chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: been sick like 2 and half days now/ He's so sick after the first.; This is a spontaneous report from a contactable consumer (patient's wife). A 61-year-old male patient (reporter's husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; NDC number/ UPC number: unknown; Batch/Lot Number: EW0176; Expiration Date: Aug2021), dose 1 via an unspecified route of administration on 04May2021 as 1st dose, single for covid-19 immunisation. The patient did not have medical history. There was no investigation. Patient did not take any concomitant medications. Reporter stated that the patient took the first dose of vaccine and experienced side effects like one does during a 2nd dose and wanted to know what people do regarding the 2nd dose if they had side effects from the first dose. He was fine until Thursday evening and he has been sick like 2 and a half days now. When probed for treatment, reporter stated, he took Ibuprofen after the shot, when he got sick 2 days later. Not the day of the shot, 2 days later when he got sick. Reporter was provided with the contact for Pfizer Medical Information. Reporter stated that her husband is still sick. Patient had no lab test. There was no product complaint to report. There was a medical information request. Outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information team. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL3303) as the 1st dose, single for COVID-19 immunization. Relevant medical history included that the patient was exposed to COVID that same day she got her first dose on 20Jan2021 to an unknown date. There were no concomitant medications. The patient tested positive for COVID on 24Jan2021. Initially, the patient reported that her 80-year-old mother got the first dose of the Pfizer COVID-19 vaccine on 20Jan2021 and was infected the same day and was treated with the antibodies on 27Jan2021. The patient was told that her mother would have to start over again. The patient stated that her mother got the second shot on 29Apr2021 and was asking if this was her mother's second dose or was it necessary to get a third shot. The patient's mother was currently good and was asking if she was protected. The patient further stated that she herself was also exposed that same day, but she did not receive antibodies, so her doctor told her to get the second shot since she did not get antibodies. The patient clarified that she herself tested positive for COVID as well. She had her first dose, but she was younger and knew it would not be as bad for herself, so she did not get antibodies; she just let COVID take its coarse and so the next time when she was supposed to get the second dose she got it. The patient confirmed she also got her first dose on 20Jan2021 and she was also exposed to COVID that same day. The patient tested positive for COVID that Saturday (as reported). They went in and she had a rapid test; her mother did not test positive with the rapid test that day, but her mother tested positive on that Monday (25Jan2021). The patient further reported that she tested positive on 24Jan2021. The patient received her 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Feb2021 (Batch/Lot number: EL1283) for COVID-19 immunization. The outcome of the event was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Burning sensation, Feeling hot, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Tingling/Fizzing/ numbing in face, gums, lips, nose, hands, feet and leg.; Tingling/Fizzing/ numbing in face, gums, lips, nose, hands, feet and leg.; Numbing in face, nose, hands, feet and leg.; Numbing in gums, lips; Lose of taste; Arms are having burning/hot sensation.. icy/hot feeling; Arms are having burning/hot sensation.. icy/hot feeling; This is a spontaneous report from a contactable consumer or other non hcp. A 34-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Pfizer NTEC), via an unspecified route of administered in Arm Left on 30Apr2021 11:15 PM as 1st dose, single for covid-19 immunisation. Patient medical history included hypothyroidism from an unknown date and unknown if ongoing. Patient Concomitant medications included Levothyroxine taken for an unspecified indication, start and stop date were not reported. Patient had no allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnose with COVID-19. Since the vaccination, did not patient been tested for COVID-19. In hospital the most recent COVID-19 vaccine was administered. The patient experienced Tingling/Fizzing/ numbing in face, gums, lips, nose, hands, feet and leg. This has continued one week after vaccine. Lose of taste the day after vaccine, taste came back & then went away once again, then finally came back. Today the numbing and tingling has slowed down but now both my arms are having burning/hot sensation. icy/hot feeling on 30-APR-2021 10:30 PM. The events assessed as non-serious. No treatment was received for the events. The patient visited doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the events was reported for Lose of taste as recovered on unknown date and while for others was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Tingling/Fizzing/ numbing in face, gums, lips, nose, hands, feet and leg.; Tingling/Fizzing/ numbing in face, gums, lips, nose, hands, feet and leg.; Numbing in face, nose, hands, feet and leg.; Numbing in gums, lips; Lose of taste; Arms are having burning/hot sensation.. icy/hot feeling; Arms are having burning/hot sensation.. icy/hot feeling; This is a spontaneous report from a contactable consumer or other non hcp. A 34-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Pfizer NTEC), via an unspecified route of administered in Arm Left on 30Apr2021 11:15 PM as 1st dose, single for covid-19 immunisation. Patient medical history included hypothyroidism from an unknown date and unknown if ongoing. Patient Concomitant medications included Levothyroxine taken for an unspecified indication, start and stop date were not reported. Patient had no allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnose with COVID-19. Since the vaccination, did not patient been tested for COVID-19. In hospital the most recent COVID-19 vaccine was administered. The patient experienced Tingling/Fizzing/ numbing in face, gums, lips, nose, hands, feet and leg. This has continued one week after vaccine. Lose of taste the day after vaccine, taste came back & then went away once again, then finally came back. Today the numbing and tingling has slowed down but now both my arms are having burning/hot sensation. icy/hot feeling on 30-APR-2021 10:30 PM. The events assessed as non-serious. No treatment was received for the events. The patient visited doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the events was reported for Lose of taste as recovered on unknown date and while for others was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I have tinnitus; This is a spontaneous report from Pfizer sponsored program Pfizer Rx pathways from a contactable (patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient stated that since second covid shot had tinnitus. Patient never had it before. Patient thought it would be temporary but it had been a couple of months and is still going on. Patient had not recovered from the event.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Fever; chills; nausea; pain; This is a spontaneous report from a contactable consumer or other non hcp.  A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 01May2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. It was reported that, on 01May2021, 7 days after second injection the patient experienced fever, chills, nausea, pain.  The outcome of events was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in my right ear.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8731 ) via an unspecified route of administration in Arm Left on 20Apr2021 at 17:45 as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included healthy, no chronic health issue. The patient previously took pseudoephedrine and experienced drug hypersensitivity, BNT162B2 (lot number: ER8727) on 27Mar2021 at 17:00 pm for covid-19 immunisation. Concomitant medication(s) included finasteride (FINASTERIDE), ascorbic acid, bifidobacterium animalis, biotin, calcium pantothenate, calcium phosphate dibasic, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, folic acid, magnesium stearate, manganese sulfate, nicotinamide, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, silicon dioxide, sodium selenate, thiamine mononitrate, tocopheryl acetate, zinc oxide (CENTRUM MULTI + PROBIOTICS), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]). The patient received Finasteride 1mg, Vitamin C 500mg, Centrum Multi within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID. The patient experienced tinnitus in my right ear on 24Apr2021, 19:00 PM, four days after vaccination. It was a fluctuating multi-tone ringing that has persisted 24hrs a day since 24Apr2021 and still continued. and saw an ENT doctor as noted for a diagnosis. No treatment was given other than rest and limit noise to the right ear and be patient. If the symptoms do not resolve in 2 more weeks, the next option is Prednisone. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Treatment was not received for the event. The outcome of tinnitus in my right ear was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest pain, Dyspnoea
Clinical narrative: My chest is constantly hurting, as if it's being pressed down.; having constant shortness of breath every day since the vaccine/I've never had any shortness of breath before; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 37 years of age), via an unspecified route of administration, administered in arm left on 02May2021 13:00 (Batch/Lot Number: EW0170) as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She had no known allergies. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. She has not been tested for COVID-19 since the vaccination. It was reported that the patient had been in constant shortness of breath every day since the vaccine. Her chest was constantly hurting, as if it was being pressed down. She never had any shortness of breath before getting this vaccine. The events started on 02May2021 04:00 PM with outcome of not recovered. It was unknown if the patient received treatment for the events. She had COVID test (nasal swab) on 25Jan2021 with negative result.  Information about lot/batch number was available. Further in formation was expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction, approx 8 hrs post vaccine; This is a spontaneous report from a contactable consumer. A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 19Mar2021 (Batch/Lot Number: EN6207) as 1st dose, single, at the age of 24-years-old for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient experienced allergic reaction, approximately 8 hours post vaccine on Mar2021. The event resulted in emergency room/department or urgent care visit. Benadryl was given as treatment. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered. The event was reported as non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Scan, Vision blurred, Visual impairment
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 13Apr2021 08:15 (lot number: EW0162) at the age of 65 years old, as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included PKD (Polycystic kidney disease), hypertension, enlarged prostate, meningioma, swollen retina, and allergies to ace inhibitors. Concomitant medications received within 2 weeks of COVID vaccination included eplerenone; tamsulosin; metoprolol; amlodipine; all taken for an unspecified indication, start and stop date were not reported. Historical vaccination included bnt162b2 on 23Mar2021 at the age of 65 years old for COVID-19 immunization (product=COVID 19, Brand=Pfizer, lot number=ER8732, administration time=08:15 AM, dose number=1, vaccine location=Left arm). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. According to the patient, he experienced "severe visual distortion starting two days after second shot (15Apr2021 at 08:00 AM). Blurriness and extreme horizontal distortion, with some vertical as well. Letters appeared crooked and having a melting drippy appearance. Straight lines appeared severely crooked. The severe distortion lasted 2 1/2 weeks, however my vision is still blurry in my right eye. All effects were in the right eye." The events resulted in Doctor or other healthcare professional office/clinic visit. Unspecified treatment was given. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included angiogram: unknown results on 2021, and 3 scans of the eyes: unknown results on 2021. The patient has not recovered from "blurriness/vision is still blurry in my right eye". The patient recovered from "severe visual distortion starting two days after second shot/extreme horizontal distortion, with some vertical as well. Letters appeared crooked and having a melting drippy appearance. Straight lines appeared severely crooked" on May2021.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, SARS-CoV-2 test negative, Troponin increased
Clinical narrative: developed chest pain; Troponin level greater than 1000; This is a spontaneous report from a contactable consumer. A 23-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 08May2021, 6 days after receiving 2nd dose, patient developed chest pain. He was admitted to hospital for 2 days. Troponin level was greater than 1000 on 08May2021. Cardiologist believes this may be a severe reaction to the vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19 via Nasal Swab (Coronavirus PCR) with negative result. The outcome of events was unknown.   Follow-up attempts are completed. The following information on the batch number has been requested.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Chest pain, Cognitive disorder, Disturbance in attention, Dysarthria
Clinical narrative: slurred speech; Memory loss; loss of cognitive functions; increased appetite; nausea; headaches; weight gain; unable to stay focused; shortness of breath / difficulty breathing; chest pain near heart; This is a spontaneous report from a contactable consumer or other non hcp. A 29-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0162) unknown dose via an unspecified route of administration in deltoid left on 15Apr2021 at 01:45 (at the age 29 years) as single dose for COVID-19 immunization. Medical history included depression. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination: Allergy medicine, ibuprofen. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Apr2021 at 16:00, the patient experienced memory loss, loss of cognitive functions, increased appetite, nausea, slurred speech, headaches, weight gain, unable to stay focused, shortness of breath, difficulty breathing, chest pain near heart. Outcome of the events was recovered with sequelae.  No follow up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Increased appetite, Nausea, Weight increased
Clinical narrative: slurred speech; Memory loss; loss of cognitive functions; increased appetite; nausea; headaches; weight gain; unable to stay focused; shortness of breath / difficulty breathing; chest pain near heart; This is a spontaneous report from a contactable consumer or other non hcp. A 29-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0162) unknown dose via an unspecified route of administration in deltoid left on 15Apr2021 at 01:45 (at the age 29 years) as single dose for COVID-19 immunization. Medical history included depression. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination: Allergy medicine, ibuprofen. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Apr2021 at 16:00, the patient experienced memory loss, loss of cognitive functions, increased appetite, nausea, slurred speech, headaches, weight gain, unable to stay focused, shortness of breath, difficulty breathing, chest pain near heart. Outcome of the events was recovered with sequelae.  No follow up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Cutaneous vasculitis, Throat irritation
Clinical narrative: Biopsy confirmed leukocytoclastic vasculitis on legs; scratchy throat; This is a spontaneous report from a contactable physician. A 41-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 11Feb2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 14Jan2021 for covid-19 immunisation. It was reported that biopsy confirmed leukocytoclastic vasculitis on legs which started on 01Mar2021, two weeks after the second Covid vaccine dose. No other systemic cause of vasculitis found on workup in rheumatology. Prednisone started and transient improvement. An antibiotic (Augmentin) was added because the patient also had a scratchy throat. A second tapering prednisone course was restarted for a few weeks.  Vasculitis totally improved by early May and prednisone was discontinued. The patient recovered from the events on an unspecified date.  Information on the lot/ batch number has been requested.; Sender's Comments: Based on current information available, the event leukocytoclastic vasculitis on legs and throat irritation mostly represented intercurrent condition in this patient, unrelated to Bnt162b2. Relevant medical history and concurrent disease are missing for a medically meaningful assessment.   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 RAs, Ethics Committees, and Investigators, as appropriate
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Postural orthostatic tachycardia syndrome
Clinical narrative: Passing out POT syndrome has occurred 10 times since initial vaccine; Passing out POT syndrome has occurred 10 times since initial vaccine; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 15:15 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included history of migraines from an unknown date and unknown if ongoing. Concomitant medication included vitamin d3 taken for an unspecified indication, start and stop date were not reported. Passing out POT syndrome has occurred 10 times since initial vaccine worsening post second vaccine on 13Apr2021 12:00. The patient experienced "passing out POT syndrome has occurred 10 times since initial vaccine" and was reported as worsening post second vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Therapeutic measures taken as a result of the event included a Heart monitor (as reported). Outcome of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Rash macular
Clinical narrative: Allergic reaction; Red blotches nose, spots inside hands/ some rashes inside hands, skin, inside hands like little dots, snow white dots surrounding red rashes, like hundreds of them white little circle dots; head rashes/nose  too high to low, lowdots on nose rashes like rashes and on nose but they come and go and they went away but these look like buyers spots in my hands; This is a spontaneous report received from a contactable consumer.  A male patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02May2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date for Covid-19 immunisation (first dose, rash). On unknown date, the patient experienced allergic reaction. On unknown date the patient experienced red blotches on nose and spots inside his hands/ the patient had some rashes inside hands, skin, on inside hands like little dots, snow white dots surrounding red rashes or something they was like hundreds of them white little circle dots (they sometime were more, sometimes they went away, then they came back, they went away). On unknown date, the patient experienced head rashes/ nose too high to low, low dots on nose rashes like rashes and on nose but they came and went ,and they went away but these look like buyers spots in hands. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: U
Vaccine: COVID19, UNK
Symptoms: Asthenia, Blood test, Fatigue, Feeling drunk
Clinical narrative: Feeling awkward like I am drunk; I had Dilantin toxicity/I went to the emergency room and they said my Dilantin level has; was too high, my Dilantin level was toxic.; I am tired; Medications have react with the vaccine; I feel like I have been weak today and then I am still not having energy for the day.; so taking 1 tablet twice a day instead of two tablets twice a day; the second dose is about to kill me, I haven't felt like it in 16 years, I am recovering alcoholic. I am on medication from 16 years; Dilantin toxicity; This is a spontaneous report received from a contactable consumer (Patient). Follow-up (08May2021) information was processed together with initial information.   A 46-year-old unspecified gender patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Lot number: EW0171 and expiration date were not reported) via an unspecified route of administration in left arm, on 27Apr2021 (at the age of 46-year-old) as single dose for COVID-19 immunization. The patient also administered a Dilantin because of 16 years back had epilepsy. The patient's medical history included epilepsy which had sixteen years back and for this taken Dilantin and Trokendi XR 200 mg. The concomitant medication included Keppra 500 mg 3 in the morning 3 in the night, Onfi 10 mg, 1 tablet twice a day, also take Trokendi 200 mg extender release XR once a day. The event was described as follows: Patient took the vaccine and Patient having awkward Patient don't even what but it was during when Patient took Dilantin always do have but when took the vaccine April 27th that was the last vaccine on the 27th (April)."Patient experiencing feel like I am drunk and Patient have been on it (Dilantin), 16 years back had epilepsy. Patient have epilepsy (History) and the medications (Dilantin and Trokendi XR 200 mg) that Patient taking would not. If vaccine would affect, the medicines (Dilantin and Trokendi XR 200 mg) that taking but think it has and take Trokendi XR 200 mg one capsule a day,  Patient take the generic brand (unspecified medication) take "6" (not clarified) capsules a day but "3" (not clarified) capsules last day 500 mg and took Dilantin. Patient supposed to be taking 2 capsules twice a day and Patient went to the Hospital in night they said I had Dilantin toxicity (Hence, conservatively PC Filed) and told me to start taking 1 Dilantin twice a day and kept down and doing that but Patient tried. Patient got no clue, feel like are any of these medications are related to or the vaccine. Patient asked any of these medications have any kind of react with the vaccine". Patient had no problem with the first dose, the second dose is about to kill, Patient haven't felt like it in 16 years, Patient recovering alcoholic. Patient on medication from 16 years." Patient underwent lab test and procedures included Blood test. The outcome of event was Unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: She was sore in the area where she got the injection, on her arm, after the first vaccine; This is a spontaneous report from a contactable consumer (patient). This female consumer of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Apr2021, in the arm, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Apr2021, after the first vaccine, the patient was sore in the area where she got the injection, in her arm. Event outcome was unknown. The second vaccine was scheduled on 17May2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack
Clinical narrative: Panic attacks; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old female patient, not pregnant, received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration administered in arm left on 06May2021 10:30 as 2nd dose, single for covid-19 immunisation. Medical history included ulcerative colitis, and hypothyroidism. Concomitant medications included adalimumab (HUMIRA); levothyroxine; and balsalazide disodium - all taken for unspecified indications, start and stop dates were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) on 15Apr2021 10:15 AM administered in the left arm for covid-19 immunisation. There were no other vaccines received within 4 weeks prior to the covid-19 vaccine. The patient was not diagnosed with covid-19 prior to the vaccination. Vaccination was done at a pharmacy or drug store. The patient experienced panic attacks on 07May2021 which resulted in emergency room/department or urgent care. The patient had not recovered from the adverse event at the time of the report. Since the vaccination the patient has not been tested for covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Hypersensitivity
Clinical narrative: assuming it was an allergic reaction; slightly dizzy and a bit sick to my stomach (likely from the dizzy feeling).; slightly dizzy and a bit sick to my stomach (likely from the dizzy feeling).; This is a spontaneous report from a non contactable consumer (patient). A 37-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 01May2021 14:30 (Lot Number: EW0176) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included multiple sclerosis and known allergies: All mammalian meats (alpha gal protein), shellfish, and tree nuts. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. On 01May2021 02:45 PM, within a few minutes of receiving his first dose of the Pfizer vaccine, the patient became slightly dizzy and a bit sick to my stomach (likely from the dizzy feeling). Since it occurred within minutes, he was assuming it was an allergic reaction to the vaccine itself. He was obviously nervous about getting his second dose now. Often times anaphylaxis occurs the 2nd time you encounter a reaction inducing stimuli. No treatment received. Since the vaccination, the patient has not been tested for COVID-19. The outcome was recovered on May2021. This case was reported as not serious.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site: redness, swelling, itchy, raised area, very similar to a bee sting/ with the 1st dose, she had a similar reaction and a red spot; injection site: redness, swelling, itchy, raised area, very similar to a bee sting/ with the 1st dose, she had a similar reaction and a red spot; injection site: redness, swelling, itchy, raised area, very similar to a bee sting/ with the 1st dose, she had a similar reaction and a red spot; mild allergic reaction; This is a spontaneous report from a non-contactable consumer (pateint). A 27-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on 07Apr2021 09:00 as 1st dose, single; then on 06May2021 18:00 as 2nd dose, single; the patient received both doses via an unspecified route of administration on the left arm at the age of 27 years old (Batch/Lot number was not reported) for COVID-19 immunisation. Medical history included mental illness, anxiety, moderate depression, bipolar depression, post-traumatic stress disorder (PTSD), migraines, polycystic ovarian syndrome (PCOS) and sulfa drugs allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC), lamotrigine (LAMICTAL), cetirizine hydrochloride (ZYRTEC ALLERGY), rizatriptan benzoate (MAXALT); all for excendrine migraine. On 07May2021, the patient had injection site: redness, swelling, itchy, raised area, very similar to a bee sting. The patient stated that with the 1st dose, she had a similar reaction on an unspecified date and a red spot about 1 inch wide remained. The patient was treated with ice (as reported), diphenhydramine (BENADRYL) and ibuprofen for mild allergic reaction. The patient had no other vaccines in four weeks and was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Oral disorder, Stomatitis
Clinical narrative: Oral lesions appeared all over inside my mouth, on my tongue, cheeks, behind my lower lip, and gums; It began with a few white-colored sores; my tongue never felt right. It felt as though the top layer was numb; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 07Mar2021 11:45 AM (Batch/Lot Number: EN6199) at the age of 48-years-old as 1st dose, single for COVID-19 immunization at urgent care center. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included asthma, arthritis, and allergies: sensitive to peppers. Concomitant medication included meloxicam taken for an unspecified indication, start and stop date were not reported (received within 2 weeks of vaccination). On 08Mar2021, oral lesions appeared all over inside her mouth, on her tongue, cheeks, behind her lower lip, and gums. It began with a few white-colored sores. They would heal and new ones would appear. They lasted for 2 weeks. While the sores were gone, her tongue never felt right. It felt as though the top layer was numb. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. A device date of 09May2021 was reported. Therapeutic measures were taken as a result of the events which included valacyclovir hydrochloride (VALTREX), chlorhexidine gluconate (PERIDEX), triamcinolone, and B12. The outcome of the events was recovered with sequelae (recovered with lasting effects).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Hypoaesthesia oral, Lip swelling, Stomatitis, Swollen tongue
Clinical narrative: that oral lesions appeared all over inside her mouth, on her tongue, cheeks, behind my lower lip, and gumsbegan with a few white-colored sores; Now the sores are gone and she's pain-free, but still experiencing some numbness; lips and tongue swelled; lips and tongue swelled; Couldn't eat anything but soup or yogurt; lost 15 pounds; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 28Mar2021 11:30 (Batch/Lot Number: ER8732) as 2ND DOSE, SINGLE for covid-19 immunization.  Medical history included asthma and arthritis. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication(s) included meloxicam taken for an unspecified indication, start and stop date were not reported. It was reported that oral lesions appeared all over inside her mouth, on her tongue, cheeks, behind my lower lip, and gums. It began with a few white-colored sores. They would heal and new ones would appear. They lasted for 2 weeks. While the sores were gone, my tongue never felt right. It felt as though the top layer was numb. 8 days after my second dose, the sores reappeared. This time it was much worse. Twice, the entire right-half of the underside of my tongue was white. Sores would move around. She could feel them forming on her tongue at night. Her lips and tongue swelled. She couldn't eat anything but soup and yogurt. It hurt to talk. She lost 15 pounds. Now the sores are gone and she's pain-free, but still experiencing some numbness. The outcome of events was recovered with lasting effects. The outcome of event was reported as Recovered/Resolved with Sequel. The events resulted in emergency room/physician's office visit. Therapeutic measures taken as result of events.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: that oral lesions appeared all over inside her mouth, on her tongue, cheeks, behind my lower lip, and gumsbegan with a few white-colored sores; Now the sores are gone and she's pain-free, but still experiencing some numbness; lips and tongue swelled; lips and tongue swelled; Couldn't eat anything but soup or yogurt; lost 15 pounds; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 28Mar2021 11:30 (Batch/Lot Number: ER8732) as 2ND DOSE, SINGLE for covid-19 immunization.  Medical history included asthma and arthritis. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication(s) included meloxicam taken for an unspecified indication, start and stop date were not reported. It was reported that oral lesions appeared all over inside her mouth, on her tongue, cheeks, behind my lower lip, and gums. It began with a few white-colored sores. They would heal and new ones would appear. They lasted for 2 weeks. While the sores were gone, my tongue never felt right. It felt as though the top layer was numb. 8 days after my second dose, the sores reappeared. This time it was much worse. Twice, the entire right-half of the underside of my tongue was white. Sores would move around. She could feel them forming on her tongue at night. Her lips and tongue swelled. She couldn't eat anything but soup and yogurt. It hurt to talk. She lost 15 pounds. Now the sores are gone and she's pain-free, but still experiencing some numbness. The outcome of events was recovered with lasting effects. The outcome of event was reported as Recovered/Resolved with Sequel. The events resulted in emergency room/physician's office visit. Therapeutic measures taken as result of events.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Insomnia, Intermenstrual bleeding, Migraine, Muscle spasms
Clinical narrative: Immediate extreme migraine; Severe neuralgia flare up; Can't sleep due to muscle pain; Can't sleep due to muscle pain; Breakthrough bleeding; Cramps; 1st dose : 15Apr2021, 2nd dose: 15Apr2021; 1st dose : 15Apr2021, 2nd dose: 15Apr2021; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 15Apr2021 09:30 (Batch/Lot Number: ER8735) as 1st dose, single, and via an unspecified route of administration, administered in right arm on 15Apr2021 (Batch/Lot Number: EW0176) as 2nd dose, single for COVID-19 immunization, in an urgent care center. Medical history included chronic migraine, occipital neuralgia, and Penicillin allergy from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination and was not COVID tested post vaccination. Concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL); and zonisamide, both taken for an unspecified indication. On 07May2021, the patient experienced immediate extreme migraine, severe neuralgia flare up, she can't sleep due to muscle pain, breakthrough bleeding, and cramps. The patient has not recovered from the events.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neuralgia, Off label use
Clinical narrative: Immediate extreme migraine; Severe neuralgia flare up; Can't sleep due to muscle pain; Can't sleep due to muscle pain; Breakthrough bleeding; Cramps; 1st dose : 15Apr2021, 2nd dose: 15Apr2021; 1st dose : 15Apr2021, 2nd dose: 15Apr2021; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 15Apr2021 09:30 (Batch/Lot Number: ER8735) as 1st dose, single, and via an unspecified route of administration, administered in right arm on 15Apr2021 (Batch/Lot Number: EW0176) as 2nd dose, single for COVID-19 immunization, in an urgent care center. Medical history included chronic migraine, occipital neuralgia, and Penicillin allergy from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination and was not COVID tested post vaccination. Concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL); and zonisamide, both taken for an unspecified indication. On 07May2021, the patient experienced immediate extreme migraine, severe neuralgia flare up, she can't sleep due to muscle pain, breakthrough bleeding, and cramps. The patient has not recovered from the events.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: acute DVT of left peroneal vein (in the left calf); This is a spontaneous report from a non-contactable consumer (patient).  This 49-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not provided), via an unknown route, on 29Apr2021 11:30 (at the age of 49-year-old) at single dose in the left arm for COVID-19 immunisation. No relevant medical history was provided. No other vaccine was received in four weeks. Relevant concomitant medications included ibuprofen (ADVIL 12 HOUR). From 03May2021, the patient developed sharp, piercing pain in my left calf over several days. The frequency increased the early morning (06:00-09:00) of 09May2021 so she contacted her primary care physician to discuss what she thought might be an indicator of deep vein thrombosis (DVT). She presented to the Emergency Room the morning of 09May2021 and was diagnosed with acute DVT of left peroneal vein (in the left calf). She was given blood thinner. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was recovering from the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Diarrhoea, Fatigue, Feeding disorder, Heart rate
Clinical narrative: nausea; vomiting; diarrhea; rapid heart rate; severe dehydration; unable to eat or drink; Extremely fatigued all day; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 47 years old, administered in arm right on 28Apr2021 12:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included spinach allergy, UC (Ulcerative colitis). Concomitant medication included mesalamine. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 47 years old, administered in arm right on 07Apr2021 12:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. On 29Apr2021 01:00, less than 24 hours of second vaccine there was nausea, vomiting, diarrhea and a rapid heart rate and severe dehydration. This progressed and led to hospitalization from Saturday 01May2021 to 04May2021 and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient also experienced unable to eat or drink and extremely fatigued in 2021. As of this message (10May2021), still unable to eat or drink without vomiting and hear rate up to 170+. This was up from a normal resting heart rate of near 60. Extremely fatigued all day, vomit several times per day and loose stool to diarrhea multiple times per day. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had been tested for COVID-19, covid-test (blood test) on 02May2021: negative. Treatment was received for all events. The outcome of the events was not recovered.  Information about batch/ Lot number has been requested.