chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Influenza like illness, Pain
Clinical narrative: Difficulty breathing; Extreme flu-like symptoms; Dizzy; Fever; Splitting headache; The worst body aches ever; This is a spontaneous report from a non-contactable consumer (patient). A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9269) via an unspecified route, administered in Right Arm on 08Feb2021 at 07:00 PM (36-year-old at vaccination) as a Dose 2, single for COVID-19 immunization. The patient's medical history included asthma. The patient had known allergies of Erythromycin. The patient's concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3249) via an unspecified route of administration on 15Jan2021 at 08:00 PM (36-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. Facility type Vaccine was reported as other. The patient had not received an other vaccine within four weeks prior to covid-19 vaccination. The patient was not diagnosed with covid prior to vaccination. The patient was not tested for Covid post vaccination. On 10Feb2021 at 03:00 PM, the patient had experienced extreme flu-like symptoms, dizzy, difficulty breathing, worst body aches ever, fever and splitting headache. No treatment medications were received by the patient for the resulted events. The outcome of the events was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information was expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Difficulty breathing; Extreme flu-like symptoms; Dizzy; Fever; Splitting headache; The worst body aches ever; This is a spontaneous report from a non-contactable consumer (patient). A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9269) via an unspecified route, administered in Right Arm on 08Feb2021 at 07:00 PM (36-year-old at vaccination) as a Dose 2, single for COVID-19 immunization. The patient's medical history included asthma. The patient had known allergies of Erythromycin. The patient's concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3249) via an unspecified route of administration on 15Jan2021 at 08:00 PM (36-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. Facility type Vaccine was reported as other. The patient had not received an other vaccine within four weeks prior to covid-19 vaccination. The patient was not diagnosed with covid prior to vaccination. The patient was not tested for Covid post vaccination. On 10Feb2021 at 03:00 PM, the patient had experienced extreme flu-like symptoms, dizzy, difficulty breathing, worst body aches ever, fever and splitting headache. No treatment medications were received by the patient for the resulted events. The outcome of the events was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information was expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Stomach pains; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EM9809, NDC number was reported as unknown) dose 1 via an unspecified route of administration in left arm on 06Feb2021 16:00 (at the age of 71 years old) as dose 1, single for COVID-19 immunisation. Medical history was none. Concomitant medication was not reported. No other product was given. No investigation assessment was reported. The patient took COVID shot to prevent getting COVID-19. On 09Feb2021 the patient experienced stomach pains. No treatment was given. The patient wanted to know if this was a side effect of the shot and stated that she went to the ER because she thought she was having an intestinal blockage but there was no blockage. The clinical outcome of the event was resolving.   Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Dizziness, Eructation, Flatulence
Clinical narrative: felt very weak; basically slept all day; runny nose and wooziness; runny nose and wooziness; pressure in the back of the head; Proceeded to belching and flatulance.; Proceeded to belching and flatulance.; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 71-year-old non pregnant female patient received bnt162b2 (BNT162B2, formulation; Solution for injection), via an unspecified route of administration on 06Feb2021 at 01:30 (Batch/Lot Number: el9269) as DOSE NUMBER UNKNOWN, SINGLE (at the age of 71-year-old) for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included diabetes 2, sleep apnea, high blood pressure from an unknown date and unknown if ongoing. Prior to vaccination the patient not diagnosed with COVID-19. The patient had no known allergies. The patient's concomitant medications were not reported. It was reported that about 30 minutes after the vaccination on 06Feb2021 at 14.00, the patient had pressure in the back of the head and proceeded to belching and flatulence. This event continued for about 2 days and the patient felt better on Monday evening. On 10Feb2021 Wednesday, the patient felt very weak, basically slept all day, had runny nose and wooziness. The patient was not tested for COVID post vaccination. The patient underwent lab tests and procedures which included blood pressure measurement: high on un unknown date. No treatment was received for the events. The outcome of events pressure in the back of the head, proceeded to belching and flatulance reported recovered on 08Feb2021 and for other events outcome was unknown.  Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Rhinorrhoea, Somnolence
Clinical narrative: felt very weak; basically slept all day; runny nose and wooziness; runny nose and wooziness; pressure in the back of the head; Proceeded to belching and flatulance.; Proceeded to belching and flatulance.; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 71-year-old non pregnant female patient received bnt162b2 (BNT162B2, formulation; Solution for injection), via an unspecified route of administration on 06Feb2021 at 01:30 (Batch/Lot Number: el9269) as DOSE NUMBER UNKNOWN, SINGLE (at the age of 71-year-old) for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included diabetes 2, sleep apnea, high blood pressure from an unknown date and unknown if ongoing. Prior to vaccination the patient not diagnosed with COVID-19. The patient had no known allergies. The patient's concomitant medications were not reported. It was reported that about 30 minutes after the vaccination on 06Feb2021 at 14.00, the patient had pressure in the back of the head and proceeded to belching and flatulence. This event continued for about 2 days and the patient felt better on Monday evening. On 10Feb2021 Wednesday, the patient felt very weak, basically slept all day, had runny nose and wooziness. The patient was not tested for COVID post vaccination. The patient underwent lab tests and procedures which included blood pressure measurement: high on un unknown date. No treatment was received for the events. The outcome of events pressure in the back of the head, proceeded to belching and flatulance reported recovered on 08Feb2021 and for other events outcome was unknown.  Follow-up attempts completed. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Burning sensation
Clinical narrative: Burning sensation on left forearm; This is a Spontaneous report from a contactable nurse (patient). A 57-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL9261, expiry date was unknown), via intramuscular, administered in Arm Right on 28Jan2021 12:00 (at the age of 57-year-old) as dose 1, single for covid-19 immunization. Medical history included High Cholesterol from an unknown date and unknown if ongoing. The patient previously took hepatitis b vaccine and experienced allergies. Prior to the vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient had not been tested for covid-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications within 2 weeks of vaccination. On 31Jan2021 15:00 the patient experienced burning sensation on left forearm. The patient underwent lab tests and procedures which included cholesterol: high on an unspecified date. Therapeutic measures were taken as a result of burning sen-sation on left forearm with triamcinolone cream and using caladryl cream. The outcome of event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Patient lymph node in right armpit began to swell starting 48 hours post receiving vaccine; This is a spontaneous report from a contactable pharmacist (patient). A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 intramuscular, administered in Arm Right on 15Jan2021 12:00 (Batch/Lot Number: EL3248) as dose 2, single (Age at vaccination 30-year-old) for covid-19 immunisation. Medical history included from an unknown date. There were no concomitant medications. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on 24Dec2020, intramuscularly administered at 12:00 PM, lot number EL1284 for covid-19 immunisation. 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. Patient did not receive other medications within 2 weeks of vaccination. No known allergies. The patient was not pregnant at the time of vaccination. The patient experienced patient lymph node in right armpit began to swell starting 48 hours post receiving vaccine on 17Jan2021 07:00. Patient lymph node in right armpit began to swell starting 48 hours post receiving vaccine. Swelling lasted one week. The outcome for event was recovered on an unknown date in 2021.   Follow-up attempts completed. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: a very strong sensitivity to smells; This is a spontaneous report from a contactable consumer (patient herself). A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL3247, expiry date: May2021) via unspecified route of administration, in left arm (left upper arm as reported) on 05Feb2021 09:40 (age at vaccination: 48-years) as dose 1, single for covid-19 immunisation. Medical history included high blood pressure (Why was the patient taking concomitant products Lisinopril HCTZ (Verbatim): high blood pressure) and sensitive to perfumes (Caller wanted to mention that there have been sometimes in her life that she has been a little sensitive to perfumes, but it has been 15 years since she has experienced that) from an unspecified date and unknown if ongoing. It didn't happen enough. She would get a headache from it if someone in the office would come in bathed in perfume. It would almost knock her out. The thing that caught her attention on Friday was because it was normal things in her home that she is accustomed to. There was nothing different about her environment. She couldn't tolerate it. Concomitant medication included ongoing Lisinopril HCTZ 20-12.5mg, 1x/day. There were no prior vaccinations (within 4 weeks). There was no AEs following prior vaccinations. She was calling the number on the COVID19 fact sheet to report side effects after the first dose. She had the first dose Friday last week. The same day as the dose, about 8 hours later, at 17: 40 she noticed a very strong sensitivity to smells. It was almost unbearable. They weren't smelly smells they were good smells like coffee and soap. Things that would not normally bother her at all. She hasn't called her primary care yet, but will do that next. She talked to her doctor before getting the vaccine and was told there was nothing contraindicated in her chart. She was going to call her primary care to get guidance because the second dose was coming up. The outcome of event was recovered on 06Feb2021.   Follow-up attempts completed. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Joint stiffness
Clinical narrative: Mild fatigue; Joint stiffness; Chills; This is a spontaneous report received via COVAES. A non-contactable nurse (patient) reported a non-pregnant 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EK5730 and Expiration date: not reported) via an unspecified route of administration, administered on the left arm on 23Dec2020 17:00 (at the age of 38 years old) as dose 1, single for COVID-19 immunisation. The vaccine was administered in a hospital. The patient's medical history included Lyme disease and insulin-dependent diabetes. The patient had known allergies to watermelon, mayonnaise, and penicillin. Concomitant medications included insulin lispro (HUMALOG) via pump for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. On 24Dec2020, one-day post-vaccination, the patient had mild fatigue, joint stiffness, and chills for 24 hours. The patient did not receive treatment and recovered from the reported events on 25Dec2020.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Lymphadenopathy, Pain in extremity
Clinical narrative: Fever; swollen lymph nodes; severe body aches; headache; fatigue; This is a spontaneous report from a contactable Nurse. A 48-years-old non-pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EM9809), intramuscular, administered in Arm Left on 03Feb2021 09:00 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Medical history included migraine, drug hypersensitivity (Sulfa allergies). There were no concomitant medications. No other vaccine in four weeks and no Other medications in two weeks. No covid prior vaccination and No covid tested post vaccination. The patient experienced fever, swollen lymph nodes, severe body aches, headache, fatigue on 03Feb2021 18:30. Adverse events were reported as 101.5 fever, severe body aches, headache, swollen lymph nodes, fatigue for 2 days. The patient underwent lab tests and procedures which included body temperature: 101.5. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; swollen lymph nodes; severe body aches; headache; fatigue; This is a spontaneous report from a contactable Nurse. A 48-years-old non-pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EM9809), intramuscular, administered in Arm Left on 03Feb2021 09:00 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Medical history included migraine, drug hypersensitivity (Sulfa allergies). There were no concomitant medications. No other vaccine in four weeks and no Other medications in two weeks. No covid prior vaccination and No covid tested post vaccination. The patient experienced fever, swollen lymph nodes, severe body aches, headache, fatigue on 03Feb2021 18:30. Adverse events were reported as 101.5 fever, severe body aches, headache, swollen lymph nodes, fatigue for 2 days. The patient underwent lab tests and procedures which included body temperature: 101.5. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Confusional state, Disturbance in attention, Feeling abnormal, Investigation
Clinical narrative: difficulty concentrating; developed acute, progressive confusion; brain fog; agitation; This is a spontaneous report from a contactable physician. A 95-years-old non pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiration date were not reported) intramuscular route of administration, administered in arm left on 04Feb2021 12:00 (age at the vaccination 95-year-old) as dose 2, single for COVID-19 immunization (Nursing Home/Senior Living Facility). The patient medical history was not reported and no prior history of dementia, living alone. Patient had no known allergies. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiration date were not reported) intramuscular route of administration, administered in arm left on 14Jan2021 12:00 as dose 1, single. On 05Feb2021 12:00, the patient had experienced within 24 hours developed acute, progressive confusion- no focal neurologic findings - no fever and stated something happened to me and was aware of her confusion, agitation, difficulty concentrating, knew where she was but did not feel it was the right place, new people and personal information - sx similar to that de-scribed in covid brain fog after infection. The patient underwent lab tests and procedures which included medical workup as normal, sars-cov-2 test as negative on has had multiple negative covid tests in past on unspecified date. The patient did not receive treatment for the adverse event. No other vaccine in four weeks. Ae resulted in: Doctor or other healthcare professional office/clinic visit. Patient had not been diagnosed with COVID-19 prior to vaccination and unknown if covid tested post vaccination. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: difficulty concentrating; developed acute, progressive confusion; brain fog; agitation; This is a spontaneous report from a contactable physician. A 95-years-old non pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiration date were not reported) intramuscular route of administration, administered in arm left on 04Feb2021 12:00 (age at the vaccination 95-year-old) as dose 2, single for COVID-19 immunization (Nursing Home/Senior Living Facility). The patient medical history was not reported and no prior history of dementia, living alone. Patient had no known allergies. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiration date were not reported) intramuscular route of administration, administered in arm left on 14Jan2021 12:00 as dose 1, single. On 05Feb2021 12:00, the patient had experienced within 24 hours developed acute, progressive confusion- no focal neurologic findings - no fever and stated something happened to me and was aware of her confusion, agitation, difficulty concentrating, knew where she was but did not feel it was the right place, new people and personal information - sx similar to that de-scribed in covid brain fog after infection. The patient underwent lab tests and procedures which included medical workup as normal, sars-cov-2 test as negative on has had multiple negative covid tests in past on unspecified date. The patient did not receive treatment for the adverse event. No other vaccine in four weeks. Ae resulted in: Doctor or other healthcare professional office/clinic visit. Patient had not been diagnosed with COVID-19 prior to vaccination and unknown if covid tested post vaccination. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 88 year old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 10Feb2021 (Batch/Lot Number: EN5318) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced chills on 11Feb2021 with outcome of unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness; Nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 79-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 10Feb2021 the patient experienced dizziness, nausea. The outcome of the events dizziness, nausea was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Insomnia, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Burning/her arm started to burn; Swelling; Itching; couldn't sleep; Swell up on her side and her legs and shoulders; she might have a little fever; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9269, Expiry date: not reported), via an unspecified route of administration in left arm on 09Feb2021 09:30 (at age of 71-years-old) as dose 1, single for covid-19 immunisation at military facility. Medical history included disability (Patient mentions she is disabled). Family medical history was none. Concomitant medication(s) included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication, start and stop date were not reported. When the patient got home at 11:30 and her arm started to burn and swell up on her side and her legs and shoulders; whole arms and everywhere was swollen and itching like crazy; and she felt like she was on fire, burning. She took two Tylenol and that didn't help. She felt like she might have a little fever but it didn't help with the burning on her skin. She took two brand Tylenol, 500mg Extra Strength UPC 122101; Lot SLC220; Expiration Date Jul2024. Mentioned that she also bought some cortisone to rub on, the intensive healing one. The patient tried it this morning and just put it on so she was waiting to see if it works. Later mention she thought the cortisone helped with the itching and burning. Added that the patient couldn't sleep at all last night. The patient was scheduled to receive the second dose of the bnt162b2 vaccine 02Mar2021. Added the patient drank vitamin C and D. History of all previous immunization with the bnt162b2 vaccine considered as suspect was none. Additional vaccines administered on same date of the bnt162b2 vaccine was none. Relevant test were none. Therapeutic measures were taken as a result of burning/her arm started to burn, swelling, itching, couldn't sleep, swell up on her side and her legs and shoulders and she might have a little fever. The outcome of the events burning/her arm started to burn, itching was recovering and the outcome of the events swelling, couldn't sleep, swell up on her side and her legs and shoulders was not recovered. The outcome of the event she might have a little fever was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Burning/her arm started to burn; Swelling; Itching; couldn't sleep; Swell up on her side and her legs and shoulders; she might have a little fever; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9269, Expiry date: not reported), via an unspecified route of administration in left arm on 09Feb2021 09:30 (at age of 71-years-old) as dose 1, single for covid-19 immunisation at military facility. Medical history included disability (Patient mentions she is disabled). Family medical history was none. Concomitant medication(s) included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication, start and stop date were not reported. When the patient got home at 11:30 and her arm started to burn and swell up on her side and her legs and shoulders; whole arms and everywhere was swollen and itching like crazy; and she felt like she was on fire, burning. She took two Tylenol and that didn't help. She felt like she might have a little fever but it didn't help with the burning on her skin. She took two brand Tylenol, 500mg Extra Strength UPC 122101; Lot SLC220; Expiration Date Jul2024. Mentioned that she also bought some cortisone to rub on, the intensive healing one. The patient tried it this morning and just put it on so she was waiting to see if it works. Later mention she thought the cortisone helped with the itching and burning. Added that the patient couldn't sleep at all last night. The patient was scheduled to receive the second dose of the bnt162b2 vaccine 02Mar2021. Added the patient drank vitamin C and D. History of all previous immunization with the bnt162b2 vaccine considered as suspect was none. Additional vaccines administered on same date of the bnt162b2 vaccine was none. Relevant test were none. Therapeutic measures were taken as a result of burning/her arm started to burn, swelling, itching, couldn't sleep, swell up on her side and her legs and shoulders and she might have a little fever. The outcome of the events burning/her arm started to burn, itching was recovering and the outcome of the events swelling, couldn't sleep, swell up on her side and her legs and shoulders was not recovered. The outcome of the event she might have a little fever was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vertigo
Clinical narrative: Nausea; vertigo; This is a spontaneous report from a contactable other hcp (Patient). A 26-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EL8982) via an unspecified route of administration (age at vaccination 26-year) in Left Arm on 11Feb2021 at 01:45 PM as dose 2, single for COVID-19 immunization. Medical history included depression, anxiety, exercise induced asthma, all from an unknown date and unknown if ongoing. Concomitant medications included trazodone 100mg; sertraline 150mg; both taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes first dose of BNT162B2 (lot number: EL8982) administered in Left arm on 19Jan2021 at 12:15 PM for COVID-19 immunization. Facility type vaccine was Hospital. No known allergies were reported. The patient received no other vaccine was received in fourweeks. No COVID prior vaccination was reported. The patient not tested COVID post vaccination. On 11Feb2021 at 06:30 PM the patient experienced nausea, vertigo; onset 6 hours after second vaccine was administered. AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of nausea and vertigo, treatment received with Mezicycline. The clinical outcome of the events was not recovered.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Speech disorder
Clinical narrative: Headache; It started making him feel not so good last night; Has some trouble talking; This is a spontaneous report from two contactable consumer (one was patient). A male patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported) dose number unknown via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. On an unspecified date the patient experienced headache, it started making him feel not so good last night, has some trouble talking. Patient got his Covid vaccination yesterday afternoon by 5'o clock through a pharmacy. He was originally feeling was headache today and all that was listed (voice feeble and incomprehensive). Later Reporter (patient's wife) was over the call and reported that I am his wife. He had some trouble talking. So, he got the vaccine yesterday like in the day. It started making him feel not so good last night. The clinical outcome of the events was unknown.   Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: aches; chills; This is a spontaneous report from a non-contactable consumer (patient) received via COVID-19 Reporting System. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number unknown), via an unspecified route of administration on an unspecified date in Feb2021 as dose number unknown, single for COVID-19 immunisation. The patient has no medical history. The patient's concomitant medications were not reported. It was unknown if the patient received other vaccines within four weeks prior to the COVID vaccine and other medications within two weeks of vaccination. On an unspecified date in Feb2021, the patient experienced aches and chills. The patient was not diagnosed with COVID-19 prior to vaccination and he has not been tested for COVID-19 since the vaccination. It was unknown whether therapeutic measures were taken as a result of the events. The outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/Batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Nasopharyngitis, Vaccination site pain
Clinical narrative: Sore around the injection site; headache; slight cold/flu like symptoms; slight cold/flu like symptoms; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date were not reported), via an unspecified route of administration on 10Feb2021 (at the age of 21-years-old), as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore around the injection site, headache, and slight cold/flu like symptoms on 11Feb2021. Patient did not receive treatment for the events. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills; fever; body aches; This is a spontaneous report from a contactable 47-year-old female Nurse. A 47-year-old non-pregnant female patient received second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: En6201), via an intramuscular route in the right arm on 10Feb2021 at 15:45 (age at vaccination: 47-year-old), as a single dose for covid-19 immunization. Medical history included Dm1, htn and high lipids. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: El3248), via an intramuscular route in the right arm on 12Jan2021 at 15:00 (age at vaccination: 47-year-old) as a single dose for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 11Feb2021 at 08:00, patient experienced chills, fever and body aches. Patient did not receive any treatment for the events. The clinical outcome of the events was recovered.  Follow-up attempts completed. No further information expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: only had a sore arm for the following 2 days after the injection; This is a spontaneous report from a non-contactable other hcp (patient). A 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: ,EL3247 Expiration date was not reported), via an unspecified route of administration on 05Feb2021 (at the age of 23-years-old), as dose number unknown, single for COVID-19 immunisation. Patient has no relevant medical history. Concomitant medications included ascorbic acid (VIT C) and ergocalciferol (VIT D), both taken for an unspecified indication, start and stop date were not reported. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced only had a sore arm for the following 2 days after the injection on 06Feb2021. It was also reported that patient had no other symptoms. Patient did not receive treatment for the event. The outcome of event was recovered on 08Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea; Vomited; This is a spontaneous report received from a contactable consumer or other non hcp. A 86-years-old female patient received 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine,Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Left on 10Feb2021 08:56,at the age of 86-years old, as Dose 1,single for covid-19 immunization.Medical history included diabetes mellitus from an unknown date and unknown if ongoing.Additional Information for Other Conditions: Caller says she has been diabetic for 8 years.There were no concomitant medications.The patient experienced nausea and vomited on 10Feb2021.Caller took her 1st dose of Pfizer covid 19 vaccine on 08:56 am and vomited on noon.The patient stated that her vaccine card is handwritten and the NDC/EXP are written on there. She stated that she has done no treatment for the nausea or vomiting, she gets nauseated real easy and her husband says it is probably one of those things.The outcome of the event nausea was unknown while the vomiting outcome was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever; Pains in body; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection, Lot Number not reported) dose 1, via unspecified route on an unspecified date as DOSE 1, SINGLE for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got covid vaccine 2 weeks ago. And experienced fever and pains in body afterwards on unspecified date. The clinical outcome of the events were unknown.     information about lot/batch number requested.     Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Experiencing soreness at injection site and achy feeling in left wrist; achy feeling in left wrist; This is a spontaneous report from a non-contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 12Feb2021 at 09:00 (at the age of 65-years-old) (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient was not pregnant at the time of the events. Known allergies was unknown. The patient did not have COVID prior to vaccination.  The patient did not receive other vaccine in four weeks. It was unknown if the patient received other medications in two weeks. On 12Feb2021 at 12:00, the patient experienced soreness at injection site and achy feeling in left wrist. No treatment was received for the events. The patient had not been tested for COVID post-vaccination. The outcome of the events was recovering/resolving.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188007 Same reporter, different patient, similar event
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Hyperhidrosis, Pain in extremity, Pyrexia
Clinical narrative: severe chills; got very hot and started to sweat; got very hot and started to sweat; Arm was sore; fever; This is a spontaneous report from a contactable consumer (patient).   A 43-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 09Feb2021 08:15 (at the age of 43 years), as Dose 1, single for COVID-19 immunisation, at workplace clinic. The patient's medical history included ongoing blood pressure and cholesterol. Patient had no known allergies. The patient received other medications (Concomitant medications) in two weeks as Blood pressure/ Cholesterol Meds. 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 10Feb2021 13:00 AM, About 16-18 hours after shot, started getting severe chills that lasted about 2 hours, then got very hot and started to sweat. Lasted for about 3 more hours, Arm was sore during this time. He was better with no fever by 05:00 hours, the next day. The patient did not receive any treatment for the adverse events. The clinical outcome of the event severe chills was recovered on 10Feb2021 at 15:00 am and fever recovered on 10Feb2021 at 17:00 am and rest all the events was recovered on unspecified date in 2021.   Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Myalgia, Pruritus
Clinical narrative: Second dose: fatigue; Episode of cold chills; Muscle ache; Rash on neck and chest; Inflamed with redness; Itchy; This is a spontaneous report from a contactable other HCP(Patient).   A 35-year-old non-pregnant female received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number was EL9264) via an unspecified route of administration, in left arm on 09Feb2021 (age at the time of vaccination was 35-year-old) as single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included Vit C/D for birth control. The patient had no known allergies. Previously the patient received first dose of bnt162b2 (COMITNATY, Solution for injection, Batch/Lot number was EL3249) via intramuscular route in left arm on 19Jan2021 11:30 (age at the time of vaccination was 35-year-old) as single dose for COVID-19 immunization. First dose: headache and fatigue for 3 days.The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. On 12Feb2021, the patient experienced Fatigue, episode of cold chills and muscle ache for 1.5 days. 72 hours post- experience rash on neck and chest (inflamed with redness and itchy. Patient received treatment as topical steroid. Outcome of all the events was unknown.   Follow-up (12May2021):.Follow-up attempts completed. No further information expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Second dose: fatigue; Episode of cold chills; Muscle ache; Rash on neck and chest; Inflamed with redness; Itchy; This is a spontaneous report from a contactable other HCP(Patient).   A 35-year-old non-pregnant female received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number was EL9264) via an unspecified route of administration, in left arm on 09Feb2021 (age at the time of vaccination was 35-year-old) as single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included Vit C/D for birth control. The patient had no known allergies. Previously the patient received first dose of bnt162b2 (COMITNATY, Solution for injection, Batch/Lot number was EL3249) via intramuscular route in left arm on 19Jan2021 11:30 (age at the time of vaccination was 35-year-old) as single dose for COVID-19 immunization. First dose: headache and fatigue for 3 days.The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. On 12Feb2021, the patient experienced Fatigue, episode of cold chills and muscle ache for 1.5 days. 72 hours post- experience rash on neck and chest (inflamed with redness and itchy. Patient received treatment as topical steroid. Outcome of all the events was unknown.   Follow-up (12May2021):.Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal blistering
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP. A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on Feb 5, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date in Feb 2021, she really did not have any side effects for the first couple of days. In the last 2 days, patient experienced blisters on the inside of her mouth. She did not know if this event was related to the vaccine. The clinical outcome of the event: unknown. Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: sore arm; headache; body aches; somewhat achy; tired; This is a spontaneous report received via COVAES. A non-contactable consumer (patient) reported a non-pregnant 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EL9264 and Expiration date: not reported) via an unspecified route of administration, administered on the right arm on 08Feb2021 08:30 (at the age of 52 years old) as dose 1, single for COVID-19 immunisation. The vaccine was administered in a hospital. The patient's medical history included severe mitral valve regurgitation and allergies to sulfa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN XL, 300mg strength) for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. On the 1st day, the patient experienced sore arm, headache, body aches, and was very tired. On the 2nd day, the patient had a sore arm, headache, somewhat achy, and tired. On the 3rd day, the patient had a headache and was tired. The patient did not receive any treatment for the events. The outcome of the reported events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia
Clinical narrative: Low fever started 12 hours after second dose, lasted for 12 hours.; Dizziness started 24 hours after second dose, lasted 2 hours; This is a spontaneous report from a Non-contactable Other Health Professional reported for a female patient. A 25-year-old adult non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: unknown), dose 2 via an intramuscular route of administration, administered in Arm Left on 10Feb2021 at 12:00 PM (at the age of 25-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient other medical history was none. The patient had no known allergies. The patient had no covid prior to vaccination. The patient concomitant medications were not reported. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: unknown), via an intramuscular route of administration, administered in Arm Left on 20Jan2021 at 09:15 AM (at the age of 25-year-old) as single dose for covid-19 immunisation and experienced Prolonged and heavier menstrual cycle after first dose on 21Jan2021. No other vaccine in four weeks. No other medications in two weeks. The patient had not been tested for covid post vaccination. On 11Feb2021, the patient experienced low fever which started 12 hours after second dose and lasted for 12 hours and Dizziness, which started 24 hours after second dose and lasted for 2 hours. No treatment was received to treat the events. The patient outcome of the events was Resolved on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.