chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 64-year-old patient received BNT162b2, on 16Oct2021 as dose number unknown, single (Batch/Lot number: unknown), in right arm, on 09Apr2022 as dose number unknown, single (Batch/Lot number: unknown) and on 12Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "Known allergies: Sulpha drugs" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; SYNTHROID, both in two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Patient received paxlovid (lot number: GC0618) from 30Jun2022 to 04Jul2022 for COVID 19 treatment. 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.
Age: 75.0
Sex: M
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) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 04May2022 as dose 4 (booster), single (Lot number: 14939) at the age of 75 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Prostrate cancer" (unspecified if ongoing); "thyroid problems" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; LEVOTHYROXINE; EZETIMIBE; DIGOXIN; ELIQUIS; LOSARTIN. 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.  Clinical course: Patient did not receive treatment for AE, Patient did not known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2021 as dose 1, single (Lot number: er8736) and on 18May2021 as dose 2, single (Lot number: ew0185) at the age of 32 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Jan2022 as dose 3 (booster), single (Lot number: 070h21a) for covid-19 immunisation. The patient's relevant medical history included: "chronic sinusitis" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "overweight" (unspecified if ongoing); "Known allergies: cipro (antibiotic)" (ongoing); "Known allergies: azo" (ongoing). Concomitant medication(s) included: ZOLOFT, start date: Mar2020; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: Nov2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: Other medications in 2 weeks were Women's multi vitamin (start date: Mar2020), Mupirocin saline rinse (start date: Apr2022). Patient received Paxlovid from 30Jun2022 for treatment of COVID-19 and experienced Metallic taste in mouth like others report constant smell like boar taint/high alcohol/racid lingering but much more pronounced around warmed foods.; Sender's Comments: Based on possible temporal association the causal role of suspect  cannot be excluded for the reported events.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Swollen lymph nodes; mild dry cough after 2nd dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 18-year-old male patient received BNT162b2 (BNT162B2), on 05Jul2021 as dose 2, single (Lot number: EW0179) at the age of 18 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Prev dose lot number: EW0183, Prev dose dose number: 1, Prev dose vaccine location: Left arm), administration date: 14Jun2021, when the patient was 18-year-old, for COVID-19 Immunization.  The following information was reported: LYMPHADENOPATHY (hospitalization, life threatening) with onset Dec2021, outcome "not recovered", described as "Swollen lymph nodes"; COUGH (hospitalization, life threatening) with onset Dec2021, outcome "not recovered", described as "mild dry cough after 2nd dose". The patient was hospitalized for lymphadenopathy, cough (hospitalization duration: 4 day(s)). The events "swollen lymph nodes" and "mild dry cough after 2nd dose" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Negative; (Dec2021) Negative. It was unknown if therapeutic measures were taken as a result of lymphadenopathy, cough.   Clinical course: It was reported that the patient did not had COVID prior vaccination and since the vaccination, the patient was tested for COVID-19. The patient had no known allergies. It was unknown if other vaccine in four weeks. It was reported that the patient had swollen lymph nodes and mild dry cough after 2nd dose. After receiving Mandatory Booster for College red blood cell and hemoglobin counts irregular. Required blood transfusions. Diagnosis is Lymphoma. only treatment is chemotherapy. Now also have stepping gait/drop foot.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200952509 same patient and product, different dose and different events;
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 48 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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 drugs" (unspecified if ongoing), notes: Known allergies: sulfa drugs; "Cough variant asthma" (unspecified if ongoing); "celiac" (unspecified if ongoing), notes: Other medical history: celiac; "juvenile rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE, start date: 01Sep2021. The following information was reported: DRUG INEFFECTIVE (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; Unknown results, notes: Rebound of Covid after paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Treatment included paxlovid from 01Jul2022 to 06Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: M
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 a contactable reporter(s) (Other HCP).  A 60-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), on 22Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 24Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "IBD" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "hypertension" (ongoing). Concomitant medication(s) included: AZATHIOPRINE oral; CITALOPRAM oral; IRBESARTAN oral. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jul2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2022) Positive; (08Jul2022) Negative; (12Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 and received Paxlovid orally.  Clinical information: The patient was treated with Paxlovid via oral from 02Jul2022 to 07Jul2022. Patient tested positive on 02Jul2022. After treatment, patient status was improved and tested negative 08Jul2022. He felt better then tested positive for COVID on 12Jul2022 with nasal congestion and headache only. No known allergies.  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 report, a causal association between reported events and suspect BNT162B2 cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 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. Add" (unspecified if ongoing), notes: Allergies. Add. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took anti viral medication Paxlovid, orally starting on 29Jun2022 and stopped on 03Jul2022. There were no other medication in 2 weeks.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to  the reported events COVID-19, drug ineffective cannot be completely excluded based on temporal association and known drug safety profile
Age: 67.0
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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 17Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma and rebounding; "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Jun2022, outcome "recovered" (2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jun2022) Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2weeks. The patient was treated with Paxlovid from COVID-19 from 01Jul2022 to 06Jul2022.  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, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 20Sep2021 as dose 3 (booster), single (Lot number: FF2588) 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 included: "Anylosing Spondolytis" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing), notes: known allergies: Sulfa drugs. Concomitant medication(s) included: ENBREL, start date: 01May2009, stop date: 19Jun2022; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Apr2021, stop date: 12Jul2022; SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE], start date: 01Apr2021, stop date: 12Jul2022. Past drug history included: Indocin, reaction(s): "known allergies: Indocin", notes: known allergies: Indocin. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jun2022, outcome "unknown", COVID-19 (medically significant) with onset Jun2022, outcome "not recovered" and all described as "COVID-19".Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid.  Clinical course: He received Paxlovid from 26Jun2022 to 30Jun2022. he also had rebound of symptoms on 11Jul2022.
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "POTS" (unspecified if ongoing); "PFO" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Addition information: Start date of treatment for COVID-19 was 02Jul2022. Stop date of treatment for COVID-19 was 06Jul2022. Adverse event: Rebound case a week after testing negative.  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, Pyrexia, SARS-CoV-2 test, Wound
Clinical narrative: had fever the week before; she had a wound; passed away from Covid; passed away from Covid; This is a spontaneous report received from a contactable reporter (Consumer or other non- HCP).  A 98-year-old female patient received BNT162b2 (COMIRNATY), as single dose (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "the nursing home had positive cases" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death), COVID-19 (death) all with onset 06Jun2022, outcome "fatal" and all described as "passed away from Covid"; PYREXIA (non-serious), outcome "unknown", described as "had fever the week before"; WOUND (non-serious), outcome "unknown", described as "she had a wound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) positive. Therapeutic measures were taken as a result of wound included bleach solution. The patient date of death was 06Jun2022. Reported cause of death: "passed away from Covid". It was not reported if an autopsy was performed. Clinical course: patient was in nursing home, the nursing home had positive cases. Patient died that day, after she tested positive 06Jun2022. She had fever the week before, but they thought it was because she had a wound. They were cleaning her aunt's wound with bleach solution and it was painful.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: passed away from Covid; passed away from Covid
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6203), in left arm, on 20Mar2021 as dose 2, single (Lot number: EN6206), in left arm and on 08Oct2021 at 09:00 as dose 3 (booster), single (Lot number: FF2587) at the age of 29 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Addition information: Start date of treatment for COVID-19 was 01Jul2022. Stop date of treatment for COVID-19 was 06Jul2022.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "psoriasis" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 01Jul2022 to 05Jul2022 (oral), for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 (COMIRNATY) to the reported events Drug ineffective and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gait inability
Clinical narrative: an 8 year old patient with pre-existing neurological issue who became weak and unable to walk after the 1st dose of the vaccine; an 8 year old patient with pre-existing neurological issue who became weak and unable to walk after the 1st dose of the vaccine; This is a spontaneous report received from contactable reporter(s) (Physician).  An 8-year-old female patient received BNT162b2 (BNT162B2), as dose 1, 10 ug single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "neurological issue" (unspecified if ongoing), notes: pre-existing neurological issue. The patient's concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), GAIT INABILITY (non-serious), all with latency 15 min after the suspect product(s) administration, outcome "unknown" and all described as "an 8 year old patient with pre-existing neurological issue who became weak and unable to walk after the 1st dose of the vaccine". The events "an 8 year old patient with pre-existing neurological issue who became weak and unable to walk after the 1st dose of the vaccine" required emergency room visit. Additional information: States the product is the Pfizer BioNTech Covid19 orange cap vaccine 10mcg dose and the reporter had an 8 year old patient with pre-existing neurological issue who became weak and unable to walk after the 1st dose of the vaccine; states the patient was sent to the emergency room immediately and the adverse event occurred immediately within 15 minutes of the patient waiting after the dose of vaccine was administered. States he does not know the route of administration of the vaccine or location of administration but the reporter was stating how she had done the vaccine in the upper arm but he does not want to mistakenly say that and he does not have the date of administration of the vaccine. Caller states the reporter did state that the patient has underlying neurological condition and did not clarify but it was a preexisting neurological condition the patient had before the vaccine was administered but did not clarify further details. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: PNC13
Symptoms: Breath holding, Seizure
Clinical narrative: afebrile seizures; breath-holding spell; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 6-month-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 2, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 13 (Dose 1), for Immunization. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "afebrile seizures"; BREATH HOLDING (non-serious), outcome "unknown", described as "breath-holding spell".  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: A possibly contributory role of PREVNAR 13 in triggering the onset of afebrile seizures cannot be fully excluded, considering the temporal relationship and known adverse event profile of the suspect vaccine.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 29.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 29 years for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) Positive, notes: Tested positive and was symptomatic again on Friday, 08Jul. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Addition information: Start date of treatment of COVID-19 was 27Jun2022. Stop date of treatment of COVID-19 was 01Jul2022. Full relapse of COVID illness one week after completing Paxlovid regimen. Tested positive and was symptomatic again on Friday, 08Jul. Known allergies was none.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Palpitations, Tachycardia
Clinical narrative: Weeks later she has tachycardia; you can even might feel her chest, heart is just jumping all around; Her pulse all that was elevated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 5 years for covid-19 immunisation. The patient's relevant medical history included: "oil fish" (unspecified if ongoing); "Oil shellfish" (unspecified if ongoing); "walnut including coconut" (unspecified if ongoing); "She can't even taken like sesame oil" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TACHYCARDIA (non-serious), outcome "unknown", described as "Weeks later she has tachycardia"; PALPITATIONS (non-serious), outcome "unknown", described as "you can even might feel her chest, heart is just jumping all around"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "Her pulse all that was elevated". The events "weeks later she has tachycardia", "you can even might feel her chest, heart is just jumping all around" and "her pulse all that was elevated" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that her daughter was 6 years but she got her first dose of the Pfizer vaccine at 5 years. Weeks later she had tachycardia, she could even might feel her chest, heart was just jumping all around. She took her to urgent care and the doctor said, she really did not know what to do. She said, she put her, she checked her pulse all that was elevated. She said get her follow up with her primary care with a (Voice not clear) so that was the result. The patient had lot of allergies like she was allergic to oil fish, oil shellfish, walnut including coconut. She could not even take like sesame oil. She kind of made her ice cream, the patient was getting better with tolerating certain ice creams and she knew, the immune system as well as allergies were similar they had similarities in terms of, what could cause for an allergen to. She did not know exactly what was going on but she wanted her to get the second dose of the Pfizer. She had her on schedule to get the second dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 18Mar2021 as dose 2, single (Lot number: ER2613), in left arm and on 24Nov2021 as dose 3 (booster), single (Lot number: FJ1620 or FJ2620) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jun2022) Positive, notes: Originally tested COVID positive (antigen) on 30Jun2022; (10Jul2022) Positive, notes: Retested positive for COVID on 10Jul2022 using home antigen test; (Jul2022) Positive, notes: I tested once more to confirm consistent negative test, I tested positive again; (Jul2022) negative, notes: After completion of paxlovid, received negative COVID result (antigen). Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: No known allergies. No other medication in 2 weeks. Originally tested COVID positive (antigen) on 30Jun2022. Initiated paxlovid treatment on 30Jun2022 and concluded complete dosing protocol at end of day on 04Jul2022. After completion of paxlovid, received negative COVID result (antigen). After completing the CDC recommendations for 5 days isolation and 5 days masking, patient tested once more to confirm consistent negative test, tested positive again. In speaking with the nurse practitioner ((email withheld), telehealth) this was identified as a rebound COVID case and that patient should report. Additionally, as patient was testing positive a second time, he was to restart the isolation/quarantine protocol. He was asymptomatic. Symptoms were minor during paxlovid treatment.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Paxlovid indication=Treatment of COVID-19; Paxlovid indication=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 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (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), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "anemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid indication=Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 at 13:15 as dose 1, single (Lot number: EL9261), in left arm, on 11Feb2021 at 13:15 as dose 2, single (Lot number: EL9264), in left arm and on 26Oct2021 at 13:15 as dose 3 (booster), single (Lot number: 30145BA) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "allergic to penvk" (unspecified if ongoing). Concomitant medication(s) included: DOXYCYCLINE, start date: Jan2020, stop date: 12Jul2022; LEVOTHYROXIN, start date: Jan1991, stop date: 12Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2022) negative; (08Jul2022) negative; (11Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that patient received vaccine and received covid treatment. It was reported that patient received other medication in 2 weeks. Patient received treatment with anti-viral for COVID 19 Treatment start on 02Jul2022 and stop on 06Jul2022 with lot number unknown. Adverse event Testing positive for COVID on 11Jul2022. Nasal congestion, cough as this was after testing negative (beginning on Wednesday, 06Jul2022 thru Friday, 08Jul2022). It was reported that adverse event start date on 12Jul2022 at 01:15 PM (not updated). Device time stamp on 12Jul2022.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; AMLOPINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: 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.  Clinical course: Patient received vaccine and other medication (Linsinopril and amlopine) in 2 weeks. Covid vaccine lot no. was unknown due to other reason that was unable to access at the time.   The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: EN6207), in right arm and on 30Apr2021 as dose 2, single (Lot number: EW070) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: AUBAGIO; SOLIFENACIN SUCCINATE; TRIAMTERENE & HCTZ. Past drug history included: Clindamycin, reaction(s): "Allergy", notes: known allergies: clindamycin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Addition information: Start date of treatment for COVID 19 was 05Jul2022. Stop date of treatment for COVID 19 was 09Jul2022.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose  2, single (Batch/Lot number: unknown) at the age of 35 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (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: positive; negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number 1, single (Batch/Lot number: unknown), as dose number 2, single (Batch/Lot number: unknown) and as dose number 3, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cancer" (unspecified if ongoing); "allergic to seafood" (unspecified if ongoing); "Iodine allergy" (unspecified if ongoing); "allergy" (unspecified if ongoing), notes: Morphine. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid, treatment start date: 03Jul2022. Patient reported that she received vaccine and no other medication were received in 2weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder
Clinical narrative: balance problems; 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 82-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose number unkn0wn, 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) with onset Mar2021, outcome "not recovered", described as "balance problems". The event "balance problems" required physician office visit.  Additional information: Serious reported as No. Patient had his Pfizer Covid19 vaccines I wouldn't have taken it if I knew the shot was like this  I took it in Jan or Feb later clarifying of last year meaning 2021. He went on to say, in Mar... like a week or two after I took the shots... my knees gave way on me then I started to have balance problems and all sort of health issues that I never had before. I'm 82 years old and up until I took that shot not many people could outrun me, or out-do, or out work there or do anything better than I could. reiterating that he has all these other problems" in addition to the balance problems but did not elaborate. Adding I'm going to a couple of doctors now, to try and see what I can do to resolve that.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngeal swab
Clinical narrative: COVID infection; COVID infection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 04Jun2022 at 10:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 44 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL; AMLODIPINE; LOSARTAN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Jun2022, outcome "recovered" (2022) and all described as "COVID infection". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (28Jun2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical Course: Report was about covid treatment. More than 3 Doses received. Facility type vaccine was Hospital. No other vaccine in four weeks. Other medication in 2 weeks were metoprolol, amlodipine, losartan. No covid prior vaccination. Covid tested positive post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Henoch-Schonlein purpura, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Inappropriate schedule of vaccine administered; Henoch-Schonlein Purpura; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 70-year-old female patient received BNT162b2 (BNT162B2), on 08Jun2021 as dose 2, single (Lot number: EN6200) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "HTN" (unspecified if ongoing), notes: other medical history: HTN; "dyslipidemia" (unspecified if ongoing); "allergic to scallops" (unspecified if ongoing), notes: allergic to scallops; "fatty liver" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose:1, lot number=EL9265), administration date: 04Feb2021, when the patient was 68-year-old, for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 08Jun2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; HENOCH-SCHONLEIN PURPURA (non-serious) with onset 2021, outcome "not recovered". The event "henoch-schonlein purpura" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of henoch-schonlein purpura.  Additional information: The patient also received Pfizer COVID vaccine as dose 4, single on 22Apr2022 and as dose 3, single (lot number: EW0164) on 20Oct2021. No other vaccine received by the patient in four weeks, The patient received other medications in two weeks. The patient in the wound clinic, who developed Henoch-Schonlein Purpura (biopsy proven) on her leg. No other symptoms. She said it started about 3 months after her second COVID vaccine shot. Patient still got booster shots, patient was treated at wound clinic. The patient did not have COVID prior vaccination. COVID was tested post vaccination.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the parent. A 5-year-old male patient received BNT162b2 (BNT162B2), on 29Nov2021 as dose 1, single (Lot number: FK5127, Expiration Date: 03Dec2021), on 17Dec2021 as dose 2, single (Lot number: FK5127, Expiration Date: 21Jan2022) and on 23May2022 as dose 3 (booster), single (Lot number: FL0007) at the age of 5 years for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jul2022, outcome "unknown" and all described as "got vaccinated still tested positive for covid19 afterwards". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive. Clinical course: Caller stated, she was vaccinated and twice boosted mother of 4 and part time acute care speech language pathologist. Her husband and four children (Ages 5, 5 (twins), 7, and 9) have each had 3 doses of the vaccine designed to lessen severe illness from a COVID-19 infection. They contracted COVID-19, likely 03Jul. Only one of the five year old's has remained negative via at home antigen testing. She was writing to ask if there are any studies that they could participate in that would assist you. Caller stated early in the pandemic they all signed up for the trial however they didn't get selected. Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200021017 Same reporter/vaccine/event, different patient;