues from time to time, especially after eating certain foods.  This, however, lasted much longer than any other times and I was only able to really eat crackers.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year, 6month old male presented to vaccine site accompanied by two parents. All three received Moderna vaccine.  Minor should have received Pfizer vaccine and received Moderna in error.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Chills Body aches Fatigue Mild headache
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Acute febrile neutrophilic dermatosis, Rash, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Two days after my 2nd injection I experienced a major Sweet's Syndrome skin outbreak.; The injection area was red about the size of a softball with large swollen, red, erythema migrants rash on chest, left arm, with smaller lesions  on my neck, face & back.; The injection area was red about the size of a softball with large swollen, red, erythema migrants rash on chest, left arm, with smaller lesions  on my neck, face & back.; rash on chest, left arm, with smaller lesions on my neck, face & back/have light rashes; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6206), via an unspecified route of administration, administered in the right arm on 07Mar2021 at 14:45 (02:45 pm) at the age of 73-years-old as single dose for COVID-19 immunization. The vaccine was administered to the patient at the facility. The patient did not receive other vaccines on the same date. The patient had no other vaccine in four weeks. The patient's medical history included myelodysplastic syndrome (MDS) and Sweet's Syndrome. Concomitant medications included amlodipine besilate (AMLODIPINE), lenalidomide (REVLIMID), prednisone, danazol, and clopidogrel bisulfate (PLAVIX); all taken for unspecified indications, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (lot number: EN6201) on 14Mar2021 (as reported; pending clarification) at 02:45 pm at the left arm for COVID-19 Immunization. The patient also previously took levofloxacin (LEVAQUIN) and valaciclovir hydrochloride (VALTREX) and experienced allergies with both drugs. The patient reported that as a person with MDS and Sweet's Syndrome, he has had a history of experiencing major skin outbreaks but it has been under control for over a year with oral meds. Two days after his 2nd injection he experienced a major Sweet's Syndrome skin outbreak. Apparently, the vaccine reacted with his autoimmune system to trigger a reaction. The injection area was red about the size of a softball with large swollen, red, erythema migrants rash on chest, left arm, with smaller lesions on his neck, face & back. Once the symptoms appeared, the outbreak followed its normal course of action. It took about 5 days to reach its apex; thereafter the symptoms began to slowly subside. He is now into day 9 and have light rashes. By day 12 he expects all traces of the rash to be completely gone. Patient's assessment: he was not allergic to the vaccine but the vaccine set off his immune system. If/when the rash took longer than the normal 6 days to reach its apex, he was prepared to significantly increase his Prednisone. The patient had no COVID prior to vaccination and post vaccination. The patient did not receive treatment for the events. The onset of events was on 09Mar2021 at 21:00 (09:00 pm) with outcome of recovering.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dystonia, Muscle spasticity, Wheelchair user
Clinical narrative: Severe spasticity c/w dystonia. Unable to maintain pt in wheelchair. Unable to control pts body while on floor. Pt remained alert and talking during incident. Incident lasted greater than 15 minutes
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Broke out in gives all over my body. Took Benadryl orally and applied Benadryl gel to skin.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I?m hearing a droning noise that isn?t there.  It?s not a ringing or buzzing  and definitely doesn?t seem to be coming from inside my head but it is.  The noise is constant and most noticeable when I?m sitting or trying to sleep.  Hoping it goes away but just thought I should report it
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia
Clinical narrative: AT 1040 AM PT RECEIVED VACCINE, APPROXIMATELY 15 MINUTES LATER PATIENT COMPLAINED OF TROUBLE SWALLOWING SIMILAR REACTION TO WHEN SHE HAD BEESTINGS WHEN YOUNGER. PT DIDN'T STATE SHE HAD ANAPHYLAXIS PREVIOUSLY. WE HAD THE EMT FROM  FIRE DEPARTMENT EVALUATE PATIENT AND THEY RELEASED HER FROM CARE SAYING SHE SHOULD BE OK IN 30 MINUTES . NO MED WAS ADMINISTERED.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Diarrhoea, Headache, Injection site pain
Clinical narrative: Headache, diarrhea, temperature, ringing in ears, burning pain in joints, severe soreness at shot site in  left arm, naseua. Took over the counter ibuprofen to no avail.  Soaked in bathtub to diminsh fever.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Tinnitus
Clinical narrative: Headache, diarrhea, temperature, ringing in ears, burning pain in joints, severe soreness at shot site in  left arm, naseua. Took over the counter ibuprofen to no avail.  Soaked in bathtub to diminsh fever.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Throat irritation
Clinical narrative: Patient received Moderna vaccine, first dose. After approximately 5-10 minutes she was observed itching her arms and she had asked for some benadryl. 50 mg oral benadryl was given and pt was taken to a room in adjoining medical clinic for observation. Patient stated back of throat was scratchy. Provider on duty administered 125 mg SoluMedrol, itchiness continued, patient had history of anxiety and laryngospasms so provider administered 1mg lorazepam. After another 1 mg dose of lorazepam pt appeared to calm down, vitals were stable and pt was discharged home with husband.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Received both doses of Pfizer vaccine and tested positive for covid -19; Received both doses of Pfizer vaccine and tested positive for covid -19; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), first dose (at the age of 78-years-old) via an unspecified route of administration on 26Jan2021 at 13:00 (Batch/Lot number: UNKNOWN) as a single dose and the second dose (at the age of 78-years-old) via an unspecified route of administration on 17Feb2021 at 12:00 (Batch/Lot number: UNKNOWN) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient has no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received both doses of the Pfizer vaccine at a pharmacy/drug store and tested positive for COVID-19 on 16Mar2021 (also reported as 17Mar2021). Lab data included SAR-COV-2 test (nasal swab) was positive on 16Mar2021. No treatment was received. The outcome of vaccine failure and COVID-19 was reported as recovering.  The lot number for the vaccine was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Erythema, Heart rate increased, Rash, Sensation of foreign body
Clinical narrative: Patient felt like she had a "lump in her throat when swallowing" 15 min post vaccination, redness on chest.  BP 158/98, HR 108. R 22 30 minutes after reaction - symptoms subsided, refused ambulance.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: Itching and welt near injection site
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Headache
Clinical narrative: Patient complained of dizziness, headache, and mild chest pain approx. 30-40 mins after receiving the vaccine. Patient recovered after extended observation and was discharged to home.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Induration, Pruritus, Rash erythematous
Clinical narrative: Red rash, goose egg size lump and some itching
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylaxis prophylaxis, Pruritus, Rash macular, Rash papular
Clinical narrative: Immediately after the shot, I felt fine and the only side effect I had was a sore arm.  On 3/30/21 (day 4) I woke up to various red blotches on my hands and feet which were intensely itchy.  The ones on my hands had 2-3 small hives.  As the day went on, the red spots would move from the hands to the chest to my neck and back to the hands.  I took a Benadryl tablet and the itching and rash was better.  After it wore off, however, the spot/rash and intense itch was back.  I still have it and if I don't take Benadryl the itch is overwhelming.  I have no other symptoms.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Sleep disorder
Clinical narrative: Awakened by serious chest pains. Rolling over and sitting up did not help.   I took an 81 mg aspirin, sat in a rocking chair by the wood stove and the pains went away ten minutes later.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Aphthous ulcer, Eye disorder
Clinical narrative: acute aphthous ulcers of tongue, Right eye conjunctivitis
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Swelling of upper arm, redness and severe itching. Went to my primary care doctor. She prescribed Cephalexin. I have been taking one 500mg capsule three times a day. I have also been using aloe for the itchiness. The redness is gone. The swelling has gone down significantly. The itchiness is gone. I also had  redness on my right arm, but it was not itchy.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Culture throat, Diarrhoea, Dysphagia, Oropharyngeal pain, Throat irritation
Clinical narrative: Sunday afternoon (3/14/21) sore throat with 3 raw spots in throat developed, exacerbated by swallowing.  Patient went to urgent care on 3/18/21:  no diagnosis determined but was given a prescription for Cefdinir.  Patient has been taking this twice daily and still has 3 doses remaining.   Around 3/28/21, diarrhea developed, followed by vomiting and patient stopped eating.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Mobility decreased, Vital signs measurement, Wheelchair user
Clinical narrative: Pt received first dose of Pfizer vaccine at 1503 and reported feeling dizzy and lightheadedness immediately following the injection. Patient did not lose consciousness and was able to lower herself to the floor. Healthcare providers were able to help her raise her legs onto a chair above the level of her heart until she was able to stand and sit in a wheelchair. Patient was wheeled to medical bay to have vitals signs Q10 minute intervals. Patient vitals were stable for all 3 cycles of vitals and was  able to walk herself to her car at 1534, reporting that she "felt much better."
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Pain
Clinical narrative: woke up at 1 am with Shivers then after shivers my  body aches, headache and upset stomach.  Finally felt better at 5:30 pm and ate some food.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Dizziness, Headache, Nausea, Tinnitus
Clinical narrative: Patient felt dizzy, nauseated, ringing in ear, headache, blurred vision after getting vaccinated. Patient stated laying down made her feel worse. Pt sat up and vomit. Paramedics arrived. Vital signs stable. Pt still feel dizzy, stopped vomiting. Pt able to talk in sentences without resp distress. Pt stable. No transportation needed to hospital. Blood sugar 165 mg/dL. Allergic to penicillin.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Vomiting
Clinical narrative: Patient felt dizzy, nauseated, ringing in ear, headache, blurred vision after getting vaccinated. Patient stated laying down made her feel worse. Pt sat up and vomit. Paramedics arrived. Vital signs stable. Pt still feel dizzy, stopped vomiting. Pt able to talk in sentences without resp distress. Pt stable. No transportation needed to hospital. Blood sugar 165 mg/dL. Allergic to penicillin.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Blood test, C-reactive protein increased, Chest X-ray, Computerised tomogram, Cough
Clinical narrative: 1st adverse event: was chest congestion with bad coughing and hard time breathing. Called 08/26/21 to clinic, prescribed over the phone high dose of prednisone for 2 weeks. Within 2 weeks after, started having muscle cramps, painful muscle tightening and stiffness all over my body. Had very hard time working. Saw another doctor, after blood test, found out that I had high c-reactive protein level at 70.8, sedimentation level at 48, then was referred to the rheumatology dept. at clinic. After many more blood test, Ct's, X-rays, I was diagnosed with Polymyalgia Rheumatica.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Dyspnoea, Impaired work ability, Muscle spasms, Muscle tightness, Musculoskeletal stiffness
Clinical narrative: 1st adverse event: was chest congestion with bad coughing and hard time breathing. Called 08/26/21 to clinic, prescribed over the phone high dose of prednisone for 2 weeks. Within 2 weeks after, started having muscle cramps, painful muscle tightening and stiffness all over my body. Had very hard time working. Saw another doctor, after blood test, found out that I had high c-reactive protein level at 70.8, sedimentation level at 48, then was referred to the rheumatology dept. at clinic. After many more blood test, Ct's, X-rays, I was diagnosed with Polymyalgia Rheumatica.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia, Polymyalgia rheumatica, Pulmonary congestion, Red blood cell sedimentation rate increased, X-ray
Clinical narrative: 1st adverse event: was chest congestion with bad coughing and hard time breathing. Called 08/26/21 to clinic, prescribed over the phone high dose of prednisone for 2 weeks. Within 2 weeks after, started having muscle cramps, painful muscle tightening and stiffness all over my body. Had very hard time working. Saw another doctor, after blood test, found out that I had high c-reactive protein level at 70.8, sedimentation level at 48, then was referred to the rheumatology dept. at clinic. After many more blood test, Ct's, X-rays, I was diagnosed with Polymyalgia Rheumatica.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Blood pressure abnormal, Blood pressure measurement, Contusion, Head injury
Clinical narrative: I lost consciousness; hitting my head; bruising body; when I had my blood pressure taken it was over 200 landing me in ER overnight to try to get my BP down; suffering with Arrhythmia; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22Feb2021 (lot number: EN6201) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), administered in the right arm on 01Feb2021 12:00 AM for COVID-19 immunisation and experienced achy body, tiredness, fever and chills. After the second vaccine early in the next morning (23Feb2021) around 3 am, the patient lost consciousness when retuning from the bathroom hitting her head and bruising body. She lay on the floor for approximately 15-20 minutes. She was ordered by her primary care physician to have a brain scan but when she had her blood pressure taken it was over 200 landing her in emergency room (ER) overnight to try to get her BP down. She was now on beta blockers and was still suffering with arrhythmia awaiting an appointment with her new cardiologist. She was hospitalized for 2 days due to the events. She had no COVID prior vaccination and has not tested COVID post vaccination. She has no other vaccine in four weeks. Therapeutic measures were taken as a result of the events. The outcome of the events were not recovered.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: I lost consciousness; hitting my head; bruising body; when I had my blood pressure taken it was over 200 landing me in ER overnight to try to get my BP down; suffering with Arrhythmia; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22Feb2021 (lot number: EN6201) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), administered in the right arm on 01Feb2021 12:00 AM for COVID-19 immunisation and experienced achy body, tiredness, fever and chills. After the second vaccine early in the next morning (23Feb2021) around 3 am, the patient lost consciousness when retuning from the bathroom hitting her head and bruising body. She lay on the floor for approximately 15-20 minutes. She was ordered by her primary care physician to have a brain scan but when she had her blood pressure taken it was over 200 landing her in emergency room (ER) overnight to try to get her BP down. She was now on beta blockers and was still suffering with arrhythmia awaiting an appointment with her new cardiologist. She was hospitalized for 2 days due to the events. She had no COVID prior vaccination and has not tested COVID post vaccination. She has no other vaccine in four weeks. Therapeutic measures were taken as a result of the events. The outcome of the events were not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clots; This is a spontaneous report from a contactable consumer (reported for herself). A 65-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6199, expiry date not reported),  via an unspecified route of administration, administered in left arm on 03Mar2021 10:45 at a single dose for covid-19 immunisation. Medical history included known allergies to sulpha. The patient had no Covid prior vaccination. Concomitant medications included atorvastatin (LIPITOR) and lisinopril, both taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient had the vaccination on a public health clinic/veterans administration facility. On 12Mar2021, patient experienced blood clots that resulted in doctor other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was not tested for Covid post vaccination. Therapeutic measures were taken as result of the event which included that the patient was put on blood thinners. The event blood clots recovered with lasting effects.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cerebrovascular accident, Headache, Hypertension, Laboratory test
Clinical narrative: having a stroke; headache; eye's vision were blurred; shaking violently; blood pressure went high for 300/150/hypertension; This is a spontaneous report from a contactable consumer reported for herself. This female patient of unspecified age received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient received the 1st dose on 25Feb2021. 4 days later she was hospitalized for three days from 01Mar2021 to 04Mar2021, she said she experienced a headache, her eye's vision were blurred, she said she was shaking violently at the emergency room and her blood pressure went high for 300/150. The patient said the hospital thought she was having a stroke later on, her test results came and it was hypertension she stated the doctor's couldn't tell if it was related with the Covid-19 vaccine. She mentioned her 2nd dose appointment is on 19Mar. (Scheduled more than 21 days). Outcome of all events was unknown.   Information on batch/lot number was requested.
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vision blurred
Clinical narrative: having a stroke; headache; eye's vision were blurred; shaking violently; blood pressure went high for 300/150/hypertension; This is a spontaneous report from a contactable consumer reported for herself. This female patient of unspecified age received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient received the 1st dose on 25Feb2021. 4 days later she was hospitalized for three days from 01Mar2021 to 04Mar2021, she said she experienced a headache, her eye's vision were blurred, she said she was shaking violently at the emergency room and her blood pressure went high for 300/150. The patient said the hospital thought she was having a stroke later on, her test results came and it was hypertension she stated the doctor's couldn't tell if it was related with the Covid-19 vaccine. She mentioned her 2nd dose appointment is on 19Mar. (Scheduled more than 21 days). Outcome of all events was unknown.   Information on batch/lot number was requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for covid, hospitalized to get antibody therapy; Tested positive for covid, hospitalized to get antibody therapy; This is a spontaneous report from a Pfizer-sponsored program,  received from a contactable consumer (patient). A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), on 23Feb2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received 23Feb2021 scheduled second shot the day after the present report (16Mar2021). Tested positive for COVID, hospitalized to get antibody therapy. He had question about getting second shot. The outcome of the events was unknown.  Information about lot/Batch number has been requested
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chromatopsia, Diplegia, Pain in extremity
Clinical narrative: body heated up from stomach to brain, vision went gray, and legs gave out; body heated up from stomach to brain, vision went gray, and legs gave out; body heated up from stomach to brain, vision went gray, and legs gave out; thighs ached; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration in left arm on 03Mar2021 14:55 (at the age of 73 -years-old) as single dose for covid-19 immunisation. The vaccination facility type was a clinic and the vaccine was not administered at a military facility. There were no vaccines administered on same date of the Pfizer suspect. The patient had no medical history, no family history and no concomitant medications. The patient got the first dose of the Pfizer vaccine on 03Mar2021, states it went well for a couple of days and on the 3rd day (06Mar2021) his thighs really ached really bad, that lasted 2 days and cleared up. On Saturday night (13Mar2021) he went to his grandsons soccer game, all of a sudden it was like his body heated up, from stomach to brain and could not see anything, vision was gray and black, and then legs started to give out. The episode lasted about 15 minutes, he did not pass out, the same thing happened again yesterday. The patient talked to the family physician and heart doctor office, they told him to call and report the event. The events did not require emergency room visit. The outcome was recovered on 08Mar2021 for pain in extremity and on 14Mar2021 for diplegia, body temperature increased and chromatopsia.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: generalized rash; This is spontaneous report from contactable healthcare professional. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced generalized rash (not just at injection site, as reported) without anaphylaxis on unspecified date and with outcome of unknown. The reporter was trying to clarify if it was safe for the patient to get the second shot.  Information on the lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My right hand started hurting in the afternoon where it would hurt when I closed my hand; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; batch/lot number and expiration date were not reported) via an unspecified route of administration in the morning of 16Mar2021 (at the age of 76-years-old) at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. In the afternoon of 16Mar2021, the patient's right hand started hurting where it would hurt when she closed her hand and it has not gone away. The patient asked how long for the pain to go away. The patient was referred to health care practitioner(HCP) provider for additional guidance. The outcome of this event was not recovered.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Cough, Ear discomfort, Ear pain
Clinical narrative: coughing with a "wheezy sounding cough; she felt "not so good in my chest"; pain in chest; mild allergic reaction; a lot of pressure and pain and tightness in my ears; a lot of pressure and pain and tightness in my ears; This is a spontaneous report from a contactable consumer (reporting for herself) via the medical information team. A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration, administered in left arm on 03Mar2021 at 04:15 as single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 03Mar2021 at 17:00 (reported as 05:00PM), the patient experienced mild allergic reaction. The patient waited for 15 minutes before leaving. On the way home, the patient experienced a lot of pressure and pain and tightness in her ears. She stated that she felt "not so good in her chest". The patient took 2 Benadryl to help. At 18:00 (reported as 06:00PM), the patient developed pain in her chest and was coughing with a "wheezy sounding cough". Her doctor instructed her to go to the emergency room where she was told she was having a mild to moderate reaction and was administered Albuterol. She states that the next day she was still coughing, but by the day after that, she felt fine. She states she already spoke with her doctor who recommended she not get the second shot. At the emergency room, they checked her pulse oximetry for the blood oxygen level. She had an albuterol treatment for her breathing. They listened to her chest with a stethoscope. The outcome of the event coughing, she felt "not so good in my chest", and pain in chest was recovered on 05Mar2021 while the outcome of the other events was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Oxygen saturation
Clinical narrative: coughing with a "wheezy sounding cough; she felt "not so good in my chest"; pain in chest; mild allergic reaction; a lot of pressure and pain and tightness in my ears; a lot of pressure and pain and tightness in my ears; This is a spontaneous report from a contactable consumer (reporting for herself) via the medical information team. A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration, administered in left arm on 03Mar2021 at 04:15 as single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 03Mar2021 at 17:00 (reported as 05:00PM), the patient experienced mild allergic reaction. The patient waited for 15 minutes before leaving. On the way home, the patient experienced a lot of pressure and pain and tightness in her ears. She stated that she felt "not so good in her chest". The patient took 2 Benadryl to help. At 18:00 (reported as 06:00PM), the patient developed pain in her chest and was coughing with a "wheezy sounding cough". Her doctor instructed her to go to the emergency room where she was told she was having a mild to moderate reaction and was administered Albuterol. She states that the next day she was still coughing, but by the day after that, she felt fine. She states she already spoke with her doctor who recommended she not get the second shot. At the emergency room, they checked her pulse oximetry for the blood oxygen level. She had an albuterol treatment for her breathing. They listened to her chest with a stethoscope. The outcome of the event coughing, she felt "not so good in my chest", and pain in chest was recovered on 05Mar2021 while the outcome of the other events was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Dysgeusia, Nausea, SARS-CoV-2 test, Vomiting
Clinical narrative: Abdominal pain; nausea; vomiting; metallic taste in mouth; This is a spontaneous report from a contactable consumer (patient). A 22-years-old male patient received BNT162B2, dose 2 via an unspecified route of administration, administered in left arm on 06Mar2021 (Lot Number: EN6205) as single dose for COVID-19 immunisation. Medical history included microscopic colitis. No known allergies. No Covid prior vaccination. The patient previously received first dose (lot number: 8982) of BNT162B2 at the age of 21-year-old, in right arm on 13Feb2021 at 12:00 AM for COVID-19 immunisation. Concomitant medications included valproate semisodium (DEPAKOTE), mesalazine (LIALDA), budesonide, bupropion hydrochloride (WELLBUTRIN), dicycloverine hydrochloride (BENTYL). The patient experienced abdominal pain, nausea, vomiting and metallic taste in mouth on 07Mar2021 12:00 AM. Required hospitalization. The patient was hospitalized for the events for 3 days. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. Treatment was received for the events which included IV fluids, anti nausea medicine pain medication. The patient underwent lab tests and procedures which included Nasal Swab: negative on 12Mar2021. The outcome of the events was recovering.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Delirium, Disorientation, Dizziness, Nausea, Pyrexia
Clinical narrative: Delirium; Fainting episode with convulsions; Fever with Chills; Nausea; Dizziness and disoriented; Dizziness and disoriented; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient (not pregnant) received first dose of bnt162b2 (Batch/Lot Number: EN6207), via an unspecified route of administration, administered in left arm on 18Mar2021 08:30 as single dose for covid-19 immunization. Medical history included cystitis interstitial from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for an unspecified indication, start and stop date were not reported. The patient experienced delirium, fainting episode with convulsions, fever with chills, nausea, dizziness and disoriented on 18Mar2021 09:00. No other vaccine in four weeks. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No treatment received. The outcome of events was resolving. No Covid prior vaccination. No Covid tested post vaccination. Not Known allergies.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Delirium; Fainting episode with convulsions; Fever with Chills; Nausea; Dizziness and disoriented; Dizziness and disoriented; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient (not pregnant) received first dose of bnt162b2 (Batch/Lot Number: EN6207), via an unspecified route of administration, administered in left arm on 18Mar2021 08:30 as single dose for covid-19 immunization. Medical history included cystitis interstitial from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for an unspecified indication, start and stop date were not reported. The patient experienced delirium, fainting episode with convulsions, fever with chills, nausea, dizziness and disoriented on 18Mar2021 09:00. No other vaccine in four weeks. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No treatment received. The outcome of events was resolving. No Covid prior vaccination. No Covid tested post vaccination. Not Known allergies.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Cerebrovascular accident, Condition aggravated, Dizziness
Clinical narrative: blood pressure sky high; blood pressure sky high; couldn't walk; almost having a stroke; little dizzy; This is a spontaneous report from a contactable consumer. A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 25Feb2021 (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation.  Medical history included atrial fibrillation, blood pressure high, asthma. There were no concomitant medications. No other products. They have not had any other recent vaccinations or started any new medications. Caller said she had her first dose of the Pfizer COVID-19 vaccine shot 25Feb2021, then two weeks later her blood pressure was sky high and she couldn't walk and she went to the emergency room and they said that she was almost having a stroke. She said she was admitted 11Mar2021 and stayed until this past Sunday which was 14Mar2021. She hadn't seen her primary care provider (PCP) yet she only saw the doctor at the hospital. She was supposed to go back on 18Mar to get her second shot, so she wanted to know if it was gonna be safe. Caller said that she has recovered, and when she came home, she was a little dizzy, but they gave her a medication for vertigo and right now she was ok. Outcome of the events was recovered in Mar2021.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: blood pressure sky high; blood pressure sky high; couldn't walk; almost having a stroke; little dizzy; This is a spontaneous report from a contactable consumer. A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 25Feb2021 (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation.  Medical history included atrial fibrillation, blood pressure high, asthma. There were no concomitant medications. No other products. They have not had any other recent vaccinations or started any new medications. Caller said she had her first dose of the Pfizer COVID-19 vaccine shot 25Feb2021, then two weeks later her blood pressure was sky high and she couldn't walk and she went to the emergency room and they said that she was almost having a stroke. She said she was admitted 11Mar2021 and stayed until this past Sunday which was 14Mar2021. She hadn't seen her primary care provider (PCP) yet she only saw the doctor at the hospital. She was supposed to go back on 18Mar to get her second shot, so she wanted to know if it was gonna be safe. Caller said that she has recovered, and when she came home, she was a little dizzy, but they gave her a medication for vertigo and right now she was ok. Outcome of the events was recovered in Mar2021.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Bell's palsy; numbness and tingling on right side of face; numbness and tingling on right side of face; tongue is also numb; This is a spontaneous report from a contactable consumer. A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 for COVID-19 immunization on an unspecified date. Patient diagnosed with Bell's palsy (medically significant) after receiving Pfizer vaccine. On an unspecified date, the patient experienced numbness and tingling on right side of face, tongue is also numb. The outcome of the events was unknown.     Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Pulmonary thrombosis
Clinical narrative: blood clot in her lungs; shortness of breath; chest pain; This is a spontaneous report from a non-contactable consumer. A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunisation.  Medical history included obesity and inactivity. The patient's concomitant medications were not reported. On an unspecified date, patient experienced blood clot in her lungs and was hospitalized on 14Mar2021. Patient also experienced shortness of breath and chest pain on an unspecified date. She was treated with anticoagulant therapy for the event "blood clot in her lungs". Outcome of event "blood clot in her lungs" recovered on an unspecified date while for all other events was unknown.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: second instance of afib; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), at vaccination age of 56-year-old via an unspecified route of administration in the left arm on 06Mar2021 09:00 (Batch/Lot Number: EN6199) as a single dose for covid-19 immunization. Medical history included afib explained (no other issues) from Sep2020 (reported as 6 months prior) to an unspecified date and post first encounter was diagnosed with obstructive sleep apnea (began cpap treatment nightly). The patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient has no known allergies. Concomitant medications included metoprolol and omeprazole magnesium (PRILOSEC). The patient reported that this was only his second instance of afib. The patient reported that the second episode came 11 hours (also reported as 22:00) post vaccine (06Mar2021) and lasted for 10 hours (07Mar2021). The patient did not received treatment. The patient has not been tested post vaccination. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room visit. The outcome of the event was recovered on 07Mar2021 (reported as 10 hours after onset).
Sex: F
Vaccine: COVID19
Symptoms: Nephrolithiasis
Clinical narrative: Kidney stones; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via unspecified route of administration on 23Feb2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that caller mentioned that after her first shot on 23Feb2021 she developed kidney stones and has been taking pain medications. Her second dose is due tomorrow and would like to know if it is okay for her to take the second dose. Outcome of the events was unknow.  Information on the lot/batch number has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Drooling, Parkinson's disease, Somnolence
Clinical narrative: Parkinson's Disease; fast asleep with drool coming out of his mouth shortly; sleepy; This is a spontaneous report from a contactable consumer (Wife). A 75-years-old male patient (husband) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Wife said her husband had Parkinson's Disease. The patient took his first COVID-19 Vaccine shot, and stayed a half hour after to be monitored. While she was driving her husband home from the COVID-19 Vaccine facility, she and her husband had only gone a couple blocks, and she saw her husband was fast asleep with drool coming out of his mouth. She said that was not normal for her husband, so she pulled their car over to wake her husband up. She was able to wake her husband. When her husband got home, he went to bed and slept the rest of the day. The patient was sleepy for a couple days after receiving his first COVID-19 Vaccine. The outcome was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: atrial fibrillation; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced atrial fibrillation a few days after administration on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Eye haemorrhage, Ocular hyperaemia, Vaccination site pain
Clinical narrative: Blood Vessels in Right Eye; Eye is extremely red/eye is blood red; had a little soreness to injection site; This is a spontaneous report from a contactable consumer. A 61-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 14Mar2021 09:40 (Batch/Lot Number: EN6206; Expiration Date: 30Jun2021) as single dose for covid-19 immunisation. Medical history included ongoing hypertension. Concomitant medications included amlodipine besylate taken for hypertension from an unspecified start date (Started years ago) and ongoing. Patient states he took his Pfizer covid19 vaccine on Sunday morning. When he woke up on Monday morning there were some blood vessels in his right eye and his eye was extremely red. States that while he is uncertain of the exact time that this happened to his eye as he was sleeping; he noticed it Monday morning around 0700 when he woke up and looked in the mirror. States he had a little soreness to injection site, but nothing serious. Outcome of event eye red was not recovered, of others was unknown.