chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash, Rash macular
Clinical narrative: Rashes and spots on both of arms and back; Rash on chest no spots; Headache increased; This is a spontaneous report from a contactable healthcare professional, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on 01Apr2021 at 13:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included migraines, iodine allergy and unspecified allergy called deloted. Concomitant medications included naratriptan (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN, tramadol (MANUFACTURER UNKNOWN) and ondansetron (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 15:00 the patient experienced rashes and spots on both arms and back, rash on chest no spots and headache increased. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of rashes and spots on both of arms and back, rash on chest no spots and headache increased included treatment with benadryl and cortizone 10. The clinical outcome of the event rashes and spots on both of arms and back, rash on the chest no spots and headache increased were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Presyncope
Clinical narrative: Vasovagal reactions; fatigue; dizziness; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 11:00 the patient experienced vasovagal reactions, fatigue and dizziness for over a week afterwards. The events did not result in doctor or other healthcare professional office/clinic visit.  No therapeutic measures were taken as the result of adverse events.  The clinical outcome of the events vasovagal reactions and fatigue was not recovered at the time of this report, whereas dizziness was recovered after a week on 13Apr2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site bruising, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness, itching, swelling and bruising around the injection site. Concern this is the 4th day and it's not improving; Redness, itching, swelling and bruising around the injection site. Concern this is the 4th day and it's not improving; Redness, itching, swelling and bruising around the injection site. Concern this is the 4th day and it's not improving; Redness, itching, swelling and bruising around the injection site. Concern this is the 4th day and it's not improving; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, chronic kidney disease stage 3 (reported as Kidney disease stage 3) and rheumatoid arthritis. The patient previously had lignocaine (reported as caines) and experienced drug allergy. Concomitant medication received within two weeks prior to vaccination included prescribed maintenance blood pressure and vitamin. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on 15Mar2021 at 09:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 19:00 the patient experienced redness, itching, swelling and bruising around the injection site. She was concerned it was the fourth day and it was not improving. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events redness, itching, swelling and bruising around the injection site was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable Pharmacist. A 52-year-old male pharmacist reported that he received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown) intramuscular into the right arm on 08Jan2021 at 10:15 AM (at the age of 52-year-old) at single dose and the second dose of  BNT162b2 (lot number unknown) on 29Jan2021at single dose for COVID-19 immunization. The patient had not  known allergies or other medical history. The patient had not Covid prior vaccination. Concomitant medications in two weeks were none. No other vaccine was administered in four weeks. The patient reported that on 07Apr2021 at 21:00 he started experiencing symptom of runny nose / head/nose congestion even though he had the Vaccine. On 09Apr2021 he underwent a rapid Nasal Swab COVID 19 test and was positive for COVID. He was treated with Vitamins for cold / sinus. the patient reported that he is the 5% or the vaccine does not block virus from coming in and it just lessen/ reduces symptoms and duration of COVID. The outcome of the event was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Swab COVID 19 test and was positive  load based on the known safety profile.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Body aches; Fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO153) via an unspecified route of administration in the left arm on 09Apr2021 at 15:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Apr2021 at 09:00, the patient experienced fever and chills, body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of fever, chills and body aches were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Mobility decreased, Myalgia, Pain
Clinical narrative: Diagnosed with PMR; severe myalgia/muscle aches - shoulders, gluteus muscles, thighs; Arthralgia - shoulders, gluteus muscles, thighs; severe chills; was unable to move; Generalized pains in muscle and joints.; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is one of the two reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was diagnosed with polymyalgia rheumatica (PMR), severe myalgia/muscle aches - shoulders, gluteus muscles, thighs, arthralgia - shoulders, gluteus muscles, thighs, severe chills, was unable to move, and generalized pains in muscle and joints. The events resulted to doctor or other healthcare professional visit. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The association between the event polymyalgia rheumatica with BNT1612b2 can not be fully excluded based on the limited information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021405461 same reporter/drug, similar event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: Diagnosed with PMR; severe myalgia/muscle aches - shoulders, gluteus muscles, thighs; Arthralgia - shoulders, gluteus muscles, thighs; severe chills; was unable to move; Generalized pains in muscle and joints.; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is one of the two reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was diagnosed with polymyalgia rheumatica (PMR), severe myalgia/muscle aches - shoulders, gluteus muscles, thighs, arthralgia - shoulders, gluteus muscles, thighs, severe chills, was unable to move, and generalized pains in muscle and joints. The events resulted to doctor or other healthcare professional visit. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The association between the event polymyalgia rheumatica with BNT1612b2 can not be fully excluded based on the limited information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021405461 same reporter/drug, similar event, different patient
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph node swollen on left side of neck; This is a spontaneous report from a contactable healthcare professional. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 19Mar2021 at 10:45 (at the age of 34-years-old) and received second dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:ER8729) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included sertraline hydrochloride (ZOLOFT) and ethinylestradiol, levonorgestrel (PORTIA-28). The patient had no known allergies. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, the patient experienced lymph node swollen on left side of neck. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of this event. The clinical outcome of the event lymph node swollen on left side of neck was not recovered at this time of report.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Henoch-Schonlein purpura
Clinical narrative: Purpura rash has been inflamed; Purpura rash has been inflamed; This is a spontaneous report. A contactable consumer (patient) reported a 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection; Lot number: EN6205 and Expiration date: not reported) via an unspecified route of administration, administered on the right arm on 26Mar2021 08:15 (at the age of 58 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history included Henoch-Schonlein purpura (HSP/Iga). Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient stated that the purpura rash has been inflamed. The patient did not receive any treatment for the event. The patient also stated that few people have noted the same. One lady hasn't had a flare-up in 30 years but after her injection did have a flare-up. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event purpura rash has been inflamed was not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 105.5; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 10:30(at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and penicillin allergy. The patient received other medication(unspecified) within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Mar2021 at 11:15 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. The patient also took acetyl salicylic acid, ascorbic acid(ASPIRIN) and ibuprofen sodium(IBUPROFEN) on unknown dates and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 01:00, the patient experienced fever of 105.5. The patient did not receive any treatment for the reported event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. On 10Apr2021, the patient underwent body temperature test and the result was 105.5(unit unspecified). The clinical outcome of the event fever of 105.5 was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Bradycardia, Feeling abnormal, Heart rate, Hyperhidrosis
Clinical narrative: Hart rate drop to 30 beats per minute from  62; Blood pressure drop; Nausea; Sweating; Could feel a change and felt very strange starting in my head and neck; The feeling got worse as the minutes ticked by; This is a spontaneous report from a contactable consumer.   A 61-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm, on 09Apr2021 14:15 (Batch/Lot Number: ew0158) as a single dose, for covid-19 immunisation. Medical history included an allergy to sulfa drugs. There were no concomitant medications.  On 09Aug2021, at 14:30,  the patient experienced "Nausea, sweating, blood pressure drop, hart rate drop to 30 beats per minute from 62 which is normal for me, within twelve minutes of getting the shot. After the shot within 3 or 4 minutes I could feel a change and felt very strange starting in my head and neck.. The feeling got worse as the minutes ticked by. Motioned for one of the girls to send the paramedics over. They hooked me to the blood and hart monitor. The reaction eventually faded and my heart rate and blood pressure went back to normal after about 15 minutes." There was no treatment nor hospitalization for the event. The outcome of the event was recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. And since the vaccination, the patient has not been tested for COVID-19.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Hart rate drop to 30 beats per minute from  62; Blood pressure drop; Nausea; Sweating; Could feel a change and felt very strange starting in my head and neck; The feeling got worse as the minutes ticked by; This is a spontaneous report from a contactable consumer.   A 61-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm, on 09Apr2021 14:15 (Batch/Lot Number: ew0158) as a single dose, for covid-19 immunisation. Medical history included an allergy to sulfa drugs. There were no concomitant medications.  On 09Aug2021, at 14:30,  the patient experienced "Nausea, sweating, blood pressure drop, hart rate drop to 30 beats per minute from 62 which is normal for me, within twelve minutes of getting the shot. After the shot within 3 or 4 minutes I could feel a change and felt very strange starting in my head and neck.. The feeling got worse as the minutes ticked by. Motioned for one of the girls to send the paramedics over. They hooked me to the blood and hart monitor. The reaction eventually faded and my heart rate and blood pressure went back to normal after about 15 minutes." There was no treatment nor hospitalization for the event. The outcome of the event was recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. And since the vaccination, the patient has not been tested for COVID-19.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Within 5-6 hours of receiving the vaccine, developed a rash on abdomen, mainly on the left side.; Rash consists of a few dozen small reditchy bumps; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8737) via an unspecified route of administration in the arm left on 03Apr2021 at 16:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE) from an unknown date and for an unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6206) via an unspecified route of administration in the arm left on 13Mar2021 at 16:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 21:30, within 5-6 hours of receiving the vaccine the patient developed a rash on abdomen, mainly on the left side. The rash consists of a few dozen small red itchy bumps. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events rash on abdomen, mainly on the left side and small red itchy bumps were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: "3 hours after receiving his first dose he vomited violently. He then vomited every hour for the next 9 hours"; "also had diarrhea"; This is a spontaneous report from a contactable consumer, the parent. A 16-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ew0153) via an unspecified route of administration in the left arm on 09Apr2021 at 17:30 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to seasonal hay fever and sulfa drugs. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 20:30, 3 hours after receiving the first dose, the patient vomited violently. The patient then vomited every hour for the next 9 hours, and also had diarrhoea. The patient had not been vomiting now (at the time of this report) for the past 8 hours but his diarrhoea continued. The vomiting was so severe that they were encouraged to bring him to the hospital, but did not do so (as reported). The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events "3 hours after receiving his first dose he vomited violently. He then vomited every hour for the next 9 hours" and "also had diarrhea" were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Chills, Feeling hot, Hyperhidrosis
Clinical narrative: slight fever; joint pain all over; severe neck pain; armpit pain; teeth pain; hands got warm sensation; sweating with no fever; slept hard for 15 hours; severe chills; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0158) via an unspecified route of administration in the right arm on 08Apr2021 at 10:45 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, asthma, blood pressure high and the patient was allergic to penicillin. Concomitant medications included metoprolol succinate (MANUFACTURER UNKNOWN) 25 mg and losartan (MANUFACTURER UNKNOWN) and potassium (MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7534) via an unspecified route of administration in the right arm on 18Mar2021 at 11:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 02:30, the patient experienced severe chills. On the same day, two hours later at 04:30, the patient experienced slight fever, joint pain all over, severe neck pain, arm pit pain, teeth pain, hands got warm sensation, sweating with no fever and slept hard for 15 hours. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events severe chills, slight fever, joint pain all over, severe neck pain, arm pit pain, teeth pain, hands got warm sensation, sweating with no fever and slept hard for 15 hours was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Neck pain, Pyrexia, Toothache
Clinical narrative: slight fever; joint pain all over; severe neck pain; armpit pain; teeth pain; hands got warm sensation; sweating with no fever; slept hard for 15 hours; severe chills; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0158) via an unspecified route of administration in the right arm on 08Apr2021 at 10:45 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, asthma, blood pressure high and the patient was allergic to penicillin. Concomitant medications included metoprolol succinate (MANUFACTURER UNKNOWN) 25 mg and losartan (MANUFACTURER UNKNOWN) and potassium (MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7534) via an unspecified route of administration in the right arm on 18Mar2021 at 11:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 02:30, the patient experienced severe chills. On the same day, two hours later at 04:30, the patient experienced slight fever, joint pain all over, severe neck pain, arm pit pain, teeth pain, hands got warm sensation, sweating with no fever and slept hard for 15 hours. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events severe chills, slight fever, joint pain all over, severe neck pain, arm pit pain, teeth pain, hands got warm sensation, sweating with no fever and slept hard for 15 hours was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Lymphadenopathy, Pain
Clinical narrative: Wednesday morning when I woke up I had severe body pain; Barely walk; Lymph node under the left arm swelled up the size of a water balloon.; Severe fatigue; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO150), via an unspecified route of administration in the left arm on 06Apr2021 at 10:45 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma, hypertension, COVID-19, shellfish allergy and allergy to nuts. Concomitant medications included clonidine (MANUFACTURER UNKNOWN) 0.1mg, 3 times a day and amlodipine (MANUFACTURER UNKNOWN) 10 mg, once a day; both from unknown dates for unspecified indications. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 14:00, the patient experienced severe fatigue Tuesday evening. On 07Apr2021, Wednesday morning when the patient woke up, had severe body pain and could barely walk, Wednesday evening into the night, the patient's lymph node under the left arm swelled up the size of a water balloon. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events severe fatigue, had severe body pain, could barely walk and lymph node under the left arm swelled up the size of a water balloon were resolving at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Fatigue, Myalgia, SARS-CoV-2 test
Clinical narrative: "I was getting: tired"; Muscle pain; Joint pain; Upset stomach; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Apr2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient had no past medical history. The patient did not receive any other medication within two weeks of vaccination. On 20Feb2021, the patient underwent COVID-19 (test type: nasal swab) and the result was negative. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 20Mar2021 at 09:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. On 10Apr2021 at 09:45, the patient was getting tired and muscle pain and joint pain and upset stomach. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event "I was getting: tired", muscle pain, joint pain and upset stomach was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Nausea, Pyrexia, Somnolence
Clinical narrative: Woke up at 5am with Fever; Deep sweat; Feeling groggy; Slight chills; About 30 mins nausea; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 09Apr2021 at 12:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included uric acid high, elevated blood pressure (bp) and penicillin allergy. Concomitant medications included colchicine (MANUFACTURER UNKNOWN), febuxostat (MANUFACTURER UNKNOWN), indometacin (MANUFACTURER UNKNOWN) and ascorbic acid, betacarotene, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine, tin, tocopheryl acetate, vanadium, vitamin k nos, zinc (CENTRUM MEN) all from unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 12Mar2021 at 16:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patient previously took Daypro on an unknown date for unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 at 13:00 about 30 mins, the patient experienced nausea, at 13:15 followed by feeling groggy then slight chills. Woke up at 5am on 10Apr2021 with fever, nausea and chills. Woke up in a deep sweat, but patient was feeling much better. Still a little nausea after lunch, but not too bad. Therapeutic measures were taken as a result of adverse events with Tylenol and Advil. The clinical outcome of the event nausea at 13:00, followed by feeling groggy then slight chills at 13:15. Woke up at 5am on 10Apr2021 with Fever, nausea and Chills. Woke up in a deep sweat, but patient was feeling much better. Still a little nausea after lunch were resolving.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Extreme fatigue; Headaches; chest pain; dizziness; sweats; chills; fever; body aches; nausea; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6199) via an unspecified route of administration in the right arm on 10Mar2021 at 11:15 (at the age of 48-year-old) as dose 1, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included Hypothyroid. Concomitant medications included unspecified daily vitamins, BHR hormone replacement and Thyroid from unknown dates for unknown indications. The patient previously took Prochlorperazine (COMPAZINE) on unknown date for unknown indication and experienced drug allergy. The patient previously took low dose crestor of dose 2.5 mg on unknown dates for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, after 1st dose, the patient experienced extreme fatigue, headaches, chest pain, dizziness, sweats, chills, fever, body aches and nausea for over a week. It was reported that the patient never had COVID and rarely got sick, had not got a vaccine for anything since college and never got sick with flu or had the flu vaccine. It was reported that the patient's health had always been good rarely get sick even if family comes down with anything. The events resulted in doctor or other healthcare professional office/clinic visit. On 19Mar2021and on 09Apr2021, the patient underwent SARS-CoV-2 test (Nasal Swab), and the result was negative both the times. Therapeutic measures were taken as a result of the events and included unspecified treatment (also reported as tested for COVID). The clinical outcome of the events extreme fatigue, headaches, chest pain, dizziness, sweats, chills, fever, body aches and nausea for over a week were recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Extreme fatigue; Headaches; chest pain; dizziness; sweats; chills; fever; body aches; nausea; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6199) via an unspecified route of administration in the right arm on 10Mar2021 at 11:15 (at the age of 48-year-old) as dose 1, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included Hypothyroid. Concomitant medications included unspecified daily vitamins, BHR hormone replacement and Thyroid from unknown dates for unknown indications. The patient previously took Prochlorperazine (COMPAZINE) on unknown date for unknown indication and experienced drug allergy. The patient previously took low dose crestor of dose 2.5 mg on unknown dates for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, after 1st dose, the patient experienced extreme fatigue, headaches, chest pain, dizziness, sweats, chills, fever, body aches and nausea for over a week. It was reported that the patient never had COVID and rarely got sick, had not got a vaccine for anything since college and never got sick with flu or had the flu vaccine. It was reported that the patient's health had always been good rarely get sick even if family comes down with anything. The events resulted in doctor or other healthcare professional office/clinic visit. On 19Mar2021and on 09Apr2021, the patient underwent SARS-CoV-2 test (Nasal Swab), and the result was negative both the times. Therapeutic measures were taken as a result of the events and included unspecified treatment (also reported as tested for COVID). The clinical outcome of the events extreme fatigue, headaches, chest pain, dizziness, sweats, chills, fever, body aches and nausea for over a week were recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Ocular discomfort
Clinical narrative: High pressure in eyes; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 09Apr2021 at 10:15 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 at 14:00, the patient experienced high pressure in eyes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of high pressure in eyes was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Skin warm
Clinical narrative: Body aches; Swollen lymph node in the underarm area, it was very tender; Lymph node slightly warm to the touch; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 08Apr2021 at 16:30 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient was not allergic to any medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. It was unknown whether the patient received any other vaccines within four weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 18Mar2021 at 16:30 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. On 10Apr2021 at around 07:30, the patient woke up with body aches and a swollen lymph node in the underarm area. The lymph node was very tender, swollen, and slightly warm to the touch. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events body aches, swollen lymph node in the underarm area, lymph node was very tender and slightly warm to the touch was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Pain, Pyrexia
Clinical narrative: Fever fatigue tired , body aches , shortening of breath, even after 5 days, getting worse daily; Fever fatigue tired , body aches , shortening of breath, even after 5 days, getting worse daily; Fever fatigue tired , body aches , shortening of breath, even after 5 days, getting worse daily; Fever fatigue tired , body aches , shortening of breath, even after 5 days, getting worse daily; Fever fatigue tired , body aches , shortening of breath, even after 5 days, getting worse daily; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 05Apr2021 at 18:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient previously had sulpha and experienced sulfonamide allergy (reported as sulpha). Concomitant medications taken within two weeks prior to vaccination were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 06:00, the patient experienced fever fatigue tired, body aches, shortening of breath, even after five days, it was getting worse daily. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fever fatigue tired, body aches, shortening of breath, even after five days, it was getting worse daily was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Chest pain
Clinical narrative: pain in left armpit.; had pain in my left armpit. Then it went around to the chest area. It was very painful. If I hiccupped I would experience extreme pain.; felt the pain in my back area after that; This is a spontaneous report from a non-contactable consumer, the patient. A 68-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 02Apr2021 at 11:00 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, arthritis, knee and hip replacement and allergy nos. The patient received unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on an unknown date, as a single dose for COVID-19 immunisation. The patient had allergies to medications, food, or other products but cannot remember what it was exactly. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 11:00, approximately 24 hours after the vaccination the patient experienced pain in left armpit which then went around to the chest area. It was very painful. If patient hiccupped, he experienced extreme pain and also felt the pain in back area after that. The events resulted in visit to emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with pain killer tramadol. The clinical outcome of the events pain in left armpit which then went around to the chest area and pain in back area were recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Myalgia, Pain in extremity, Paraesthesia oral
Clinical narrative: Tingling in tongue; Soreness in arm; Muscle pains; Low back pain; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 09Apr2021 at 11:15 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included postpartum depression and blood pressure high. The patient was allergic to nuts and psyllium. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) and bupropion hydrochloride (WELLBUTRIN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 11:30, the patient experienced tingling in tongue approximately 15 minutes after vaccine lasting upwards of 6 hours, soreness in arm, muscle pains, low back pain and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events tingling in tongue, soreness in arm, muscle pains, low back pain and tiredness were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.