chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Self test positive for Covid 19 twice on 08Apr2022/Tested positive at doctor office on 08Apr2022; Self test positive for Covid 19 twice on 08Apr2022/Tested positive at doctor office on 08Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 67-year-old male patient received BNT162b2 (BNT162B2), on 22Oct2021 at 10:30 as dose 3 (booster), single (Lot number: 32030BD) at the age of 67 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: "drug allergy" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN, start date: 01Jan2017, stop date: 07Apr2022.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 07Apr2022, outcome "recovered" (25Apr2022) and all described as "Self test positive for Covid 19 twice on 08Apr2022/Tested positive at doctor office on 08Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Apr2022) Positive, notes: Self test positive for Covid 19 and at doctor office; (25Apr2022) Negative, notes: Self test. Therapeutic measures were taken as a result of covid-19, drug ineffective as patient received Paxlovid for the treatment of COVID-19 from 09Apr2022 to 13Apr2022. The patient did a self test which was positive for Covid 19 twice on 08Apr2022 and Tested positive at doctor office on 08Apr2022. The symptoms fatigue and sore throat began on 07Apr2022. Began fever on 09Apr2022. Began Paxlovid prescription on 09Apr2022 and completed 5 days series on 13Apr2022. Felt good on 12Apr2022. After 5 days isolated and no symptoms per CDC, went to retail store, all wearing mask, and one restaurant on 17Apr2022. Woke up on 18Apr2022 with significant cold like symptoms. Contacted doc for guidance and was not instructed to take Covid test. Instructed to treat symptoms and report if anything changed. For next 5 days, had Covid like symptoms but different from first round symptoms like low fever, tired, runny nose, congestion. Started feeling a little better after about another 5 days. No further Covid testing done after 08Apr2022 until 25Apr2022 self test which was negative. No Hospitalization or prolongation. No Known allergies.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Rash, Urticaria, Wheezing
Clinical narrative: Hives; Rash; SOB; Wheezing; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), 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: URTICARIA (non-serious), outcome "unknown", described as "Hives"; RASH (non-serious), outcome "not recovered"; DYSPNOEA (non-serious), outcome "unknown", described as "SOB"; WHEEZING (non-serious), outcome "unknown".  Additional information: Hives, sob and wheezing 45 min after vaccine, rash ongoing 2 weeks after vaccine; Event took place after use of product.  The information on the batch/lot number for (Comirnaty) has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; Fever; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), 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: CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Fever". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Two positive home Covid tests 17Apr2022; Two positive home Covid tests 17Apr2022; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 20Oct2021 at 13:00 as dose 3 (booster), single (Lot number: EW 0170) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Recently diagnosed with asthma and some improvement with Advair and Singular take.; "COVID", start date: Mar2020 (unspecified if ongoing), notes: Best I've felt in two years following my initial bout with COVID and hospitalization in Mar2020. Concomitant medication(s) included: ADVAIR, start date: 30Mar2022, stop date: 29Apr2022; MONTELUKAST, start date: 30Mar2022, stop date: 29Apr2022. Vaccination history included: Covid-19 vaccine (Primary vaccination Details was Unk since Dose Number Unk also considered [Did you/the patient previously receive a COVID-19 Vaccine? Yes]), for covid-19 immunisation.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Apr2022, outcome "not recovered" and all described as "Two positive home Covid tests 17Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Apr2022) Positive, notes: Two positive, home COVID tests; (17Apr2022) Positive, notes: Two positive, home COVID tests; (30Apr2022) Positive, notes: Once again tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course COVID 19 Treatment with Paxlovid, treatment start date: 17ap2022, treatment stop date: 21apr2022. Other medication in 2weeks lot number: 57422002A3. The patient started Paxlovid after two positive home COVID tests 17Apr2022. he was significantly improved within 24 hours and completely normal within 48 hours of starting Paxlovid. he completed the 5-day course and felt great perhaps the best he has felt in two years following his initial bout with COVID and hospitalization in Mar2020. On Tuesday 26Apr2022 he started feeling sick again with similar Covid symptoms of headache though much more mild, sore neck, chest tightness, cough, and sore throat. His symptoms persisted until 30Apr2022, and he couldn't sleep so he just got up in the middle of the night and have once again tested positive for COVID. Recently diagnosed with asthma and some improvement with Advair and Singular take. For three weeks before developing COVID which was diagnosed after worsening of my asthma symptoms. The patient had no known allergies. The AE did not result in physician office visit or emergency room.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 57.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 28Mar2021 at 16:00 as dose 1, single (Lot number: Er8727), in left arm, on 18Apr2021 at 16:00 as dose 2, single (Lot number: Ew961), in left arm and on 29Oct2021 at 16:00 as dose 3 (booster), single (Lot number: FH8027) at the age of 57 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. Patient had no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Negative; (Apr2022) Positive. Therapeutic measures were taken as a result of drug ineffective and covid-19 included Paxlovid (Lot number: FX2740) from 18Apr2022 to 23Apr2022. Clinical course was reported as, Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. Patient had a relapse of covid (symptoms and + antigen) 12 days after beginning Paxlovid after testing negative on 27Apr2022 at 15:00 (and no treatment Received for the symptoms). Patient had no Hospitalization Prolonged.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Got COVID; Got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6200), on 18Mar2021 as dose 2, single (Lot number: EN6204) and on 04Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol abnormal. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Apr2022, outcome "unknown" and all described as "Got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (24Apr2022) Positive; (25Apr2022) Negative; (26Apr2022) Negative; (29Apr2022) Positive; SARS-CoV-2 test: (18Apr2022) Positive, notes: Got COVID - PCR positive; (26Apr2022) Negative. Therapeutic measures were taken as a result of covid-19. Clinical course: Patient appear to have Paxlovid rebound. Got covid - PCR positive on 18Apr2022 and started Paxlovid on 19Apr2022 (Lot number: FY4422) for treatment of COVID-19, finished it on 23Apr2022. Currently not experiencing symptoms.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment/ continued to test positive over four days; COVID 19 Treatment/ continued to test positive over four days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Aug2021 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 08Jan2022 as dose 3 (booster), single (Lot number: LGH022887060), in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 06Mar2021 as dose 1, single (Lot number: 1805022), in left arm for covid-19 immunisation. The patient's relevant medical history included: "mild occasional asthma" (unspecified if ongoing), notes: mild occasional asthma; "Johnson & Johnson/ Pfizer/ Moderna" (unspecified if ongoing), notes: Johnson & Johnson/ Pfizer/ Moderna. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Apr2022, outcome "recovering" and all described as "COVID 19 Treatment/ continued to test positive over four days". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative; positive, notes: test positive over four days; negative, notes: tested negative today (5th day). Therapeutic measures were taken as a result of covid-19. Additional information- It was reported that the patient had previously receive a COVID-19 Vaccine and Five days after completing a five day treatment w paxlovid, and all symptoms disappearing and testing negative, symptoms reappeared and I tested positive. I continued to test positive over four days and finally tested negative today (5th day)  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Lot number: EW0178) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN; LIPITOR, start date: 20Apr2022, stop date: 21Apr2022; IBUPROFEN, start date: 20Apr2022, stop date: 25Apr2022; ROBITUSSIN DM, start date: 20Apr2022, stop date: 25Apr2022. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: adverse event Positive with symptoms 5 days after finishing course of Paxlovid. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Retested myself again (3times) and Once again Positive; Retested myself again (3times) and Once again Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 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 was not reported. Concomitant medication(s) included: SERTRALINE; ADDERALL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Retested myself again (3times) and Once again Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Negative; (30Apr2022) Positive, notes: retested myself again (three times; (30Apr2022) Positive, notes: retested myself again (three times; (30Apr2022) Positive, notes: retested myself again (three times. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient previously received a COVID-19 Vaccine. The patient taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient tested negative for Covid the following Tuesday (26Apr2022) and woke up this morning with a sore throat and headache. Patient retested again (three times) and was once again positive. Anti viral details: product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 20Apr2022, Treatment stop date: 24Apr2022, Indication: Treatment of COVID-19. Adverse event start date: 30Apr2022, Ae resulted in: None of the above, If patient recovered: Recovering, If treatment ae: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: product=COVID 19 Treatment, brand=Paxlovid/if_vaccine_received Yes/vaccine_brand=Pfizer / BioNTech; product=COVID 19 Treatment, brand=Paxlovid/if_vaccine_received Yes/vaccine_brand=Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years 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: "Allergies: Penecillin" (unspecified if ongoing). Concomitant medication(s) included: EFFECO HEALTH, start date: 07Mar2022. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Apr2022, outcome "unknown", COVID-19 (medically significant) with onset Apr2022, outcome "not recovered" and all described as "product=COVID 19 Treatment, brand=Paxlovid/if_vaccine_received Yes/vaccine_brand=Pfizer / BioNTech". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (29Apr2022) Negative. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: How many people have to die before y'all stop injecting?; 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 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: DEATH (death, medically significant), outcome "fatal", described as "How many people have to die before y'all stop injecting?". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Reporter responded to the IVR as (misplaced comment) How many people have to die before we all will stop injecting and customer service. Any medical questions addressed by this program forwarded/referred to medical information were not applicable.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: How many people have to die before y'all stop injecting?
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Chills, Cough, Fatigue
Clinical narrative: Positive Ag test then; Positive Ag test then; Cough; Fatigue; ST arthralgias; Chills; Sick; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 41-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3247), on 18Feb2021 as dose 2, single (Lot number: EL3247) and on 12Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CHILLS (non-serious) with onset 28Apr2022, outcome "unknown"; COUGH (non-serious) with onset 28Apr2022, outcome "unknown"; FATIGUE (non-serious) with onset 28Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Apr2022, outcome "unknown" and all described as "Positive Ag test then"; ARTHRALGIA (non-serious) with onset 28Apr2022, outcome "unknown", described as "ST arthralgias"; ILLNESS (non-serious) with onset 28Apr2022, outcome "unknown", described as "Sick". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2022) Positive, notes: covid test name post vaccination: hOME aG covid test type post vaccination=Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, cough, fatigue, arthralgia, chills, illness.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive Ag test then; Positive Ag test then; Cough; Fatigue; ST arthralgias; Chills; Sick; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 41-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3247), on 18Feb2021 as dose 2, single (Lot number: EL3247) and on 12Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CHILLS (non-serious) with onset 28Apr2022, outcome "unknown"; COUGH (non-serious) with onset 28Apr2022, outcome "unknown"; FATIGUE (non-serious) with onset 28Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Apr2022, outcome "unknown" and all described as "Positive Ag test then"; ARTHRALGIA (non-serious) with onset 28Apr2022, outcome "unknown", described as "ST arthralgias"; ILLNESS (non-serious) with onset 28Apr2022, outcome "unknown", described as "Sick". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2022) Positive, notes: covid test name post vaccination: hOME aG covid test type post vaccination=Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, cough, fatigue, arthralgia, chills, illness.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 at 16:45 as dose 1, single (Batch/Lot number: unknown), in left arm, on 26Mar2021 at 17:15 as dose 2, single (Batch/Lot number: unknown), in left arm and on 01Nov2021 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: other medical history: Diabetes; "known allergies: sulpher drugs" (unspecified if ongoing), notes: known allergies: sulpher drugs. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, suspected covid-19. Patient received treatment for the event COVID-19 as Paxlovid (Lot number: FY4445) from 25Apr2022 to 30Apr2022. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. After the first 2 doses of Paxlovid developed a metalic/chalk like taste in my mouth from 25Apr2022 at 06:45 pm. Patient did not received treatment for this event.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Dysphonia, Illness
Clinical narrative: I had a problem just a hoarseness and I was sick like 2 weeks; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FK8729) for covid-19 immunisation. The patient's relevant medical history included: "Immune system problem" (unspecified if ongoing), notes: Verbatim:Immune system problem., I have immune system problem (history). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 2, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose: 1, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: DYSPHONIA (non-serious), outcome "unknown", described as "I had a problem just a hoarseness and I was sick like 2 weeks"; ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional Information: It was reported that, this report was not related to study or program. So the 3rd Booster and had a problem with too but it was just a hoarseness, and I was sick like 2 weeks from it but this one was the first time that actually had an anaphylaxis and that was not something you usually get. Patient had immune system problem (history). Consumer was informed about  Pfizer Drug Safety. Consumer was informed about Pfizer  Department. As consumer was not willing to proceed the call. Hence further probing could not be done. Limited information available over the call and appropriate response could not be provided.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Renal failure
Clinical narrative: Starting to suffer from Kidney Failure because of the protein did not breakdown correctly in my kidney, I have kidney failure to the rest of my life.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: 33023BD) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RENAL FAILURE (medically significant), outcome "unknown", described as "Starting to suffer from Kidney Failure because of the protein did not breakdown correctly in my kidney, I have kidney failure to the rest of my life.".  Clinical course: The patient got the Pfizer Vaccine a two months ago unfortunately. The patient was starting to suffer from Kidney Failure because of the protein did not breakdown correctly in patient's kidney. So the Pfizer, the whatever vaccine (Clarified as Pfizer COVID-19 Vaccine) would it be, 'as using the' Vaccine it didn't breakdown correctly in patient's kidney and now the patient was having kidney problems.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Drug ineffective, Inflammation, Suspected COVID-19
Clinical narrative: she already took the full doses of the Pfizer covid-19 vaccine; she already took the full doses of the Pfizer covid-19 vaccine; arthritis or hands and bumps; inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  An 80-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 INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she already took the full doses of the Pfizer covid-19 vaccine"; ARTHRITIS (non-serious), outcome "recovering", described as "arthritis or hands and bumps"; INFLAMMATION (non-serious), outcome "recovering". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: The caller stated about her experience with the Paxlovid, that it made her arthritis or hands and bumps healed after having some medical issue and mentioned that she already took the full doses of the Pfizer covid-19 vaccine. She said she just wanted to let Pfizer know that Paxlovid has done her a great deal with her hands or arthritis and the inflammation was healed when she took her second dose of Paxlovid.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19, PPV
Symptoms: Chills, Headache, Nausea, Vaccination site pain
Clinical narrative: Nausea; chills; severe headache; pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years intramuscular, in left arm for covid-19 immunisation; pneumococcal vaccine (PNEUMOCOCCAL VACCINE), on 29Apr2022 as dose 2, single (Batch/Lot number: unknown), in left arm. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Second dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Third dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 29Apr2022, outcome "recovering"; CHILLS (non-serious) with onset 29Apr2022, outcome "recovering"; VACCINATION SITE PAIN (non-serious) with onset 29Apr2022, outcome "recovering", described as "pain at injection site"; HEADACHE (non-serious) with onset 29Apr2022, outcome "recovering", described as "severe headache". Therapeutic measures were not taken as a result of nausea, chills, headache, vaccination site pain. Additional information: The Facility where patient was administered the most recent COVID-19 vaccine was Unknown. It was Unknown if the patient receives any other vaccines within 4 weeks prior to the COVID vaccine and List of any other medications the patient received within 2 weeks of vaccination. It was Unknown that, the patient was diagnosed with COVID prior to vaccination and since the vaccination, the patient has been tested for COVID-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, FLUX, VARZOS
Symptoms: Off label use, Seizure
Clinical narrative: He is having severe seizure and they put drip in him; they gave him the covid shot and flu shot and shingles shot all at once; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), (Batch/Lot number: unknown) for immunisation; varicella zoster vaccine (VARICELLA ZOSTER VACCINE), (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series complete but unknown manufacturer.), for COVID-19 immunization. The following information was reported: SEIZURE (hospitalization, medically significant, life threatening), outcome "unknown", described as "He is having severe seizure and they put drip in him"; OFF LABEL USE (non-serious), outcome "unknown", described as "they gave him the covid shot and flu shot and shingles shot all at once".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest pain, Chills, Cough, Dyspnoea
Clinical narrative: COVID-19; COVID-19; fever; chills; cough; congestion; headache; difficulty breathing; chest pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL9261), on 17Feb2021 as dose 2, single (Lot number: EN6200) and on 03Oct2021 as dose 3 (booster), single (Lot number: ff2590) at the age of 66 years for covid-19 immunization. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing), notes: Other Medical History: Thyroid; "esophagitis" (unspecified if ongoing), notes: Other medical History: esophagitis. Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Jan2019, stop date: 30Apr2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "not recovered" and all described as "COVID-19"; CHEST PAIN (non-serious) with onset 2022, outcome "not recovered"; CHILLS (non-serious) with onset 2022, outcome "not recovered"; NASAL CONGESTION (non-serious) with onset 2022, outcome "not recovered", described as "congestion"; COUGH (non-serious) with onset 2022, outcome "not recovered"; DYSPNOEA (non-serious) with onset 2022, outcome "not recovered", described as "difficulty breathing"; PYREXIA (non-serious) with onset 2022, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset 2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Negative; (30Apr2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. The relapse of covid on 30Apr2022 after taking Paxlovid. Tested negative yesterday, then positive today with all symptoms returning fever, chills, cough, serious congestion, difficulty breathing, headache, chest pain. As I have compromised lungs, I am concerned I will end up in the hospital. No Paxlovid this time. Known allergies was reported as no. Device Date was reported as 30Apr2022.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; fever; chills; cough; congestion; headache; difficulty breathing; chest pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL9261), on 17Feb2021 as dose 2, single (Lot number: EN6200) and on 03Oct2021 as dose 3 (booster), single (Lot number: ff2590) at the age of 66 years for covid-19 immunization. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing), notes: Other Medical History: Thyroid; "esophagitis" (unspecified if ongoing), notes: Other medical History: esophagitis. Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Jan2019, stop date: 30Apr2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "not recovered" and all described as "COVID-19"; CHEST PAIN (non-serious) with onset 2022, outcome "not recovered"; CHILLS (non-serious) with onset 2022, outcome "not recovered"; NASAL CONGESTION (non-serious) with onset 2022, outcome "not recovered", described as "congestion"; COUGH (non-serious) with onset 2022, outcome "not recovered"; DYSPNOEA (non-serious) with onset 2022, outcome "not recovered", described as "difficulty breathing"; PYREXIA (non-serious) with onset 2022, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset 2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Negative; (30Apr2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. The relapse of covid on 30Apr2022 after taking Paxlovid. Tested negative yesterday, then positive today with all symptoms returning fever, chills, cough, serious congestion, difficulty breathing, headache, chest pain. As I have compromised lungs, I am concerned I will end up in the hospital. No Paxlovid this time. Known allergies was reported as no. Device Date was reported as 30Apr2022.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She took the test twice and the results are positive.; She took the test twice and the results are positive.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-healthcare professional), Program ID: (159558). 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), 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 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 "She took the test twice and the results are positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: She took the test twice and the results are positive.   Clinical course: Patient got the first and second dose of the Pfizer COVID-19 vaccine and also the first and second booster shot, and out of curiosity she took the test twice and the results are positive. Caller was asking if we ever heard of this situation.  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, SARS-CoV-2 test, Vaccination failure
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). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 19Apr2021 as dose 2, single (Lot number: EU0161), in left arm and on 16Nov2021 as dose 3 (booster), single (Lot number: EW047) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: allergic to eggs" (unspecified if ongoing); "pagets disease of the bone" (unspecified if ongoing); "spinal stenosis" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (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: (unspecified date) Negative, notes: Tested negative four days later; (25Apr2022) Positive, notes: Tested positive again on 25Apr2022; (27Apr2022) Negative, notes: Tested negative again on 27Apr2022; (29Apr2022) Negative, notes: again today on 29Apr2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not receive other medication in 2 weeks.The patient took Paxlovid for the treatment of COVID-19 from 10Apr2022 to 15Apr2022, started feeling better two days later. Tested negative four days later. Then, five days after testing negative, patient became ill again with a low fever and horrible sinus infection. Tested positive again on 25Apr2022. Tested negative again on 27Apr2022 and again on 29Apr2022. Feeling much better on the day of reporting.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: if_vaccine_received Yes/vaccine_brand=Pfizer / BioNTech/product=COVID 19 Treatment, brand=Paxlovid; if_vaccine_received Yes/vaccine_brand=Pfizer / BioNTech/product=COVID 19 Treatment, brand=Paxlovid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years 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. There were no concomitant medications. Past drug history included: Cephalexin, reaction(s): "known allergies: Cephalexin", notes: known allergies: Cephalexin.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "if_vaccine_received Yes/vaccine_brand=Pfizer / BioNTech/product=COVID 19 Treatment, brand=Paxlovid". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical information:other medication in 2weeks: No.Covid-19 treatment =Paxlovid  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID the other day; tested positive for COVID the other day; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and on 26Apr2021 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 INEFFECTIVE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset 27Apr2021, outcome "unknown" and all described as "tested positive for COVID the other day". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Apr2021) Positive, notes: tested positive for COVID the other day. Additional information: Patient tested positive for COVID the other day. Patient experienced a metallic and bitter taste in his mouth which lasted for a few hours. Patient had read in the site that altered sense of taste is a possible side effect.  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: Dermatitis
Clinical narrative: presents with pruritic rash (dermatitis) on upper buttocks and upper back that began 2 days following first dose of Pfizer COVID-19 vaccine.; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  A 54-year-old female patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DERMATITIS (non-serious), outcome "unknown", described as "presents with pruritic rash (dermatitis) on upper buttocks and upper back that began 2 days following first dose of Pfizer COVID-19 vaccine".  Additional information: The clinical course was reported as reporter stated, presents with pruritic rash (dermatitis) on upper buttocks and upper back that began 2 days following first dose of Pfizer COVID-19 vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Past store has got an outbreak case after getting second shot of Pfizer COVID-19 Vaccine; Past store has got an outbreak case after getting second shot of Pfizer COVID-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  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: 01), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Past store has got an outbreak case after getting second shot of Pfizer COVID-19 Vaccine".  Additional information: Medical enquiry information was reported. Transferring agent stated, "he had a consumer on the other line. He said that their past store on their charge after getting Pfizer COVID-19 Vaccine, he got an outbreak case. The concern was their past store had got an outbreak case after getting second shot of Pfizer COVID-19 Vaccine and he had also some questions regarding for yearly vaccine of COVID-19. The agent already answered his question about clinical trials.  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: Emotional disorder
Clinical narrative: they are going crazy and want peace of mind; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization.  The following information was reported: EMOTIONAL DISORDER (non-serious), outcome "unknown", described as "they are going crazy and want peace of mind".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.