chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
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) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 02Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Gastric reflux" (unspecified if ongoing). There were no concomitant medications. The patient has no known allergies. 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 which included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 (BNT162B2), on 25Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 17Aug2021 as dose 3, (booster), single (Batch/Lot number: unknown), in left arm and on 29Mar2022 as dose 4, (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Colitis ulcerative" (unspecified if ongoing). Concomitant medication(s) included: STELARA, start date: 20May2022; BENICAR HCT, start date: 01Jul2022, stop date: 19Jul2022; ZOVIRAX [ACICLOVIR], start date: 11Jul2022, stop date: 15Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Rebound Covid infection. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid-19 on 18Jul2022; Tested positive for Covid-19 on 18Jul2022; This is a spontaneous report received from a contactable reporter(s) (Other HCP) via COVID-19 Adverse Event Reporting. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6207), on 01Apr2021 as dose 2, single (Lot number: ER8730) and on 05Dec2021 as dose 3 (booster), single (Lot number: 33130BO) at the age of 48 years for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jul2022, and all described as "Tested positive for Covid-19 on 18Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) Positive. Therapeutic measures were not taken as a result of vaccination failure and covid-19. The clinical outcome of the events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162b2 vaccine,  cannot be excluded for the suspected vaccination failure and COVID-19. There is limited information provided in this report.  This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6208), in left arm and on 07Apr2021 as dose 2, single (Lot number: EP7533) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 17Nov2021 as dose 3 (booster), single (Lot number: 003F21A), in left arm and on 09May2022 as dose 4 (booster), single (Lot number: 057M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: Immune thrombocytopenia in 2 healthy young women after the Pfizer-BioNTech BNT16B2b2; This is a literature report.  A female patient received BNT162b2 (BNT162B2), 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: IMMUNE THROMBOCYTOPENIA (medically significant), outcome "unknown", described as "Immune thrombocytopenia in 2 healthy young women after the Pfizer-BioNTech BNT16B2b2".; Sender's Comments: Based on the temporal relationship, the reasonable possibility of an association between Immune thrombocytopenia and suspect product BNT162b2 cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200986371 Same Article/drug/event; Different patient.;
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 58-year-old male patient received BNT162b2 (BNT162B2), on 13Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 12Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. 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 "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jul2022) Positive, notes: tested Positive that morning on a home covid test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course:After 5-day dose of Paxlovid patient felt vibrant and healthy and normal and did about 4 days of heavy yard work because had felt so fit and back to normal. On Sunday 17Jul started sneezing a lot in the morning and becoming very lightheaded. By evening developed a bad headache that lasted until the next morning and tested Positive that morning on a home covid test and managing the headache with ibuprofen and had congestion and runny nose and extremely exhausted as if he cannot get enough sleep and writing this on day 2 of experience of returned symptoms. Anti-viral details product: COVID 19 Treatment (Brand Paxlovid), Treatment start date 04Jul2022 and  treatment stop date :09Jul2022 Indication was treatment of COVID-19.  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 known the information available the Causal relation between the events and suspect drug cannot be excluded completely
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Body temperature, Chills, Deafness, Headache
Clinical narrative: headache; 6 hours after Phizer COVID 19 Booster vaccine I started getting chills; 100 degree fever; sinus pain; hearing loss; loud tinnitus in both ears; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2022 at 11:00 as dose 3 (booster), single (Lot number: FJ4991) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Birt Hoggs Dube Syndrome" (unspecified if ongoing); "Valley Fever" (unspecified if ongoing); "Egg white allergy" (unspecified if ongoing), notes: Allergy: Egg white allergy; "if covid prior vaccination : yes" (unspecified if ongoing), notes: if covid prior vaccination : yes. Concomitant medication(s) included: ARMOUR THYROID. Vaccination history included: BNT162b2 (Dose 2, COVID-19,, lot number=301458A,, administration date=28Sep2021,time=11:00 AM,, vaccine location=Left arm,), administration date: 28Sep2021, when the patient was 72-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, COVID 19,, lot number=FC3184,, administration date=06Sep2021, time=12:00 PM,, vaccine location=Left arm), administration date: 06Sep2021, when the patient was 72-year-old, for COVID-19 immunization. The following information was reported: PYREXIA (disability) with onset 10Apr2022 at 17:00, outcome "recovered" (12Apr2022), described as "100 degree fever"; CHILLS (disability) with onset 10Apr2022 at 17:00, outcome "recovered" (12Apr2022), described as "6 hours after Phizer COVID 19 Booster vaccine I started getting chills"; HEADACHE (disability) with onset 10Apr2022 at 17:00, outcome "recovered" (12Apr2022); DEAFNESS (disability) with onset 10Apr2022 at 17:00, outcome "not recovered", described as "hearing loss"; TINNITUS (disability) with onset 10Apr2022 at 17:00, outcome "not recovered", described as "loud tinnitus in both ears"; SINUS PAIN (disability) with onset 10Apr2022 at 17:00, outcome "recovered" (12Apr2022). The events "headache", "6 hours after phizer covid 19 booster vaccine i started getting chills", "100 degree fever", "sinus pain", "hearing loss" and "loud tinnitus in both ears" required physician office visit. The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: (22Jun2022) Unknown results; Body temperature: (unspecified date) 100 degree, notes: 100 degree fever; SARS-CoV-2 test: (18Jul2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of headache, chills, pyrexia, sinus pain, deafness, tinnitus.  Clinical course: Covid prior vaccination reported as yes. Covid tested post vaccination reported yes. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Sinus pain, Tinnitus
Clinical narrative: headache; 6 hours after Phizer COVID 19 Booster vaccine I started getting chills; 100 degree fever; sinus pain; hearing loss; loud tinnitus in both ears; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2022 at 11:00 as dose 3 (booster), single (Lot number: FJ4991) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Birt Hoggs Dube Syndrome" (unspecified if ongoing); "Valley Fever" (unspecified if ongoing); "Egg white allergy" (unspecified if ongoing), notes: Allergy: Egg white allergy; "if covid prior vaccination : yes" (unspecified if ongoing), notes: if covid prior vaccination : yes. Concomitant medication(s) included: ARMOUR THYROID. Vaccination history included: BNT162b2 (Dose 2, COVID-19,, lot number=301458A,, administration date=28Sep2021,time=11:00 AM,, vaccine location=Left arm,), administration date: 28Sep2021, when the patient was 72-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, COVID 19,, lot number=FC3184,, administration date=06Sep2021, time=12:00 PM,, vaccine location=Left arm), administration date: 06Sep2021, when the patient was 72-year-old, for COVID-19 immunization. The following information was reported: PYREXIA (disability) with onset 10Apr2022 at 17:00, outcome "recovered" (12Apr2022), described as "100 degree fever"; CHILLS (disability) with onset 10Apr2022 at 17:00, outcome "recovered" (12Apr2022), described as "6 hours after Phizer COVID 19 Booster vaccine I started getting chills"; HEADACHE (disability) with onset 10Apr2022 at 17:00, outcome "recovered" (12Apr2022); DEAFNESS (disability) with onset 10Apr2022 at 17:00, outcome "not recovered", described as "hearing loss"; TINNITUS (disability) with onset 10Apr2022 at 17:00, outcome "not recovered", described as "loud tinnitus in both ears"; SINUS PAIN (disability) with onset 10Apr2022 at 17:00, outcome "recovered" (12Apr2022). The events "headache", "6 hours after phizer covid 19 booster vaccine i started getting chills", "100 degree fever", "sinus pain", "hearing loss" and "loud tinnitus in both ears" required physician office visit. The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: (22Jun2022) Unknown results; Body temperature: (unspecified date) 100 degree, notes: 100 degree fever; SARS-CoV-2 test: (18Jul2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of headache, chills, pyrexia, sinus pain, deafness, tinnitus.  Clinical course: Covid prior vaccination reported as yes. Covid tested post vaccination reported yes. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: patient was treated with Paxlovid for COVID-19; patient was treated with Paxlovid for COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient has no known allergies. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "patient was treated with Paxlovid for COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8132), in left arm, on 24Apr2021 as dose 2, single (Lot number: EL00170), in left arm, on 08Dec2021 as dose 3 (booster), single (Lot number: 330308D), in right arm and on 09Jun2022 at 14:30 as dose 4 (booster), single (Lot number: FJ4989) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfa drugs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jul2022) Negative, notes: Tested negative on evening of 16Jul22; (18Jul2022) Positive, notes: tested a strong positive on morning of 18Jul22. Therapeutic measures were taken as a result of vaccination failure, covid-19 including PAXLOVID on 08Jul2022 less than 24 hours after symptoms appeared. Patient took PAXLOVID (Lot number: GC9422) from 08Jul2022 to 12Jul2022.
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: Immune thrombocytopenia in 2 healthy young women after the Pfizer-BioNTech BNT16B2b2; This is a literature report.  A female patient received BNT162b2 (BNT162B2), 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: IMMUNE THROMBOCYTOPENIA (medically significant), outcome "unknown", described as "Immune thrombocytopenia in 2 healthy young women after the Pfizer-BioNTech BNT16B2b2".; Sender's Comments: Based on a temporal association, a causal relationship between the event immune thrombocytopenia and BNT162B2 is considered possible.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200986266 Same Article/drug/event; Different patient.;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Jun2022 as dose 4 (booster), single (Lot number: FM7553), in left arm 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient experienced Covid on an unspecified date. The patient received PAXLOVID as treatment of COVID-19 from 07Jul2022 to 11Jul2022. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events Covid 19 and Drug ineffective and suspect drug BNT162B2 cannot be excluded.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tachyphrenia, Thinking abnormal
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (the patient). A 58-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0196), at the age of 57, in left arm, Jun 2021, single dose, for COVID-19 immunization. Medical history included anxiety (unspecified if ongoing). Concomitant medication included diazepam taken for anxiety. The patient experienced abnormal thinking/avalanche of different thoughts and tachyphrenia/racing thoughts, with outcome of recovered. No therapeutic measures taken as a result of abnormal thinking and tachyphrenia. Additional information: It was reported when he got his first Pfizer vaccine, he had racing thoughts. He could not control his thoughts. He had multiple thoughts. Sender's comments: Linked reports: US-PFIZER INC-202200986923 (same reporter/drug/events/patient, different dose); US-PFIZER INC-202200986924 (same reporter/drug/event, different patient).
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Tachyphrenia, Thinking abnormal
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (the patient). A 58-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0196), at the age of 57, in left arm, Jun 2021, single dose, for COVID-19 immunization. Medical history included anxiety (unspecified if ongoing). Concomitant medication included diazepam taken for anxiety. The patient experienced abnormal thinking/avalanche of different thoughts and tachyphrenia/racing thoughts, with outcome of recovered. No therapeutic measures taken as a result of abnormal thinking and tachyphrenia. Additional information: It was reported when he got his first Pfizer vaccine, he had racing thoughts. He could not control his thoughts. He had multiple thoughts. Sender's comments: Linked reports: US-PFIZER INC-202200986923 (same reporter/drug/events/patient, different dose); US-PFIZER INC-202200986924 (same reporter/drug/event, different patient).
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tachyphrenia, Thinking abnormal
Clinical narrative: avalanche of different thoughts; racing thoughts; On the second one I got, it was worst; 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 57-year-old male patient received BNT162b2 (BNT162B2), in Jun2021 as dose 2, single (Lot number: FA6780) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: DIAZEPAM taken for anxiety. Vaccination history included: Bnt162b2 (Dose 1; Batch/lot number: EW0196), administration date: Jun2021, when the patient was 57 years old, for Covid-19 Immunization, reaction(s): "racing thoughts", "avalanche of different thoughts". The following information was reported: THINKING ABNORMAL (non-serious), outcome "recovered", described as "avalanche of different thoughts"; TACHYPHRENIA (non-serious), outcome "recovered", described as "racing thoughts"; CONDITION AGGRAVATED (non-serious), outcome "recovered", described as "On the second one I got, it was worst". Therapeutic measures were not taken as a result of thinking abnormal, tachyphrenia, condition aggravated.   Additional information: The patient reported "when I got my first Pfizer vaccine, I had this kind of racing thoughts, turning my head I could not control my thoughts. I had like multiple thoughts. On the second one I got; it was worse. I had quite a long time where my thoughts were conflicting and multiple thoughts and just kind of strange, kind of avalanche of thoughts happened, but it went away after a while." He experienced it with both doses but longer with the second dose. He reported this was how his body was, even with Benadryl instead of calming down, it was worked up. He also noticed that because he drank a lot, whenever he would drink now, his brain was different when he drank alcohol, which was not a big deal. He also mentioned that him and his brother had always been similar, similar physically and he got the similar racing thought thing that the patient got but he got no medication at all. He wanted to know if these side effects had been reported. He was scheduled today to get a booster dose.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200986924 Same reporter/drug/event ,different patient;
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Tachyphrenia, Thinking abnormal
Clinical narrative: avalanche of different thoughts; racing thoughts; On the second one I got, it was worst; 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 57-year-old male patient received BNT162b2 (BNT162B2), in Jun2021 as dose 2, single (Lot number: FA6780) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: DIAZEPAM taken for anxiety. Vaccination history included: Bnt162b2 (Dose 1; Batch/lot number: EW0196), administration date: Jun2021, when the patient was 57 years old, for Covid-19 Immunization, reaction(s): "racing thoughts", "avalanche of different thoughts". The following information was reported: THINKING ABNORMAL (non-serious), outcome "recovered", described as "avalanche of different thoughts"; TACHYPHRENIA (non-serious), outcome "recovered", described as "racing thoughts"; CONDITION AGGRAVATED (non-serious), outcome "recovered", described as "On the second one I got, it was worst". Therapeutic measures were not taken as a result of thinking abnormal, tachyphrenia, condition aggravated.   Additional information: The patient reported "when I got my first Pfizer vaccine, I had this kind of racing thoughts, turning my head I could not control my thoughts. I had like multiple thoughts. On the second one I got; it was worse. I had quite a long time where my thoughts were conflicting and multiple thoughts and just kind of strange, kind of avalanche of thoughts happened, but it went away after a while." He experienced it with both doses but longer with the second dose. He reported this was how his body was, even with Benadryl instead of calming down, it was worked up. He also noticed that because he drank a lot, whenever he would drink now, his brain was different when he drank alcohol, which was not a big deal. He also mentioned that him and his brother had always been similar, similar physically and he got the similar racing thought thing that the patient got but he got no medication at all. He wanted to know if these side effects had been reported. He was scheduled today to get a booster dose.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200986924 Same reporter/drug/event ,different patient;
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tachyphrenia, Thinking abnormal
Clinical narrative: avalanche of different thoughts/ I drink now my brain is different; racing thoughts; 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 58-year-old male patient received BNT162b2 (BNT162B2), in Jun2021 as dose 1, single (Lot number: EW0196) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "drink a lot" (ongoing). Concomitant medication(s) included: DIAZEPAM taken for anxiety. The following information was reported: THINKING ABNORMAL (non-serious) with onset Jun2021, outcome "unknown", described as "avalanche of different thoughts/ I drink now my brain is different "; TACHYPHRENIA (non-serious) with onset Jun2021, outcome "unknown", described as "racing thoughts". Therapeutic measures were not taken as a result of thinking abnormal, tachyphrenia.  Additional information: The patient reported he received 2 shots of the Pfizer covid vaccine back in Jun2021 (he was 57-Year-old when he got it). After the first shot he starting experiencing "racing thoughts, avalanche of different thoughts". The patient reported this is how his body is, even with Benadryl instead of calming down, its worked up. Event as reported was kind of racing thoughts, turning his head could not control my thoughts. The patient had like multiple thoughts; thoughts were conflicting and multiple thoughts; kind of avalanche of thoughts happened. Another weird thing is whatever it is with patient thoughts and stuff but it is not a big deal because he drink a lot but he noticed whenever he drink now his brain is different when he drinks alcohol which is not big deal. No Investigations was reported.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200986923 Same reporter/drug/event ,different patient;US-PFIZER INC-202200986438 Same reporter/drug/event ,different patient;
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Tachyphrenia, Thinking abnormal
Clinical narrative: avalanche of different thoughts/ I drink now my brain is different; racing thoughts; 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 58-year-old male patient received BNT162b2 (BNT162B2), in Jun2021 as dose 1, single (Lot number: EW0196) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "drink a lot" (ongoing). Concomitant medication(s) included: DIAZEPAM taken for anxiety. The following information was reported: THINKING ABNORMAL (non-serious) with onset Jun2021, outcome "unknown", described as "avalanche of different thoughts/ I drink now my brain is different "; TACHYPHRENIA (non-serious) with onset Jun2021, outcome "unknown", described as "racing thoughts". Therapeutic measures were not taken as a result of thinking abnormal, tachyphrenia.  Additional information: The patient reported he received 2 shots of the Pfizer covid vaccine back in Jun2021 (he was 57-Year-old when he got it). After the first shot he starting experiencing "racing thoughts, avalanche of different thoughts". The patient reported this is how his body is, even with Benadryl instead of calming down, its worked up. Event as reported was kind of racing thoughts, turning his head could not control my thoughts. The patient had like multiple thoughts; thoughts were conflicting and multiple thoughts; kind of avalanche of thoughts happened. Another weird thing is whatever it is with patient thoughts and stuff but it is not a big deal because he drink a lot but he noticed whenever he drink now his brain is different when he drinks alcohol which is not big deal. No Investigations was reported.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200986923 Same reporter/drug/event ,different patient;US-PFIZER INC-202200986438 Same reporter/drug/event ,different patient;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19/Positive; Treatment of COVID-19/Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 at 12:00 as dose number unknown, single (Lot number: EN6198), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "heart attack" (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 "not recovered" and all described as "Treatment of COVID-19/Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Embolism venous, Ultrasound scan
Clinical narrative: 3 blocked veins/blood clots going from his liver to his heart and from his intestines to his liver; diarrhea every 15min; getting stomach cramps/pain in his stomach; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team. The reporter is the parent (father).  An adult (reported 28-29 years old) male patient received BNT162b2 as dose 2, single (Batch/Lot number: unknown) (reported as over one year ago) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization. The following information was reported: EMBOLISM VENOUS (medically significant), outcome " Not recovered/Not resolved", described as "3 blocked veins/blood clots going from his liver to his heart and from his intestines to his liver"; DIARRHOEA (medically significant), outcome "unknown", described as "diarrhea every 15min"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "getting stomach cramps/pain in his stomach". Months later the patient started getting stomach cramps, diarrhea and kind of messed up. 3-4 months afterwards he started developing pain in his stomach and was having diarrhea every 15 minutes. He was diagnosed with 3 blocked veins, one going from liver to heart, another from intestines to liver, and one other one. The events "diarrhea every 15min" and "getting stomach cramps/pain in his stomach" required physician office visit. The events "3 blocked veins/blood clots going from his liver to his heart and from his intestines to his liver" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Ultrasound scan: diagnosed with 3 blocked veins, notes: one going from liver to heart, another from intestines to liver, and one other one. Therapeutic measures were taken as a result of embolism venous. The patient has been taking blood thinners Xarelto to get rid of the blood clots. Two of the veins were open now but one vein was 100% blocked and had been for 6 months.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Pain in extremity
Clinical narrative: Dose 5, booster; sore arm; 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 female patient received BNT162b2 (BNT162B2), on 11Jul2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 11Jul2022, outcome "unknown", described as "Dose 5, booster"; PAIN IN EXTREMITY (non-serious) with onset Jul2022, outcome "unknown", described as "sore arm".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Exposure during pregnancy, Illness, Internal haemorrhage
Clinical narrative: Is bleeding internally; Heart problems; She is pregnant; Very sick; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the parent.  A female patient (pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERNAL HAEMORRHAGE (medically significant), outcome "unknown", described as "Is bleeding internally"; CARDIAC DISORDER (medically significant), outcome "unknown", described as "Heart problems"; EXPOSURE DURING PREGNANCY (medically significant), outcome "unknown", described as "She is pregnant"; ILLNESS (non-serious), outcome "unknown", described as "Very sick". The patient's parent reported that her daughter (the patient) was very sick. She says her daughter has heart problems. She says her daughter was pregnant, and she told her she shouldn't get it. The patient has heart problems from it, she is pregnant and is bleeding internally and has all kinds of stuff that she didn't have prior until she took the shot. She says her daughter worked at a hospital where it was a mandatory thing, so she got it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200987084 same reporter and product, different patient, similar events.;
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive after receiving 4 doses of the Pfizer Covid vaccines; Tested positive after receiving 4 doses of the Pfizer Covid vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EL1283), on 26Feb2021 as dose 2, single (Lot number: EN6202), on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 16Jun2022 as dose 4 (booster), single (Lot number: 9992VM) at the age of 81 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Tested positive after receiving 4 doses of the Pfizer Covid vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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), on 12Mar2021 at 08:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 26Mar2021 at 08:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 20Aug2021 at 11:45 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "GERD" (unspecified if ongoing); "thrombocytopenia" (unspecified if ongoing); "Known allergies: mushrooms" (unspecified if ongoing); "Known allergies: sulfite" (unspecified if ongoing); "PFO closure" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Vfen, reaction(s): "Known allergies:VFen"; Anastrazole, start date: 26Nov2014. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Low; 77/45; SARS-CoV-2 test: Unknown results.  Clinical information: Despite completing the treatment with Paxlovid, still feel COVID-19 symptoms. Additionally, I have felt super dizzy and right-side numbness. I ended up in the hospital. Since treatment, my blood pressure kept dropping too low (77/45) causing me to pass out. Before diagnosed with Covid and took Paxlovid, I was healthy. During treatment, I felt weak, nauseous, dizzy, and unable to stand up. It reminded me of an awful chemotherapy drug called Adriamicin. I was as sick now as I was then. Frankly, I have not been able to return to work since treatment. How long would these symptoms last and if there was anything else to fix me.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Rhinorrhoea
Clinical narrative: don't have any taste in my mouth/ no taste; nose runs; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in 2021 as dose number unkown, 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: AGEUSIA (non-serious), outcome "unknown", described as "don't have any taste in my mouth/ no taste"; RHINORRHOEA (non-serious), outcome "unknown", described as "nose runs".  Additional information: The patient had the shots over a year ago. The patient had no taste since the shot for over 8 months and his nose runs. The patient's wife thought maybe it was covid. The patient had limburger cheese and can't taste it. The patient was asking how come he don't have any taste in his mouth for over a year and he can barely taste a lemon.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Diarrhoea, Drug ineffective, Oropharyngeal pain
Clinical narrative: tested positive with Covid-19; tested positive with Covid-19; extreme diarrhea; high fever; sore throat; cough; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 77-year-old male patient received BNT162b2 (BNT162B2), 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) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "CKD" (unspecified if ongoing), notes: Optional Information:, (Name withheld) has CKD, diabetes, atrial fibrillation.; "diabetes" (unspecified if ongoing), notes: Optional Information:, (Name withheld) has CKD, diabetes, atrial fibrillation.; "atrial fibrillation" (unspecified if ongoing), notes: Optional Information:, (Name withheld) has CKD, diabetes, atrial fibrillation.; "monoclonal antibody infusion", start date: 17Jun2022, stop date: 17Jun2022, notes: (Name withheld) received a monoclonal antibody infusion on 17Jun. Concomitant medication(s) included: COUMADIN; INSULIN. The following information was reported: COUGH (hospitalization) with onset 17Jul2022, outcome "unknown"; DIARRHOEA (hospitalization) with onset 17Jul2022, outcome "unknown", described as "extreme diarrhea"; PYREXIA (hospitalization) with onset 17Jul2022, outcome "unknown", described as "high fever"; OROPHARYNGEAL PAIN (hospitalization) with onset 17Jul2022, outcome "unknown", described as "sore throat"; DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 17Jul2022, outcome "unknown" and all described as "tested positive with Covid-19". The patient was hospitalized for drug ineffective, covid-19, diarrhoea, pyrexia, oropharyngeal pain, cough (start date: 18Jul2022). The patient underwent the following laboratory tests and procedures: Pyrexia: (17Jul2022) high, notes: (Name withheld) tested positive for Covid-19 on 17Jul. His symptoms included extreme diarrhea, sore throat, cough, and high fever; SARS-CoV-2 test: (17Jul2022) Positive, notes: tested positive for Covid-19 on 17Jul.  Clinical course:(Name withheld) tested positive for Covid-19 on 17Jul. His symptoms included extreme diarrhea, sore throat, cough, and high fever. (Name withheld) also received four Pfizer Covid-19 vaccination shots. (Name withheld) DOB is (DOB withheld). He is 6'1 and approximately 360 pounds. (Name withheld) received a monoclonal antibody infusion on 17Jun, and was hospitalized on 18Jul. (Name withheld) has CKD, diabetes, atrial fibrillation, He is also on Coumadin, insulin shots, and numerous other co-morbid medications. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200026265 same reporter/product/event, different patient;