chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 5 (booster), single (Lot number: GLO446) at the age of 73 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: "Known allergies: penicillin" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "EPI" (unspecified if ongoing), notes: Exocrine pancreatic insufficiency. Concomitant medication(s) included: METFORMIN; CREON. 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.  Clinical course: Report about covid treatment was reported as yes. Reporter type patient, If vaccine received was reported as yes. Other medication in 2weeks was reported as yes. Patient received Paxlovid treatment from 03Jan2023 to 07Jan2023 for Covid-19.
Age: 56.0
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). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient had no known allergies. She treated with Paxlovid (anti viral) for COVID-19 from 07Dec2022 to 11Jan2023.  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: 42.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 12:00 as dose 4 (booster), single (Lot number: GH9703) at the age of 42 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Apr2021 at 15:00 as dose 1, single (Lot number: ER8731), in right arm, on 03May2021 at 12:00 as dose 2, single (Lot number: EW0175), in right arm and on 02Dec2021 at 12:00 as dose 3 (booster), single (Lot number: FF2598), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Myacin Family" (unspecified if ongoing), notes: Known allergies: Myacin Family. Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Jan2022. 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 83.0
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). The reporter is the patient.  An 84-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 11:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 83 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: "Fibromyalgia" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Known allergies: ancef antibodies, reaction(s): "Known allergies: Ancef antibodies". 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, notes: Treatment of COVID-19; (Dec2022) Negative, notes: Tested negative for 3 days after Plaxovid treatment ended; (Dec2022) Negative, notes: Tested negative for 3 days after Plaxovid treatment ended; (Dec2022) Negative, notes: Tested negative for 3 days after Plaxovid treatment ended. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report about covid treatment was reported as yes. Reporter type patient, if vaccine received was reported as yes. Patient received Paxlovid treatment from 14Dec2022 to 18Dec2022 for Covid-19.  The lot number for [BNT162b2, BNT162b2 omi ba.4-5], was not provided and will be requested during follow up.
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 82 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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. 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient received Paxlovid for COVID-19 treatment indication for COVID-19. Other medication received in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 at 16:00 as dose 5 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL8982), in left arm, on 13Feb2021 as dose 2, single (Lot number: EN6201), in left arm, on 02Dec2021 as dose 3 (booster), single (Lot number: FH8027), in left arm and on 29Apr2022 as dose 4 (booster), single (Lot number: FM7553), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolaemia" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR, start date: 01Jan2022, stop date: 02Jan2023; CALTRATE [CALCIUM CARBONATE], start date: 01Jan2022, stop date: 02Jan2023; CENTRUM WOMEN 50+, start date: 01Jan2022, stop date: 02Jan2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jan2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient not received any treatment for adverse event. Patient had no Known allergies, Patient received other medication in 2 weeks.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old male patient received BNT162b2 (BNT162B2), on 22Sep2022 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 82 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hairy cell leukemia" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "DVT" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: XARELTO, start date: 08Feb2022; ROSUVASTATIN, start date: 09Aug2022; LEVOTHYROXINE; DILTIAZEM, start date: 04Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID 19 Treatment with Paxlovid from 18Dec2022 to 22Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (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), on 20Sep2022 as DOSE 5 (BOOSTER), SINGLE (batch/lot number: unknown) at the age of 68 years, administered in the 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), as DOSE 3 (BOOSTER), SINGLE (batch/lot number: unknown) and as DOSE 4 (BOOSTER), SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history was not reported. Concomitant medication included: NEXIUM [ESOMEPRAZOLE SODIUM], start date: 01Jan2006, stop date: 13Jan2023. 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, notes: Treatment of COVID-19. 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EL3302), in left arm, on 23Feb2021 as dose 2, single (Lot number: EL9263), in left arm, on 04Oct2021 as dose 3 (booster), single (Lot number: FC3184), in left arm and on 23May2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "environmental allergies" (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), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID-19 treatment; Positive, notes: tested positive after completing Paxlovid treatment regimen. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 01Jan2023 to 06Jan2023. No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Lot number: gh9702) at the age of 70 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL9269), on 25Feb2021 as dose 2, single (Lot number: en10200), on 26Sep2021 as dose 3 (booster), single (Lot number: fc3184) and on 16Apr2022 as dose 4 (booster), single (Lot number: fp4554) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Known allergies: z pack, reaction(s): "Known allergies: z pack". The following information was reported: DRUG INEFFECTIVE (medically significant), 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: Positive, notes: covid test positive; Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 including PAXLOVID given on 01Jan2023 to 06Jan2023. Patient reported that he had no issues with vaccines itself but after 9 days after covid test (positive), it tested (positive) again. Still no symptoms other than some congestion which he usually have in am.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 09:00 as dose 4 (booster), single (Lot number: CH9694) at the age of 79 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6203), in left arm, on 26Mar2021 as dose 2, single (Lot number: EP7534), in left arm and on 28Sep2021 as dose 3 (booster), single (Lot number: FE3592), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Afib" (unspecified if ongoing); "heart failure" (unspecified if ongoing); "dilated ascending aorta" (unspecified if ongoing); "BHP" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Covid symptoms included nasal and throat congestion, cough, sore throat, and fatigue. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GJ2524), 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), 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 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: Rebound for 8 days one day after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.
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 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose 5 (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), 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: "Diabetes" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; JARDIANCE; LOSARTAN; DULOXETINE; OMEPRAZOLE; PRAVASTATIN; FAMOTIDINE; ZOLPIDEM; TAMSULOSIN; ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered with sequelae" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: testing negative for 2 days. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No known allergies. Rebound COVID-19 after completing medication and testing negative for 2 days. The patient recovered with lasting effects.  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: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: PGJ2524), in right arm and on 27Dec2022 at 15:00 as dose 6 (booster), single (Lot number: GJ3274) 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), 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: "High blood pressure" (unspecified if ongoing); "asthma" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "menopause" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment drug included Paxlovid from 01Jan2023 to 06Jan2023
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 at 11:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 71 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6203), in right arm, on 18Mar2021 as dose 2, single (Lot number: ER8727), in right arm and on 01Oct2021 as dose 3 (booster), single (Lot number: FF2589), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Ceftin, reaction(s): "Known allergies: ceftin", notes: Known allergies: ceftin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (06Jan2023) 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 vaccination failure, covid-19 including Paxlovid.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 38-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 31Dec2022 to 05Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, the reported events Drug ineffective and COVID-19 cannot be excluded for the suspect product  BNT162b2, BNT162b2 omi ba.4-5.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Vaccine brand=Pfizer / BioNTech, Vaccine administration date=05Oct2022, Vaccine dose number=5 / Vaccine brand other=Moderna, Vaccine administration date=01Apr2022, Vaccine dose number=4; 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 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 65 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Mar2021 as dose 1, single (Lot number: 003B21A), in left arm, on 30Apr2021 as dose 2, single (Lot number: 041B21A), in left arm, on 02Sep2021 as dose 3 (booster), single (Lot number: 007C21A), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: 084J21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HIV" (unspecified if ongoing), notes: Other medical history: HIV; "Duodenal Ulcer" (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 2022, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Oct2022, outcome "unknown", described as "Vaccine brand=Pfizer / BioNTech, Vaccine administration date=05Oct2022, Vaccine dose number=5 / Vaccine brand other=Moderna, Vaccine administration date=01Apr2022, Vaccine dose number=4". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2023) Negative, notes: After taking Paxlovid, tested negative for 2 days; (04Jan2023) Negative, notes: After taking Paxlovid, tested negative for 2 days; (05Jan2023) Positive, notes: had a rebound with a positive test on the 3rd day. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid.
Age: 63.0
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) (Other HCP).  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 at 16:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 63 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: "S/p Gastric Bypass" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine". 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 29Dec2022 to 03Jan2023.; Sender's Comments: Based on the available information, the reported events Drug Ineffective and COVID-19 cannot be excluded for the suspect product BNT162b2, BNT162b2 omi ba.4-5.
Age: 54.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Arthralgia, COVID-19, Cough, Dyspnoea, Headache
Clinical narrative: It started on day one with sinus, sneezing, red eyes, watering eyes, runny nose. I had a fever, sore throat. I could barely talk, cough, headache, chest congestion, head cold, shortness of breath, sinus pressure in my head. I also had body aches and joint pains. I had a viral infection about a week before. I then got in touch with an on-call provider via telehealth on 01/06/2022 and they prescribed PAXLOVID for treatment.
Age: 54.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Lacrimation increased, Nasopharyngitis, Ocular hyperaemia, Oropharyngeal pain, Pain
Clinical narrative: It started on day one with sinus, sneezing, red eyes, watering eyes, runny nose. I had a fever, sore throat. I could barely talk, cough, headache, chest congestion, head cold, shortness of breath, sinus pressure in my head. I also had body aches and joint pains. I had a viral infection about a week before. I then got in touch with an on-call provider via telehealth on 01/06/2022 and they prescribed PAXLOVID for treatment.
Age: 54.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Paranasal sinus discomfort, Pyrexia, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: It started on day one with sinus, sneezing, red eyes, watering eyes, runny nose. I had a fever, sore throat. I could barely talk, cough, headache, chest congestion, head cold, shortness of breath, sinus pressure in my head. I also had body aches and joint pains. I had a viral infection about a week before. I then got in touch with an on-call provider via telehealth on 01/06/2022 and they prescribed PAXLOVID for treatment.
Age: 54.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Sinus disorder, Sneezing, Speech disorder
Clinical narrative: It started on day one with sinus, sneezing, red eyes, watering eyes, runny nose. I had a fever, sore throat. I could barely talk, cough, headache, chest congestion, head cold, shortness of breath, sinus pressure in my head. I also had body aches and joint pains. I had a viral infection about a week before. I then got in touch with an on-call provider via telehealth on 01/06/2022 and they prescribed PAXLOVID for treatment.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Fatigue, Feeling abnormal
Clinical narrative: I had chills, exhaustion, running nose, muscle aches and sneezing. I took NYQUIL before I knew it was COVID-19. I tested positive for COVID-19. I talked to a doctor and said I would be fine to ride it out. I tested positive again for COVID-19 on 12/09/2022. I had fatigue, brain fog, chills, and coughing when I laid down. I went to the urgent care, and she said I would be fine if I just rested. I still have brain fog.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Rhinorrhoea, SARS-CoV-2 test positive, Sneezing
Clinical narrative: I had chills, exhaustion, running nose, muscle aches and sneezing. I took NYQUIL before I knew it was COVID-19. I tested positive for COVID-19. I talked to a doctor and said I would be fine to ride it out. I tested positive again for COVID-19 on 12/09/2022. I had fatigue, brain fog, chills, and coughing when I laid down. I went to the urgent care, and she said I would be fine if I just rested. I still have brain fog.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Significant ringing in both ears that has persisted
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site rash, Myalgia, Pyrexia
Clinical narrative: Per patient, he started to experience fever, rash at injection site, and some muscular/joint pain on the right lower side at midnight of 01/14/2023.  Today is the 3rd day. All symptoms are subsiding except for residual muscular and joint pain. Patient notified his PCP and is instructed to take Tylenol 650mg today. As it today, patient hasn't taken any medication to alleviate the symptoms.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Nasal congestion, Respiratory tract congestion, SARS-CoV-2 test, Sinus congestion
Clinical narrative: I started having a lot of sinus congestion and coughing that wasn't getting any better. After taking three COVID-19 that came back negative, my daughter insisted I go to the doctor, I called my primary care physician who wanted me to go to the clinic so they could listen to my chest. She said she heard congestion but not fluid in my lungs, she did prescribe amoxicillin to help clear up the infection. I do have some congestion in my nose but I am feeling better.
Age: 75.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Arthralgia, Cold sweat, Fatigue, Full blood count normal, Inflammation
Clinical narrative: After dose 4 and 5 I experienced body pains especially in my shoulders they hurt so much that I couldn't lift them. I also had severe joint pain and fatigue for 2 to 3 days after the vaccine and felt better afterwards. In August is when I had a major anti inflammatory flare up my mouth was blistered and raw, body pains, pain in my knees and hands. My lips were swollen and I was getting cold sweats. These episodes lasted from August through December. I started feeling better in December.
Age: 75.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Lip swelling, Mobility decreased, Oral mucosal blistering, Pain, Pain in extremity
Clinical narrative: After dose 4 and 5 I experienced body pains especially in my shoulders they hurt so much that I couldn't lift them. I also had severe joint pain and fatigue for 2 to 3 days after the vaccine and felt better afterwards. In August is when I had a major anti inflammatory flare up my mouth was blistered and raw, body pains, pain in my knees and hands. My lips were swollen and I was getting cold sweats. These episodes lasted from August through December. I started feeling better in December.
Age: 75.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Stomatitis
Clinical narrative: After dose 4 and 5 I experienced body pains especially in my shoulders they hurt so much that I couldn't lift them. I also had severe joint pain and fatigue for 2 to 3 days after the vaccine and felt better afterwards. In August is when I had a major anti inflammatory flare up my mouth was blistered and raw, body pains, pain in my knees and hands. My lips were swollen and I was getting cold sweats. These episodes lasted from August through December. I started feeling better in December.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired on 01/13/2023, no current sx.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Impaired work ability, Oropharyngeal pain, Pyrexia
Clinical narrative: I received my second Moderna COVID-19 booster on 7/17/2022. On 12/22/2022, I began having symptoms that included a sore throat, head congestion, and fever. I took a home antigen test, and the result was negative. I called my PCP, and he advised me to go to a local walk-in clinic to get retested. I did this, and the result on the clinical test was positive. They offered me an antiviral, which I declined, and advised me to go home and isolate for 5 days. I stayed home for 5 days. I had fever, sore throat, coughing, and head congestion with drainage in the throat. During this time, I took NYQUIL to help me sleep at night, because I had a cough. It helped somewhat, since I was able to get some sleep. After the 5 days were up, I returned to work on 12/27/2022. While I was at work, I masked for an additional 5 days. At the time of this writing, I still have some residual cough and congestion. I don't take any medicine for them, though, since they do not impede my functioning.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Upper-airway cough syndrome
Clinical narrative: I received my second Moderna COVID-19 booster on 7/17/2022. On 12/22/2022, I began having symptoms that included a sore throat, head congestion, and fever. I took a home antigen test, and the result was negative. I called my PCP, and he advised me to go to a local walk-in clinic to get retested. I did this, and the result on the clinical test was positive. They offered me an antiviral, which I declined, and advised me to go home and isolate for 5 days. I stayed home for 5 days. I had fever, sore throat, coughing, and head congestion with drainage in the throat. During this time, I took NYQUIL to help me sleep at night, because I had a cough. It helped somewhat, since I was able to get some sleep. After the 5 days were up, I returned to work on 12/27/2022. While I was at work, I masked for an additional 5 days. At the time of this writing, I still have some residual cough and congestion. I don't take any medicine for them, though, since they do not impede my functioning.
Age: 3.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: COVID-19, Cough, Fatigue, Pyrexia, Respiratory tract congestion
Clinical narrative: He ran a low-grade fever for one night and a cough with chest congestion. He tested positive on December 8, 2022 for COVID-19. Since then, he has been really tired and has a congested cough.
Age: 3.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: SARS-CoV-2 test positive
Clinical narrative: He ran a low-grade fever for one night and a cough with chest congestion. He tested positive on December 8, 2022 for COVID-19. Since then, he has been really tired and has a congested cough.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Ear infection, Impaired work ability, Laboratory test
Clinical narrative: Got Covid 11/29/2022 after the November holiday, off from work 10 days. 12/13/2022 went to a clinic, diagnosed with ear infection. Developing problem in both ears, prescribed steroids.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Headache, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I tested at home test for COVID-19, and it was positive on 12/28/2022. I contacted my provider via telehealth I started 12/29/2022 PAXLOVID due to provider prescribed. I treated myself for 5 days. I started feeling better within 3 days of medicine. I was very congestion and had a headache. I had a massive headache due to prone to headaches due to stroke 9 years ago, but I did follow up with PCP on 01/13/2023 and I was fine.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Echocardiogram, Electrocardiogram, Implantable cardiac monitor insertion, Magnetic resonance imaging
Clinical narrative: Hospitalization for transient ischemic attack (TIA)
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack, Ultrasound Doppler
Clinical narrative: Hospitalization for transient ischemic attack (TIA)
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram abnormal, Dyspnoea, Pneumonia, Pulmonary oedema, Wheezing
Clinical narrative: I had a really bad, difficulty breathing, and wheezing. I had to use my general inhaler and nebulizer every four hours. My doctor gave me steroids. I had a CAT scan on my lungs, and it showed pneumonia. I also had fluid in my lungs.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Induration, Inflammation, Myalgia, Pain
Clinical narrative: Onset of symptoms: approximately 4-5 hours after vaccination Signs & symptoms: body aches; muscle aches; severe skin tenderness all over body, but especially on back, upper thighs, and abdomen; hard, swollen upper left arm with raised, red reaction as large as fist in size. Headache is moderate, felt all over, but especially back of head and back of neck
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: Onset of symptoms: approximately 4-5 hours after vaccination Signs & symptoms: body aches; muscle aches; severe skin tenderness all over body, but especially on back, upper thighs, and abdomen; hard, swollen upper left arm with raised, red reaction as large as fist in size. Headache is moderate, felt all over, but especially back of head and back of neck
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Customer requested the Pfizer bivalent dose #5 and presented her immunization card , and she was given the immunization as it was requested. and confirmed at time of immunization the  Pfizer bivalent and the dose #. After she goes home she found another immunization card which shows she had already the bivalent on 10/04/22 and found out duplicated and called the pharmacy to inform us.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Chills, Feeling cold, Headache, Hypersensitivity
Clinical narrative: The patient received pneumovax23(lot #u034712 exp 30/jul/23) and then right after she got an allergy reaction( lips swelled up and chest pain and then started shaking and feeling cold then left side headache). However she was conscious and was talking normally.  As soon as she had the reaction I gave her 50mg benadryl and then 2 tabs of acetamenophen (325mg) instructed by her doctor. After taking benadryl chest pain got a little better, but her headache and a chill didn't go away. We called 911 and they came and checked her. Since her blood pressure was a little high and had a headache and a chill she was sent to ER. She said that she will follow up with us. She has allergy to aspirin, NSAID and sulfa, but never had any reaction to vaccines.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Hypertension, Immediate post-injection reaction, Lip swelling, Tremor
Clinical narrative: The patient received pneumovax23(lot #u034712 exp 30/jul/23) and then right after she got an allergy reaction( lips swelled up and chest pain and then started shaking and feeling cold then left side headache). However she was conscious and was talking normally.  As soon as she had the reaction I gave her 50mg benadryl and then 2 tabs of acetamenophen (325mg) instructed by her doctor. After taking benadryl chest pain got a little better, but her headache and a chill didn't go away. We called 911 and they came and checked her. Since her blood pressure was a little high and had a headache and a chill she was sent to ER. She said that she will follow up with us. She has allergy to aspirin, NSAID and sulfa, but never had any reaction to vaccines.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Palpitations, Presyncope
Clinical narrative: palpitations with near syncope, event happened 3 days after vaccination and patient did not seek care so no treatment provided
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram, Ischaemic stroke, Laboratory test
Clinical narrative: Fatal Lacunar ischemic stroke
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Ear pain, Pain in jaw, Swelling face
Clinical narrative: In September 2022 I noticed I was having pain in right ear. I went to the doctor and received some medication to help the symptoms. However, the problem persisted. One day in mid-December, I woke up and I was in severe pain in my jaw and my ear. I visited with a doctor again and received pain relievers and was told to take SUDAFED. The pain in my ear is a constant ache and my ear feels full. My right lower jaw swelled a little bit near my ear with constant pain like a toothache. The pain will resolve itself and return and as of today I have a slight pain in my ear.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Chromaturia, Nausea, Nephrolithiasis, Protein urine absent
Clinical narrative: Nausea and pain in side of abdomen; discovered kidney stones.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Red blood cells urine, Urine analysis, White blood cells urine, pH urine normal
Clinical narrative: Nausea and pain in side of abdomen; discovered kidney stones.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Blood test, Computerised tomogram thorax abnormal, Fibrin D dimer, Pelvic venous thrombosis
Clinical narrative: 12/12/22 diagnosed with unprovoked Pulmonary Embolism and Iliac DVT. survived. On blood thinners for life.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism, Scan abdomen abnormal
Clinical narrative: 12/12/22 diagnosed with unprovoked Pulmonary Embolism and Iliac DVT. survived. On blood thinners for life.
Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angiogram abnormal, Angiogram cerebral abnormal, Aphasia, Carotid artery dissection, Cerebral artery occlusion
Clinical narrative: Jan 6th 230 am awoke with new onset right sided weakness from foot through right arm.   Also, developed partial aphasia.  After arriving to er, CT?s  showed high Lt internal carotid dissection and complete Lt M1 branch thrombus occlusion.  Neurosurgeon started emergent stent placement  to fix the dissection and embolectomy of  thrombus from  M1 to distal M2 branch.  All this was completed by 630 to 7 am.  Fortunately, once I recovered from anesthetic I felt like most prior symptoms were completely gone.  I was discharged from the hospital on 1-8-23 light duty for the next 4.5 weeks until f/u with neuro.
Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cerebral artery stent insertion, Cerebral artery thrombosis, Computerised tomogram head abnormal, Computerised tomogram neck, Hemiparesis
Clinical narrative: Jan 6th 230 am awoke with new onset right sided weakness from foot through right arm.   Also, developed partial aphasia.  After arriving to er, CT?s  showed high Lt internal carotid dissection and complete Lt M1 branch thrombus occlusion.  Neurosurgeon started emergent stent placement  to fix the dissection and embolectomy of  thrombus from  M1 to distal M2 branch.  All this was completed by 630 to 7 am.  Fortunately, once I recovered from anesthetic I felt like most prior symptoms were completely gone.  I was discharged from the hospital on 1-8-23 light duty for the next 4.5 weeks until f/u with neuro.
Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: Thromboembolectomy
Clinical narrative: Jan 6th 230 am awoke with new onset right sided weakness from foot through right arm.   Also, developed partial aphasia.  After arriving to er, CT?s  showed high Lt internal carotid dissection and complete Lt M1 branch thrombus occlusion.  Neurosurgeon started emergent stent placement  to fix the dissection and embolectomy of  thrombus from  M1 to distal M2 branch.  All this was completed by 630 to 7 am.  Fortunately, once I recovered from anesthetic I felt like most prior symptoms were completely gone.  I was discharged from the hospital on 1-8-23 light duty for the next 4.5 weeks until f/u with neuro.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Headache, Lethargy
Clinical narrative: I became Covid positive on 12/21/2022 - sore throat, achy, cough, congestion, sinus pain, headache - got paxlovid - symptoms lasted about 5 days. Then got rebound covid positive on 1/10/2023- symptoms were sore throuat, hedache, archy, cough, congestion, sinus pian, lethargy, headache - lasted about 3.5 days then just had cough and somewhat tired.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Pain, Respiratory tract congestion, SARS-CoV-2 test positive, Sinus pain
Clinical narrative: I became Covid positive on 12/21/2022 - sore throat, achy, cough, congestion, sinus pain, headache - got paxlovid - symptoms lasted about 5 days. Then got rebound covid positive on 1/10/2023- symptoms were sore throuat, hedache, archy, cough, congestion, sinus pian, lethargy, headache - lasted about 3.5 days then just had cough and somewhat tired.