chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth, Pain, Wound
Clinical narrative: Shortness of breath (still to this day)  Headache Body pain Blister in left side of stomach that resulted in wound. Wound on left lower back with skin coming off from light scratch Severe redness on injection site (left arm) that was hot to touch and lasted for 2 weeks post vaccination.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: per pt is having swelling at ankles near sock indention
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Chills, Headache, Insomnia, Lethargy
Clinical narrative: I was released from quarantine from my Covid-19 infection 5 days prior to getting the first Moderna vaccine in the morning. By the evening, I felt sicker than I ever have in my entire life. I was shaking uncontrollably, had a fever, extreme chills, and a pounding headache and muscle aches. I didn't sleep that night and couldn't get out of bed until noon the next day. I am still lethargic today and seemed to have lost my sense of smell.   My Covid-19 symptoms from the 2 weeks prior were extremely mild and the vaccine experience was 1,000x worse. Something isn't right and I am questioning whether I should get the second shot.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Mobility decreased, Myalgia, Pyrexia, Tremor
Clinical narrative: I was released from quarantine from my Covid-19 infection 5 days prior to getting the first Moderna vaccine in the morning. By the evening, I felt sicker than I ever have in my entire life. I was shaking uncontrollably, had a fever, extreme chills, and a pounding headache and muscle aches. I didn't sleep that night and couldn't get out of bed until noon the next day. I am still lethargic today and seemed to have lost my sense of smell.   My Covid-19 symptoms from the 2 weeks prior were extremely mild and the vaccine experience was 1,000x worse. Something isn't right and I am questioning whether I should get the second shot.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Confusional state, Dizziness, Dysarthria, Emotional disorder
Clinical narrative: April 7th about 6:30pm: I became very confused, having trouble remembering where I was or answering simple questions.  Around that same time my vision became blurry, and my face in and around my mouth became numb, I began to slur as a result.  The numbness and slurring increased over the next hour or so.  After that hour or so, I realized I was exhausted and my head hurt so I went to sleep. I also had a strange emotional response to all of this, I behaved giddily and as though it were funny.  April 8th about 8am: I woke up and the confusion, blurry vision, numbness, and slurring were gone.  I had a mild headache, brain fog, and was still more tired than usual.  Later that evening the headache developed in to something more like a migraine, intense pain focused behind my right eye and blurred vision.  At this time I again decided to go to sleep.  It would have been about 8pm.  April 9th about 8am: I woke up still feeling a moderate headache focused on the right side, still tired, and brain fog.  The symptoms weakened throughout the day and by the evening I was feeling mostly normal again.   I have felt healthy and normal since.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Fatigue, Feeling abnormal, Headache, Hypoaesthesia oral
Clinical narrative: April 7th about 6:30pm: I became very confused, having trouble remembering where I was or answering simple questions.  Around that same time my vision became blurry, and my face in and around my mouth became numb, I began to slur as a result.  The numbness and slurring increased over the next hour or so.  After that hour or so, I realized I was exhausted and my head hurt so I went to sleep. I also had a strange emotional response to all of this, I behaved giddily and as though it were funny.  April 8th about 8am: I woke up and the confusion, blurry vision, numbness, and slurring were gone.  I had a mild headache, brain fog, and was still more tired than usual.  Later that evening the headache developed in to something more like a migraine, intense pain focused behind my right eye and blurred vision.  At this time I again decided to go to sleep.  It would have been about 8pm.  April 9th about 8am: I woke up still feeling a moderate headache focused on the right side, still tired, and brain fog.  The symptoms weakened throughout the day and by the evening I was feeling mostly normal again.   I have felt healthy and normal since.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate affect, Memory impairment, Migraine, Vision blurred
Clinical narrative: April 7th about 6:30pm: I became very confused, having trouble remembering where I was or answering simple questions.  Around that same time my vision became blurry, and my face in and around my mouth became numb, I began to slur as a result.  The numbness and slurring increased over the next hour or so.  After that hour or so, I realized I was exhausted and my head hurt so I went to sleep. I also had a strange emotional response to all of this, I behaved giddily and as though it were funny.  April 8th about 8am: I woke up and the confusion, blurry vision, numbness, and slurring were gone.  I had a mild headache, brain fog, and was still more tired than usual.  Later that evening the headache developed in to something more like a migraine, intense pain focused behind my right eye and blurred vision.  At this time I again decided to go to sleep.  It would have been about 8pm.  April 9th about 8am: I woke up still feeling a moderate headache focused on the right side, still tired, and brain fog.  The symptoms weakened throughout the day and by the evening I was feeling mostly normal again.   I have felt healthy and normal since.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vertigo
Clinical narrative: Headache for 2 days. Vertigo 4 days, then recurs at times
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: Gout-like reaction (self-diagnosed) at joint of large toe of right foot. No previous history of gout. Symptoms include significant swelling and joint pain, redness and warmth at affected area. Condition persisted 3 days; condition has begun to subside (at present date, only minor swelling remains).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood glucose increased, Confusional state, Disorientation, Respiratory arrest
Clinical narrative: twelve hours after getting the shot my wife woke up with an upset stomach; her blood sugar was also slightly elevated; within ~the next two hours she became disoriented and confused; I called 911 and within a couple of minutes of the first 911 call she stopped breathing and could not be revived.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 17 year old patient received the 2nd dose of Moderna COVID vaccine. No adverse events reported
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Eye swelling, Facial paralysis
Clinical narrative: Woke up with closed eye and drooping on left side of face. ER diagnosis of Bells Palsy
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Death
Clinical narrative: Witnessed cardiac arrest with death as the outcome
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache x 3 days
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Magnetic resonance imaging
Clinical narrative: Stroke
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Malaise, Swollen tongue, Tongue discolouration
Clinical narrative: Metal taste in mouth. Toung swollen and discolored with red and white patches. Keeped clean and rinsed with salt water. I still have the symptoms, but it does seem to be getting slightly better. It did not seem to change when I received my second shot. Second shot made me tired and I felt like I was coming down with the flu. I slept for 10.5 hours and woke up feeling much better. All the flu symptoms where gone by the following day.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Lip swelling, Paraesthesia, Paraesthesia oral
Clinical narrative: Pt developed difficulty breathing, tingling in lips and face, elevated pulse and swelling of lips. 50mg diphenhydramine IM in R deltoid, symptoms slowly subsided over the course of 1 hour.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blindness, Dry mouth, Nasal congestion
Clinical narrative: distance vision loss began happening four days after being vaccinated; salivatory glands in mouth dried up, felt like sucking on lemons, nostrils became stuffed up. This was with in about ten minutes after vaccination was given.; salivatory glands in mouth dried up, felt like sucking on lemons, nostrils became stuffed up. This was with in about ten minutes after vaccination was given.; The initial spontaneous report information received from a contactable consumer (patient) on 23Mar2021 safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 28Mar2021, this case now contains serious adverse reactions. A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EP7534) via an unspecified route of administration to right arm on 22Mar2021 15:00 at single dose for COVID-19 immunization. Patient medical history included high blood pressure, lymes disease, dengue fever, artheritis, known allergies: bees, known allergies: mold, botox and known allergies: some meds. Concomitant medications included lisinopril, vitamins nos and ascorbic acid, thiamine hydrochloride (VITAMIN B AND C COMPLEX). On 22Mar2021 patient reported with salivatory glands in mouth dried up, felt like sucking on lemons, nostrils became stuffed up. This was within about ten minutes after vaccination was given. Patient took benadryl and was observed for 30 min for the events. On 26Mar2021 20:00 patient experienced with distance vision loss began happening four days after being vaccinated patient did not received any treatment for this event. Outcome of event Vision loss was not recovered and Recovered with sequel for other events.  No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Bone pain, Hypersensitivity, Retinal tear, Salivary gland disorder
Clinical narrative: distance vision loss began happening four days after being vaccinated; salivatory glands in mouth dried up, felt like sucking on lemons, nostrils became stuffed up. This was with in about ten minutes after vaccination was given.; salivatory glands in mouth dried up, felt like sucking on lemons, nostrils became stuffed up. This was with in about ten minutes after vaccination was given.; The initial spontaneous report information received from a contactable consumer (patient) on 23Mar2021 safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 28Mar2021, this case now contains serious adverse reactions. A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EP7534) via an unspecified route of administration to right arm on 22Mar2021 15:00 at single dose for COVID-19 immunization. Patient medical history included high blood pressure, lymes disease, dengue fever, artheritis, known allergies: bees, known allergies: mold, botox and known allergies: some meds. Concomitant medications included lisinopril, vitamins nos and ascorbic acid, thiamine hydrochloride (VITAMIN B AND C COMPLEX). On 22Mar2021 patient reported with salivatory glands in mouth dried up, felt like sucking on lemons, nostrils became stuffed up. This was within about ten minutes after vaccination was given. Patient took benadryl and was observed for 30 min for the events. On 26Mar2021 20:00 patient experienced with distance vision loss began happening four days after being vaccinated patient did not received any treatment for this event. Outcome of event Vision loss was not recovered and Recovered with sequel for other events.  No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: distance vision loss began happening four days after being vaccinated; salivatory glands in mouth dried up, felt like sucking on lemons, nostrils became stuffed up. This was with in about ten minutes after vaccination was given.; salivatory glands in mouth dried up, felt like sucking on lemons, nostrils became stuffed up. This was with in about ten minutes after vaccination was given.; The initial spontaneous report information received from a contactable consumer (patient) on 23Mar2021 safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 28Mar2021, this case now contains serious adverse reactions. A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EP7534) via an unspecified route of administration to right arm on 22Mar2021 15:00 at single dose for COVID-19 immunization. Patient medical history included high blood pressure, lymes disease, dengue fever, artheritis, known allergies: bees, known allergies: mold, botox and known allergies: some meds. Concomitant medications included lisinopril, vitamins nos and ascorbic acid, thiamine hydrochloride (VITAMIN B AND C COMPLEX). On 22Mar2021 patient reported with salivatory glands in mouth dried up, felt like sucking on lemons, nostrils became stuffed up. This was within about ten minutes after vaccination was given. Patient took benadryl and was observed for 30 min for the events. On 26Mar2021 20:00 patient experienced with distance vision loss began happening four days after being vaccinated patient did not received any treatment for this event. Outcome of event Vision loss was not recovered and Recovered with sequel for other events.  No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Intermittent facial palsy on left cheek, about one inch below the eye; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN6205), via an unspecified route of administration in the left arm on 03Mar2021 16:00 (at the age of 44-years-old) at single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EB8727), via an unknown route, in the left arm on 25Mar2021 08:00 (at the age of 44-years-old) at single dose for COVID-19 immunization. Medical history included Slight gluten interance. Concomitant medications were not reported. The patient experienced Intermittent facial palsy on left cheek, about one inch below the eye on 04Mar2021 and intensified after second dose. Therapeutic measures were taken as a result of event are not reported. Treatment received was reported as no. The outcome of the event was not recovered.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Aggression, Confusional state, Feeding disorder, Incoherent, Mental disorder
Clinical narrative: a few days after the first shot i started having mental issues; becoming confused; paranoid; aggressive; not making any sense; have not been able to sleep; I cant eat; This is a spontaneous report received from a contactable consumer (patient himself). A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: en6202) via an unspecified route of administration on the right arm on 06Mar2021 at 11.30 (at the age of 35-year-old) at a single dose and second dose on arm on 27Mar2021 (at the age of 35-year-old) at single dose for COVID-19 immunization. The patient medical history included CRPS, ADHD and PTSD. Concomitant medications were not reported. The patient was previously took haloperidol and experienced with allergy. On 07Mar2021 at 14:30 started having mental issues. Becoming confused, paranoid, aggressive, not making any sense. No one believed and send patient to a mental hospital and drugged him more and put him through terrible medical practices. He received his second dose of the vaccine and after that he had same side effect again but worse. He needed some sort of treatment asap. He also reported that no one believed him this was the vaccine. He was not able to sleep but 4 hours every 36 hours and he could not eat. These adverse events led the patient's hospitalization and Disabling/Incapacitating. Outcome of events was not recovered.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Paranoia, Sleep disorder
Clinical narrative: a few days after the first shot i started having mental issues; becoming confused; paranoid; aggressive; not making any sense; have not been able to sleep; I cant eat; This is a spontaneous report received from a contactable consumer (patient himself). A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: en6202) via an unspecified route of administration on the right arm on 06Mar2021 at 11.30 (at the age of 35-year-old) at a single dose and second dose on arm on 27Mar2021 (at the age of 35-year-old) at single dose for COVID-19 immunization. The patient medical history included CRPS, ADHD and PTSD. Concomitant medications were not reported. The patient was previously took haloperidol and experienced with allergy. On 07Mar2021 at 14:30 started having mental issues. Becoming confused, paranoid, aggressive, not making any sense. No one believed and send patient to a mental hospital and drugged him more and put him through terrible medical practices. He received his second dose of the vaccine and after that he had same side effect again but worse. He needed some sort of treatment asap. He also reported that no one believed him this was the vaccine. He was not able to sleep but 4 hours every 36 hours and he could not eat. These adverse events led the patient's hospitalization and Disabling/Incapacitating. Outcome of events was not recovered.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis, Headache
Clinical narrative: Bell's palsy/eyes droopy; annoying headache 3-4 days; This is a spontaneous report from a contactable consumer (patient, self-reported). A 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry dates were not provided) via unknown route, on 22Mar2021 (last Monday) as a single dose for COVID-19 immunisation. Patient's medical history included Bell's palsy. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Lot number and expiry dates were not reported) for COVID-19 immunisation. Patient stated that patient received COVID-19 Vaccine second dose last Monday, (22Mar2021). He had started with annoying headaches for 3-4 days. On Friday (26Mar2021), had lost control with talking, eyes were droopy etc. Patient mentioned that he had Bells palsy once before, and that now got it again. Patient asked if it would be possible that the vaccine caused the disease?. He mentioned that the hospital gave him Prednisone and Valtrex. Seriousness of the events was considered as hospitalization. Outcome of the events was unknown.  Information on about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hallucination, Miosis, Thinking abnormal
Clinical narrative: The feeling intensified further over the next 20 minutes until the feeling became almost a psychedelic experience.; About 30 minutes after the second shot I began to get very light headed.; My pupils were tiny; the my perceptions were off any my "way of thinking" had changed.; The only other effect was I would get an uncontrollable tired feeling once a day for about 10 days.; This is a spontaneous report from a contactable consumer (patient). This 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration in right arm on 09Mar2021 at 09:00 as a single dose for COVID-19 immunisation. The patient medical history included High blood pressure (had a history of drugs having unusual reactions in his system). The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 in the right arm on 16Feb2021 at 10:00 for COVID-19 immunisation and had light head. the patient not receive any other vaccines within 4 weeks prior to the COVID vaccine; other medications the patient not received within 2 weeks of vaccination; 30 minutes after the first shot he felt light head. Not too bad but a bit concerning. About 30 minutes after the second shot (09Mar2021 09:30) patient began to get very light headed. The feeling intensified further over the next 20 minutes until the feeling became almost a psychedelic experience. his pupils were tiny, the my perceptions were off any his "way of thinking" had changed. he had take psychedelics in my youth (but not in 30 years) and it were not for that previous experience and ability to stay calm he was very well may have ended up in the emergency room. The whole experience lasted till he went to bed but the "peak high" lasted about an hour. The next morning he again felt like someone who had done a psychedelic drug the night before. The only other effect was he would get an uncontrollable tired feeling once a day for about 10 days. No treatment received for the adverse event; Prior to vaccination, the patient not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19; The outcome of all the events was recovered in 2021.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Muscle spasms, Pyrexia
Clinical narrative: Fever to 103.9; severe muscle cramping; joint swelling and pain. Joint swelling and pain has continued to this day; joint swelling and pain. Joint swelling and pain has continued to this day; This is a spontaneous report from a contactable other health care professional. A 44-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: EK9231; Age at vaccination 44 Year), dose 2 via administered in Arm Left on 06Jan2021 17:00 as single dose for covid-19 immunisation. Medical history included Allergies to peanuts, tree nuts. Concomitant medications included famotidine. The patient previously took zithromax and experienced Allergies, bnt162b2 (Lot number: EK5730; 17Dec2020 17:00, Left arm, dose number=1). the patient not receive any other vaccines within 4 weeks prior to the COVID vaccine; other medications the patient received within 2 weeks of vaccination: Famotidine; Prior to vaccination, the patient not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. On 06Jan2021 22:30, Fever to 103.9, severe muscle cramping, joint swelling and pain. Joint swelling and pain has continued to this day. ae resulted in Disability or permanent damage; Recovered with lasting effects. The patient not received treatment AE. The outcome of the events was resolved with sequel. ~; Sender's Comments: A possible contributory effect of suspect BNT162B2 on the reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neuropathy peripheral, Pain in extremity
Clinical narrative: neuropathy; stabbing pain in the right foot; arthritis type of pain; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 (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 had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation. The patient received the second dose of the Pfizer Covid vaccine on last Friday (26Mar2021) and experiencing stabbing pain in the right foot, it's like neuropathy, since 2 am yesterday morning (28Mar2021). On Sunday morning (28Mar2021) at 02:00, the patient woke up and he was getting a stabbing pain in the top of his foot, like kind of neuropathy or it could be a arthritis type of pain; he don't know but he was just wondering if that was the side effect of the vaccine. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected. Information about lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Concussion, Head injury
Clinical narrative: Had an accident (concussion/head injury) and was in the hospital for 8 days; Had an accident (concussion/head injury) and was in the hospital for 8 days; This is a spontaneous report from a contactable nurse. An 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 20Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 26Jan2021, she had an accident (concussion/head injury) and was in the hospital for 8 days. She missed her second dose and is trying to get a second dose. Her local vaccination site is refusing to give her the second dose because it is out of the 6 week window. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.; Sender's Comments: Based on information provided, the events of concussion/head injury are accident but unrelated to bnt162b2. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Brain injury, Dizziness, Drug interaction, SARS-CoV-2 antibody test
Clinical narrative: brain zaps; dizziness; Desvenlafaxine anxiety medication did not work once I received the vaccine; This is a spontaneous report from a contactable consumer (Patient, Self-reported). A 29 years old female patient(who was not pregnant at the time of vaccination) received  first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8732 and expiry date was not provided), via an unspecified route of administration, in the left arm, on 27Mar2021 09:00 AM(at the age of 29-years-old), as a single dose for COVID-19 immunisation at other facility where the most recent COVID-19 vaccine was administered. Medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient received Desvenlafaxine in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. On 04Sep2020 patient had been tested for COVID with test result: Negative. The patient reported that Desvenlafaxine anxiety medication did not work for her, On 27Mar2021  when she received the vaccine and the day after she had experienced with brain zaps and dizziness almost like she didn't even take the Desvenlafaxine (50 mg) for the day. The patient underwent nasal swab test and procedures which included SARS-CoV-2 antibody test: negative on 04-SEP-2020. Outcome of the events was recovering/resolving.   Follow-up activities are closed as no further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Vertigo, Vomiting
Clinical narrative: sudden severe onset of vertigo; dizziness; syncope; vomiting; This is a spontaneous report from a contactable consumer (patient, self-reported). A 51-Year-old female patient (who was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6204 and expiry date was not provided) via an unspecified route of administration, in left arm on 12Mar2021 at 13:30 as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and immunotherapy. The patient had allergies to penicillin, sulfa drugs and peanuts. The patient's concomitant medications were not reported. The patient previously took ibuprofen and had allergy. The patient stated that On 18Mar2021 at 12:30, the patient experienced sudden severe onset of vertigo and dizziness with syncope and vomiting. The patient was hospitalized for 3 days. On an unknown date in Mar2021, the patient was hospitalized, and a week and a half later still had dizziness which prevents patient from performing daily tasks. Patient received unspecified treatment for the adverse event. Seriousness of the events was reported as hospitalization. Outcome of the events vertigo, syncope, vomiting and loss of personal information was recovering, and for the events dizziness it was not recovered.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood urine present, Deep vein thrombosis
Clinical narrative: DVT; blood in urine; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A patient of unspecified age and gender received the second dose of bnt162b2 (BNT162B2, Solution for injection lot number and expiry date were not reported), via an unspecified route of administration on 25Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, Solution for injection lot number and expiry date were not reported), on 03Feb2021 for COVID-19 immunization. On 24Mar2021, the patient had blood in urine. After visiting ER (emergency room) 2 times, the patient got DVT (Deep Vein Thrombosis). The doctors were also not sure if that's because of the shot or not. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood urine present, Deep vein thrombosis
Clinical narrative: I got DVT-Deep Vein Thrombosis; blood in my urine; This is a spontaneous report from a contactable consumer (patient) via the Pfizer sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE first dose on 03Feb2021 for COVID-19 immunisation. The patient got dvt-deep vein thrombosis on an unspecified date with outcome of unknown and blood in urine on 24Mar2021 with outcome of unknown. It was mentioned that the patient got first shot on 03Feb21, and second shot on 25Feb21. But on 24Mar21, blood in his/her urine. After visit ER 2 times, the patient got DVT (Deep Vein Thrombosis). Also doctors were not sure that's because of the shot or not.   Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Heart rate, Heart rate increased, Rash
Clinical narrative: overwhelming since of hotness; Dizziness; broke out in a rash everywhere; heart rate went up; This is a spontaneous report from a contactable Nurse. This female Nurse reported for herself that a 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot no: EP7534, Expire Date: 31Jul2021), 0.3ml intramuscular injection in left deltoid as a single dose for covid 19 immunisation on 26Mar2021 at 1:00PM. The patient medical history included blood pressure, migraine. The patient concomitant medication included Amitriptyline 100mg once a day for Blood pressure, Amlodipine Besilate at 5mg every day for Migraine, Sumatriptan (Sumatriptan)100mg as needed for Migraine. The patient received the first dose of Pfizer COVID19 vaccine on 26Mar2021 and had an immediate reaction. She needed 50mg of Benadryl, within 15 seconds of the vaccine. she had an overwhelming since of hotness and did not last very long, maybe 3 seconds and It washed over her. The feeling like she was going to pass out came after the overwhelming since of hotness. They put her feet up and put on nasal cannula with 2L of oxygen. The feeling like she was going to pass out came and went with the dizziness. She was dizzy on and off for 30 minutes. The rash started immediately, and It went away about 5 o'clock that evening and the Heart rate went up: it was 122 beats per minutes on 26Mar2021. It came down back to normal within an hour. All the events were assessed as medically significant. The outcome of felt like she was going to pass out, overwhelming since of hotness, Dizziness, broke out in a rash and heart rate went up was recovered on 26Mar2021.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect product BNT162B2 and all reported events. 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram, Ear pain, Headache, Magnetic resonance imaging
Clinical narrative: Facial paralysis/Bell's palsy/lip and tongue paralyzed; Lip and Tongue Paralyzed; reports neck, ear & head pain that started on 21Mar2021; reports neck, ear & head pain that started on 21Mar2021; reports neck, ear & head pain that started on 21Mar2021; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 13Mar2021 between 15:00-16:00 as SINGLE DOSE for COVID-19 immunization. Medical history included diabetes mellitus from 2016 and ongoing States it started 5 years ago, and it is under control, hypertension from 2016 and ongoing States it started 5 years ago, and it is under control. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks. On 21mar2021, the patient experienced neck, ear & head pain on the left side. On 24Mar2021, the patient experienced facial paralysis, lip and tongue paralyzed the left side of the face, bell's palsy. The patient states that everything started before on sunday then on wednesday he started to get paralyzed on his face. The patient went to the ER on 24Mar2021 and they thought he was having a stroke, so they did a CT and MRI and his brain is fin and Stated that the Neurologist diagnosed him with Bells Palsy. He was admitted to the hospital on 24Mar2021 and discharge 25Mar2021 at 18:00. The patient enquired about getting second shot and he wants to know what is going to happen if he gets the second shot, was it recommended or not recommended. The patient underwent lab tests and procedures which included computerized tomogram: normal on 24Mar2021 brain is fine, magnetic resonance imaging: normal on 24Mar2021 brain is fine. Therapeutic measures were taken. The patient was treated with Acyclovir and Methylprednisolone. The outcome of the events facial paralysis, lip and tongue paralyzed were not recovered and for neck,ear and head pain was recovering  Information on the lot/batch number has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Tongue paralysis
Clinical narrative: Facial paralysis/Bell's palsy/lip and tongue paralyzed; Lip and Tongue Paralyzed; reports neck, ear & head pain that started on 21Mar2021; reports neck, ear & head pain that started on 21Mar2021; reports neck, ear & head pain that started on 21Mar2021; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 13Mar2021 between 15:00-16:00 as SINGLE DOSE for COVID-19 immunization. Medical history included diabetes mellitus from 2016 and ongoing States it started 5 years ago, and it is under control, hypertension from 2016 and ongoing States it started 5 years ago, and it is under control. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks. On 21mar2021, the patient experienced neck, ear & head pain on the left side. On 24Mar2021, the patient experienced facial paralysis, lip and tongue paralyzed the left side of the face, bell's palsy. The patient states that everything started before on sunday then on wednesday he started to get paralyzed on his face. The patient went to the ER on 24Mar2021 and they thought he was having a stroke, so they did a CT and MRI and his brain is fin and Stated that the Neurologist diagnosed him with Bells Palsy. He was admitted to the hospital on 24Mar2021 and discharge 25Mar2021 at 18:00. The patient enquired about getting second shot and he wants to know what is going to happen if he gets the second shot, was it recommended or not recommended. The patient underwent lab tests and procedures which included computerized tomogram: normal on 24Mar2021 brain is fine, magnetic resonance imaging: normal on 24Mar2021 brain is fine. Therapeutic measures were taken. The patient was treated with Acyclovir and Methylprednisolone. The outcome of the events facial paralysis, lip and tongue paralyzed were not recovered and for neck,ear and head pain was recovering  Information on the lot/batch number has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram, Magnetic resonance imaging
Clinical narrative: Facial paralysis/Bell's palsy/lip and tongue paralyzed; Lip and Tongue Paralyzed; reports neck, ear & head pain that started on 21Mar2021; reports neck, ear & head pain that started on 21Mar2021; reports neck, ear & head pain that started on 21Mar2021; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 13Mar2021 between 15:00-16:00 as SINGLE DOSE for COVID-19 immunization. Medical history included diabetes mellitus from 2016 and ongoing States it started 5 years ago, and it is under control, hypertension from 2016 and ongoing States it started 5 years ago, and it is under control. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks. On 21mar2021, the patient experienced neck, ear & head pain on the left side. On 24Mar2021, the patient experienced facial paralysis, lip and tongue paralyzed the left side of the face, bell's palsy. The patient states that everything started before on sunday then on wednesday he started to get paralyzed on his face. The patient went to the ER on 24Mar2021 and they thought he was having a stroke, so they did a CT and MRI and his brain is fin and Stated that the Neurologist diagnosed him with Bells Palsy. He was admitted to the hospital on 24Mar2021 and discharge 25Mar2021 at 18:00. The patient enquired about getting second shot and he wants to know what is going to happen if he gets the second shot, was it recommended or not recommended. The patient underwent lab tests and procedures which included computerized tomogram: normal on 24Mar2021 brain is fine, magnetic resonance imaging: normal on 24Mar2021 brain is fine. Therapeutic measures were taken. The patient was treated with Acyclovir and Methylprednisolone. The outcome of the events facial paralysis, lip and tongue paralyzed were not recovered and for neck,ear and head pain was recovering  Information on the lot/batch number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood pressure measurement, Feeling abnormal, Hypertension, Nervousness
Clinical narrative: her blood pressure was off/her blood pressure was off, she clarifies it was high; thyroid was off; she went to the hospital ER for A fib (Atrial fibrillation); funny feeling; she is nervous to go out; This is a spontaneous report from a contactable pharmacist (patient). A 81-year-old female patient received second dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 11Feb2021 as single dose for COVID-19 immunisation. Patient's medical history included stroke (She did have a problem 2 years ago, she had a stroke but other than that she has been active). Patient had historical vaccine at 81-year-old BNT162B2 on 25Jan2021 lot number EL9262 for Coronavirus immunisation. There were no concomitant medications. The patient experienced she went to the hospital ER for a fib on 04Mar2021, her blood pressure was off/her blood pressure was off, she clarifies it was high (hypertension), thyroid was off, funny feeling, she is nervous to go out. She said the second dose was 11Feb2021 and she first noticed the atrial fib 04Mar2021, she went into the hospital 04Mar2021 and was discharged 05Mar2021. The patient underwent lab tests and procedures which included blood pressure was up and blood pressure was off on an unspecified date. When probed for causality reporter states, it could be related but she is not sure because she just cant understand how everything, her thyroid, her blood pressure went up, way up, and her heart. She really doesn't know, she thinks it is pretty serious, she is nervous to go out. She confirms it was requiring hospitalization, they kept her, the cardiovert was that afternoon and they kept her until next morning. The outcome of event was unknown.  Information related to lot/batch number was requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events atrial fibrillation, hypertension, and thyroid disorder and the suspect drug. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid disorder
Clinical narrative: her blood pressure was off/her blood pressure was off, she clarifies it was high; thyroid was off; she went to the hospital ER for A fib (Atrial fibrillation); funny feeling; she is nervous to go out; This is a spontaneous report from a contactable pharmacist (patient). A 81-year-old female patient received second dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 11Feb2021 as single dose for COVID-19 immunisation. Patient's medical history included stroke (She did have a problem 2 years ago, she had a stroke but other than that she has been active). Patient had historical vaccine at 81-year-old BNT162B2 on 25Jan2021 lot number EL9262 for Coronavirus immunisation. There were no concomitant medications. The patient experienced she went to the hospital ER for a fib on 04Mar2021, her blood pressure was off/her blood pressure was off, she clarifies it was high (hypertension), thyroid was off, funny feeling, she is nervous to go out. She said the second dose was 11Feb2021 and she first noticed the atrial fib 04Mar2021, she went into the hospital 04Mar2021 and was discharged 05Mar2021. The patient underwent lab tests and procedures which included blood pressure was up and blood pressure was off on an unspecified date. When probed for causality reporter states, it could be related but she is not sure because she just cant understand how everything, her thyroid, her blood pressure went up, way up, and her heart. She really doesn't know, she thinks it is pretty serious, she is nervous to go out. She confirms it was requiring hospitalization, they kept her, the cardiovert was that afternoon and they kept her until next morning. The outcome of event was unknown.  Information related to lot/batch number was requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events atrial fibrillation, hypertension, and thyroid disorder and the suspect drug. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Delusion, Hallucination
Clinical narrative: Hallucinations; delusions; This is a spontaneous report from a contactable consumer. An elderly female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1st via an unspecified route of administration on 14Mar2021 as single dose for covid-19 immunisation. Medical history included asthma, afib, seasonal allergies, hbp. The patient's concomitant medications were not reported. The patient experienced hallucination and delusions on 18Mar2021 which resulted in hospitalization. The outcome of the event was not recovered. Patient is not pregnant and was not tested for COVID post vaccination. Patient did not took other vaccine in four weeks. The treatment for adverse event was unknown  Information on the batch/lot number has been requested.