chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Myalgia
Clinical narrative: Right lower eyelid twitching; Sore deltoid muscle; This is a spontaneous report from a contactable healthcare professional, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via intramuscular route of administration in the left arm on 02Jul2021 at 11:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to sulfa and penicillin. The patient did not receive any concomitant medications. prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via intramuscular route of administration in the left arm on 11Jun2021 at 11:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. On 09Jun2021 the patient experienced sore deltoid muscle and right lower eyelid twitching. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events sore deltoid muscle and right lower eyelid twitching was not resolved at the time of this report.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Headache, Hot flush, Myalgia
Clinical narrative: Headache (waning); Tiredness; Arm muscle pain; Clammy; hot and cold flashes; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Jul2021 at 16:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any concomitant medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Jul2021 at 00:00 the patient experienced headache (waning), tiredness, arm muscle pain, clammy, hot and cold flashes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events headache (waning) was recovering and the clinical outcome of the events tiredness, arm muscle pain, clammy and hot and cold flashes was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patients who have been vaccinated (unsure of which Covid-19 vaccine or vaccines) and that many of them test positive afterwards,; patients who have been vaccinated (unsure of which Covid-19 vaccine or vaccines) and that many of them test positive afterwards, many of them are positive with the variants of Covid-19; The initial case was missing the following minimum criteria: ICH unspecified no. of patients. Upon receipt of follow-up information on 13Aug2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (Patient). A 57-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown) via intramuscular, in the left arm (left shoulder) on Mar2021 at 12:00 (at the age of 57-years-old) as dose 2, single and dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown) via intramuscular, in the left arm (left shoulder) on Feb2021 at 11:00 (at the age of 57-years-old) as dose 1, single for covid-19 immunisation. Vaccination facility type was military base. The patient medical history and concomitant medications were none. The patient did not receive any vaccines within four weeks prior to the vaccination. Caller stated that patients who have been vaccinated (unsure of which covid-19 vaccine or vaccines) and that many of them test positive afterwards, (drug ineffective and sars-cov-2 test positive). Although fully vaccinated patient became severally infected with Delta Covid variant, within 6 months of vaccinations. Patient had no reactions to the vaccine when given. Seriousness criteria reported persistent, significant disability, incapacity, important medical event. The patient did not receive any treatment for the event. Adverse event required visit to emergency room. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. Outcome of the events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202100942252 Same reporter, drug and different patient, event.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Atrial fibrillation, Dizziness, Fatigue, Nausea
Clinical narrative: Atrial fibrillation; feeling weak; Dizzy; Nauseous; chronic fatigue; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 01May2021 (Batch/Lot number was not reported; at the age of 61-years) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included gabapentin (NEURONTIN); famotidine (PEPCID [FAMOTIDINE]). On 01May2021, it was reported that the patient had horrible symptoms with the Pfizer Covid-19 Vaccine. Patient stayed there out of the place because they thought she was drunk, but she slept all weekend long basically and later found out that she went into atrial fibrillation because of that. On the same day, patient also was  feeling weak and dizzy; was nauseous and had like chronic fatigue. The patient was advised not to take the second dose. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer. A patient of unknown age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced shingles. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event shingles was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in arm; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Jul2021 at 15:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any medication within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Jun2021 at 17:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 10Jul2021 at 00:00, the patient experienced pain in arm and it was ongoing 14 plus days after the vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event pain in arm was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia, Rash macular, SARS-CoV-2 test
Clinical narrative: she had a fever; sore arm; tired; swollen tonsils with red/white spots; Within a couple days she had swollen tonsils with red/white spots; This is a spontaneous report from a contactable consumer. A 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0196) dose 2 via an unspecified route of administration on 21Jun2021 (at the age of 20-year-old) as single dose for COVID-19 immunisation at pharmacy or drug store. Medical history was none. No known allergies. Concomitant medications were unspecified. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0180) dose 1 an unspecified route of administration on 30May2021 (at the age of 20-year-old) as single dose for COVID-19 immunisation and she was fine after 1st 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. On 22Jun2021, after the second dose she had a fever, sore arm, and tired. Within a couple days she had swollen tonsils with red/white spots. She has been on antibiotics for month, which has helped with spots, but still has swollen tonsils. She still feels more tired than usual but not as bad as day after the 2nd vaccine. She is going to an ENT on 30Jul2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests which included post vaccination bi-weekly at client in Jun2021: Negative. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Tonsillar hypertrophy
Clinical narrative: she had a fever; sore arm; tired; swollen tonsils with red/white spots; Within a couple days she had swollen tonsils with red/white spots; This is a spontaneous report from a contactable consumer. A 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0196) dose 2 via an unspecified route of administration on 21Jun2021 (at the age of 20-year-old) as single dose for COVID-19 immunisation at pharmacy or drug store. Medical history was none. No known allergies. Concomitant medications were unspecified. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0180) dose 1 an unspecified route of administration on 30May2021 (at the age of 20-year-old) as single dose for COVID-19 immunisation and she was fine after 1st 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. On 22Jun2021, after the second dose she had a fever, sore arm, and tired. Within a couple days she had swollen tonsils with red/white spots. She has been on antibiotics for month, which has helped with spots, but still has swollen tonsils. She still feels more tired than usual but not as bad as day after the 2nd vaccine. She is going to an ENT on 30Jul2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests which included post vaccination bi-weekly at client in Jun2021: Negative. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Ultrasound scan abnormal
Clinical narrative: Had a very bad reaction and I have a lifetime deformity on my arm; Got a golf ball size bump; I am stuck with this bumps on my arm, its awful; Had a very bad reaction and I have a lifetime deformity on my arm; Got a golf ball size bump; I am stuck with this bumps on my arm, its awful; I have allergies; Allergic to the something that is in the shot, in the vaccine; Lipoma; Got a big bump it looks like a golf ball sticking out where the injection site was; This is a spontaneous report from a contactable consumer. This consumer (patient) received pneumococcal 13-val conj vac (dipht crm197 protein) (Prevnar 13, Solution for injection in pre-filled syringe) via unspecified route of administration on an unspecified date as dose number unknown, single for Immunization. Medical history and concomitant medications were not reported. Consumer stated, "I got this shot (Prevnar 13), I had a very bad reaction and I have a lifetime deformity on my arm and I already have talked to someone at your place maybe last year (further clarification unknown). So, I do not recommend this to anybody, and I have got a golf ball size bump. Regarding Lot# of Prevnar 13: Consumer stated, "I don't know what you mean a LOT number, I don't have this, I don't know where the LOT number would be. The doctors, they just give you the shot they don't tell you the numbers or anything. I am not the nurse or the physician, I am just the patient who received the Prevnar 13 three years ago and I got, my doctor said that I have a very bad rare, very rare reaction. I have allergies, he said that you probably were allergic to the something that is in the shot, in the vaccine and then he sent me for ultrasound, MRI and they both said, it is a lipoma and I have got a big bump it looks like a golf ball sticking out where the injection site was and I tell you doctor said no more vaccines for you, it's too risky. So, I didn't take Covid vaccine, I take no flu vaccine, I have to live with this now, I tell you I am very angry that this happened, I am very angry that the side effect with the vaccines is terrible and I am so upset with myself that I probably, like you know when you are at the doctor's office for your annual check-up and they say you are over 65 you want the, we can do it and then he want to mail and then a year later you get the 'Prevnar 26' (not clarified further, hence captured as-Unspecified Medication) and all this. So, you trust the doctor and they you say I am here now and will talk to it and it was the worst experience that I ever have." Consumer further stated, I am angry, but you know it may have saved my life in one respect because of this Prevnar 13 reaction that I got, I will never get another injection, another vaccine and I am seeing with the Covid vaccine and all the reactions like people dying (further clarification unknown). So, in a way it may have saved my life because I am not taking the Covid vaccine (not clarified further). Outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 53-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0172) on 02May2021 (at the age of 53-year-old) at dose 2, single and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8729) on 11Apr2021 (at the age of 53-year-old) at dose 1, single, both the doses via an unspecified route of administration, administered in arm left for covid-19 immunisation. Medical history included sleep apnoea syndrome (uses an air mask at night and has for a long time). Reporter stated that he takes medication, no further details provided, stated he has sleep apnea, uses an air mask every night, been using it for a long time now. Concomitant medications were not reported. On an unspecified in 2021 the patient experienced fatigue. Reporter stated that he got the 2nd dose of the Pfizer Biontech Covid vaccine on 02May2021 then he came down with an awful fatigue he's never experienced before. He said he's been experiencing fatigue ever since the 2nd dose. Reporter asked how come his fatigue is lasting very long. He mentioned that for the 1st shot, he experienced a little bit of fatigue and for the 2nd shot, he's had it ever since. Question: Reporter commented that MI has no answer as to why his symptom is taking too long. Reporter stated that he is reporting side effects from Pfizer vaccine, states he got second shot around beginning of May, states about 3 weeks or a month later came down with awful fatigue, states has had bad fatigue ever since, states he usually walks everywhere and never had any trouble and now he has to rest a couple of times on the bench. Wants to know if this is a side effect of the vaccine. Event Details: unknown exact start date of event, gotten a little bit better but it is still persisting. Outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I have Constant Ringing in my ears. It never goes away; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 29Mar2021 at 13:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication was not reported. The patient had no known allergies to food, medication or other products. On 30Mar2021 at 13:00, the patient experienced constant ringing in ears and it never gone away. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event constant ringing in ears were not resolved at the time of this report.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder, Condition aggravated, Gastrointestinal disorder, Pyrexia, SARS-CoV-2 test
Clinical narrative: Triggered an auto-immune response, had a strong fever, GI problems after the first shot escalated dramatically after the second shot; Triggered an auto-immune response, had a strong fever, GI problems after the first shot escalated dramatically after the second shot; Triggered an auto-immune response, had a strong fever, GI problems after the first shot escalated dramatically after the second shot; Triggered an auto-immune response, had a strong fever, GI problems after the first shot escalated dramatically after the second shot; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (at the age of 38-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date (at the age of 38-year-old) for COVID-19 immunization and experienced triggered an auto-immune response, had a strong fever, GI problems after the first shot. It was reported that triggered an auto-immune response, had a strong fever, GI problems after the first shot experienced on 15May2021 escalated dramatically after the second shot. Patient was hospitalized on an unspecified date for 1 day and was treated with colonoscopy and prescription anti-inflammatories. The events required physician office visit. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 16Jul2021. Outcome of events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Fingers and arms tingling; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196), 0.30 ML via an unspecified route of administration in the left arm on 23Jul2021 at 14:45 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to eggs, seafood, iodine and penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 25Jul2021, the patient experienced fingers and arms tingling. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events fingers and arms tingling was not recovered at the time of this report.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Hyperhidrosis, Investigation, Loss of consciousness, Pallor
Clinical narrative: He started to he is like his eyes roll back and then he is like started to seizure a little it was minor like he kind of combo fainted; He started to he is like his eyes roll back and then he is like started to seizure a little it was minor like he kind of combo fainted; his BP was fluctuating and he was profusely sweating; his BP was fluctuating and he was profusely sweating; he started to get a little pale as soon as he got pale, he started sweating a lot; lost his consciousness; This is a spontaneous report from a contactable consumer. A 35-year-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Right on 05Jul2021 (around 17:35 ot 17:40) (Batch/Lot Number: EW0198) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient experienced his BP was fluctuating and he was profusely sweating. The pharmacy called an ambulance, they ran a few tests and he was hospitalized. After 5-10 minutes after getting vaccine he started to get a little pale as soon as he got pale he started sweating a lot. Patient started to have his eyes roll back and then he is like started to seizure a little it was minor like he kind of combo fainted. Patient was just moving a lot. Patient had a combo fainted  or seizure.Patient was aggressively moving he was just like moving his arm like back and forth and it was 30 or not even 10.Patient he was combo fainting a little after that he was profusely sweaty and it was like he lost his consciousness and another second he was like faint. He also his blood pressure was also fluctuating it was going up and it was going down. Patient was hospitalized on 05Jul2021. The hospital did a whole bunch of lab test and they all came back normal. Patient was discharged from hospital on 05Jul2021. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Syncope
Clinical narrative: He started to he is like his eyes roll back and then he is like started to seizure a little it was minor like he kind of combo fainted; He started to he is like his eyes roll back and then he is like started to seizure a little it was minor like he kind of combo fainted; his BP was fluctuating and he was profusely sweating; his BP was fluctuating and he was profusely sweating; he started to get a little pale as soon as he got pale, he started sweating a lot; lost his consciousness; This is a spontaneous report from a contactable consumer. A 35-year-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Right on 05Jul2021 (around 17:35 ot 17:40) (Batch/Lot Number: EW0198) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient experienced his BP was fluctuating and he was profusely sweating. The pharmacy called an ambulance, they ran a few tests and he was hospitalized. After 5-10 minutes after getting vaccine he started to get a little pale as soon as he got pale he started sweating a lot. Patient started to have his eyes roll back and then he is like started to seizure a little it was minor like he kind of combo fainted. Patient was just moving a lot. Patient had a combo fainted  or seizure.Patient was aggressively moving he was just like moving his arm like back and forth and it was 30 or not even 10.Patient he was combo fainting a little after that he was profusely sweaty and it was like he lost his consciousness and another second he was like faint. He also his blood pressure was also fluctuating it was going up and it was going down. Patient was hospitalized on 05Jul2021. The hospital did a whole bunch of lab test and they all came back normal. Patient was discharged from hospital on 05Jul2021. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report from a contactable consumer or other non hcp via medical information team. The consumer reported for a patient in 40's. A 5-decade-old (in 40's) patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced fever, chills on an unspecified date. Reporter is a consumer. Reporter asked What happens to a person if they were accidentally given the second dose of the vaccine first instead of the first dose initially. Everyone else in the room was receiving the second dose. Reporter is asking because she thought people got sick after the second dose, not the first dose. Reporter is asking on behalf of another person, no demographics provided. She does not want to provide any information without first getting consent and person was not available to come to phone. Reporter said I want them to get the second dose. Reporter said this person experienced fever and chills but is better now. Reporter may call back with patient at a later time. Outcome of the events was recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Migraine, Nausea, Rash
Clinical narrative: Rash down both arms; On/off dizzy spells; Nausea; Migraine; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Jul2021 at 18:15 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. The patient received unspecified medication within two weeks of vaccination. The patient previously took oxycodone (MANUFACTURER UNKNOWN) and hydrocodone (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Jul2021 at 21:30, the patient experienced rash down both arms, on and off dizzy spells, nausea and migraine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events rash down both arms, on and off dizzy spells, nausea and migraine were not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Pain in body; Headache; Chills; Fever of 100; This is a spontaneous report from a non-contactable consumer. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route on 24Jul2021 at 10:00 in the left arm (at the age of 42-year-old) as single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Jul2021 at 10:00, the patient had headache, chills, fever of 100 and pain in her body. Therapeutic measures were taken as a result of the events and included treatment with TYLENOL every 4 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, chills, fever of 100 and pain in body was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vomiting
Clinical narrative: 102 degree temperature; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Jul2021 at 15:00 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient previously took pertussis vaccine (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other medications within two weeks of vaccination. On an unknown date in Jul2021 the patient received meningitis b vaccine (MANUFACTURER UNKNOWN). On an unknown date in Jul2021 the patient experienced 102 degree temperature and vomiting. On an unknown date in Jul2021 patient underwent test which include body temperature and the result was 102 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events 102 degree temperature and vomiting were unknown.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Lymph node pain, Lymphadenopathy
Clinical narrative: Painful breasts; Large painful swelling in underarm of the injected arm; Large painful swelling in underarm of the injected arm; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Jul2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On an unknown date in Jul2021, the patient experienced large painful swelling in underarm of the injected arm and painful breasts. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of events large painful swelling in underarm of the injected arm and painful breasts were not resolved at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Echocardiogram, Electroencephalogram, Feeling abnormal
Clinical narrative: sore arm; vertigo; dizzy; pupils contract; feel dehydrated; health has declined since getting the second shot; Caller has not slept in two days.; This is a spontaneous report from a contactable consumer. This 47-year-old male consumer (patient) reported for himself.  A 47-year-old male patient received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EW0175, Expiration date: unknown), via unspecified route, administered on 26Apr2021 (at the age of 47-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient received first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6201, Expiration date: unknown), via unspecified route, administered on 03Apr2021 (at the age of 47-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, 3 months after the second dose vaccination, the patient experienced sore arm, next morning patient woke up with vertigo, also sometimes patient get dizzy and pupils' contract, patient also feels dehydrated. Patient also reports that he hasn't slept for two days. Patient explained his health has declined since getting the second shot. Patient talked with nurse every week and nurse thought patient had a brain damage. Caller declined to complete full report at this time but confirms his consent for follow up at a later time. Caller states that he has previously worked as a Pharmacy Technician. The patient lab data includes Echocardiogram on an unspecified date with no enlargement findings and Electroencephalogram on an unspecified date with no brain damage. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Miosis, Sleep disorder, Vertigo
Clinical narrative: sore arm; vertigo; dizzy; pupils contract; feel dehydrated; health has declined since getting the second shot; Caller has not slept in two days.; This is a spontaneous report from a contactable consumer. This 47-year-old male consumer (patient) reported for himself.  A 47-year-old male patient received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EW0175, Expiration date: unknown), via unspecified route, administered on 26Apr2021 (at the age of 47-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient received first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6201, Expiration date: unknown), via unspecified route, administered on 03Apr2021 (at the age of 47-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, 3 months after the second dose vaccination, the patient experienced sore arm, next morning patient woke up with vertigo, also sometimes patient get dizzy and pupils' contract, patient also feels dehydrated. Patient also reports that he hasn't slept for two days. Patient explained his health has declined since getting the second shot. Patient talked with nurse every week and nurse thought patient had a brain damage. Caller declined to complete full report at this time but confirms his consent for follow up at a later time. Caller states that he has previously worked as a Pharmacy Technician. The patient lab data includes Echocardiogram on an unspecified date with no enlargement findings and Electroencephalogram on an unspecified date with no brain damage. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, C-reactive protein, C-reactive protein increased, Oropharyngeal pain, Platelet count increased
Clinical narrative: throat pain; joint paint; fever (2-3 weeks duration); rash; Blood work showed high Ferritin (2000+); Blood work showed high Ferritin (2000+), WBC, CRP, Sed Rate and elevated platelets; Blood work showed high Ferritin (2000+), WBC, CRP, Sed Rate and elevated platelets.; elevated platelets; I was diagnosed with Adult Onset Still's disease; Sed rate high; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 23Mar2021 13:00 at the age of 34 years old (Lot Number: ER8730) as DOSE 2, SINGLE for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. 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 has not been COVID-9 tested since the vaccination. The patient previously had BNT162B2 dose 1, (lot number: EN6204) on 02Mar2021 at 01:30 PM in the left arm for COVID-19 immunisation at the age of 34 years old. The patient stated, "In the beginning of Jun2021, I developed a throat pain, joint paint, fever (2-3 weeks duration) and a rash. Blood work showed high Ferritin (2000+), WBC, CRP, Sed Rate and elevated platelets. After two hospital visits where infections as the cause of my symptoms were ruled out, I was diagnosed with Adult Onset Still's Disease. The events started on 05Jun2021 08:00. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events resulted in 8 days hospitalization: 8. the patient received treatment NSAIDS and steroids for the adverse events. The patient underwent lab tests and procedures which included PCR Nasal Swab negative on 07Jun2021, 21Jun2021 and 09Jul2021. Sed rate high in Jun2021, ferritin 2000+ high in Jun2021, WBC high in Jun2021, CRP high in Jun2021 and platelets elevated in Jun2021. The outcome of events was not recovered.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Polymerase chain reaction, Pyrexia, Rash, Red blood cell sedimentation rate increased, Serum ferritin
Clinical narrative: throat pain; joint paint; fever (2-3 weeks duration); rash; Blood work showed high Ferritin (2000+); Blood work showed high Ferritin (2000+), WBC, CRP, Sed Rate and elevated platelets; Blood work showed high Ferritin (2000+), WBC, CRP, Sed Rate and elevated platelets.; elevated platelets; I was diagnosed with Adult Onset Still's disease; Sed rate high; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 23Mar2021 13:00 at the age of 34 years old (Lot Number: ER8730) as DOSE 2, SINGLE for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. 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 has not been COVID-9 tested since the vaccination. The patient previously had BNT162B2 dose 1, (lot number: EN6204) on 02Mar2021 at 01:30 PM in the left arm for COVID-19 immunisation at the age of 34 years old. The patient stated, "In the beginning of Jun2021, I developed a throat pain, joint paint, fever (2-3 weeks duration) and a rash. Blood work showed high Ferritin (2000+), WBC, CRP, Sed Rate and elevated platelets. After two hospital visits where infections as the cause of my symptoms were ruled out, I was diagnosed with Adult Onset Still's Disease. The events started on 05Jun2021 08:00. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events resulted in 8 days hospitalization: 8. the patient received treatment NSAIDS and steroids for the adverse events. The patient underwent lab tests and procedures which included PCR Nasal Swab negative on 07Jun2021, 21Jun2021 and 09Jul2021. Sed rate high in Jun2021, ferritin 2000+ high in Jun2021, WBC high in Jun2021, CRP high in Jun2021 and platelets elevated in Jun2021. The outcome of events was not recovered.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Serum ferritin increased, Still's disease, White blood cell count, White blood cell count increased
Clinical narrative: throat pain; joint paint; fever (2-3 weeks duration); rash; Blood work showed high Ferritin (2000+); Blood work showed high Ferritin (2000+), WBC, CRP, Sed Rate and elevated platelets; Blood work showed high Ferritin (2000+), WBC, CRP, Sed Rate and elevated platelets.; elevated platelets; I was diagnosed with Adult Onset Still's disease; Sed rate high; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 23Mar2021 13:00 at the age of 34 years old (Lot Number: ER8730) as DOSE 2, SINGLE for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. 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 has not been COVID-9 tested since the vaccination. The patient previously had BNT162B2 dose 1, (lot number: EN6204) on 02Mar2021 at 01:30 PM in the left arm for COVID-19 immunisation at the age of 34 years old. The patient stated, "In the beginning of Jun2021, I developed a throat pain, joint paint, fever (2-3 weeks duration) and a rash. Blood work showed high Ferritin (2000+), WBC, CRP, Sed Rate and elevated platelets. After two hospital visits where infections as the cause of my symptoms were ruled out, I was diagnosed with Adult Onset Still's Disease. The events started on 05Jun2021 08:00. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events resulted in 8 days hospitalization: 8. the patient received treatment NSAIDS and steroids for the adverse events. The patient underwent lab tests and procedures which included PCR Nasal Swab negative on 07Jun2021, 21Jun2021 and 09Jul2021. Sed rate high in Jun2021, ferritin 2000+ high in Jun2021, WBC high in Jun2021, CRP high in Jun2021 and platelets elevated in Jun2021. The outcome of events was not recovered.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Condition aggravated, Dizziness, Fatigue, Headache
Clinical narrative: flare up of her Lyme disease/Possibly flared up her Lyme disease; flare up of her Lyme disease/Possibly flared up her Lyme disease; Back pain; Headache; Dizziness; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on 19Jul2021 (Batch/lot number not reported), at age 28 years old, as dose 2, single, for COVID-19 immunisation. Relevant medical history included Lyme disease from an unknown date and ongoing. Concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection) received on an unspecified date, as dose 1, single for COVID-19 immunsation with no reaction reported. On 19Jul2021 (Monday), the patient received her second dose of the Pfizer COVID-19 vaccine. The patient was fine during the first couple of days. On 22Jul2021 (Thursday), the patient had a bad headache, dizziness, fatigue and back pain. She stated that she was trying to call her doctor in case the vaccine flared up her Lyme disease to see if the doctor wanted to do a round of antibiotics. Her doctor advised her to call Pfizer to see if there is any information about the vaccine causing a flare up of her Lyme disease. She stated that the doctor will not do anything until he knows if it flared up her Lyme disease. She stated that she had Lyme disease before she started getting the shot. She wanted to know if the vaccine flared up her Lyme disease. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.