chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site erythema, Vaccination site haematoma, Vaccination site pain
Clinical narrative: developed a knot in her left arm at the site of the injection and that arm is sore and red at the site; developed a knot in her left arm at the site of the injection and that arm is sore and red at the site; red at the site; Fever; This is a spontaneous report received from non-contactable reporter(s) (Nurse). The reporter is the parent.  A 2-year-old female patient received BNT162b2 (BNT162B2), on 22Jun2022 as dose number unknown, single (Batch/Lot number: unknown) intramuscular, in left arm for covid-19 immunization. The patient's relevant medical history included: "allergy to eggs" (ongoing), notes: diagnosed at age 6 or 7 months old. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 22Jun2022, outcome "recovering", described as "Fever"; VACCINATION SITE HAEMATOMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 22Jun2022, outcome "not recovered" and all described as "developed a knot in her left arm at the site of the injection and that arm is sore and red at the site"; VACCINATION SITE ERYTHEMA (non-serious) with onset 22Jun2022, outcome "not recovered", described as "red at the site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Reporter stated that after her niece received the vaccine on 22Jun2022 she developed a knot in her left arm at the site of the injection and that arm was sore and red at the site. Stated that started later in the afternoon and was persisting. Stated that she also developed a fever of 102 degrees Fahrenheit last evening, 22Jun2022 around bedtime which was about 8:30pm. Caller stated the fever was improved but they are treating with Children's Tylenol. Stated at this time her sister feels it was not serious. Stated no change to dose at this time as they have not notified their physician.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from 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 03Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 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: "Hypertension" (unspecified if ongoing); "Known allergies: Sulfur" (unspecified if ongoing), notes: Known allergies: Sulfur. Concomitant medication(s) included: CARVEDILOL; HYDRALAZINE. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with antiviral from 22Jun2022 to Jun2022 (Lot number=GA5120). The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Thyroid function test, Vaccination failure
Clinical narrative: Got his first dose of vaccine and he got mild Covid, it could have been flu but he has never had flu; Got his first dose of vaccine and he got mild Covid, it could have been flu but he has never had flu; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid related symptoms" (unspecified if ongoing), notes: He had Covid related symptoms in Jan2019 or Feb2019, right at the onset; Covid vaccines were not available back then, so he quarantined; "Heart condition" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Smallpox vaccine (no other vaccinations in his life besides small pox and polio), for Immunization; Polio vaccine (no other vaccinations in his life besides small pox and polio), for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Got his first dose of vaccine and he got mild Covid, it could have been flu but he has never had flu". Therapeutic measures were taken as a result of drug ineffective, suspected 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: Linked Report(s) : US-PFIZER INC-202200893445 Same patient, same vaccine in different dose, partial same event;
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Got his first dose of vaccine and he got mild Covid, it could have been flu but he has never had flu; Got his first dose of vaccine and he got mild Covid, it could have been flu but he has never had flu; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid related symptoms" (unspecified if ongoing), notes: He had Covid related symptoms in Jan2019 or Feb2019, right at the onset; Covid vaccines were not available back then, so he quarantined; "Heart condition" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Smallpox vaccine (no other vaccinations in his life besides small pox and polio), for Immunization; Polio vaccine (no other vaccinations in his life besides small pox and polio), for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Got his first dose of vaccine and he got mild Covid, it could have been flu but he has never had flu". Therapeutic measures were taken as a result of drug ineffective, suspected 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: Linked Report(s) : US-PFIZER INC-202200893445 Same patient, same vaccine in different dose, partial same event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient tested positive for COVID after receiving 3 COVID 19 Vaccines; Patient tested positive for COVID after receiving 3 COVID 19 Vaccines; This is a spontaneous report received from contactable reporter(s) (Physician).  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 (caused and prolonged hospitalization, medically significant), COVID-19 (caused and prolonged hospitalization, medically significant) all with onset 10Jun2022, outcome "unknown" and all described as "Patient tested positive for COVID after receiving 3 COVID 19 Vaccines". The patient was hospitalized and prolonged hospitalization for drug ineffective, covid-19 (start date: 21Jun2022). The event "patient tested positive for covid after receiving 3 covid 19 vaccines" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jun2022) Positive, notes: Unit: Not Provided; (04Jun2022) Negative, notes: had taken a rapid test and the patient was negative on 04Jun2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She was a Pfizer Field Representative calling in regards to Paxlovid. The patient was on the late end of getting Paxlovid prescribed. It was on 10Jun2022 that the patient came in and had a positive PCR test and was prescribed Paxlovid. Previously the patient had been ill for about a week prior to 10Jun2022 and had taken a rapid test and the patient was negative on 04Jun2022 but then came to the doctor on 10Jun2022. The patient took Paxlovid for 5 days, felt better, then on day 10 roughly, Tuesday 21Jun2022 the patient came in and was in terrible shape. The patient was getting nebulizer in office, getting shortness of breath, wheezing, and coughing. The patient was referred for hospitalization. She does know that the doctor did say the patient did receive 3 COVID Vaccines and they were Pfizer Vaccines. She did not know the NDC/LOT/EXPIRY or dates of the previous vaccinations.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Rebound of covid symptoms and positive rapid test; Rebound of covid symptoms and positive rapid test; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 03Mar2021 as dose 2, single (Lot number: EN6199), in right arm and on 06Oct2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Rebound of covid symptoms and positive rapid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jun2022) Negative, notes: positive rapid test on day 10 after being negative on day 6; (23Jun2022) Positive, notes: positive rapid test on day 10 after being negative on day 6. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received no other medication in 2 weeks. Patient had no known allergies.; Sender's Comments: As there is limited information in the case provided, the causal association between the events vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer Covid vaccine - Covid; Pfizer Covid vaccine - Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 65-year-old male patient received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Insulin dependent diabetic" (unspecified if ongoing), notes: Insulin dependent diabetic. 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 "Pfizer Covid vaccine - Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: this patient and patient from report 1 tested positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Covid vaccine for all 4 doses. States her first dose was 30Jan2021 and she believes her 2nd dose was 20Feb2021, she thought they did it 3 weeks after the 1st dose. States the 1st booster was Sep2021, she thought the 12th or something, and her 2nd booster was Apr2022. States she got all doses in her left arm. Caller states her husband was a 65 year old diabetic and he said he felt like he was 31, he felt that good and he thought there was a steroid in it.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Pfizer / BioNTech 1-FEB-2022 / Treatment of COVID-19 22-JUN-2022; Pfizer / BioNTech 1-FEB-2022 / Treatment of COVID-19 22-JUN-2022; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 01Feb2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: COREG, start date: Dec2021, stop date: May2022; LIPITOR, start date: Dec2021, stop date: 22Jun2022; PRILOSEC [OMEPRAZOLE], start date: Dec2021, stop date: May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Pfizer / BioNTech 1-FEB-2022 / Treatment of COVID-19 22-JUN-2022". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report about covid treatment reported as Yes. If vaccine received reported as Yes. Other medication in 2 weeks reported as Yes. Anti-viral details: Product: COVID 19 Treatment, Treatment start date: 22Jun2022, Treatment stop date: May2022, Indication: Treatment of COVID-19. Known allergies reported as No. Other medical history reported as none.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2021 as dose 1, single (Lot number: EW0150), on 25Apr2021 as dose 2, single (Lot number: EW0170), on 14Nov2021 as dose 3 (booster), single (Lot number: FH8028) and on 20Apr2022 as dose 4 (booster), single (Lot number: FJ4991) for covid-19 immunisation. The patient's relevant medical history included: "known allergies penicillin" (unspecified if ongoing), notes: known allergies penicillin. Concomitant medication(s) included: LEVOTHYROXINE; ALENDRONATE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jun2022, outcome "recovering" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (10Jun2022) Positive, notes: 10Jun tested positive for Covid; (19Jun2022) Negative, notes: Tested negative on 19Jun; (21Jun2022) Positive, notes: Tested positive 21Jun; (24Jun2022) Positive, notes: 24Jun (again positive test). Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: The patient received Levothyroxine and Alendronate within 2 weeks of the vaccination. It was reported that the on 10Jun2022, the patient tested positive for Covid, started Paxlovid in PM and concluded 15Jun AM. The patient tested negative on 19Jun. The symptoms were not fully resolved though and returned more strongly than before. The patient tested positive 21Jun2022. The strong flu-like symptoms persisted through today 24Jun22 (again positive test) but feeling a bit better now. All were in home antigen testing.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dyspnoea, Illness, Malaise, Pyrexia
Clinical narrative: Fever; Shortness of breath; I started throwing up/she is puking; I am totally out of it; I felt like a truck ran me over; Sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 22Jun2022 as dose 4 (booster), single (Lot number: FJ4991) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 23Jun2022, outcome "unknown", described as "Fever"; CONFUSIONAL STATE (non-serious) with onset 23Jun2022, outcome "unknown", described as "I am totally out of it"; MALAISE (non-serious) with onset 23Jun2022, outcome "unknown", described as "I felt like a truck ran me over"; VOMITING (non-serious) with onset 23Jun2022, outcome "unknown", described as "I started throwing up/she is puking"; DYSPNOEA (non-serious) with onset 23Jun2022, outcome "unknown", described as "Shortness of breath"; ILLNESS (non-serious) with onset 23Jun2022, outcome "unknown", described as "Sick".  Additional information: It was reported that the caller experienced side effects of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever; Shortness of breath; I started throwing up/she is puking; I am totally out of it; I felt like a truck ran me over; Sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 22Jun2022 as dose 4 (booster), single (Lot number: FJ4991) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 23Jun2022, outcome "unknown", described as "Fever"; CONFUSIONAL STATE (non-serious) with onset 23Jun2022, outcome "unknown", described as "I am totally out of it"; MALAISE (non-serious) with onset 23Jun2022, outcome "unknown", described as "I felt like a truck ran me over"; VOMITING (non-serious) with onset 23Jun2022, outcome "unknown", described as "I started throwing up/she is puking"; DYSPNOEA (non-serious) with onset 23Jun2022, outcome "unknown", described as "Shortness of breath"; ILLNESS (non-serious) with onset 23Jun2022, outcome "unknown", described as "Sick".  Additional information: It was reported that the caller experienced side effects of the vaccine.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles/my case of shingles as severe; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 27Jul2021 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot No: Unknown), administration date: 06Jul2021, when the patient was 59-year-old, for Covid-19 immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 03Apr2022, outcome "not recovered", described as "shingles/my case of shingles as severe". The event "shingles/my case of shingles as severe" required physician office visit. Therapeutic measures were taken as a result of herpes zoster.  Additional Information: The patient did not receive any other vaccine in four weeks. The patient did not have Covid prior vaccination and was not tested for it post vaccination. The patient was healthy and was on no other medications. He had no other immune compromised health conditions. On 04Apr2022, the patient broke out with shingles (also reported as 03Apr2022). The patient primary care physician described shingles as severe.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: they are red, raised, long lines; They are raised curves about 4 to 5 inches long; there is horrible itching with them; 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 78-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 Immunization. The following information was reported: SWELLING (non-serious) with onset Oct2021, outcome "recovering", described as "They are raised curves about 4 to 5 inches long"; PRURITUS (non-serious) with onset Oct2021, outcome "recovering", described as "there is horrible itching with them"; ERYTHEMA (non-serious) with onset Oct2021, outcome "recovering", described as "they are red, raised, long lines". The events "they are red, raised, long lines", "they are raised curves about 4 to 5 inches long" and "there is horrible itching with them" required physician office visit. Therapeutic measures were taken as a result of erythema, swelling, pruritus. Additional information: It is not round hives or lumps, they are red, raised, long lines.  They are raised curves about 4 to 5 inches long.  They change everyday.  The same thing happens every day, they come and go, and there is horrible itching with them.  The only remedy she has found that works is Hydroxyzine or Visteril.  Back in Oct2021 is when this all first started.  The itching was horrible and her Doctor prescribed her Zyrtec and another over-the-counter medication, but only in Dec2021 did she finally receive the prescription for Visteril, 10mg, that brought her any relief.  The medication makes her incredibly sleepy and she sleeps for 10 hours.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
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). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Nov2021 at 12:00 as dose 3 (booster), single (Lot number: FF2593) at the age of 49 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: ADVIL COLD & SINUS, start date: 11Jun2022, stop date: 11Jun2022 and also reported as patient took other medication in 2weeks. Past drug history included: Phenagren, reaction(s): "Known alllergies: Phenagren". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results; (13Jun2022) Positive, notes: I tested positive Monday 13Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 12Jun2022 and stopped on 16Jun2022. Clinical course was reported as, patient tested positive Monday 13Jun. Got the antiviral medicine that night. 5 day treatment. Patient was feeling much better she would say she started feeling bad again on that following Tuesday 21Jun. Headache not as bad but allergy and flu type symptoms. 100.1 fever on 20Jun2022 at 15.00. No treatment received for symptoms and patient was not recovered from symptoms.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Pfizer / BioNTech / Treatment of COVID-19; Pfizer / BioNTech / 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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: ER2613), on 09Apr2021 as dose 2, single (Lot number: EW0158) and on 08Nov2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 52 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01May2022 as dose 1, single (Lot number: 004M21A) for covid-19 immunisation. The patient's relevant medical history included: "slightly overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: codeine and percocet/percodan, reaction(s): "Known allergies: Codeine and Percocet/Percodan", notes: Known allergies: Codeine and Percocet/Percodan; Known allergies: codeine and percocet/percodan, reaction(s): "Known allergies: Codeine and Percocet/Percodan", notes: Known allergies: Codeine and Percocet/Percodan; Known allergies: codeine and percocet/percodan, reaction(s): "Known allergies: Codeine and Percocet/Percodan", notes: Known allergies: Codeine and Percocet/Percodan. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech / Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Jun2022) positive, notes: Tested positive for Covid on 11Jun2022; (Jun2022) positive, notes: Tested positive again on Jun2022; (20Jun2022) negative, notes: Tested negative on 20Jun2022. Therapeutic measures were taken as a result of covid-19.  Clinical information: Tested positive for Covid on 11Jun2022. Started Paxlovid on 12Jun2022. Tested negative on 20Jun2022. Right after that, started having sore throat and congestion. Tested positive again on Jun2022. The action taken for MODERNA COVID-19 VACCINE was not applicable.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested covid positive; tested covid positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group.  An 11-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), in Oct2021 as dose 1, single (Lot number: FK5618) and on 09Dec2021 as dose 2, single (Lot number: FL0007) at the age of 10 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), COVID-19 (medically significant) all with onset 22Jun2022, outcome "recovering" and all described as "tested covid positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Additional Information: The patient did not have COVID-19 prior to vaccination and was tested for COVID-19 post vaccination. No treatment was received for the adverse events.  No follow-up attempts are possible. No further information is expected.
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 contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), 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 included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Penicillin Sulfa. 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: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid start on 07Jun2022 till 11Jun2022.  Clinical course: The patient did not receive any other medications in 2 weeks. It was reported that on 20Jun2022 reoccurrence of symptoms 10 days post Paxlovid treatment end date and patient was recovering.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rashes on the face and even in few places on body as well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FJ8757) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0161), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE; Lot number: ER8736), for Covid-19 Immunization, reaction(s): "rashes on the face and even in few places on body as well". The following information was reported: RASH (non-serious), outcome "unknown", described as "rashes on the face and even in few places on body as well". The events "rashes on the face and even in few places on body as well" required physician office visit. Therapeutic measures were taken as a result of rash.  Additional information: Consumer stated, that he just wanted to check in case after taking the Pfizer vaccination for COVID, Are there any non-side effect with respected to any skin allergy on face. The patient is a software, Engineer. Consumer didn't have Expiration Date. The patient had three dosages of Vaccination. No lab test was done. The consumer had consulted dermatologist, who actually prescribed hydrocortisone to apply wherever the rashes on the face and even in few places on body as well. The patient did not receive other vaccines within four weeks prior to COVID vaccine. Anatomical site of vaccination consumer stated on arm left and right arm. Reporter stated, that after taking the vaccination only he was facing the problem of rashes and everything and rashes are not going away from last two years after he got vaccinated for the second dose.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200893189 same product and event, different dose;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 at 09:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: patient did not received other medication in 2weeks. Anti-viral details: Product=COVID 19 Treatment. Treatment start date=21Jun2022. Treatment Stop date=22Jun2022. Adverse event: Stomach upset and diarrhea. Adverse event start date: 21Jun2022. Adverse event start time: 11:00 AM. If patient recovered: Recovered. patient did not have other medical history. patient did not received any treatment ae and had no Known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder
Clinical narrative: he experienced loss of balance after his last two shots of the Pfizer covid 19 vaccine; 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.  An 84-year-old male 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: BALANCE DISORDER (non-serious), outcome "unknown", described as "he experienced loss of balance after his last two shots of the Pfizer covid 19 vaccine". Additional information: Caller reported that he experienced loss of balance after his last two shots of the Pfizer covid 19 vaccine. Caller wanted to know if it is safe to get the next booster. Caller asked does Pfizer recommend that he get the booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Catheterisation cardiac, Echocardiogram, Ejection fraction, Full blood count
Clinical narrative: he experienced loss of balance after his last two shots of the Pfizer covid 19 vaccine; 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.  An 84-year-old male 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: BALANCE DISORDER (non-serious), outcome "unknown", described as "he experienced loss of balance after his last two shots of the Pfizer covid 19 vaccine". Additional information: Caller reported that he experienced loss of balance after his last two shots of the Pfizer covid 19 vaccine. Caller wanted to know if it is safe to get the next booster. Caller asked does Pfizer recommend that he get the booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lipids, Metabolic function test, Myocardial infarction, Thyroid function test, Ultrasound Doppler
Clinical narrative: he experienced loss of balance after his last two shots of the Pfizer covid 19 vaccine; 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.  An 84-year-old male 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: BALANCE DISORDER (non-serious), outcome "unknown", described as "he experienced loss of balance after his last two shots of the Pfizer covid 19 vaccine". Additional information: Caller reported that he experienced loss of balance after his last two shots of the Pfizer covid 19 vaccine. Caller wanted to know if it is safe to get the next booster. Caller asked does Pfizer recommend that he get the booster.  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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: then a few days later you test positive; then a few days later you test positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "then a few days later you test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Dec2020 at 14:00 as dose 1, single (Lot number: EJ1685), in left arm, on 10Jan2021 at 12:00 as dose 2, single (Lot number: EL1284), in left arm, on 26Aug2021 at 13:00 as dose 3 (booster), single (Lot number: FC3184), in left arm and on 11May2022 at 13:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "HTN" (unspecified if ongoing), notes: Other medical history: HTN; "Known allergies: Pcn" (unspecified if ongoing), notes: Known allergies: Pcn. Concomitant medication(s) included: SYNTHROID; ATENOLOL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Vaccination failure and the administration of the vaccine cannot be excluded.
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 contactable reporter(s) (Nurse). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) 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: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: LOSARTAN; ESCITALOPRAM. Past drug history included: Bactrim, reaction(s): "Known allergies: bactrim", notes: Known allergies: bactrim. 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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case narrative, reported events drug ineffective, Covid 19 with BNT162B2 are possible
Age: 30.0
Sex: M
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 non-contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), on 05Dec2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 30 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. 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: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient did not receive any other medications in two weeks.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 25Mar2021 as dose 2, single (Lot number: ER8730), in left arm and on 10Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa" (unspecified if ongoing); "known allergies: Dairy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: Patient did not receive other medication in 2 weeks. Patient received Paxlovid (anti-viral) from 14Jun2022 to 18Jun2022 for COVID 19 treatment. Rebound of Covid 19 after 5 days of taking Paxlovid.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; sars cov2 infection; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6208), on 01Apr2021 as dose 2, single (Lot number: ER8732), on 08Oct2021 as dose 3 (booster), single (Lot number: FE3590) and on 15Apr2022 as dose 4 (booster), single (Lot number: FJ8762) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hay fever" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; CETIRIZINE; ADVAIR; FLONASE [FLUTICASONE PROPIONATE]; ALBUTEROL [SALBUTAMOL]. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen". The following information was reported: VACCINATION FAILURE (medically significant), outcome "recovered" (18Jun2022), described as "COVID-19 Treatment"; COVID-19 (medically significant), outcome "recovered" (18Jun2022), described as "sars cov2 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jun2022) Positive, notes: rebound 8 days after completing course of Paxlovid with concurrent strong positivity, COVID-19 antigen rapid test; (unspecified date) Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient had stopped rosuvastatin and Advair from 1 day before through 2 days after treatment.; Sender's Comments: Considering the nature of the reported events and product profile, a causal role of the suspect BNT162B2 cannot be denied for the reported events.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid positive (RTPCR); Covid positive (RTPCR); This is a spontaneous report received from a 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 10Mar2021 as dose 1, single (Lot number: EL3248), on 29Mar2021 as dose 2, single (Lot number: EL3248) and on 26Oct2021 as dose 3 (booster), single (Lot number: EN6199) at the age of 39 years for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Jun2022, outcome "unknown" and all described as "Covid positive (RTPCR)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.