chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Bone tuberculosis, Cough, Fatigue, Headache, Influenza like illness
Clinical narrative: Result: Positive; Result: Positive; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 78 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 02Feb2021 as dose 2, single (Lot number: N9581), in left arm, as dose 3 (booster), single (Lot number: FK49894F), in right arm and on 12Apr2022 as dose 4 (booster), single (Lot number: FK9894), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Potts" (unspecified if ongoing), notes: Potts. Concomitant medication(s) included: LOSARTAN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Nov2022, outcome "unknown" and all described as "Result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Nov2022) Positive.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out
Age: 78.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: Result: Positive; Result: Positive; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 78 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 02Feb2021 as dose 2, single (Lot number: N9581), in left arm, as dose 3 (booster), single (Lot number: FK49894F), in right arm and on 12Apr2022 as dose 4 (booster), single (Lot number: FK9894), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Potts" (unspecified if ongoing), notes: Potts. Concomitant medication(s) included: LOSARTAN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Nov2022, outcome "unknown" and all described as "Result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Nov2022) Positive.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out
Age: 78.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Result: Positive; Result: Positive; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 78 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 02Feb2021 as dose 2, single (Lot number: N9581), in left arm, as dose 3 (booster), single (Lot number: FK49894F), in right arm and on 12Apr2022 as dose 4 (booster), single (Lot number: FK9894), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Potts" (unspecified if ongoing), notes: Potts. Concomitant medication(s) included: LOSARTAN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Nov2022, outcome "unknown" and all described as "Result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Nov2022) Positive.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: tested positive/Treatment of COVID-19; tested positive/Treatment of COVID-19; Dose 1,2,3 and 4 are Moderna vaccine and Dose 5 are Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 31Mar2021 at 09:30 as dose 2, single (Batch/Lot number: unknown), in right arm, on 22Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 31Mar2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "known allergies: sulfa allergy" (unspecified if ongoing), notes: known allergies: sulfa allergy. Concomitant medication(s) included: FOSAMAX. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022 at 12:00, outcome "unknown", described as "Dose 1,2,3 and 4 are Moderna vaccine and Dose 5 are Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "tested positive/Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Dec2022) Negative; (15Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The event had not resulted in for death, life-threatening, prolonged hospitalisation, disabling/incapacitating or Congenital anomaly/birth defect. Other medication in 2weeks reported as Yes includes Fosamax and OTC vits. Anti-viral details: as COVID 19 Treatment patient received Paxlovid, from 06Dec2022 to 10Dec2022. The patient reported she took the full course of paxlovid. She tested negative for COVID on 13Dec2022 and currently, on 15Dec2022 she tested positive.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for COVID-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing), notes: Glaucoma in left eye only. Concomitant medication(s) included: COMBIGAN, start date: Jan2008; DORZOLOMIDE HYDROCHLORIDE, start date: Jan2008; TRAVOPROST, start date: Jan2008; RHOPRESSA, start date: Jan2008. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.  Clinical course: Treatment start date: 07Dec2022, Treatment stop date: 11Dec2022,Completed course of Paxlovid on 11Dec. Tested positive for COVID on 14Dec. Return of cough on 15Dec. Return of sore throat and runny nose on 16Dec (today). Adverse event start date: 14Dec2022, Adverse event start time: 08: 00 AM,Device timestamp: 16Dec2022  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 63.0
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 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 at 10:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 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: "Known allergies: possibly sulpha" (unspecified if ongoing), notes: Known allergies: possibly sulpha. The patient's concomitant medications were not reported. Past drug history included: Statin, reaction(s): "Allergy_Statin", notes: I am on a statin but didn't take while on the Paxlovid. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Seriousness criteria-Caused/prolonged hospitalization, Seriousness criteria-Disabling/Incapacitating, Seriousness criteria-Congenital anomaly/birth defect was No. The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was yes. The patient previously receive a COVID-19 Vaccine was yes. COVID-19 Treatment, Treatment start date was 29Nov2022 and stop date=04Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19-2
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Lot number: FJ4989), 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: "Past Breast Cancer" (unspecified if ongoing); "GERD" (unspecified if ongoing); "known allergies: sulfa drugs" (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 Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 02Dec2022 to 07Dec2022).  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2022 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 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 had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Fentanyl, reaction(s): "Allergy_Fentanyl", notes: known allergies Fentanyl. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously receive a COVID-19 Vaccine. Paxlovid was taken on 14Dec2022.   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 available information in the case, the causal association between the events drug ineffective, COVID-19 and the suspect drug cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 19:00 as dose 5 (booster), single (Lot number: GH9697) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Amputee" (unspecified if ongoing), notes: Other medical conditions: Amputee, Intracranial Pressure, SVT; "Intracranial Pressure" (unspecified if ongoing), notes: Intracranial Pressure; "SVT" (unspecified if ongoing), notes: I have SVT - where it went over 200 even while taking 50mg of metoprolol. Concomitant medication(s) included: METOPROLOL; ACETAZOLAMIDE; FERROUS SULFATE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The event "treatment of covid-19" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Dec2022) Positive, notes: I had a PCR lab test done; (Dec2022) Faintly positive, notes: Was testing very faintly positive; (15Dec2022) positive, notes: also did two at home tests; (15Dec2022) positive, notes: also did two at home tests; (16Dec2022) positive, notes: Lab test came back positive today as well. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details: COVID 19 Treatment with Paxlovid. Treatment start date: 07Dec2022. Treatment stop date: 11Dec2022. Indication: Treatment of COVID-19.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Illness, Limb discomfort, Speech disorder
Clinical narrative: Got very sick for two days; headache; losing control of feet and speech; losing control of feet and speech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 31Aug2022 at 12:00 as dose 4 (booster), single (Lot number: FP715) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "loss of hearing 70 % right ear" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: ER2613, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 27Jun2021, when the patient was 51-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EN6199, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 05Mar2021, when the patient was 50-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: GL9767, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 12Feb2021, when the patient was 50-year-old, for COVID-19 immunization. The following information was reported: ILLNESS (caused and prolonged hospitalization, disability) with onset 07Sep2022 at 16:00, outcome "not recovered", described as "Got very sick for two days"; HEADACHE (caused and prolonged hospitalization, disability) with onset 07Sep2022 at 16:00, outcome "not recovered"; LIMB DISCOMFORT (caused and prolonged hospitalization, disability), SPEECH DISORDER (caused and prolonged hospitalization, disability) all with onset 07Sep2022 at 16:00, outcome "not recovered" and all described as "losing control of feet and speech". The patient was hospitalized and prolonged hospitalization for illness, headache, limb discomfort, speech disorder (hospitalization duration: 12 day(s)). The events "got very sick for two days", "headache" and "losing control of feet and speech" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of illness, headache, limb discomfort, speech disorder.  Clinical course: Patient visited Public Health Clinic/facility for administration of COVID-19 vaccine. It was unknown if patient received other vaccines within 4 weeks PRIOR to the COVID-19 vaccine. Patient received other medication in two weeks. Patient got very sick for two days, had a bad headache for 3 days, started losing control of feet and speech and symptoms have worsened to wheelchair and feels like its in arms and head now. Prior to vaccination, the patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 at 10:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Systemic Lupus Erythematous" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Antiviral details (product covid-19 Treatment, brand Paxlovid started on 07Dec2022 and stopped on 11Dec2022). Lupus patient on Plaquenil & Methotrexate. + test and symptoms of COVID on 07Dec2022. Held methotrexate, 5 day course of Paxlovid with almost immediate resolution of all symptoms after 3 doses. Rebound illness 3 days after last dose. All URI symptoms although no fever. Feels just like day 1 of initial illness. Still holding immunosuppressants while ill.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
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 a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which was included with treatment Paxlovid from 08Dec2022 to 13Dec2022. Clinical Course: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. No other medication taken in 2weeks. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
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 contactable reporter(s) (Nurse). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jun2021 as dose 1, single (Lot number: EW0168), in left arm and on 17Jul2021 as dose 2, single (Lot number: EV0202) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "IBS" (unspecified if ongoing); "known_allergies pineapple" (unspecified if ongoing). Concomitant medication(s) included: LORAZEPAM, start date: 01Jan2018. Past drug history included: Codeine, reaction(s): "known allergies : Codeine"; Asparaginase, reaction(s): "known allergies :asparaginase"; Xanax, reaction(s): "known allergies :Xanax".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Pxizer Treatment start date was 13Dec2022 and stop date was 14Dec2022.; Sender's Comments: The contributory role of the suspect vaccine to the reported drug ineffective cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency.
Age: 62.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: ER8733), in left arm, on 21Apr2021 as dose 2, single (Lot number: EW0161), in left arm, on 09Dec2021 as dose 3 (booster), single (Lot number: 3300ba), in left arm and on 27Jun2022 at 13:15 as dose 4 (booster), single (Lot number: FN2908) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "copd" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing), notes: hypothyroid; "Gerd" (unspecified if ongoing); "IBS-D" (unspecified if ongoing), notes: IBS-D; "Osteoarthritis" (unspecified if ongoing); "Elhers Danlos Syndrome" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "PTSD" (unspecified if ongoing), notes: PTSD. The patient's concomitant medications were not reported. Past drug history included: Vicodin, reaction(s): "known allergies: vicodin", notes: known allergies: vicodin; Codeine, reaction(s): "known allergies: codeine", notes: known allergies: codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It is unknown whether other medication was received in 2 weeks. Patient received treatment for COVID-19 with Paxlovid from 06Dec2022 to 11Dec2022.
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: high blood pressure. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, 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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient. A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in right arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6199), in right arm, on 23Mar2021 as dose 2, single (Lot number: EP7534), in right arm, on 21Sep2021 as dose 3 (booster), single (Lot number: 301308a), in right arm and on 11Apr2022 as dose 4 (booster), single (Lot number: FD3350), in right arm for covid-19 immunization. The patient's relevant medical history included: "Known allergies: Shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (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 vaccination failure and COVID-19 as the patient received PAXLOVID on 02Dec2022 until 07Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I took the vaccine, the last booster of Pfizer Booster and unknowingly that same day I had Covid; I tested myself and had Covid; I was feeling sick; I am sick with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovering", described as "I took the vaccine, the last booster of Pfizer Booster and unknowingly that same day I had Covid; I tested myself and had Covid"; COVID-19 (medically significant), outcome "recovering", described as "I was feeling sick; I am sick with Covid". The patient underwent the following laboratory tests and procedures: Body temperature: over 102; SARS-CoV-2 test: Positive, notes: I tested myself and had COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient took the vaccine, the last booster of Pfizer Booster(Clarified as COVID-19 vaccine Booster) and unknowingly that same day patient had COVID-19 and patient did not realized that because patient came back home and was feeling sick. Patient tested self and had COVID. So, patient took the vaccine and had COVID at the same time and patient talked to the doctor. Patient was running a very high fever over 102 and they put on Paxlovid (Intent: Treatment) and patient am getting, appeared to be getting much better in two days, less than 2 days. So, patient was wondering if that vaccine was any good number one, number 2 were there any side effect that patient was going to have from taking of that booster while was sick with COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Sep2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 26 years, in right 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. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (Treatment start date: 07Dec2022, Treatment stop date: 12Dec2022).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; Dose 1 and Dose 2 BNT162B2, Dose 3 and Dose 4 Moderna, Dose 5 BNT162B2, BNT162B2 OMI BA.4-5; 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 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 at 11:45 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Jan2021 at 12:45 as dose 1, single (Lot number: EL3246), in left arm and on 12Feb2021 at 12:45 as dose 2, single (Lot number: EM9709), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Oct2021 at 18:00 as dose 3 (booster), single (Lot number: 027C21A), in left arm and on 24Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation" (unspecified if ongoing); "known allergies: Minor non-specific food allergy (runny nose)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Oct2022 at 11:45, outcome "unknown", described as "Dose 1 and Dose 2 BNT162B2, Dose 3 and Dose 4 Moderna, Dose 5 BNT162B2, BNT162B2 OMI BA.4-5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: initial positive test; (16Dec2022) Negative, notes: negative test on day 8; (17Dec2022) Positive, notes: Positive test on Day 9. Therapeutic measures were taken as a result of interchange of vaccine products, drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: 029L20A), on 13Feb2021 as dose 2, single (Lot number: 030M20A), on 01Nov2021 as dose 3 (booster), single (Lot number: 032F21A) and on 02Jun2022 as dose 4 (booster), single (Lot number: 037A22B) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing); "HLD" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "HTN" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE oral; LEVOTHYROXINE oral; HYDROCHLOROTHIAZIDE oral; OLMESARTAN oral; ROSUVASTATIN oral. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: several negative tests. Therapeutic measures, Paxlovid from 06Dec2022 to 10Dec2022, were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 16:00 as dose 4 (booster), single at the age of 46 years, in right 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: "Obesity" (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 Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Dec2022) Negative; (16Dec2022) Negative; (17Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Received paxlovid treatment from 09Dec2022 to 14Dec2022 for COVID-19. It was unknown if the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Rebound COVID. Tested negative 14Dec2022 and 16Dec2022. Tested positive again 17Dec2022 (mild symptoms).  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Interchange of vaccine products, Ultrasound Doppler
Clinical narrative: Doppler confirmed DVT on same date; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Nov2022 at 14:30 as dose 5 (booster), single (Lot number: GH9702) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VALSARTAN & HCTZ; LEVOTHYROXINE; LIOTHYRONINE. Vaccination history included: moderna (DOSE 4 (BOOSTER), SINGLE, lot number=005M217), administration date: 14May2022, for COVID-19 immunization; Moderna (DOSE 1, SINGLE,  lot number=037K207), for COVID-19 immunization; Moderna (DOSE 2, SINGLE,  lot number=023m2017), for COVID-19 immunization; Moderna (DOSE 3 (BOOSTER), SINGLE, lot number =026021A), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Nov2022 at 14:30, outcome "not recovered"; DEEP VEIN THROMBOSIS (medically significant) with onset 15Dec2022, outcome "not recovered", described as "Doppler confirmed DVT on same date". The event "doppler confirmed dvt on same date" required physician office visit. The patient underwent the following laboratory tests and procedures: Ultrasound Doppler: (15Dec2022) DVT, notes: Doppler confirmed DVT on same date. Therapeutic measures were taken as a result of deep vein thrombosis.  Clinical course: It was reported that after receiving vaccine, about a week or so later noticed swelling and tenderness left lower leg. Saw Doctor on 15Dec2022. Doppler confirmed DVT on same date. Eliquis started that day. She was a healthy, active 73 year, Play golf 3-4 times each week. Clean, cook, run errands, etc. She had no reason to have developed DVT. No long car trips, no air flights, no medical issue requiring bedrest. No previous blood clotting disorder. No meds that cause clotting. The patient received unspecified multivitamin medication. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.
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.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Negative, notes: Tested negative after 3 days of treatment ; (Dec2022) Positive, notes: tested positive again 5 days after ending medicine. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID 19 treatment with Paxlovid from 05Dec2022 to 09Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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. Past drug history included: Codeine, reaction(s): "known allergy: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Negative, notes: Positive 3 days after negative test after Paxlovid treatment; (Dec2022) Positive, notes: Positive 3 days after negative test after Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti-viral details: Product: COVID 19 Treatment, Brand: Pfzier, Treatment start date: 09Dec2022, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Vaccine brand: Pfizer/BioNTech/Vaccine dose number: 4; 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 68-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 68 years for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 11Sep2022 at 11:30 as dose 5 (booster), single (Lot number: AS7148B), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Mar2021 as dose 1, single (Lot number: 002A21A), on 02Apr2021 as dose 2, single (Lot number: 046A21A) and on 12Nov2021 as dose 3 (booster), single (Lot number: 032F21A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Apr2022, outcome "unknown", described as "Vaccine brand: Pfizer/BioNTech/Vaccine dose number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Dec2022) Negative, notes: COVID rebound after testing negative on 10Dec2022 and 11Dec2022; (11Dec2022) Negative, notes: COVID rebound after testing negative on 10Dec2022 and 11Dec2022; (18Dec2022) Unknown results, notes: I retested on 18Dec2022 due to runny nose, sneezing, and cough symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: COVID rebound after testing negative on 10Dec2022 and 11Dec2022. I retested on 18Dec2022 due to runny nose, sneezing, and cough symptoms. The patient had no known allergies.
Age: 38.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 38 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Oct2022 at 15:45 as dose 4 (booster), single (Lot number: 051D22A), 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: "Overweight" (unspecified if ongoing); "Chronic depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codine, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Dec2022) Negative; (09Dec2022) Negative; (17Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid from 02Dec2022 to 06Dec2022.