chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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) (Other HCP).  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Batch/Lot number: unknown), on 21Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "MDD" (unspecified if ongoing); "asthma" (unspecified if ongoing); "food allergies" (unspecified if ongoing); "pecan, pine nut, casein, milk, walnut," (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; TRAZODONE; CETIRIZINE; FLONASE ALLERGY RELIEF; IBUPROFEN; DAYQUIL; NYQUIL. Past drug history included: Erythromycin for known_allergies: erythromycin. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Negative, notes: Recurrence of positive antigen test result after previous negative results since treatment; Positive, notes: Recurrence of positive antigen test result after previous negative results since treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.She received Paxlovid for the treatment of COVID-19 (start date: 24May2022, stop date: 28May2022).  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 provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the drug ineffective, covid-19 cannot be completely excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-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: "Asplenia" (unspecified if ongoing); "congenital scoliosis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (unspecified date) Negative, notes: previous negative results; (06Jun2022) Positive, notes: Tested positive again 6 days post treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. On 06Jun2022, Tested positive again 6 days post treatment after previous negative results. Patient received the other medication in 2 weeks. Patient received antiviral Paxlovid from 27May2022 to 31May2022 for treatment of COVID-19.  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: Bell's palsy, COVID-19, Drug ineffective, Facial paralysis
Clinical narrative: prescribed Paxlovid  after vaccination; prescribed Paxlovid  after vaccination; Partial Facial Paralysis; Bell's Palsy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 04Dec2021 at 15:00 as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Bell's Palsy Earlier in the Year" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: None, reaction(s): "Allergy". The following information was reported: BELL'S PALSY (medically significant) with onset 04Jun2022 at 18:30, outcome "unknown"; FACIAL PARALYSIS (medically significant) with onset 04Jun2022 at 18:30, outcome "unknown", described as "Partial Facial Paralysis"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "prescribed Paxlovid  after vaccination". Therapeutic measures were not taken as a result of facial paralysis, bell's palsy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6198), in left arm, on 19Mar2021 as dose 2, single (Lot number: EP7534), in left arm and on 16Oct2021 as dose 3 (booster), single (Lot number: EW0202) at the age of 30 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Cyclic neutropenia" (unspecified if ongoing); "Peanuts" (unspecified if ongoing); "pollen (seasonal)" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM, start date: 03Jan2014; VITAMIN D [VITAMIN D NOS]; MUCINEX, start date: 27May2022, stop date: 29May2022; DAYQUIL AND NYQUIL SEVERE+ VICKS VAPOCOOL COLD AND FLU, start date: 25May2022, stop date: 30May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jun2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Indication: Covid-19 treatment; (03Jun2022) Negative; (04Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical Information: Reporter stated that, Report about Covid treatment. Age Group was reported as, Adult (18-64 Years). Other medication received in 2 weeks. Anti viral details reported as, Product: COVID-19 Treatment, Brand: Paxlovid, Treatment started on 27May2022 and stop date was 01Jun2022, Indication was reported as Treatment of COVID-19. Other medication details reported: Other medication in 2 weeks product reported as, Escitalopram, 20 mg daily, start date: 03Jan2014. Vitamin D, 3000 ug daily. DayQuil/NyQuil, start date: 25May2022 and stop date: 30May2022. Mucinex, start date: 27May2022 and stop date: 29May2022. Adverse event: Rebound Covid. Started Paxlovid 27May, tested negative 03Jun, then began testing positive again 04Jun. Adverse event start date was reported as, 04Jun2022. Patient was Recovering. No treatment ae. Known allergies was reported as, Peanuts, pollen (seasonal). No follow-up attempts are possible. No further information is expected.
Age: 26.0
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 26-year-old male patient received BNT162b2 (BNT162B2), on 15Nov2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 26 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. No known allergies were reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient did not receive other vaccine in 2 weeks. Patient had no known allergies. COVID 19 Treatment with Paxlovid was started from 24May2022 to 29May2022.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 67 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: "Diabetes" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "Psoriasis Arthritis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Known allergies: acyclovir, reaction(s): "Allergy"; Known allergies: dicyclomine, reaction(s): "Allergy"; Known allergies: flagyl, reaction(s): "Allergy"; Known allergies: liothyronine, reaction(s): "Allergy"; Known allergies: nabumetone, reaction(s): "Allergy"; Known allergies: sulfasalazine, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (May2022) Positive, notes: Tested COVID positive 8, 9, and 11 days after Paxlovid; (May2022) Positive, notes: Tested COVID positive 8, 9, and 11 days after Paxlovid; (May2022) Positive, notes: Tested COVID positive 8, 9, and 11 days after Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: If vaccine received: Yes, Other medication in 2weeks: Yes. Adverse event: COVID rebound after Paxlovid series. Tested COVID positive 8, 9, and 11 days after Paxlovid and still feeling ill (13 days after end of series). Known allergies: Acyclovir, Dicyclomine, Flagyl, Liothyronine, Nabumetone, Sulfasalazine. Other medical history: Diabetes, Thyroid, Psoriasis Arthritis
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 11Nov2021 as dose 3 (booster), single (Lot number: 320308D) at the age of 47 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: Nsaids" (unspecified if ongoing), notes: Nsaids. The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Known allergies Aspirin", notes: known allergies Aspirin. 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) Negative, notes: 2 negative covid rapid tests; (unspecified date) Negative, notes: 2 negative covid rapid tests; (04Jun2022) Positive, notes: tested positive again on rapid tests on day 5 post paxlovid; (unspecified date) Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid treatment, start date: 26May2022 and Stop date: 30May2022 Clinical course: Bad taste while taking Paxlovid; Rebound Covid symptoms started 3 days after Paxlovid (after 2 negative covid rapid tests) and tested positive again on rapid tests on day 5 post paxlovid. Patient was recovering from symptoms and did not take treatment. No other medication reported in 2weeks.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 31 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2022) Positive, notes: Two at-home positive tests on 05Jun22; (05Jun2022) Positive, notes: Two at-home positive tests on 05Jun22; (unspecified date) Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Finished Paxlovid on 29May2022, started experiencing symptoms again on 03Jun2022. Two at-home positive tests on 05Jun2022.
Age: 64.0
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 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 03Apr2021 at 02:00 as dose 2, single (Lot number: FR8737) at the age of 64 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's relevant medical history and concomitant medications were not reported. She did not had known allergies.   The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took Paxlovid anti-viral as Covid-19 Treatment.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
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) (Other HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: Fk9893) at the age of 52 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 and concomitant medications were not reported. Patient had no known allergies.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment start date:25May2022 treatment stop date:29May2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 74.0
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 contactable reporter(s) (Consumer or other non-healthcare professional) from product quality. The reporter is the patient. A 74-year-old female patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: Fk9896) 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 relevant medical history included: "AFIB" (unspecified if ongoing), "hypertension" (unspecified if ongoing), "high cholesterol" (unspecified if ongoing), "low thyroid" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive result 6 days after completion of medication; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 69 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 was not reported. Concomitant medication(s) included: SIMVASTATIN. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine".  The following information was reported: COVID-19 (medically significant) with onset 06Jun2022 at 06:45, outcome "not recovered"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Positive result 6 days after completion of medication". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (06Jun2022) Positive, notes: Positive result. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 39-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 at 13:15 as dose 1, single (Lot number: EN6204), in left arm, on 01Apr2021 at 15:00 as dose 2, single (Lot number: ER8737), in left arm and on 29Dec2021 at 15:00 as dose 3 (booster) single (Lot number: FJ8757) at the age of 39 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: Patient received other medication in 2 weeks. Anti viral details for COVID-19 treatment included PAXLOVID (Lot number: PAA183761), treatment start date was on 04Jun2022. While taking medication, on 04Jun2022 at 04:00 PM, lost appetite and had dizziness and blurred vision for short periods of time. No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12May2022, outcome "recovered" (01Jun2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Positive, notes: testing positive; (18May2022) Negative, notes: Tested negative on day 7; (23May2022) Positive, notes: tested positive again on day 12. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid from 13May2022 to 18May2022 for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 29-year-old female patient received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti-viral details: product: COVID-19 treatment. Other medication in 2 weeks was reported as no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID breakthrough; COVID breakthrough; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 18-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Lot number: ER2613), in Apr2021 as dose 2, single (Lot number: ER2613) and on 15Dec2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 18 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022, outcome "recovered" (2022) and all described as "COVID breakthrough". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jan2022) Unknown results, notes: COVID breakthrough. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: The patient did not receive any other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.
Age: 82.0
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.  An 83-year-old male patient received BNT162b2 (BNT162B2), on 09Feb2021 at 12:00 as dose 2, single (Lot number: EM9810) at the age of 82 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's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (05Jun2022) Positive, notes: five days after completing Paxlovid, positive rapid home test on day 10. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: No other medication in 2 weeks. COVID 19 Treatment with Pfizer Paxlovid from 26May2022 to 31May2022. Full rebound of symptoms on day 10 from positive test, five days after completing Paxlovid, positive rapid home test on day 10 on 05Jun2022 at 12:00.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: all tested positive for Covid last week.; all tested positive for Covid last week.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent.  An 8-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "unknown" and all described as "all tested positive for Covid last week.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
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 34-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (02Jun2022) negative; (04Jun2022) positive; (07Jun2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Tested negative using rapid antigen test on 02Jun. Symptoms had resolved. Symptoms returned (runny nose, fatigue, chest pressure) on 04Jun. Rapid antigen tests have been positive 04Jun and 07Jun. Adverse event start date: 04Jun2022, If patient recovered: Recovering, If treatment ae: No (as reported). Anti viral details: Product: COVID 19 Treatment. Brand: Pfizer. Treatment start date: 26May2022. Treatment stop date: 06Jun2022. Indication: Treatment of COVID-19. Other medication in 2weeks: No.  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, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Lot number: FJ6381) 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (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) negative, notes: after testing negative; (06Jun2022) positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical information: The patient did not receive any medications in two weeks. The patient had no known allergies and no other medical history. Recurrence ("rebound")of COVID symptoms and positive test on 06Jun after testing negative and no symptoms on 02Jun, without additional exposure. Also accompanied by acrid odour in nostrils.  No follow-up attempts possible. No further information expected.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline". 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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Malaise, SARS-CoV-2 test
Clinical narrative: not feeling well; her daughter had 2 Moderna and 1 Pfizer vaccines / tested positive again; her daughter had 2 Moderna and 1 Pfizer vaccines / tested positive again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 26-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 26 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "her daughter had 2 Moderna and 1 Pfizer vaccines / tested positive again"; MALAISE (non-serious), outcome "unknown", described as "not feeling well". Reporter reported that one of her daughter was 26 year old female had took Paxlovid because she had a history of asthma and then tested negative four times and then she was tested positive again and not feeling well. Patient was vaccinated twice and then boosted once. She had the Moderna (COVID-19 Vaccine) the first two times and then the Pfizer (COVID-19 Vaccine, booster shot) the third time. 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Sep2021 at 13:00 as dose 2, single (Batch/Lot number: Unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic pain neuropathy back pain" (unspecified if ongoing), notes: other medical history: Chronic pain neuropathy back pain; "Penicillin: Allergy" (unspecified if ongoing), notes: Relevant past drug history:, Penicillin and Sulpha: Allergy; "Sulpha: Allergy" (unspecified if ongoing), notes: Relevant past drug history:, Penicillin and Sulpha: Allergy. Concomitant medication(s) included: LIPITOR; VICODIN. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 08Mar2022 at 12:15, outcome "not recovered", described as "Hair loss". It was unknown if therapeutic measures were taken as a result of alopecia.  Addition information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Aphonia, COVID-19, Chest pain, Cough
Clinical narrative: Six months later, she tested positive for covid for a second time; Six months later, she tested positive for covid for a second time; Shortness of breath/hard to breath; bad cough; voice gone; respiratory; taste not back; pain in center of chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for Covid-19 immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Six months later, she tested positive for covid for a second time"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath/hard to breath"; COUGH (non-serious), outcome "unknown", described as "bad cough"; APHONIA (non-serious), outcome "unknown", described as "voice gone"; RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "respiratory"; AGEUSIA (non-serious), outcome "unknown", described as "taste not back"; CHEST PAIN (non-serious), outcome "unknown", described as "pain in center of chest". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Six months later, she tested positive for covid for a second time. Lasted about a week, but still have residual symptoms. Event took place after use of product.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Dyspnoea, Respiratory disorder, SARS-CoV-2 test
Clinical narrative: Six months later, she tested positive for covid for a second time; Six months later, she tested positive for covid for a second time; Shortness of breath/hard to breath; bad cough; voice gone; respiratory; taste not back; pain in center of chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for Covid-19 immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Six months later, she tested positive for covid for a second time"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath/hard to breath"; COUGH (non-serious), outcome "unknown", described as "bad cough"; APHONIA (non-serious), outcome "unknown", described as "voice gone"; RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "respiratory"; AGEUSIA (non-serious), outcome "unknown", described as "taste not back"; CHEST PAIN (non-serious), outcome "unknown", described as "pain in center of chest". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Six months later, she tested positive for covid for a second time. Lasted about a week, but still have residual symptoms. Event took place after use of product.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Diarrhoea, Drug ineffective, Dyspnoea, Feeding disorder
Clinical narrative: Six months later, she tested positive for covid for a second time; Six months later, she tested positive for covid for a second time; Shortness of breath/hard to breath; bad cough; voice gone; respiratory; taste not back; pain in center of chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for Covid-19 immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Six months later, she tested positive for covid for a second time"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath/hard to breath"; COUGH (non-serious), outcome "unknown", described as "bad cough"; APHONIA (non-serious), outcome "unknown", described as "voice gone"; RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "respiratory"; AGEUSIA (non-serious), outcome "unknown", described as "taste not back"; CHEST PAIN (non-serious), outcome "unknown", described as "pain in center of chest". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Six months later, she tested positive for covid for a second time. Lasted about a week, but still have residual symptoms. Event took place after use of product.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Vomiting
Clinical narrative: Six months later, she tested positive for covid for a second time; Six months later, she tested positive for covid for a second time; Shortness of breath/hard to breath; bad cough; voice gone; respiratory; taste not back; pain in center of chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for Covid-19 immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Six months later, she tested positive for covid for a second time"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath/hard to breath"; COUGH (non-serious), outcome "unknown", described as "bad cough"; APHONIA (non-serious), outcome "unknown", described as "voice gone"; RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "respiratory"; AGEUSIA (non-serious), outcome "unknown", described as "taste not back"; CHEST PAIN (non-serious), outcome "unknown", described as "pain in center of chest". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Six months later, she tested positive for covid for a second time. Lasted about a week, but still have residual symptoms. Event took place after use of product.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Product administered at inappropriate site, Vaccination site haemorrhage
Clinical narrative: Vaccine injected into blood vessel; Vaccine injected into blood vessel with bleeding occurring; I felt dizzy and lightheaded; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 03Jun2022 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: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 03Jun2022, outcome "unknown", described as "Vaccine injected into blood vessel"; DIZZINESS (non-serious) with onset Jun2022, outcome "unknown", described as "I felt dizzy and lightheaded "; VACCINATION SITE HAEMORRHAGE (non-serious) with onset Jun2022, outcome "unknown", described as "Vaccine injected into blood vessel with bleeding occurring".  Additional information: The patient was without pre-existing conditions. The patient took the 1st Pfizer dose on 03Jun2022, 2 days ago. The vaccine was injected into blood vessel with bleeding occurring. The patient felt dizzy and lightheaded during waiting period. She was concerned and worried and wanted to know if the vaccine would be effective and whether the lightheaded feeling would go away and what was the possibility of blood clots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Syringe issue
Clinical narrative: The top of the syringe broke when they were trying to put the syringe on.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), 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: SYRINGE ISSUE (non-serious), outcome "unknown", described as "The top of the syringe broke when they were trying to put the syringe on.". Additional information: with one of the prefilled syringes and to the top of the syringe broke when they were trying to put the syringe on, but actually would this Prevnar more 'appropriately' to you, she just wanted to file report this and this syringe is not administer to patients when it broke.   The reporter considered "the top of the syringe broke when they were trying to put the syringe on." associated to pneumococcal 13-val conj vac (dipht CRM197 protein).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Arm soreness; Fever (101); nausea; headache; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient received BNT162b2 (COMIRNATY), on 05Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm soreness"; PYREXIA (non-serious), outcome "unknown", described as "Fever (101)"; NAUSEA (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body aches". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.