chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: threw up approximately 45min; nausea; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 72-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 72 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: VOMITING (non-serious), outcome "unknown", described as "threw up approximately 45min"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness".  Additional information: My husband (also 72), who went with me and got the same vaccination at the same time and same place threw up approximately 45min. after the shot + felt nausea + dizziness for 1 or 2 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Fatigue, Headache, Joint swelling, Oral herpes
Clinical narrative: Cold sores / herpes simplex virus (HSV-1), resolved about 3 weeks after booster; Large swelling, left armpit, starting day following and lasting over a week; Swelling and rash at joints, may be 3 days following; Swelling and rash at joints, may be 3 days following; Swelling/bursitus in left elbow, still present 1- month following booster; Headache; Body ache; Tiredness; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 at 11:15 (Lot number: FL3197) at the age of 63 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: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation and Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation.  The following information was reported: ORAL HERPES (non-serious) with onset an unknown date in Jan2022, outcome "recovered" (an unknown date in Jan2022), described as "Cold sores / herpes simplex virus (HSV-1), resolved about 3 weeks after booster"; SWELLING (non-serious) with onset an unknown date in Jan2022, outcome "not recovered", described as "Large swelling, left armpit, starting day following and lasting over a week"; JOINT SWELLING (non-serious), RASH (non-serious) all with onset an unknown date in Jan2022, outcome "not recovered", and all described as " Swelling and rash at joints, may be 3 days following"; BURSITIS (non-serious) with onset an unknown date in Jan2022, outcome "not recovered", described as "Swelling/bursitus in left elbow, still present 1- month following booster"; HEADACHE (non-serious) with onset an unknown date in Jan2022, outcome "not recovered", described as "Headache"; PAIN (non-serious) with onset an unknown date in Jan2022, outcome "not recovered", described as "Body ache"; FATIGUE (non-serious) with onset an unknown date in Jan2022, outcome "not recovered", described as "Tiredness". The event "Swelling/bursitus in left elbow, still present 1- month following booster" was evaluated at the physician office visit. It was unknown whether any therapeutic measures were taken as a result of the reported events.   Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash, Swelling
Clinical narrative: Cold sores / herpes simplex virus (HSV-1), resolved about 3 weeks after booster; Large swelling, left armpit, starting day following and lasting over a week; Swelling and rash at joints, may be 3 days following; Swelling and rash at joints, may be 3 days following; Swelling/bursitus in left elbow, still present 1- month following booster; Headache; Body ache; Tiredness; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 at 11:15 (Lot number: FL3197) at the age of 63 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: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation and Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation.  The following information was reported: ORAL HERPES (non-serious) with onset an unknown date in Jan2022, outcome "recovered" (an unknown date in Jan2022), described as "Cold sores / herpes simplex virus (HSV-1), resolved about 3 weeks after booster"; SWELLING (non-serious) with onset an unknown date in Jan2022, outcome "not recovered", described as "Large swelling, left armpit, starting day following and lasting over a week"; JOINT SWELLING (non-serious), RASH (non-serious) all with onset an unknown date in Jan2022, outcome "not recovered", and all described as " Swelling and rash at joints, may be 3 days following"; BURSITIS (non-serious) with onset an unknown date in Jan2022, outcome "not recovered", described as "Swelling/bursitus in left elbow, still present 1- month following booster"; HEADACHE (non-serious) with onset an unknown date in Jan2022, outcome "not recovered", described as "Headache"; PAIN (non-serious) with onset an unknown date in Jan2022, outcome "not recovered", described as "Body ache"; FATIGUE (non-serious) with onset an unknown date in Jan2022, outcome "not recovered", described as "Tiredness". The event "Swelling/bursitus in left elbow, still present 1- month following booster" was evaluated at the physician office visit. It was unknown whether any therapeutic measures were taken as a result of the reported events.   Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Photosensitivity reaction, Urticaria
Clinical narrative: Consistent Hives on body for at least 6 months; Hives from increased sun exposure; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Jul2021 at 16:00 (Lot number: FA7485) at the age of 24 years as dose 1, single for COVID-19 immunisation and also received bnt162b2 (BNT162B2), administered in arm left, administration date 03Aug2021 at 16:00 (Lot number: FA7484) at the age of 24 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None", notes: Other medical history: N/A. Concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset an unknown date in Jul2021, outcome "not recovered", described as "Consistent Hives on body for at least 6 months"; PHOTOSENSITIVITY REACTION (non-serious) with onset an unknown date in Jul2021, outcome "not recovered", described as "Hives from increased sun exposure". Therapeutic measures were not taken as a result of urticaria and photosensitivity reaction.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: I have had consistent regular periods using Isobloom for several years, since my second dose of the vaccine I have missed 3 periods, I absolutely am not pregnant.; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 22Nov2021 at 08:00 (Lot number: unknown) at the age of 38 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: sulfa. Concomitant medications included: ISIBLOOM, VALTREX and unspecified WOMENS MULTIVITAMIN. Past drug history included: Septra, reactions: "Drug allergy". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN, Anatomical site: left arm, Administration time: 08:00), administration date: 01Nov2021, when the patient was 38 years old, for COVID-19 immunisation.  The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 29Nov2021, outcome "not recovered", described as "I have had consistent regular periods using Isobloom for several years, since my second dose of the vaccine I have missed 3 periods, I absolutely am not pregnant". The event "I have had consistent regular periods using Isobloom for several years, since my second dose of the vaccine I have missed 3 periods, I absolutely am not pregnant." was evaluated at the physician office visit. Therapeutic measures were taken as a result of menstruation irregular.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Treatment included change of birth control pill with lower estrogen for menstruation irregular.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he tested positive for COVID a week ago; he tested positive for COVID a week ago; 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 male patient received bnt162b2 (Formulation: Solution for injection) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "he has leukemia" (unspecified if ongoing), notes: He has 3 doses of the vaccine but produced no antibodies on him because he has leukemia. The patient's 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "he tested positive for COVID a week ago". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: He tested positive for COVID a week ago on Thursday; negative, notes: He took a COVID test and resulted negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Caller is a patient. On call the patient stated that he recently finished a course of Paxlovid and wanted to know if Paxlovid produces COVID antibodies after completing the treatment. Caller stated I thought you might like to follow up on my experience and stated that he tested positive for COVID a week ago on Thursday and took the five day course of Paxlovid and then he took a COVID test and resulted negative. Caller mentioned that in that sense the drug worked for him, with no side effects, that it was easy to take and ended up with a Thanks Pfizer. Caller also mentioned he has 3 doses of the vaccine but produced no antibodies on him because he has leukemia.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Within 48 hours developed a case of acute urticaria (hives) on waistline and abdomen which continues to persist; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 28-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jan2022 at 13:00 (Lot number: FJ1614) at the age of 28 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Allergy to nuts" (unspecified if ongoing), notes: Known allergies: Tree nut allergy. Concomitant medication included: ADVIL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EP7534; Anatomical site: Left arm; Administration time: 13:00), administration date: 20Mar2021, when the patient was 27 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: ER8731; Anatomical site: Left arm; Administration time: 13:00), administration date: 10Apr2021, when the patient was 27 years old, for COVID-19 immunisation. The following information was reported: URTICARIA (non-serious) with onset 28Jan2022 at 20:00, outcome "recovering", described as "Within 48 hours developed a case of acute urticaria (hives) on waistline and abdomen which continues to persist". The event "Within 48 hours developed a case of acute urticaria (hives) on waistline and abdomen which continues to persist" was evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient reported that he required a doctor's visit and prescription ointment. Treatment included steroid ointment and ZYRTEC. Since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use, SARS-CoV-2 test
Clinical narrative: had suspected clinical vaccination failure; had suspected covid-19 infection (cough, head congestion/clogged head, Sinus pain and runny nose); experienced crackly ears; interchange of vaccine product; off label use; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. Other Case identifier(s): 20220126728(0.0) (Janssen).  A female patient received bnt162b2 (BNT162B2), intramuscular, administration date 04Jan2022 (Lot number: FJ8762) as dose 2 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "Drug allergy", notes: Drug allergy (Unk) (continuing: Yes): Ibuprofen. Vaccination history included: Janssen covid-19 vaccine (dose 1, lot number: 1805029), administration date: 16Mar2021, for covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Jan2022, outcome "unknown", described as "interchange of vaccine product"; OFF LABEL USE (medically significant) with onset 04Jan2022, outcome "unknown", described as "off label use"; DRUG INEFFECTIVE (medically significant) with onset 12Jan2022, outcome "unknown", described as "had suspected clinical vaccination failure"; COVID-19 (medically significant) with onset 12Jan2022, outcome "unknown", described as "had suspected covid-19 infection (cough, head congestion/clogged head, Sinus pain and runny nose)"; TINNITUS (medically significant) with onset 11Jan2022, outcome "not recovered", described as "experienced crackly ears". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) positive, notes: Binax now antigen.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: had suspected clinical vaccination failure; had suspected covid-19 infection (cough, head congestion/clogged head, Sinus pain and runny nose); experienced crackly ears; interchange of vaccine product; off label use; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. Other Case identifier(s): 20220126728(0.0) (Janssen).  A female patient received bnt162b2 (BNT162B2), intramuscular, administration date 04Jan2022 (Lot number: FJ8762) as dose 2 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "Drug allergy", notes: Drug allergy (Unk) (continuing: Yes): Ibuprofen. Vaccination history included: Janssen covid-19 vaccine (dose 1, lot number: 1805029), administration date: 16Mar2021, for covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Jan2022, outcome "unknown", described as "interchange of vaccine product"; OFF LABEL USE (medically significant) with onset 04Jan2022, outcome "unknown", described as "off label use"; DRUG INEFFECTIVE (medically significant) with onset 12Jan2022, outcome "unknown", described as "had suspected clinical vaccination failure"; COVID-19 (medically significant) with onset 12Jan2022, outcome "unknown", described as "had suspected covid-19 infection (cough, head congestion/clogged head, Sinus pain and runny nose)"; TINNITUS (medically significant) with onset 11Jan2022, outcome "not recovered", described as "experienced crackly ears". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) positive, notes: Binax now antigen.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: His sister received all 3 doses of the Pfizer COVID vaccine and then contracted the COVID virus; His sister received all 3 doses of the Pfizer COVID vaccine and then contracted the COVID virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 71 years as dose 3 (booster), single, administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (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), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "His sister received all 3 doses of the Pfizer COVID vaccine and then contracted the COVID virus". Reporter stated his sister received all 3 doses of the Pfizer COVID vaccine and then contracted the COVID virus. He did not have any other information for her and said she was a very private person. Reporter did now know his sister's height, weight, and Primary care provider. She got two shots and the booster and she got COVID within the last 2 months. She was pro-vaccine and then bingo she got the vaccine. She said she was ok now. She got the booster and she got the disease. She had the booster 4 months ago, unknown date and unknown date of first two doses. Then 5 months ago, she would have had her 2nd shot and 6 months ago, the 1st shot. Lot and expiration are all unknown.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: After the vaccine she got covid; After the vaccine she got covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 09:00 (Lot number: FK5127) at the age of 10 years as dose 2, single and administered in arm left, administration date 15Nov2021 10:15 (Lot number: FK5618) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma; "Otitis media" (unspecified if ongoing), notes: Otitis media. The patient took concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "After the vaccine she got covid". The event "after the vaccine she got covid" and "after the vaccine she got covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) positive, notes: SWAB. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course : Treatment received 600 ML OF IBUPROPHEN, IRON AND MULTIVITAMINS.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Symptomatic covid confirmed by PCR; Symptomatic covid confirmed by PCR; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Nov2021 (Lot number: FH8020) at the age of 35 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 04Feb2021 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm left, administration date 14Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. On 23Jan2022, the patient experienced symptomatic covid confirmed by PCR (medically significant) with outcome of recovered on an unspecified date in 2022. The event "symptomatic covid confirmed by PCR" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: Abbott Alinity m Resp-4-Plex assay (PCR) (24Jan2022) negative, notes: Nasal Swab; (27Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Additional information: The patient had no other vaccine in four weeks. The patient did not have covid prior to vaccination.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain
Clinical narrative: diarrhea; ache; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 50 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Feb2021 (Batch/Lot number: unknown) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "Asthma" (ongoing); "hypertension" (ongoing); "thyroid cancer" (unspecified if ongoing), notes: Pertinent details: s/p thyroidectomy; "thyroidectomy" (unspecified if ongoing), notes: Pertinent details: s/p thyroidectomy. Concomitant medication(s) included: BUPROPION taken for depression (ongoing); SERTRALINE taken for depression (ongoing); SYNTHROID taken for hypothyroidism (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Anatomical Site of injection : left, Route of administration : Intramuscular), administration date: 15Jan2021, when the patient was 50 years old, for COVID-19 immunization, reaction(s): "Diarrhea", "Ache". The following information was reported: DIARRHOEA (non-serious) with onset 05Feb2021, outcome "recovered" (07Feb2021), described as "diarrhea"; PAIN (non-serious) with onset 05Feb2021, outcome "recovered" (07Feb2021), described as "ache". Therapeutic measures were not taken as a result of diarrhoea, pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive Covid test; positive Covid test; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Nov2021 (Lot number: FF3389) at the age of 56 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 18Feb2021 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm left, administration date 28Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Jan2022, outcome "recovered" and all described as "positive Covid test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient did not take any other vaccine in four weeks. The patient did not have covid prior vaccination. No known allergies were reported. No other medical history.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; 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 parent.  A 10 year-old male patient received bnt162b2 (COMIRNATY), administration date 10Dec2021 (Batch/Lot number: unknown) as dose 1 (tris), 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 07Jan2022, outcome "unknown", described as "tested positive for COVID-19"; COVID-19 (medically significant) with onset 07Jan2022, outcome "unknown", described as "tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Jan2022) positive. He was currently quarantining and he could not get his second dose until 26Feb2022 or on 02Mar2022 with his pediatrician, 11 weeks after first dose.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Tension headache
Clinical narrative: had almost like a tension headache, starts in back of neck and goes up and across the head.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "Sleeping poorly" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TENSION HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "had almost like a tension headache, starts in back of neck and goes up and across the head.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021351522 Same reporter, suspect drug and event; different patient
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: fever; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 28Feb2021 11:00 (Lot number: EN6198) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension", start date: 1995 (ongoing); "A-fib", start date: 2010 (ongoing). Concomitant medication(s) included: METOPROLOL taken for atrial fibrillation (ongoing); LISINOPRIL taken for hypertension (ongoing); ELIQUIS taken for atrial fibrillation (ongoing); HYDROCHLOROTHIAZIDE taken for hypertension. Vaccination history included: Bnt162b2 (Dose 1, Date: 07Feb2021, Time: 13:00 , Anatomical site of injection: L arm, Route of administration: Intramuscular, Batch/Lot number: EL9269), administration date: 07Feb2021, when the patient was 68 years old, for Covid-19 Immunization.  The following information was reported: DIARRHOEA (non-serious) with onset 28Feb2021, outcome "recovered" (01Mar2021), described as "diarrhea"; PYREXIA (non-serious) with onset 01Mar2021, outcome "recovered" (01Mar2021), described as "fever". Therapeutic measures were not taken as a result of diarrhoea, pyrexia.  Additional Information: It was reported that Pfizer product had a casual effect to the adverse event. No prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Polymerase chain reaction, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: I tested positive for Covid 19 after receiving 3 doses.; I tested positive for Covid 19 after receiving 3 doses.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date Oct2021 (Batch/Lot number: unknown) at the age of 62 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 04Feb2021 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm left, administration date 14Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADVIL [IBUPROFEN]. The following information was reported: VACCINATION FAILURE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset 03Feb2022 04:00, outcome "recovering" and all described as "I tested positive for Covid 19 after receiving 3 doses.". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (03Feb2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, sars-cov-2 test positive. Clinical course:If other vaccine in fourweeks: No,Other medications in twoweeks: Advil.I tested positive for Covid 19 after receiving 3 doses. Tested positive on 03Feb2021.If covid prior vaccination: No.If covid tested post vaccination: Yes.Covid test type post vaccination; Nasal Swab.Covid test name post vaccination: PCR.Known allergies: no. Other medical history: no.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Breast pain, Swelling, Thrombosis
Clinical narrative: it can possibly be a Blood clot; Under my arm, under my armpit, it's extremely swollen; it is going pain like in my breast area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 04Feb2022 (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 number: 1, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose number: 2, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: THROMBOSIS (medically significant) with onset Feb2022, outcome "unknown", described as "it can possibly be a Blood clot"; SWELLING (non-serious) with onset Feb2022, outcome "unknown", described as "Under my arm, under my armpit, it's extremely swollen"; BREAST PAIN (non-serious) with onset Feb2022, outcome "unknown", described as "it is going pain like in my breast area".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Very sore Arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 30Jan2021 (Batch/Lot number: unknown) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies to adhesive" (unspecified if ongoing). Concomitant medication(s) included: METROGEL, start date: Jan2020, stop date: 30Jan2021; ASCORBIC ACID, start date: 2015 (ongoing); COLECALCIFEROL, start date: 2015 (ongoing); MEGARED OMEGA 3 KRILL OIL, start date: 2015 (ongoing); CYANOCOBALAMIN, start date: 2015 (ongoing). Past drug history included: Triple antibiotic ointment, reaction(s): "allergy". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE at 11:30 AM in left arm), administration date: 11Jan2021, when the patient was 67 years old, for COVID-19 immunization, reaction(s): "Slight tenderness at injection site", "Extreme fatigue". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Jan2021 20:00, outcome "recovered" (2021), described as "Very sore Arm". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: extreme insomnia/ can no longer sleep; 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-202200223003 (Pfizer).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious), outcome "not recovered", described as "extreme insomnia/ can no longer sleep". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid Arthritis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (I ran a slight temperature after the first shot), for Covid-19 immunization, reaction(s): "slight temperature". The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid Arthritis". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I did receive the  Booster in October but unfortunately got Covid in January 2022; I did receive the Phuket Booster in October but unfortunately got Covid in January 2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Oct2021 (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: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "I ran a slight temperature after the first shot"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization, reaction(s): "Rheumatoid Arthritis". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "I did receive theBooster in October but unfortunately got Covid in January 2022". The clinical course reported as patient was diagnosed with Rheumatoid Arthritis 3 months after receiving my second Pfizer vaccine for Covid. Patient ran a slight temperature after the first shot and none with the second. Patient did receive the Booster in October but unfortunately got Covid in Jan2022. Patient wondering if you had any feedback similar to experience.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cold sweat, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: Chest pain (described as someone squeezing heart); Rapid heart rate; Shortness of breath; Sweating; Pale and clammy skin; Pale and clammy skin; This is a spontaneous report from a contactable reporter (Consumer or other non-HCP). The reporter is the patient. A 17 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 12Jan2022 at 15:30 (Lot number: FJ5683) at the age of 17 years as dose 1 (TRIS), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication included unspecified birth control medications. Past drug history included: Flu vaccine, for Immunisation, reaction: "Allergy to vaccine", notes: Known allergies : Flu vaccine. The following information was reported: CHEST PAIN (non-serious) with onset 13Jan2022 at 00:15, outcome "recovering", described as "Chest pain (described as someone squeezing heart)"; HEART RATE INCREASED (non-serious) with onset 13Jan2022 at 00:15, outcome "recovering", described as "Rapid heart rate"; DYSPNOEA (non-serious) with onset 13Jan2022 at 00:15, outcome "recovering", described as "Shortness of breath"; HYPERHIDROSIS (non-serious) with onset 13Jan2022 at 00:15, outcome "recovering", described as "Sweating"; PALLOR (non-serious), COLD SWEAT (non-serious), all with onset 13Jan2022 at 00:15, outcome "recovering", and all described as "Pale and clammy skin". Relevant laboratory tests and procedures are available in the appropriate section. The events "Chest pain (described as someone squeezing heart)", "Rapid heart rate", "Shortness of breath", "Sweating" and "Pale and clammy skin" were evaluated at the doctor or other healthcare professional office/clinic visit and emergency room visit. Therapeutic measures were taken as a result of chest pain, heart rate increased, dyspnoea, hyperhidrosis, pallor and cold sweat. Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Treatment included rest requirement for the events chest pain, heart rate increased, dyspnoea, hyperhidrosis, pallor and cold sweat. Since the vaccination, the patient had not been tested for COVID-19.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pallor
Clinical narrative: Chest pain (described as someone squeezing heart); Rapid heart rate; Shortness of breath; Sweating; Pale and clammy skin; Pale and clammy skin; This is a spontaneous report from a contactable reporter (Consumer or other non-HCP). The reporter is the patient. A 17 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 12Jan2022 at 15:30 (Lot number: FJ5683) at the age of 17 years as dose 1 (TRIS), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication included unspecified birth control medications. Past drug history included: Flu vaccine, for Immunisation, reaction: "Allergy to vaccine", notes: Known allergies : Flu vaccine. The following information was reported: CHEST PAIN (non-serious) with onset 13Jan2022 at 00:15, outcome "recovering", described as "Chest pain (described as someone squeezing heart)"; HEART RATE INCREASED (non-serious) with onset 13Jan2022 at 00:15, outcome "recovering", described as "Rapid heart rate"; DYSPNOEA (non-serious) with onset 13Jan2022 at 00:15, outcome "recovering", described as "Shortness of breath"; HYPERHIDROSIS (non-serious) with onset 13Jan2022 at 00:15, outcome "recovering", described as "Sweating"; PALLOR (non-serious), COLD SWEAT (non-serious), all with onset 13Jan2022 at 00:15, outcome "recovering", and all described as "Pale and clammy skin". Relevant laboratory tests and procedures are available in the appropriate section. The events "Chest pain (described as someone squeezing heart)", "Rapid heart rate", "Shortness of breath", "Sweating" and "Pale and clammy skin" were evaluated at the doctor or other healthcare professional office/clinic visit and emergency room visit. Therapeutic measures were taken as a result of chest pain, heart rate increased, dyspnoea, hyperhidrosis, pallor and cold sweat. Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Treatment included rest requirement for the events chest pain, heart rate increased, dyspnoea, hyperhidrosis, pallor and cold sweat. Since the vaccination, the patient had not been tested for COVID-19.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Dementia Alzheimer's type, Magnetic resonance imaging head
Clinical narrative: Alzheimer disease; This is a spontaneous report received from a contactable reporter(s) (Physician).  An 85-year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) at the age of 85 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing); "subdural hematoma", start date: 2019 (unspecified if ongoing); "cognitive age-related impairment", start date: 2017 (ongoing). The patient's concomitant medications were not reported.Alzheimer disease The following information was reported: DEMENTIA ALZHEIMER'S TYPE (medically significant), outcome "unknown", described as "Alzheimer disease". The patient's daughter went part-time for work around 2015 because that is when she started to realize that her mother (the patient) couldn't do her pill box or do stuff like that anymore. The daughter started to accompany her mother to all of her doctor's appointments. At that point is when she noticed it but she thinks it started even prior to that. They did testing and at first it showed just cognitive age related impairment on that initial testing in 2017 and then they did testing again in Mar2021 or so and that showed definite change. They also did a functional MRI that showed loss of volume in regions that are pretty commonly associated with Alzheimer's. Her mother is on donepezil (ARICEPT) to try and help with that, she is on the max dose of 10 BID. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging head: loss of volume in regions. Therapeutic measures were taken as a result of dementia alzheimer's type.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Based on available information and known safety  profile the reported "Alzheimer disease"  is an intercurrent medical condition and is unrelated to  bnt162b2.  Case will be reassessed if additional information is received.  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.,Linked Report(s) : US-PFIZER INC-202200133054 same patient, different dose (2)/ events;US-PFIZER INC-202200149139 same patient, different doses (1,2,3)/events;US-PFIZER INC-202200221790 same patient, different dose (3)/events
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; tiredness; 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 (005570). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "In 2021, patient had treatments for cancer: surgery, chemotherapy, radiation therapy, and aromatase inhibitors.", start date: 2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "tiredness".  Additional information: It was reported that Are you currently studying the outcomes of FOUR Pfizer dose vaccinations? Is it protecting me and for how long? Do I need a different vaccination for the Omicron variant? Had four doses since Apr2021, last one competed yesterday. Side effects for all four doses seems to be just a sore arm and tiredness for about 2 days. In 2021, patient had treatments for cancer: surgery, chemotherapy, radiation therapy, and aromatase inhibitors.  The lot number for bnt162b2 was not provided and will be requested during follow up.