chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19, 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 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years 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.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19.Other medication in 2 weeks were reported as none. Reason for vaccine lot unknown, not available or provided to reporter at the time of report completion.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: PAXAES report with Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2); Report with Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 17Mar2021 as dose 2, single (Lot number: EP7534), in right arm and on 15Oct2021 as dose 3 (booster), single (Lot number: EN6203) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos" (unspecified if ongoing), notes: Other medical history: Hashimotos; "Known allergies: Gluten" (unspecified if ongoing), notes: Known allergies: Gluten, penicillin; "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: Gluten, penicillin. Concomitant medication(s) received in 2weeks of vaccination which included: TIROSINT, start date: 01Dec2011; LEXAPRO, start date: 01Mar2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset 05May2022, outcome "unknown", COVID-19 (medically significant) with onset 05May2022, outcome "recovering" and all described as "report with Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2)". Therapeutic measures were not 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.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive for Covid; positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 at 14:00 as dose 1, single (Lot number: EP7534) at the age of 74 years, in left arm, on 09Apr2021 at 13:00 as dose 2, single (Lot number: EW0153), in left arm and on 10Dec2021 at 15:00 as dose 3 (booster), single (Lot number: FF8841), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies; sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: KLONOPIN; FINASTERIDE; GABAPENTIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Apr2022, outcome "unknown" and all described as "positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Apr2022) Positive; (29Apr2022) Negative; (02May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course: Started Paxlovid when first tested positive for Covid 23Apr2022 with home test. Really helped symptoms by next day - no fever or cough and most aches gone. Finished Paxlovid on 27Apr2022. Tested negative with home test 29Apr2022. On evening of 01May2022 started symptoms - runny nose, stuffy head. Tested positive again 2May2022 with home test. Still positive 6May2022 with head congestion and fatigue. Paxlovid did keep symptoms from getting severe.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: First time tested positive; First time tested positive; Sore throat; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: Er2613), in left arm, on 09Apr2021 at 10:00 as dose 2, single (Lot number: Ew0153), in left arm and on 30Nov2021 at 10:00 as dose 3 (booster), single (Lot number: Fj8762) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; METFORMIN HYDROCHLORIDE; CALCIUM; VITAMIN B COMPLEX; CRANBERRY [ASCORBIC ACID;VACCINIUM MACROCARPON]. Past drug history included: Reglan, reaction(s): "Known allergies: Reglan"; Compazine, reaction(s): "Known allergies: Compazine".  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "First time tested positive"; OROPHARYNGEAL PAIN (non-serious) with onset 2022, outcome "unknown", described as "Sore throat"; FATIGUE (non-serious) with onset 2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: First time tested positive; (2022) Negative, notes: 5 days later tested negative; (27Apr2022) Positive, notes: Tested positive for Covid a second time. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: The patient took other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. First time tested positive Sore throat, fatigue. Mild symptoms. 5 days later tested negative. The patient received treatment for the adverse event with Paxlovid. 4 days later started with stuffy nose, sneezing, and mild cough. On day 5 after completing Paxlovid, tested positive for Covid a second time. The symptoms are much worse this time. Date of start of reaction/event: 27Apr2022. Date of end of reaction/event: 02May2022. No Hospitalization Prolonged. AE resulted in none of the above.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test negative, SARS-CoV-2 test positive
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 60-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Mildly high blood pressure" (unspecified if ongoing); "Penicillin" (unspecified if ongoing), notes: Known allergies Penicillin; sulfa; "Sulfa" (unspecified if ongoing), notes: Known allergies Penicillin; sulfa. The patient's 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 (1st booster dose , manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test negative: (Apr2022) negative, notes: Fully recovered from Covid after five day course of Paxlovid; antigen test negative; SARS-CoV-2 test positive: (Apr2022) positive, notes: four days later symptoms returned and antigen test turned positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Fully recovered from Covid after five day course of Paxlovid; antigen test negative; four days later symptoms returned and antigen test turned positive again; sore throat, congestion, cough, fatigue. I'm on day 8 since symptoms returned -- improving slowly but still testing positive on antigen test  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 52 years, in left arm for covid-19 immunisation; COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 27Apr2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant) with onset 27Apr2022, outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Apr2022) positive; (02May2022) negative, notes: a rapid in home test; (06May2022) negative, notes: a rapid in home test; (07May2022) positive. Therapeutic measures were taken as a result of covid-19. COVID 19 Treatment included Paxlovid from 27Apr2022 to 02May2022.  Clinical course: No known allergies reported. The patient received no other medications in 2 weeks. Patient had tested positive on 27Apr and took the 5 days of Paxlovid and felt no symptoms upon completion. On his last day of taking Paxlovid 02May, he was tested negative with a rapid in home test. 3 days later on 05May he began experiencing minor symptoms (cough, runny nose). On 06May the symptoms worsened and he took a rapid in home test which was negative. On 07May the cough was much worse and he tested positive.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2021 at 01:00 as dose 3 (booster) , single (Lot number: 30145BA) at the age of 70 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 068H21A) 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); "High Cholesterol" (unspecified if ongoing). Known allergies were reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19. Anti-viral details was covid 19 treatment, paxlovid, treatment start date 22apr2022, treatment stop date=27apr2022, for treatment of covid-19.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: Tested positive with immediate strong test line in rapid antigen test on day 12 and day 14.; Tested positive with immediate strong test line in rapid antigen test on day 12 and day 14.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: EW0161) and on 04May2021 as dose 2, single (Lot number: EW0173) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 08Dec2021 as dose 3 (booster), single (Lot number: 018F21A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Apr2022, outcome "recovering" and all described as "Tested positive with immediate strong test line in rapid antigen test on day 12 and day 14.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (23Apr2022) Positive; (May2022) Positive, notes: Tested positive with immediate strong test line in rapid antigen test on day 12 and day 14; (May2022) Positive, notes: Tested positive with immediate strong test line in rapid antigen test on day 12 and day 14. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; No further information is expected.
Age: 27.0
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: ER8732), in left arm, on 23Apr2021 as dose 2, single (Lot number: EW0164), in left arm and on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Major depression" (unspecified if ongoing); "generalized anxiety" (unspecified if ongoing), notes: generalized anxiety. There were no concomitant medications. Past drug history included: Compazine, reaction(s): "known allergies Compazine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Dry throat, Nasal congestion, SARS-CoV-2 test, Sinus pain
Clinical narrative: Tested extremely positively on day 10; Tested extremely positively on day 10; Congestion; Lingering dry throat; Sinus pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 at 13:00 as dose 1, single (Lot number: Ew0151), in left arm and on 30Apr2021 at 11:00 as dose 2, single (Lot number: Ea8736) at the age of 30 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Nov2021 at 18:00 as dose 3 (booster), single (Lot number: 067F21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: NASAL CONGESTION (non-serious) with onset 07May2022 at 08:00, outcome "recovering", described as "Congestion"; DRY THROAT (non-serious) with onset 07May2022 at 08:00, outcome "recovering", described as "Lingering dry throat"; SINUS PAIN (non-serious) with onset 07May2022 at 08:00, outcome "recovering"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07May2022 at 08:00, outcome "recovering" and all described as "Tested extremely positively on day 10". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2022) I took paxlovid on the first day of my positive; (08May2022) Tested extremely positively on day 10. Therapeutic measures were taken as a result of covid-19. Therapeutic measures were not taken as a result of nasal congestion, dry throat, sinus pain.  Clinical course: No other medication patient received in 2 weeks. Patient administered Paxlovid from 28Apr2022 to 03May2022 for the treatment of COVID-19. Patient took paxlovid on the first day of his positive test and ran the full series. By day 5, he was no longer exhibiting any symptoms except for a lingering dry throat, and he started testing negative on day 8. On day 9 he had congestion and sinus pain, and tested extremely positively on day 10.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination failure
Clinical narrative: Tested extremely positively on day 10; Tested extremely positively on day 10; Congestion; Lingering dry throat; Sinus pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 at 13:00 as dose 1, single (Lot number: Ew0151), in left arm and on 30Apr2021 at 11:00 as dose 2, single (Lot number: Ea8736) at the age of 30 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Nov2021 at 18:00 as dose 3 (booster), single (Lot number: 067F21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: NASAL CONGESTION (non-serious) with onset 07May2022 at 08:00, outcome "recovering", described as "Congestion"; DRY THROAT (non-serious) with onset 07May2022 at 08:00, outcome "recovering", described as "Lingering dry throat"; SINUS PAIN (non-serious) with onset 07May2022 at 08:00, outcome "recovering"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07May2022 at 08:00, outcome "recovering" and all described as "Tested extremely positively on day 10". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2022) I took paxlovid on the first day of my positive; (08May2022) Tested extremely positively on day 10. Therapeutic measures were taken as a result of covid-19. Therapeutic measures were not taken as a result of nasal congestion, dry throat, sinus pain.  Clinical course: No other medication patient received in 2 weeks. Patient administered Paxlovid from 28Apr2022 to 03May2022 for the treatment of COVID-19. Patient took paxlovid on the first day of his positive test and ran the full series. By day 5, he was no longer exhibiting any symptoms except for a lingering dry throat, and he started testing negative on day 8. On day 9 he had congestion and sinus pain, and tested extremely positively on day 10.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dry throat, Nasal congestion, SARS-CoV-2 test, SARS-CoV-2 test positive, Sinus pain
Clinical narrative: Tested extremely positively on day 10; Tested extremely positively on day 10; Congestion; Lingering dry throat; Sinus pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 at 13:00 as dose 1, single (Lot number: Ew0151), in left arm and on 30Apr2021 at 11:00 as dose 2, single (Lot number: Ea8736) at the age of 30 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Nov2021 at 18:00 as dose 3 (booster), single (Lot number: 067F21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: NASAL CONGESTION (non-serious) with onset 07May2022 at 08:00, outcome "recovering", described as "Congestion"; DRY THROAT (non-serious) with onset 07May2022 at 08:00, outcome "recovering", described as "Lingering dry throat"; SINUS PAIN (non-serious) with onset 07May2022 at 08:00, outcome "recovering"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07May2022 at 08:00, outcome "recovering" and all described as "Tested extremely positively on day 10". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2022) I took paxlovid on the first day of my positive; (08May2022) Tested extremely positively on day 10. Therapeutic measures were taken as a result of covid-19. Therapeutic measures were not taken as a result of nasal congestion, dry throat, sinus pain.  Clinical course: No other medication patient received in 2 weeks. Patient administered Paxlovid from 28Apr2022 to 03May2022 for the treatment of COVID-19. Patient took paxlovid on the first day of his positive test and ran the full series. By day 5, he was no longer exhibiting any symptoms except for a lingering dry throat, and he started testing negative on day 8. On day 9 he had congestion and sinus pain, and tested extremely positively on day 10.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive antigen test on day 10 and day 11; positive antigen test on day 10 and day 11; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 08Jan2021 as dose 2, single (Lot number: EK9231), in left arm and on 29Sep2021 as dose 3 (booster), single (Lot number: EW0183) at the age of 48 years, in left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient's relevant medical history included: "Type 1 DM" (unspecified if ongoing); "s/p partial thyroidectomy on thyroid replacement" (unspecified if ongoing). Other medical history included Type 1 DM, s/p partial thyroidectomy on thyroid replacement and patient had no known drug allergies (NKDA). Concomitant medication(s) included: HUMALOG; SYNTHROID; VITAMIN D NOS. Patient received other medication in 2 weeks which included Humalog insulin, Synthroid, Multivitamin and Vitamin D.  The following information was reported: VACCINATION FAILURE (medically significant) with onset Apr2022, outcome "unknown", COVID-19 (medically significant) with onset Apr2022, outcome "recovered" (2022) and all described as "positive antigen test on day 10 and day 11". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: On Day 11 with positive  antigen test on day 10 and day 11, following a negative antigen test on day 7; Positive, notes: On Day 11 with positive antigen test on day 10 and day 11, following a negative antigen test on day 7; Positive, notes: On Day 11 with positive antigen test on day 10 and day 11, following a negative antigen test on day 7; unknown result. Anti-viral details included COVID 19 Treatment with Paxlovid started on 23Apr2022 and ended on 05May2022 with indication as treatment of COVID-19. Patient experienced rebound symptoms like congestion, fatigue on day 11 with positive antigen test on day 10 and day 11, following a negative antigen test on day 7. Therapeutic measures were taken as a result of covid-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the events Covid 19 and the suspect product BNT162B2 cannot be completely ruled out.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness
Clinical narrative: Treatment of COVID-19/ Covid rebounded. After taking Paxlovid, 1 week to day of finishing the treatment; Treatment of COVID-19/ Covid rebounded. After taking Paxlovid, 1 week to day of finishing the treatment; I have been symptomatic and quite sick for 6 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from PAXAES. The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 19Mar2021 as dose 2, single (Lot number: ER2913), in right arm and on 17Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 46 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ILLNESS (non-serious) with onset 02May2022, outcome "not recovered", described as "I have been symptomatic and quite sick for 6 days"; DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19/ Covid rebounded. After taking Paxlovid, 1 week to day of finishing the treatment". Therapeutic measures were taken as a result of covid-19. Therapeutic measures were not taken as a result of illness.  Clinical information: Current age of patient was 47 Years (as reported). If vaccine received: Yes. Other medication in 2 weeks: No. Patient had no known allergies. Adverse event: After taking Paxlovid, 1 week to day of finishing the treatment, Covid rebounded. I have been symptomatic and quite sick for 6 days. AE resulted in: [None of the above].  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested negative after treatment then tested positive about 6 days after treatment; Tested negative after treatment then tested positive about 6 days after treatment; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), 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: "Penicillin" (unspecified if ongoing); "Latex" (unspecified if ongoing). There were no concomitant medications.The patient had no other medications in two weeks and no other vaccine in four weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02May2022, outcome "recovering" and all described as "Tested negative after treatment then tested positive about 6 days after treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (02May2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162b2.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: positive line on rapid antigen test Day 13 after initial symptoms; positive line on rapid antigen test Day 13 after initial symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 4 (booster), single (Lot number: FK9895) at the age of 74 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: "Stage 3 kidney disease" (unspecified if ongoing); "AFib" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05May2022, outcome "not recovered" and all described as "positive line on rapid antigen test Day 13 after initial symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (05May2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical Course: Patient taken Other medication in 2 weeks was Pravastatin. Patient did not had any known allergies.Anti viral details:COVID 19 Treatment,Pfizer Paxlovid, Treatment start date 26Apr2022, stop date 20Apr2022.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive on 25Apr2022; tested positive on 25Apr2022; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Oct2021 at 13:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 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: "Seasonal allergies" (unspecified if ongoing); "Mild asthma" (unspecified if ongoing), notes: Mild asthma; "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: LOESTRIN 24 FE; ALLEGRA; SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]; ALBUTEROL [SALBUTAMOL].  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 25Apr2022, outcome "unknown" and all described as "tested positive on 25Apr2022". Serious: No, Seriousness criteria-Results in death: No, Seriousness criteria-Life threatening: No, Seriousness criteria-Caused/prolonged hospitalization: No, Seriousness criteria-Disabling/Incapacitating: No, Seriousness criteria-Congenital anomaly/birth defect: No. Dose Number: 3 Batch/Lot No: Unknown. Unable to locate or read the details. the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient took Paxlovid for 5 days. I tested positive on 25Apr2022 and started Paxlovid on 27Apr2022. symptoms improved, and went back to work, but then symptoms returned on 06May2022. My congestion is worse now than it was before. Some of my other symptoms (sore throat, muscle aches, and chills) are more mild. Date of start of reaction/event was 06May2022 (08:00 AM). Outcome of reaction/event at the time of last observation was Not recovered/ not resolved. No Hospitalization Prolonged. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Apr2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 at 13:00 as dose 1, single (Lot number: EN6206), in left arm, on 04Apr2021 at 13:00 as dose 2, single (Lot number: GW0150), in left arm, on 19Oct2021 at 19:00 as dose 3 (booster), single (Lot number: 3203080), in left arm and on 19Apr2022 at 18:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LATANOPROST, start date: 01Jan2015; ATORVASTATIN, start date: 01Jan2008; FINASTERIDE, start date: 01Jan2021. 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 05May2022.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: testing positive on a rapid test; testing positive on a rapid test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: El9269), on 27Feb2021 as dose 2, single (Lot number: EN6202) and on 16Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Penicillin Allergy" (unspecified if ongoing), notes: Penicillin Allergy. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Apr2022, outcome "not recovered" and all described as "testing positive on a rapid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2022) Positive; (07May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information -It was reported that on Day 10 since testing positive for Covid and still testing positive on a rapid test. Patient tested positive on 28Apr (Day 0) and started Paxlovid the same day. She completed her Paxlovid prescription on 02May (Day 4). Her symptoms improved and were completely resolved after a few days. Yesterday her symptoms returned. They are more mild this time. But the rapid test is bright line pink positive immediately after applying the solution   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: covid vaccine-related myocarditis/suffering from this; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  A 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 patient wife called to gain information or research on covid vaccine-related myocarditis. Her husband who is a healthy, young male is suffering from this with an unknown cause. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "covid vaccine-related myocarditis/suffering from this".  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: got Covid symptoms again and tested positive; got Covid symptoms again and tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 61 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Feb2021 as dose 1, single (Lot number: 031M20A), in right arm and on 20Mar2021 as dose 2, single (Lot number: 045A21A), in right arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. Concomitant medication (other medication in 2weeks product) included: ASPRIN, start date: 29Apr2022, stop date: 01May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08May2022 at 12:00 and all described as "got Covid symptoms again and tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (unspecified date) Positive, notes: After taking Paxlovid and testing negative for consecutive days/Brand: Paxlovid/Indication: Treatment of Covid-19; (08May2022) Positive, notes: got Covid symptoms again and tested positive; (2022) Negative, notes: After taking Paxlovid and testing negative for consecutive days. Therapeutic measures were not taken as a result of drug ineffective, covid-19. On 02May2022, he started Paxlovid for Covid-19 and stopped on 06May2022. After taking Paxlovid and testing negative for consecutive days, got covid symptoms again and tested positive.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, UNK
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: got Covid symptoms again and tested positive; got Covid symptoms again and tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 61 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Feb2021 as dose 1, single (Lot number: 031M20A), in right arm and on 20Mar2021 as dose 2, single (Lot number: 045A21A), in right arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. Concomitant medication (other medication in 2weeks product) included: ASPRIN, start date: 29Apr2022, stop date: 01May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08May2022 at 12:00 and all described as "got Covid symptoms again and tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (unspecified date) Positive, notes: After taking Paxlovid and testing negative for consecutive days/Brand: Paxlovid/Indication: Treatment of Covid-19; (08May2022) Positive, notes: got Covid symptoms again and tested positive; (2022) Negative, notes: After taking Paxlovid and testing negative for consecutive days. Therapeutic measures were not taken as a result of drug ineffective, covid-19. On 02May2022, he started Paxlovid for Covid-19 and stopped on 06May2022. After taking Paxlovid and testing negative for consecutive days, got covid symptoms again and tested positive.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Lot number: ZW0167) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 08Apr2022 as dose 4 (booster), single (Lot number: 048L21A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details: Product=COVID 19. Treatment. Brand=Pfizer. Treatment start date=21Apr2022. Treatment Stop date=26Apr2022.Indication=Treatment of COVID-19. Covid vaccine details: Vaccine brand=Other, Vaccine brand other=Moderna. Vaccine administration date=08Apr2022, Vaccine lot number= 048L21A, Vaccine dose number=4, Vaccine dose number unknown=False, Vaccine location=Left arm Vaccine brand=Pfizer / BioNTech, Vaccine brand unknown=False, Vaccine administration date=04Oct2021, Vaccine lot number= ZW0167, Vaccine lot unknown=False, Vaccine dose number=3, Vaccine dose number unknown=False, Vaccine location=Left arm. Adverse event: Relapse after Paxlovid. Adverse event country: (specified). Adverse events start date: 03May2022.AE resulted in: None of the above. If patient recovered: Recovering. If treatment ae: Yes. AE treatment: Paxlovid. Known allergies: No.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 11Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FF8841) at the age of 75 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), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (Apr2022) positive, notes: I kept testing positive until 21Apr; (21Apr2022) positive, notes: I kept testing positive until 21Apr. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had received any other medication in 2weeks. The patient had received Paxlovid on 06Apr2022 for treatment of Covid -19 and stop on 11Apr2022. Other medication in 2weeks product was Breo, lot number=TP3U. 5 days after finishing Paxlovid he began having symptoms he had when he tested positive. They were less severe. By day 9 he felt fine. He kept testing positive until 21Apr.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2020 as dose 1, single (Lot number: EL0142), in left arm and on 22Jan2020 as dose 2, single (Lot number: EL3302) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SERVENT. Other medication patient received in 2weeks of vaccination included product: Servent, brand: GlaxoSmithKine, lot number: 10 c59c.Known allergies: None.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date:05May2022, Treatment Stop date:06May2022, Lot number: FY0461, Indication: Treatment of COVID-19.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded
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) from Regulatory Authority. The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: shellfish" (unspecified if ongoing). Concomitant medication(s) included: COVID-19 VACCINE taken for covid-19 immunisation as dose 1, single as dose 2, single. 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". 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.