chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Epistaxis, Headache
Clinical narrative: bloody nose; Lower back pain; Headache; This is a spontaneous report from a contactable Physician (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via intramuscular route of administration in right arm on an unspecified date as dose 2, single for COVID-19 immunisation at hospital. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via unknown route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient not had COVID-19. Since the vaccination, the patient had not been with COVID-19. The patient experienced bloody nose, lower back pain, headache on an unspecified date. The patient did not receive any treatment for the events. The outcome of events was reported as recovered on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Skin discolouration, Skin exfoliation, Swelling
Clinical narrative: rough skin almost scaly in that area; pink and itchy for 3 inches near sight and slightly swollen; pink and itchy for 3 inches near sight and slightly swollen; pink and itchy for 3 inches near sight and slightly swollen; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself). A 70-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 05Feb2021 at 14:00 (02:00 PM) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications included terazosin, metformin, lovastatin, amlodipine, lis, all drugs taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within four weeks. Patient was not diagnosed with COVID prior vaccination. Patient was not COVID tested post vaccination. The patient previously took niacin and experienced drug allergy. On 15Feb2021, the patient experienced rough skin almost scaly in that area, pink and itchy for 3 inches near sight and slightly swollen. Adverse event: 8 days after vaccination pink and itchy for 3 inches near sight and slightly swollen. Only for one day but now rough skin almost scaly in that area. The patient did not receive treatment for the events. Outcome of the event rough skin almost scaly in that area was recovering and outcome of remaining events was recovered on an unspecified date in 2021.  Information on the lot/batch number has been requested.  Follow-up (PRD/SRD 13May2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Nausea, Pain
Clinical narrative: Nausea; fever; Body aches; headache; sweating.; chills; This is a spontaneous report from a non-contactable consumer (patient). A patient with unspecified age and gender received second dose of bnt162b2 (Pfizer BioNtech covid-19 vaccine, Solution for injection, Lot number: EL3302), via an unspecified route on 17Feb2021 at 14:15, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer BioNtech covid-19 vaccine, Solution for injection) as a single dose for covid-19 immunization. Prior to vaccination, patient was not diagnosed with COVID-19. On 18Feb2021, patient experienced nausea, fever, sweating, body aches, chills and headache. Patient did not receive any treatment for the events. The clinical outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Nausea; fever; Body aches; headache; sweating.; chills; This is a spontaneous report from a non-contactable consumer (patient). A patient with unspecified age and gender received second dose of bnt162b2 (Pfizer BioNtech covid-19 vaccine, Solution for injection, Lot number: EL3302), via an unspecified route on 17Feb2021 at 14:15, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer BioNtech covid-19 vaccine, Solution for injection) as a single dose for covid-19 immunization. Prior to vaccination, patient was not diagnosed with COVID-19. On 18Feb2021, patient experienced nausea, fever, sweating, body aches, chills and headache. Patient did not receive any treatment for the events. The clinical outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Pain, Pyrexia, Viral test
Clinical narrative: headache, body ache, lethargy, fever; headache, body ache, lethargy, fever; headache, body ache, lethargy, fever; headache, body ache, lethargy, fever; This is a spontaneous report from a contactable other health care professional (Patient). A 36-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 02Feb2021 15:00 as dose 2, single for Covid -19 immunization at Nursing Home/Senior Living Facility. No Covid prior to vaccination. The patient medical history was not reported. No known drug allergies reported. Concomitant medication(s) in two weeks included fluoxetine (FLUOXETINE). No other vaccine taken in four weeks. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number), via an unspecified route of administration, administered in Arm Left on 12Jan2021 09:00AM as dose 1, single for Covid -19 immunization. On 03Feb2021 06:00, the patient experienced headache, body ache, lethargy, fever. Covid was tested post vaccination. The patient underwent lab tests and procedures which included Nasal Swab: unknown results on 05Feb2021 [{covid test type post vaccination-Nasal Swab, covid test date-05Feb2021, covid test result-Pending}]. No treatment received for the events. Outcome of events was not resolved.  Information about lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: swollen lymph nodes on my left side which was the side I got the vaccine on (swollen lymph node under my left armpit, swollen lymph node near my left clavicle bone); Extreme soreness at injection site; This is a spontaneous report from a contactable other hcp (patient). A 31-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in Arm Left on 20Jan2021 (at the age of 31-year-old) as dose 1, single for covid-19 immunisation. The patient medical history included none. No concomitant medications. Patient had no allergies. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Feb2021, 12 days after vaccination the patient experienced swollen lymph nodes on her left side which was the side she got the vaccine on (swollen lymph node under my left armpit, swollen lymph node near my left clavicle bone), extreme soreness at injection site. No treatment was taken as a result of events. The outcome of the events were recovering.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache on 08Feb2021. It was reported that, patient took vaccine on Saturday and started having a headache yesterday and still had it. Patient wanted to know if there was anything for her to be concerned about. The outcome of the event was not recovered.  Information about Lot/Batch number is requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body height decreased, Erythema, Pruritus, Rash, Weight
Clinical narrative: rash on her side, the size of a baseball; Body, back, and side itches; It was dark red and then went away/Stated it was kind of a bright red. It was really red. She has never seen a rash that red; she developed a little red spots a couple days after the first time. It also went away; she lost half an inch; This is a spontaneous report from a contactable consumer or other non-Hcp (patient herself). A 77-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: Unknown, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 29Jan2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date the patient experienced rash on her side, the size of a baseball, body, back, and side itches, it was dark red and then went away/stated it was kind of a bright red. it was really red. she had never seen a rash that red; she developed a little red spots a couple days after the first time. it also went away; she lost half an inch (body height decreased). The patient underwent lab tests and procedures which included weight was between 102-103lbs. The outcome of the events was not recovered.  Information about Lot/Batch number is requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Exercise electrocardiogram, Feeling abnormal
Clinical narrative: Stated he "felt out of it for the day" after receiving his first dose of the COVID-19 Vaccine; This is a spontaneous report from a contactable consumer (patient), from a sponsored program.   A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 19Jan2021 as dose 1, single for covid-19 immunization. The patient medical history included ongoing diabetes. Concomitant medications were not reported. It was reported that, patient stated he felt out of it for the day after receiving his first dose of the COVID-19 Vaccine. Patient stated he has his second COVID-19 Vaccine scheduled today, 09Feb2021. He said there is a snow storm in his area, and he doesn't know if where his is scheduled to receive his second COVID-19 Vaccine will be available to administer his second COVID-19 Vaccine dose.  He said his first COVID-19 Vaccine dose was on 19Jan2021. He said he has a cardiologist and has done his treadmill stress test. He said he has no stents. No further details provided. The patient underwent lab tests and procedures which included treadmill stress test (exercise electrocardiogram): unknown results on an unspecified date. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: A few days later, I developed psoriasis outbreak on my right elbow and right knee.  I hadn't had an outbreak at all in over 2 years.  I still have the outbreak as of today.; This is a spontaneous report from a contactable consumer (patient). A 55-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9269), via an unspecified route of administration, administered in left arm on 03Feb2021 09:15 as (at the age of 55-year-old) DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included overweight and psoriasis. The patient reported known allergies to penicillin, bactrim, tetracycline, erythromicin, and benzoyl peroxide. The patient's concomitant medication(s) included colecalciferol (VITAMIN D COLECALCIFEROL]), acetylsalicylic acid (ASPRIN), cyanocobalamin (B12 [CYANOCOBALAMIN]), ascorbic acid, glucosamine sulfate (MOVE-FREE), and levocetirizine dihydrochloride (XYZAL). No other vaccine in four weeks. On a few days later, 07Feb2021, the patient developed psoriasis outbreak on the right elbow and the right knee. The patient did not have an outbreak at all in over 2 years. And still have the outbreak as of today. Patient did not have any treatment for an event. Prior to vaccination the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event not recovered.    Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Nausea, Sinus headache
Clinical narrative: numb lips; numb fingers; bad headache; nausea; This is a spontaneous report from a contactable consumer or other non hcp. An unknown pregnant female patient of an unspecified age received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified) dose 1, via an unspecified route of administration on 17Feb2021 as single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if known allergies occurred. It was unknown if covid prior vaccination or if tested post vaccination. On 18Feb2021, the patient started developing numb lips and fingers, bad headache, and nausea. It was unknown if treatment was taken for adverse events. The outcome of the events was reported as unknown.  Information about lot/Batch number has been requested  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chills, Nausea, Vomiting
Clinical narrative: throwing up; Nauseated; Chills; This is a spontaneous report from a contactable other hcp/nurse (patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN5318 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 08Feb2021 at 10:00 as DOSE 2 (age at vaccination: 66-years-old), SINGLE for covid-19 immunisation. The patient received dose 1 of BNT162B2 on 11JAN2021 for COVID-19 immunisation (Lot Number: EL1283, Expiry Date: unknown, Anatomical Location: Right Arm). The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced nauseated and chills on 08Feb2021 (In the middle of the night on 08Feb2021 is when she got nausea and chills), throwing up on an unknown date. The patient underwent lab tests and procedures which included blood test: everything was within normal range on an unknown date. Outcome of the event (nauseated) was Not recovered, chills and throwing up was unknown.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Achy for 24 hours after receiving 2nd dose; This is a spontaneous report from a contactable consumer. A male patient in his 40s received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced achy for 24 hours after receiving 2nd dose of BNT162B2. Therapeutic measures were taken as a result of the event included intake of paracetamol (TYLENOL) and ibuprofen, alternating for 24 hours following vaccination to manage achy symptoms. Outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Hypoaesthesia, Joint injury, Joint lock
Clinical narrative: joint pain in his elbow on his right side, and on the right side of his body in his hip and leg; right leg numb and his right upper thigh time to time; sometime hard to walk; right wrist pops sometimes; right knee locks up; Muscle pain; This is a spontaneous report from a contactable consumer or other non hcp.     A 69-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 (Batch/Lot Number: EM9810) as dose 1 single for an unspecified indication. Medical history included hypertension from 2008, Blood pressure high, cardiac disorder. The patient's concomitant medications were not reported. It was Reported,  Caller stated first dose was injected into his left arm, and he is having joint pain in his elbow on his right side, and on the right side of his body in his hip and leg and at his right leg is numb, and his right upper thigh time to time it is sometime hard to walk and also had his right wrist pops sometimes when he moves it, and it seems to give out in his arm. He said his right knee locks up sometimes. Caller says his vaccine card is handwritten, he can't read it, and needs to get his glasses. He says that the card says his first date was 03Feb2021, but he thought it was the 04Feb2021. He says that the second dose is scheduled for 24Feb2021.Caller say that he has just been taking his regular prescribed meds. He said that they took him off Aspirin and stuff like that. He says that they were giving him pain pills, and he can't take Tylenol, but he doesn't have pain pills, them things are hard to get these days. Caller does not clarify these statements, no further details provided about Aspirin, Tylenol, or pain pills. The outcome of the events was unknown on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: joint pain in his elbow on his right side, and on the right side of his body in his hip and leg; right leg numb and his right upper thigh time to time; sometime hard to walk; right wrist pops sometimes; right knee locks up; Muscle pain; This is a spontaneous report from a contactable consumer or other non hcp.     A 69-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 (Batch/Lot Number: EM9810) as dose 1 single for an unspecified indication. Medical history included hypertension from 2008, Blood pressure high, cardiac disorder. The patient's concomitant medications were not reported. It was Reported,  Caller stated first dose was injected into his left arm, and he is having joint pain in his elbow on his right side, and on the right side of his body in his hip and leg and at his right leg is numb, and his right upper thigh time to time it is sometime hard to walk and also had his right wrist pops sometimes when he moves it, and it seems to give out in his arm. He said his right knee locks up sometimes. Caller says his vaccine card is handwritten, he can't read it, and needs to get his glasses. He says that the card says his first date was 03Feb2021, but he thought it was the 04Feb2021. He says that the second dose is scheduled for 24Feb2021.Caller say that he has just been taking his regular prescribed meds. He said that they took him off Aspirin and stuff like that. He says that they were giving him pain pills, and he can't take Tylenol, but he doesn't have pain pills, them things are hard to get these days. Caller does not clarify these statements, no further details provided about Aspirin, Tylenol, or pain pills. The outcome of the events was unknown on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Movement disorder, Myalgia, Sleep disorder
Clinical narrative: Extremely tired back muscles; body heat; felt unstable; lost a lot of sleep; could not lay prone; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 01Feb2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Extremely tired back muscles, body heat, felt unstable, lost a lot of sleep, and could not lay prone. Caller declined to complete a report and requested to be transferred to USMI to have her questions addressed. The outcome for all the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Laboratory test, Muscle discomfort
Clinical narrative: Muscle discomfort; Muscle discomfort was reported as worsened.; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 85-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration, administered in arm left on 05Feb2021 13:15 (at the age of 85 years) as dose number unknown, single for covid-19 immunization. Medical history included ongoing gout. There were no concomitant medications. Prior Vaccinations (within 4 weeks) Patient took pneumonia shot as his doctor recommend this product. On unspecified date of Feb2021 over the weekend the patient experienced muscle discomfort and in the last day or so it has gotten really severe. Patient had muscle discomfort before due to gout but nothing like this. The patient underwent lab tests and procedures which included laboratory test with unknown results on 09Feb2021. The outcome of the events was unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence, Therapeutic response unexpected
Clinical narrative: some soreness in her arm; didn't know if there was some kind of sleep medicine in the COVID-19 Vaccine because she hasn't slept that good in years; didn't know if there was some kind of sleep medicine in the COVID-19 Vaccine because she hasn't slept that good in years; This is a spontaneous report from a contactable consumer (daughter) reported for her mother. A 95-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced some soreness in her arm and didn't know if there was some kind of sleep medicine in the covid-19 vaccine because she hadn't slept that good in years on an unspecified date. No further details provided. Clinical outcome of events was unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood blister, Glossodynia
Clinical narrative: developed blood blister on side of tongue; then was like a sore on the side of her tongue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 29Jan2021 (at the age of 67-year-old) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 05Feb2021, the patient developed blood blister on side of tongue, then was like a sore on the side of her tongue. Blood blister came on right away, it lasted two hours and burst, then was like a sore on the side of her tongue. Patient went to her physician who said it was healing. The patient underwent lab tests and procedures which included blood test: everything looked excellent on an unspecified date in 2021, everything looked excellent, there was nothing abnormal at all. Which is good. The events resulted in physician office visit. the events did not require treatment. The outcome of the event blood blister was recovering and the outcome of then it became sore on the side of tongue was unknown.   Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Fever; sore joints; very tired; injection site pain; Headache; This is a spontaneous report from a contactable other health professional (patient). A 51-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in arm left on 16Feb2021 11:00 (at the age of 51 years old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in arm left on 26Jan2021 (at the age of 51 years old) as single for COVID-19 immunisation. Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior vaccination. The patient experienced fever, sore joints, very tired, injection site pain, headache on 17Feb2021. No treatment were given for the adverse events. Patient did not tested for COVID post vaccination. Outcome of all the events were recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itchy; Rash; This is a spontaneous report from a contactable Pharmacist. A 54-year-old female patient received first dose of bnt162b2 (Pfizer COVID-19 vaccine, Solution for injection, Batch/lot number: not provided, Expiration date: not provided), via an unspecified route on 19Jan2021 (age at vaccination: 54-year-old), as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 19Jan2021, patient experienced rash. Patient wanted to know if she can get the second dose. Patient got her first dose on 19Jan2021 and today is the 21-day mark. Today, patient still has a rash on her arm and body from the last time got vaccine now still has rash and itchy. The clinical outcome of the events was still having rash and itchy.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Memory impairment
Clinical narrative: Period of confusion; Her memory cleared up; This is a spontaneous report from a contactable Nurse. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL3247, Expiration Date: not reported), via an unspecified route of administration in left arm on 20Jan2021 11:30 as dose 1, single for COVID-19 immunization (at the age of 70-year-old). Patient historical vaccine included 20 days prior to COVID shot had Shingles shot, NDC/Lot/exp for shingles shot was not reported. Patient had no AEs follow prior vaccinations. Medical history included depression and had COVID last March before it was even being tested. Knew she had COVID because she couldn't taste her food. It was like the flu but she couldn't taste. History of all previous immunizations was not provided. Additional vaccines was not administered on same date of pfizer suspect. Family medical history included patients mother was 91 when she died. Patient was sure her mother had memory problems. There was no early onset Alzheimer's or Parkinson's in the family. No further details provided. Concomitant medication(s) included fluoxetine hydrochloride (PROZAC) taken for depression and was on very little medicine. Had no NDC/Lot/exp for the Prozac. The patient experienced period of confusion and her memory cleared up on an unspecified date. It was reported that, patient got the Pfizer shot and was getting the second one tomorrow on 10Feb2021. Patient had period of confusion. Couldn't remember where she put her credit card. It happened four times. It felt crazy. Had misplaced her credit card, but never lost her credit card like that. Didn't know if that had anything to do with the COVID shot. Worked as an RN and LPN. Patient wanted to know if the period of confusion was related. Occurred four time almost within a couple hours. It was a block of confusion and quite scary. Was in a store, put her credit card away and then couldn't find it. Was asked her phone number and couldn't remember her phone number. A couple days later was driving down the road and didn't know where she was. Her memory cleared up when she was at an intersection and could name areas she knew. Stated that experience was different. Just thought it was an offshoot of the memory problem. Period of confusion began a week and a half to two weeks ago. Reported seriousness was not serious. It was concerning when that happened and wondered how long it will go on. Didn't call her doctor. Patient was just paying attention to how often it was happening. Relatedness for period of confusion was unknown. Causality was reported as patient was under stress with work and wasn't sleeping and wanted to just check it out before receiving second dose. The outcome of the events was unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in the arm; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3249 and expiry date: unknown), dose 1 via intramuscular, administered in Arm Right on 13Jan2021 as DOSE 1 (age at vaccination: 50-years-old), SINGLE for covid-19 immunisation. Her flu shot was in Oct2020. Medical history included , seasonal allergy. There were no concomitant medications. The patient experienced pain in the arm on 13Jan2021. Outcome of the event was recovered on an unknown date.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Migraine, Pain
Clinical narrative: bad headache; low grade fever; fatigue; body aches; dizziness; migraine; This is a spontaneous report from a Pfizer-sponsored program Support reported by a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation; etanercept (ENBREL), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date for an unspecified indication. The patient medical history and concomitant medications were not reported. Patient received her 1st dose of BNT162B2 for Covid-19 Immunization and experienced just some arm soreness. It was reported that there was a call from a caller who had migraine for past 9 days since receiving the 2nd vaccine dose. The patient received her 1st Pfizer vaccine dose 4weeks ago and received her 2nd Vaccine dose last Tuesday, 09Feb2021. Patient states she was never asked about medications or hx at vaccination location. Patient states after receiving the 2nd vaccine dose she experienced a low grade fever, fatigue, body aches, dizziness and a bad headache on an unspecified date in Feb2021. The patient states she takes Enbrel once per week and received IV IGG, Methyl prednisone and Toradol to prevent a headache from this treatment on Friday, 12Feb2021. She was seen by an Internist on 15Feb2021 at an ED like place where she received IV Toradol, IV fluids and Zofran for treatment of the post vaccine headache. The patient stated her headache was a little better after receiving this treatment. She routinely sees a Neurologist and a Rheumatologist for her multiple health issues. One doctor wants to put her on steroids and the other doctor said to wait 14 days from the 2nd dose because it may effect the efficacy of the Pfizer vaccine. The action taken in response to the event for etanercept was unknown. The outcome of the event headache was recovering. The outcome of all the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: bad headache; low grade fever; fatigue; body aches; dizziness; migraine; This is a spontaneous report from a Pfizer-sponsored program Support reported by a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation; etanercept (ENBREL), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date for an unspecified indication. The patient medical history and concomitant medications were not reported. Patient received her 1st dose of BNT162B2 for Covid-19 Immunization and experienced just some arm soreness. It was reported that there was a call from a caller who had migraine for past 9 days since receiving the 2nd vaccine dose. The patient received her 1st Pfizer vaccine dose 4weeks ago and received her 2nd Vaccine dose last Tuesday, 09Feb2021. Patient states she was never asked about medications or hx at vaccination location. Patient states after receiving the 2nd vaccine dose she experienced a low grade fever, fatigue, body aches, dizziness and a bad headache on an unspecified date in Feb2021. The patient states she takes Enbrel once per week and received IV IGG, Methyl prednisone and Toradol to prevent a headache from this treatment on Friday, 12Feb2021. She was seen by an Internist on 15Feb2021 at an ED like place where she received IV Toradol, IV fluids and Zofran for treatment of the post vaccine headache. The patient stated her headache was a little better after receiving this treatment. She routinely sees a Neurologist and a Rheumatologist for her multiple health issues. One doctor wants to put her on steroids and the other doctor said to wait 14 days from the 2nd dose because it may effect the efficacy of the Pfizer vaccine. The action taken in response to the event for etanercept was unknown. The outcome of the event headache was recovering. The outcome of all the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Haematoma
Clinical narrative: Bled in to a golf ball size hematoma; This is a spontaneous report from a contactable pharmacist. A 34-years-old male patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: was not reported; Expiration Date: Mar2021), via an intramuscular route of administration, administered in Arm right on an unspecified date (at the age of 34-years-old) as 0.3 ml dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Height and weight information was unknown. Historical vaccine included received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, as single for COVID-19 immunization. Investigation assessment was not provided. On Jan2021 (about 3 weeks to a month ago) the patient experienced bled into a golf ball size hematoma. Reporter said that the medical assistant gave the injection too low and hit a blood vessel. Reporter wanted to know about the affect the efficacy and the mechanism of action of the product and revaccination. The reporter highlighted the term and considered the events as non-serious. The outcome of the event was recovered on Jan2021.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Headache, Illness, Myalgia
Clinical narrative: Dizziness; having trouble staying focused; not thinking clearly; Muscle pain; body aches; Headache; She was really sick; This is a spontaneous report from a contactable consumer. This 50-year-old female Consumer reported.  A 50-year-old female patient received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EL9269, Expiration date: 31May2021), via intramuscular, administered in right arm on 05Feb2021 (at the age of 50-year-old) as dose 2, single for COVID-19 immunization. Patient received first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EL3249, Expiration date: unknown), via unspecified route, administered on 13Jan2021 (at the age of 50-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes seasonal allergies and concomitant medications were not reported. Patient historical vaccine include flu shot in Oct2020 and patient experienced Pain in extremity. on 07Feb2021, after the vaccination, the patient experienced body aches worse than the activities she did would cause and patient said that she also had a headache. She attributed the headache to the weather change at first, but she does not know, she said that she has seasonal allergies, but this headache is different because it is a dull headache in her whole head, instead of in her sinuses. On 08Feb2021 patient experienced muscle pain and feels like she has done crunches. On 09feb2021 She also reported that she was very dizzy and almost fell over a couple of times. She said that the dizziness started in the morning. She could barely function with it. She was sick and dizzy at about 11:00-12:00. She must watch what she is doing so she does not fall. It is persisting but comes and goes. She was having trouble staying focused because of this. She said that she is not a dizzy person and does not have high blood pressure and is not on any medications. Patient explained she is little confused because of this and she is not thinking clearly. Patient was asking to do anything and worried about vertigo recurrence. The outcome of the events was not recovered at the time of this report.  No follow-up attempts possible. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Thinking abnormal
Clinical narrative: Dizziness; having trouble staying focused; not thinking clearly; Muscle pain; body aches; Headache; She was really sick; This is a spontaneous report from a contactable consumer. This 50-year-old female Consumer reported.  A 50-year-old female patient received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EL9269, Expiration date: 31May2021), via intramuscular, administered in right arm on 05Feb2021 (at the age of 50-year-old) as dose 2, single for COVID-19 immunization. Patient received first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EL3249, Expiration date: unknown), via unspecified route, administered on 13Jan2021 (at the age of 50-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes seasonal allergies and concomitant medications were not reported. Patient historical vaccine include flu shot in Oct2020 and patient experienced Pain in extremity. on 07Feb2021, after the vaccination, the patient experienced body aches worse than the activities she did would cause and patient said that she also had a headache. She attributed the headache to the weather change at first, but she does not know, she said that she has seasonal allergies, but this headache is different because it is a dull headache in her whole head, instead of in her sinuses. On 08Feb2021 patient experienced muscle pain and feels like she has done crunches. On 09feb2021 She also reported that she was very dizzy and almost fell over a couple of times. She said that the dizziness started in the morning. She could barely function with it. She was sick and dizzy at about 11:00-12:00. She must watch what she is doing so she does not fall. It is persisting but comes and goes. She was having trouble staying focused because of this. She said that she is not a dizzy person and does not have high blood pressure and is not on any medications. Patient explained she is little confused because of this and she is not thinking clearly. Patient was asking to do anything and worried about vertigo recurrence. The outcome of the events was not recovered at the time of this report.  No follow-up attempts possible. No further information expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling cold, Nausea, Tremor
Clinical narrative: Real bad chills; Nausea; Weakness; shaking; get real cold; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 08Feb2021 (at the age of 69-year) as dose 1, single for COVID-19 immunisation (didn't want to catch it. Was up in age thought she needed it). Medical history included eye surgery three weeks ago from "yesterday" to an unknown date. There were no concomitant medications. The vaccine was not administered at facility. Investigation assessment was not provided. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had first COVID-19 Vaccine on Monday (08Feb2021). Did alright until early "this" morning. Wanted to know if it was natural for this to happen. Was having real bad chills, nausea, and feeling weak. She was started to experience nausea, real bad chills, and weakness around 09:00-10:00 this morning. She was started get real cold and put a heating pad in her bed. She was shaking. Was alright until she took the shot. Assuming it was side effects of the shot. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Extreme body pains/aches; Nausea; Headache; Chills; fever; body aching is severe/every symptom intensified at once; This is a spontaneous report from a contactable consumer (Patient). A 63-years-old female patient received first dose of BNT162B2 (COMIRNATY; Formulation: Solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in Arm Left on 08Feb2021 16:00 (At the age of 63 years old) as dose 1, single for COVID-19 immunization. Medical history included covid-19 from 10Sep2020 to an unknown date. Reporter had COVID back in Sep2020. Reporter was diagnosed on 10Sep2020 and ended up with Pneumonia on 23Sep2020 to an unknown date. The patient's concomitant medications were not reported. Other products, patient history and Investigation assessment was not provided. Patient took COVID Vaccine because she had travelled in Mar2021 which means she was exposed more. On 09Feb2021 the patient experienced extreme body pains/aches, nausea, headache, chills, fever and on Feb2021 Patient experienced body aching is severe/every symptom intensified at once. Reporter was unsure if she had a fever. Reporter had not taken her temperature. But the body aching was severe. Reporter confirmed she knew these feelings as they were the same as when she had COVID. Only now it was every symptom intensified at once. With COVID you had them spread out over 2 weeks. Reporter just needs some relief. She was so sick. She did not think she would get like this. Reporter thought maybe she got the vaccine too soon after she had COVID. Reporter just finished off the bottle of Ibuprofen, which was in fact the brand name Advil. LOT R41362, EXP: Sep2019. Therapeutic measures were taken as a result of extreme body pains/aches (pain) with Ibuprofen and Tylenol. Ibuprofen and Tylenol do not seem to do much. Reporter did not realize it was old. The Tylenol was actually a generic. Costco's generic brand, Kirkland's Extra Strength Acetaminophen. LOT: 0GV1265, EXP: May2022. Reporter had some Hydrocodone-Acetaminophen left over, could she take one of those to knock her out so she can sleep. The outcome of the events extreme body pains/aches, nausea, headache, and chills was not recovered, and outcome of the event fever and body aching is severe/every symptom intensified at once was unknown   Follow-up attempts are completed. No further information is expected.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Nasal congestion
Clinical narrative: stuffy nose; eyes are watering; This is a spontaneous report from a contactable consumer (patient). A 95-years-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, administrated in Left arm on 08Feb2021 13:10 (age at the time of vaccination 95-years-old), as a single dose for COVID-19 immunization. The patient's medical history included blood pressure. The patient's concomitant medication was blood pressure pills. On 09Feb2021, the patient experienced stuffy nose, and eyes are watering. The outcome for all the events was not recovered.  Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.