chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Capillary disorder
Clinical narrative: it broke all the capillaries in my body; 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 61-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; hydroxychloroquine (HYDROXYCHLOROQUINE). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CAPILLARY DISORDER (non-serious), outcome "unknown", described as "it broke all the capillaries in my body". The action taken for hydroxychloroquine was unknown.  Additional information: Reporter stated Twice I've gotten the vaccine. The first one I was on Methotrexate, and it didn't mix with that, it inflamed my lungs and I was on oxygen for a year. The second one I was on hydroxychloroquine, and it broke all the capillaries in my body. So, I had to go off both. I just want to make sure that if I get another vaccination that it's not going to do something horrendous.  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: Guttate psoriasis
Clinical narrative: Guttate psoriasis; This is a literature report.  A 58-year-old male patient received BNT162b2 (COMIRNATY), as DOSE 2, SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; manufacturer unknown), for COVID-19 immunization. The following information was reported: GUTTATE PSORIASIS (medically significant), 14 days after the suspect product(s) administration, outcome "recovered."  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 known drug safety profile, there is reasonable possibility of causal association between the event GUTTATE PSORIASIS and BNT162B2.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Gait disturbance, Investigation
Clinical narrative: Can barely walk/Use a walker; Balance is off; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Can barely walk/Use a walker"; BALANCE DISORDER (non-serious), outcome "unknown", described as "Balance is off". The events "can barely walk/use a walker" and "balance is off" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of gait disturbance, balance disorder. Additional information: Caller is calling about "Super COVID-19 vaccine". She had the vaccine and can barely walk and a lot of people she knows had the same thing. Her balance is off and she has to use a walker. There is one lady at church and were the only 2 that got vaccinated and both have some problem. She is really pissed off. She has been to Physical Therapy and everything and done a lot of testing. She knows the vaccine caused this. She has seen her primary care doctor and neurologist. She states hang on she has to take this call.  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): PFIZER INC-202300051110 same product and event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Gait disturbance
Clinical narrative: can barely walk; balance is off; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "can barely walk"; BALANCE DISORDER (non-serious), outcome "unknown", described as "balance is off".  Additional information: Reporter was calling about "Super COVID-19 vaccine".  Reporter had the vaccine and can barely walk and a lot of people she knows had the same thing. Her balance was off and she has to use a walker. There was one lady at church and they were the only 2 that got vaccinated and both have some problem. She was really pissed off. Reporter has been to Physical Therapy and everything and done a lot of testing. She knows the vaccine caused this. She has seen her primary care doctor and neurologist. She states hang on she has to take this call.  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): PFIZER INC-202300051026 same product and event, different patient;
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Pfizer/ Dose #4: Pfizer/ Dose #5: UNKNOWN; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 08Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 01Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "osteopenia" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "rosacea" (unspecified if ongoing); "IBS-D" (unspecified if ongoing), notes: IBS-D; "IBS-D" (unspecified if ongoing), notes: IBS-D. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Pfizer/ Dose #4: Pfizer/ Dose #5: UNKNOWN"; 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: SARS-CoV-2 test: (unspecified date) Positive, notes: just tested positive for covid again 8 days after finishing my Paxlovid dose; (31Jan2023) Positive, notes: just tested positive for covid again 8 days after finishing my Paxlovid dose. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not received any Other medication in 2weeks. I just tested positive for covid again 8 days after finishing my Paxlovid dose. Patient had no Known allergies. Paxlovid Treatment for COVID 19 from 19Jan2023 to 23Jan2023.  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 current available limited information in the case provided, the causal association between the events drug ineffective, COVID-19, interchange of vaccine products and the use of suspect product cannot be fully excluded.
Age: 68.0
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 a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 as dose 3 (booster), single (Lot number: GH9702) at the age of 68 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 had no known allergies. The patient's relevant medical history included: "type 2 diabetes" (unspecified if ongoing); "hypertension" (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.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events drug ineffective, COVID-19 and the use of suspect product cannot be fully excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Caller has had 3 shots total (2 primary and 1 booster) of Pfizer; Caller has had 3 shots total (2 primary and 1 booster) of Pfizer; 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), 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), COVID-19 (medically significant), outcome "unknown" and all described as "Caller has had 3 shots total (2 primary and 1 booster) of Pfizer". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient started taking Paxlovid two days ago and she sick. Really sick. Caller has had 3 shots total (2 primary and 1 booster) of Pfizer and was asking how soon can she get another booster. Last booster was received over a year ago.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: ST started 28Jan2023 after daughter's school had an outbreak; ST started 28Jan2023 after daughter's school had an outbreak; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 48-year-old female patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EL3247), on 24Mar2021 as dose 2, single (Lot number: EL3247) and on 17Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 28Jan2023, outcome "unknown", COVID-19 (medically significant) with onset 28Jan2023, outcome "unknown" and all described as "ST started 28Jan2023 after daughter's school had an outbreak". The event "st started 28jan2023 after daughter's school had an outbreak" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jan2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: ST started 28Jan2023 after daughter's school had an outbreak. Unknown if COVID prior vaccination. Tested for COVID post vaccination. COVID test post vaccination- Home AG: Nasal Swab  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events VACCINATION FAILURE and COVID-19 and BNT162B2.
Sex: F
Vaccine: COVID19, 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 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2022 as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes insipitus" (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 "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative, notes: Tested positive for COVID after testing negative; (2023) Positive, notes: Tested positive for COVID after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid for COVID 19 from 23Jan2023 to 27Jan2023.  Clinical information : Known allergies were reported as No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
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) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10May2022 as dose 2, single (Batch/Lot number: unknown) at the age of 37 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: "Asthma" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: Tested positive for COVID again after 4 days of negative tests; (2023) Negative, notes: 4 days of negative tests; (2023) Negative, notes: 4 days of negative tests; (2023) Negative, notes: 4 days of negative tests; (2023) Negative, notes: 4 days of negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 24Jan2023 to 28Jan2023, lot number GF6389, indication 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 information currently available,The casual association between the reported events and suspected drug cannot be completely excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of 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 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), 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 was not reported. Concomitant medication(s) included: BUPROPION, start date: 01Nov2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 20Jan2023 to 25Jan2023.  Clinical information : No Known allergies were reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had covid; had covid; This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer or other non HCP), Program ID. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "had covid". clinical course: Medication: Pfizer covid-19 vaccine. Patient states she had covid in dec.  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 available information and temporal association, the causal relationship between the reported events Drug ineffective and COVID-19 cannot be excluded for the suspect product BNT162b2.
Sex: U
Vaccine: COVID19
Symptoms: Monoplegia
Clinical narrative: lost use of my right arm which is my predominant arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "After my first covid vaccine dose, I slept". The following information was reported: MONOPLEGIA (medically significant), outcome "not recovered", described as "lost use of my right arm which is my predominant arm".  Clinical information: After the first Covid vaccine dose, the patient slept. After the second Covid vaccine dose, the patient lost use of right arm which was the predominant arm and the patient still did not have close to total range of motion. There was no way the patient would receive a booster. This had cost the patient much money.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Sep2022 as dose 1, single (Batch/Lot number: unknown) at the age of 38 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Plaque psoriasis" (unspecified if ongoing); "asthma" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing). The patient did not have any known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 23Jan2023 to 28Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: M
Vaccine: 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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 at 14:00 as dose 1, single (Lot number: EP6955) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bladder Cancer" (unspecified if ongoing); "Anterior left hip replacement" (unspecified if ongoing), notes: Anterior left hip replacement. 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 "Treatment of COVID-19". 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 with Paxlovid tablets from 01Feb2023.  Clinical information: No known allergies were reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; Dose 1, dose 2: Moderna, Dose 3: Pfizer: Dose 4: Moderna, dose 5: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: GH9695) at the age of 40 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Mar2021 as dose 1, single (Lot number: 036A21A), in left arm, on 05Apr2021 as dose 2, single (Lot number: 026B21A), in left arm and on 04Apr2022 as dose 4 (booster), single (Lot number: 027L21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Eggs" (unspecified if ongoing), notes: known allergies: Eggs; "Sunflowers" (unspecified if ongoing), notes: known allergies: Sunflowers. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Oct2021, outcome "unknown", described as "Dose 1, dose 2: Moderna, Dose 3: Pfizer: Dose 4: Moderna, dose 5: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (29Jan2023) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (29Jan2023) Negative; (31Jan2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid from 23Jan2023 to 28Jan2023, Lot number: GF7317 used for treatment of COVID-19. Covid Reinfection, Confirmed positive via test on 02Feb2023. Initially took Paxlovid on 23Jan2023. Tested negative on 29Jan2023. Tested negative again on 31Jan2023.
Age: 79.0
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) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 79 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: "arthritis" (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.  Clinical course: Patient was received Paxlovid as treatment. Treatment start date: 22Jan2023, Treatment stop date: 27Jan2023.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Disease recurrence; COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: ER8732), in left arm and on 17Apr2021 as dose 2, single (Lot number: EW0162) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "endometriosis" (unspecified if ongoing); "mild psoriasis" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Flagyl, reaction(s): "known allergies: Flagyl". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "COVID-19"; DISEASE RECURRENCE (medically significant) with onset Dec2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: COVID test type post vaccination: Nasal Swab; (Nov2021) Positive, notes: COVID test type post vaccination: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300054550 same patient, different events after different doses of the vaccine;
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Condition aggravated, Fatigue, Headache, Neck pain
Clinical narrative: Disease recurrence; COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: ER8732), in left arm and on 17Apr2021 as dose 2, single (Lot number: EW0162) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "endometriosis" (unspecified if ongoing); "mild psoriasis" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Flagyl, reaction(s): "known allergies: Flagyl". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "COVID-19"; DISEASE RECURRENCE (medically significant) with onset Dec2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: COVID test type post vaccination: Nasal Swab; (Nov2021) Positive, notes: COVID test type post vaccination: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300054550 same patient, different events after different doses of the vaccine;
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Psoriasis, Psoriatic arthropathy, Tinea pedis
Clinical narrative: Disease recurrence; COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: ER8732), in left arm and on 17Apr2021 as dose 2, single (Lot number: EW0162) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "endometriosis" (unspecified if ongoing); "mild psoriasis" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Flagyl, reaction(s): "known allergies: Flagyl". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "COVID-19"; DISEASE RECURRENCE (medically significant) with onset Dec2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: COVID test type post vaccination: Nasal Swab; (Nov2021) Positive, notes: COVID test type post vaccination: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300054550 same patient, different events after different doses of the vaccine;
Age: 58.0
Sex: F
Vaccine: COVID19, 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 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 02Nov2022 at 13:00 as dose 4 (booster), single (Lot number: GJ5342) at the age of 58 years, 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 included: "Known allergies: perfume" (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 Jan2023, 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: the patient received Paxlovid from 23Jan2023 to 27Jan2023 for treatment of COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. 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". 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, included Paxlovid from 29Dec2022 to 03Jan2023.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 07Jun2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 75 years 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: "Other medical history: HBP" (unspecified if ongoing); "Other medical history: Interstitial lung dis" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). No known allergies. 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: Paxlovid from 24Jan2023 to 29Jan2023.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: she chose Pfizer for all her boosters/came down with COVID and are taking Paxlovid now; she chose Pfizer for all her boosters/came down with Covid and are taking Paxlovid now; 3rd dose:Pfizer booster Date: 24Oct2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 64-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 64 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Oct2021 as dose 3 (booster), single (Lot number: FE3590) and on 23May2022 as dose 4 (booster), single (Lot number: FM9992) for covid-19 immunisation; coviD-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA), on 22Dec2020 as dose 1, single (Lot number: AO3324) and as dose 2, single (Lot number: AO3468) for covid-19 immunisation. The patient had no relevant medical history (Other Conditions: No). There were no concomitant medications (Other Products: No). The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Oct2021, outcome "unknown", described as "3rd dose:Pfizer booster Date: 24Oct2021"; DRUG INEFFECTIVE (medically significant) with onset 28Jan2023, outcome "unknown", described as "she chose Pfizer for all her boosters/came down with COVID and are taking Paxlovid now"; COVID-19 (medically significant) with onset 28Jan2023, outcome "unknown", described as "she chose Pfizer for all her boosters/came down with Covid and are taking Paxlovid now". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient weight: Averages 122 pounds, but now had lost weight. Caller refered she and her husband were positive for COVID-19 and were prescribed Paxlovid. They are both fully vaccinated. First time with COVID, patient was shocked. Tested positive on Monday, got really sick Saturday, super sick, came on super fast. Tested negative Sunday, body aches, major explosive headache, teeth hurt, complete body aches, which all came on really fast Saturday night, was trembling and had chills. The evening of 28Jan2023 was when this all started, around 7:30PM. Caller was literally fine at 5PM, went from no symptoms, maybe a runny nose, to a train wreck. The patient was getting free home tests, used last one and some tests caller had to buy and said tests not available. Booster dose was not due to high risk or frequent institutional or occupational exposure to coronavirus or a weakened immune system.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol increased, Chest pain, Dizziness, Fatigue, Palpitations
Clinical narrative: fainting; Horrible dizziness; tierdness; loss of feeling in arms and legs; heart racing; high cholesterol; Chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2022 as dose 2, single (Batch/Lot number: unknown) at the age of 23 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Batch/Lot No: Unknown. Misplaced/discarded), for COVID-19 immunization. The following information was reported: CHEST PAIN (life threatening) with onset 16Sep2022, outcome "not recovered"; DIZZINESS (life threatening) with onset 16Sep2022, outcome "not recovered", described as "Horrible dizziness"; SYNCOPE (medically significant, life threatening) with onset 16Sep2022, outcome "not recovered", described as "fainting"; PALPITATIONS (life threatening) with onset 16Sep2022, outcome "not recovered", described as "heart racing"; BLOOD CHOLESTEROL INCREASED (life threatening) with onset 16Sep2022, outcome "not recovered", described as "high cholesterol"; SENSORY LOSS (life threatening) with onset 16Sep2022, outcome "not recovered", described as "loss of feeling in arms and legs"; FATIGUE (life threatening) with onset 16Sep2022, outcome "not recovered", described as "tierdness". The events "fainting", "horrible dizziness", "tierdness", "loss of feeling in arms and legs", "heart racing", "high cholesterol" and "chest pain" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jan2023) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of syncope, dizziness, fatigue, sensory loss, palpitations, blood cholesterol increased, chest pain. Clinical course: The patient experienced horrible dizziness, tierdness, loss of feeling in arms and legs, heart racing, high cholesterol, fainting. Chest pain. The patient wanted answers to all this and treatment. The patient was perfectly fine before and was thinking about to sue the company. Stated that the doctor told him it was the vaccine. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Events were reported to be life threatening illness (immediate risk of death from the event). The patient had no covid prior vaccination. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sensory loss, Syncope
Clinical narrative: fainting; Horrible dizziness; tierdness; loss of feeling in arms and legs; heart racing; high cholesterol; Chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2022 as dose 2, single (Batch/Lot number: unknown) at the age of 23 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Batch/Lot No: Unknown. Misplaced/discarded), for COVID-19 immunization. The following information was reported: CHEST PAIN (life threatening) with onset 16Sep2022, outcome "not recovered"; DIZZINESS (life threatening) with onset 16Sep2022, outcome "not recovered", described as "Horrible dizziness"; SYNCOPE (medically significant, life threatening) with onset 16Sep2022, outcome "not recovered", described as "fainting"; PALPITATIONS (life threatening) with onset 16Sep2022, outcome "not recovered", described as "heart racing"; BLOOD CHOLESTEROL INCREASED (life threatening) with onset 16Sep2022, outcome "not recovered", described as "high cholesterol"; SENSORY LOSS (life threatening) with onset 16Sep2022, outcome "not recovered", described as "loss of feeling in arms and legs"; FATIGUE (life threatening) with onset 16Sep2022, outcome "not recovered", described as "tierdness". The events "fainting", "horrible dizziness", "tierdness", "loss of feeling in arms and legs", "heart racing", "high cholesterol" and "chest pain" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jan2023) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of syncope, dizziness, fatigue, sensory loss, palpitations, blood cholesterol increased, chest pain. Clinical course: The patient experienced horrible dizziness, tierdness, loss of feeling in arms and legs, heart racing, high cholesterol, fainting. Chest pain. The patient wanted answers to all this and treatment. The patient was perfectly fine before and was thinking about to sue the company. Stated that the doctor told him it was the vaccine. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Events were reported to be life threatening illness (immediate risk of death from the event). The patient had no covid prior vaccination. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 at 13:00 as dose 1, single (Lot number: ER8732), in left arm, on 21Apr2021 as dose 2, single (Lot number: ER8727), in left arm and on 23Oct2021 as dose 3 (booster), single (Lot number: Ff8841) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy to animals" (unspecified if ongoing); "Allergy to dust" (unspecified if ongoing); "Allergy to mold" (unspecified if ongoing); "Allergy to pollen" (unspecified if ongoing); "asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "childhood allergies" (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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 21Jan2023 to 25Jan2023,
Sex: F
Vaccine: COVID19
Symptoms: Drug eruption
Clinical narrative: MRNA COVID-19 VACCINE-ASSOCIATED BULLOUS FIXED DRUG ERUPTION; This is a literature report for the following literature source(s):  A 47-year-old female patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG ERUPTION (medically significant), 2 weeks after the suspect product(s) administration, outcome "recovered", described as "MRNA COVID-19 VACCINE-ASSOCIATED BULLOUS FIXED DRUG ERUPTION". Therapeutic measures were taken as a result of drug eruption.  Clinical information: After the 1st dose on her left deltoid, she developed persistent right arm pruritus from mid-forearm to wrist that gradually became well-demarcated and erythematous by day four. Rash improved within seven days of using hydrocortisone but left hyperpigmentation of the skin. Two weeks after receiving her 2nd dose on her left deltoid, the same location on her right forearm flared up with more pronounced pruritus, erythema and a few bullous lesions. Rash improved after a week of using hydrocortisone leaving behind hyperpigmentation; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2, and the reported event drug eruption cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: PNC20
Symptoms: Myalgia
Clinical narrative: mild muscle pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from Agency.  A 74-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 30Jan2023 as dose number unknown, 0.5 ml single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "mild muscle pain".  Additional Information: An consumer who received a dose of the Prevnar 20 0.5mL yesterday and experienced mild muscle pain as a side effect has a question. He wanted to know when a patient can get the Shingrix shot after getting the Prevnar 20 injection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Blood immunoglobulin G, Drug ineffective, Upper respiratory tract infection
Clinical narrative: high incidence of upper respiratory infections/IgG antibody levels and the following serotypes (3, 5, and 14) were less than 0.3 mcg/ml; high incidence of upper respiratory infections/IgG antibody levels and the following serotypes (3, 5, and 14) were less than 0.3 mcg/ml; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A 7-year-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), 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 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), UPPER RESPIRATORY TRACT INFECTION (medically significant), outcome "unknown" and all described as "high incidence of upper respiratory infections/IgG antibody levels and the following serotypes (3, 5, and 14) were less than 0.3 mcg/ml". The patient underwent the following laboratory tests and procedures: Blood immunoglobulin G: 0.3 ug/ml, notes: the following serotypes (3, 5, and 14) were less than 0.3 mcg/ml.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between lack of effect (upper respiratory tract infection serotype 3,5,14) with PREVNAR 13 can not be fully excluded.