chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Insomnia, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID with a home test kit; Tested positive for COVID with a home test kit/runny nose for 24 hours; had difficulty sleeping last night; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 as dose 4 (booster), single (Lot number: GJ3274) intramuscular 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 included: "low thyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism.  The following information was reported: INSOMNIA (non-serious) with onset 19Jul2023, outcome "not recovered", described as "had difficulty sleeping last night"; DRUG INEFFECTIVE (medically significant) with onset 20Jul2023, outcome "not recovered", described as "Tested positive for COVID with a home test kit"; COVID-19 (medically significant) with onset 20Jul2023, outcome "not recovered", described as "Tested positive for COVID with a home test kit/runny nose for 24 hours". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Tested positive for COVID with a home test kit; (20Jul2023) Positive, notes: Nasal Swab. Clinical course: Patient complained of runny nose for 24 hours, had difficulty sleeping last night. Tested positive for COVID with a home test kit. No Covid prior vaccination and Covid was tested post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the events drug ineffective, covid-19 and suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202300255944 same patient, different vaccine dose number, different event;
Sex: F
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Endometriosis" (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 Jul2023, outcome "not recovered" and all described as "COVID 19 Treatment". 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. Clinical course: The patient took the Paxlovid treatment from 15Jul2023 to 19Jul2023.  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-202300256132 Same patient, different drug, different event;
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Maternal cousin got shingles after Pfizer Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: HERPES ZOSTER (non-serious), outcome "unknown", described as "Maternal cousin got shingles after Pfizer Covid vaccine".  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.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Illness, Non-Hodgkin's lymphoma
Clinical narrative: Non-Hodgkins Lymphoma; I became very ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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), for Covid-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "I became very ill", "Non-Hodgkins Lymphoma". The following information was reported: NON-HODGKIN'S LYMPHOMA (medically significant), outcome "unknown", described as "Non-Hodgkins Lymphoma"; ILLNESS (non-serious), outcome "unknown", described as "I became very ill". Therapeutic measures were taken as a result of non-hodgkin's lymphoma. Clinical course: Patient's last two booster shots caused lymph nodes to swell, some for over a year. Patient became very ill. Patient was currently receiving chemo treatments.  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-PV202300126869 same reporter/patient /AE different dose number;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Illness, Non-Hodgkin's lymphoma
Clinical narrative: Non-Hodgkins Lymphoma; I became very ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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), for COVID-19 immunisation. The following information was reported: NON-HODGKIN'S LYMPHOMA (medically significant), outcome "unknown", described as "Non-Hodgkin's Lymphoma"; ILLNESS (non-serious), outcome "unknown", described as "I became very ill". Therapeutic measures were taken as a result of non-Hodgkin's lymphoma. Clinical course: Patient's last two booster shots caused lymph nodes to swell, some for over a year. Patient became very ill. Patient was currently receiving chemo treatments.  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-202300256305 same reporter/patient /AE different dose number;
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: contracted COVID-19 2-3 weeks after receiving their third PFZ vaccine; contracted COVID-19 2-3 weeks after receiving their third PFZ vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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 following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "contracted COVID-19 2-3 weeks after receiving their third PFZ vaccine". Clinical course: In the recorded interaction from Jul2022, a Patient contracted COVID-19, 2-3 weeks after receiving their third Pfizer vaccine. Patient's partner said that they got COVID like two or three weeks later. They didn't have it for like two and a half years.  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-PV202300126914 same reporter/drug/event, different patient;
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left leg 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 included: "Breast cancer", start date: 2018 (unspecified if ongoing), notes: Breast cancer survivor 2018. The patient's concomitant medications were not reported. Past drug history included: Known allergies: amaoxicillin, reaction(s): "Penicillin allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (20Jul2023) Positive, notes: tested positive again tonight. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 10Jul2023 to 15Jul2023. Clinical course: Covid rebound- finished Paxlovid 15Jul2023, tested positive again that night, 20Jul2023 after symptoms started 19Jul2023.  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-202300256198 Same patient, different drug/event;
Age: 62.0
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) (Nurse). 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 24Oct2022 at 11:00 as dose 5 (booster), single (Lot number: GH9697) at the age of 62 years, in right 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), 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 included: "Reactive airway" (unspecified if ongoing); "Bronchitis" (unspecified if ongoing); "Over weight" (unspecified if ongoing); "combination pain medications" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (start date: 12Jul2023 and stop date: 16Jul2023.; Sender's Comments: Based on the information in the case report and known drug safety profile, a possible causal relationship between the events Drug ineffective, COVID-19 and suspect product cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300257123 Same patient, different drug, different event;
Age: 73.0
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 74-year-old male patient received BNT162b2 (BNT162B2), on 13Nov2022 as dose 2, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (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". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 35.0
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 36-year-old male patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 35 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: "Asthma" (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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Biopsy kidney, Blood creatinine, Blood immunoglobulin G, Blood immunoglobulin M
Clinical narrative: PRIMARY MEMBRANOUS NEPHROPATHY SHORTLY AFTER COVID-19 VACCINATION; This is a literature report.  A 56-year-old 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: GLOMERULONEPHRITIS MEMBRANOUS (hospitalization, medically significant, life threatening), 2 weeks after the suspect product(s) administration, outcome "recovering", described as "PRIMARY MEMBRANOUS NEPHROPATHY SHORTLY AFTER COVID-19 VACCINATION". Therapeutic measures were taken as a result of glomerulonephritis membranous.  Clinical course: As COVID- 19 vaccinations have increased worldwide, there has been a rise in associations between the COVID- 19 vaccine and various glomerular diseases. This case displays the onset of PLA2R-positive primary MN occurring shortly after an episode of COVID -19 vaccination. A 56 year old female was admitted with hypertensive urgency, nephrotic syndrome and anasarca. She had developed generalized edema two weeks after receiving the Pfizer-BioNTech COVID-19 vaccine series. Patient reported no prior history of COVID-19 Infection. Labs showed elevated proteinuria (urine protein creatinine ratio 19g/g), serum hypoalbuminemia (1.7 gm/dL) stable serum Cr of 1.3 -1.5, normal complements and unremarkable SPEP. Serum PLA2R Antibody was positive. Renal biopsy findings: By LM, diffuse and global capillary wall thickening in most of the glomeruli. By IF, diffuse 3+ positivity for IgG (3+) and light chains, along with variable moderate to weak positivity for C3 (2+), C1q (1-2+) and IgM (trace). By EM, rows of subepithelial electron dense deposits and near-diffuse effacement of podocyte foot processes in sampled glomeruli, Tubuloreticular inclusions were absent. Findings are consistent with PLA2R-positive Primary Membranous Nephropathy. Patient was treated with tacrolimus with good clinical remission This case suggests possible association between the Covid-19 vaccine and loss of self-tolerance to the PLA2-R antigen.; Sender's Comments: Based on provided information and temporal association reported event causal relationship to the suspect drug methylprednisolone cannot be excluded. Case to be re-assessed upon receipt of new information. 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: F
Vaccine: COVID19
Symptoms: Complement factor C1, Complement factor C3, Electrophoresis protein, Glomerulonephritis membranous, Hypoalbuminaemia
Clinical narrative: PRIMARY MEMBRANOUS NEPHROPATHY SHORTLY AFTER COVID-19 VACCINATION; This is a literature report.  A 56-year-old 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: GLOMERULONEPHRITIS MEMBRANOUS (hospitalization, medically significant, life threatening), 2 weeks after the suspect product(s) administration, outcome "recovering", described as "PRIMARY MEMBRANOUS NEPHROPATHY SHORTLY AFTER COVID-19 VACCINATION". Therapeutic measures were taken as a result of glomerulonephritis membranous.  Clinical course: As COVID- 19 vaccinations have increased worldwide, there has been a rise in associations between the COVID- 19 vaccine and various glomerular diseases. This case displays the onset of PLA2R-positive primary MN occurring shortly after an episode of COVID -19 vaccination. A 56 year old female was admitted with hypertensive urgency, nephrotic syndrome and anasarca. She had developed generalized edema two weeks after receiving the Pfizer-BioNTech COVID-19 vaccine series. Patient reported no prior history of COVID-19 Infection. Labs showed elevated proteinuria (urine protein creatinine ratio 19g/g), serum hypoalbuminemia (1.7 gm/dL) stable serum Cr of 1.3 -1.5, normal complements and unremarkable SPEP. Serum PLA2R Antibody was positive. Renal biopsy findings: By LM, diffuse and global capillary wall thickening in most of the glomeruli. By IF, diffuse 3+ positivity for IgG (3+) and light chains, along with variable moderate to weak positivity for C3 (2+), C1q (1-2+) and IgM (trace). By EM, rows of subepithelial electron dense deposits and near-diffuse effacement of podocyte foot processes in sampled glomeruli, Tubuloreticular inclusions were absent. Findings are consistent with PLA2R-positive Primary Membranous Nephropathy. Patient was treated with tacrolimus with good clinical remission This case suggests possible association between the Covid-19 vaccine and loss of self-tolerance to the PLA2-R antigen.; Sender's Comments: Based on provided information and temporal association reported event causal relationship to the suspect drug methylprednisolone cannot be excluded. Case to be re-assessed upon receipt of new information. 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: F
Vaccine: COVID19
Symptoms: Investigation, Urine protein/creatinine ratio
Clinical narrative: PRIMARY MEMBRANOUS NEPHROPATHY SHORTLY AFTER COVID-19 VACCINATION; This is a literature report.  A 56-year-old 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: GLOMERULONEPHRITIS MEMBRANOUS (hospitalization, medically significant, life threatening), 2 weeks after the suspect product(s) administration, outcome "recovering", described as "PRIMARY MEMBRANOUS NEPHROPATHY SHORTLY AFTER COVID-19 VACCINATION". Therapeutic measures were taken as a result of glomerulonephritis membranous.  Clinical course: As COVID- 19 vaccinations have increased worldwide, there has been a rise in associations between the COVID- 19 vaccine and various glomerular diseases. This case displays the onset of PLA2R-positive primary MN occurring shortly after an episode of COVID -19 vaccination. A 56 year old female was admitted with hypertensive urgency, nephrotic syndrome and anasarca. She had developed generalized edema two weeks after receiving the Pfizer-BioNTech COVID-19 vaccine series. Patient reported no prior history of COVID-19 Infection. Labs showed elevated proteinuria (urine protein creatinine ratio 19g/g), serum hypoalbuminemia (1.7 gm/dL) stable serum Cr of 1.3 -1.5, normal complements and unremarkable SPEP. Serum PLA2R Antibody was positive. Renal biopsy findings: By LM, diffuse and global capillary wall thickening in most of the glomeruli. By IF, diffuse 3+ positivity for IgG (3+) and light chains, along with variable moderate to weak positivity for C3 (2+), C1q (1-2+) and IgM (trace). By EM, rows of subepithelial electron dense deposits and near-diffuse effacement of podocyte foot processes in sampled glomeruli, Tubuloreticular inclusions were absent. Findings are consistent with PLA2R-positive Primary Membranous Nephropathy. Patient was treated with tacrolimus with good clinical remission This case suggests possible association between the Covid-19 vaccine and loss of self-tolerance to the PLA2-R antigen.; Sender's Comments: Based on provided information and temporal association reported event causal relationship to the suspect drug methylprednisolone cannot be excluded. Case to be re-assessed upon receipt of new information. 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: Asthma, Exercise tolerance decreased
Clinical narrative: asthma worsened; could not exercise as much anyone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ASTHMA (non-serious), outcome "unknown", described as "asthma worsened"; EXERCISE TOLERANCE DECREASED (non-serious), outcome "unknown", described as "could not exercise as much anyone". Additional information: Patient's asthma worsened after their Pfizer Covid vaccine, could not exercise as much anyone.  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.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Complement analysis, Complement factor C1, Complement factor C4, Erythema, Eye pruritus
Clinical narrative: blurred vision; calf redness pain; calf redness; rash torso arms legs; Itchiness eyes; This was a booster after 2 earlier moderna shots; 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 patient received BNT162b2 (BNT162B2), on 30Nov2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (DOSE 1, SINGLE), for COVID-19 immunisation; Moderna (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (disability) with onset 30Nov2021 at 14:00, outcome "recovered", described as "This was a booster after 2 earlier moderna shots"; EYE PRURITUS (disability) with onset 02Dec2021, outcome "recovered", described as "Itchiness eyes"; RASH (disability) with onset 02Dec2021, outcome "recovered", described as "rash torso arms legs"; ERYTHEMA (disability) with onset 06Dec2021, outcome "recovered", described as "calf redness"; PAIN IN EXTREMITY (disability) with onset 06Dec2021, outcome "recovered", described as "calf redness pain"; VISION BLURRED (disability), outcome "recovered", described as "blurred vision". The events "rash torso arms legs", "itchiness eyes", "blurred vision", "calf redness pain" and "calf redness" required physician office visit. The patient underwent the following laboratory tests and procedures: Complement analysis: (06Dec2021) Normal, notes: Normal; Complement factor C1: (06Dec2021) Normal, notes: Normal; Complement factor C4: (06Dec2021) Normal, notes: Normal; Full blood count: (10Dec2021) Normal, notes: Normal; Metabolic function test: (10Dec2021) Normal, notes: Normal; Multisystem inflammatory syndrome in children: (06Dec2021) Normal, notes: Normal. Therapeutic measures were taken as a result of rash, eye pruritus, vision blurred. Therapeutic measures were not taken as a result of pain in extremity, erythema which included Antihistamine for 2-3 weeks. Clinical course: Vaccination Facility Type was Hospital.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Full blood count, Interchange of vaccine products, Metabolic function test, Multisystem inflammatory syndrome in children, Pain in extremity
Clinical narrative: blurred vision; calf redness pain; calf redness; rash torso arms legs; Itchiness eyes; This was a booster after 2 earlier moderna shots; 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 patient received BNT162b2 (BNT162B2), on 30Nov2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (DOSE 1, SINGLE), for COVID-19 immunisation; Moderna (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (disability) with onset 30Nov2021 at 14:00, outcome "recovered", described as "This was a booster after 2 earlier moderna shots"; EYE PRURITUS (disability) with onset 02Dec2021, outcome "recovered", described as "Itchiness eyes"; RASH (disability) with onset 02Dec2021, outcome "recovered", described as "rash torso arms legs"; ERYTHEMA (disability) with onset 06Dec2021, outcome "recovered", described as "calf redness"; PAIN IN EXTREMITY (disability) with onset 06Dec2021, outcome "recovered", described as "calf redness pain"; VISION BLURRED (disability), outcome "recovered", described as "blurred vision". The events "rash torso arms legs", "itchiness eyes", "blurred vision", "calf redness pain" and "calf redness" required physician office visit. The patient underwent the following laboratory tests and procedures: Complement analysis: (06Dec2021) Normal, notes: Normal; Complement factor C1: (06Dec2021) Normal, notes: Normal; Complement factor C4: (06Dec2021) Normal, notes: Normal; Full blood count: (10Dec2021) Normal, notes: Normal; Metabolic function test: (10Dec2021) Normal, notes: Normal; Multisystem inflammatory syndrome in children: (06Dec2021) Normal, notes: Normal. Therapeutic measures were taken as a result of rash, eye pruritus, vision blurred. Therapeutic measures were not taken as a result of pain in extremity, erythema which included Antihistamine for 2-3 weeks. Clinical course: Vaccination Facility Type was Hospital.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Rash, Vision blurred
Clinical narrative: blurred vision; calf redness pain; calf redness; rash torso arms legs; Itchiness eyes; This was a booster after 2 earlier moderna shots; 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 patient received BNT162b2 (BNT162B2), on 30Nov2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (DOSE 1, SINGLE), for COVID-19 immunisation; Moderna (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (disability) with onset 30Nov2021 at 14:00, outcome "recovered", described as "This was a booster after 2 earlier moderna shots"; EYE PRURITUS (disability) with onset 02Dec2021, outcome "recovered", described as "Itchiness eyes"; RASH (disability) with onset 02Dec2021, outcome "recovered", described as "rash torso arms legs"; ERYTHEMA (disability) with onset 06Dec2021, outcome "recovered", described as "calf redness"; PAIN IN EXTREMITY (disability) with onset 06Dec2021, outcome "recovered", described as "calf redness pain"; VISION BLURRED (disability), outcome "recovered", described as "blurred vision". The events "rash torso arms legs", "itchiness eyes", "blurred vision", "calf redness pain" and "calf redness" required physician office visit. The patient underwent the following laboratory tests and procedures: Complement analysis: (06Dec2021) Normal, notes: Normal; Complement factor C1: (06Dec2021) Normal, notes: Normal; Complement factor C4: (06Dec2021) Normal, notes: Normal; Full blood count: (10Dec2021) Normal, notes: Normal; Metabolic function test: (10Dec2021) Normal, notes: Normal; Multisystem inflammatory syndrome in children: (06Dec2021) Normal, notes: Normal. Therapeutic measures were taken as a result of rash, eye pruritus, vision blurred. Therapeutic measures were not taken as a result of pain in extremity, erythema which included Antihistamine for 2-3 weeks. Clinical course: Vaccination Facility Type was Hospital.  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: Drug ineffective, Suspected COVID-19
Clinical narrative: contracted COVID-19 2-3 weeks after receiving their third PFZ vaccine; contracted COVID-19 2-3 weeks after receiving their third PFZ vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient in her 30's received BNT162b2 (BNT162B2), 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 following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "contracted COVID-19 2-3 weeks after receiving their third PFZ vaccine". Clinical course: In this recorded HCP-PT (Health care professional- Patient) interaction from Jul2022, a Patient reported that her partner and she contracted COVID-19, 2-3 weeks after receiving their third Pfizer vaccine. Patient said that they got COVID like two or three weeks later. They didn't have it for like two and a half years.  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-202300256318 same reporter/drug/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: it made her "sick"; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: ILLNESS (non-serious), outcome "unknown", described as "it made her "sick"".  Additional information: After taking a Pfizer COVID vaccine, she had "reactions" and that it made her "sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid positive Jun2021; Covid positive Jun2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EL32646), in arm and on 05Feb2021 as dose 2, single (Lot number: FL9264) at the age of 58 years, in arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Asthma", start date: 01Jan1987 (ongoing); "T2 Diabetes", start date: 01Jan2017 (ongoing); "Bipolar Disorder", start date: 01Jan2019 (ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2021, outcome "unknown" and all described as "Covid positive Jun2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2021) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300026646 Same reporter/patient,different drug/dose/AE;US-PFIZER INC-202300026822 Same reporter/patient,different drug/dose/AE;US-PFIZER INC-PV202300127465 Same reporter/drug/patient, different dose.;
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Hives; Allergy; This is a spontaneous report received from a contactable reporter(s) (Physician), Program ID: (RA).  A 49-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Drug Allergy", start date: 31Mar2023 (unspecified if ongoing); "Allergies: Tomato", start date: 31Mar2023 (unspecified if ongoing); "Itching", start date: 31Mar2023 (unspecified if ongoing); "Rash", start date: 31Mar2023 (unspecified if ongoing); "Swelling", start date: 31Mar2023 (unspecified if ongoing). Concomitant medication(s) included: IBRANCE oral, start date: 30Apr2023. The following information was reported: HYPERSENSITIVITY (medically significant) with onset 17Jul2023, outcome "unknown", described as "Allergy"; URTICARIA (medically significant) with onset 17Jul2023, outcome "unknown", described as "Hives".  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: Based on the information in the case report, a possible causal relationship between the events urticaria, hypersensitivity and suspect drug BNT162B2 cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: had an illness/ illness after having the covid 19 vaccine; 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: ILLNESS (non-serious), outcome "unknown", described as "had an illness/ illness after having the covid 19 vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, Medication error
Clinical narrative: expired tenivac was given to a patient with no reported adverse event; Initial information received on 19-Jul-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient for whom expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] was given to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Jul-2023, the patient received expired dose of 0.5 ml of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult suspension for injection (lot: U6922AA, Expiry date: 22-Jan-2023) via unknown route in unknown administration site for Prophylactic Vaccination (Immunisation) with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Syncope
Clinical narrative: Patient experienced transient (< a few seconds) syncope after standing up after receiving both vaccines.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: On about 6/6/2022, I developed a terrible headache, which Tylenol and ibuprofen couldn't help. I was also very fatigued and nauseous. I didn't vomit, but I was really nauseous. The only thing that helped the headache was occasionally pressing my head very hard into a pillow. I didn't have any respiratory symptoms, though. I took a home antigen test on 6/6/2022, and the result was negative. When I took another test on 6/7/2022, the result was positive.  On 6/8/2022, I began to get a fever in the evening. It was on that day that I also was prescribed Paxlovid, which I began taking the same day. The Paxlovid left such a horrible taste in my mouth that I woke up in the middle of the night. I continued taking it, though, and I began feeling better the next day. The headache had most especially improved, and the fever was gone. By 6/10/2022, I was pretty much over the symptoms, though I continued to have the foul taste that was caused by the medication.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: On about 6/6/2022, I developed a terrible headache, which Tylenol and ibuprofen couldn't help. I was also very fatigued and nauseous. I didn't vomit, but I was really nauseous. The only thing that helped the headache was occasionally pressing my head very hard into a pillow. I didn't have any respiratory symptoms, though. I took a home antigen test on 6/6/2022, and the result was negative. When I took another test on 6/7/2022, the result was positive.  On 6/8/2022, I began to get a fever in the evening. It was on that day that I also was prescribed Paxlovid, which I began taking the same day. The Paxlovid left such a horrible taste in my mouth that I woke up in the middle of the night. I continued taking it, though, and I began feeling better the next day. The headache had most especially improved, and the fever was gone. By 6/10/2022, I was pretty much over the symptoms, though I continued to have the foul taste that was caused by the medication.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Blindness, Confusional state, Dizziness, Fatigue, Gait inability
Clinical narrative: Pt was given vaccine and immediately allowed to leave. Came out to waiting area, said she felt faint. Sat down, had ringing in her ears that lasted 10 minutes, confusion, had vision loss that lasted 3 minutes, passed out, vomited. Extremely fatigued, couldn't walk to car, had to go by wheelchair. 2 hours later still has extreme fatigue.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Tinnitus, Vomiting, Wheelchair user
Clinical narrative: Pt was given vaccine and immediately allowed to leave. Came out to waiting area, said she felt faint. Sat down, had ringing in her ears that lasted 10 minutes, confusion, had vision loss that lasted 3 minutes, passed out, vomited. Extremely fatigued, couldn't walk to car, had to go by wheelchair. 2 hours later still has extreme fatigue.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: pt was given Tdap vs. TD per pt preference. Pt dose not have any allergies to this vaccine. Miscommunication with pt for clarification and was attempting to accommodate for pt appointment time in lab. Pt has had tdap vaccine in the past with no adverse reactions. No adverse reactions at end of pt visit.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: There may have been a break in the cold chain storage of the vaccine upon arrival.  We reached out to pfizer and got an incident number.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: There may have been a break in the cold chain storage of the vaccine upon arrival.  We reached out to pfizer and got an incident number.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dysstasia, Gait inability, Hyperhidrosis
Clinical narrative: Severe "Flu Like"  Chills, Sweats, Bilateral Thigh Myalgia, Temporary loss of bladder control during the night x3, Temporary loss of the ability to stand/walk for 36 hours, Orthostatic Vertigo, and generalized weakness. All s/s resolved within 72 hours.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia, Urinary incontinence, Vertigo
Clinical narrative: Severe "Flu Like"  Chills, Sweats, Bilateral Thigh Myalgia, Temporary loss of bladder control during the night x3, Temporary loss of the ability to stand/walk for 36 hours, Orthostatic Vertigo, and generalized weakness. All s/s resolved within 72 hours.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: There may have been a break in the cold chain storage of the vaccine upon arrival.  We explained what we knew of the events surrounding the shipment to Pfizer and received the following incident number
Age: 74.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Blood test, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Patient received both Shingrix (muscle of left arm) and Prevnar 20 (muscle of right arm) immunizations on 7/10/23. On 7/24/23, the patient's daughter called to inform us that he was fine for about 1.5 days (~36 hours) after the immunization without any symptoms. She mentioned that he started to develop fever, nausea, vomiting, and body aches on 7/11/23. He is still experiencing fever to this day and his fever would not break. She mentions that he has been to 4 different hospitals and they could not definitively determine what could be wrong. She stated that the first 3 hospitals did not have any answers and thought the fever would eventually pass, however it still has not. She states that the current hospital that patient is at is the only one who is doing extensive blood work and they are determining if it's sepsis.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythematous patch, painful and swollen, at injection site
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Conjunctivitis, Cough, Ear congestion, Migraine, Nasopharyngitis
Clinical narrative: Minor cold like symptoms that progressed into worse cold like symptoms with pink eye & migraines.  Cold like symptoms: cough, sinus congestion & drip, sore throat & congested ears Still have symptoms currently. Symptoms kind of get worse & better but never fully go away.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Oropharyngeal pain, Paranasal sinus hypersecretion, Sinus congestion, Streptococcus test
Clinical narrative: Minor cold like symptoms that progressed into worse cold like symptoms with pink eye & migraines.  Cold like symptoms: cough, sinus congestion & drip, sore throat & congested ears Still have symptoms currently. Symptoms kind of get worse & better but never fully go away.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Vaccination site pain, Vaccination site rash
Clinical narrative: Patient describes a very large rash developing following vaccine and encompassing the entirety of his back, parts of his chest and the area around the vaccine site, as well as some of the typical soreness associated with an IM vaccination. Patient not extremely distressed or in pain due to reaction, however did wish to report it.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: patient stated has redness and swelling in left arm accompanied by a fever and back ache on 7/23, stated that fever had resolved and back ache was better on 7/24 than on 7/23, redness in arm was slightly better.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Blood test, Dizziness, Dysarthria, Heart rate abnormal
Clinical narrative: My daughter was having a normal day and no history of fainting. She began slurring words, feeling sick, talking slow and vomiting. She became very pale and collapsing. We were in a store and this came on in an instant. The store staff called EMS and she was taken by ambulance to the ER. She fainted again during blood draw. She was given IV fluids and spent many hours in the hospital. She went back to the hospital again the next day for severe dizziness, weakness and was given more fluids. She was then sent to cardiology where she was diagnosed with POTS.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Laboratory test, Malaise, Pallor, Postural orthostatic tachycardia syndrome, Pulse abnormal
Clinical narrative: My daughter was having a normal day and no history of fainting. She began slurring words, feeling sick, talking slow and vomiting. She became very pale and collapsing. We were in a store and this came on in an instant. The store staff called EMS and she was taken by ambulance to the ER. She fainted again during blood draw. She was given IV fluids and spent many hours in the hospital. She went back to the hospital again the next day for severe dizziness, weakness and was given more fluids. She was then sent to cardiology where she was diagnosed with POTS.