chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Petechiae, Rash macular
Clinical narrative: Severe allergic reaction and it looks like my left arm got bad rash and it's bloody; Severe allergic reaction and it looks like my left arm got bad rash and it's bloody; I got blotches on my left arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration in 2021 (Batch/Lot Number: EL9266, Expiry Date, NDC number and UPC number were unknown) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Patient historical vaccine includes received first dose of BNT162B2 via an unspecified route of administration in 2021 (Batch/Lot Number: 0151 Expiry Date unknown) as dose 1, single for covid-19 immunisation. The patient's concomitant medications were not reported. In 2021 the patient experienced severe allergic reaction and it looks like my left arm got bad rash and it's bloody, I got blotches on my left arm. The patient reported that I don't understand, I am lost. The patient reported that I had the second shot done on Thursday the Covid shot (Pfizer, Covid-19 Vaccine) and I am looking at the severe allergic reaction. I don't know it looks like in my left arm I got a bad rash. It's bloody and today and I noticed is last night, today is Saturday and yesterday I noticed I got blotches on my left arm and I do not know if that is a reaction from the shot. Does it usually happen right away? The patient did not want to answer any of that. The patient stated, I have got Pfizer B100151. Is that it? There is another my second dose EL9266. I do not know I do not see the dose on there. I think that is the LOT, I do not know. It says 0151 for the first shot. Then on the second one it is EL9266, alright. For Expiry date the patient stated that I do not see what you are asking me here. The outcome of the event was unknown.   As consumer was not willing to proceed the call. Product details (LOT, Expiration date, NDC and UPC), Pharmacy details and treatment could not be probed over the call. Limited information was available over the call.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I currently have severe rash over legs, arms and upper chest.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID 19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE UNMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced that currently having severe rash over legs, arms and upper chest. The patient reported that I received Pfizer Covid vaccines. I currently have severe rash over legs, arms and upper chest. Could this possibly be from vaccines and what is best course of treatment. I can send pictures if necessary. Only looking for advice. Seeking nothing else. The outcome of the events unknown.  Follow up (02May2021): This is a follow up spontaneous report from a Pfizer sponsored program   Follow up(05May2021): case number has been provided. No new information.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Paraesthesia, Vaccination site pain
Clinical narrative: Arm soreness/Tingling sensation also felt in fingers, as well as the sharper soreness; Soreness around site of injection; Tingling sensation also felt in fingers; Soreness also encompassed shoulder and left section of my chest; This is a spontaneous report from a contactable consumer. A 26-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 03Apr2021 14:00, (at the age of 26-year-old), as 1st dose, single for COVID-19 immunization. Medical history included electrocardiogram qt prolonged, covid-19, food allergy (Some fruits (mainly skins on apples, kiwis, carrots, celery, etc.) But nothing severe). Concomitant medications included Nadolol (20mg, 3x daily). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have covid prior vaccination and no covid tested post vaccination. On Apr2021, the patient experienced arm soreness/tingling sensation also felt in fingers, as well as the sharper soreness, soreness around site of injection, tingling sensation also felt in fingers, soreness also encompassed shoulder and left section of my chest. This lasted 7 days after the first dose, then it was gone. The outcome of the events pain in extremity, vaccination site pain and paresthesia was recovered on an unspecified date in Apr2021 (7 days after vaccination). And outcome of event arthralgia was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dry skin, Pruritus, Skin fissures, Sleep disorder
Clinical narrative: skin is itchy everyday; sleep is disturbed 1-2 days; skin is cracked and dry 1-2 days of the week.; skin is cracked and dry 1-2 days of the week.; flare up; This is a spontaneous report from a contactable other hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2,Solution for injection,Batch/Lot number was not reported, Expiry date was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1,SINGLE,and bnt162b2 (BNT162B2,Solution for injection, Batch/Lot number was not reported, Expiry date was not reported dose 2 via an unspecified route of administration on an unspecified date DOSE 2,SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced skin is itchy, sleep is disturbed, skin is cracked and dry 1-2 days of the week (skin dry),skin is cracked and dry 1-2 days of the week, flare up.The clinical outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; chills; body aches (severe); fatigue; This is a spontaneous report from a contactable nurse (patient). A 38-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EL3246, Expiry date: not reported) via an intramuscular route of administration in arm left on 15Jan2021 (age at vaccination 38-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included hypertension during pregnancy only 2011 and 2012 and non-smoker from an unknown date and unknown if ongoing. Concomitant medications included multi vitamin d3, zinc, bupropion and fluoxetine taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EK5730, Expiry date: Mar2021), dose 1 via an intramuscular route of administration, administered in arm left on 26Dec2020 as DOSE 1, SINGLE for COVID-19 immunisation. It was reported that the patient had no pre-existing diseases worsened during the SARS-CoV2 infection. The patient had no display clinical signs at rest indicative of severe systemic illness. The patient had not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. There were not any of the events above considered serious due to being life-threatening or due to persistent or significant disability/incapacity or any other reason. On an unspecified date, the patient experienced fever, chills, body aches (severe) and fatigue. The events did not require hospitalization. Adverse events did not require to visit intensive care unit/ emergency room/ physician office. The event required the initiation of new medication or other treatment or procedure included OTC supplements, ASA 50mg, vit c, vitd3, zinc, famotidine, melatonin, vit b complex, elderberry, multi vitamin and quercetin. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 04Jan2021 (Nasal swab NAA/PCR). The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018130 same patient/drug, different dose
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Myalgia
Clinical narrative: Very sore arm for 4 days after vaccine (expected); On day 5, woke up with extreme fatigue; muscle soreness; Headache; Dizziness; Brain fog; Nausea; Feeling feverish; This is a spontaneous report from a contactable consumer (patient). A 25-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: ER8731, expiration date was not reported), via an unspecified route of administration, administered in right arm on 21Apr2021 16:15 (at the age of 25-years-old) as dose 1, single for covid-19 immunization at hospital. The patient medical history included hashimoto's thyroiditis, ADHD, Strattera (allergies to  Strattera), covid-19 (I had COVID in early Feb and  this feels similar, but not as intense) , allergy. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), metformin, levothyroxine sodium (SYNTHROID), clarithromycin (CLARITAB), azelastine, all taken for unknown indications from an unknown date. List of any other medications the patient received within 2 weeks of vaccination included adderall, metformin, synthroid, azelastine, Clarit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 26Apr2021 at 07:00am the patient experienced very sore arm for 4 days after vaccine (expected). On day 5, woke up with extreme fatigue, muscle soreness, headache, dizziness, brain fog, nausea, and feeling feverish. Still ongoing as of today, but the headache, dizziness, and nausea are gone. I had COVID in early Feb and this feels similar, but not as intense. The patient underwent lab tests and procedures which included had COVID in early Feb (sars-cov-2 test): positive on Feb2021. The adverse events did not result in death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating, congenital anomaly/birth defect. The reporter assessed the seriousness as non-serious. No treatment was received for the adverse events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Very sore arm for 4 days after vaccine (expected); On day 5, woke up with extreme fatigue; muscle soreness; Headache; Dizziness; Brain fog; Nausea; Feeling feverish; This is a spontaneous report from a contactable consumer (patient). A 25-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: ER8731, expiration date was not reported), via an unspecified route of administration, administered in right arm on 21Apr2021 16:15 (at the age of 25-years-old) as dose 1, single for covid-19 immunization at hospital. The patient medical history included hashimoto's thyroiditis, ADHD, Strattera (allergies to  Strattera), covid-19 (I had COVID in early Feb and  this feels similar, but not as intense) , allergy. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), metformin, levothyroxine sodium (SYNTHROID), clarithromycin (CLARITAB), azelastine, all taken for unknown indications from an unknown date. List of any other medications the patient received within 2 weeks of vaccination included adderall, metformin, synthroid, azelastine, Clarit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 26Apr2021 at 07:00am the patient experienced very sore arm for 4 days after vaccine (expected). On day 5, woke up with extreme fatigue, muscle soreness, headache, dizziness, brain fog, nausea, and feeling feverish. Still ongoing as of today, but the headache, dizziness, and nausea are gone. I had COVID in early Feb and this feels similar, but not as intense. The patient underwent lab tests and procedures which included had COVID in early Feb (sars-cov-2 test): positive on Feb2021. The adverse events did not result in death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating, congenital anomaly/birth defect. The reporter assessed the seriousness as non-serious. No treatment was received for the adverse events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Rhinorrhoea
Clinical narrative: I began having lots of diarrhea; then it persisted all week; I do have a very runny nose; which was running earlier a little bit; now it's running quite a lot; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0151), via an unspecified route of administration, administered in Arm Left on 20Apr2021 (at the age of 83-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included blood pressure (Verbatim: Blood pressure). Concomitant medication included metoprolol 200 mg Orally, once a day, Tablet taken for blood pressure, start and stop date were not reported. The patient reported that the next day of vaccination on 21Apr2021, he began having lots of diarrhea and then it persisted all week and he had not got any medical help for this. Patient also stated that he had a very runny nose, which was running earlier a little bit but then it was running quite a lot. The patient did not receive treatment for adverse events. The outcome of events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Rash
Clinical narrative: Rash on my whole upper torso/ rash from groin to up under her arms and entire upper torso; Sick; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 71-years-old female patient received second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8731) single dose via an unspecified route of administration on 27Apr2021 for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included Escitalopram (LEXAPRO), captopril, hydrochlorothiazide (Hydrochlorothiazide), Losartan (LOSARTAN), Metoprolol (METOPROLOL) and Vitamins: (Consumer stated, Vitamins and something like that). Historical vaccine included first dose (Lot number: ER8730). The patient reported she had her second COVID shot on Tuesday morning on 27Apr2021 and she had many symptoms and sick and also she had rash from groin to up under her arms and entire upper torso. She did not have any rash on the injection site. There were no unaddressed medical questions referred or forwarded to Medical Information. The outcome for the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Seasonal allergy, Therapeutic response unexpected
Clinical narrative: Encounters an allergen, in my case mold, the vaccine appears to attack the allergen.; Hay fever,; But within 2 days I developed a fever; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported) for Covid-19 Immunization. The patient's concomitant medications were not reported. On an unspecified date the patient were encounters an allergen, in this patient case mold, the vaccine appears to attack the allergen, hay fever, but within 2 days patient developed a fever. Patient recently received your vaccination shots. Patient had found an interesting reaction that occurs. When a vaccinated person encounters an allergen, in patient case mold, the vaccine appears to attack the allergen. patient encountered mold days after patient 2nd shot. patient reaction started as hay fever, which is normal, but within 2 days patient developed a fever. It's as if the vaccine was trying to rid patient of the allergen by attacking it. Patient a friend who has had the same reaction but with cotton wood trees pollen. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Chills, Decreased appetite, Malaise, Vomiting
Clinical narrative: Really sick; Vomiting; Chills with no fever; lost appetite; Weight loss, lost 6 pounds; no taste; This is a spontaneous report from a contactable consumer (parent, mother).   A 62-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date (age at vaccination was 62 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hernia repair from 2020 to an unknown date, covid-19 (he had Covid in Nov 2020 he lost 6 pounds) from Nov2020 to an unknown date, weight loss (he had Covid in Nov 2020 he lost 6 pounds) from Nov2020 to an unknown date. Family medical history was reported none. Prior vaccination within 4 weeks was reported as none. Additional vaccines administered on same date of the pfizer suspect was reported as none. Concomitant medications were not reported. Report stated that the patient received the first dose of the Covid-19 vaccine a week and a half ago (exact dates not clarified). On an unspecified date in Apr2021, within a couple days the patient was really sick. It was reported that the patient only vomited once and it was a small amount. He had chills the next day that lasted only for a day. He had lost his appetite a couple of days later. He had lost 6 pounds and the weight loss was due to having no appetite. He also had no taste. The events did not result in visit to ER or physician office. No investigation assessment was reported. The patient underwent laboratory tests that included: weight: lost 6 pounds on an unspecified date in Apr2021. Outcome of all the events was recovered on an unspecified date in 2021 while outcome of event weight loss, sick was unknown.  No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: Really sick; Vomiting; Chills with no fever; lost appetite; Weight loss, lost 6 pounds; no taste; This is a spontaneous report from a contactable consumer (parent, mother).   A 62-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date (age at vaccination was 62 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hernia repair from 2020 to an unknown date, covid-19 (he had Covid in Nov 2020 he lost 6 pounds) from Nov2020 to an unknown date, weight loss (he had Covid in Nov 2020 he lost 6 pounds) from Nov2020 to an unknown date. Family medical history was reported none. Prior vaccination within 4 weeks was reported as none. Additional vaccines administered on same date of the pfizer suspect was reported as none. Concomitant medications were not reported. Report stated that the patient received the first dose of the Covid-19 vaccine a week and a half ago (exact dates not clarified). On an unspecified date in Apr2021, within a couple days the patient was really sick. It was reported that the patient only vomited once and it was a small amount. He had chills the next day that lasted only for a day. He had lost his appetite a couple of days later. He had lost 6 pounds and the weight loss was due to having no appetite. He also had no taste. The events did not result in visit to ER or physician office. No investigation assessment was reported. The patient underwent laboratory tests that included: weight: lost 6 pounds on an unspecified date in Apr2021. Outcome of all the events was recovered on an unspecified date in 2021 while outcome of event weight loss, sick was unknown.  No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Back pain, Cold sweat, Gait disturbance
Clinical narrative: he had lost his taste and smell,; he had lost his taste and smell,; had cold sweats; pain in back and legs so bad could not walk.; pain in back and legs so bad could not walk.; pain in back and legs so bad could not walk.; This is a spontaneous report received from a contactable consumer (Patient) from Pfizer. A 48-year-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 18Apr2021 as dose 2, single for COVID-19 immunization. No Medical history reported.  He has went to an urgent care and to his doctor and they were unable to find anything that could be wrong and the Covid shot is the only thing different from his regular routine. The patient's concomitant medications were not reported.  The patient reported that he had lost his taste and smell, had cold sweats, pain in back and legs so bad could not walk, he went back to work the next week but still has no energy, is still in pain and having cold sweats. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: he had lost his taste and smell,; he had lost his taste and smell,; had cold sweats; pain in back and legs so bad could not walk.; pain in back and legs so bad could not walk.; pain in back and legs so bad could not walk.; This is a spontaneous report received from a contactable consumer (Patient) from Pfizer. A 48-year-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 18Apr2021 as dose 2, single for COVID-19 immunization. No Medical history reported.  He has went to an urgent care and to his doctor and they were unable to find anything that could be wrong and the Covid shot is the only thing different from his regular routine. The patient's concomitant medications were not reported.  The patient reported that he had lost his taste and smell, had cold sweats, pain in back and legs so bad could not walk, he went back to work the next week but still has no energy, is still in pain and having cold sweats. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Feeling cold, Heart rate abnormal
Clinical narrative: freezing; still weak; tired; Fever; tried to get my bed but I couldn't my heart was beating kept beating would not stop, beat; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0161; Expiration Date: not reported) via an unspecified route of administration, administered in upper left arm on 01May2021 (age at vaccination 66-year-old) as dose 2, single for COVID-19 immunization. Medical history included diabetic. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in upper left arm, on 03Apr2021 as dose 1, single for COVID-19 immunization. Concomitant medications included lisinopril and tamsulosin. The patient reported that on an unspecified date in May2021 at 10 PM at night he started freezing so he got upstairs and got a couple of blankets and a pocket warmer, real weak, then he tried to get his bed, but he could not, his heart was beating kept beating would not stop, beat. Another side effect, he woke up his fever was with 100. The patient was still weak. Patient asked could he get over now, too tired. He was tired to go anywhere, somewhere. Patient underwent lab tests which included body temperature: 100 on an unspecified date in May2021 and white blood cell count: no result with unspecified date. The patient took two Tylenol as a result of fever and tried to treat lower his fever. Outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, White blood cell count
Clinical narrative: freezing; still weak; tired; Fever; tried to get my bed but I couldn't my heart was beating kept beating would not stop, beat; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0161; Expiration Date: not reported) via an unspecified route of administration, administered in upper left arm on 01May2021 (age at vaccination 66-year-old) as dose 2, single for COVID-19 immunization. Medical history included diabetic. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in upper left arm, on 03Apr2021 as dose 1, single for COVID-19 immunization. Concomitant medications included lisinopril and tamsulosin. The patient reported that on an unspecified date in May2021 at 10 PM at night he started freezing so he got upstairs and got a couple of blankets and a pocket warmer, real weak, then he tried to get his bed, but he could not, his heart was beating kept beating would not stop, beat. Another side effect, he woke up his fever was with 100. The patient was still weak. Patient asked could he get over now, too tired. He was tired to go anywhere, somewhere. Patient underwent lab tests which included body temperature: 100 on an unspecified date in May2021 and white blood cell count: no result with unspecified date. The patient took two Tylenol as a result of fever and tried to treat lower his fever. Outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Antibody test, Head discomfort, Rash
Clinical narrative: Full body rash- lichen planus like; Head pressure; memory loss; This is a spontaneous report from a contactable consumer. A 43-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: ep7534), dose 1 via an unspecified route of administration, administered in Arm Left on 14Mar2021 14:00 as dose 1, single for COVID-19 immunisation (at the age of 43 years). Medical history included asthma and lichen from an unknown date and unknown if ongoing. Concomitant medications included vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), zinc (ZINC), clarithromycin (CLARITIN [CLARITHROMYCIN]) taken for an unspecified indication, start and stop date were not reported. The patient previously took wheat germ. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Mar2021 patient experienced full body rash- lichen planus like. Took several weeks to subside. Head pressure. Two weeks after severe memory loss, and I could not work. The patient received treatment with antihistamines. The patient underwent lab tests and procedures which included antibody test: positive on 01May2021. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was recovered. No follow up attempt are needed: No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Hyperaesthesia, Pyrexia, Vomiting
Clinical narrative: skin sensitivity; 103-104F fever for 12 hours (beginning 12 hours post injection); vomiting; This is a spontaneous report from a contactable consumer (patient) or other non hcp.  A 39-years-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0167, Expiration date: unknown), via an unspecified route of administration on 04May2021, 10:00 AM (at the age of 39-years-old) as dose 1, single for covid-19 immunisation. Medical history included hypothyroidism, Chronic active Epstein-Barr virus infection (caEBV). Concomitant medication included levothyroxine sodium, bupropion hydrochloride (WELLBUTRIN), aciclovir sodium (ACYCLOVIR ABBOTT VIAL), calcium pantothenate, folic acid, vitamins nos (MULTI-VITAMINS VITAFIT) all taken for unspecified indication start and stop date were not reported. Prior to vaccination,  patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 04May2021, at 22:00 the patient experienced skin sensitivity, 103-104f fever for 12 hours (beginning 12 hours post injection), vomiting. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination, patient had been not tested for COVID-19. The patient underwent lab tests and procedures which included body temperature 103-104 Fahrenheit on 04May2021. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Limb discomfort, Pain
Clinical narrative: he leaned on his left arm this morning and it felt like it was going to explode; increased inflammation in his arm pushing against nerves/muscle and generating tension/pressure; sharper soreness feels more intense; This is a spontaneous report received from a contactable consumer (patient himself). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 01May2021 14:00 as dose 2, single for COVID-19 immunization (Age at Vaccination was 26 years). The patient medical history included prolonged QT interval syndrome. Concomitant medications included Nadolol, 20mg, 3x daily. It was reported that, he did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The other medications that he received within 2 weeks of vaccination was Nadolol, 20mg, 3x daily. He was diagnosed with COVID-19, prior to vaccination and was not tested for COVID-19, since the vaccination. He took some fruits (mainly skins on apples, kiwis, carrots, celery, etc.), but nothing severe reaction. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration on 03Apr2021 14:00 as dose 1, single for covid-19 immunisation (Age at Vaccination was 26 years). On 02May2021, the patient experienced the sharper soreness feels more intense. More intense pain but subsided completely after about 3 minutes. On an unspecified date, he leaned on his left arm this morning and it felt like it was going to explode and increased inflammation in his arm pushing against nerves/muscle and generating tension/pressure. No therapeutic measures were taken as a result of events. The outcome of the event pain was recovered on an unspecified date in May2021, outcome of other events was unknown. No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Fatigue, Lymphadenopathy, Pain
Clinical narrative: Swollen lymph nodes in armpit, neck, and near ear on left side of body-same side as vaccine.; Tiredness, aches, and feeling down on energy for 3-4 days after second shot; Tiredness, aches, and feeling down on energy for 3-4 days after second shot; Tiredness, aches, and feeling down on energy for 3-4 days after second shot; This is a spontaneous report from a non-contactable consumer or other non hcp.     A 36-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 07:00 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included migraine. The patient's concomitant medications were not reported. The patient previously took bnt162b2 for covid-19 immunisation, capsaicin and experienced drug hypersensitivity. It was reported that, on 27Apr2021 06:00 patient experienced Swollen lymph nodes in armpit, neck, and near ear on left side of body same side as vaccine. Tiredness, aches, and feeling down on energy for 3-4 days after second shot. The outcome of the events was recovered on unknown date of 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. .
Sex: F
Vaccine: PNC13
Symptoms: Adverse drug reaction, Rash erythematous
Clinical narrative: red rash; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on Oct2020 (Batch/Lot number was not reported) as dose number unknown, single for immunization. Medical history included lots of allergies soy, cow milk, shellfish, and other medication allergies, patient also has asthma. The patient's concomitant medications were not reported. The patient was asking if PFIZER-BIONTECH COVID-19 VACCINE contains any of the listed ingredients since the patient received "Prevnar 13" on Oct2020 and had a red rash that spread on an unspecified date. The pharmacist told her to take a antihistamine and it went away within a few days. Medical provider told her it wasn't an allergic reaction but just an expected side effect of vaccine. The outcome of the event was recovered on unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Asthenia, Chills, Feeling of body temperature change, Headache, Pain
Clinical narrative: Eperiencing aches at 4am; Hot and cold chills at 4 am; Fever at 4 am; Weakness at 4 am; Headache at 4am; Hot and cold chills at 4 am; This is a spontaneous report from a contactable consumer or other health care professional.     A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported) unspecified route of administration on 04May2021 11:00 as dose 2, single for covid-19 immunization. Patient previously took first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported) unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization.The patient received DESCOVY on May2020 for treatment of PrEP. Patient Medical history included prophylaxis against hiv infection from an unknown date and unknown if ongoing. Other relevant history was not reported. No laboratory and diagnostic tests were reported. The patient's concomitant medications were not reported. The patient experienced aches (pain), hot and cold chills (feeling of body temperature change), hot and cold chills (chills), fever (pyrexia, weakness (asthenia) and headache on 05Mar2021 04:00. The outcome of the events were resolving.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pyrexia
Clinical narrative: Eperiencing aches at 4am; Hot and cold chills at 4 am; Fever at 4 am; Weakness at 4 am; Headache at 4am; Hot and cold chills at 4 am; This is a spontaneous report from a contactable consumer or other health care professional.     A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported) unspecified route of administration on 04May2021 11:00 as dose 2, single for covid-19 immunization. Patient previously took first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported) unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization.The patient received DESCOVY on May2020 for treatment of PrEP. Patient Medical history included prophylaxis against hiv infection from an unknown date and unknown if ongoing. Other relevant history was not reported. No laboratory and diagnostic tests were reported. The patient's concomitant medications were not reported. The patient experienced aches (pain), hot and cold chills (feeling of body temperature change), hot and cold chills (chills), fever (pyrexia, weakness (asthenia) and headache on 05Mar2021 04:00. The outcome of the events were resolving.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: Day 3: Very tired; Day 2: Low grade fever and body aches; Day 2: Low grade fever and body aches; First 24 hrs: Arm hurt a lot; This is a spontaneous report from a contactable consumer (patient).  A female patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: EP6955 and expiry date: Not reported), via Intramuscular on 08Apr2021 at 10: 00 am on left arm as Dose 2, single for COVID-19 immunization. Medical history was not reported. No known allergies were reported. Concomitant medications included: paracetamol (TYLENOL) and calcium carbonate, colecalciferol (VITAMIN D 2000) within 2 weeks of covid vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: EP6955 and expiry date: Not reported), via Intramuscular on 18Mar2021 at 10: 00 am on left arm as Dose 2, single for COVID-19 immunization and was tired in the evening of the same day. The patient did not receive any other vaccines with in four weeks prior of COVID vaccine intake. The patient was neither diagnosed with COVID prior taking vaccine nor been tested for COVID-19 Since the vaccination. The patients arm hurt a lot for the first 24 hours (08Apr2021) of taking second dose of vaccine and then had Low grade fever (<100F) and Body aches on day 2 (09Apr2021) of vaccination. The patient was very tired on day 3 (10Apr2021) of second dose of vaccination. The patient did not receive any treatment for all reported events. The patient got recovered from all the events on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Off label use, Palpitations, Product use issue
Clinical narrative: Other symptoms with first injection were the same as well as severe headache, fatigue, rash on my feet.; Other symptoms with first injection were the same as well as severe headache, fatigue, rash on my feet.; Other symptoms with first injection were the same as well as severe headache, fatigue, rash on my feet.; heart racing/palpitation; Elbow Joint Pain on injection arm; Off label use (Pregnant at the time of vaccination); Drug use in unapproved population (Pregnant at the time of vaccination); This is a spontaneous report from a contactable consumer or other non health care professional (patient). This is a maternal report.    A 35-years-old female patient received  first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported: not reported, expiry date: not reported), via an unspecified route of administration, administered in arm right on 20Apr2021 15:00 (at age of 35-years-old) as dose 1, single for covid-19 immunization. Medical history included sulfa allergy, covid-19. Concomitant medication(s) included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]) taken an unspecified indication start and stop date were not reported. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The mother reported she became pregnant while taking bnt162b2. The mother was 17 Weeks pregnant at the onset of the event. The patient experienced other symptoms with first injection were racing heart, heart palpitations, elbow joint pain, as well as severe headache, fatigue, rash on my feet in 2021. After both injections the patient had reactions similar to my symptoms while the patient had Covid. My most severe symptoms are racing heart, heart palpitations. Other symptoms are elbow joint pain on injection arm. Other symptoms with first injection were the same as well as severe headache, fatigue, rash on my feet. No treatment was received for the events.The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported: not reported, expiry date: not reported), via an unspecified route of administration, administered in arm right on 11May2021 14:00 (at age of 35-years-old) as dose 2, single for covid-19 immunization The outcome of the events was not recovered.    Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site joint pain
Clinical narrative: Other symptoms with first injection were the same as well as severe headache, fatigue, rash on my feet.; Other symptoms with first injection were the same as well as severe headache, fatigue, rash on my feet.; Other symptoms with first injection were the same as well as severe headache, fatigue, rash on my feet.; heart racing/palpitation; Elbow Joint Pain on injection arm; Off label use (Pregnant at the time of vaccination); Drug use in unapproved population (Pregnant at the time of vaccination); This is a spontaneous report from a contactable consumer or other non health care professional (patient). This is a maternal report.    A 35-years-old female patient received  first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported: not reported, expiry date: not reported), via an unspecified route of administration, administered in arm right on 20Apr2021 15:00 (at age of 35-years-old) as dose 1, single for covid-19 immunization. Medical history included sulfa allergy, covid-19. Concomitant medication(s) included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]) taken an unspecified indication start and stop date were not reported. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The mother reported she became pregnant while taking bnt162b2. The mother was 17 Weeks pregnant at the onset of the event. The patient experienced other symptoms with first injection were racing heart, heart palpitations, elbow joint pain, as well as severe headache, fatigue, rash on my feet in 2021. After both injections the patient had reactions similar to my symptoms while the patient had Covid. My most severe symptoms are racing heart, heart palpitations. Other symptoms are elbow joint pain on injection arm. Other symptoms with first injection were the same as well as severe headache, fatigue, rash on my feet. No treatment was received for the events.The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported: not reported, expiry date: not reported), via an unspecified route of administration, administered in arm right on 11May2021 14:00 (at age of 35-years-old) as dose 2, single for covid-19 immunization The outcome of the events was not recovered.    Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: bad hives; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer sponsored program. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the Covid-19 vaccine gave me me a bad hives so, I would not be able to get the second dose. Patient was prescribed Xeljanz 5mg. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rash
Clinical narrative: rash on both arms; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number and Expiry date: not reported), via unspecified route on an unspecified date as dose 2, single for COVID-19 immunization. Co-suspect included Tymlos (abaloparatide), injection, 80 mcg once day subcutaneously on 22Jan2021 for osteoporosis. The patient's medical history and concomitant medication was not reported. On an unknown date, the patient had broke out with rash on both arms. The outcome of the event was unknown.  Follow-up attempts completed. No further information was expected.