chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle contractions involuntary
Clinical narrative: Experienced extreme muscle contractions 2 weeks after the second dose of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 46 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 46 years as dose 2, single for covid-19 immunisation. Family history included: "Disease Parkinson's" (unspecified if ongoing), notes: Family history includes Parkinson's disease (mother). Concomitant medication(s) included: NICOTINE. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: MUSCLE CONTRACTIONS INVOLUNTARY (non-serious) with onset Feb2021, outcome "recovered", described as "Experienced extreme muscle contractions 2 weeks after the second dose of the vaccine". Therapeutic measures were not taken as a result of muscle contractions involuntary.  Additional information: Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was reported that patient received more than 3 doses and the patient also received fourth dose of BNT162b2 (BNT162B2; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The reporter stated that I do not have any further information. The person who reported the event indicated that he would be willing to provide follow-up information to Pfizer.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: joint pain; moderate swelling in both hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Aug2021 16:00 (Lot number: EW0183) at the age of 37 years as dose 1,single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Note :Asthma. Concomitant medication(s) included: ADVAIR HFA; ALBUTEROL SULFATE; OXYCODONE. The following information was reported: ARTHRALGIA (disability) with onset 23Aug2021 02:30, outcome "not recovered", described as "joint pain"; PERIPHERAL SWELLING (disability) with onset 23Aug2021 02:30, outcome "not recovered", described as "moderate swelling in both hands". The events "joint pain" and "moderate swelling in both hands" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive, notes: Nasal Swab; (07Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of arthralgia, peripheral swelling.  No follow-up attempts are possible, No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Nasal Swab Result :Positive; Nasal Swab Result :Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 16:00 (Lot number: FGJ527) at the age of 60 years as dose 3 (booster), single, administered in arm left, administration date 01Apr2021 11:30 (Lot number: EN6208) as dose 2, single and administered in arm left, administration date 11Mar2021 12:00 (Lot number: EN6201) 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 FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "unknown" and all described as "Nasal Swab Result :Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Jan2022) positive, notes: Nasal Swab. The patient received no other vaccine in four weeks. The patient did not have covid prior vaccination. The patient was tested for covid post vaccination.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Platelet count, Platelet count decreased, SARS-CoV-2 test
Clinical narrative: Nasal Swab Result :Positive; Nasal Swab Result :Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 16:00 (Lot number: FGJ527) at the age of 60 years as dose 3 (booster), single, administered in arm left, administration date 01Apr2021 11:30 (Lot number: EN6208) as dose 2, single and administered in arm left, administration date 11Mar2021 12:00 (Lot number: EN6201) 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 FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "unknown" and all described as "Nasal Swab Result :Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Jan2022) positive, notes: Nasal Swab. The patient received no other vaccine in four weeks. The patient did not have covid prior vaccination. The patient was tested for covid post vaccination.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis, Magnetic resonance imaging, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: Appendicitus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 8-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Dec2021 (Batch/Lot number: unknown) at the age of 8 years as dose 2 (tris), single for covid-19 immunisation. Relevant medical history included: "Allergy-Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (prev dose product: COVID 19, prev dose Brand unknown: True, Prev dose Brand name unknown: COVID 19 Vaccine,, prev dose brand unknown: True, prev dose lot unknown reason: Not available/ provided to reporter at the time of report completion,, prev dose administration date: 23Nov2021, prev dose number: 1, prev dose vaccine location: Right arm), administration date: 23Nov2021, when the patient was 8 years old, for Covid-19 immunization. The following information was reported: APPENDICITIS (hospitalization, medically significant) with onset 03Feb2022 18:30, outcome "recovering", described as "Appendicitus". The patient was hospitalized for appendicitis (hospitalization duration: 2 day(s)). The event "appendicitus" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: unknown results; sars-cov-2 test: negative; ultrasound scan: unknown results. Therapeutic measures were taken as a result of appendicitis. Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. The facility type vaccine was doctor's office/urgent care. Patient was treated with IV, MRI, Ultrasound and Antibiotics. Patient did not had covid prior vaccination. Patient was tested negative for covid via nasal swab test post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 6 out of 10 Got COVID; 6 out of 10 Got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "6 out of 10 Got COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Fatigue, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: tested positive with Omicron; tested positive ; pretty frazzled moments; 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 (159558; 172086).  A 96 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "tested positive with "; FATIGUE (non-serious), outcome "unknown", described as "pretty frazzled moments". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive for , notes: positive for .  Clinical course: The reporter stated that his mother contracted Covid a little while ago and his mother got pretty frazzled moments. He stated that Paxlovid was not yet available in their area and the nurse at the hospital did not know where to get Paxlovid.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Fatigue, Gait disturbance, Musculoskeletal discomfort
Clinical narrative: Severe chest pain; jaw pain; could barely open my mouth; felt like someone sitting on my shoulders; I could barely walk; extreme fatigue; My arm was very sore; I had no energy and I was just dragging; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Oct2021 13:15 (Lot number: FE3590) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EN6201, Location of injection: Arm Left, Vaccine Administration Time: 10:15 AM), administration date: 02Mar2021, when the patient was 69 years old, for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EL9265, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 09Feb2021, when the patient was 69 years old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (medically significant) with onset 13Oct2021 20:30, outcome "recovered" (2021), described as "Severe chest pain"; PAIN IN JAW (non-serious) with onset 13Oct2021 20:30, outcome "recovered" (2021), described as "jaw pain"; ORAL DISCOMFORT (non-serious) with onset 13Oct2021 20:30, outcome "recovered" (2021), described as "could barely open my mouth"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 13Oct2021 20:30, outcome "recovered" (2021), described as "felt like someone sitting on my shoulders"; GAIT DISTURBANCE (non-serious) with onset 13Oct2021 20:30, outcome "recovered" (2021), described as "I could barely walk"; FATIGUE (non-serious) with onset 13Oct2021 20:30, outcome "recovered" (2021), described as "extreme fatigue"; PAIN IN EXTREMITY (non-serious) with onset 13Oct2021 20:30, outcome "recovered" (2021), described as "My arm was very sore"; ASTHENIA (non-serious) with onset 13Oct2021 20:30, outcome "recovered" (2021), described as "I had no energy and I was just dragging". The events "severe chest pain", "jaw pain", "could barely open my mouth", "felt like someone sitting on my shoulders", "i could barely walk", "extreme fatigue", "my arm was very sore" and "i had no energy and i was just dragging" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of chest pain, pain in jaw, oral discomfort, musculoskeletal discomfort, gait disturbance, fatigue, pain in extremity, asthenia. Additional Information: Patient did not received any treatment for AE. Patient did not tested Covid post vaccination. There was no Known allergies. Other medical history was N/A. Patient had Covid prior vaccination. Device timestamp was 14Feb2022.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort, Pain in extremity, Pain in jaw
Clinical narrative: Severe chest pain; jaw pain; could barely open my mouth; felt like someone sitting on my shoulders; I could barely walk; extreme fatigue; My arm was very sore; I had no energy and I was just dragging; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Oct2021 13:15 (Lot number: FE3590) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EN6201, Location of injection: Arm Left, Vaccine Administration Time: 10:15 AM), administration date: 02Mar2021, when the patient was 69 years old, for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EL9265, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 09Feb2021, when the patient was 69 years old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (medically significant) with onset 13Oct2021 20:30, outcome "recovered" (2021), described as "Severe chest pain"; PAIN IN JAW (non-serious) with onset 13Oct2021 20:30, outcome "recovered" (2021), described as "jaw pain"; ORAL DISCOMFORT (non-serious) with onset 13Oct2021 20:30, outcome "recovered" (2021), described as "could barely open my mouth"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 13Oct2021 20:30, outcome "recovered" (2021), described as "felt like someone sitting on my shoulders"; GAIT DISTURBANCE (non-serious) with onset 13Oct2021 20:30, outcome "recovered" (2021), described as "I could barely walk"; FATIGUE (non-serious) with onset 13Oct2021 20:30, outcome "recovered" (2021), described as "extreme fatigue"; PAIN IN EXTREMITY (non-serious) with onset 13Oct2021 20:30, outcome "recovered" (2021), described as "My arm was very sore"; ASTHENIA (non-serious) with onset 13Oct2021 20:30, outcome "recovered" (2021), described as "I had no energy and I was just dragging". The events "severe chest pain", "jaw pain", "could barely open my mouth", "felt like someone sitting on my shoulders", "i could barely walk", "extreme fatigue", "my arm was very sore" and "i had no energy and i was just dragging" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of chest pain, pain in jaw, oral discomfort, musculoskeletal discomfort, gait disturbance, fatigue, pain in extremity, asthenia. Additional Information: Patient did not received any treatment for AE. Patient did not tested Covid post vaccination. There was no Known allergies. Other medical history was N/A. Patient had Covid prior vaccination. Device timestamp was 14Feb2022.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, Vaccination failure
Clinical narrative: exposed to son who lives with her who was COVID positive 2/5 through School testing and she became sick 2/9 with mild sx and she tested PCR positive on 2/11; exposed to son who lives with her who was COVID positive 2/5 through School testing and she became sick 2/9 with mild sx and she tested PCR positive on 2/11; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 01Oct2021 (Lot number: FF2589) at the age of 40 years as dose 3(booster), single, administration date 18Feb2021 (Lot number: EL3247) as dose 2, single and administration date 28Jan2021 (Lot number: EL3247) 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 FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Feb2022, outcome "unknown" and all described as "exposed to son who lives with her who was COVID positive 2/5 through School testing and she became sick 2/9 with mild sx and she tested PCR positive on 2/11". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (11Feb2022) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events vaccination failure and COVID-19 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she tested positive; she tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200229279.  A 78-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: PHENYLEPHRINE taken for nasal congestion; CEPHALEXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative; positive.  Additional information: Additional information: The patient first stated already having two COVID 19 Vaccines and booster dose almost 4 months ago (no brand stated). She had annoying dry eyes, a mild headache and that her throat still hurt with the same intensity as previous to treatment. She said she usually works with special education kids as a volunteer, which causes her to regularly get bacterial infections and she stated not being completely sure at first if she was having this infection or COVID-19, but that her Doctor was on vacation and she was left in charge with a Nurse Practitioner who didn't believe she had a bacterial infection and refused to perform a throat culture on the caller. The patient stated a discomfort with the treatment received with by the Nurse Practitioner, so much, that she stated that she preferred going to an emergency room or waiting for her doctor to return, instead of asking him for assistance. She then stated that she lives in causes her to have allergies that just keep getting worse and worse, but that she takes phenylephrine tablets for nasal decongestion, which she stopped after starting her treatment with Paxlovid. She stated that the symptoms that she described could be cause by not taking her medicine, but that she wasn't sure and that that's why she was calling. She also said that, since at first, when she tested negative for COVID-19 and thought it was a bacterial infection, she went to her medicine cabinet and started taking Cephalexin. The patient was tested positive and her doctor, who was unavailable until 22Feb2022, started her on Paxlovid. she stopped the antibiotic. Then she stated that the first 2 days after started the antibiotic and previous to the treatment with Paxlovid, she felt her chest and throat much better, like if they were being freed.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Angiopathy, Bone disorder, Computerised tomogram, Inflammation, Pain
Clinical narrative: inflammatory reaction to old Juvederm facial filler; the inflammation caused vascular dilation and throbbing, pain; the inflammation caused vascular dilation and throbbing, pain; Possible compromise to bony structure of lower face; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 21:30 (Lot number: FE3594) at the age of 48 years as dose 3 (booster), single, administered in arm left, administration date 04May2021 16:45 (Lot number: EW0175) as dose 2, single and administered in arm left, administration date 13Apr2021 15:45 (Lot number: ER8731) as dose 1, single for covid-19 immunisation. Relevant medical history included: "old Juvederm facial filler", start date: Jun2018 (unspecified if ongoing), notes: old Juvederm facial filler, known allergies: No. There were no concomitant medications. The following information was reported: INFLAMMATION (disability) with onset Jan2022, outcome "not recovered", described as "inflammatory reaction to old Juvederm facial filler"; ANGIOPATHY (disability), PAIN (disability) all with onset Jan2022, outcome "not recovered" and all described as "the inflammation caused vascular dilation and throbbing, pain"; BONE DISORDER (disability) with onset Jan2022, outcome "not recovered", described as "Possible compromise to bony structure of lower face". The events "inflammatory reaction to old juvederm facial filler", "the inflammation caused vascular dilation and throbbing, pain", "the inflammation caused vascular dilation and throbbing, pain" and "possible compromise to bony structure of lower face" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (08Feb2022) unknown; sars-cov-2 test: (08Feb2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of inflammation, angiopathy, pain, bone disorder.  Clinical course: The patient was not diagnosed with Prior to vaccination COVID-19, Since the vaccination, the patient has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. treatment received for the adverse event Medrol dose pack, doxycycline, CT facial scan, ASA.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: inflammatory reaction to old Juvederm facial filler; the inflammation caused vascular dilation and throbbing, pain; the inflammation caused vascular dilation and throbbing, pain; Possible compromise to bony structure of lower face; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 21:30 (Lot number: FE3594) at the age of 48 years as dose 3 (booster), single, administered in arm left, administration date 04May2021 16:45 (Lot number: EW0175) as dose 2, single and administered in arm left, administration date 13Apr2021 15:45 (Lot number: ER8731) as dose 1, single for covid-19 immunisation. Relevant medical history included: "old Juvederm facial filler", start date: Jun2018 (unspecified if ongoing), notes: old Juvederm facial filler, known allergies: No. There were no concomitant medications. The following information was reported: INFLAMMATION (disability) with onset Jan2022, outcome "not recovered", described as "inflammatory reaction to old Juvederm facial filler"; ANGIOPATHY (disability), PAIN (disability) all with onset Jan2022, outcome "not recovered" and all described as "the inflammation caused vascular dilation and throbbing, pain"; BONE DISORDER (disability) with onset Jan2022, outcome "not recovered", described as "Possible compromise to bony structure of lower face". The events "inflammatory reaction to old juvederm facial filler", "the inflammation caused vascular dilation and throbbing, pain", "the inflammation caused vascular dilation and throbbing, pain" and "possible compromise to bony structure of lower face" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (08Feb2022) unknown; sars-cov-2 test: (08Feb2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of inflammation, angiopathy, pain, bone disorder.  Clinical course: The patient was not diagnosed with Prior to vaccination COVID-19, Since the vaccination, the patient has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. treatment received for the adverse event Medrol dose pack, doxycycline, CT facial scan, ASA.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Feeling abnormal, Headache, Malaise
Clinical narrative: body started to feel funny; real woozy; Headache/it hurts from her nose to  between her forehead/woosy headache; sore arm; just not feeling right; dizzy, like she was walking funny; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200284522 (Pfizer).  A 43 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Feb2022 12:20 (Lot number: FM0698) at the age of 43 years as dose 1, 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Hepatitis vaccine (had 1 year or 2 ago at the latest. It was Hepatitis vaccine and she did perfectly fine with that), for Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 13Feb2022, outcome "not recovered", described as "body started to feel funny"; DIZZINESS (non-serious) with onset 13Feb2022, outcome "recovering", described as "real woozy"; HEADACHE (non-serious) with onset 13Feb2022, outcome "unknown", described as "Headache/it hurts from her nose to  between her forehead/woosy headache"; PAIN IN EXTREMITY (non-serious) with onset 13Feb2022, outcome "not recovered", described as "sore arm"; MALAISE (non-serious) with onset 13Feb2022, outcome "not recovered", described as "just not feeling right"; DIZZINESS (non-serious) with onset 13Feb2022, outcome "unknown", described as "dizzy, like she was walking funny". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling abnormal, dizziness, headache, pain in extremity, malaise, dizziness.  Additional information: She stated that event Real woozy it is off and on and not to the point she is passing out, it is just making her feel funny. The strange feeling, like if you walk funny. Caller states it is in-between improved and persisting. She stated that Headache, it is not like the top of the head headache feeling, it hurts from her nose to between her forehead. States it is off and on. Sore arm: Started a couple of hours after the shot. States she was perfectly fine before this. She had no underlying condition. She never had to go to a hospital. Then she took this shot, and this started.   No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tuberculosis
Clinical narrative: body started to feel funny; real woozy; Headache/it hurts from her nose to  between her forehead/woosy headache; sore arm; just not feeling right; dizzy, like she was walking funny; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200284522 (Pfizer).  A 43 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Feb2022 12:20 (Lot number: FM0698) at the age of 43 years as dose 1, 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Hepatitis vaccine (had 1 year or 2 ago at the latest. It was Hepatitis vaccine and she did perfectly fine with that), for Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 13Feb2022, outcome "not recovered", described as "body started to feel funny"; DIZZINESS (non-serious) with onset 13Feb2022, outcome "recovering", described as "real woozy"; HEADACHE (non-serious) with onset 13Feb2022, outcome "unknown", described as "Headache/it hurts from her nose to  between her forehead/woosy headache"; PAIN IN EXTREMITY (non-serious) with onset 13Feb2022, outcome "not recovered", described as "sore arm"; MALAISE (non-serious) with onset 13Feb2022, outcome "not recovered", described as "just not feeling right"; DIZZINESS (non-serious) with onset 13Feb2022, outcome "unknown", described as "dizzy, like she was walking funny". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling abnormal, dizziness, headache, pain in extremity, malaise, dizziness.  Additional information: She stated that event Real woozy it is off and on and not to the point she is passing out, it is just making her feel funny. The strange feeling, like if you walk funny. Caller states it is in-between improved and persisting. She stated that Headache, it is not like the top of the head headache feeling, it hurts from her nose to between her forehead. States it is off and on. Sore arm: Started a couple of hours after the shot. States she was perfectly fine before this. She had no underlying condition. She never had to go to a hospital. Then she took this shot, and this started.   No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye contusion, Eye haemorrhage, Fatigue, Feeding disorder
Clinical narrative: Dry heaves; Very tired; Not able to eat in am; Left large black eye; Chills; Blood vessel in right eye bursted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 28Mar2021 (Batch/Lot number: unknown) at the age of 81 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 (Lot/Batch number: EN6206, Doses: 0.3 mL, Route of administration: Intramuscular, Anatomical location: Upper arm muscle, Dose no: 1), administration date: 07Mar2021, when the patient was 81 years old, for COVID-19 immunization. The following information was reported: EYE HAEMORRHAGE (medically significant) with onset 2021, outcome "unknown", described as "Blood vessel in right eye bursted"; RETCHING (non-serious) with onset 29Mar2021, outcome "recovering", described as "Dry heaves"; FATIGUE (non-serious) with onset 2021, outcome "recovering", described as "Very tired"; FEEDING DISORDER (non-serious) with onset 2021, outcome "recovering", described as "Not able to eat in am"; EYE CONTUSION (non-serious) with onset 2021, outcome "recovering", described as "Left large black eye"; CHILLS (non-serious) with onset 2021, outcome "recovering", described as "Chills".  Clinical course: The reporter stated that several weeks before eye/ face cleaned up started feeling better by 02Apr2021 except for blood eye. Had booster shot administered in upper arm muscle but did not put date down, had mild symptoms, but was prepared. Prior vaccination: None. No specific relevant test for thromboembolic with thrombocytopenia. No relevant tests.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: Dry heaves; Very tired; Not able to eat in am; Left large black eye; Chills; Blood vessel in right eye bursted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 28Mar2021 (Batch/Lot number: unknown) at the age of 81 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 (Lot/Batch number: EN6206, Doses: 0.3 mL, Route of administration: Intramuscular, Anatomical location: Upper arm muscle, Dose no: 1), administration date: 07Mar2021, when the patient was 81 years old, for COVID-19 immunization. The following information was reported: EYE HAEMORRHAGE (medically significant) with onset 2021, outcome "unknown", described as "Blood vessel in right eye bursted"; RETCHING (non-serious) with onset 29Mar2021, outcome "recovering", described as "Dry heaves"; FATIGUE (non-serious) with onset 2021, outcome "recovering", described as "Very tired"; FEEDING DISORDER (non-serious) with onset 2021, outcome "recovering", described as "Not able to eat in am"; EYE CONTUSION (non-serious) with onset 2021, outcome "recovering", described as "Left large black eye"; CHILLS (non-serious) with onset 2021, outcome "recovering", described as "Chills".  Clinical course: The reporter stated that several weeks before eye/ face cleaned up started feeling better by 02Apr2021 except for blood eye. Had booster shot administered in upper arm muscle but did not put date down, had mild symptoms, but was prepared. Prior vaccination: None. No specific relevant test for thromboembolic with thrombocytopenia. No relevant tests.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Drug ineffective, Pain in extremity, Pyrexia
Clinical narrative: Soreness in arm; fever; chills; runny nose; cough; COVID-19; Covid-19; 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 29 year-old female patient received bnt162b2 (BNT162B2), administration date 28Dec2021 (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: DRUG INEFFECTIVE (medically significant) with onset 28Dec2021, outcome "unknown", described as "Covid-19"; SUSPECTED COVID-19 (medically significant) with onset Jan2022, outcome "unknown", described as "COVID-19"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Soreness in arm"; PYREXIA (non-serious), outcome "recovered", described as "fever"; CHILLS (non-serious), outcome "recovered", described as "chills"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; COUGH (non-serious), outcome "unknown", described as "cough".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Suspected COVID-19
Clinical narrative: Soreness in arm; fever; chills; runny nose; cough; COVID-19; Covid-19; 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 29 year-old female patient received bnt162b2 (BNT162B2), administration date 28Dec2021 (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: DRUG INEFFECTIVE (medically significant) with onset 28Dec2021, outcome "unknown", described as "Covid-19"; SUSPECTED COVID-19 (medically significant) with onset Jan2022, outcome "unknown", described as "COVID-19"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Soreness in arm"; PYREXIA (non-serious), outcome "recovered", described as "fever"; CHILLS (non-serious), outcome "recovered", described as "chills"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; COUGH (non-serious), outcome "unknown", described as "cough".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Pain in extremity, Ventricular extrasystoles
Clinical narrative: PVC is on EKG; lethargy; headache; sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 25Jan2022 12:30 (Lot number: FJ1614) at the age of 80 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Elevated BP" (unspecified if ongoing), notes: Elevated BP; "Glaucoma" (unspecified if ongoing). Patient had no prior Vaccinations with in 4 weeks. Concomitant medication(s) included: LISINOPRIL taken for blood pressure increased, start date: 1980 (ongoing); LATANOPROST OPTIC taken for glaucoma, start date: 2021 (ongoing); TIMOLOL [TIMOLOL MALEATE] taken for glaucoma, start date: 2021 (ongoing). Vaccination history included: Bnt162b2 (dose:1, Time (24hr): AM, Anatomical site of injection: Left Deltoid, Route of administration: Intramuscular, Batch/Lot number: EL3242), administration date: 06Feb2021, when the patient was 79 years old, for COVID-19 Immunization; Bnt162b2 (dose:2, Time (24hr): AM, Anatomical site of injection: Left Deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6202), administration date: 27Feb2021, when the patient was 79 years old, for COVID-19 Immunization.  The following information was reported: VENTRICULAR EXTRASYSTOLES (medically significant) with onset 28Jan2022, outcome "unknown", described as "PVC is on EKG"; PAIN IN EXTREMITY (non-serious) with onset 25Jan2022 13:00, outcome "unknown", described as "sore arm"; HEADACHE (non-serious) with onset 26Jan2022 06:00, outcome "unknown", described as "headache"; LETHARGY (non-serious) with onset 26Jan2022 13:00, outcome "unknown", described as "lethargy". The event "pvc is on ekg" was evaluated at the physician office visit. Therapeutic measures were taken as a result of ventricular extrasystoles included HCTZ to BP med. No relevant test for thromboembolic events with thrombocytopenia.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events due to temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Injury, Off label use, Respiratory arrest, Seizure
Clinical narrative: he has stopped breathing; seizures; a 3 yr. old vaccine-injured child; vaccine-injured child; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A 3 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: RESPIRATORY ARREST (medically significant), outcome "unknown", described as "he has stopped breathing"; SEIZURE (medically significant), outcome "unknown", described as "seizures"; OFF LABEL USE (non-serious), outcome "unknown", described as "a 3 yr. old vaccine-injured child"; INJURY (non-serious), outcome "unknown", described as "vaccine-injured child". Clinical course: I have grave concerns about the safety of a covid vaccine for children 6 months - 4 years. Children have already experienced adverse reactions to the vaccine including heart inflammation, heart attack, and death. Since children have almost a 0% chance of dying from the virus, this vaccine is totally unnecessary. I am the grandmother of a 3 yr. old vaccine-injured child who in spite of medication has frequent seizures during many of which he has stopped breathing. Please reverse this effort  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: developed A-fib after booster; This is a spontaneous report received from contactable reporter(s) (Physician).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number (booster), single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer- Unknown, Dose 1), for COVID-19 immunization; Covid-19 vaccine (Manufacturer- Unknown, Dose 2), for COVID-19 immunization.  The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "developed A-fib after booster".  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Ear injury, Tinnitus
Clinical narrative: I was diagnosed w tinnitus/I started getting a buzzing in my right ear; the audiologist noted some damage most likely due to my booster .; 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 Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "I was diagnosed w tinnitus/I started getting a buzzing in my right ear"; EAR INJURY (non-serious), outcome "unknown", described as "the audiologist noted some damage most likely due to my booster .". The events "i was diagnosed w tinnitus/i started getting a buzzing in my right ear" and "the audiologist noted some damage most likely due to my booster ." were evaluated at the physician office visit.  Additional information: The patient had booster in November in approx. a week and a half and started getting a buzzing in the right ear that was relentless and the patient was struggling with it. The patient was diagnosed with tinnitus and the audiologist noted some damage most likely due to the booster. The patient hoping the vaccine would dissipate so that maybe this horrible buzzing subsided.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Symptoms of Covid (fatigue, cough, congestion, hiccups). On Sat (05Feb2022) I tested +./ I still tested +[health] for covid on Wed 09Feb2022.; Symptoms of Covid (fatigue, cough, congestion, hiccups). On Sat (05Feb2022) I tested +./ I still tested +[health] for covid on Wed 09Feb2022.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 01Oct2021 14:00 (Lot number: FC3184) at the age of 71 years as dose 3 (booster), single, intramuscular, administered in arm right, administration date 06Mar2021 14:00 (Lot number: EN6205) as dose 2, single and intramuscular, administered in arm right, administration date 13Feb2021 10:00 (Lot number: EM9809) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 05Feb2022, outcome "not recovered", VACCINATION FAILURE (medically significant) with onset 05Feb2022, outcome "unknown" and all described as "Symptoms of Covid (fatigue, cough, congestion, hiccups). On Sat (05Feb2022) I tested +./ I still tested +[health] for covid on Wed 09Feb2022.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Feb2022) positive; (05Feb2022) positive. On Fri 04Feb2022 he had symptoms of covid [Fatigue, Cough, congestion, Hiccups]. On sat 05Feb2022 he tested positive using OTC test [Binax Now]. On Saturday and Sunday the symptoms were at their worst, but he never had shortness of breath or a fever. By Tuesday he was almost fully recovered. It was reported that with vaccine #2 and Booster (#3), he developed Hiccups that lasted over 2hrs at a time and gone the next day. With his current covid infection- Hiccups were started on Friday, by Saturday &Sunday (05Feb2022& 06Feb2022) that lasted 5 to 6 hours, but they tapered out on Mon (07Feb2022) and never gone by Tuesday.