chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: No reaction to first dose beyond sore injection site; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 72-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Apr2021 10:00 (Lot number: EP7533) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing), notes: known allergies: Yes. Concomitant medication(s) included: PROTONIX [OMEPRAZOLE]. The following information was reported: INJECTION SITE PAIN (non-serious) with onset 05Apr2021 08:00, outcome "not recovered", described as "No reaction to first dose beyond sore injection site". Therapeutic measures were not taken as a result of injection site pain.  Additional information: Blisters on tongue following second dose only. First dose 01Apr2021 Second dose 22Apr2021. No reaction to first dose beyond sore injection site. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not diagnosed with covid-19 prior to vaccination since vaccination patient not tested for covid-19. Nonchronic, no surgeries  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: period was about 5 days early; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 10:15 (Lot number: ER8733) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset Apr2021, outcome "unknown", described as "period was about 5 days early". Therapeutic measures were not taken as a result of menstruation irregular. Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: one cheek feels stiff/tight; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 10:00 (Lot number: ER8733) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1 at 10:15 am administered on left arm (Lot number: ER8733)), administration date: 05Apr2021, when the patient was 40 years old, for COVID-19 immunisation, reaction(s): "period was about 5 days early". The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 26Apr2021 11:00, outcome "recovering", described as "one cheek feels stiff/tight". Therapeutic measures were not taken as a result of musculoskeletal stiffness. Additional information: Patient stated that after receiving the second dose this morning (as of reporting), one cheek feels stiff/tight when I try to smile or move it. About 4 hours later, and the stiffness is subsiding. Patient had no COVID prior vaccination and not COVID tested post vaccination. Patient had no known allergies.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Pain in extremity, Paraesthesia
Clinical narrative: tingling on my right fingers; numbing on my right cheek & lip; numbing on my right cheek & lip; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Apr2021 15:00 (Lot number: EW0161) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Meniere's disease" (unspecified if ongoing); "Tree nut allergy" (unspecified if ongoing); "Seasonal allergy" (unspecified if ongoing); "Dust mites allergy" (unspecified if ongoing); "Cats allergy" (unspecified if ongoing). Concomitant medication(s) included: DIURETIC [HYDROCHLOROTHIAZIDE]; NORTREL [ETHINYLESTRADIOL;NORETHISTERONE]; POTASSIUM. Vaccination history included: Bnt162b2 (dose 1, single, Lot number: ER8734, Administration time: 01:15 PM, Vaccine location: Left arm), administration date: 26Mar2021, when the patient was 44 years old, for Covid-19 Immunisation, reaction(s): "tingling in the my fingers and cheeks", "Tingling in lips", "heavy cheek", "Sore arm". The following information was reported: PARAESTHESIA (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "tingling on my right fingers"; HYPOAESTHESIA (non-serious), HYPOAESTHESIA ORAL (non-serious) all with onset Apr2021, outcome "recovered" (Apr2021) and all described as "numbing on my right cheek & lip"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "sore arm". Therapeutic measures were taken as a result of paraesthesia, hypoaesthesia, hypoaesthesia oral, pain in extremity.  Additional Information: The vaccine was administered at a hospital. The patient did not receive other vaccine in four weeks. The patient reported that she was instructed to take diphenhydramine (BENADRYL) right before receiving the second shot. It was further reported that the patient did have tingling on her right fingers, but not nearly as bad as the first one and not as soon. She waited there for 30-40 minutes. The patient then felt numbing on her right cheek & lip, but not as bad as last time & not tingling. After the patient left she felt the numbing move to the left side of her upper lip. The patient's nurse friend told her to take another diphenhydramine (BENADRYL). After a nap, about 5:00 that evening the patient's face & fingers were fine but the sore arm persisted for a few days.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug interaction
Clinical narrative: Interaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (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: DRUG INTERACTION (non-serious), outcome "unknown", described as "Interaction".  Additional information: The reporter wanted to know if there were any problems with diabetes medicine and COVID vaccine. The reporter clarified that the patient already had problems with interaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: After the second vaccination, it continued and has changed to a more metallic, sour taste; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 53-year-old male patient received BNT162B2 (BNT162B2), administered in arm left, administration date 18Apr2021 11:15 (Lot number: ER8736) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "overweight" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]. Vaccination history included: BNT162B2 (Dose 1, Single, Lot number: ER8732.), for Covid-19 immunisation, reaction(s): "Salty taste in my mouth". The following information was reported: DYSGEUSIA (non-serious), outcome "not recovered", described as "After the second vaccination, it continued and has changed to a more metallic, sour taste". Therapeutic measures were not taken as a result of dysgeusia. Additional Information: About a week or two after the first vaccination, the patient started having a salty taste in my mouth. After the second vaccination, it continued and has changed to a more metallic, sour taste. He had his 6-month dental checkup a few days ago, and my gums were in excellent condition, with no infections or gingivitis. The sour taste continued at the time of report.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021465515 same patient and reporter, different dose and event
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feeling low level malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 41 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and administered in arm, administration date 27Apr2021 (Batch/Lot number: unknown) as dose 2, 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 "feeling low level malaise".  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 in extremity, Vaccination site pain
Clinical narrative: soreness to their arm where the injection was given; soreness to their arm where the injection was given; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administered in arm (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 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "soreness to their arm where the injection was given".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: 1st dose: his arm didn't feel too bad when he got it but then on the second day he had soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 30Mar2021 (Lot number: ER8733) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "thyroid condition" (unspecified if ongoing); "Nephrolithiasis" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE taken for nephrolithiasis; POTASSIUM CITRATE taken for nephrolithiasis.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 31Mar2021, outcome "unknown", described as "1st dose: his arm didn't feel too bad when he got it but then on the second day he had soreness".  Additional information: His first COVID vaccine was kind of opposite, his arm did not feel too bad when he got it but then on the second day he had soreness but for the second COVID vaccine it was the worst on the first day.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm was a little sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2) (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My arm was a little sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Myalgia
Clinical narrative: Like the soreness and stuff; 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 male patient received bnt162b2 (BNT162B2), administration date 12Feb2021 (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, single), for Covid-19 immunization, reaction(s): "Slight soreness".  The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "Like the soreness and stuff". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: At the time the patient received it and he was a little concerned the way it was given, wasn't confident it was properly given and he contacted his PCP, he ordered a quantitative antibody test to see if it in fact (vaccination) did give some level of protection, agreed to do it, had the lab test.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Vaccination site pain
Clinical narrative: injected in her left arm / had tenderness there; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 14:40 (Lot number: EN6199) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hearing disability", start date: 2018 (unspecified if ongoing), notes: uses speakerphone so she can hear instead of wearing a hearing aid; "osteoporosis prevention" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; D3; ALENDRONATE taken for osteoporosis prophylaxis. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "injected in her left arm / had tenderness there". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Clinical course of events: The patient got her first dose March 5th, this was injected in her left arm and had tenderness there. Patient did not get any other vaccinations the same days as her Pfizer COVID-19 vaccine, or in the four weeks prior and has not started new medications recently. Concomitant medication also included multivitamin.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: 4 days after receiving my first dose of the Pfizer vaccine I found 2 lumps directly above my collarbone on my right side; They are sore to the touch like a bruise but nothing painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), ( Age at vaccination : 24) administered in arm right, administration date 23Apr2021 13:30 (Lot number: ER8736) at the age of 24 years as 1st dose, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 28Apr2021 13:00, outcome "unknown", described as "4 days after receiving my first dose of the Pfizer vaccine I found 2 lumps directly above my collarbone on my right side"; LYMPH NODE PAIN (non-serious) with onset 28Apr2021 13:00, outcome "unknown", described as "They are sore to the touch like a bruise but nothing painful". The events "4 days after receiving my first dose of the pfizer vaccine i found 2 lumps directly above my collarbone on my right side" and "they are sore to the touch like a bruise but nothing painful" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of lymphadenopathy, lymph node pain.  Additional information: The patient was not diagnosed with Covid-19 Prior to vaccination. The patient not been tested for Covid-19 Since the vaccination. 4 days after receiving my first dose of the Pfizer vaccine I found 2 lumps directly above my collarbone on my right side. I assume they are swollen lymph nodes. I am going to urgent care tomorrow to check it out since it has been two days since I have found them and they are not going away. They are sore to the touch like a bruise but nothing painful. The size of the lumps go down when the patient takes ibuprofen but go back to the same size when it wears off. No Prolonged Hospitalization was noted.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: extremely tired all the time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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. Vaccination history included: Bnt162b2 (Patient had both the shots.), for Covid-19 immunisation. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "extremely tired all the time".  Additional Information: since patient had both shots, patient was extremely tired, all the time this was normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had a sore arm for a few days; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 08Apr2021 10:59 (Lot number: EN6204) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "had a sore arm for a few days". No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left arm pain; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 42-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Apr2021 10:00 (Lot number: ER8733) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Apr2021, outcome "recovering", described as "Left arm pain".  Additional Information: The patient experienced left arm pain worse than second dose within minutes of 10:00. The patient did not receive additional vaccines on same date of the Pfizer suspect. No emergency room or physician's office required. The patient had no prior vaccinations within 4 weeks and no adverse events following prior vaccinations. No relevant test was done by the patient.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021481071 Same patient and drug, different dose and events.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Therapeutic response unexpected
Clinical narrative: He has only had one minor flare up (shortly after the second vaccine); His symptoms (rash, pain, raw skin) have been gone since about 2 weeks after his second dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "fungoides mycosis lymphoma", start date: Jan2021 (unspecified if ongoing), notes: He had symptoms for 4 plus years, had numerous biopsies, and had seen many doctors.; "numerous biopsies" (unspecified if ongoing); "rash" (unspecified if ongoing); "pain" (unspecified if ongoing); "raw skin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization. The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "He has only had one minor flare up (shortly after the second vaccine)"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "His symptoms (rash, pain, raw skin) have been gone since about 2 weeks after his second dose".  Additional information: The daughter of the patient reported that her father has been diagnosed with fungoides mycosis lymphoma. He has had symptoms for 4+years, had numerous biopsies, and seen many doctors. He was given the diagnosis in January of 2021. He was ready to start a treatment (a chemotherapy topical cream), however, after his second dose of your vaccine, he has only had one minor flare up (shortly after the second vaccine). His symptoms (rash, pain, raw skin) have been gone since about 2 weeks after his second dose. He contacted Pfizer and they transferred him to the FDA, but they were only concerned about adverse reactions. She wanted to inform in case the cessation of his symptoms were not just a coincidence. Her father's condition had been persistent, and he has been documenting it with photos over the years. He continues to document his newly clear skin every couple of days. This may be just a coincidence, or it could be a great thing!  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Euphoric mood
Clinical narrative: had another report of "feeling high" after vaccination from a "20-something year old man".; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient in his 20's 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: EUPHORIC MOOD (non-serious), outcome "unknown", described as "had another report of "feeling high" after vaccination from a "20-something year old man". The action taken for bnt162b2 was unknown.  Additional Information: Additional information: She mentioned this to her vaccination site when she returned, and they said they'd had another report of "feeling high" after vaccination from a "20-something year old man". Reporter stated she mentioned her experiencing of feeling high after receiving the COVID 19 vaccine to the nurse at the facility of where she got the vaccine, and she was told another guy in his 20s reported the same thing to them. Reporter seriousness for feeling high was unspecified. Report 2 of 2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Headache, Pain, SARS-CoV-2 test
Clinical narrative: She says that the only side effect was body aches for her daughter and a little headache; She says that the only side effect was body aches for her daughter and a little headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A 22 year-old female 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 (Dose 1, Single), for COVID-19 immunization. The following information was reported: PAIN (non-serious), HEADACHE (non-serious), outcome "unknown" and all described as "She says that the only side effect was body aches for her daughter and a little headache". Relevant laboratory tests and procedures are available in the appropriate section.  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-2021416620 same reporter/ product, different patient.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Intraocular pressure increased, Intraocular pressure test, Visual field defect, Visual impairment
Clinical narrative: Feel eye pressure the day after the 2nd COVID; Lost vision at focus point in my eyes for 2 hours, I could see peripheral vision mostly, but not at focus point of eyes.; Also lost peripheral vision in myleft eye; This is a spontaneous report received from 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 29Apr2021 11:30 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset 29Apr2021 12:00, outcome "recovered", described as "Lost vision at focus point in my eyes for 2 hours, I could see peripheral vision mostly, but not at focus point of eyes."; VISUAL FIELD DEFECT (non-serious) with onset 29Apr2021 12:00, outcome "recovered", described as "Also lost peripheral vision in myleft eye"; INTRAOCULAR PRESSURE INCREASED (non-serious) with onset 30Apr2021 12:00, outcome "unknown", described as "Feel eye pressure the day after the 2nd COVID". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: No other vaccine in four weeks, no treatment for AE, no covid prior vaccination, no covid tested post vaccination, no allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gastroenteritis viral
Clinical narrative: stomach flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (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: GASTROENTERITIS VIRAL (non-serious), outcome "unknown", described as "stomach flu".  Additional information:Patient wants to check if she can take the covid-19 vaccine today since she had been diagnosed with stomach flu in between doses. She had the first dose last April 7. 2nd dose is today (April 28).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administration error, Vaccination site discharge, Wrong technique in product usage process
Clinical narrative: didn't feel anything, there was moisture after needle was pulled out, had moisture on sleeve; Doesn't believe vaccine was administered properly; didn't feel anything, there was moisture after needle was pulled out, had moisture on sleeve; didn't feel anything, there was moisture after needle was pulled out, had moisture on sleeve; 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 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 (Dose 1), for COVID-19 immunization. The following information was reported: VACCINATION SITE DISCHARGE (non-serious), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "didn't feel anything, there was moisture after needle was pulled out, had moisture on sleeve"; PRODUCT ADMINISTRATION ERROR (non-serious), outcome "unknown", described as "Doesn't believe vaccine was administered properly".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Said after 1st dose his arm was a bit sore after getting vaccine; 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 male 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Said after 1st dose his arm was a bit sore after getting vaccine".  Additional Information: Reporter (patient) said that he received 2nd dose of vaccine today. Doesn't believe vaccine was administered properly. Said didn't feel anything, there was moisture after needle was pulled out, had moisture on sleeve. Had also spoken to person that gave vaccine and said they were confident in giving vaccine. Caller doesn't think so. Said after 1st dose his arm was a bit sore after getting vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (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: URINARY TRACT INFECTION (non-serious) with onset 20Apr2021, outcome "unknown", described as "UTI". Therapeutic measures were taken as a result of urinary tract infection.  Additional information: Consumer had her first dose on the 07Apr2021 and scheduled tomorrow the 28th of April for the second dose. Patient had taken antibiotics for her UTI infection dated the 20Apr2021 and asking if it's safe to take the second 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: Headache
Clinical narrative: she has headache but nothing more; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 12Apr2021 (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) with onset Apr2021, outcome "recovered" (Apr2021), described as "she has headache but nothing more".  Additional information: The patient had headache but nothing more and wanted to make sure that she is okay.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oral disorder, Oral pruritus, Throat irritation, Vaccination site pain
Clinical narrative: scratchy, slightly itchy sensation at the back of my mouth and upper throat area; scratchy, slightly itchy sensation at the back of my mouth and upper throat area; scratchy, slightly itchy sensation at the back of my mouth and upper throat area; mild tiredness; soreness in the injection area; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Apr2021 14:15 (Lot number: ER8729) at the age of 61 years as dose 1, single and administered in arm right, administration date 29Apr2021 14:15 (Lot number: ER8736) (at the age of 61-year-old) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Allergy to metals/ Nickel Sensitivity" (unspecified if ongoing); "Allergy to molds/ Mold/Mildew" (unspecified if ongoing). There were no concomitant medications. Past drug history included: BACTRIM, reaction: "Drug allergy". The following information was reported: ORAL PRURITUS (non-serious), THROAT IRRITATION (non-serious), ORAL DISORDER (non-serious) all with onset 08Apr2021 14:45, outcome "recovered" and all described as "scratchy, slightly itchy sensation at the back of my mouth and upper throat area"; FATIGUE (non-serious) with onset 08Apr2021 14:45, outcome "recovered", described as "mild tiredness"; VACCINATION SITE PAIN (non-serious) with onset 08Apr2021 14:45, outcome "recovered", described as "soreness in the injection area". Therapeutic measures were not taken as a result of oral pruritus, throat irritation, oral disorder, fatigue, vaccination site pain.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. It was reported approximately 20-30 minutes after each dose, the patient experienced a scratchy, slightly itchy sensation at the back of mouth and upper throat area.  The patient did not report this symptom at her second vaccine visit- forgot about it actually. After receiving her second dose she knew for sure that it was related, though after her first dose she had strong conclusion. She would equate the feeling as "like coming down with something." In both cases, the feeling was mild and lasted five to six hours. Of note, she was a Respiratory Therapist, but not currently practicing- she had been unemployed since a few months before COVID-19. Other than that she only experienced mild tiredness and soreness in the injection area that went away within a couple days. Event onset date was reported as 08Apr2021 at 14:45. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Vaccination site swelling
Clinical narrative: feeling week; swollen arm where injected.; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "feeling week"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swollen arm where injected.".  Additional information: Patient got first dose at clinic. And patient did get few side effects like feeling week and swollen arm where injected. Now it was invalid so she started revaccination and got first dose this Monday 19Apr with side effects like swollen arm , headaches. Patient second dose was on 10May. Based on the above observations patient had a feeling if dose with clinic was valid, 10May dose will be 3rd dose. But it was mentioned that clinical trials were going on to see what happens with 3rd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Peripheral swelling
Clinical narrative: swollen arm; headaches; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 19Apr2021 (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, single, But it was considered as invalid and restarted vaccination.), for COVID-19 Immunization, reaction(s): "feeling week", "swollen arm where injected". The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swollen arm"; HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: Patient got first dose at withheld clinic and did get few side effects like feeling week and swollen arm where injected. Reported as, now it was invalid so patient started revaccination and got first dose this Monday April 19th (considered as dose 2) with side effects like swollen arm and headaches. Patient's next dose (reported as second dose) scheduled on May 10th. Based on the above observations patient had a feeling if dose with withheld is valid, May 10th dose will be 3rd dose. But it was mentioned that clinical trials are going on to see what happens with 3rd 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: Rash macular
Clinical narrative: Few small red spots on her body; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 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: RASH MACULAR (non-serious), outcome "unknown", described as "Few small red spots on her body". Therapeutic measures were taken as a result of rash macular.  Additional information: Caller was calling for a patient who received both doses of the Pfizer COVID Vaccine. She mentioned that on her 1st dose, the patient experienced a few small red spots on her body. The 2nd dose, which she received last week, blew her up with a pretty significant rash all over her body that look like underlying diffused erythema with a multiforma look. She mentioned that she was already given steroids at a fairly moderate amount without improvement. She was considering on giving her a high dose of steroids. She was asking if there have been any reports on this and for any input on the situation.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenopia, Blood pressure measurement, Dysphagia, Eye pain, Heart rate
Clinical narrative: eyes felt tired and hurt; eyes felt tired and hurt; difficulty swallowing; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 50 year-old patient received bnt162b2 (BNT162B2) (Lot number: EW0169) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing); "Hx thyroid " (unspecified if ongoing). The patient took concomitant medications. The following information was reported: ASTHENOPIA (non-serious), EYE PAIN (non-serious), outcome "unknown" and all described as "eyes felt tired and hurt"; DYSPHAGIA (non-serious), outcome "unknown", described as "difficulty swallowing". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Time of Vaccine: 5:30. Time of Reaction: 5:50. Prescriptions, OTC meds, supplements: Thyroid meds, Allergy meds. Allergies(food/drugs/etc.): Denies. Daughter taking mother to the hospital for AMA form signed.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Investigation, Oxygen saturation
Clinical narrative: eyes felt tired and hurt; eyes felt tired and hurt; difficulty swallowing; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 50 year-old patient received bnt162b2 (BNT162B2) (Lot number: EW0169) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing); "Hx thyroid " (unspecified if ongoing). The patient took concomitant medications. The following information was reported: ASTHENOPIA (non-serious), EYE PAIN (non-serious), outcome "unknown" and all described as "eyes felt tired and hurt"; DYSPHAGIA (non-serious), outcome "unknown", described as "difficulty swallowing". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Time of Vaccine: 5:30. Time of Reaction: 5:50. Prescriptions, OTC meds, supplements: Thyroid meds, Allergy meds. Allergies(food/drugs/etc.): Denies. Daughter taking mother to the hospital for AMA form signed.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Muscle twitching
Clinical narrative: Burning sensations in nerves; his arm was twitching; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male 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 was not reported. There were no concomitant medications. The following information was reported: BURNING SENSATION (non-serious), outcome "unknown", described as "Burning sensations in nerves"; MUSCLE TWITCHING (non-serious) with onset Mar2021, outcome "recovered" (Apr2021), described as "his arm was twitching".  Additional information: It was reported as, patient had pfizer vaccine 3 weeks ago. 20 minutes later his arm was twitching. Twitching for a week. Burning sensations in nerves.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypoaesthesia, Pain in extremity
Clinical narrative: arm pain throughout the day, but woke up in the middle of the night with terrible, intense pain/soreness throughout my entire left arm, down to my fingers; Felt like my arm was on fire; Terrible pain almost numbed my arm/fingers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 09:45 (Lot number: EW0172) at the age of 23 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZOLOFT; TOPIRAMATE; MELATONIN; MULTIVIT [VITAMINS NOS]. Vaccination history included: Bnt162b2 (dose 1, single, lot number: EW0159, administration time: 09:45, vaccine location: left arm), administration date: 08Apr2021, when the patient was 23 years old, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Apr2021 02:45, outcome "recovered with sequelae", described as "arm pain throughout the day, but woke up in the middle of the night with terrible, intense pain/soreness throughout my entire left arm, down to my fingers"; FEELING HOT (non-serious) with onset 30Apr2021 02:45, outcome "recovered with sequelae", described as "Felt like my arm was on fire"; HYPOAESTHESIA (non-serious) with onset 30Apr2021 02:45, outcome "recovered with sequelae", described as "Terrible pain almost numbed my arm/fingers". Therapeutic measures were taken as a result of pain in extremity, feeling hot, hypoaesthesia.  Additional Information: The vaccine was administered at a Public Health Clinic/Veterans Administration facility. The patient did not have COVID prior to vaccination was not tested after vaccination. The patient has no known allergies. The patient did not receive other vaccine in four weeks. The patient took 2 ibuprofen but couldn't get back to sleep for another hour. In the morning, it was back to a dull ache/numbness.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Blood test abnormal, Dizziness, Euphoric mood, Feeling abnormal
Clinical narrative: felt high and giddy; felt high and giddy; tested Positive for PCP in her blood test; had a rushing sensation comparable to an IV rushing into her veins/ felt weird; 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) (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 (Event:She mentioned that it felt weird and that she also felt high and giddy after the 1st and 2nd dose), for Covid-19 immunization. The following information was reported: EUPHORIC MOOD (non-serious), DIZZINESS (non-serious), outcome "unknown" and all described as "felt high and giddy"; BLOOD TEST ABNORMAL (non-serious), outcome "unknown", described as "tested Positive for PCP in her blood test"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "had a rushing sensation comparable to an IV rushing into her veins/ felt weird". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient mentioned that it felt weird and that she also felt high and giddy after the 1st and 2nd dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.