chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other=MODERNA, vaccine dose number=1, 2, 3, 4/vaccine brand=Pfizer; BioNTech, vaccine dose number=5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Mar2021 as dose 1, single (Lot number: 025A21A), in left arm, on 30Mar2021 as dose 2, single (Lot number: 044A21A), in left arm, on 11Nov2021 as dose 3 (booster), single (Lot number: 004F21A), in left arm and on 05Jun2022 as dose 4 (booster), single (Lot number: 005M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "osteoporosis" (unspecified if ongoing); "macular degeneration" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Grains" (unspecified if ongoing); "Known allergies: Nightshades" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Sep2022, outcome "unknown", described as "Vaccine brand other=MODERNA, vaccine dose number=1, 2, 3, 4/vaccine brand=Pfizer; BioNTech, vaccine dose number=5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: the patient was treated with Paxlovid.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand=Pfizer/BioNTech, vaccine dose number=1, 2, 3/Vaccine brand other=Moderna, Vaccine dose number=4, 5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 10Feb2021 as dose 2, single (Lot number: EM9810), in left arm and on 15Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Mar2022 as dose 4 (booster), single (Lot number: 042121A), in left arm and on 25Sep2022 as dose 5 (booster), single (Lot number: AS7164B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "seizure disorder" (unspecified if ongoing); "cancer (base of tongue)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Mar2022, outcome "unknown", described as "Vaccine brand=Pfizer/BioNTech, vaccine dose number=1, 2, 3/Vaccine brand other=Moderna, Vaccine dose number=4, 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "drug allergy", notes: Known allergies: penicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment from 14Mar2023 to 18Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19  are related to BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) cannot be excluded. This case will be reassessed should additional information become available.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19/Tested positive; COVID-19/Tested positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Lot number: FM0698), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 10Feb2021 as dose 2, single (Lot number: EL9269), in left arm and on 29Sep2021 as dose 3 (booster), single (Lot number: 301458A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Pre-diabetes" (unspecified if ongoing); "Allergy" (unspecified if ongoing), notes: Known allergies: yes. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Mar2023, outcome "unknown" and all described as "COVID-19/Tested positive". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) High; SARS-CoV-2 test: (09Mar2023) Positive, notes: Tested positive on 09Mar2023 first time; (15Mar2023) negative, notes: tested negative since 15Mar2023. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: All the Pfizer / BioNTech vaccine doses were given at 12:00 AM. Tested positive on 09Mar2023 first time. Started Paxlovid on 10Mar2023 (Treatment of COVID-19, Paxlovid Treatment start date was on 10Mar2023 and stop date was on 14Mar2023). Tested negative since 15Mar2023.; Sender's Comments: The reported "COVID-19/Tested positive" is considered ineffective of BNT162B2 (BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5)), and the Company cannot completely exclude the possible causality between the reported event and suspect vaccines administration.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test abnormal, Feeling abnormal, Full blood count, Sjogren's syndrome
Clinical narrative: Sjogren disease; my blood count is 2.2 exceptionally low; still felt horrible, terrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (first dose was on 06Dec2020 Lot EW0173), administration date: 06Dec2020, for Covid-19 immunization; Bnt162b2 (Second dose lot EW0153), for Covid-19 immunization; Bnt162b2 (Third dose on 2021 FL3197), administration date: 2021, for Covid-19 immunization; Bnt162b2 (Fourth FM9992), for Covid-19 immunization. The following information was reported: SJOGREN'S SYNDROME (medically significant) with onset 2023, outcome "unknown", described as "Sjogren disease"; BLOOD TEST ABNORMAL (non-serious) with onset 2023, outcome "unknown", described as "my blood count is 2.2 exceptionally low"; FEELING ABNORMAL (non-serious) with onset 2023, outcome "not recovered", described as "still felt horrible, terrible". The patient underwent the following laboratory tests and procedures: Full blood count: (2023) my blood count is 2.2 exceptionally low.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300128996 same reporter/patient/product, different dose/event.;
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Full blood count, SARS-CoV-2 test
Clinical narrative: Sjogren disease; my blood count is 2.2 exceptionally low; still felt horrible, terrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (first dose was on 06Dec2020 Lot EW0173), administration date: 06Dec2020, for Covid-19 immunization; Bnt162b2 (Second dose lot EW0153), for Covid-19 immunization; Bnt162b2 (Third dose on 2021 FL3197), administration date: 2021, for Covid-19 immunization; Bnt162b2 (Fourth FM9992), for Covid-19 immunization. The following information was reported: SJOGREN'S SYNDROME (medically significant) with onset 2023, outcome "unknown", described as "Sjogren disease"; BLOOD TEST ABNORMAL (non-serious) with onset 2023, outcome "unknown", described as "my blood count is 2.2 exceptionally low"; FEELING ABNORMAL (non-serious) with onset 2023, outcome "not recovered", described as "still felt horrible, terrible". The patient underwent the following laboratory tests and procedures: Full blood count: (2023) my blood count is 2.2 exceptionally low.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300128996 same reporter/patient/product, different dose/event.;
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, Blood test, Fibrin D dimer, Fibrin D dimer increased, Rhabdomyolysis
Clinical narrative: Rhabdomyolysis; She had a high D-dimer but there were no clots; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 24-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Mar2023 as dose number unknown (booster), single (Lot number: GL0447) at the age of 24 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: RHABDOMYOLYSIS (hospitalization, medically significant) with onset 15Mar2023, outcome "unknown"; FIBRIN D DIMER INCREASED (hospitalization) with onset Mar2023, outcome "unknown", described as "She had a high D-dimer but there were no clots". The patient was hospitalized for rhabdomyolysis, fibrin d dimer increased (hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures: Blood creatine phosphokinase (normal high range 100): (Mar2023) 77000; Blood test: (Mar2023) Unknown Results, notes: followed to make sure that kidney were not affected; Fibrin D dimer: (Mar2023) high. Therapeutic measures were taken as a result of rhabdomyolysis and high D-dimer.  Additional information: One of my patients actually ended up getting admitted with Rhabdomyolysis and she had actually worked out the day before the vaccine, she was a physical therapist, sports trainer, she was 24 years old, and she had worked out the day before. The next day she worked and with elderly doing physical therapy, this was 15Mar2023 and after working that day and not doing that much physically because they were older people, she went in she got a Pfizer Bivalent vaccine. The next day she actually started to feel very achy to the point that she could not walk down the stairs and she actually just put up with it. The next day was Friday and it was to the point that her urine turned tea color and she called the doctor on the Saturday, she shouldn't do too much that day and then she got admitted to the hospital (Further hospitalization details was not available over the call hence event captured as per verbatim). A normal CK (Creatinine Kinase) was about a 100-Creatinine kinase her was 77000 and she needed hydration and fortunately there was no kidney damage. The urine returned to normal, she had a high D-dimer but there were no clots.  The patient was admitted to a hospital, and she was hydrated over four days and the blood test (Further name of test was not clarified) was followed to make sure that kidney were not affected. She was hydrated.; Sender's Comments: Based on information provided, the events are inter-current conditions, thus unrelated to the suspect drug.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Immunisation reaction, Rash
Clinical narrative: keeps getting rash, it comes and goes in body/broke out in rash and mostly on the trunk of body, little bit on neck and little bit on the sides/ breaking out with rash; immune response; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) 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; unknown manufacturer, Batch/ Lot number unknown), for COVID-19 immunization. The following information was reported: RASH (non-serious), 2 weeks after the suspect product(s) administration, outcome "not recovered", described as "keeps getting rash, it comes and goes in body/broke out in rash and mostly on the trunk of body, little bit on neck and little bit on the sides/ breaking out with rash"; IMMUNISATION REACTION (non-serious), 2 weeks after the suspect product(s) administration, outcome "not recovered", described as "immune response". The events "keeps getting rash, it comes and goes in body/broke out in rash and mostly on the trunk of body, little bit on neck and little bit on the sides/ breaking out with rash" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient got the booster shot at the beginning of December and kept getting rash; it came and went in his body after receiving the booster shot. The patient broke out in rash about two weeks later of booster vaccination, mostly on the trunk of his body, little bit on his neck and little bit on the sides. He kept breaking out with rash and had been to two doctors and had a biopsy done which was inclusive for Viral fungi and so first, he could not figure out; went to another doctor and they could not figure it out. The doctors said they did not know, and the reporter and patient were wondering if other people had broken out with a rash that came and went; they checked out everything. It was not shingles and they have cross checked and very concerned of that it was may be just an immune response and wondered of other people experienced it. The reporter and patient checked up everything from laundry detergent, to what the patient was eating and was just sort of scratching their heads, it is what happens sometimes. They were glad that they got the booster and everything like that, and liked to know about the rash that comes and goes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Dry mouth, Fatigue, Malaise
Clinical narrative: I did come down with covid 2 months ago; I was very ill for about 3 weeks; I couldn't move or do nothing out of bed; I did come down with covid 2 months ago; I was very ill for about 3 weeks; I couldn't move or do nothing out of bed; Heart racing/Heart palpitations; Fatigue; Dry mouth; I am not feeling good; And I couldn't move or do nothing out of bed.; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I did come down with covid 2 months ago; I was very ill for about 3 weeks; I couldn't move or do nothing out of bed"; PALPITATIONS (non-serious), outcome "unknown", described as "Heart racing/Heart palpitations"; FATIGUE (non-serious), outcome "unknown"; DRY MOUTH (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown", described as "I am not feeling good"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "And I couldn't move or do nothing out of bed.". Therapeutic measures were not taken as a result of drug ineffective, covid-19, palpitations, fatigue, dry mouth, malaise, movement disorder. Patient got 2 Pfizer shots. The only thing they wrote down was the nurse's name, the date that it was given to her which is, in 2020 or 2021. But lately noticed like fatigue a lot and dry mouth a lot and heart racing and heart palpitations, never had that before. She did come down with Covid 2 months ago. She thinks it was one of the variants and she was very ill for about 3 weeks/ not feeling good. And she couldn't move or do nothing out of bed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19  are  related to BNT162b2 cannot be excluded.  This case will be reassessed should additional information become available.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Movement disorder, Palpitations
Clinical narrative: I did come down with covid 2 months ago; I was very ill for about 3 weeks; I couldn't move or do nothing out of bed; I did come down with covid 2 months ago; I was very ill for about 3 weeks; I couldn't move or do nothing out of bed; Heart racing/Heart palpitations; Fatigue; Dry mouth; I am not feeling good; And I couldn't move or do nothing out of bed.; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I did come down with covid 2 months ago; I was very ill for about 3 weeks; I couldn't move or do nothing out of bed"; PALPITATIONS (non-serious), outcome "unknown", described as "Heart racing/Heart palpitations"; FATIGUE (non-serious), outcome "unknown"; DRY MOUTH (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown", described as "I am not feeling good"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "And I couldn't move or do nothing out of bed.". Therapeutic measures were not taken as a result of drug ineffective, covid-19, palpitations, fatigue, dry mouth, malaise, movement disorder. Patient got 2 Pfizer shots. The only thing they wrote down was the nurse's name, the date that it was given to her which is, in 2020 or 2021. But lately noticed like fatigue a lot and dry mouth a lot and heart racing and heart palpitations, never had that before. She did come down with Covid 2 months ago. She thinks it was one of the variants and she was very ill for about 3 weeks/ not feeling good. And she couldn't move or do nothing out of bed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19  are  related to BNT162b2 cannot be excluded.  This case will be reassessed should additional information become available.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Dry mouth, Fatigue, Malaise, Neuropathy peripheral
Clinical narrative: I did come down with covid 2 months ago; I was very ill for about 3 weeks; I couldn't move or do nothing out of bed; I did come down with covid 2 months ago; I was very ill for about 3 weeks; I couldn't move or do nothing out of bed; Heart racing/Heart palpitations; Fatigue; Dry mouth; I am not feeling good; And I couldn't move or do nothing out of bed.; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I did come down with covid 2 months ago; I was very ill for about 3 weeks; I couldn't move or do nothing out of bed"; PALPITATIONS (non-serious), outcome "unknown", described as "Heart racing/Heart palpitations"; FATIGUE (non-serious), outcome "unknown"; DRY MOUTH (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown", described as "I am not feeling good"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "And I couldn't move or do nothing out of bed.". Therapeutic measures were not taken as a result of drug ineffective, covid-19, palpitations, fatigue, dry mouth, malaise, movement disorder. Patient got 2 Pfizer shots. The only thing they wrote down was the nurse's name, the date that it was given to her which is, in 2020 or 2021. But lately noticed like fatigue a lot and dry mouth a lot and heart racing and heart palpitations, never had that before. She did come down with Covid 2 months ago. She thinks it was one of the variants and she was very ill for about 3 weeks/ not feeling good. And she couldn't move or do nothing out of bed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19  are  related to BNT162b2 cannot be excluded.  This case will be reassessed should additional information become available.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: I did come down with covid 2 months ago; I was very ill for about 3 weeks; I couldn't move or do nothing out of bed; I did come down with covid 2 months ago; I was very ill for about 3 weeks; I couldn't move or do nothing out of bed; Heart racing/Heart palpitations; Fatigue; Dry mouth; I am not feeling good; And I couldn't move or do nothing out of bed.; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I did come down with covid 2 months ago; I was very ill for about 3 weeks; I couldn't move or do nothing out of bed"; PALPITATIONS (non-serious), outcome "unknown", described as "Heart racing/Heart palpitations"; FATIGUE (non-serious), outcome "unknown"; DRY MOUTH (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown", described as "I am not feeling good"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "And I couldn't move or do nothing out of bed.". Therapeutic measures were not taken as a result of drug ineffective, covid-19, palpitations, fatigue, dry mouth, malaise, movement disorder. Patient got 2 Pfizer shots. The only thing they wrote down was the nurse's name, the date that it was given to her which is, in 2020 or 2021. But lately noticed like fatigue a lot and dry mouth a lot and heart racing and heart palpitations, never had that before. She did come down with Covid 2 months ago. She thinks it was one of the variants and she was very ill for about 3 weeks/ not feeling good. And she couldn't move or do nothing out of bed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19  are  related to BNT162b2 cannot be excluded.  This case will be reassessed should additional information become available.
Age: 0.5
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: rash on both his right and left thigh; This is a spontaneous report received from contactable reporter (healthcare professional). A 6-month-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 23Jan2023 as dose 3, single (Lot number: FP2144, Expiration Date: 30Sep2024) at the age of 6 months intramuscular, in left thigh for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Prevnar 13 (Dose 1; lot number: Unknown), for immunization; Prevnar 13 (Dose 2; lot number: Unknown), for immunization. The following information was reported: RASH (non-serious) with onset 25Jan2023, outcome "recovered" (27Jan2023), described as "rash on both his right and left thigh". Therapeutic measures were taken as a result of rash. Additional information: The reported NDC number is 00005-1971-02. The reporter stated that she has two affected patients. They cannot be sure that it was Prevnar 13 but the caller does not think so since they have been doing Prevnar vaccines for as long as she can remember. The reporter stated that the patient had no fever. The reporter stated that the patient was seen in the practice and given and unspecified ointment. The reporter also mentioned that the patient's rash was gone on 27Jan2023. Caller denies any other medications, medical conditions, labs, testing, or treatments for the patient relevant to these events.
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Insomnia, Laboratory test
Clinical narrative: I have not been able to sleep; I have been awake the complete night; it has caused me complete insomnia and a total sleepless night; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 23Mar2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 75 years. The patient's relevant medical history included: "Hypertension" (ongoing); "Hypothyroidism" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism. The following information was reported: INSOMNIA (non-serious) with onset 23Mar2023, outcome "unknown", described as "I have not been able to sleep; I have been awake the complete night; it has caused me complete insomnia and a total sleepless night". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of insomnia.  Additional information: The patient took Zolpidem for the sleep and it has not saved her. The patient took that at 11 o'clock."  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Gastrointestinal pain, Headache
Clinical narrative: Diarrhea; Colon spasms; Extreme headaches; Chills; Fever 104; 1st dose: 13Mar2023, 2nd dose: 03Jun2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult patient received BNT162b2 (BNT162B2), on 03Jun2021 as dose 2, single (Lot number: EW0168), in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "extreme pain" (unspecified if ongoing); "flam vax (headache)" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN oral taken for pain, headache. Vaccination history included: BNT162b2 (dose 1, single, time: 15:00, anatomical site of injection: left shoulder, batch/lot number: FL0182), administration date: 13Mar2021, for covid-19 immunisation, reaction(s): "diarrhea", "colon spasms", "extreme headaches", "fever 104 F", "chills". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 03Jun2021, outcome "unknown", described as "1st dose: 13Mar2023, 2nd dose: 03Jun2021"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; GASTROINTESTINAL PAIN (non-serious), outcome "unknown", described as "Colon spasms"; HEADACHE (non-serious), outcome "unknown", described as "Extreme headaches"; CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Fever 104". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300056924 Same reporter/patient/drug, different vaccine dose/event;US-PFIZER INC-202300085419 Same reporter/patient/drug, different vaccine dose/ event;
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Laboratory test, Pyrexia, X-ray
Clinical narrative: Diarrhea; Colon spasms; Extreme headaches; Chills; Fever 104; 1st dose: 13Mar2023, 2nd dose: 03Jun2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult patient received BNT162b2 (BNT162B2), on 03Jun2021 as dose 2, single (Lot number: EW0168), in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "extreme pain" (unspecified if ongoing); "flam vax (headache)" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN oral taken for pain, headache. Vaccination history included: BNT162b2 (dose 1, single, time: 15:00, anatomical site of injection: left shoulder, batch/lot number: FL0182), administration date: 13Mar2021, for covid-19 immunisation, reaction(s): "diarrhea", "colon spasms", "extreme headaches", "fever 104 F", "chills". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 03Jun2021, outcome "unknown", described as "1st dose: 13Mar2023, 2nd dose: 03Jun2021"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; GASTROINTESTINAL PAIN (non-serious), outcome "unknown", described as "Colon spasms"; HEADACHE (non-serious), outcome "unknown", described as "Extreme headaches"; CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Fever 104". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300056924 Same reporter/patient/drug, different vaccine dose/event;US-PFIZER INC-202300085419 Same reporter/patient/drug, different vaccine dose/ event;
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2022 as dose 1, single (Lot number: FJ1614) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "breast cancer" (unspecified if ongoing); "childhood bronchitis" (unspecified if ongoing); "regular allergies" (unspecified if ongoing); "Known allergies: sulfas" (unspecified if ongoing). 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 "COVID 19 Treatment".; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19 are related to BNT162b2 cannot be excluded.  This case will be reassessed should additional information become available.
Sex: M
Vaccine: COVID19
Symptoms: Allergy test, COVID-19, Drug ineffective
Clinical narrative: covid; covid; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4467523-00 (Company).  A 50-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Oct2021 as dose 1, single (Batch/Lot number: unknown) and on 03Nov2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "allergy to cat dander" (unspecified if ongoing); "allergy to 12 cats" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "covid". The patient underwent the following laboratory tests and procedures: Allergy test: (2023) allergy to cat dander.  Clinical course: Solicited report by a consumer of a 50.000 year old male with events of Pneumocystis pneumonia, shoulder surgery, and bad knee, and non-serious covid, on bad days patient limp, sickness, left arm was numb since covid vaccinated, sinus pressure and pain, coughing, sinus pressure and pain, and cold with Adalimumab Solution for Injection, Single-Dose Pen. On Jun2022, the patient experienced covid. On Oct2022, the patient experienced sickness. On 11Oct2022, the patient experienced Pneumocystis pneumonia. On unknown date(s), the patient experienced cold, sinus pressure and pain, coughing, sinus pressure and pain, left arm was numb since covid vaccinated, on bad days patient limp, bad knee, shoulder surgery. On Feb2023, sickness recovered/resolved. On unknown date, left arm was numb since covid vaccinated recovered/resolved. The patient had numbness for seven months. He got several surgeries for shoulder and his left knee was replaced. He had coughing 38 days straight. He had bad knee, eight knee surgeries, two knee replacement.  The reporter's assessment of the causal relationship of "covid" with the suspect product(s) BNT162b2 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 information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect products to the reported events Drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-PV202200026444 same patient, different dose/event;US-PFIZER INC-202200988922 same patient, different dose/event;
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye
Clinical narrative: dry eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TURMERIC CURCUMIN taken for rheumatoid arthritis (ongoing); TURMERIC [CURCUMA LONGA RHIZOME] taken for rheumatoid arthritis (ongoing). Vaccination history included: BNT162b2 (dose 1, single , Lot number: EN5318), administration date: 10Feb2021, when the patient was 69-year-old, for covid-19 immunisation, reaction(s): "Rheumatoid arthritis involving multiple sites with positive rheumatoid factor (HCC)", "couldn't sleep last night", "going through a depression because her life had got destroyed", "she can't clean her house, she can't do nothing/You can't even do your work, you can't do your dishes, you can't clean your stove", "exploded in her immune system", "Sick"; BNT162b2 (dose 2, single, Lot number: EL9264), administration date: 04Mar2021, when the patient was 69-year-old, for covid-19 immunisation. The following information was reported: DRY EYE (non-serious), outcome "unknown". Additional information: concomitant drug Black pepper from Dec2022 and ongoing.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300028889 same reporter/patient, different dose and event;
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chronic inflammatory demyelinating polyradiculoneuropathy, Pain
Clinical narrative: CIDP an extremely painful and debilitating issue; CIDP an extremely painful and debilitating issue; CIDP an extremely painful and debilitating issue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (medically significant), PAIN (non-serious), ASTHENIA (non-serious), outcome "unknown" and all described as "CIDP an extremely painful and debilitating issue".  Clinical course details: The patient has been struggling with what appears to be CIDP, an extremely painful and debilitating issue. The patient has been told that gammagobulin can treat this disorder but it takes months for someone to get him in for an appointment. The patient was afraid that his time was running out.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant, SARS-CoV-2 test, White blood cell count, White blood cell count decreased
Clinical narrative: Cancer; WBC was down to 4; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "testicular cancer" (unspecified if ongoing), notes: Treated for Cancer in 17Dec2020. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/lot number: EN6203, Time: at 13:00, Anatomical location: Left arm, Route of administration: Intramuscular), administration date: 25Feb2021, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE, Batch/Lot number: EP7534, Time : at 11:30 Anatomical location: Right arm and Route of administration: Intramuscular), administration date: 18Mar2021, for COVID-19 immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Batch/Lot number: FF2590; At time : 14:00, ), administration date: 26Oct2021, for COVID-19 immunisation. The following information was reported: NEOPLASM MALIGNANT (medically significant) with onset 08Dec2022, outcome "not recovered", described as "Cancer"; WHITE BLOOD CELL COUNT DECREASED (medically significant) with onset 08Dec2022, outcome "unknown", described as "WBC was down to 4". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jan2023) Positive; (2023) Positive, notes: COVID symptoms returned 21Jan2023 and tested positive again; White blood cell count: (08Dec2022) 4, notes: WBC was down to 4. Therapeutic measures were taken as a result of neoplasm malignant. Clinical course: Vaccination Facility Type: Doctors Office/Urgent Care. Concomitant Medications: one a day multivitamin, route: daily. WBC was low due to cancer.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300031485 same patient, different vaccine dose/different event;US-PFIZER INC-202300031252 same patient, different product/event;
Sex: F
Vaccine: COVID19
Symptoms: Dental care, Transient ischaemic attack
Clinical narrative: transient ischemic attack; Dental procedure; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DENTAL CARE (medically significant) with onset 2022, outcome "unknown", described as "Dental procedure"; TRANSIENT ISCHAEMIC ATTACK (hospitalization, medically significant) with onset 2022, 3 days after the suspect product(s) administration, outcome "unknown", described as "transient ischemic attack". The patient was hospitalized for transient ischaemic attack (start date: 2022).  Clinical course: female patient after receiving the COVID-19 vaccine (possibly from Pfizer) had a transient ischemic attack 3 days after and was hospitalized some time last year (2022). Reporter noted that she also had a dental procedure around the same time and it was thought that could be an explanation for her symptoms. Reporter doesn't have a lot of information because it happened last year (2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that the suspect drug contributed to the reported events, that most likely were due to underlying medical conditions. The case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Catheterisation cardiac, Myocardial infarction, Myocarditis, Pericarditis
Clinical narrative: Pericarditis; Myocarditis; Heart attack; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A 49-year-old male patient received BNT162b2 (BNT162B2), in May2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset May2022, outcome "unknown", described as "Heart attack"; MYOCARDITIS (medically significant) with onset May2022, outcome "unknown"; PERICARDITIS (medically significant) with onset May2022, outcome "unknown". The events "pericarditis", "myocarditis" and "heart attack" required emergency room visit. The patient underwent the following laboratory tests and procedures: Catheterisation cardiac: Unknown results. Therapeutic measures were taken as a result of pericarditis, myocarditis, myocardial infarction.  Clinical course: In May2022, patient experienced Pericarditis and Myocarditis. After received first BioNTech Covid vaccine and 8-12 hours later developed chest pain. Patient felt like heart attack and went to ER. Patient had heart cath and cardiologist for follow up. Sign and symptoms were resolved at this time. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, a causal association between the reported events and 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 RAs, Ethics Committees, and investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations in the night; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "Heart palpitations in the night".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.