chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache
Clinical narrative: dizziness; weakness; headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation. The following information was reported: DIZZINESS (non-serious) with onset 01Apr2021, outcome "unknown", described as "dizziness"; ASTHENIA (non-serious) with onset 01Apr2021, outcome "unknown", described as "weakness"; HEADACHE (non-serious) with onset 01Apr2021, outcome "unknown", described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: I had terrible chills/horrible chills/Shivering; felt achy/aches all over; headache; pain at the injection site; arm stiff and sore; arm stiff and sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Lot number: EP6955, Expiration Date: 30Jun2021) at the age of 69 years as dose 1, 0.3mg single for covid-19 immunisation. Relevant medical history included: "small TIA", start date: 2018 (unspecified if ongoing), notes: Verbatim: small TIA, Has had no issues from this.; "Covid-19", start date: Dec2020, stop date: Jan2021, notes: verbatim:COVID in the past December 2020 into January 2021 and she was very sick; "respiratory" (unspecified if ongoing), notes: Verbatim: respiratory issues her whole life. Concomitant medication(s) included: ATORVASTATIN CALCIUM (ongoing); BABY ASPIRIN (ongoing). Vaccination history included: Flu vaccination (but doesn't know what company it was from. never had any ill affects from.), for Immunisation. The following information was reported: CHILLS (non-serious) with onset 02Apr2021, outcome "recovered" (02Apr2021), described as "I had terrible chills/horrible chills/Shivering"; PAIN (non-serious) with onset 02Apr2021, outcome "recovering", described as "felt achy/aches all over"; HEADACHE (non-serious) with onset 02Apr2021, outcome "not recovered", described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 01Apr2021, outcome "recovering", described as "pain at the injection site"; MUSCULOSKELETAL STIFFNESS (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 01Apr2021, outcome "recovering" and all described as "arm stiff and sore". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had inoculation yesterday morning. In the night she had terrible chills. she was shivering and felt achy. she had a headache and she still do. Consumer stated that she had the first dose yesterday of Pfizer COVID-19 and somewhere in middle of night she woke up with horrible chills, shivering and now has headache and aches all over. Consumer asked can she take Tylenol and would that be ok. Caller also added she had pain at the injection site that didn't bother her until she went to bed last night somewhere around 7pm and now it has improved but definitely hasn't gone away. Consumer stated she doesn't have chills and shivering anymore, it lasted about 2 hours and then went away. Started on 02APR2021 and ended on 02APR2021. The adverse events did not require any emergency room visit or physician office visit. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: I had terrible chills/horrible chills/Shivering; felt achy/aches all over; headache; pain at the injection site; arm stiff and sore; arm stiff and sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Lot number: EP6955, Expiration Date: 30Jun2021) at the age of 69 years as dose 1, 0.3mg single for covid-19 immunisation. Relevant medical history included: "small TIA", start date: 2018 (unspecified if ongoing), notes: Verbatim: small TIA, Has had no issues from this.; "Covid-19", start date: Dec2020, stop date: Jan2021, notes: verbatim:COVID in the past December 2020 into January 2021 and she was very sick; "respiratory" (unspecified if ongoing), notes: Verbatim: respiratory issues her whole life. Concomitant medication(s) included: ATORVASTATIN CALCIUM (ongoing); BABY ASPIRIN (ongoing). Vaccination history included: Flu vaccination (but doesn't know what company it was from. never had any ill affects from.), for Immunisation. The following information was reported: CHILLS (non-serious) with onset 02Apr2021, outcome "recovered" (02Apr2021), described as "I had terrible chills/horrible chills/Shivering"; PAIN (non-serious) with onset 02Apr2021, outcome "recovering", described as "felt achy/aches all over"; HEADACHE (non-serious) with onset 02Apr2021, outcome "not recovered", described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 01Apr2021, outcome "recovering", described as "pain at the injection site"; MUSCULOSKELETAL STIFFNESS (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 01Apr2021, outcome "recovering" and all described as "arm stiff and sore". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had inoculation yesterday morning. In the night she had terrible chills. she was shivering and felt achy. she had a headache and she still do. Consumer stated that she had the first dose yesterday of Pfizer COVID-19 and somewhere in middle of night she woke up with horrible chills, shivering and now has headache and aches all over. Consumer asked can she take Tylenol and would that be ok. Caller also added she had pain at the injection site that didn't bother her until she went to bed last night somewhere around 7pm and now it has improved but definitely hasn't gone away. Consumer stated she doesn't have chills and shivering anymore, it lasted about 2 hours and then went away. Started on 02APR2021 and ended on 02APR2021. The adverse events did not require any emergency room visit or physician office visit. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Peripheral swelling
Clinical narrative: vaccine may have been administered subcutaneously instead of intramuscularly; swelling in arm; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A 53 year-old female patient received bnt162b2 (BNT162B2), subcutaneous, administration date 30Mar2021 (Lot number: ER8733, Expiration Date: Jul2021) at the age of 53 years as dose 1, 0.3 ml,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "vaccine may have been administered subcutaneously instead of intramuscularly"; PERIPHERAL SWELLING (non-serious) with onset 31Mar2021, outcome "unknown", described as "swelling in arm".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Illness, Malaise
Clinical narrative: she doesnt feel well; diarrhea; chills; headache; she was sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program (159558). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MALAISE (non-serious), outcome "unknown", described as "she doesnt feel well"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; CHILLS (non-serious), outcome "unknown", described as "chills"; HEADACHE (non-serious), outcome "unknown", described as "headache"; ILLNESS (non-serious), outcome "unknown", described as "she was sick".  Additional information: Caller (name) was calling because she had an appointment today (02Apr2021) for her 2nd dose but she was sick and wanted to reschedule. Also, she added what happens if she will not show up for her 2nd dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Lymphadenopathy
Clinical narrative: intermittent dizziness; chills; swollen lymph nodes in her neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 28Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "intermittent dizziness"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "swollen lymph nodes in her neck".  Additional information:No seriousness was reported. A patient asked what to do after experiencing intermittent dizziness, chills, and swollen lymph nodes in her neck after receiving her first dose of the Pfizer-BioNTech COVID-19 vaccine on 28Mar2021. The dizziness is so severe that he had to come home early from work one day this week. She was not sure if the next dose should be given.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: Mild fatigue; mild chills; mild muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 09:45 (Lot number: EL3247) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID-19, brand=Pfizer,, lot_number=EL3247,, lot_unknown=False,, administration_date=10Mar2021,, administration_time=09:45, vaccine_location=Left arm,, dose_number=1), administration date: 10Mar2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 01Apr2021 10:00, outcome "recovered" (2021), described as "Mild fatigue"; CHILLS (non-serious) with onset 01Apr2021 10:00, outcome "recovered" (2021), described as "mild chills"; MYALGIA (non-serious) with onset 01Apr2021 10:00, outcome "recovered" (2021), described as "mild muscle pain". Therapeutic measures were not taken as a result of fatigue, chills, myalgia.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination,  patient had not been tested for COVID-19. No Allergies to medications, food, or other products.  No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Tenosynovitis
Clinical narrative: Tenosynovitis; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 83 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date Jan2021 (Lot number: EL3247) at the age of 83 years as dose 2, single and intramuscular, administered in arm left, administration date 11Feb2021 12:30 (Lot number: EL9264) as dose 1, single for covid-19 immunisation. Relevant medical history included: "AFIB" (unspecified if ongoing), notes: Other medical history: AFIB, HTN,; "HTN" (unspecified if ongoing), notes: Other medical history: AFIB, HTN,; "allergies: Penicillin" (unspecified if ongoing), notes: Known allergy: PCN. The patient's concomitant medications were not reported.  The following information was reported: TENOSYNOVITIS (non-serious), outcome "not recovered", described as "Tenosynovitis". The event "tenosynovitis" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tenosynovitis.  Additional information: Vaccination facility type is hospital. No vaccine received prior to 4 weeks.AE treatment: Steroids, seen Rheumatologist. The patient did not reported COVID prior vaccination and did not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Toothache
Clinical narrative: He is in so much pain with his tooth; My husband is in a lot of pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: TOOTHACHE (non-serious), outcome "unknown", described as "He is in so much pain with his tooth"; PAIN (non-serious), outcome "unknown", described as "My husband is in a lot of pain".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Feeling stiffy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Feeling stiffy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: my brother had the second dose and felt like he was run over by a truck, his muscles hurt so bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1 st dose), for COVID-19 immunisation. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "my brother had the second dose and felt like he was run over by a truck, his muscles hurt so bad".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Motion sickness, Vertigo
Clinical narrative: not feeling right.; Vertigo; Motion sickness; dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Lot number: ER8730) at the age of 80 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "vertigo" (unspecified if ongoing); "headache" (unspecified if ongoing); "Parkinsons" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 30Mar2021, outcome "recovering", described as "dizzy"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "not feeling right."; VERTIGO (non-serious), outcome "unknown", described as "Vertigo"; MOTION SICKNESS (non-serious), outcome "unknown", described as "Motion sickness". Therapeutic measures were taken as a result of dizziness, vertigo, motion sickness.  Additional Information: Action(s) taken with drug was Unknown. None history of all previous immunization with the Pfizer vaccine considered as suspect. None additional vaccines administered on same date of the Pfizer suspect. Any AE(s) doesn't required a visit to Emergency Room or Physician Office. None prior Vaccinations (within 4 weeks). None AE(s) following prior vaccinations. No Patient's Medical History (including any illness at time of vaccination. No Relevant Tests.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: mild fatigue; Moderate headache from 5hrs after dose through bedtime (12.5hrs after dose).  And very mild on/off headaches the following day.  I also took a 30min nap on day two which is unusual for me.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 10:30 (Lot number: EPG955) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PANTOPRAZOLE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, administration time:10:30 AM,, vaccine location Left arm, lot number: EL3247), administration date: 09Mar2021, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 01Apr2021 16:00, outcome "recovering", described as "Moderate headache from 5hrs after dose through bedtime (12.5hrs after dose). And very mild on/off headaches the following day. I also took a 30min nap on day two which is unusual for me."; FATIGUE (non-serious) with onset 02Apr2021 16:00, outcome "recovering", described as "mild fatigue". Therapeutic measures were not taken as a result of headache, fatigue.  Additional Information: The patient started to get a headache on 01April2021, around 4:00PM (awareness date). He believe the report says 3:30 PM, but he would revise it to 4:00 PM because he remember that he was on a work call when he experienced the headache. He reported the event on 02Apr202 around 3:30-4:00 PM so that he reported his event within 24hours per policy. He waited the 24 hours to see if any additional symptoms happened. Per his report, he only experienced headache and mild fatigue.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head discomfort, Lymphadenopathy, Nausea, SARS-CoV-2 test
Clinical narrative: Lymphs in neck; heavy head; Nauseas; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Mar2021 09:00 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination : Yes. Concomitant medication(s) included: METFORMIN; LOSARTAN. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 29Mar2021 05:00, outcome "recovered with sequelae" (2021), described as "Lymphs in neck"; HEAD DISCOMFORT (non-serious) with onset 29Mar2021 05:00, outcome "recovered with sequelae" (2021), described as "heavy head"; NAUSEA (non-serious) with onset 29Mar2021 05:00, outcome "recovered with sequelae" (2021), described as "Nauseas"; DIZZINESS (non-serious) with onset 29Mar2021 05:00, outcome "recovered with sequelae" (2021), described as "dizziness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, head discomfort, nausea, dizziness.  Additional information: No other vaccine in four weeks. Other medications in two weeks included metformin, losartan. Patient had no known allergies. If covid prior vaccination: Yes. Covid was tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Discomfort, Neck pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Apr 1, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had neck pain, back pain/has a lot joint neck and back pain, arthralgia and discomfort, with outcome of unknown. Clinical course: The patient received first shot yesterday and experienced a little bit of discomfort, which was not that bad. Nurse told him he will not be able to take Tylenol or ibuprofen. Patient has a lot joint neck and back pain. The patient does not take them regularly but might have taken it the night before the vaccine. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Paraesthesia
Clinical narrative: mild pins and needles; dizziness; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021395390 (Pfizer).  A 53 year-old female patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (Lot number: ER8735) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid" (ongoing); "Asthma" (ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; ATORVASTATIN taken for blood cholesterol; CALCIUM; MAGNESIUM; ZINC; ALEVE; FAMOTIDINE; VITAMIN A [RETINOL]; VITAMIN C [ASCORBIC ACID]; VITAMIN D3. The following information was reported: PARAESTHESIA (non-serious) with onset 29Mar2021, outcome "recovered" (2021), described as "mild pins and needles"; DIZZINESS (non-serious) with onset 29Mar2021, outcome "recovered" (2021), described as "dizziness"; NAUSEA (non-serious) with onset 29Mar2021, outcome "recovered" (2021), described as "nausea".  Additional information: Patient reported she took levothyroxine 2 dose, micrograms. Consumer said events were Immediately following the shot and not experiencing this any longer.The consumer was concern if second dose should be taken or not and, and is pins and needles and feeling dizzy and nauseated were a severe reaction or not. Patient experienced events that the day of vaccine. It happened the first day. This is not ongoing. This is still not happening. The patient reported for concomitant medication yes she was that day or daily medicine. For Laboratory test the patient stated, she go to lab every 6 months, not till have she took the vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Taste disorder
Clinical narrative: Reduction of taste and "salty".; Reduction of taste and "salty".; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose number, unknown single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TASTE DISORDER (non-serious), DYSGEUSIA (non-serious), outcome "unknown" and all described as "Reduction of taste and "salty".  Additional information: Pfizer sponsored program Support.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: dizziness and to feel her body "different"; dizziness and to feel her body "different"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), DIZZINESS (non-serious) all with onset Mar2021, outcome "unknown" and all described as "dizziness and to feel her body "different".  Additional information: Patient received the vaccine on 17Mar and a week ago she started to feel dizziness and to feel her body "different". Referred to her physician for treatment recommendations.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: not much soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 29Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Latex allergy" (unspecified if ongoing), notes: The first vaccine I didn't have any real side effects; I have a latex allergy. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "not much soreness".  Additional information: age 53 (units not provided) as reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle strain
Clinical narrative: muscle pull in the back; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administration date 21Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunisation. The following information was reported: MUSCLE STRAIN (non-serious) with onset 01Apr2021, outcome "unknown", described as "muscle pull in the back". Therapeutic measures were taken as a result of muscle strain.  Additional information: Patient received his second dose of the Pfizer COVID vaccine on the 21Mar2021 and he saw his orthopedic doctor who gave him Toradol injection 1CC for a muscle pull in the back.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia
Clinical narrative: muscle pull in the back; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administration date 21Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunisation. The following information was reported: MUSCLE STRAIN (non-serious) with onset 01Apr2021, outcome "unknown", described as "muscle pull in the back". Therapeutic measures were taken as a result of muscle strain.  Additional information: Patient received his second dose of the Pfizer COVID vaccine on the 21Mar2021 and he saw his orthopedic doctor who gave him Toradol injection 1CC for a muscle pull in the back.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle strain
Clinical narrative: muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administration date 21Mar2021 (Batch/Lot number: unknown) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, administration date: 21Feb2021, for Covid-19 immunisation. The following information was reported: MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "muscle pain". The event "muscle pain" was evaluated at the physician office visit. Therapeutic measures were taken as a result of myalgia.  Additional information: The patient went to his orthopedic doctor yesterday (01Apr2021) because he had some muscle pain, clarified as some skeletal issue he has had for the past couple of days that the caller states has nothing to do with the vaccine. His doctor usually stays up to date on his history and the patient had gotten 1 cc of Toradol in his hip.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia
Clinical narrative: muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administration date 21Mar2021 (Batch/Lot number: unknown) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, administration date: 21Feb2021, for Covid-19 immunisation. The following information was reported: MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "muscle pain". The event "muscle pain" was evaluated at the physician office visit. Therapeutic measures were taken as a result of myalgia.  Additional information: The patient went to his orthopedic doctor yesterday (01Apr2021) because he had some muscle pain, clarified as some skeletal issue he has had for the past couple of days that the caller states has nothing to do with the vaccine. His doctor usually stays up to date on his history and the patient had gotten 1 cc of Toradol in his hip.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: itchy throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 12:00 (Lot number: EN6205) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid" (unspecified if ongoing); "allergic animals" (unspecified if ongoing), notes: allergic to dogs, cats, bee sting; she has an allergic reaction and had some swelling years ago. The patient's concomitant medications were not reported. The following information was reported: THROAT IRRITATION (non-serious) with onset 19Mar2021, outcome "recovered" (2021), described as "itchy throat".  Additional information: It was reported that the patient received first dose of the Pfizer-BioNTech COVID-19 vaccine on 19Mar2021. She explained she was monitored for 15 minutes, then 0.5 hour later, while driving back, she experienced an 'itchy throat' for 10-15 minutes and it; subsided'. She specified she had no anaphylactic in the past. She mentioned she has an allergy to dogs, cat, some medications and possibly to bees. She explained she got stung by a bee on her finger, and 4 hours later she had "numb, tingly, and a weird sensation on her whole/entire arm". She asked if she may get a stronger reaction to the second dose of the vaccine. She also asked if an itchy throat may be included as symptoms of anaphylactic reaction. She then asked if the vaccination providers will have an EpiPen in place during vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Hot flush
Clinical narrative: Fatigue; headache; hot flashes; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Lot number: ER8737) at the age of 35 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID; TOPIRAMATE. The following information was reported: FATIGUE (non-serious) with onset 02Apr2021, outcome "recovering", described as "Fatigue"; HEADACHE (non-serious) with onset 02Apr2021, outcome "recovering", described as "headache"; HOT FLUSH (non-serious) with onset 02Apr2021, outcome "recovering", described as "hot flashes"; DIARRHOEA (non-serious) with onset 02Apr2021, outcome "recovering", described as "diarrhea". Therapeutic measures were not taken as a result of fatigue, headache, hot flush, diarrhoea.  Additional Information: The patient did not patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient  was not diagnosed with COVID, prior to vaccination. The patient  had not  tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nasopharyngitis
Clinical narrative: cold; tired; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 02Apr2021, outcome "unknown", described as "cold"; FATIGUE (non-serious) with onset 02Apr2021, outcome "unknown", described as "tired".  Additional information: Reporter reported that reporter's son had the Pfizer vaccine last Saturday and at day of reporting he was so cold. They have 2 blankets on him and a heater. He was really tired. Reporter asked if other reports like this. Reporter scared for son to get the second dose. Reporter asked If vaccine building an immunity for him.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: tired; arm was sore; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Lot number: ER8732) at the age of 38 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 24Mar2021, outcome "unknown", described as "tired"; PAIN IN EXTREMITY (non-serious) with onset 24Mar2021, outcome "unknown", described as "arm was sore". Additional information: The patient stated the day after receiving vaccine her whole arm was sore and she was tired.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: whole body is aching; my lower body is throbbing/my whole body is aching, but especially my lower body; arm was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Apr2021 09:15 (Lot number: EN 8730) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Only animal allergies" (unspecified if ongoing); "Moderate-severe asthma" (unspecified if ongoing). Concomitant medication(s) included: SPRINTEC; BUPROPION HYDROCHLORIDE. Vaccination history included: Bnt162b2 (dose 1, single, administration time: 09:15 AM, vaccine location: Right arm,), administration date: 12Mar2021, when the patient was 25 years old, for COVID-19 immunisation, reaction(s): "sore arm"; Tetanus shot (after tetanus shot in summer, her lower body was in extreme pain and even temperature changes or wind would cause pain in her legs), administration date: 2021, for Immunisation, reaction(s): "lower body was in extreme pain", "pain in my legs". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 02Apr2021 19:30, outcome "not recovered", described as "arm was sore"; PAIN (non-serious) with onset 02Apr2021 21:15, outcome "not recovered", described as "whole body is aching"; PAIN IN EXTREMITY (non-serious) with onset 02Apr2021 21:15, outcome "not recovered", described as "my lower body is throbbing/my whole body is aching, but especially my lower body". Therapeutic measures were not taken as a result of pain in extremity, pain, pain in extremity.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at time of 19:30, the patient experienced Within a few hours arm was sore. About 12 hours after second vaccine. Her whole body was aching, but especially lower body. Any movement hurts and she did not feel like she could warm up her legs. Even when she was not moving it feels like her lower body was throbbing. She was not experiencing a headache or any effects on her upper body. The patient did not receive any treatment for the event. The adverse event did not result in doctor or other healthcare professional office/clinic visit/ emergency visit.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: slight headache; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 (unit unknown) female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "slight headache". Patient stated she had no problems other than a slight headache.  No follow-up attempts are possible. Information on lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021354545 same patient, drug(different dose), different event
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: stopped medication for 1 week, 2 weeks ago while he got his COVID vaccine. Has since resumed; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a sponsored program (051529).  A 53 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: XELJANZ XR, start date: 01Mar2021. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "stopped medication for 1 week, 2 weeks ago while he got his COVID vaccine. Has since resumed".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from a contactable reporter (Consumer).  A 86 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route, administered in arm left, administration date 19Mar2021 12:00 (Lot number: EN6207) at the age of 86 years as dose number unknown, single for covid-19 immunization. Relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Diagnosed several years ago. She does not take any medications and is diet controlled.; "High blood pressure" (unspecified if ongoing); "sinus infection" (unspecified if ongoing). Concomitant medications included: LISINOPRIL taken for hypertension; AMLODIPINE taken for hypertension; AUGMENTIN [AMOXICILLIN;CLAVULANIC ACID] taken for sinusitis, start date: 16Mar2021. The following information was reported: TINNITUS (non-serious) with onset 23Mar2021, outcome "not recovered", described as "Tinnitus".  Additional information: Patient experienced 2 to 3 days after receiving the vaccine, her ears have been ringing with tinnitus. Patient was taking blood pressure medication and antibiotic for a sinus infection. This was diagnosed and prescribed prior to receiving the vaccine. She was also a Diabetic, diagnosed several years ago. She did not take any medications for this condition and was diet controlled. The patient had not received any other vaccine within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Diarrhoea, Feeling abnormal, Taste disorder
Clinical narrative: Caller states all of them, have a low temperature of 97.2; Vomiting; diarrhea heavily; it was bile and tasted like medicine, very bile tasting; she was feeling strange/she had that awful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 95 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 (Lot number: EN6073) at the age of 95 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Glaucoma" (unspecified if ongoing), notes: drops in both eyes twice a day; "gone down from 140 lbs to 90 lbs" (unspecified if ongoing), notes: it was all before and she had some other problems; "height has gone down from 5 feet 4 inches to about 5 feet 2 inches" (unspecified if ongoing); "she does have a small esophagus" (unspecified if ongoing); "one of the lungs has a little problem breathing" (unspecified if ongoing); "one of the lungs has a little problem breathing" (unspecified if ongoing), notes: breathe into the lungs and she does it for 5-6 minutes twice a day.; "she has nothing but bones with skin stretched over" (unspecified if ongoing); "she has nothing but bones with skin stretched over" (unspecified if ongoing), notes: pinch the skin and he put the covid in that; "She lost so much of her fat and muscle" (unspecified if ongoing); "She lost so much of her fat and muscle" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious) with onset 15Mar2021, outcome "unknown", described as "she was feeling strange/she had that awful"; VOMITING (non-serious) with onset 16Mar2021, outcome "recovered" (16Mar2021), described as "Vomiting"; DIARRHOEA (non-serious) with onset 16Mar2021, outcome "recovered" (16Mar2021), described as "diarrhea heavily"; TASTE DISORDER (non-serious) with onset 16Mar2021, outcome "recovered", described as "it was bile and tasted like medicine, very bile tasting"; BODY TEMPERATURE DECREASED (non-serious), outcome "unknown", described as "Caller states all of them, have a low temperature of 97.2". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vomiting, diarrhoea.   Additional information: The concomitant medication included drops for eyes for glaucoma in both eyes twice a day.  No follow-up attempts are possible. No further information is expected.