chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: Racing heart rate; 104+fever; shortness of breath; Pain in Chest/Throat; Pain in Chest/Throat; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 15-years-old male patient received second dose of bnt162b2 (BNT162B2), Formulation: Solution for injection, Batch/Lot Number: EW0177; Expiration Date: Aug2021), via an intramuscular, administered in Arm Left on 04Jun2021 at 10:00 (at the age of 15-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient was 15-years-old at the time of vaccination. Facility type vaccine was Other, Facility type vaccine other was a former grocery store now, vacant/(Facility name), No other vaccine in four weeks. No, other medications in two weeks, No, covid prior vaccination, No, vaccination administered facility was not military facility. The patient medical history included autism spectrum disorder, autism spectrum disorder. There were no concomitant medications. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient previously received first dose of COMIRNATY (Lot Number: EJ6134), via an Intramuscular, administered in Arm Left on 14May2021 at 10:00 AM for COVID-19 immunisation. It was reported that on 04Jun2021 22:30, the patient experienced racing heart rate, 104+fever, shortness of breath, pain in chest/throat, pain in chest/throat. No, treatment for ae. Therapeutic measures were taken as a result of racing heart rate, 104+fever, shortness of breath. No, covid tested post vaccination. Yes, treatment (NSAID, call to on call physician, cool bath). The patient underwent lab tests and procedures which included body temperature was 104+ fever, heart rate was racing heart rate. The outcome of event was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Racing heart rate; 104+fever; shortness of breath; Pain in Chest/Throat; Pain in Chest/Throat; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 15-years-old male patient received second dose of bnt162b2 (BNT162B2), Formulation: Solution for injection, Batch/Lot Number: EW0177; Expiration Date: Aug2021), via an intramuscular, administered in Arm Left on 04Jun2021 at 10:00 (at the age of 15-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient was 15-years-old at the time of vaccination. Facility type vaccine was Other, Facility type vaccine other was a former grocery store now, vacant/(Facility name), No other vaccine in four weeks. No, other medications in two weeks, No, covid prior vaccination, No, vaccination administered facility was not military facility. The patient medical history included autism spectrum disorder, autism spectrum disorder. There were no concomitant medications. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient previously received first dose of COMIRNATY (Lot Number: EJ6134), via an Intramuscular, administered in Arm Left on 14May2021 at 10:00 AM for COVID-19 immunisation. It was reported that on 04Jun2021 22:30, the patient experienced racing heart rate, 104+fever, shortness of breath, pain in chest/throat, pain in chest/throat. No, treatment for ae. Therapeutic measures were taken as a result of racing heart rate, 104+fever, shortness of breath. No, covid tested post vaccination. Yes, treatment (NSAID, call to on call physician, cool bath). The patient underwent lab tests and procedures which included body temperature was 104+ fever, heart rate was racing heart rate. The outcome of event was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 53-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 30May2021 at 00:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient has no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. 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 02May2021 at 00:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jun2021 at 04:00 the patient experienced fever and also got shingles two days after the second COVID vaccine dose. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. On 06Jun2021, the patient underwent PCR test (nasal swab) and the result was negative. The clinical outcome of the events fever and shingles were not recovered at the time of the report.  The lot number for the vaccine [BNT162b2] was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle spasms, Myalgia, Spinal pain
Clinical narrative: Extreme joint and muscle pain in shoulders, upper arms, wrists, hands; Extreme joint and muscle pain in shoulders, upper arms, wrists, hands, and occasionally lower spine.; Extreme joint and muscle pain in shoulders, upper arms, wrists, hands; Muscle spasms in upper back and shoulders.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 12:00 (at the age of 56-years-old) as a dose 2, single for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any other medications within 2 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 on an unknown date (at the age of 56-years-old) as a dose 1 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 04Mar2021 at 03:00, the patient experienced extreme joint and muscle pain in shoulders, upper arms, wrists, hands and occasionally lower spine and muscle spasms in upper back and shoulders. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events extreme joint and muscle pain in shoulders, upper arms, wrists, hands and occasionally lower spine and muscle spasms in upper back and shoulders were not resolved.    The batch/lot numbers for BNT162b2 were not provided and will be requested during follow-up.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Headache, Pain in extremity, Pyrexia
Clinical narrative: Arm pain; Arm pain that reflected also in the back; Arm pain that reflected also in the left hand.; Fever below 100; headache; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Jun2021 at 20:00 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and hypothyroidism and penicillin allergy. Concomitant medications included metformin (MANUFACTURER UNKNOWN), semaglutide (RYBELSUS), empagliflozin (JARDIANCE), glipizide (MANUFACTURER UNKNOWN) and simvastatin (SEVERAL). The patient previously took Codeine on an unspecified date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Jun2021 at 01:00, the patient experienced arm pain that reflected also in the back and left hand, fever below 100 and headache. No therapeutic measures were taken as a result of the events. The clinical outcome of the events arm pain that reflected in the back and left hand, fever below 100 and headache was resolving at the time of this report.    The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Excessive periods. I was in perimenopause with lighter/ cycles over past 4 yrs.  Since vaccination began, I have had cycles on 01Apr, 29Apr & 05Jun which were each heavier; This is a spontaneous report from a contactable consumer reporting for herself. A 48-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 intramuscular, administered in Arm Left on 09Apr2021 16:00 (Batch/Lot Number: EW0153; Expiration Date: 31Jul2021) as dose 2, single, dose 1 intramuscular, administered in Arm Left on 17Mar2021 17:30 (Batch/Lot Number: EN6204; Expiration Date: 30Jun2021) as dose 1, single (at the age of 48-years-old) for covid-19 immunization. Medical history included menopause from Mar2017 and ongoing. Concomitant medication included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) via unspecified route in arm as single dose taken for immunization in 03Mar2021. Historical vaccine included TDAP on 17May2011 + prior via unspecified route in arm for immunization. The patient did not have any known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Pertinent details included Monthly cycle slowing X 4years. In 2020 laveraged 5 cycles of lele days long. Last period before vaccine was 31Oct2020 and cycle lasted 152 days. It was reported that, excessive periods, she was in perimenopause with lighter/shorter cycles over past 4 yrs. No cycle at all in 5 months. Since vaccination began, she has had cycles on 01Apr2021, 29Apr2021 & 05Jun2021 which were each heavier than she had had in several years. Vaccine 1 on 17Mar2021 and Period on 01Apr2021 (28 days cycle), then Vaccine 2 on 09Apr2021 and Periods on 29Apr2021 (37 days cycle). Again period on 06May2021. This one was very heavy in first 24 hours heaviest she had in year. She had made it 5 months w/o menses before vaccine triggered monthly cycles. Saw primary care physician (PCP) on 16Jun2021 but symptoms had resolved. As of 25Jul2021 still waiting on next monthly cycle but hoping frequency resumes the prior normal length. The patient did not receive any treatment for adverse event. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort
Clinical narrative: Ears clogged and wont pop back; This is a spontaneous report from a contactable consumer, the patient. A 16-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 05Jun2021 at 09:15 (at the age of 16-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included antidepressants and ADD meds from unknown dates for unspecified indications. 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 07May2021 at 09:00 (at the age of 16-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 06Jun2021 at 18:00, the patient experienced ears clogged and won't pop back (like when fly on a plane). It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event ears clogged and won't pop back was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Decreased appetite, Dizziness, Fatigue, Nausea
Clinical narrative: "Beginning on day 2 after first dose, extreme tiredness no matter how much sleep I get".; Always nauseated; No appetite whatsoever; "Vomiting occurred on one day only"; Vivid dreams every night; Nightmarish dreams every night; Dizziness only for the first week.; This is a spontaneous report from a contactable consumer, the patient. A 59-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 19May2021 at 18:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included COVID-19, shellfish allergy that caused severe nausea, blood pressure abnormal and ankle bloating caused due to ace inhibitors which were tried previously for BP (blood pressure) control. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide (HCTZ) and carvedilol (MANUFACTURER UNKNOWN); both for unknown indications from unspecified dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 21May2021, beginning on the second day after the first dose, the patient experienced extreme tiredness no matter how much sleep she got, she was always nauseated, she had no appetite whatsoever, she had vomiting which occurred on one day only, she had vivid nightmarish dreams every night which was not normal for her and dizziness only for the first week. Since the vaccination, the patient had not been tested for COVID-19.  The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of these events. The clinical outcome of the event's extreme tiredness, nauseated, no appetite, vivid nightmarish dreams was not resolved at the time of the report. The clinical outcome of the event vomiting was resolved on 22May2021. The clinical outcome of the event dizziness was resolved on an unspecified date in May2021, after the duration of a week at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nightmare, Vomiting
Clinical narrative: "Beginning on day 2 after first dose, extreme tiredness no matter how much sleep I get".; Always nauseated; No appetite whatsoever; "Vomiting occurred on one day only"; Vivid dreams every night; Nightmarish dreams every night; Dizziness only for the first week.; This is a spontaneous report from a contactable consumer, the patient. A 59-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 19May2021 at 18:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included COVID-19, shellfish allergy that caused severe nausea, blood pressure abnormal and ankle bloating caused due to ace inhibitors which were tried previously for BP (blood pressure) control. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide (HCTZ) and carvedilol (MANUFACTURER UNKNOWN); both for unknown indications from unspecified dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 21May2021, beginning on the second day after the first dose, the patient experienced extreme tiredness no matter how much sleep she got, she was always nauseated, she had no appetite whatsoever, she had vomiting which occurred on one day only, she had vivid nightmarish dreams every night which was not normal for her and dizziness only for the first week. Since the vaccination, the patient had not been tested for COVID-19.  The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of these events. The clinical outcome of the event's extreme tiredness, nauseated, no appetite, vivid nightmarish dreams was not resolved at the time of the report. The clinical outcome of the event vomiting was resolved on 22May2021. The clinical outcome of the event dizziness was resolved on an unspecified date in May2021, after the duration of a week at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza, Loss of personal independence in daily activities, Pain
Clinical narrative: Flu symptoms; Full body ache; Headache; Could not function; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27May2021 at 14:00 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure/ high cholesterol and COVID-19. Concomitant medications included alfuzosin hydrochloride (MANUFACTURER UNKNOWN), olmesartan medoxomil(OMESAR), rosuvastatin (MANUFACTURER UNKNOWN) and tadalafil (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient previously took clindamycin (MANUFACTURER UNKNOWN) for unspecified indication from unknown date and experienced drug allergy. Prior to 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 28May2021, the patient experienced full body ache to include headache, by 24 hours patient could not function. On 29May2021, day 3, pain was subsiding. On 30May2021, by day 4, the patient experienced flu symptoms. The events 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 event full body ache, headache, could not function and flu symptoms was recovered on an unknown date of 2021.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Vertigo; Numb hands and arms; Was sore all over; Throat closed; Trouble swallowing; Trouble breathing; Itchy feeling all over body; Bad headaches; Tingly hands and arms; Fatigue feeling/tired very easily; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0176) via an unspecified route of administration in the arm right on 02May2021 at 16:30(at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any other medications within two weeks of vaccination. Prior to 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 02May2021 at 18:00, the patient had bad headaches within a couple of hours worst in his life for about 4 days, vertigo for 6-7 days, itchy feeling all over body, numb and tingly hands and arms. The patient was sore all over and fatigue feeling for at least 6 days. Throat closed had trouble swallowing and had trouble breathing got tired very easily. Patient was in so much pain; as patient wanted to pull his hair out. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events vertigo, numb and tingly hands and arms, sore all over, throat closed, trouble swallowing, trouble breathing, itchy feeling all over body, bad headaches and fatigue feeling/tired very easily were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Pruritus, Throat tightness, Vertigo
Clinical narrative: Vertigo; Numb hands and arms; Was sore all over; Throat closed; Trouble swallowing; Trouble breathing; Itchy feeling all over body; Bad headaches; Tingly hands and arms; Fatigue feeling/tired very easily; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0176) via an unspecified route of administration in the arm right on 02May2021 at 16:30(at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any other medications within two weeks of vaccination. Prior to 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 02May2021 at 18:00, the patient had bad headaches within a couple of hours worst in his life for about 4 days, vertigo for 6-7 days, itchy feeling all over body, numb and tingly hands and arms. The patient was sore all over and fatigue feeling for at least 6 days. Throat closed had trouble swallowing and had trouble breathing got tired very easily. Patient was in so much pain; as patient wanted to pull his hair out. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events vertigo, numb and tingly hands and arms, sore all over, throat closed, trouble swallowing, trouble breathing, itchy feeling all over body, bad headaches and fatigue feeling/tired very easily were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Severe pain in joints; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6203) via an unspecified route of administration in the right arm on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history included arthritis on an unknown date. Concomitant medications were not reported. The patient previously received sulfa drugs (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced sulfonamide allergy, codeine (MANUFACTURER UNKNOWN) and morphine (MANUFACTURER UNKNOWN) both for unknown indication on unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EM9809) via an unspecified route of administration in the right arm on 02Feb2021 at 13:00 as a single dose for COVID-19 immunisation. On 05Mar2021, since the patient got the second dose the patient had severe pain in her joints. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event and included treatment with prednisolone (MANUFACTURER UNKNOWN) from an unknown date in 2021 and without relief. This pain had lasted 3 months. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe pain in joints was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Genital lesion
Clinical narrative: Genital lesions appeared one week after second dose; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), second dose via an unspecified route of administration on 21Apr2021 (at the age of 37 years) as single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. On an unspecified date 2021 the patient experienced genital lesions which appeared one week after second dose. The adverse event was resulted in Doctor or other healthcare professional office/clinic visit. Patient was treated with steroids and topical ointments for the adverse event. The outcome of the event was not recovered.   The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Sore arm; Exhaustion; Chills; Sweats; Tense muscles; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on 03Jun2021 at 09:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was reported as none. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW077) via an unspecified route of administration in the left arm on 12May2021 at 16:15 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 03Jun2021 at 22:00, the patient experienced sore arm, exhaustion, chills, sweats and tense muscles. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events sore arm, exhaustion, chills, sweats, and tense muscles were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Got shingles 4weeks after 2nd dose; This is a spontaneous report from a non-contactable consumer, the patient. A 52-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 on an unknown date as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient experienced shingles 4 weeks after the second dose. The patient underwent COVID-19 test (nasal swab test) on an unknown date and the result was negative. Therapeutic measures were taken as a result of shingles. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event shingles was recovering at the time of reporting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Gait disturbance, Vaccination site pruritus
Clinical narrative: Loss of appetite; tiredness; itching at injection site; diarrhea; and difficultywalking 1st day after vaccine.; This is a spontaneous report from a contactable consumer, the patient. An 86-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW018S) via an unspecified route of administration in the left arm on 27May2021 at 11:15 as a single dose for COVID-19 immunisation. Medical history included diabetes, hypertension and stenosis in L-5. The patient had no known allergies to medications, food or other products. Concomitant medications included metformin (MANUFACTURER UNKNOWN), glipizide (GLUCOTROL) and acetylsalicylic acid (BABY ASPIRIN) all from an unknown date for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWONO) via an unspecified route of administration in the left arm on 06May2021 at 11:15 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 COVID vaccine. On 28May2021, the patient experienced loss of appetite, tiredness itching at injection site, diarrhea, and difficulty walking 1st day after vaccine. Each subsequent day ambulation improved, then normal for patient. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included home therapies. The clinical outcomes of the events loss of appetite, tiredness itching at injection site, diarrhea, and difficulty walking were recovered on unknown date in 2021.  No follow-up attempts are needed. No further information is expected
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Palpitations, Swelling
Clinical narrative: Swelling; Anxiety attacks; Palpitations; Chest pains; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: CL8729) via an unspecified route of administration in the arm left on 29Apr2021(at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included lupus syndrome, hypothyroidism, hypercholesterolemia and sulfonamide allergy. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), Levothyroxine (MANUFACTURER UNKNOWN) and hydroxychloroquine (MANUFACTURER UNKNOWN) all from an unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:EL00171) via an unspecified route of administration in the arm left on 07Apr2021(at the age of 51-year-old) as a single dose for COVID-19 immunisation. 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 an unknown date in May2021 the patient experienced anxiety attacks, swelling, chest pains and palpitations. No therapeutic measures were taken as a result of the events. The clinical outcome of the events anxiety attacks, swelling, chest pains and palpitations were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood beta-D-glucan, Breast swelling, Bronchospasm, Chest discomfort
Clinical narrative: anaphylactic reaction; Respiratory distress; Bilateral wheeze/bronchospasm; Shortness of breath, walking and severe if uphill/Difficulty breathing; Sudden Coughing outburst; Diarrhea; Migraine; Overall not well; Tachycardia; chest tightness; swollen left lymphnode and left breast; swollen left lymphnode and left breast; fatigue; This is a spontaneous report from a contactable Other-HCP (patient). This is one of two reports reporting the same patient/same drug with different dose (the first) and events  A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ686), via an unspecified route of administration, administered in Arm Left on 04Jan2021 as single dose (at the age of 40) for covid-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination (nasal swab) was negative. Medical history included attention deficit hyperactivity disorder, gluten sensitivity, migraine. Concomitant medications included linaclotide (LINZESS), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), topiramate (TOPAMAX), ibuprofen (IBUPROFEN). The patient experienced respiratory distress on an unspecified date, anaphylactic reaction on an unspecified date, tachycardia on 04Jan2021, chest tightness on 04Jan2021, swollen left lymphnode and left breast on 04Jan2021, fatigue on 04Jan2021, bilateral wheeze/bronchospasm on an unspecified date, shortness of breath on an unspecified date, walking and severe if uphill/difficulty breathing on an unspecified date, sudden coughing outburst on an unspecified date, diarrhea on an unspecified date, migraine on an unspecified date, overall not well on an unspecified date. No treatment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events anaphylactic reaction, respiratory distress, bronchospasm and dyspnea and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: anaphylactic reaction; Respiratory distress; Bilateral wheeze/bronchospasm; Shortness of breath, walking and severe if uphill/Difficulty breathing; Sudden Coughing outburst; Diarrhea; Migraine; Overall not well; Tachycardia; chest tightness; swollen left lymphnode and left breast; swollen left lymphnode and left breast; fatigue; This is a spontaneous report from a contactable Other-HCP (patient). This is one of two reports reporting the same patient/same drug with different dose (the first) and events  A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ686), via an unspecified route of administration, administered in Arm Left on 04Jan2021 as single dose (at the age of 40) for covid-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination (nasal swab) was negative. Medical history included attention deficit hyperactivity disorder, gluten sensitivity, migraine. Concomitant medications included linaclotide (LINZESS), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), topiramate (TOPAMAX), ibuprofen (IBUPROFEN). The patient experienced respiratory distress on an unspecified date, anaphylactic reaction on an unspecified date, tachycardia on 04Jan2021, chest tightness on 04Jan2021, swollen left lymphnode and left breast on 04Jan2021, fatigue on 04Jan2021, bilateral wheeze/bronchospasm on an unspecified date, shortness of breath on an unspecified date, walking and severe if uphill/difficulty breathing on an unspecified date, sudden coughing outburst on an unspecified date, diarrhea on an unspecified date, migraine on an unspecified date, overall not well on an unspecified date. No treatment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events anaphylactic reaction, respiratory distress, bronchospasm and dyspnea and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory, Fatigue, Fibrin D dimer, Heart rate, Lymphadenopathy
Clinical narrative: anaphylactic reaction; Respiratory distress; Bilateral wheeze/bronchospasm; Shortness of breath, walking and severe if uphill/Difficulty breathing; Sudden Coughing outburst; Diarrhea; Migraine; Overall not well; Tachycardia; chest tightness; swollen left lymphnode and left breast; swollen left lymphnode and left breast; fatigue; This is a spontaneous report from a contactable Other-HCP (patient). This is one of two reports reporting the same patient/same drug with different dose (the first) and events  A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ686), via an unspecified route of administration, administered in Arm Left on 04Jan2021 as single dose (at the age of 40) for covid-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination (nasal swab) was negative. Medical history included attention deficit hyperactivity disorder, gluten sensitivity, migraine. Concomitant medications included linaclotide (LINZESS), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), topiramate (TOPAMAX), ibuprofen (IBUPROFEN). The patient experienced respiratory distress on an unspecified date, anaphylactic reaction on an unspecified date, tachycardia on 04Jan2021, chest tightness on 04Jan2021, swollen left lymphnode and left breast on 04Jan2021, fatigue on 04Jan2021, bilateral wheeze/bronchospasm on an unspecified date, shortness of breath on an unspecified date, walking and severe if uphill/difficulty breathing on an unspecified date, sudden coughing outburst on an unspecified date, diarrhea on an unspecified date, migraine on an unspecified date, overall not well on an unspecified date. No treatment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events anaphylactic reaction, respiratory distress, bronchospasm and dyspnea and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Migraine, Respiratory distress, SARS-CoV-1 test, Stress echocardiogram
Clinical narrative: anaphylactic reaction; Respiratory distress; Bilateral wheeze/bronchospasm; Shortness of breath, walking and severe if uphill/Difficulty breathing; Sudden Coughing outburst; Diarrhea; Migraine; Overall not well; Tachycardia; chest tightness; swollen left lymphnode and left breast; swollen left lymphnode and left breast; fatigue; This is a spontaneous report from a contactable Other-HCP (patient). This is one of two reports reporting the same patient/same drug with different dose (the first) and events  A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ686), via an unspecified route of administration, administered in Arm Left on 04Jan2021 as single dose (at the age of 40) for covid-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination (nasal swab) was negative. Medical history included attention deficit hyperactivity disorder, gluten sensitivity, migraine. Concomitant medications included linaclotide (LINZESS), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), topiramate (TOPAMAX), ibuprofen (IBUPROFEN). The patient experienced respiratory distress on an unspecified date, anaphylactic reaction on an unspecified date, tachycardia on 04Jan2021, chest tightness on 04Jan2021, swollen left lymphnode and left breast on 04Jan2021, fatigue on 04Jan2021, bilateral wheeze/bronchospasm on an unspecified date, shortness of breath on an unspecified date, walking and severe if uphill/difficulty breathing on an unspecified date, sudden coughing outburst on an unspecified date, diarrhea on an unspecified date, migraine on an unspecified date, overall not well on an unspecified date. No treatment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events anaphylactic reaction, respiratory distress, bronchospasm and dyspnea and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Troponin
Clinical narrative: anaphylactic reaction; Respiratory distress; Bilateral wheeze/bronchospasm; Shortness of breath, walking and severe if uphill/Difficulty breathing; Sudden Coughing outburst; Diarrhea; Migraine; Overall not well; Tachycardia; chest tightness; swollen left lymphnode and left breast; swollen left lymphnode and left breast; fatigue; This is a spontaneous report from a contactable Other-HCP (patient). This is one of two reports reporting the same patient/same drug with different dose (the first) and events  A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ686), via an unspecified route of administration, administered in Arm Left on 04Jan2021 as single dose (at the age of 40) for covid-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination (nasal swab) was negative. Medical history included attention deficit hyperactivity disorder, gluten sensitivity, migraine. Concomitant medications included linaclotide (LINZESS), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), topiramate (TOPAMAX), ibuprofen (IBUPROFEN). The patient experienced respiratory distress on an unspecified date, anaphylactic reaction on an unspecified date, tachycardia on 04Jan2021, chest tightness on 04Jan2021, swollen left lymphnode and left breast on 04Jan2021, fatigue on 04Jan2021, bilateral wheeze/bronchospasm on an unspecified date, shortness of breath on an unspecified date, walking and severe if uphill/difficulty breathing on an unspecified date, sudden coughing outburst on an unspecified date, diarrhea on an unspecified date, migraine on an unspecified date, overall not well on an unspecified date. No treatment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events anaphylactic reaction, respiratory distress, bronchospasm and dyspnea and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral
Clinical narrative: After about 25 minutes,  had numbness in my tongue and a strong metallic taste; After about 25 minutes, had numbness in my tongue and a strong metallic taste; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Jun2021 at 11:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to medications, food, or other products. The patient did not have any past drug history. The patient received unspecified medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Jun2021 at 11:30, about 25 minutes after vaccination, the patient experienced numbness in his tongue and a strong metallic taste. 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 numbness in tongue and a strong metallic taste was resolved on 05Jun2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.