chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling face
Clinical narrative: Swelling of face and lips; Swelling of face and lips; face felt like it was on fire; rash developed within minutes after swelling subsided; I was in bed since I didn't feel well; I was in bed since I didn't feel well; Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Dec2021 14:00 (Lot number: 330268D) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "reynauds" (unspecified if ongoing), notes: other medical history: reynauds; "High blood pressure" (unspecified if ongoing), notes: other medical history: High blood pressure; "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex., I also have an allergy to latex with the same type of symptoms; "known allergies: tetracycline" (unspecified if ongoing), notes: known allergies: tetracycline; "known allergies: iodine" (unspecified if ongoing), notes: known allergies: iodine. Concomitant medication(s) included: METOPROLOL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6201, Location of injection: Arm Left), administration date: 14Feb2021, when the patient was 71 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3249, Location of injection: Arm Left), administration date: 24Jan2021, when the patient was 71 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021 14:00, outcome "unknown", described as "Dose Number: 3"; LIP SWELLING (non-serious), SWELLING FACE (non-serious) all with onset 09Dec2021 16:00, outcome "recovering" and all described as "Swelling of face and lips"; BURNING SENSATION (non-serious) with onset 09Dec2021 16:00, outcome "recovering", described as "face felt like it was on fire"; RASH (non-serious) with onset 09Dec2021 16:00, outcome "recovering", described as "rash developed within minutes after swelling subsided"; MALAISE (non-serious) with onset 09Dec2021 16:00, outcome "recovering", described as "I was in bed since I didn't feel well"; BEDRIDDEN (non-serious) with onset 09Dec2021 16:00, outcome "recovering", described as "I was in bed since I didn't feel well". Therapeutic measures were not taken as a result of lip swelling, swelling face, burning sensation, rash, malaise, bedridden. Additional information: Rash may have been concurrent with swelling. About 24 hours after shot. Patient also have an allergy to latex with the same type of symptoms. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19 and Prior to vaccination, the patient was not diagnosed with COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hair disorder, Immunisation
Clinical narrative: Diarrhea; got a knot but on side of my brows and my hair; booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).   A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Dec2021 (Lot number: 32030B1) at the age of 61 years 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 Bnt162b2 (Dose: 02, EN6404 PFIZER), administration date: 20Mar2021, when the patient was 60 years old, for COVID-19 Immunization; Bnt162b2 (Dose: 01), for COVID-19 Immunization. The following information was reported IMMUNISATION (non-serious) with onset 05Dec2021, outcome unknown; DIARRHOEA (non-serious) with onset 06Dec2021, outcome unknown; HAIR DISORDER (non-serious) with onset 06Dec2021, outcome unknown. Therapeutic measures were not taken as a result of diarrhoea, hair disorder.  Additional information: Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Protein total, Protein total abnormal
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional) for a Pfizer sponsored program (005570). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) administration date 04Oct2021 (Batch/Lot number: Unknown) as dose 3 (booster), single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 20Jan2021 for COVID-19 immunisation, Bnt162b2 (DOSE 2, SINGLE), administration date: 10Feb2021 for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 04Oct2021, outcome "unknown", described as "booster shot on 04Oct2021", PROTEIN TOTAL ABNORMAL (non-serious) with onset 29Nov2021, outcome "unknown", described as "I had a spike proteins test done on 29Nov2021. The results were I had a number of 5034.4". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Malaise, Nausea
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Dec2021 10:30 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown., Location of injection: Arm Left), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown., Location of injection: Arm Left), for COVID-19 immunization. The following information was reported: immunization, chills, nausea, headache, pain in extremity and malaise with onset 08Dec2021, outcome recovered. Therapeutic measures were not taken as a result of chills, nausea, headache, pain in extremity, malaise. Additional information: Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. 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 was not prolonged hospitalization. The events reported as non-serious. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Dec2021 10:30 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown., Location of injection: Arm Left), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown., Location of injection: Arm Left), for COVID-19 immunization. The following information was reported: immunization, chills, nausea, headache, pain in extremity and malaise with onset 08Dec2021, outcome recovered. Therapeutic measures were not taken as a result of chills, nausea, headache, pain in extremity, malaise. Additional information: Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. 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 was not prolonged hospitalization. The events reported as non-serious. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immunisation, Nausea, Vertigo
Clinical narrative: feeling nausea; vertigo; felt a bit dizzy; booster; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 02Dec2021 (Batch/Lot number: unknown) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: INFLUENZA taken for immunisation, administration date 25Nov2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown), administration date: 31Mar2021, when the patient was 44 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown), when the patient was 44 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021, outcome "unknown", described as "booster"; NAUSEA (non-serious) with onset 02Dec2021 12:00, outcome "recovered" (Dec2021), described as "feeling nausea"; VERTIGO (non-serious) with onset 02Dec2021, outcome "recovered" (Dec2021), described as "vertigo"; DIZZINESS (non-serious) with onset 02Dec2021, outcome "recovered" (Dec2021), described as "felt a bit dizzy". Therapeutic measures were taken as a result of nausea, vertigo, dizziness. Additional information: No known allergies. Three days after patient received the 3rd dose she woke up feeling nauseas and had vertigo. Patient was in bed the entire day the next day she felt a bit dizzy. Treatment included meclizine 12.5 mg. No covid prior vaccination. No covid tested post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Conjunctivitis, Eye pain, Eye pruritus, Ocular hyperaemia
Clinical narrative: severe redness in left eye; the eye was sore and itching; the eye was sore and itching; pink eye; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 06:15 (Lot number: FK5127) at the age of 11 years as dose 1 (tris), single and administered in arm left, administration date 03Dec2021 17:45 (Lot number: FK5618) as dose 2 (tris), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported OCULAR HYPERAEMIA (non-serious) with onset 15Nov2021 09:30, outcome recovering; EYE PAIN (non-serious), EYE PRURITUS (non-serious) all with onset 15Nov2021 09:30, outcome recovering; CONJUNCTIVITIS (non-serious) with onset 15Nov2021 09:30, outcome recovering. The events severe redness in left eye, the eye was sore and itching, the eye was sore and itching, and pink eye were evaluated at the physician office visit. Therapeutic measures were taken as a result of ocular hyperaemia, eye pain, eye pruritus, and conjunctivitis. No other vaccine in four weeks. After the first dose, on day three appeared to get symptoms of what we thought was pink eye. No fever, no discharge, but had severe redness in left eye. Later in the evening, the eye was sore and itching. Went to Urgent Care and was given drops and cleared with a few days. After second vaccine, the same thing has occurred again but in the right eye this time. This is the first time ever experiencing issues with eyes, so not a normal occurrence. Resulted in Doctor or other healthcare professional office/clinic visit. Treatment included eye drops. No Covid prior vaccination. No Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1. Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2. Manufacturer unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "I complain about Pfizer booster dose"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "both arms in so much pain"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "not recovered", described as "can't even pick up gallon of milk".  Additional information: My aunt complained earlier this morning about the booster, Can I complain about Pfizer booster dose since I had this dose, my both arms in so much pain, not getting better can't even pick up gallon of milk.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear pain, Ear swelling, Facial pain, Fatigue
Clinical narrative: Pain and swelling in lymph nodes; Pain and swelling in lymph nodes; Pain and swelling in lymph nodes, neck, face and ear on right side; Pain and swelling in lymph nodes, neck, face and ear on right side; Pain and swelling in lymph nodes, neck, face and ear on right side; Pain and swelling in lymph nodes, neck, face and ear on right side; Pain and swelling in lymph nodes, neck, face and ear on right side; Pain and swelling in lymph nodes, neck, face and ear on right side; Heart palpitations; dizziness; fatigue; body aches; headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Nov2021 15:00 (Lot number: Fh8030) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Ff2590, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 22Oct2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious), outcome "not recovered" and all described as "Pain and swelling in lymph nodes"; NECK PAIN (non-serious), FACIAL PAIN (non-serious), EAR PAIN (non-serious), SWELLING (non-serious), SWELLING FACE (non-serious), EAR SWELLING (non-serious), outcome "not recovered" and all described as "Pain and swelling in lymph nodes, neck, face and ear on right side"; PALPITATIONS (non-serious), outcome "not recovered", described as "Heart palpitations"; DIZZINESS (non-serious), outcome "not recovered", described as "dizziness"; FATIGUE (non-serious), outcome "not recovered", described as "fatigue"; PAIN (non-serious), outcome "not recovered", described as "body aches"; HEADACHE (non-serious), outcome "not recovered", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymph node pain, lymphadenopathy, neck pain, facial pain, ear pain, swelling, swelling face, ear swelling, palpitations, dizziness, fatigue, pain, headache. Additional information: Patient received no other vaccine in four weeks and no covid prior vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Neck pain, Pain
Clinical narrative: Pain and swelling in lymph nodes; Pain and swelling in lymph nodes; Pain and swelling in lymph nodes, neck, face and ear on right side; Pain and swelling in lymph nodes, neck, face and ear on right side; Pain and swelling in lymph nodes, neck, face and ear on right side; Pain and swelling in lymph nodes, neck, face and ear on right side; Pain and swelling in lymph nodes, neck, face and ear on right side; Pain and swelling in lymph nodes, neck, face and ear on right side; Heart palpitations; dizziness; fatigue; body aches; headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Nov2021 15:00 (Lot number: Fh8030) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Ff2590, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 22Oct2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious), outcome "not recovered" and all described as "Pain and swelling in lymph nodes"; NECK PAIN (non-serious), FACIAL PAIN (non-serious), EAR PAIN (non-serious), SWELLING (non-serious), SWELLING FACE (non-serious), EAR SWELLING (non-serious), outcome "not recovered" and all described as "Pain and swelling in lymph nodes, neck, face and ear on right side"; PALPITATIONS (non-serious), outcome "not recovered", described as "Heart palpitations"; DIZZINESS (non-serious), outcome "not recovered", described as "dizziness"; FATIGUE (non-serious), outcome "not recovered", described as "fatigue"; PAIN (non-serious), outcome "not recovered", described as "body aches"; HEADACHE (non-serious), outcome "not recovered", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymph node pain, lymphadenopathy, neck pain, facial pain, ear pain, swelling, swelling face, ear swelling, palpitations, dizziness, fatigue, pain, headache. Additional information: Patient received no other vaccine in four weeks and no covid prior vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Polymerase chain reaction, SARS-CoV-2 test, Swelling, Swelling face
Clinical narrative: Pain and swelling in lymph nodes; Pain and swelling in lymph nodes; Pain and swelling in lymph nodes, neck, face and ear on right side; Pain and swelling in lymph nodes, neck, face and ear on right side; Pain and swelling in lymph nodes, neck, face and ear on right side; Pain and swelling in lymph nodes, neck, face and ear on right side; Pain and swelling in lymph nodes, neck, face and ear on right side; Pain and swelling in lymph nodes, neck, face and ear on right side; Heart palpitations; dizziness; fatigue; body aches; headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Nov2021 15:00 (Lot number: Fh8030) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Ff2590, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 22Oct2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious), outcome "not recovered" and all described as "Pain and swelling in lymph nodes"; NECK PAIN (non-serious), FACIAL PAIN (non-serious), EAR PAIN (non-serious), SWELLING (non-serious), SWELLING FACE (non-serious), EAR SWELLING (non-serious), outcome "not recovered" and all described as "Pain and swelling in lymph nodes, neck, face and ear on right side"; PALPITATIONS (non-serious), outcome "not recovered", described as "Heart palpitations"; DIZZINESS (non-serious), outcome "not recovered", described as "dizziness"; FATIGUE (non-serious), outcome "not recovered", described as "fatigue"; PAIN (non-serious), outcome "not recovered", described as "body aches"; HEADACHE (non-serious), outcome "not recovered", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymph node pain, lymphadenopathy, neck pain, facial pain, ear pain, swelling, swelling face, ear swelling, palpitations, dizziness, fatigue, pain, headache. Additional information: Patient received no other vaccine in four weeks and no covid prior vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Illness, Immunisation, Lymphadenopathy
Clinical narrative: booster; sick; chills; Under my armpit my lymph nodes are swollen as the size of tennis ball; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Dec2021 17:30 (Lot number: 33030BD) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 01), for Covid-19 Immunization; Bnt162b2 (Dose Number: 02), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 17:30, outcome "unknown", described as "booster"; ILLNESS (non-serious) with onset Dec2021, outcome "unknown", described as "sick"; CHILLS (non-serious) with onset Dec2021, outcome "unknown", described as "chills"; LYMPHADENOPATHY (non-serious) with onset Dec2021, outcome "unknown", described as "Under my armpit my lymph nodes are swollen as the size of tennis ball". Therapeutic measures were taken as a result of illness, chills.  Additional information: clinical course: Patient reporting an adverse effect to the vaccine, for the Pfizer booster shot. So, this part is normal the whole getting sick, having chills and all of that, that is not his biggest concern. (Further clarification unknown. Hence, captured as event conservatively). The biggest concern is that effect that he was really concerned about was under his armpit his lymph nodes were swollen as the size of tennis ball. Patient asking that have you heard this happening because 1st two shots he did not feel anything he was totally fine. Have you heard of this happening with swollen lymph node before from the booster shot? He never had a reaction; this was the first time it happened to him 2 days after the vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Cardiac discomfort, Carditis, Chest discomfort
Clinical narrative: Heart pain/discomfort; inflammation of heart tissue; Heart pain/discomfort; chest discomfort; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Jul2021 (Lot number: FA6780) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Shell fish" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: EDARBYCLOR. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3180), administration date: 10Aug2021, when the patient was 31 years old, for COVID-19 immunization. The following information was reported: ANGINA PECTORIS (medically significant), CARDIAC DISCOMFORT (medically significant) all with onset 18Jul2021, outcome "not recovered" and all described as "Heart pain/discomfort"; MYOCARDITIS (medically significant) with onset 18Jul2021, outcome "not recovered", described as "inflammation of heart tissue"; CHEST DISCOMFORT (medically significant) with onset 18Jul2021, outcome "not recovered", described as "chest discomfort". The events "heart pain/discomfort", "heart pain/discomfort", "inflammation of heart tissue" and "chest discomfort" were evaluated at the physician office visit. Therapeutic measures were taken as a result of angina pectoris, cardiac discomfort, myocarditis, chest discomfort.
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Cerebrovascular accident
Clinical narrative: suffered a stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; tofacitinib citrate (XELJANZ XR) (Batch/Lot number: unknown) at 11 mg daily (11 mg, daily); methotrexate sodium (METHOTREXATE SODIUM) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "suffered a stroke". The action taken for tofacitinib citrate and methotrexate sodium was unknown. Clinical course: Patient takes Xeljanz XR 11mg 1 daily. Patient stated after she took the 1st Pfizer Covid-19 injection she had a stroke. caller takes xeljanz and methotrexate. She recently had the pfizer covid vaccine (1st dose) and suffered a stroke after receiving vaccine  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 available information the causality between the  event cerebro vascular accident and the suspect product ,comirnaty cannot be ruled out , with tofacitinib is unrelated , methotrexate sodium is unrelated
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Hip surgery, Lymph node pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: hip surgery; painful scapula; stabbing pain in lymph nodes; soreness of his arms; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on 10Dec2021. this case now contains serious adverse reaction(s). Information processed together.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Mar2021 (Lot number: ER8733) at the age of 67 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 (First dose, Lot no: EN6206), administration date: 10Mar2021, when the patient was 67 years old, for COVID-19 Immunization. The following information was reported: HIP SURGERY (medically significant) with onset 14Sep2021, outcome "recovered" (Sep2021), described as "hip surgery"; MUSCULOSKELETAL PAIN (non-serious) with onset 2021, outcome "recovered" (Sep2021), described as "painful scapula"; LYMPH NODE PAIN (non-serious) with onset 2021, outcome "recovered" (Sep2021), described as "stabbing pain in lymph nodes"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (Sep2021), described as "soreness of his arms". Clinical course: The patient stated that he received the booster of the Pfizer covid 19 vaccine and experienced same side effects as he had with the second dose of the Pfizer Covid vaccine and that was soreness of his arms. Pain going down in the arm and in the back and neck, pain started in shoulder blade it got down in arm not in injections site, it was in arm. The events started two weeks after second dose and lasted 6 months. Patient had hip surgery on 14Sep2021 and after his surgery all those side effects disappeared.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: after the 1st dose of the Pfizer Covid19 vaccine, patient come up with Covid; after the 1st dose of the Pfizer Covid19 vaccine, patient come up with Covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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 "after the 1st dose of the Pfizer Covid19 vaccine, patient come up with Covid".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: her wife tested positive for COVID-19 between Oct 20-21 of this year; her wife tested positive for COVID-19 between Oct 20-21 of this year; 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.  A female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset Oct2021, outcome "unknown" and all described as "her wife tested positive for COVID-19 between Oct 20-21 of this year". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Oct2021) positive. Therapeutic measures were taken as a result of vaccination failure, sars-cov-2 test positive. Clinical course: the reporter called on behalf of his wife, stating that she received the first and second dose of the Pfizer Biontech COVID 19 vaccine adult formulation in Jan2021 and Feb2021. He also stated that her wife tested positive for COVID-19 between Oct 20-21 of 2021 while she was in a skilled nursing facility after a fall. It was asked how long should the patient wait until receiving the booster dose. They also gave her an antibody shot while she was in the nursing facility and she's wanting to get the third shot or the booster shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She received her first dose of the Pfizer COVID-19 vaccine in April of 2021, she was diagnosed with COVID-19 after her first dose; She received her first dose of the Pfizer COVID-19 vaccine in April of 2021, she was diagnosed with COVID-19 after her first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: high risk patient with history of high blood pressure, asthma, and COPD. The patient's concomitant medications were not reported. The following information was reported: At the time of report, patient currently 63 years old, is due for her Pfizer Covid-19 Booster dose on Jan2022. She received her first dose in Apr2021, then was diagnosed with COVID-19 on an unspecified date in 2021, and had her second dose in Jul2021. Patient was asking if can she take the Booster dose in Dec2021 due to her medical history. The patient underwent the following laboratory tests and procedures: COVID-19: (2021) then was diagnosed with COVID-19. The outcome of the event was unknown.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101772894 Same patient/ vaccine, different dose/AE
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Stated positive PCR test/Covid Test with reported symptoms of headache and congestion; Stated positive PCR test/Covid Test with reported symptoms of headache and congestion; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a representative.  A 18 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY) (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) all with onset Dec2021, outcome unknown. The patient underwent the following laboratory tests and procedures sars-cov-2 test (Dec2021) positive, Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. It was unknown if the patient received other vaccines in four weeks. The patient did not have COVID-19 prior to vaccination.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough case of COVID-19 after booster shot; Breakthrough case of COVID-19 after booster shot; booster; This is a spontaneous report received from a contactable reporter (Other HCP). A 23 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 30Sep2021 11:00 (Lot number: 301358A) at the age of 23 years as dose 3 (booster), single, administered in arm left, administration date 31Mar2021 16:00 (Lot number: ER8730) at the age of 22 years as dose 2, single and administered in arm left, administration date 10Mar2021 16:00 (Lot number: EN6208) at the age of 23 years as dose 1, single for covid-19 immunisation. There were no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported IMMUNISATION (medically significant) with onset 30Sep2021 11:00, outcome unknown; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Dec2021, outcome not recovered. The patient underwent the following laboratory tests and procedures sars-cov-2 test (08Dec2021) negative, Post vaccination: Nasal Swab; (11Dec2021) positive, notes: Post vaccination: Nasal Swab; (15Nov2021) negative, Post vaccination: Nasal Swab; (28Nov2021) negative, Post vaccination: Nasal Swab; (05Dec2021) negative, Post vaccination: Nasal Swab; (10Dec2021) positive, Post vaccination: Nasal Swab. The report of patient was a Breakthrough case of COVID-19 after booster shot. Therapeutic measures were taken as a result of vaccination failure, covid-19 including OTC cough and cold meds. The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure and immunization cannot be ruled out.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Headache, Suspected COVID-19
Clinical narrative: Covid; Covid; Headache; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT PROVIDED). The reporter is the patient. Other Case identifier(s): 21K-163-4189938-00 (Facilitating Company).  A 60 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 30Mar2021 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single and intramuscular, administration date 29Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Nov2021, outcome "recovering" and all described as "Covid"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Headache".  Causality for Humira (Adalimumab)  The reporter's causality for the event(s) of COVID and headache after vaccine was not provided.  Causality for Pfizer Biontech Covid-19 Vaccine  The reporter's causality for events of COVID-19 and Headache provided as probable.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective, suspected covid19, headache cannot be totally excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Oral mucosal blistering
Clinical narrative: Blister inside/back of mouth on the roof of mourth; Booster; Dose 1: Moderna, Dose 2: Moderna; Dose 1: Moderna, Dose 2: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Dec2021 14:30 (Lot number: FH8030) at the age of 52 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: Moderna (Dose Number: 2, Batch/Lot No: DO8B21A, Location of injection: Arm Right), administration date: 01Apr2021, when the patient was 52 years old, for COVID-19 Immunization; Moderna (Dose Number: 1, Batch/Lot No: 029A21S, Location of injection: Arm Right), administration date: 05Mar2021, when the patient was 52 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 08Dec2021, outcome "unknown" and all described as "Dose 1: Moderna, Dose 2: Moderna"; ORAL MUCOSAL BLISTERING (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Blister inside/back of mouth on the roof of mourth". Therapeutic measures were not taken as a result of oral mucosal blistering.  Additional information: Prior vaccination, the patient was not diagnosed with Covid-19. Post vaccination the patient had not been tested positive for Covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizure outbreak of 15 seizures within a week of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Dec2021 16:30 (Lot number: Fk5127) at the age of 5 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Epilepsy" (unspecified if ongoing); "Adhd" (unspecified if ongoing). Concomitant medication(s) included: ONFI; INTUNIV; LACTOSE. The following information was reported: SEIZURE (medically significant, life threatening) with onset 05Dec2021 22:00, outcome "not recovered", described as "Seizure outbreak of 15 seizures within a week of the vaccine". The event "seizure outbreak of 15 seizures within a week of the vaccine" was evaluated at the physician office visit. Therapeutic measures were taken as a result of seizure.  Additional information: Seizure was life-threatening and medically significant. It did not result to death, no hospitalization, not disabling/incapacitating, not congenital anomaly/birth defect. No other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No known allergies. AE treatment: Increase in seizure medication and reduce meds. AE resulted in: Doctor or other healthcare professional office/clinic visit. Life threatening illness (immediate risk of death from the event).  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, SARS-CoV-2 test, Tinnitus
Clinical narrative: two weeks after my third shot, the tinnitus symptoms (pretty severe--mainly plugged up right ear) reappeared; third shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 17:00 (Batch/Lot number: unknown) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Prev dose vaccine location=Left arm, Prev dose product=COVID 19, Prev dose brand unknown=True, Prev dose brand name unknown=COVID19 Vaccine, Prev dose lot unknown=True, Prev dose lot unknown reason=Unable to locate or read the details, Prev dose administration date=16Mar2021, Prev dose administration time=08:15AM, Prev dose dose number=1), administration date: 16Mar2021, when the patient was 50 years old, for Covid-19 Immunization; Bnt162b2 (Prev dose product=COVID 19, Prev dose brand unknown=True, Prev dose brand name unknown=COVID19 Vaccine, Prev dose lot unknown=True, Prev dose lot unknown reason=Unable to locate or read the details, Prev dose administration date=06Apr2021, Prev dose administration time=08:15AM, Prev dose dose number=2), administration date: 06Apr2021, when the patient was 50 years old, for COVID-19 immunization, reaction(s): "tinnitus". The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 17:00, outcome "unknown", described as "third shot"; TINNITUS (non-serious) with onset 02Dec2021 07:00, outcome "not recovered", described as "two weeks after my third shot, the tinnitus symptoms (pretty severe--mainly plugged up right ear) reappeared". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus.  Additional information: Facility type vaccine: Pharmacy or Drug Store, No other vaccine in four weeks, No Other medications in two weeks. I started experiencing tinnitus shortly after my second dose in April. After six months, the symptoms started to disappear. Then right at two weeks after my third shot, the tinnitus symptoms (pretty severe-mainly plugged up right ear) reappeared. I do not know for sure if the vaccinations caused the tinnitus, but it is very coincidental that it would flare up right after two weeks from the second and 3rd shots. However, I am so grateful for the vaccine and really appreciate what Pfizer has done to help out humanity! Thank you so much. Just wanted you to know that it may have caused a side-effect for me. No covid prior vaccination. Tested for covid post vaccination. No known allergies.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: This is a spontaneous report received from a contactable reporter (consumer).  A 5 year-old female patient (not pregnant) received bnt162b2, administration date 08Dec2021 (Batch/Lot number: unknown) at the age of 5 years as dose 2, single for COVID-19 immunization. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: yes child has had allergic episodes in the past but the root cause for her, allergies not identified. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Pre Dose Dose Number: 1, prev dose product=COVID 19, prev dose brand=pfizer biontech vaccine, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion, prev dose administration_date=Nov2021, prev dose dose number=1), administration date: Nov2021, when the patient was 5 years old, for Covid-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 10Dec2021, outcome "recovered", described as "Hives started from abdomen and spread through over a few hours covered all upper body up to her neck"; HYPERSENSITIVITY (non-serious) with onset 10Dec2021, outcome "recovered", described as "The child had the vaccine on 08Dec and allergic reaction started on 10Dec". The events "hives started from abdomen and spread through over a few hours covered all upper body up to her neck" and "the child had the vaccine on 08dec and allergic reaction started on 10dec" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of urticaria, hypersensitivity.  Clinical course: the patient had the vaccine on 08Dec2021 and allergic reaction started on 10Dec2021. Hives started from abdomen and spread through over a few hours covered all upper body up to her neck. Hives were not itchy and there was no respiratory difficulty in her breathing. The child has allergic history without any particular root cause defined. Parents took her to ER and ER doctor stated that it may have been allergic reaction to the covid 19 vaccines or anything else she may have ate at home or at school. The doctor gave Zyrtec and child recovered from hives in a few hours. No covid prior vaccination. Not covid tested post vaccination. Patient has had allergic episodes in the past but the root cause for her allergies not identified. No other vaccine in four weeks.  The lot number for bnt162b2 was not provided and will be requested during follow up.