chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
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 66-year-old male patient received BNT162b2 (BNT162B2), on 06Feb2021 at 10:00 as dose 1, single (Lot number: EL3247), in left arm, on 01Mar2021 at 10:00 as dose 2, single (Lot number: EN6200), in left arm, on 26Nov2021 at 10:00 as dose 3 (booster), single (Lot number: FH8030), in left arm and on 02Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TADALAFIL, start date: 01Apr2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: Continue to test COVID positive on home antigen test (Day 11). Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: COVID symptoms resolved 3 days after being on Paxlovid (Day 3). COVID Rebound began 3 days after finishing 5-day course (Day 8 of infection). With runny nose, cough, malaise. Temperature beginning to rise 6 days after ending 5-day treatment (Day 11) currently 99.9. Continue to test COVID positive on home antigen test (Day 11). No known allergies. No treatment AE.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6204), on 01Apr2021 as dose 2, single (Lot number: ER8737) and on 09Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; BISOPROLOL /HCTZ; VITAMIN D [COLECALCIFEROL]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20May2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) Negative, notes: tested negative on antigen tests on 17May, 18May and 19May; (18May2022) Negative, notes: tested negative on antigen tests on 17May, 18May and 19May; (19May2022) Negative, notes: tested negative on antigen tests on 17May, 18May and 19May; (21May2022) Positive, notes: symptoms returned 20May along with positive antigen test 21May; (27May2022) Positive, notes: positive antigen test 27May; (24May2022) Positive, notes: positive PCR test 24May. Therapeutic measures were not taken as a result of vaccination failure, covid-19. No follow-up attempts are possible. No further information is expected.
Age: 34.0
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose number unknown, single (Lot number: ER8733) and on 14Apr2021 as dose number unknown, single (Lot number: EW0158) at the age of 34 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15May2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: After taking the entire course of paxlovid, I felt better, but a couple days later I started getting symptoms again and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course of the events: Other medication in 2weeks: Yes. Adverse event: Patient had a bitter taste in my mouth after taking Paxlovid. After taking the entire course of Paxlovid, patient felt better, but a couple days later started getting symptoms again and tested positive. Adverse event start date: 15May2022. Patient recovered: Recovering.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 55-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 25Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "kleinfelter's syndrome" (unspecified if ongoing); "Known allergies:Iodine based contrast dye" (unspecified if ongoing), notes: Iodine based contrast dye; "Known allergies:Iodine based contrast dye" (unspecified if ongoing), notes: Iodine based contrast dye. Concomitant medication(s) included: LYUMJEV [INSULIN LISPRO], start date: Jan2020; LANTUS, start date: Jan2013; ATORVASTATIN, start date: Jan2015; LEVOTHYROXINE, start date: Jan2015; TESTOSTERONE, start date: Jun1994; VITAMIIN C, start date: Jan2000; VITAMIN D [COLECALCIFEROL], start date: Jan2000; CALCIUM, start date: Jan2018. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: PNC20
Symptoms: Axillary pain, Nausea, Vaccination site erythema, Vaccination site pain
Clinical narrative: I had a side effect; I have soreness under my arm, the left arm where I had the shot; My arm is red; Nausea; 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 pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "I had a side effect; I have soreness under my arm, the left arm where I had the shot"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "My arm is red"; NAUSEA (non-serious), outcome "unknown".  Additional Information: Concern: Consumer (patient) stated, had a side effect from this Prevnar 20 vaccine and patient wanted, was there any kind of medication patient could take. Patient did have soreness under arm, the left arm where patient had this shot and arm was red. So, was there any kind of medication that kind of like get me calm back that or not. Paraphrase concern: Consumer stated, "Yes." Consumer was informed about the role of Pfizer Drug Safety Department. Consumer was informed about the Pfizer Medical Information Department and provided with the number, timings as 8 am to 9 pm on Monday to Friday. In response to file safety report: Consumer stated, "was it concerned a medication because you know, to help patient with this nausea that patient had (Appropriate response was provided). Okay, go ahead." When probed for mailing address consumer hung up the call abruptly. Further probing could not be done as consumer hung up the call abruptly. Hence, product details (lot, expiration date, NDC, UPC), purchase details and other details were unknown and limited information was available over the call. Reporter type was not available over the call hence, reporter type captured as consumer or other non health professional in tab by default.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 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: "known allergies: Almonds and walnuts" (unspecified if ongoing), notes: known allergies: Almonds and walnuts. Concomitant medication(s) included: ZINC; VITAMIN D [COLECALCIFEROL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Positive, notes: Positive test two days after a negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid,19May2022 to 24May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Off label use
Clinical narrative: Booster; Off label use; 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 66-year-old male patient received BNT162b2 (BNT162B2), on 04May2022 as dose 4 (booster), single (Lot number: Fk9895) at the age of 66 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: "Pre diabetes" (unspecified if ongoing), notes: Pre diabetes; "gout" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: other medical history:  Pre diabetes, gout, high bl, hypercholesterolemia. Concomitant medication(s) included: ATORVASTATIN; OLMESARTAN/HYDROCHLOROTHIAZIDE; ALLOPURINOL. The following information was reported: IMMUNISATION (medically significant) with onset 04May2022, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 04May2022, outcome "unknown"; 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.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Heart rate, 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 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 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: "Known allergies: Seasonal" (unspecified if ongoing), notes: Known allergies: Seasonal. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE]. 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". The patient underwent the following laboratory tests and procedures: Heart rate: (27May2022) low heart rate (48-52), notes: occurred for 4 hours, 2 hours after taking the 3rd and 4th doses. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course Paxaloid was taken for covid-19 and adverse events noticed Chest pain with low heart rate (48-52) occurred for 4 hours, 2 hours after taking the 3rd and 4th doses.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 31.0
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 32-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Lot number: ER8735), in left arm and on 11May2021 as dose 2, single (Lot number: EW0173) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 22Nov2021 as dose 3 (booster), single (Lot number: CILFZIA), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Date of last menstrual period: 27Sep2021. The patient was 8 weeks pregnant at the time of exposure to coviD-19 vaccine mrna (mrna 1273). The patient was 34 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 04Jul2022. Concomitant medication(s) included: CALCIUM, start date: 01Sep2021; IRON, start date: 01Mar2022; ASPIRIN [ACETYLSALICYLIC ACID], start date: 16May2022. 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: (May2022) Positive; (23May2022) Negative, notes: Had previously tested negative on a home antigen test. Therapeutic measures were taken as a result of covid-19, vaccination failure. Clinical course: Symptoms returned (congestion, body aches) today, then tested positive on a home antigen test. Had previously tested negative on a home antigen test on 23May2022. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, 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 40-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Batch/Lot number: unknown), on 01May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 17Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 11May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Relapse of COVID19 symptoms, notes: Relapse of COVID 19 symptoms (congestion, headache, fatigue, night sweats) following 14 days from initial onset of symptoms. I had recovered, and was symptom-free by day 4 of disease onset. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Other medication in 2weeks was reported as no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 23.0
Sex: M
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) (Other HCP). The reporter is the patient.  A 23-year-old male patient received BNT162b2 (BNT162B2), on 05May2022 as dose 4 (booster), single (Lot number: 017F21AFM9992) at the age of 23 years, in left arm for covid-19 immunization; 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 immunization. The patient's relevant medical history included: "Hydronephrosis" (unspecified if ongoing); "kidney stones" (unspecified if ongoing); "dairy" (unspecified if ongoing), notes: Reaction: Allergy: dairy. Concomitant medication(s) included: ALLEGRA, start date: 01Jan2015; LEXAPRO, start date: 01Aug2020; PRILOSEC [OMEPRAZOLE], start date: 01Jan2021; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, start date: 03May2022; TIVICAY, start date: 03May2022; also reported as patient received other medications in two weeks of starting COVID-19 treatment. Past drug history included: Nsaids, reaction(s): "NSAIDs: Drug Allergy"; Amoxicillin, reaction(s): "amoxicillin: Drug allergy". 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: negative for 8 days; Positive, notes: positive on Day 9. Therapeutic measures were taken as a result of drug ineffective, covid-19 included COVID 19 treatment started on 17May2022 and stopped on 22May2022. Clinical course was reported as, Paxlovid rebound. Tested positive on Day 9 after negative for 8 days, on 26May2022. No treatment received for symptoms and patient was recovering from symptoms.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: tomatoes" (unspecified if ongoing), notes: known allergies: tomatoes. Concomitant medication(s) included: PRAVASTATIN, start date: Dec2021, stop date: 19May2022; VITAMIN D [COLECALCIFEROL]; CLARITIN [LORATADINE] and also reported as, other medications/products within 2 weeks. 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: (2022) Negative, notes: Had two negative COVID tests after initial infection; (2022) Positive, notes: Positive COVID test after symptoms recurred; (2022) Negative, notes: Had two negative COVID tests after initial infection. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid (start date: 19May2022, stop date: 23May2022). Clinical course was reported as, The patient had positive COVID test after symptoms recurred. congestion, cough, headache. Had two negative COVID tests after initial infection. Patient was not recovered from symptoms and no treatment received for symptoms. Vaccine lot number was not available/provided to reporter at the time of report completion.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Nov2021 as dose 2 (booster), single (Lot number: 3302680) at the age of 62 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 01Apr2021 as dose 1, single (Lot number: 1808978), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "unknown", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid, treatment start date: 18May2022, treatment stop date: 16May2022.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, Off label use, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; OFF LABEL USE; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6199), in left arm and on 29Mar2021 as dose 2, single (Lot number: ER2613), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Oct2021 as dose 3 (booster), single (Lot number: 017F21A), in left arm and on 05Apr2022 as dose 4 (booster), single (Lot number: 022L21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OFF LABEL USE (medically significant) with onset 05Apr2022, outcome "unknown"; IMMUNISATION (medically significant) with onset 05Apr2022, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28May2022, 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 positive after being negative; (28May2022) Positive, notes: tested positive after being negative. Therapeutic measures were taken as a result of vaccination failure, covid-19, off label use, immunisation.  Clinical course information: The patient was not taking any other medications within 2 weeks and the patient had return of congestion and tested positive after being negative. The patient had no known allergies.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 16May - tested positive; 16May - tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 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 16May2022, outcome "unknown" and all described as "16May - tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) positive; (25May2022) negative; (28May2022) positive, notes: Minor symptoms start again. 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Off label use
Clinical narrative: Booster; Off label use; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6198), on 25Mar2021 as dose 2, single (Lot number: ER8730), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19Apr2022 as dose 4 (booster), single (Lot number: 002M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Inflammatory Polyarthropathy" (unspecified if ongoing), notes: Inflammatory Polyarthropathy; "Interchange of vaccine" (unspecified if ongoing), notes: vaccine brand other=Moderna, vaccine lot number=Moderna 002M21A, vaccine dose number=4. Concomitant medication(s) included: HYDROXYCHLOROQUINE. The following information was reported: IMMUNISATION (medically significant) with onset 19Apr2022, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 19Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug BNT162B2 to all the reported events cannot be completely excluded based on temporal association and known drug safety profile
Age: 70.0
Sex: M
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 71-year-old male patient received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 13Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Overweight" (unspecified if ongoing); "Known allergies:Some antibiotics and pain killers" (unspecified if ongoing), notes: Known allergies: Some antibiotics and pain killers. The patient's concomitant medications were not reported. 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, suspected covid-19. Adverse event: First I want to say it stopped the progress of COVID within 24 hours and I felt much better in just a few days. The adverse effect is a horrible bitter taste in my mouth 24/7 while taking the medication. I would wake up every 2 hours at night with extremely dry mouth and the bitter taste. I took my last dose this morning and at 2:30 I still have the taste. I just finished the course of doses so hopefully tomorrow I will have some relief.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: M
Vaccine: COVID19
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 contactable reporter(s) (Physician). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 31Jan2021 as dose 1, single (Lot number: En5318), in left arm, on 21Feb2021 as dose 2, single (Lot number: En6203), in left arm and on 01Oct2021 as dose 3 (booster), single (Lot number: Fe3592) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "reflux" (unspecified if ongoing), notes: reflux. Concomitant medication(s) included: AMLODIPINE; FLUOXETINE [FLUOXETINE HYDROCHLORIDE]; PANTOPRAZOLE; CELEBREX; ZOLPIDEM; VITAMIN D [COLECALCIFEROL]; VITAMIN E [TOCOPHEROL]; ZINC; COENZYME Q10 [UBIDECARENONE]; SAW PALMETO. The following information was reported: VACCINATION FAILURE (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: (25May2022) Negative, notes: Negative test at 10 days; (May2022) Positive, notes: Positive at 12 days. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: COVID relapse Negative test at 10 days Positive at 12 days with return of fever cough and nasal congestion. No known allergies.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug BNT162B2 to all the reported events cannot be completely excluded based on temporal association and known drug safety profile
Age: 36.0
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 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history included: "Hodgkin Lymphoma cancer survivor" (unspecified if ongoing), notes: Hodgkin Lymphoma cancer survivor. Concomitant medication(s) included: FISH OIL. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 18May2022, outcome "unknown", COVID-19 (medically significant) with onset 18May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) Negative, notes: at-home antigen test was negative on day 8; (27May2022) Positive, notes: Day 9, symptoms began to return and began to test positive again; (18May2022) Positive, notes: Tested PCR positive for COVID. Treatment start date was 18May2022 and Treatment stop date was 22May2022. COVID vaccine details: Vaccine administration date: 02Apr2021. Vaccine lot unknown reason: Not available/provided to reporter at the time of report completion. Other medication in 2weeks brand: Fish Oil. Adverse event: Paxlovid rebound experience. Tested PCR positive for COVID on 18May2022. Began full course of Paxlovid on 18May2022. Completed full course of Paxlovid on 22May2022. Symptoms subsided and at-home antigen test was negative on day 8. Day 9, symptoms began to return and began to test positive again. By day 11 (time of filing) returned to same symptoms experienced on Day 1. Other medical history: Hodgkin Lymphoma cancer survivor. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for (BNT162N2) has been requested and will be submitted if and when received.
Age: 85.0
Sex: F
Vaccine: COVID19, 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.  An 85-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 85 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Blood pressure" (unspecified if ongoing); "just diagnosed with lung cancer" (unspecified if ongoing), notes: just diagnosed with lung cancer; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical Course: It was reported that, the patient received Paxlovid (Lot number: GA3588) from 24May2022 to 26May2022 for treatment of COVID-19. The patient reported that, after taking PAXLOVID for two days, it was impossible for her to get any sleep day or night. She had two almost sleepless nights. Very unpleasant worse than the COVID which was mild as she was vaccinated twice and had two boosters.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive rapid test; Positive rapid test; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Oct2021 at 19:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in right arm 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 and concomitant medications were not reported. No other medications the patient received within 2 weeks of vaccination. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "Positive rapid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective included Paxlovid (Batch/lot number: Ga5120) started on 18May2022 and stopped on 22May2022. Clinical course was reported as, Rebound congestion symptoms. Treatment received for symptoms was unknown and patient was not recovered from symptoms.  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 currently available, a possible contributory role of the suspect drug BNT162b2 to all the reported events cannot be completely excluded based on temporal association and known drug safety profile
Age: 65.0
Sex: M
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 65-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 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 immunization. The patient's relevant medical history included: "Prostate cancer" (unspecified if ongoing), no known allergies. There were no concomitant medications, reported as, no other medications/products within 2 weeks.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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: for five days; (2022) Positive, notes: for the last five days. Therapeutic measures were taken as a result of covid-19 included (Treatment start date: 13May2022, treatment stop date: 18May2022). Clinical course was reported as, Paxlovid created rebound COVID. After testing negative for five days the patient was tested positive for the last five days. Patient was recovering from symptoms and no treatment received for symptoms. Vaccine lot was not available/provided to reporter at the time of report completion  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 at 11:00 as dose 1, single (Lot number: ER8727), in left arm, on 09Apr2021 at 10:00 as dose 2, single (Lot number: ER8735), in left arm and on 13Dec2021 at 09:00 as dose 3 (booster), single (Lot number: 331308A) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "overweight" (unspecified if ongoing); "known allergies: Sulfas" (unspecified if ongoing), notes: known allergies: Sulfas. Concomitant medication(s) included: LEVOTHYROXINE. 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.  Clinical course information: On 27May2022 the patient had cramping in her stomach, on 28May2022 she had aches and chills and on 29May2022, she had body aches as no chills and headache  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19, 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 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Sep2021 at 12:00 as dose 3 (booster), single (Lot number: 301308A) at the age of 72 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 included: "High cholesterol" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: LIPITOR, stop date: 17May2022; FOSAMAX, stop date: 02May2022. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin. 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, suspected covid-19 included Anti viral from 18May2022 to 23May2022.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Off label use, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Booster; Off label use; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Apr2022 at 09:45 as dose 4 (booster), single (Lot number: FJ4989) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing), notes: Other medical history: Lupus; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: HYDROXYCHLOROQUINE, start date: 07Jul2019; PROPRANOLOL, start date: 01Oct2018; LEVOTHYROXINE, start date: 27Mar2021. The following information was reported: IMMUNISATION (medically significant) with onset 29Apr2022, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 29Apr2022, outcome "unknown"; 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: (26May2022) Negative; (29May2022) 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: 67.0
Sex: M
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 67-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EL9267), in right arm, on 18Mar2021 as dose 2, single (Lot number: EP7534), in right arm, on 11Sep2021 as dose 3 (booster), single (Lot number: FF2588), in right arm and on 30Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "polymyalgia rheumatica" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE, start date: 20Mar2021; BREO ELLIPTA. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11May2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) Positive; (19May2022) Negative; (24May2022) Positive; (29May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course included patient received other medication in 2 weeks. COVID 19 relapse after Paxlovid. Onset of symptoms 08May2022. First positive test 11May2022. Course of Paxlovid 11May to 15May2022. First  Negative test 19May2022. Return of symptoms and positive test 24May2022. Symptoms and positive test still continuing as of 29May2022. The CDC guidance suggested reporting this event
Age: 41.0
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) (Nurse). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient 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 "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. No other medications the patient received within 2 weeks of vaccination. I had bad rebound symptoms 4 days after taking Paxlovid and also started testing positive again.  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 BNT162b2  to all the reported events cannot be completely excluded based on temporal association and known drug safety profile