chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: After the vaccine I have been having trouble with my asthma. Every night I get asthma problems out of nowhere; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 28 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHMA (non-serious), outcome "unknown", described as "After the vaccine I have been having trouble with my asthma. Every night I get asthma problems out of nowhere".  Additional information: The Seriousness criteria reported as NO included: results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect. Reason why batch/lot is Unknown: Unable to locate or read the details. The seriousness of the adverse events reported as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: small bruise on the top of the left foot after first shot/A small bruise on the top of the right foot after the second shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2, Solution for injection) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONTUSION (non-serious), outcome "unknown", described as "small bruise on the top of the left foot after first shot/A small bruise on the top of the right foot after the second shot". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: Left eye was red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Sep2021 13:00 (Lot number: FF2588) at the age of 56 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: OCULAR HYPERAEMIA (non-serious) with onset 18Sep2021, outcome "not recovered", described as "Left eye was red".  Additional information: He stated about one week after he had the shot he had red eye on left eye. Left eye was red, in the afternoon, like 2 or 3 clock. The vaccine was administered in left shoulder. No other additional vaccines were administered on same date of the Pfizer suspect. The adverse events did not require emergency room or physician office. There was no prior vaccinations (within 4 weeks).  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Yesterday morning, at the time she got up, it was a little swollen. She figured it was because that happened with the first shot but, she did not get any rash the first time.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Aug2021 16:00 (Lot number: FA7485) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Surgery", start date: Jun2020 (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID], start date: Jun2020 (ongoing). The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Yesterday morning, at the time she got up, it was a little swollen. She figured it was because that happened with the first shot but, she did not get any rash the first time.". No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101225786 same reporter/patient/product, different dose/event.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: after injection immediately started itching then broke out into hives; after injection immediately started itching then broke out into hives; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Sep2021 07:15 (Lot number: EW0176) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "PCOS" (unspecified if ongoing); "Allergies: Eggs" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Allergies: sulfur, reaction(s): "Drug allergy". The following information was reported: PRURITUS (non-serious), URTICARIA (non-serious) all with onset 10Sep2021, outcome "recovered" (Sep2021) and all described as "after injection immediately started itching then broke out into hives". The event "after injection immediately started itching then broke out into hives" and "after injection immediately started itching then broke out into hives" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of pruritus, urticaria.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID, Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, was not tested for COVID-19. After injection immediately started itching then broke out into hives.  No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Palpitations
Clinical narrative: heart palpitations; short of breath; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15May2021 19:30 (Lot number: EW0179) at the age of 20 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, Batch/lot number: EW0161 , left arm), administration date: 26Apr2021, when the patient was 20 years old, for Covid-19 immunization. The following information was reported: PALPITATIONS (non-serious) with onset 15May2021, outcome "unknown", described as "heart palpitations"; DYSPNOEA (non-serious) with onset 15May2021, outcome "recovering", described as "short of breath". Therapeutic measures were not taken as a result of palpitations, dyspnoea.  Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. He states he received the Covid 19 vaccine because his mother was a doctor and she advised him to get the vaccine. If it wasn't for her telling him to get the vaccine he would not have gotten it. Patient got his second dose and it gave him side effects like heart palpitations and he was short of breath. When probing if the caller is still experiencing side effects he states when he exercises he feels like short of breath a little bit. When he does hard exercises he is still short of breath.  His side effects started about 25 minutes after he received the Covid 19 vaccine. He states he has no medical history and he does not take any medications. He does not do drugs and he does not smoke. He doesn't do anything. When probing for his date of birth he said first 1998, then 1999, and then 2000. He said he was 20 years old. This is discrepant but documented as provided by patient. He declines to provide the day and month. He did not have to see a doctor or go to the emergency room for treatment. No adverse events reported following prior vaccinations. No relevant tests reported.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Fatigue, Nausea, Oropharyngeal pain
Clinical narrative: diarrhea; nausea; sneezing; coughing; sore throat; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Sep2021 08:30 (Lot number: EW0217) at the age of 27 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "irregular heartbeat" (unspecified if ongoing); "diabetic" (unspecified if ongoing); "Known allergies: Bee stings" (unspecified if ongoing); "Known allergies: pineapple" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC; VITAMIN C [ASCORBIC ACID]; VITAMIN D3; VITAMIN E [TOCOPHEROL]; ZINC. Past drug history included: Paxil, reaction(s): "Known allergies: Paxil"; Bupropion, reaction(s): "Known allergies: bupropion". Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer-biontech COVID-19 vaccine eua, lot number=Pfizer EW0217, administration date=28Aug2021, administration time=01:30 PM, dose number=1, vaccine location=Right arm), administration date: 28Aug2021, when the patient was 27 years old, for Covid-19 Immunization. The following information was reported: DIARRHOEA (non-serious) with onset 19Sep2021, outcome "not recovered", described as "diarrhea"; NAUSEA (non-serious) with onset 19Sep2021, outcome "not recovered", described as "nausea"; SNEEZING (non-serious) with onset 19Sep2021, outcome "not recovered", described as "sneezing"; COUGH (non-serious) with onset 19Sep2021, outcome "not recovered", described as "coughing"; OROPHARYNGEAL PAIN (non-serious) with onset 19Sep2021, outcome "not recovered", described as "sore throat"; FATIGUE (non-serious) with onset 19Sep2021, outcome "not recovered", described as "fatigue". Therapeutic measures were not taken as a result of diarrhoea, nausea, sneezing, cough, oropharyngeal pain, fatigue.  Additional information included: 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-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: diarrhea; nausea; sneezing; coughing; sore throat; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Sep2021 08:30 (Lot number: EW0217) at the age of 27 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "irregular heartbeat" (unspecified if ongoing); "diabetic" (unspecified if ongoing); "Known allergies: Bee stings" (unspecified if ongoing); "Known allergies: pineapple" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC; VITAMIN C [ASCORBIC ACID]; VITAMIN D3; VITAMIN E [TOCOPHEROL]; ZINC. Past drug history included: Paxil, reaction(s): "Known allergies: Paxil"; Bupropion, reaction(s): "Known allergies: bupropion". Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer-biontech COVID-19 vaccine eua, lot number=Pfizer EW0217, administration date=28Aug2021, administration time=01:30 PM, dose number=1, vaccine location=Right arm), administration date: 28Aug2021, when the patient was 27 years old, for Covid-19 Immunization. The following information was reported: DIARRHOEA (non-serious) with onset 19Sep2021, outcome "not recovered", described as "diarrhea"; NAUSEA (non-serious) with onset 19Sep2021, outcome "not recovered", described as "nausea"; SNEEZING (non-serious) with onset 19Sep2021, outcome "not recovered", described as "sneezing"; COUGH (non-serious) with onset 19Sep2021, outcome "not recovered", described as "coughing"; OROPHARYNGEAL PAIN (non-serious) with onset 19Sep2021, outcome "not recovered", described as "sore throat"; FATIGUE (non-serious) with onset 19Sep2021, outcome "not recovered", described as "fatigue". Therapeutic measures were not taken as a result of diarrhoea, nausea, sneezing, cough, oropharyngeal pain, fatigue.  Additional information included: 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-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives-right arm/.neck; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Sep2021 11:00 (Lot number: EW0191) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Known Allergies: Seafood/Shellfish" (unspecified if ongoing); "Known Allergies: Seafood/Shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine, reaction(s): "hives-right arm/.neck". The following information was reported: URTICARIA (non-serious) with onset 11Sep2021, outcome "not recovered", described as "hives-right arm/.neck". The event "hives-right arm/.neck" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of urticaria.  Additional information: The patient did not receive other vaccine in four weeks. The patient had same reaction to  the flu vaccine. The patient had not covid prior vaccination. The patient had not tested covid post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 36 year-old female patient received bnt162b2 (BNT162B2), administration date 23Jul2021 (Lot number: EW0176) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHEST PAIN (non-serious) with onset 24Jul2021, outcome "recovered" (25Jul2021), described as "chest pain".  Additional information: Caller says that she is calling because she had the 1st dose of the Pfizer COVID vaccine on 23Jul2021 and the day after and the next day she had sharp chest pains. She talked to her doctor about being revaccinated and the doctor wasn't sure if the caller could be revaccinated.   Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tachycardia
Clinical narrative: palpitations worsened after 2nd dose.; tachycardia; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 13Feb2021 12:00 (Lot number: EL9266) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing); "Back Spasm" (unspecified if ongoing); "Sleep" (unspecified if ongoing). Concomitant medication(s) included: HAILEY 24 FE taken for contraception, start date: 2013 (ongoing); MONTELUKAST taken for hypersensitivity (ongoing); SOMA [CARISOPRODOL] taken for muscle spasms (ongoing); DOXEPINE taken for sleep disorder (ongoing); ATROVENT taken for hypersensitivity (ongoing); FLONASE [FLUTICASONE PROPIONATE] taken for hypersensitivity (ongoing). Vaccination history included: Bnt162b2 (Note: Dose: 1st, Date (dd-Mmm-yyyy): 23Jan2021, Time (24 hr): 14:00, Anatomical Site of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: EN5318, Patient started having heart palpitations at night after 1st dose of vaccine), administration date: 23Jan2021, when the patient was 41 years old, for Covid-19 Immunization, reaction(s): "heart palpitations". The following information was reported: PALPITATIONS (non-serious) with onset 2021, outcome "not recovered", described as "palpitations worsened after 2nd dose."; TACHYCARDIA (non-serious) with onset 2021, outcome "not recovered", described as "tachycardia". The events "palpitations worsened after 2nd dose." and "tachycardia" were evaluated at the physician office visit. Therapeutic measures were taken as a result of palpitations, tachycardia.  Additional information: Palpitations worsened after 2nd dose. Pt. went to PCP on 01Mar2021 for treatment, Dr. diagnosed with tachycardia due to unknown cause (Not sure if vaccine or panic attacks). Pt. has no history of anxiety or panic attacks. Heart palpitation decreased slightly in Jul2021. Pt. still has heart palpitation at night and is still taking atenolol 25 mg/Daily. Pt. also seeing endocrinologist. Pt. had no heart or anxiety problems before vaccine. Dr. not sure if heart palpitations from vaccine but pt. did not have then before vaccine also with no heart problems in history. Family Medical History relevant to AE(s) was None.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Headache, Myalgia, Nausea, Pain
Clinical narrative: weakness; fever; sorness at sight; aches; nausea; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 06Apr2021 (Lot number: EW0150) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Unknown Lung infection contracted 1995", start date: 1995 (ongoing), notes: Contracted in (state-withheld) on vacation while staying with family in (city-withheld) outside of (city-withheld) Apt. was over active butcher shop (100s of years old) next to post office, Dont know address, fever onset then congestion in lungs, Cough was very productive, sticky green sum, at one point cough produced so much started to chore and had to use sink edge to push diaphragm and push sum forward before black out. Was over a cup of sum in one cough. Brother found me passed out and could not wake me. He said my ups were blue. I think I was unconscious around 10 hours. After I recovered and went back to (state-withheld) doctor said air sacs were damaged but could not say what illness was. Every morning cough up infection ever since. Concomitant medication(s) included: LISINOPRIL; HCTZ; B12 [CYANOCOBALAMIN]; FOLIC ACID; POTASSIUM; MAGNESIUM; D3; ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: PAIN (non-serious) with onset 07Apr2021, outcome "recovered", described as "aches"; NAUSEA (non-serious) with onset 07Apr2021, outcome "recovered", described as "nausea"; HEADACHE (non-serious) with onset 07Apr2021, outcome "recovered", described as "headache"; ASTHENIA (non-serious), outcome "unknown", described as "weakness"; PYREXIA (non-serious), outcome "unknown", described as "fever"; MYALGIA (non-serious), outcome "unknown", described as "sorness at sight". Therapeutic measures were not taken as a result of pain, nausea, headache.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: weakness; fever; sorness at sight; aches; nausea; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 06Apr2021 (Lot number: EW0150) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Unknown Lung infection contracted 1995", start date: 1995 (ongoing), notes: Contracted in (state-withheld) on vacation while staying with family in (city-withheld) outside of (city-withheld) Apt. was over active butcher shop (100s of years old) next to post office, Dont know address, fever onset then congestion in lungs, Cough was very productive, sticky green sum, at one point cough produced so much started to chore and had to use sink edge to push diaphragm and push sum forward before black out. Was over a cup of sum in one cough. Brother found me passed out and could not wake me. He said my ups were blue. I think I was unconscious around 10 hours. After I recovered and went back to (state-withheld) doctor said air sacs were damaged but could not say what illness was. Every morning cough up infection ever since. Concomitant medication(s) included: LISINOPRIL; HCTZ; B12 [CYANOCOBALAMIN]; FOLIC ACID; POTASSIUM; MAGNESIUM; D3; ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: PAIN (non-serious) with onset 07Apr2021, outcome "recovered", described as "aches"; NAUSEA (non-serious) with onset 07Apr2021, outcome "recovered", described as "nausea"; HEADACHE (non-serious) with onset 07Apr2021, outcome "recovered", described as "headache"; ASTHENIA (non-serious), outcome "unknown", described as "weakness"; PYREXIA (non-serious), outcome "unknown", described as "fever"; MYALGIA (non-serious), outcome "unknown", described as "sorness at sight". Therapeutic measures were not taken as a result of pain, nausea, headache.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Fatigue, Headache, Hypertension
Clinical narrative: migraine; body aches; fatigue; tachycardia; fever; swollen lymphnode; blood pressure started to elevate; nauseous; bad headache; dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 07Sep2021 14:30 (Lot number: FD0809) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose , Date: 16Aug2021, Time: 14:20 , Site and Route of injection:, Anatomical site of injection: Right Arm, Route of administration: Intramuscular, Batch number: EW0171 (Pfizer)), administration date: 16Aug2021, for COVID-19 Immunization, reaction(s): "Headaches", "Lightheadness", "Dizziness", "Nausea", "Tachycardia". The following information was reported: HYPERTENSION (non-serious) with onset 07Sep2021, outcome "unknown", described as "blood pressure started to elevate"; NAUSEA (non-serious) with onset 07Sep2021, outcome "unknown", described as "nauseous"; HEADACHE (non-serious) with onset 07Sep2021, outcome "unknown", described as "bad headache"; DIZZINESS (non-serious) with onset 07Sep2021, outcome "unknown", described as "dizzy"; MIGRAINE (non-serious) with onset 08Sep2021, outcome "unknown", described as "migraine"; PAIN (non-serious) with onset 08Sep2021, outcome "unknown", described as "body aches"; FATIGUE (non-serious) with onset 08Sep2021, outcome "unknown", described as "fatigue"; TACHYCARDIA (non-serious) with onset 08Sep2021, outcome "unknown", described as "tachycardia"; PYREXIA (non-serious) with onset 08Sep2021, outcome "unknown", described as "fever"; LYMPHADENOPATHY (non-serious) with onset 08Sep2021, outcome "unknown", described as "swollen lymphnode". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nausea, headache.  Additional information: On 07Sep2021 at 02:30pm I received the second COVID-19 vaccine LOT# FD0809 at the same location after waiting 30 minutes with a nurse that was monitoring me my blood pressure started to elevated to high very high number and I started to feel super nauseous with a really bad headache. Once my time was up I left and started to drive home when I had to stop and pull over because I felt dizzy. On 08Sep2021 I began to have a migraine severe nausea, body aches, dizziness, fatigue tachycardia, fever, and swollen lymph node under my right arm that continued until 09Sep2021. I still have headaches, nausea and slight headaches as of 11Sep2021 that I have to take medication that was prescribed after the first vaccine on 16Aug2021. Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Migraine, Nausea, Pain, Pyrexia
Clinical narrative: migraine; body aches; fatigue; tachycardia; fever; swollen lymphnode; blood pressure started to elevate; nauseous; bad headache; dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 07Sep2021 14:30 (Lot number: FD0809) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose , Date: 16Aug2021, Time: 14:20 , Site and Route of injection:, Anatomical site of injection: Right Arm, Route of administration: Intramuscular, Batch number: EW0171 (Pfizer)), administration date: 16Aug2021, for COVID-19 Immunization, reaction(s): "Headaches", "Lightheadness", "Dizziness", "Nausea", "Tachycardia". The following information was reported: HYPERTENSION (non-serious) with onset 07Sep2021, outcome "unknown", described as "blood pressure started to elevate"; NAUSEA (non-serious) with onset 07Sep2021, outcome "unknown", described as "nauseous"; HEADACHE (non-serious) with onset 07Sep2021, outcome "unknown", described as "bad headache"; DIZZINESS (non-serious) with onset 07Sep2021, outcome "unknown", described as "dizzy"; MIGRAINE (non-serious) with onset 08Sep2021, outcome "unknown", described as "migraine"; PAIN (non-serious) with onset 08Sep2021, outcome "unknown", described as "body aches"; FATIGUE (non-serious) with onset 08Sep2021, outcome "unknown", described as "fatigue"; TACHYCARDIA (non-serious) with onset 08Sep2021, outcome "unknown", described as "tachycardia"; PYREXIA (non-serious) with onset 08Sep2021, outcome "unknown", described as "fever"; LYMPHADENOPATHY (non-serious) with onset 08Sep2021, outcome "unknown", described as "swollen lymphnode". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nausea, headache.  Additional information: On 07Sep2021 at 02:30pm I received the second COVID-19 vaccine LOT# FD0809 at the same location after waiting 30 minutes with a nurse that was monitoring me my blood pressure started to elevated to high very high number and I started to feel super nauseous with a really bad headache. Once my time was up I left and started to drive home when I had to stop and pull over because I felt dizzy. On 08Sep2021 I began to have a migraine severe nausea, body aches, dizziness, fatigue tachycardia, fever, and swollen lymph node under my right arm that continued until 09Sep2021. I still have headaches, nausea and slight headaches as of 11Sep2021 that I have to take medication that was prescribed after the first vaccine on 16Aug2021. Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: migraine; body aches; fatigue; tachycardia; fever; swollen lymphnode; blood pressure started to elevate; nauseous; bad headache; dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 07Sep2021 14:30 (Lot number: FD0809) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose , Date: 16Aug2021, Time: 14:20 , Site and Route of injection:, Anatomical site of injection: Right Arm, Route of administration: Intramuscular, Batch number: EW0171 (Pfizer)), administration date: 16Aug2021, for COVID-19 Immunization, reaction(s): "Headaches", "Lightheadness", "Dizziness", "Nausea", "Tachycardia". The following information was reported: HYPERTENSION (non-serious) with onset 07Sep2021, outcome "unknown", described as "blood pressure started to elevate"; NAUSEA (non-serious) with onset 07Sep2021, outcome "unknown", described as "nauseous"; HEADACHE (non-serious) with onset 07Sep2021, outcome "unknown", described as "bad headache"; DIZZINESS (non-serious) with onset 07Sep2021, outcome "unknown", described as "dizzy"; MIGRAINE (non-serious) with onset 08Sep2021, outcome "unknown", described as "migraine"; PAIN (non-serious) with onset 08Sep2021, outcome "unknown", described as "body aches"; FATIGUE (non-serious) with onset 08Sep2021, outcome "unknown", described as "fatigue"; TACHYCARDIA (non-serious) with onset 08Sep2021, outcome "unknown", described as "tachycardia"; PYREXIA (non-serious) with onset 08Sep2021, outcome "unknown", described as "fever"; LYMPHADENOPATHY (non-serious) with onset 08Sep2021, outcome "unknown", described as "swollen lymphnode". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nausea, headache.  Additional information: On 07Sep2021 at 02:30pm I received the second COVID-19 vaccine LOT# FD0809 at the same location after waiting 30 minutes with a nurse that was monitoring me my blood pressure started to elevated to high very high number and I started to feel super nauseous with a really bad headache. Once my time was up I left and started to drive home when I had to stop and pull over because I felt dizzy. On 08Sep2021 I began to have a migraine severe nausea, body aches, dizziness, fatigue tachycardia, fever, and swollen lymph node under my right arm that continued until 09Sep2021. I still have headaches, nausea and slight headaches as of 11Sep2021 that I have to take medication that was prescribed after the first vaccine on 16Aug2021. Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Immune system disorder
Clinical narrative: extreme joint pain; arthritis; destroys your immune system; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): NUS2021US142704.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2, Solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "extreme joint pain"; ARTHRITIS (non-serious), outcome "unknown", described as "arthritis"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "destroys your immune system". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Chills, Illness, Malaise
Clinical narrative: Her temperature was 100.6 but it was enough to keep her in bed.; Mentions with the second dose she had fever;; chills; body aches; and her arm hurt; she didn't feel well; She felt sick the day after the vaccination.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 10:00 (Lot number: ER8727, Expiration Date: 31Jul2021) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ulcerative Colitis", start date: 2003 (ongoing), notes: Verbatim: Ulcerative colitis; "Irritable bowel syndrome" (unspecified if ongoing), notes: Verbatim: Irritable bowel, From her late 20's. Concomitant medication(s) included: MERCAPTOPURINE taken for colitis ulcerative, start date: 2003 (ongoing). Vaccination history included: Bnt162b2 (First Dose, Time: 09:30 to 10:00AM , Anatomical Location:left upper arm, Lot No: EN6205, Expiry:30Jun2021), administration date: 06Mar2021, when the patient was 66 years old, for COVID-19 Immunization. The following information was reported: BODY TEMPERATURE ABNORMAL (non-serious) with onset 28Mar2021, outcome "recovered" (29Mar2021), described as "Her temperature was 100.6 but it was enough to keep her in bed."; PYREXIA (non-serious) with onset 28Mar2021, outcome "recovered" (28Mar2021), described as "Mentions with the second dose she had fever;"; CHILLS (non-serious) with onset 28Mar2021, outcome "recovered" (28Mar2021), described as "chills"; PAIN (non-serious) with onset 28Mar2021, outcome "recovered" (28Mar2021), described as "body aches"; PAIN IN EXTREMITY (non-serious) with onset 28Mar2021, outcome "recovered" (28Mar2021), described as "and her arm hurt"; MALAISE (non-serious) with onset 28Mar2021, outcome "recovered" (28Mar2021), described as "she didn't feel well"; ILLNESS (non-serious) with onset 28Mar2021, outcome "recovered" (29Mar2021), described as "She felt sick the day after the vaccination.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She had fever, chills, body aches, and her arm hurt and she didn't feel well but all this went away within a day. She felt sick the day after the vaccination. Her temperature was 100.6 but it was enough to keep her in bed. Adds she felt better after 24 hours and the next day she was okay. The patient had no additional vaccines administered on same date of the Pfizer suspect. The adverse events did not require a visit to the emergency room or physicians office. The patient had not prior vaccination (within four weeks).  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Her temperature was 100.6 but it was enough to keep her in bed.; Mentions with the second dose she had fever;; chills; body aches; and her arm hurt; she didn't feel well; She felt sick the day after the vaccination.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 10:00 (Lot number: ER8727, Expiration Date: 31Jul2021) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ulcerative Colitis", start date: 2003 (ongoing), notes: Verbatim: Ulcerative colitis; "Irritable bowel syndrome" (unspecified if ongoing), notes: Verbatim: Irritable bowel, From her late 20's. Concomitant medication(s) included: MERCAPTOPURINE taken for colitis ulcerative, start date: 2003 (ongoing). Vaccination history included: Bnt162b2 (First Dose, Time: 09:30 to 10:00AM , Anatomical Location:left upper arm, Lot No: EN6205, Expiry:30Jun2021), administration date: 06Mar2021, when the patient was 66 years old, for COVID-19 Immunization. The following information was reported: BODY TEMPERATURE ABNORMAL (non-serious) with onset 28Mar2021, outcome "recovered" (29Mar2021), described as "Her temperature was 100.6 but it was enough to keep her in bed."; PYREXIA (non-serious) with onset 28Mar2021, outcome "recovered" (28Mar2021), described as "Mentions with the second dose she had fever;"; CHILLS (non-serious) with onset 28Mar2021, outcome "recovered" (28Mar2021), described as "chills"; PAIN (non-serious) with onset 28Mar2021, outcome "recovered" (28Mar2021), described as "body aches"; PAIN IN EXTREMITY (non-serious) with onset 28Mar2021, outcome "recovered" (28Mar2021), described as "and her arm hurt"; MALAISE (non-serious) with onset 28Mar2021, outcome "recovered" (28Mar2021), described as "she didn't feel well"; ILLNESS (non-serious) with onset 28Mar2021, outcome "recovered" (29Mar2021), described as "She felt sick the day after the vaccination.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She had fever, chills, body aches, and her arm hurt and she didn't feel well but all this went away within a day. She felt sick the day after the vaccination. Her temperature was 100.6 but it was enough to keep her in bed. Adds she felt better after 24 hours and the next day she was okay. The patient had no additional vaccines administered on same date of the Pfizer suspect. The adverse events did not require a visit to the emergency room or physicians office. The patient had not prior vaccination (within four weeks).  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Petechiae, Rash, Rash papular
Clinical narrative: light rash on top of my feet and across my stomach/ rash on top of her elbow, feet, and stomach; petechiae; red bumps; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Sep2021 15:00 (Lot number: FC3184) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "Blood Pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE. Past drug history included: Sulfa drugs, reaction(s): "known allergies : Sulfa drugs". The following information was reported: RASH (non-serious) with onset 04Sep2021 05:00, outcome "not recovered", described as "light rash on top of my feet and across my stomach/ rash on top of her elbow, feet, and stomach"; PETECHIAE (non-serious) with onset 2021, outcome "unknown", described as "petechiae"; RASH PAPULAR (non-serious) with onset 2021, outcome "unknown", described as "red bumps". Therapeutic measures were not taken as a result of rash. Additional information: 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. No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Mouth swelling, Pharyngeal swelling, Swelling face, Urticaria
Clinical narrative: Swelling of the face; Swelling of the mouth; Swelling of the throat; Broke out in hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in upper arm left, administration date 02Sep2021 12:30 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was none. concomitant medications were not reported.  The following information was reported: SWELLING FACE (non-serious), outcome "not recovered", described as "Swelling of the face"; MOUTH SWELLING (non-serious), outcome "not recovered", described as "Swelling of the mouth"; PHARYNGEAL SWELLING (non-serious), outcome "not recovered", described as "Swelling of the throat"; URTICARIA (non-serious), outcome "not recovered", described as "Broke out in hives". The events "swelling of the face", "swelling of the mouth", "swelling of the throat" and "broke out in hives" were evaluated at the physician office visit. Therapeutic measures were taken as a result of swelling face, mouth swelling, pharyngeal swelling, urticaria.  Additional information: It was reported that three weeks ago patient received the first dose of the covid 19 vaccine.The patient experienced a terrible reaction. Swelling of the face, mouth, throat. Broke out in hives. He continues to have all these symptoms. His purpose for calling, any compound or compound that could be causing the reaction. Basically the ingredients since he has not had allergies. He stated that, he have never had any allergies or an allergic reaction. He have had multiple surgeries. He did have a reaction once to anesthesia in an emergency situation.  He did not know if there was a particular compound, chemical within the vaccine that you could tell me to avoid that could be exacerbating this reaction.  Patient was almost sent to the ER for intubation. Since then he continues to have all the symptoms. He was calling to report and ask what compound or chemical could be causing his reaction since he has no allergies and has never been allergic to anything else. Even just last night he broke out really bad. His doctor prescribed Xyzal which he takes in the evening and it seems to help pretty well and seems to subdue the symptoms. Prior vaccinations medical history was none. There were no family medical history relevant to adverse events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101253599 Pfizer
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Diarrhoea, Dizziness
Clinical narrative: Racing/pounding heart; short of breath; nasuea; fever; diarehea; dizziness; headache; chills; body aches; weakess; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Sep2021 12:00 (Lot number: fd8448) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Had Covid Nov 2020", start date: Nov2020 (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: LEVOTHYROXINE and multi vitamin. The following information was reported: PALPITATIONS (non-serious) with onset 05Sep2021, outcome "not recovered", described as "Racing/pounding heart"; DYSPNOEA (non-serious) with onset 05Sep2021, outcome "not recovered", described as "short of breath"; NAUSEA (non-serious) with onset 05Sep2021, outcome "not recovered", described as "nasuea"; PYREXIA (non-serious) with onset 05Sep2021, outcome "not recovered", described as "fever"; DIARRHOEA (non-serious) with onset 05Sep2021, outcome "not recovered", described as "diarehea"; DIZZINESS (non-serious) with onset 05Sep2021, outcome "not recovered", described as "dizziness"; HEADACHE (non-serious) with onset 05Sep2021, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 05Sep2021, outcome "not recovered", described as "chills"; PAIN (non-serious) with onset 05Sep2021, outcome "not recovered", described as "body aches"; ASTHENIA (non-serious) with onset 05Sep2021, outcome "not recovered", described as "weakess". The events "racing/pounding heart", "short of breath", "nasuea", "fever", "diarehea", "dizziness", "headache", "chills", "body aches" and "weakess" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of palpitations, dyspnoea, nausea, pyrexia, diarrhoea, dizziness, headache, chills, pain, asthenia.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Nausea, Pain, Palpitations
Clinical narrative: Racing/pounding heart; short of breath; nasuea; fever; diarehea; dizziness; headache; chills; body aches; weakess; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Sep2021 12:00 (Lot number: fd8448) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Had Covid Nov 2020", start date: Nov2020 (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: LEVOTHYROXINE and multi vitamin. The following information was reported: PALPITATIONS (non-serious) with onset 05Sep2021, outcome "not recovered", described as "Racing/pounding heart"; DYSPNOEA (non-serious) with onset 05Sep2021, outcome "not recovered", described as "short of breath"; NAUSEA (non-serious) with onset 05Sep2021, outcome "not recovered", described as "nasuea"; PYREXIA (non-serious) with onset 05Sep2021, outcome "not recovered", described as "fever"; DIARRHOEA (non-serious) with onset 05Sep2021, outcome "not recovered", described as "diarehea"; DIZZINESS (non-serious) with onset 05Sep2021, outcome "not recovered", described as "dizziness"; HEADACHE (non-serious) with onset 05Sep2021, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 05Sep2021, outcome "not recovered", described as "chills"; PAIN (non-serious) with onset 05Sep2021, outcome "not recovered", described as "body aches"; ASTHENIA (non-serious) with onset 05Sep2021, outcome "not recovered", described as "weakess". The events "racing/pounding heart", "short of breath", "nasuea", "fever", "diarehea", "dizziness", "headache", "chills", "body aches" and "weakess" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of palpitations, dyspnoea, nausea, pyrexia, diarrhoea, dizziness, headache, chills, pain, asthenia.  No follow-up attempts are possible. No further information is expected.