chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative, notes: Tested negative on day5; (May2022) Positive, notes: Tested positive without symptoms on day 10. Therapeutic measures were taken as a result of covid-19, drug ineffective. Treatment received start date 17May2022 and stop date 21May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Body temperature, Illness, Platelet count, Pyrexia
Clinical narrative: terribly sick; fever of 102 degrees; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): EC-2022-111115.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; pembrolizumab (KEYTRUDA), (Batch/Lot number: unknown) and on 06Apr2022 (Batch/Lot number: unknown); lenvatinib mesilate (LENVIMA), as 20 mg (Batch/Lot number: unknown) and on 13Apr2022 (Batch/Lot number: unknown) for endometrial cancer. The patient's relevant medical history included: "Endometrial Cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete), for COVID-19 IMMUNIZATION. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "terribly sick"; PYREXIA (non-serious), outcome "unknown", described as "fever of 102 degrees". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for pembrolizumab and lenvatinib mesilate was temporarily withdrawn.  Additional information: Patient was taking Lenvima 20 milligrams for Endometrial Cancer and it had been put on hold due to her platelet count being low (previously reported). Keytruda was also put on hold. Patient states she resumed Keytruda on 04/06/2022. Her platelet count was better so the Lenvima was resumed on 04/13/2022. Patient reports last Wednesday she received her Covid booster and got terribly sick. She had a fever of 102 degrees.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 05Oct2021 as dose 3 (booster), single (Lot number: FC3180) at the age of 68 years, in right 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: SIMVASTATIN, in Dec1995. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset 18May2022, outcome "not recovered" and all described as "Treatment of covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 female patient (not pregnant) 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) at the age of 48 years for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Relapsing Polychondritis" (unspecified if ongoing), notes: Relapsing Polychondritis; "known allergies: Avocado" (unspecified if ongoing), notes: known allergies: Avocado; "known allergies: latex" (unspecified if ongoing), notes: known allergies: latex; "known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Cecile; "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA, stop date: 14May2022; CRESTOR, stop date: 15May2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective included Paxlovid started on 15May2022 and stopped on 13May2022. Clinical course was reported as, Rebound symptoms on 25May2022. No treatment received for symptoms and patient was not recovered from symptoms.  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: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 21-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization; 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 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL oral. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took oral Paxlovid for the treatment of COVID-19 started on 24May2022.  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 covid 19 , drug ineffective and the suspect drug BNT162b2 cannot be excluded. The case will be reassessed once new information is available.
Age: 71.0
Sex: M
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 71-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 30Sep2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 17Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunization. The patient had no relevant medical history. Concomitant medication(s) included: SIMVASTATIN, start date: 01Feb2008, stop date: 11May2022 and also reported as, other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: home antigen test kit; (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid (treatment start date: 11May2022, treatment stop date: 16May2022). Clinical course was reported as, after 3 days full treatment of Paxlovid, the patient was recovered and began to feel normal. Then on 21May2022, he began to have allergy like symptoms. The patient retested with home antigen test kit and tested Positive, followed up the next day with withheld drive thru PCR test which came back positive, he was at day 16 and still Positive but beginning to feel better. Patient was recovering from symptoms and no treatment received for symptoms.Vaccine lot unknown, unable to locate or read the details.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 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: "hypertension" (unspecified if ongoing); "known allergies: sulfa drugs" (unspecified if ongoing), notes: known allergies: sulfa drugs; "migraines" (unspecified if ongoing); "IBS" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; HYDROCHLOROTHIAZIDE; TOPIRAMATE; PANTOPRAZOLE. Past drug history included: Doxazosin, reaction(s): "known allergies: Doxazosin", notes: known allergies: Doxazosin. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 26May2022, outcome "unknown", COVID-19 (medically significant) with onset 26May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course information: The patient began having recurrence of COVID-19 symptoms 23May2022. Sinus congestion, scratchy throat, loss of taste and tested positive again for COVID-19 26May2022.  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 available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19.
Age: 51.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21May2022) Negative, notes: Negative test results; (23May2022) Negative; (24May2022) Negative; (25May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient did not receive other medications within 2 weeks of starting COVID-19 treatment. Anti viral details: Paxlovid, from 16May2022 to 21May2022, for COVID 19 treatment. After taking Paxlovid was getting negative test results on 21May2022 and 23May2022. On 24May2022 symptoms resumed and tested positive on 25May2022.
Age: 24.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old male patient received BNT162b2 (BNT162B2), on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 24 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: "lymphoma" (unspecified if ongoing), notes: Past: Lymphoma.; "anxiety" (ongoing), notes: Current: Anxiety; "Asthma" (ongoing), notes: Current: Asthma. Concomitant medication(s) included: PROZAC, start date: Dec2017; ALBUTEROL SULFATE HFA, start date: Sep2019. Past drug history included: Amoxicillin, reaction(s): "Allergy", notes: known allergies:Amoxicillin, Regalin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Re-tested positive after testing negative; (2022) Negative, notes: Re-tested positive after testing negative. 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: 30.0
Sex: F
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(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing), notes: Type 1 diabetes; "hypothyroid" (unspecified if ongoing), notes: hypothyroid. Concomitant medication(s) included: NOVOLOG; LEVOTHYROXINE; WELLBUTRIN; FLUOXETINE. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), SUSPECTED COVID-19 (hospitalization, medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient was hospitalized for drug ineffective, suspected covid-19 (hospitalization duration: 1 day(s)). Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: Finished Paxlovid five days after COVID diagnosis; felt better the following couple of days. Then out of nowhere, I got nauseous and started throwing up for about two hours. I had to go to the hospital to get IV fluids and anti nausea meds, and the 3-4 days since getting home I have had bad cold symptoms: cough, sneezing, congestion, runny nose, fatigue. Treatment includes pepcid and anti-nausea meds and fluids.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 25Sep2021 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 14Apr2022 as dose 2, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Coronary Artery Disease" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing). The patient's relevant medical history was not reported. No known allergies. There were no concomitant medications, also reported as no other medications in two weeks. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. Therapeutic measures were taken as a result of covid-19, vaccination failure included Paxlovid started on 30Apr2022 and stopped on 14May2022. Clinical course was reported as, Rebound of coryza, nasal congestion, sore throat, fatigue, myalgia, headache, malaise beginning about 4 days after completing Paxlovid on 18May2022. No treatment received for symptoms and patient was recovered from symptoms.  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 available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Covid-19 and drug ineffective.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vomiting
Clinical narrative: vomiting; chills; fever; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (2nd dose, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3, booster, Manufacturer unknown), for Covid-19 immunization. The following information was reported: VOMITING (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever"; HEADACHE (non-serious), outcome "unknown".  Additional information: It was reported that the patient experienced all the events the day following 4th Pfizer COVID booster vaccine at 6pm the day prior.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN 6199), in left arm and on 11Apr2021 as dose 2, single (Lot number: ER 8729) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Nov2021 as dose 3 (booster), single (Lot number: 011F22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products", start date: 12Nov2021, stop date: 12Nov2021, notes: Vaccine brand other: moderna. Concomitant medication(s) included: ESCITALOPRAM, start date: Jan2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2022) Negative, notes: Home rapid test was negative on day 5; (25May2022) Positive, notes: Tested positive on home rapid test. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: non-serious rheumatoid arthritis flareup in right foot/Usually it was in left foot; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4405472-00.  A 74-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovering", described as "non-serious rheumatoid arthritis flareup in right foot/Usually it was in left foot". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "non-serious rheumatoid arthritis flareup in right foot/usually it was in left foot" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the reported event: "Rheumatoid arthritis" and the suspect drug BNT162B2 cannot be completely excluded.   The impact of this report on the benefit/risk profile of the Pfizer drug 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: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Vaccination site pain
Clinical narrative: the patient had chills and body aches for a day or two after.; the patient had chills and body aches for a day or two after.; As well as tenderness at the injection site; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 9-year-old female patient received BNT162b2 (BNT162B2), on 14Dec2021 as dose 2, 0.2 ml single (Lot number: FK5618, Expiration Date: 25Feb2022) at the age of 9 years, in left arm and on 22May2022 as dose 3 (booster), 0.2 ml single (Lot number: FL8094, Expiration Date: 30Sep2022), in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose:1, Lot: FK5127, Expiry: 28Feb2022 , Dose and Route: 0.2mL IM, left arm), administration date: 22Nov2021, for Covid-19 Immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered", described as "As well as tenderness at the injection site"; CHILLS (non-serious), PAIN (non-serious) all with onset 2021, outcome "recovered" and all described as "the patient had chills and body aches for a day or two after.".  Additional Information: It was reported as no Emergency Room, no Physician Office visit, but this patient's mother did mention the patient had an immune reaction after she received the 2nd and 3rd dose, the patient had chills and body aches for a day or two after. As well as tenderness at the injection site, caller said the usual stuff. The 2nd dose was back in the winter. No Prior Vaccinations (within 4 weeks). No, nothing documented for AE(s) prior vaccinations. No Family Medical History.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 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 13Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "hypertension" (unspecified if ongoing); "seasonal and environmental allergies" (unspecified if ongoing), notes: other medical history: seasonal and environmental allergies; "environmental allergies" (unspecified if ongoing), notes: other medical history: seasonal and environmental allergies. Concomitant medication(s) included: LOSARTAN; HCTZ. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive; (May2022) Negative. Therapeutic measures were taken as a result of covid-19, vaccination failure. Clinical course included Return of symptoms - runny nose, fatigue, then cough and tested positive for COVID with home test. I had no symptoms by day 3 of Paxlovid treatment and tested negative 3 days after my final doses. (day 10 of my COVID infection)  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 25Mar2021 as dose 2, single (Lot number: EN6204), in right arm and on 30Sep2021 as dose 3 (booster), single (Lot number: FC3180) at the age of 55 years, in right arm for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Apr2022 as dose 4 (booster), single (Lot number: 002M21A), in right arm for covid-19 immunization. The patient's relevant medical history included: "Type II diabetes" (unspecified if ongoing), notes: Type II diabetes; "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "depression" (unspecified if ongoing) and " chronic congestion". Concomitant medication(s) included: METFORMIN; MONTELUKAST; LOSARTAN; SERTRALINE; LORATADINE; VITAFUSION FIBER WELL FIT, Kirkland mature multivitamin, also reported as patient received other medications in two weeks of starting COVID-19 treatment. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Negative, notes: Positive test result 6 days after negative result; (26May2022) Positive, notes: Positive test result 6 days after negative result. Therapeutic measures were taken as a result of covid-19, vaccination failure included Paxlovid started on 15May2022 and stopped on 20May2022. Clinical course was reported as, Positive test result 6 days after negative result and end of Paxlovid treatment. Symptoms (very mild so far) have resumed as well on 26May2022. No treatment received for symptoms and patient was not recovered from symptoms.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 14May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "minor asthma" (unspecified if ongoing), notes: minor asthma. Concomitant medication(s) included: SERTRALINE, start date: 01May2010; MONTELUKAST, start date: 01Jan2010; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Jan2000. Past drug history included: Quinolones, reaction(s): "known allergies: Quinolones". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course information: It was reported that the patient was taking other medications/products within 2 weeks of starting COVID-19 treatment  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
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) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 70 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. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (21May2022) Negative, notes: Negative test on 21May; (26May2022) positive, notes: Symptoms came back on 26May and test was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: If vaccine received: yes, other medication in 2 weeks: No. adverse event: Negative test on 21May. Symptoms came back on 26May and test was positive. Known allergies: No, Other medical history: No.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 12Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 30Oct2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 51 years, in left arm for Covid-19 immunisation; coviD-19 vaccine miRNA (miRNA 1273) (COVID-19 VACCINE MODERNA), on 08Apr2022 as dose 4 (booster), single (Lot number: 002M21A), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE, start date: 01Jan2022; METOPROLOL SUCCINATE, start date: 01Jan2022; LOSARTAN, start date: 01Jan2022; VITAMIN D 3, start date: 01Feb2022; KIRKLAND ALLER-TEC, start date: 01Jan2022; FLORA, start date: 04May2022; FLONASE SENSIMIST ALLERGY RELIEF, start date: 01Feb2022. Past drug history included: Lisinopril (cough), reaction(s): "Known allergies: Lisinopril (cough)", notes: known allergies Lisinopril (cough); Lisinopril (cough), reaction(s): "Known allergies: Lisinopril (cough)", notes: known allergies Lisinopril (cough). The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Positive Covid rapid test; (unspecified date) Negative, notes: tested negative for 8 consecutive days; (May2022) Positive, notes: tested negative for 8 consecutive days and then tested positive; (May2022) Positive, notes: Positive test was 5 days after completing Paxlovid. Therapeutic measures were taken as a result of Covid-19, vaccination failure. Clinical course: The patient received anti-viral product for Covid-19 treatment, brand-Paxlovid, treatment start date 15may2022, treatment stop date 19may2022. Positive Covid rapid test and mild Covid symptoms after treatment with Paxlovid. The patient tested negative for 8 consecutive days and then tested positive and experienced mild symptoms on day 9. Positive test was 5 days after completing Paxlovid treatment. Symptoms are mild but he concerned that he may still be contagious and he getting conflicting advice from his doctor over whether he should continue to quarantine or not.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 12Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 30Oct2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 51 years, in left arm for Covid-19 immunisation; coviD-19 vaccine miRNA (miRNA 1273) (COVID-19 VACCINE MODERNA), on 08Apr2022 as dose 4 (booster), single (Lot number: 002M21A), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE, start date: 01Jan2022; METOPROLOL SUCCINATE, start date: 01Jan2022; LOSARTAN, start date: 01Jan2022; VITAMIN D 3, start date: 01Feb2022; KIRKLAND ALLER-TEC, start date: 01Jan2022; FLORA, start date: 04May2022; FLONASE SENSIMIST ALLERGY RELIEF, start date: 01Feb2022. Past drug history included: Lisinopril (cough), reaction(s): "Known allergies: Lisinopril (cough)", notes: known allergies Lisinopril (cough); Lisinopril (cough), reaction(s): "Known allergies: Lisinopril (cough)", notes: known allergies Lisinopril (cough). The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Positive Covid rapid test; (unspecified date) Negative, notes: tested negative for 8 consecutive days; (May2022) Positive, notes: tested negative for 8 consecutive days and then tested positive; (May2022) Positive, notes: Positive test was 5 days after completing Paxlovid. Therapeutic measures were taken as a result of Covid-19, vaccination failure. Clinical course: The patient received anti-viral product for Covid-19 treatment, brand-Paxlovid, treatment start date 15may2022, treatment stop date 19may2022. Positive Covid rapid test and mild Covid symptoms after treatment with Paxlovid. The patient tested negative for 8 consecutive days and then tested positive and experienced mild symptoms on day 9. Positive test was 5 days after completing Paxlovid treatment. Symptoms are mild but he concerned that he may still be contagious and he getting conflicting advice from his doctor over whether he should continue to quarantine or not.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Fatigue, SARS-CoV-2 test positive
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 12Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 30Oct2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 51 years, in left arm for Covid-19 immunisation; coviD-19 vaccine miRNA (miRNA 1273) (COVID-19 VACCINE MODERNA), on 08Apr2022 as dose 4 (booster), single (Lot number: 002M21A), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE, start date: 01Jan2022; METOPROLOL SUCCINATE, start date: 01Jan2022; LOSARTAN, start date: 01Jan2022; VITAMIN D 3, start date: 01Feb2022; KIRKLAND ALLER-TEC, start date: 01Jan2022; FLORA, start date: 04May2022; FLONASE SENSIMIST ALLERGY RELIEF, start date: 01Feb2022. Past drug history included: Lisinopril (cough), reaction(s): "Known allergies: Lisinopril (cough)", notes: known allergies Lisinopril (cough); Lisinopril (cough), reaction(s): "Known allergies: Lisinopril (cough)", notes: known allergies Lisinopril (cough). The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Positive Covid rapid test; (unspecified date) Negative, notes: tested negative for 8 consecutive days; (May2022) Positive, notes: tested negative for 8 consecutive days and then tested positive; (May2022) Positive, notes: Positive test was 5 days after completing Paxlovid. Therapeutic measures were taken as a result of Covid-19, vaccination failure. Clinical course: The patient received anti-viral product for Covid-19 treatment, brand-Paxlovid, treatment start date 15may2022, treatment stop date 19may2022. Positive Covid rapid test and mild Covid symptoms after treatment with Paxlovid. The patient tested negative for 8 consecutive days and then tested positive and experienced mild symptoms on day 9. Positive test was 5 days after completing Paxlovid treatment. Symptoms are mild but he concerned that he may still be contagious and he getting conflicting advice from his doctor over whether he should continue to quarantine or not.
Sex: M
Vaccine: COVID19
Symptoms: Blepharitis
Clinical narrative: Blepharitis; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A 50-year-old male 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: BLEPHARITIS (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Myalgia, Surgery
Clinical narrative: Stiffness; soreness in his shoulder and arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Hernia" (unspecified if ongoing), notes: Hernia, Was in his belly; "Blood pressure" (unspecified if ongoing); "thyroid" (unspecified if ongoing). Concomitant medication(s) included: FINASTERIDE; LEVOTHYROXINE; LISINOPRIL; TAMSULOSIN HCL. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Stiffness"; MYALGIA (non-serious), outcome "unknown", described as "soreness in his shoulder and arm".  Additional information: Stiffness: It occurred probably within 2 weeks of the last shot which was around 01Arp2022. Caller then stated it was actually 31Mar2022 that he got the last shot, the second booster and not 01Apr2022 as previously stated. Does not know exactly when he noticed it. It was within 2 weeks of the shot. Had surgery on 20May2022 and when he was going into surgery, he was aware of them. Outcome: Was really a weird thing that was couple of times, he thought. Thought he was coming out of it persisted and he thought he was coming out of it. It is a hard thing to describe. It progressed from stiffness to soreness and has been a really weird thing. He sleeps on his side and when he had surgery, he had to sleep on that sore shoulder all the time. It was hernia surgery and he couldn't sleep on the right side. Clarified that it was his left arm that had the stiffness and soreness in the shoulder. His left side has taken a beating. Soreness in shoulder and arm: He states that when they test the arm and stuff and when he has a checkup, they have to put out his arms to see how much he can lift with his arm. They put their arm on his arm and when he puts his arm straight, that is where he really feels it, when his arms are straight out and he is trying to push his arm up. It is like trying to lift something with his arm. When his arm is straight out, he can really feel it. He is doing it right now and he can't do it. It is just not right. It may have been the pneumonia vaccine or something. He has gotten all kinds of vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 54-year-old male patient received BNT162b2 (BNT162B2), on 19Apr2022 as dose 4 (booster), single (Lot number: FK98494) at the age of 54 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 26Mar2021 as dose 1, single (Lot number: 038A21A), on 23Apr2021 as dose 2, single (Lot number: 048B21A) and on 01Nov2021 as dose 3 (booster), single (Lot number: 039021A) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "obesity" (unspecified if ongoing); "former smoker" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: He continued to test positive another week; (08May2022) Positive, notes: he tested strong positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: other medication in 2weeks product includes Atorvastatin. The patient did not have any known allergies. The patient received Paxlovid (Ora) from 29Apr2022 to 03May2022, for the treatment of COVID-19; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Drug ineffective, Covid 19 cannot be completely excluded.
Age: 48.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 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 had no relevant medical history. Concomitant medication(s) included: SYNTHROID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: symptomatic six days after testing negative; Positive, notes: tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other medication in 2weeks. COVID 19 Treatment: Paxlovid, treatment was received from 14May2022 to 19May2022. On 23May2022, rebound tested positive and symptomatic six days after testing negative. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: M
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 50-year-old male patient received BNT162b2 (BNT162B2), on 16Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing); "Enlarged Prostrate" (unspecified if ongoing). There were no concomitant medications. 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: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Addition information: Other medication in 2 weeks was none. Known allergies was none. Vaccine received was yes. Treatment start date was 16May2022 and treatment stop date was 20May2022. Got rebound COVID after antiviral on 26May2022 and no treatment was received for it and recovering.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.