chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Headache, Pain in extremity
Clinical narrative: Strong headache with pain in left leg Tight chest pain; Pain in left leg; Tight chest pain; This is a spontaneous report from a contactable consumer, the patient. A 64-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 arm on 08Apr2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The medical history included hipo thyroid. The patient had no known allergies. 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 concomitant medications included levothyroxine sodium (SYNTHROID) for an unknown indication from an unknown date and unknown if ongoing. 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 19Mar2021 at 09:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 08Apr2021 at 18:00, the patient experienced strong headache with pain in left leg and tight chest pain. The adverse 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events strong headache with pain in left leg and tight chest pain was not resolved at the time of this report.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysmenorrhoea, Polymenorrhoea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 30-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EP7355), at the age of 30, via an unspecified route of administration, in the left arm, on Mar 28, 2021, at 20:45, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 4, 2021 (7 days after vaccine), patient experienced extreme menstrual cramps for 2 days. On Apr 11, 2021 (14 days after vaccine), patient experienced a period 7 days early (only lasted 2 days). The events did not result in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. No therapeutic measures taken as a result of events. Since the vaccination, patient has not tested for COVID-19. The outcome of extreme menstrual cramps for 2 days recovered on Apr 6, 2021; a period 7 days early (only lasted 2 days) recovered on Apr 13, 2021. No follow-up attempts needed. No further information expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstruation irregular, Premenstrual pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 30-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EP7355), at the age of 30, via an unspecified route of administration, in the left arm, on Mar 28, 2021, at 20:45, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 4, 2021 (7 days after vaccine), patient experienced extreme menstrual cramps for 2 days. On Apr 11, 2021 (14 days after vaccine), patient experienced a period 7 days early (only lasted 2 days). The events did not result in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. No therapeutic measures taken as a result of events. Since the vaccination, patient has not tested for COVID-19. The outcome of extreme menstrual cramps for 2 days recovered on Apr 6, 2021; a period 7 days early (only lasted 2 days) recovered on Apr 13, 2021. No follow-up attempts needed. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Dizziness, Dysphonia
Clinical narrative: Difficult breathing; Fast heart beat; Dizzy; Weak; Difficult breathing, fast heart beat, dizzy and weak, chest pain 10 -14 days after; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 01Apr2021 at 02:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took levofloxacin (LEVAQUIN) for unknown indication on an unknown date and experienced drug allergy. On 02Apr2021, the patient experienced difficult breathing, fast heartbeat, dizzy and weak. On an unknown date in Apr2021, 10 -14 days after patient experienced chest pain. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with acetaminophen (TYLENOL). Since the vaccination, the patient had been tested for COVID-19. On 10Apr2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the event difficult breathing, fast heartbeat, dizzy and weak, chest pain 10 -14 days after was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Gait disturbance, Paraesthesia, SARS-CoV-2 test negative
Clinical narrative: Difficult breathing; Fast heart beat; Dizzy; Weak; Difficult breathing, fast heart beat, dizzy and weak, chest pain 10 -14 days after; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 01Apr2021 at 02:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took levofloxacin (LEVAQUIN) for unknown indication on an unknown date and experienced drug allergy. On 02Apr2021, the patient experienced difficult breathing, fast heartbeat, dizzy and weak. On an unknown date in Apr2021, 10 -14 days after patient experienced chest pain. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with acetaminophen (TYLENOL). Since the vaccination, the patient had been tested for COVID-19. On 10Apr2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the event difficult breathing, fast heartbeat, dizzy and weak, chest pain 10 -14 days after was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chest pain, Dizziness, Dyspnoea, Palpitations
Clinical narrative: Difficult breathing; Fast heart beat; Dizzy; Weak; Difficult breathing, fast heart beat, dizzy and weak, chest pain 10 -14 days after; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 01Apr2021 at 02:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took levofloxacin (LEVAQUIN) for unknown indication on an unknown date and experienced drug allergy. On 02Apr2021, the patient experienced difficult breathing, fast heartbeat, dizzy and weak. On an unknown date in Apr2021, 10 -14 days after patient experienced chest pain. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with acetaminophen (TYLENOL). Since the vaccination, the patient had been tested for COVID-19. On 10Apr2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the event difficult breathing, fast heartbeat, dizzy and weak, chest pain 10 -14 days after was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Difficult breathing; Fast heart beat; Dizzy; Weak; Difficult breathing, fast heart beat, dizzy and weak, chest pain 10 -14 days after; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 01Apr2021 at 02:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took levofloxacin (LEVAQUIN) for unknown indication on an unknown date and experienced drug allergy. On 02Apr2021, the patient experienced difficult breathing, fast heartbeat, dizzy and weak. On an unknown date in Apr2021, 10 -14 days after patient experienced chest pain. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with acetaminophen (TYLENOL). Since the vaccination, the patient had been tested for COVID-19. On 10Apr2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the event difficult breathing, fast heartbeat, dizzy and weak, chest pain 10 -14 days after was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Diarrhoea, Dizziness, Vertigo, Vomiting
Clinical narrative: dizziness; vertigo; cognitive confusion; nausea; fatigue; diarrhea; vomiting; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew1050) via an unspecified route of administration in the left arm on 13Apr2021 at 15:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, migraine, iodine allergy, CT scan contrast dye allergy, shellfish allergy and fish allergy. The patient did not take concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks, prior to the vaccination. On 14Apr2021 at 07:00, the patient experienced dizziness, vertigo, cognitive confusion and fatigue, nausea, diarrhea and vomiting. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness, vertigo, cognitive confusion and fatigue, nausea, diarrhea and vomiting was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Diarrhoea, Dizziness, Fatigue, Nausea
Clinical narrative: dizziness; vertigo; cognitive confusion; nausea; fatigue; diarrhea; vomiting; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew1050) via an unspecified route of administration in the left arm on 13Apr2021 at 15:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, migraine, iodine allergy, CT scan contrast dye allergy, shellfish allergy and fish allergy. The patient did not take concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks, prior to the vaccination. On 14Apr2021 at 07:00, the patient experienced dizziness, vertigo, cognitive confusion and fatigue, nausea, diarrhea and vomiting. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness, vertigo, cognitive confusion and fatigue, nausea, diarrhea and vomiting was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: dizziness; vertigo; cognitive confusion; nausea; fatigue; diarrhea; vomiting; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew1050) via an unspecified route of administration in the left arm on 13Apr2021 at 15:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, migraine, iodine allergy, CT scan contrast dye allergy, shellfish allergy and fish allergy. The patient did not take concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks, prior to the vaccination. On 14Apr2021 at 07:00, the patient experienced dizziness, vertigo, cognitive confusion and fatigue, nausea, diarrhea and vomiting. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness, vertigo, cognitive confusion and fatigue, nausea, diarrhea and vomiting was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood immunoglobulin A, Blood immunoglobulin E, Blood immunoglobulin G, Blood immunoglobulin M, C-reactive protein
Clinical narrative: Went from being allergic to nothing to allergic to many things. even things I do, eat, drink, on a daily basis; 40th day face swollen.; Red rash all over body; This is a spontaneous report from a contactable other health care professional. A 32-years-old non-pregnant female patient received bnt162b2 second dose of (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN5318) (age at the time of vaccination was 32 years and non-pregnant at the time of vaccination) via an intramuscular route of administration, administered in arm left on 05Feb2021 12:00 PM as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history included allergic to what feels like everything. Known allergies: Never allergic to anything before the shot. After the vaccine allergic to what feels like everything. Cannot even live a normal daily life the last 40 days. Concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL3248) (age at the time of vaccination was 32 years and non-pregnant at the time of vaccination) via an intramuscular route of administration, administered in arm left on 15Jan2021 12:00 PM as DOSE 1, SINGLE for COVID-19 immunization. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. On 08Mar2021 05:00 AM, (40th day) the patient had face swollen. Has not gone back to normal one time since the days started. Red rash all over body comes and goes each day. Went from being allergic to nothing to allergic to many things. Even things I do, eat, drink, on a daily basis. Allergic reactions leading to use an epi pen. AE resulted in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. AE treatment included blood tests, CT scan, multiple different medications. The outcome of the events was not recovered/not resolved.  Follow-up attempts are completed. No further information was expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Dyspnoea, Full blood count, Laboratory test normal, Metabolic function test
Clinical narrative: Went from being allergic to nothing to allergic to many things. even things I do, eat, drink, on a daily basis; 40th day face swollen.; Red rash all over body; This is a spontaneous report from a contactable other health care professional. A 32-years-old non-pregnant female patient received bnt162b2 second dose of (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN5318) (age at the time of vaccination was 32 years and non-pregnant at the time of vaccination) via an intramuscular route of administration, administered in arm left on 05Feb2021 12:00 PM as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history included allergic to what feels like everything. Known allergies: Never allergic to anything before the shot. After the vaccine allergic to what feels like everything. Cannot even live a normal daily life the last 40 days. Concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL3248) (age at the time of vaccination was 32 years and non-pregnant at the time of vaccination) via an intramuscular route of administration, administered in arm left on 15Jan2021 12:00 PM as DOSE 1, SINGLE for COVID-19 immunization. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. On 08Mar2021 05:00 AM, (40th day) the patient had face swollen. Has not gone back to normal one time since the days started. Red rash all over body comes and goes each day. Went from being allergic to nothing to allergic to many things. Even things I do, eat, drink, on a daily basis. Allergic reactions leading to use an epi pen. AE resulted in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. AE treatment included blood tests, CT scan, multiple different medications. The outcome of the events was not recovered/not resolved.  Follow-up attempts are completed. No further information was expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Rash erythematous, Sinusitis, Swelling face, Urine analysis
Clinical narrative: Went from being allergic to nothing to allergic to many things. even things I do, eat, drink, on a daily basis; 40th day face swollen.; Red rash all over body; This is a spontaneous report from a contactable other health care professional. A 32-years-old non-pregnant female patient received bnt162b2 second dose of (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN5318) (age at the time of vaccination was 32 years and non-pregnant at the time of vaccination) via an intramuscular route of administration, administered in arm left on 05Feb2021 12:00 PM as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history included allergic to what feels like everything. Known allergies: Never allergic to anything before the shot. After the vaccine allergic to what feels like everything. Cannot even live a normal daily life the last 40 days. Concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL3248) (age at the time of vaccination was 32 years and non-pregnant at the time of vaccination) via an intramuscular route of administration, administered in arm left on 15Jan2021 12:00 PM as DOSE 1, SINGLE for COVID-19 immunization. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. On 08Mar2021 05:00 AM, (40th day) the patient had face swollen. Has not gone back to normal one time since the days started. Red rash all over body comes and goes each day. Went from being allergic to nothing to allergic to many things. Even things I do, eat, drink, on a daily basis. Allergic reactions leading to use an epi pen. AE resulted in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. AE treatment included blood tests, CT scan, multiple different medications. The outcome of the events was not recovered/not resolved.  Follow-up attempts are completed. No further information was expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Hypersensitivity, Rash, Swelling face
Clinical narrative: Went from being allergic to nothing to allergic to many things. even things I do, eat, drink, on a daily basis; 40th day face swollen.; Red rash all over body; This is a spontaneous report from a contactable other health care professional. A 32-years-old non-pregnant female patient received bnt162b2 second dose of (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN5318) (age at the time of vaccination was 32 years and non-pregnant at the time of vaccination) via an intramuscular route of administration, administered in arm left on 05Feb2021 12:00 PM as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history included allergic to what feels like everything. Known allergies: Never allergic to anything before the shot. After the vaccine allergic to what feels like everything. Cannot even live a normal daily life the last 40 days. Concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL3248) (age at the time of vaccination was 32 years and non-pregnant at the time of vaccination) via an intramuscular route of administration, administered in arm left on 15Jan2021 12:00 PM as DOSE 1, SINGLE for COVID-19 immunization. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. On 08Mar2021 05:00 AM, (40th day) the patient had face swollen. Has not gone back to normal one time since the days started. Red rash all over body comes and goes each day. Went from being allergic to nothing to allergic to many things. Even things I do, eat, drink, on a daily basis. Allergic reactions leading to use an epi pen. AE resulted in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. AE treatment included blood tests, CT scan, multiple different medications. The outcome of the events was not recovered/not resolved.  Follow-up attempts are completed. No further information was expected.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Severe tinnitus; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 13Apr2021 at 10:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamins (MANUFACTURER UNKNOWN) for unknown an indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 23Mar2021 at 14:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 13Apr2021 at 11:00, the patient experienced severe tinnitus 15 minutes after the second shot and also headaches. The events resulted in doctor or other healthcare professional office/clinic visit and also, emergency room/department visit or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events severe tinnitus and headaches was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: Severe tinnitus; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 13Apr2021 at 10:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamins (MANUFACTURER UNKNOWN) for unknown an indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 23Mar2021 at 14:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 13Apr2021 at 11:00, the patient experienced severe tinnitus 15 minutes after the second shot and also headaches. The events resulted in doctor or other healthcare professional office/clinic visit and also, emergency room/department visit or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events severe tinnitus and headaches was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Malaise, Muscle spasms
Clinical narrative: Stomach pain/diarrhea that started a few hours after injection and lasted about 24 hours; Stomach pain/diarrhea that started a few hours after injection and lasted about 24 hours; General sense of malaise for about 72 hours after shot; An extreme headache for about 24 hours which then turned into a mile headache for about 4 days; I developed tinnitus which has not gone away.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 01Apr2021 at 09:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and paracetamol (ACETAMINOPHEN); both taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 13Mar2021 at 08:30 as a single dose for COVID-19 immunisation. On 01Apr2021, the patient experienced stomach pain/diarrhea that started a few hours after injection and lasted about 24 hours. General sense of malaise for about 72 hours after shot followed by an extreme headache for about 24 hours which then turned into a mild headache for about 4 days. On an unspecified date in Apr2021, when the headache turned milder, the patient developed tinnitus which has not gone away. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event stomach pain/diarrhea that started a few hours after injection and lasted about 24 hours was recovered on 02Apr2021. The clinical outcome of event general sense of malaise for about 72 hours after shot was recovered on 24Apr2021. The clinical outcome of the event an extreme headache for about 24 hours which then turned into a mild headache for about 4 days was not recovered at the time of the report. The clinical outcome of the event "I" developed tinnitus which has not gone away was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Stomach pain/diarrhea that started a few hours after injection and lasted about 24 hours; Stomach pain/diarrhea that started a few hours after injection and lasted about 24 hours; General sense of malaise for about 72 hours after shot; An extreme headache for about 24 hours which then turned into a mile headache for about 4 days; I developed tinnitus which has not gone away.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 01Apr2021 at 09:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and paracetamol (ACETAMINOPHEN); both taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 13Mar2021 at 08:30 as a single dose for COVID-19 immunisation. On 01Apr2021, the patient experienced stomach pain/diarrhea that started a few hours after injection and lasted about 24 hours. General sense of malaise for about 72 hours after shot followed by an extreme headache for about 24 hours which then turned into a mild headache for about 4 days. On an unspecified date in Apr2021, when the headache turned milder, the patient developed tinnitus which has not gone away. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event stomach pain/diarrhea that started a few hours after injection and lasted about 24 hours was recovered on 02Apr2021. The clinical outcome of event general sense of malaise for about 72 hours after shot was recovered on 24Apr2021. The clinical outcome of the event an extreme headache for about 24 hours which then turned into a mild headache for about 4 days was not recovered at the time of the report. The clinical outcome of the event "I" developed tinnitus which has not gone away was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Malaise, Tinnitus
Clinical narrative: Stomach pain/diarrhea that started a few hours after injection and lasted about 24 hours; Stomach pain/diarrhea that started a few hours after injection and lasted about 24 hours; General sense of malaise for about 72 hours after shot; An extreme headache for about 24 hours which then turned into a mile headache for about 4 days; I developed tinnitus which has not gone away.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 01Apr2021 at 09:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and paracetamol (ACETAMINOPHEN); both taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 13Mar2021 at 08:30 as a single dose for COVID-19 immunisation. On 01Apr2021, the patient experienced stomach pain/diarrhea that started a few hours after injection and lasted about 24 hours. General sense of malaise for about 72 hours after shot followed by an extreme headache for about 24 hours which then turned into a mild headache for about 4 days. On an unspecified date in Apr2021, when the headache turned milder, the patient developed tinnitus which has not gone away. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event stomach pain/diarrhea that started a few hours after injection and lasted about 24 hours was recovered on 02Apr2021. The clinical outcome of event general sense of malaise for about 72 hours after shot was recovered on 24Apr2021. The clinical outcome of the event an extreme headache for about 24 hours which then turned into a mild headache for about 4 days was not recovered at the time of the report. The clinical outcome of the event "I" developed tinnitus which has not gone away was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Pain/Body ache; Swelling; Itching at site; Headache; Joint pain; Diarrhea; Nausea; Abdominal pin; Muscle ache; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm  on 26Mar2021 at 15:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included Ehlers-Danlos syndrome, dysautonomia, postural orthostatic tachycardia syndrome (POTS), fibromyalgia, food allergy and drug allergy (allergy to 20 foods and 3 medications). Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included liothyronine sodium t3 (MANUFACTURER UNKNOWN), propranolol (MANUFACTURER UNKNOWN), fexofenadine hydrochloride (ALLEGRA), duloxetine (MANUFACTURER UNKNOWN), ondansetron (ZOFRAN), imit (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing and the patient also received fremanezumab vfrm (AJOVY)  on 21Mar2021. On 26Mar2021 at 19:00 the patient experienced pain, body ache, swelling, itching at site. headache, joint pain, diarrhea, nausea, abdominal pain, fatigue and muscle ache. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain, body ache, swelling, itching at site. headache, joint pain, diarrhea, nausea, abdominal pain, fatigue and muscle ache were resolved on an unknown date in 2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: Pain/Body ache; Swelling; Itching at site; Headache; Joint pain; Diarrhea; Nausea; Abdominal pin; Muscle ache; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm  on 26Mar2021 at 15:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included Ehlers-Danlos syndrome, dysautonomia, postural orthostatic tachycardia syndrome (POTS), fibromyalgia, food allergy and drug allergy (allergy to 20 foods and 3 medications). Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included liothyronine sodium t3 (MANUFACTURER UNKNOWN), propranolol (MANUFACTURER UNKNOWN), fexofenadine hydrochloride (ALLEGRA), duloxetine (MANUFACTURER UNKNOWN), ondansetron (ZOFRAN), imit (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing and the patient also received fremanezumab vfrm (AJOVY)  on 21Mar2021. On 26Mar2021 at 19:00 the patient experienced pain, body ache, swelling, itching at site. headache, joint pain, diarrhea, nausea, abdominal pain, fatigue and muscle ache. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain, body ache, swelling, itching at site. headache, joint pain, diarrhea, nausea, abdominal pain, fatigue and muscle ache were resolved on an unknown date in 2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Arthralgia, Diarrhoea, Headache, Myalgia
Clinical narrative: Pain/Body ache; Swelling; Itching at site; Headache; Joint pain; Diarrhea; Nausea; Abdominal pin; Muscle ache; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm  on 26Mar2021 at 15:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included Ehlers-Danlos syndrome, dysautonomia, postural orthostatic tachycardia syndrome (POTS), fibromyalgia, food allergy and drug allergy (allergy to 20 foods and 3 medications). Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included liothyronine sodium t3 (MANUFACTURER UNKNOWN), propranolol (MANUFACTURER UNKNOWN), fexofenadine hydrochloride (ALLEGRA), duloxetine (MANUFACTURER UNKNOWN), ondansetron (ZOFRAN), imit (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing and the patient also received fremanezumab vfrm (AJOVY)  on 21Mar2021. On 26Mar2021 at 19:00 the patient experienced pain, body ache, swelling, itching at site. headache, joint pain, diarrhea, nausea, abdominal pain, fatigue and muscle ache. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain, body ache, swelling, itching at site. headache, joint pain, diarrhea, nausea, abdominal pain, fatigue and muscle ache were resolved on an unknown date in 2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Swelling, Vaccination site pruritus
Clinical narrative: Pain/Body ache; Swelling; Itching at site; Headache; Joint pain; Diarrhea; Nausea; Abdominal pin; Muscle ache; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm  on 26Mar2021 at 15:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included Ehlers-Danlos syndrome, dysautonomia, postural orthostatic tachycardia syndrome (POTS), fibromyalgia, food allergy and drug allergy (allergy to 20 foods and 3 medications). Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included liothyronine sodium t3 (MANUFACTURER UNKNOWN), propranolol (MANUFACTURER UNKNOWN), fexofenadine hydrochloride (ALLEGRA), duloxetine (MANUFACTURER UNKNOWN), ondansetron (ZOFRAN), imit (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing and the patient also received fremanezumab vfrm (AJOVY)  on 21Mar2021. On 26Mar2021 at 19:00 the patient experienced pain, body ache, swelling, itching at site. headache, joint pain, diarrhea, nausea, abdominal pain, fatigue and muscle ache. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain, body ache, swelling, itching at site. headache, joint pain, diarrhea, nausea, abdominal pain, fatigue and muscle ache were resolved on an unknown date in 2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial spasm, Rash pruritic
Clinical narrative: Rash to shoulders, back, neck and face.; Facial spasms.; This is a spontaneous report from a contactable consumer. A 17-years-old Non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8731), via an unspecified route of administration, administered in Arm Left on 16Apr2021 16:30 (Age at vaccination 17 Years) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included current ankle FX, h/o tonsillitis with tonsillectomy and adenoidectomy, ear infections with myringotomy. Concomitant medication(s) included ethinylestradiol, ferrous fumarate, norethisterone acetate 1/20 (LOESTRIN FE) taken for an unspecified indication, start and stop date were not reported; meloxicam (MOBIC) taken for an unspecified indication, start and stop date were not reported; diclofenac taken for an unspecified indication, start and stop date were not reported.  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient was not tested for COVID-19. On 16Apr2021 18:45 the patient experienced rash to shoulders, back, neck and face, facial spasms.  Patient visited Emergency room/department or urgent care. Therapeutic measures were taken as a result of events include Benedryl 50mg, Solumedrol 125mg IV. Reporter enquired about current guidance for administration of second dose after rash and facial tremors seen in a patient 2 hours post 1st dose. Outcome of events was recovered on unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event rash and facial spasm and the suspect drug BNT162B2. 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.