chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis, Hypersensitivity, Systemic lupus erythematosus, Urticaria
Clinical narrative: Lupus; Hashimoto's; Allergic reaction; Hives; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team from a Pfizer sponsored program (005570). The reporter is the patient.  A 47-year-old female patient received BNT162B2 (BNT162B2), administration date Feb2021 (Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (dose 1, single; manufacturer unknown), for COVID-19 immunization. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant) with onset 2021, outcome "unknown", described as "Lupus"; AUTOIMMUNE THYROIDITIS (medically significant) with onset 2021, outcome "unknown", described as "Hashimoto's"; HYPERSENSITIVITY (medically significant) with onset 2021, outcome "not recovered", described as "Allergic reaction"; URTICARIA (medically significant) with onset 2021, outcome "not recovered", described as "Hives". Therapeutic measures were taken as a result of hypersensitivity, urticaria. Clinical course: The patient reported that she received the 2nd dose of the Pfizer-BioNTech COVID-19 vaccine in Feb2021 and experienced severe hives on a daily basis ever since. She had to get Xolair shots monthly. The patient believes she was having an allergic reaction because she broke out in hives everyday which was really bad and no meds or cream was helping. The patient also found out 2 autoimmmune - Hashimoto's and Lupus that she never had and trying to see if it was related to the vaccine.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: probably infected by another clinical person or someone; probably infected by another clinical person or someone; This is a spontaneous report received from a contactable reporter(s) (Physician). A child patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (tris), single for covid-19 immunisation. Relevant medical history included: "disability" (unspecified if ongoing), notes: it was a child with disability.  The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "probably infected by another clinical person or someone".  Clinical course: the caller says she has never had COVID until 03Jan, she didnt have alpha and not delta, she was cautious and mindful about what she does then on 31Dec she was exposed when she took off her mask and gloves when she was gave tea and cake on 31Dec, she thought ok fine lets see if she would still be vaccinated. She says the child she was working with showed no sign they had anything, they were happy and smiling and drooling all over the place, it was a child with disability who she knows was probably infected by another clinical person or someone who brought it into the home, the parents and nanny had been boosted with the child, this was when she herself was trying to get her second shot. Caller provides no further information about the patient, patient's parents, or patient's nanny. Caller says that for her husband also had a good positive experience with no allergic reaction to his Johnson & Johnson COVID-19 vaccine, he did have a stroke earlier this year, and has a history of multiple myelomas which is a different cancer, but he had a very good reaction to his vaccine. Caller says she doesnt have time to complete a report on her husband, and would like to be transferred for more information about getting Paxlovid and to find out about the email that she didnt receive yet still. Caller declines to complete a report on her husband. No further details captured, reported, or documented at this time.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain, approximately 5 minutes post vaccination; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 16 year-old male patient received bnt162b2 (BNT162B2), administration date 07Jan2022 (Lot number: FD0809, Expiration Date: 10Jan2022) at the age of 16 years as dose number, unknown, 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: CHEST PAIN (non-serious) with onset 07Jan2022, outcome "unknown", described as "Chest pain, approximately 5 minutes post vaccination". The event "chest pain, approximately 5 minutes post vaccination" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of chest pain.  Follow-Up (18Jan2022): Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Inappropriate schedule of product administration, Systemic lupus erythematosus
Clinical narrative: Lupus/ about 1 week after getting the 2nd dose of the vaccine; she got her 1st dose in May2021/ Her 2nd dose was in Dec2021; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date Dec2021 (Batch/Lot number: unknown) at the age of 20 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Diagnosed about 4 years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, Anatomical Location: Left arm), administration date: May2021, when the patient was 20 years old, for COVID-19 immunization, reaction(s): "She was so sick", "symptoms of Lupus". The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "Lupus/ about 1 week after getting the 2nd dose of the vaccine"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset Dec2021, outcome "unknown", described as "she got her 1st dose in May2021/ Her 2nd dose was in Dec2021". The event "lupus/ about 1 week after getting the 2nd dose of the vaccine" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown results. Clinical course: It was reported that, patient did not had lupus before she got the vaccine but, 2 weeks ago, she was diagnosed with Lupus, which was about 1 week after getting the second dose of the vaccine. She started to get symptoms after she received the first dose of the vaccine in May2021, but she wasn't diagnosed with Lupus until just recently. She reported that she waited all that time to get the second dose because she was so sick. She decided to finally get the second dose due to the Omicron strain, but she was still sick and was going to doctors to try to figure out what was wrong, so she doesn't know if it was the first dose that did it or the second dose. She confirmed that the doctors don't want to link this to the vaccine, but she feels that it's related.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Tic
Clinical narrative: severe ticcing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the parent.  A child male patient received bnt162b2 (BNT162B2), administration date 20Dec2021 (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: TIC (non-serious) with onset Dec2021, outcome "unknown", described as "severe ticcing". The event "severe ticcing" was evaluated at the physician office visit. Additional information: The patient received the first shot of the Covid vaccine on 20Dec2021. Within two days, he began having what they now know was severe ticcing. The first pediatrician they saw said he should not get the second shot. The second pediatrician they saw said he should still get the second shot. They were referred to a neurologist who will be doing an EEG next week. She said he should get the second shot as well.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Postmenopausal haemorrhage
Clinical narrative: This lasted for 6 months, with extremely heavy menstruation; I was menopausal,started menstruating. This lasted for 6 months; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 10:00 (Lot number: EL9266) at the age of 50 years as dose 2, single for covid-19 immunization. Relevant medical history included: "I was menopausal" (unspecified if ongoing), notes: I was menopausal (no periods for over, a year), known allergies: No. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9265, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM), administration date: 01Feb2021, when the patient was 50 years old, for COVID-19 Immunization, reaction(s): "was menopausal (no periods for over a year), but after the first shot, I felt abdominal pains". The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The patient didn't receive any other medications within 2 weeks of vaccination.  Prior to vaccination, patient was not diagnosed with COVID-19. After the vaccination patient has not been tested for COVID-19. The following information was reported: HEAVY MENSTRUAL BLEEDING (medically significant) with onset 2021, outcome "recovered" (2021), described as "This lasted for 6 months, with extremely heavy menstruation"; POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 2021, outcome "recovered" (2021), described as "I was menopausal, started menstruating. This lasted for 6 months". Therapeutic measures were not taken as a result of heavy menstrual bleeding, postmenopausal hemorrhage.; Sender's Comments: Based on the current available information and a possible contributory role of the suspect product BNT162B2 to the development of events postmenopausal bleeding, heavy menstrual bleeding cannot be totally excluded. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Postmenopausal haemorrhage
Clinical narrative: booster; I stopped menstruating, but as soon as I received my booster shot, I started cycling again.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jan2022 11:00 (Lot number: FL3197) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Menopause" (unspecified if ongoing), notes: no periods for over a year. There were no concomitant medications. Patient had no other vaccines in 4 weeks. Patient had no COVID prior vaccination. Patient had no known allergies. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9266, Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 22Feb2021, when the patient was 50 years old, for COVID-19 Immunization, reaction(s): "menopausal (no periods for over a year)/by the time I had my second shot, I started menstruating", "This lasted for 6 months, with extremely heavy menstruation"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9265, Arm Left, Vaccine Administration Time: 09:30 AM), administration date: 01Feb2021, when the patient was 50 years old, for COVID-19 Immunization, reaction(s): "menopausal (no periods for over a year), but after the first shot, I felt abdominal pains". The following information was reported: IMMUNISATION (medically significant) with onset 06Jan2022 11:00, outcome "unknown", described as "booster"; POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset Jan2022, outcome "unknown", described as "I stopped menstruating, but as soon as I received my booster shot, I started cycling again.". Therapeutic measures were not taken as a result of postmenopausal haemorrhage. Patient was not tested for COVID post vaccination.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID; Tested positive for COVID; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 20Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date 24May2021 (Batch/Lot number: unknown) as dose 2, single and administration date 03May2021 (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: IMMUNISATION (medically significant) with onset 20Dec2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "unknown" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2022) positive. The patient had a slight head cold after the dose 1 and NyQuil got rid of it in few days. Following week after booster dose, patient got a real bad head cold that took a week to go away.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heavy menstrual bleeding, Migraine, SARS-CoV-2 test
Clinical narrative: started menstrual bleeding that lasted continually for 68 days; severe headaches; migraines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 14:30 (Lot number: EN6207) at the age of 44 years as dose 1, single for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies. Relevant medical history included: "Breast Cancer IDC stage 1", start date: 2018 (unspecified if ongoing), notes: No lymph involvement. Concomitant medication(s) included: ZOLOFT. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: HEAVY MENSTRUAL BLEEDING (medically significant) with onset 20Mar2021 12:00, outcome "recovered with sequelae", described as "started menstrual bleeding that lasted continually for 68 days"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "severe headaches"; MIGRAINE (non-serious) with onset 2021, outcome "not recovered", described as "migraines". The events "started menstrual bleeding that lasted continually for 68 days", "severe headaches" and "migraines" were evaluated at the emergency room visit. Since the vaccination, the patient has been tested for COVID-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) negative, notes: test type Nasal Swab. Therapeutic measures were taken as a result of heavy menstrual bleeding, headache, migraine. Reported Event: With in 24 hours of the first dose of the Covid vaccine, the patient started menstrual bleeding that lasted continually for 68 days. The patient developed severe headaches and migraines that have continued presently. Adverse event start time was 20Mar2021 12:00 PM. The treatment of the event included Nurtec, Nose packed, Ibuprofen. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19, White blood cell count
Clinical narrative: Booster; Drug Ineffective; Pt states that she is getting over COVID currently; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing). Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis. Vaccination history included: Comirnaty (Dose 1, single, Route of administration: unknown.), for COVID-19 immunization; Comirnaty (Dose 2, single, Route of administration: unknown.), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), outcome "recovering", described as "Drug Ineffective"; SUSPECTED COVID-19 (medically significant), outcome "recovering", described as "Pt states that she is getting over COVID currently". The patient stated that her case was mild and only felt bad for three days. No treatment information was received. The patient underwent the following laboratory tests and procedures: white blood cell count: low, notes: her WBC (white blood cell) laboratory test tends to run low.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Choking, Epistaxis, SARS-CoV-2 test
Clinical narrative: choking on the blood.; nosebleed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 10Apr2021 14:30 (Lot number: EN6206) at the age of 44 years as dose 2, single for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies. Relevant medical history included: "Breast Cancer IDC, stage 1", start date: 2018 (unspecified if ongoing), notes: no lymph involvement. Concomitant medication(s) included: ZOLOFT. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Pfizer/EN6207, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 19Mar2021, when the patient was 44 years old, for COVID-19 immunization, reaction(s): "started menstrual bleeding that lasted continually for 68 days", "severe headaches", "Migraines". The following information was reported: CHOKING (medically significant) with onset 2021, outcome "unknown", described as "choking on the blood."; EPISTAXIS (medically significant) with onset 2021, outcome "unknown", described as "nosebleed". The events "choking on the blood." and "nosebleed" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: test type Nasal Swab. Therapeutic measures were taken as a result of choking, epistaxis. After the second dose of the Covid vaccine the patient was taken to urgent care for a nosebleed that would not stop. It was so severe that the patient was choking on the blood. The treatment of the event included Nurtec, Nose packed, Ibuprofen.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Thrombosis
Clinical narrative: Pfizer booster; blood clot two; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization, medically significant), outcome "unknown", described as "Pfizer booster"; THROMBOSIS (hospitalization, medically significant), outcome "unknown", described as "blood clot two". The reporter stated reporter's father was in the hospital with a blood clot two. The symptoms started two days after the Pfizer booster.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Immunisation, SARS-CoV-2 test
Clinical narrative: Atrial Fibrillation; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 17:00 (Batch/Lot number: unknown) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VIAGRA taken for erectile dysfunction; CENTRUM SILVER +50; CLARITIN D 12 HOUR. Vaccination history included: Bnt162b2 (Dose Number: 2, Lot # unknown, Arm Left, 10:00 AM), administration date: 24Mar2021, when the patient was 51 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Lot # unknown, Arm Left, 10:00 AM), administration date: 03Feb2021, when the patient was 51 years old, for Covid-19 Immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The following information was reported: ATRIAL FIBRILLATION (hospitalization) with onset 18Dec2021, outcome "recovering", described as "Atrial Fibrillation"; IMMUNISATION (hospitalization, medically significant) with onset 18Dec2021, outcome "recovering", described as "Booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) negative. Therapeutic measures taken as a result of the eventts included cardioversion.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Hypersensitivity, Movement disorder
Clinical narrative: had a severe allergic reaction; he couldn't move for two weeks; schedule to take the Moderna shoot as a second dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-001325 .  A 56 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "immunocompromise for kidney transplant" (unspecified if ongoing); "lupus" (unspecified if ongoing); "Wagner's disease" (unspecified if ongoing). Concomitant medication(s) included: ZORTRESS; AZATHIOPRINE. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "had a severe allergic reaction"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "he couldn't move for two weeks"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "schedule to take the Moderna shoot as a second dose".  Additional information: patient call because they took the Pfizer vaccine and had a severe allergic reaction. They mentioned that they were immunocompromise for kidney transplant, and that they had lupus and Wagner's disease. Also that they were schedule to take the Moderna shoot as a second dose, and its worry was going to have the same reaction. Also he mentioned that he couldn't move for two weeks and had no antibody's and couldn't leave the house.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Urticaria
Clinical narrative: Hives and bug bites (she never got bug bites prior to this); Hives and bug bites (she never got bug bites prior to this); This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 59-year-old female patient (not pregnant) received bnt162b2 (PFIZER COVID-19 VACCINE), administered in arm left, administration date 20May2021 16:15 (Lot number: EW0171) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "IBS" (unspecified if ongoing); "Hiatal hernia" (unspecified if ongoing); "known allegy: Aloe" (unspecified if ongoing). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive other medications within 2 weeks or other vaccines within 4 weeks prior to the COVID vaccine. Vaccination history included: Bnt162b2 (Dose 1, lot number: EW0161, administration time: 16:15, location: left arm), administration date: 29Apr2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: ARTHROPOD BITE (medically significant), URTICARIA (medically significant) all with onset 21May2021, outcome "recovered" and all described as "Hives and bug bites (she never got bug bites prior to this)". Therapeutic measures were taken as a result of arthropod bite, urticaria and included treatment with lots and lots of benadryl.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Immunisation, Nasal congestion
Clinical narrative: Tested positive for covid; Tested positive for covid; congestion; sore throat; lost of smell and taste; lost of smell and taste; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 21Oct2021 (Lot number: FH8020) at the age of 62 years as dose 3 (booster), single, administered in arm left, administration date 19Feb2021 (Lot number: EL9266) as dose 2, single and administered in arm left, administration date 29Jan2021 (Lot number: EL9269) as dose 1, single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing). None of known allergies. No covid prior vaccination. Concomitant medication(s) included: ACCURETIC; LIPITOR; TOPROL XL; ASA. No other vaccine in four weeks.  The following information was reported: IMMUNISATION (medically significant) with onset 21Oct2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022, outcome "unknown" and all described as "Tested positive for covid"; NASAL CONGESTION (non-serious) with onset 07Jan2022 15:00, outcome "recovering", described as "congestion"; OROPHARYNGEAL PAIN (non-serious) with onset 07Jan2022 15:00, outcome "recovering", described as "sore throat"; ANOSMIA (non-serious), AGEUSIA (non-serious) all with onset 07Jan2022 15:00, outcome "recovering" and all described as "lost of smell and taste". The patient underwent the following laboratory tests and procedures: saliva analysis: (11Jan2022) pending, notes: Other; sars-cov-2 test: (10Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of nasal congestion, oropharyngeal pain, anosmia, ageusia.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test, Saliva analysis, Vaccination failure
Clinical narrative: Tested positive for covid; Tested positive for covid; congestion; sore throat; lost of smell and taste; lost of smell and taste; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 21Oct2021 (Lot number: FH8020) at the age of 62 years as dose 3 (booster), single, administered in arm left, administration date 19Feb2021 (Lot number: EL9266) as dose 2, single and administered in arm left, administration date 29Jan2021 (Lot number: EL9269) as dose 1, single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing). None of known allergies. No covid prior vaccination. Concomitant medication(s) included: ACCURETIC; LIPITOR; TOPROL XL; ASA. No other vaccine in four weeks.  The following information was reported: IMMUNISATION (medically significant) with onset 21Oct2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022, outcome "unknown" and all described as "Tested positive for covid"; NASAL CONGESTION (non-serious) with onset 07Jan2022 15:00, outcome "recovering", described as "congestion"; OROPHARYNGEAL PAIN (non-serious) with onset 07Jan2022 15:00, outcome "recovering", described as "sore throat"; ANOSMIA (non-serious), AGEUSIA (non-serious) all with onset 07Jan2022 15:00, outcome "recovering" and all described as "lost of smell and taste". The patient underwent the following laboratory tests and procedures: saliva analysis: (11Jan2022) pending, notes: Other; sars-cov-2 test: (10Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of nasal congestion, oropharyngeal pain, anosmia, ageusia.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
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) (Consumer or other non HCP).  A 59 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 17Apr2021 (Batch/Lot number: unknown) at the age of 58 years as dose 2, single and intramuscular, administration date 27Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No covid prior vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jan2022, outcome "not recovered" and all described as "Positive COVID test". The event "positive covid test" and "positive covid test" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: SARs-COV2- PCR test via saliva obtained on 10Jan2022 was positive; SARs-COV2- PCR test via saliva obtained on 10Jan2022 was positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the parent.  A 8 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Dec2021 13:00 (Lot number: FL0007) at the age of 8 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=PFIZER,, prev dose brand unknown=False,, prev dose lot number=FK5618,, prev dose lot unknown=False,, prev dose administrator route=Intramuscular,, prev dose administration date=10Nov2021,, prev dose administration time=09:00 AM, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: 10Nov2021, when the patient was 7 years old, for covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022, outcome "unknown" and all described as "SARs-COV2- PCR test via saliva obtained on 10Jan2022 was positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive; (22Sep2021) negative. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient had received no other vaccination within four weeks of vaccination. The patient had received no other medication within two weeks of vaccination. The patient had not diagnosed with COVID-19 prior vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Investigation, Postmenopausal haemorrhage
Clinical narrative: having menstrual bleeding that lasted for 1.5 weeks/experienced menstrual bleeding and this is way after she went through menopause, that was three years 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 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "went through menopause" (unspecified if ongoing), notes: three years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot Number: Unknown; , Anatomical Location: Left arm), for COVID-19 immunization. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 09Dec2021, outcome "recovered" (Dec2021), described as "having menstrual bleeding that lasted for 1.5 weeks/experienced menstrual bleeding and this is way after she went through menopause, that was three years ago". The event "having menstrual bleeding that lasted for 1.5 weeks/experienced menstrual bleeding and this is way after she went through menopause, that was three years ago" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: biopsy: unknown results; investigation: unknown results. Reporter stated that she had been through all kinds of testing over the last 3 weeks and has had biopsies done and her physician could not find any other reason for her symptoms. Caller stated that her doctor had called her symptoms uncommon and random. Caller states when she asked the doctor directly were her symptoms caused by the vaccine the doctor did not say yes or no just that she could not say for sure. Reporter seriousness for experienced menstrual bleeding and this is way after she went through menopause was unspecified. Reporter stated that menstrual bleeding began on 09Dec2021. She was not experiencing this at the moment. It went away probably about a week and a half after it was first noticed, confirmed to be in Dec2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Throat tightness
Clinical narrative: Prolonged pressure and tightness in throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 25May2021 (Lot number: EW0178) at the age of 19 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Alopecia areata" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0158, Location of injection: Arm Right), administration date: 03May2021, when the patient was 19 years old, for COVID-19 immunization. The following information was reported: THROAT TIGHTNESS (medically significant) with onset 08Jun2021, outcome "not recovered", described as "Prolonged pressure and tightness in throat". The event "prolonged pressure and tightness in throat" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: Nasal Swab. Therapeutic measures were taken as a result of throat tightness.  Clinical course: Prolonged pressure and tightness in throat present for 7 months starting 2 weeks after 2nd dose. No response to prednisone, or numerous other treatments. Patient received Prednisone, PPI, steroid injections, speech therapy as treatment. 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 had been tested for COVID-19. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: booster; contracted the Omicron variant of SARS-COV-2; contracted the Omicron variant of SARS-COV-2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "contracted the Omicron variant of SARS-COV-2".  Clinical courses: Earlier last week, the patient contracted the Omicron variant of SARS-COV-2 and experienced mild symptoms.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200058493 same reporter/drug/event, different patient
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ankylosing spondylitis, Cardiac disorder, Heart rate, Heart rate increased, Stress
Clinical narrative: Spondylitis ankylosing aggravated; Cardiac disorder; Stress; Heart rate increased; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4228486-00.  A 59 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Feb2021 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "not recovered", described as "Spondylitis ankylosing aggravated"; CARDIAC DISORDER (non-serious), outcome "not recovered", described as "Cardiac disorder"; STRESS (non-serious), outcome "not recovered", described as "Stress"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "Heart rate increased". The patient underwent the following laboratory tests and procedures: heart rate: went up; heart rate increased. The action taken for adalimumab was dosage permanently withdrawn.   Clinical course: It was stated that It was unknown if patient was enrolled in a covid-19 vaccine trial.   The reporter's causality for the event(s) of cardiac issues with humira(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of ankylosing spondylitis flare up due to stress unknown onset and ankylosing spondylitis flare up due to stress unknown onset with humira(adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of heart rate went up was not provided.   The reporter's assessment of the causal relationship of the cardiac disorder with Pfizer Biontech Covid-19 Vaccine was Possible. The reporter's assessment of the causal relationship of the ankylosing spondylitis flare up due to stress and for the event stress was possible. The reporter's causality for the event(s) of heart rate went up was possible.  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  information in the case report, a possible causal relationship between the events  and suspect drug BNT162B2 cannot be excluded. 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.
Age: 51.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4229574-00 (Abbvie).  A 51 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Jul2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 08Jun2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis. 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 "recovered" and all described as "COVID-19". The action taken for adalimumab was unknown.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter considered "covid-19" related to bnt162b2. The reporter's causality for the event(s) of COVID with HUMIRA (ADALIMUMAB) was no reasonable possibility. Event abate after stopping drug was NA. The reporter's causality for the event(s) of COVID with HUMIRA (ADALIMUMAB) was no reasonable possibility.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: COVID-19; COVID-19; MARKETING PROGRAM NAME IS NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single and intramuscular, administration date 23Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for Moderate To Severe Hidradenitis Suppurativa. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: positive. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of the (DRUG INEFFECTIVE, COVID-19 ) with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available reported information, the causal association between the events drug ineffective and covid-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.