chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Batch/Lot number: unknown), on 04May2021 as dose 2, single (Batch/Lot number: unknown) and on 10Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "BMI of 33.2" (unspecified if ongoing), notes: BMI of 33.2 No other serious health conditions. Concomitant medication(s) included: VITAMIN D3; LORATADINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Nov2022 at 23:30, outcome "recovered" (15Dec2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Nov2022) Positive, notes: I tested positive for Covid-19 on 30Nov22 at 11:30 pm; (30Nov2022) Negative, notes: testing negative the same day at 4:30 am; (03Dec2022) Negative, notes: on 03Dec I tested negative; (05Dec2022) Negative, notes: 05Dec I was still negative; (07Dec2022) Negative, notes: but I still tested negative; (10Dec2022) Positive, notes: I was positive again; (15Dec2022) Negative, notes: on 15Dec, when I tested negative again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Rebound Covid. I tested positive for Covid-19 on 30Nov2022 at 11:30 pm, after testing negative the same day at 4:30 am. On 31Nov2022 I was prescribed Paxlovid and began taking it that evening. I improved quickly and finished the Paxlovid the morning of 03Dec. At 4:30 pm on 03Dec I tested negative. I was not completely symptom free but felt much better. The afternoon of 05Dec I was still negative with minimal symptoms. I went out on 06Dec and developed a scratchy throat. On 07Dec I thought I felt a strange feeling in my nose again but I still tested negative. On 08Dec I had full-blown cold symptoms again but did not test again until 10Dec; I was positive again. My doctor did not prescribe more medicine. It took longer for the symptoms to improve after the rebound. I began improving the evening of 12Dec and finally had minimal symptoms on 15Dec, when I tested negative again. Known Allergies: No. Other medical history: BMI of 33.2 No other serious health conditions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 51-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: gj2524) at the age of 51 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Lot number: EL9262), in right arm, on 13Mar2021 as dose 2, single (Lot number: en6208), in right arm, on 28Sep2021 as dose 3 (booster), single (Lot number: fc3182), in left arm and on 15Apr2022 as dose 4 (booster), single (Lot number: fk9894) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, vaccination failure which included Paxlovid taken from 01Dec2022 to 06Dec2022.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose5 (Moderna Bivalent)/ Dose4, 3, 2 and 1 (Pfizer); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 14Mar2021 at 14:30 as dose 1, single (Lot number: EN6208), in right arm, on 04Apr2021 at 16:00 as dose 2, single (Lot number: ER8733), in right arm, on 22Oct2021 at 10:00 as dose 3 (booster), single (Lot number: 30125BA), in right arm and on 08Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FJ1620) at the age of 68 years, in right arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 07Sep2022 at 13:00 as dose 5 (booster), single (Lot number: AS7144B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing), notes: Hypothyroid; "High BP (controlled)" (unspecified if ongoing), notes: High BP (controlled); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: COLCHICINE, start date: 01Nov2022, stop date: 05Dec2022; ALLOPURINOL, start date: May2016; BUPROPION, start date: Jul1998; LEVOTHYROXINE [LEVOTHYROXINE SODIUM], start date: Aug2010; HCTZ, start date: Jan2011; METOPROLOL, start date: Jan2009; PAROXETINE, start date: Jan1997; SULPHAMETHOXAZOLE, start date: 14Nov2022, stop date: 25Nov2022. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Sep2022 at 13:00, outcome "unknown", described as "Dose5 (Moderna Bivalent)/ Dose4, 3, 2 and 1 (Pfizer)"; VACCINATION FAILURE (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 vaccination failure, covid-19.
Age: 56.0
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 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 12:00 as dose 4 (booster), single (Lot number: GH9694) 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), 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 2022, outcome "unknown" and all described as "COVID 19 Treatment.". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details: Product: COVID 19 Treatment Brand: Paxlovid. Report about COVID treatment.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Received Paxlovid for COVID-19 Treatment on 10Dec2022 to 14Dec2022; Received Paxlovid for COVID-19 Treatment on 10Dec2022 to 14Dec2022; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 as dose 4 (booster), single (Lot number: GJ6665) at the age of 49 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: EL9261), in left arm, on 22Feb2021 as dose 2, single (Lot number: EN6200), in right arm and on 02Nov2021 as dose 3 (booster), single (Lot number: FH8028), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Hypercholesteremia" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "known_allergies sulfa meds" (unspecified if ongoing), notes: audio and photosensitivity. The patient took concomitant medications which included thyroid medications & antidepressants and cholesterol medications. Past drug history included: Bactrim, reaction(s): "photosensitivity"; Bactrim, reaction(s): "audio sensitivity". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Received Paxlovid for COVID-19 Treatment on 10Dec2022 to 14Dec2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Dec2022) Negative, notes: 3 Days post negative test and end of 5 day course on 14Dec2022; (17Dec2022) Positive, notes: Paxlovid rebound with positive test on 17Dec2022. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drugs BNT162B2 and BNT162b2, BNT162b2 omi ba.4-5 cannot be excluded. The case will be reassessed once new information is available.
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: ENG 202) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: High blood pressure. The patient's concomitant medications were not reported. Past drug history included: Imuran, reaction(s): "Allergy_Imuran", notes: Allergy_Imuran; Plaquenil, reaction(s): "Allergy_Plaquenil", notes: Allergy_Plaquenil; Lisinopril, reaction(s): "Allergy_Lisinopril", notes: Allergy_Lisinopril. 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 taking any other medication within 2 weeks of COVID vaccine reported as Meds for high blood pressure and lupus. Patient previously received COVID-19 vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID/Treatment of COVID-19; Tested positive for COVID/Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Nurse) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EK9231), on 05Feb2021 as dose 2, single (Lot number: EL9261), on 03Nov2021 as dose 3 (booster), single (Lot number: 32030BD) and on 16Apr2022 as dose 4 (booster), single (Lot number: FM9992) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). Concomitant medication included: TYMLOS, start date: 02Dec2022. Past drug history included: Tetracycline, reaction: "known allergies: Tetracycline"; Hydromorphone, reaction: "Known allergies: Hydromorphone"; Iopromide, reaction: "Known allergies: Iopromide". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Dec2022, outcome "unknown" and all described as "Tested positive for COVID/Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Dec2022) Positive, notes: Tested positive for COVID; (17Dec2022) Positive, notes: Tested positive for COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient tested positive for COVID on 08Dec2022 and again on 17Dec2022. The patient was treated with Paxlovid from 08Dec2022 to 12Dec2022, indication: Treatment of COVID-19.; Sender's Comments: A contributory role of BNT162B2 to event Tested positive for COVID/Treatment of COVID-19 cannot be excluded based on temporal association and available information.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose 5, 4 (Moderna)/ Dose 3, 2 and 1 (Pfizer); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 11Apr2021 as dose 2, single (Lot number: ER8729) and on 12Nov2021 as dose 3 (booster), single (Lot number: Pg3527) at the age of 33 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Apr2022 as dose 4 (booster), single (Lot number: 006a22a), in right arm and on 12Sep2022 at 15:45 as dose 5 (booster), single (Lot number: 19811), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: MUCINEX, start date: 05Dec2022, stop date: 10Dec2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Apr2022, outcome "unknown", described as "Dose 5, 4 (Moderna)/ Dose 3, 2 and 1 (Pfizer)"; 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 had received other medications in 2 weeks. Paxlovid used for COVID 19 Treatment.
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 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Lot number: GJ6739) 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: "Wilson's disease" (unspecified if ongoing), notes: Other medical history: Wilson's disease. Concomitant medication(s) included: GALZIN, start date: 01Apr2016. 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. No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; 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 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 3 (booster), single (Lot number: GJ2524) 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's relevant medical history included: "High cholesterol" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: There were no known allergies reported. The patient did not receive other medication in 2 weeks. High cholesterol but patient did not take statin while on Paxlovid and had not taken any since stopping Paxlovid. Paxlovid, from 09Dec2022 to 14Dec2022, Paxlovid was given as antiviral treatment for COVID-19.
Age: 59.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 at 16:00 as dose 5 (booster), single (Lot number: GH9703) at the age of 59 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 and 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (17Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 07Dec2022 to 12Dec2022. Clinical Course: Country: Patient received other medication of atarvostatin in 2weeks as from 01Dec2022 to 07Dec2022. Patient became symptomatic and positive on 17Dec2022, it was unknown if patient recovered. Patient did not receive treatment.  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, 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 77-year-old female patient received BNT162b2 (BNT162B2), 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 and 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
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(s) (Other HCP) from product quality group. The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GJ2524) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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: "HTN" (unspecified if ongoing); "Monoclonal B-Cell Lymphocytosis" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: 31Aug2022; VALSARTAN, start date: 30Nov2022; CRESTOR, start date: 01Jun2021; METFORMIN, start date: 03Nov2019. Past drug history included: Compzine, reaction(s): "Known allergies:Compzine". 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: (unspecified date) Positive, notes: Treatment of COVID-19; (14Dec2022) Negative; (15Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Product for COVID 19 Treatment was noted as Paxlovid. Treatment start date was 07Dec2022 and treatment stop date was 11Dec2022. Indication was noted as treatment of COVID-19.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events drug ineffective, covid-19 and suspect drug BNT162B2 cannot be excluded.
Age: 32.0
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 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 23Mar2022 as dose 2, single (Batch/Lot number: unknown) at the age of 32 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "heart condition" (unspecified if ongoing). There were no concomitant medications in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid from 08Dec2022 to 14Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; 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 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 10:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 53 years, in left arm for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 16Apr2022 at 10:00 as dose 4 (booster), single (Lot number: 084J21A), 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 was not reported. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Sep2022 at 10:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Dec2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Dec2022) Negative, notes: Tested negative on 09Dec; (16Dec2022) Positive, notes: Cough came back a few days later. Felt worse and tested positive again on 16Dec. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no known allergies. Other medication in 2 weeks reported as no. The patient was not pregnant at the time of vaccination. Therapeutic measures included Antiviral details, Product: COVID 19 Treatment, Brand: Paxlovid, Indication: Treatment of COVID-19.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19May2021 as dose 1, single (Lot number: Ew0177), in right arm and on 05Jul2021 as dose 2, single (Lot number: Ew0196) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Rather not say . I do have asthma though" (unspecified if ongoing). Concomitant medication(s) included: TRELEGY; NORETHINDRONE [NORETHISTERONE ACETATE]. Past drug history included: Keflex, reaction(s): "known allergies: Keflex"; Minocycline, reaction(s): "known allergies: minocycline"; Aspirin, reaction(s): "Known allergies: aspirin"; Percocet, reaction(s): "Known allergies: Percocet"; Iodine, reaction(s): "Known allergies: iodine"; Cephalosporin, reaction(s): "Known allergies: Cephalosporin". 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: (unspecified date) Positive, notes: COVID 19 Treatment; (11Dec2022) Negative, notes: Tested negative 11Dec or 12Dec after treatment; (12Dec2022) Negative, notes: Tested negative 11Dec or 12Dec after treatment; (15Dec2022) Positive, notes: I thought I had flu but checked again for COVID on 15Dec evening and it came out positive . Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patent received Trelegy and Norethindrone as other medication in 2 weeks. Patent received Paxlovid as treatment for COVID 19. Treatment start date: 05Dec2022 and Treatment stop date: 10Dec2022. Patient had a virtual doctor apt on 16Dec2022.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 at 12:00 as dose 4 (booster), single (Lot number: Unknown) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Lot number: Unknown), as dose 2, single (Lot number: Unknown) and as dose 3 (booster), single (Lot number: Unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: three negative tests; Negative, notes: three negative tests; Negative, notes: three negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks: No. the patient received COVID 19 Treatment with Paxlovid from 09Dec2022 to 13Dec2022. Recurrence of COVID symptoms 4 days after medication series was complete. The followed improved symptoms and three negative tests. Known allergies: No. Other medical history: No  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: 66.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown) and in Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "obese" (unspecified if ongoing), notes: Other medical history: obese. Concomitant medication(s) included: MUCINEX. 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. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical details: Patient received COVID 19 Treatment with Paxlovid from 08Dec2022 to 13Dec2022. Other medication in 2weeks product include Mucinex. Patient reported, he was well for about 3 days, then cough and tiredness returned in Dec2022. He was Not recovered and No treatment was given. No Known allergies. Other medical history include High blood pressure and obese.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood pressure measurement, 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 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 01Nov2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EL8982), in left arm, on 07Feb2021 as dose 2, single (Lot number: EL8982), in left arm, on 30Sep2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 23May2022 as dose 4 (booster), single (Lot number: FM9992), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Elevated BP" (unspecified if ongoing); "elevated cholesterol" (unspecified if ongoing); "menaires" (unspecified if ongoing). Concomitant medication(s) included: VERAPAMIL; AMLODIPINE; ATORVASTATIN; ESTRADIOL; VITAMIN D NOS. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood cholesterol: (unspecified date) Elevated; Blood pressure measurement: (unspecified date) Elevated; SARS-CoV-2 test: (unspecified date) Positive; (Dec2022) Negative; (Dec2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19: Paxlovid.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "known allergies Erythromycin", notes: known allergies Erythromycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 15Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-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 31Oct2022 at 10:00 as dose 5 (booster), single (Lot number: Gh9693) at the age of 73 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25May2022 at 14:00 as dose 4 (booster), single (Lot number: Fn9992), 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: "Waldenstrom macroglobulinemia" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL, start date: Jan2019, stop date: Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
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 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), on 30Nov2022 as dose 5 (booster), single (Lot number: GJ6796) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6203), in left arm, on 22Mar2021 as dose 2, single (Lot number: ER2613), in left arm, on 05Oct2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 18Jul2022 as dose 4 (booster), single (Lot number: FM7553), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seizure" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "prostate cancer" (unspecified if ongoing); "Known allergies: Seasonal" (unspecified if ongoing). Concomitant medication(s) included: OXCARBAZEPINE; NEBIVOLOL; CETIRIZINE; ACETAMINOPHEN; DEXTROMETHORPHAN; GUAIFENESIN; PHENYLEPHRINE; TRIPROLIDINE. 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: Result of antigen test was positive; (Dec2022) Negative, notes: Antigen test three days prior was negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (Treatment start date: 08Dec2022, Treatment stop date: 12Dec2022).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Apr2021 as dose 1, single (Lot number: EW0167), in left arm, on 20May2021 as dose 2, single (Lot number: ER8736), in left arm and on 20Dec2021 as dose 3 (booster), single (Lot number: 3302580) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "Type 2 Diabetes" (unspecified if ongoing), notes: other medical history: Type 2 Diabetes; "Hypertension" (unspecified if ongoing), notes: other medical history: Hypertension; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: SYMBICORT; METFORMIN. The following information was reported: VACCINATION FAILURE (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, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Lot number: gh9694) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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: "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM, start date: Oct2018; LISINOPRIL, start date: Dec2018; CETIRIZINE HYDROCHLORIDE, start date: Mar2017. Past drug history included: Aspirin, reaction(s): "allergies"; Erythromycin, reaction(s): "allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID-19"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". 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.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: got Covid once after receiving my [Pfizer] initial shots and once again after receiving a [Pfizer] booster.; got Covid once after receiving my [Pfizer] initial shots and once again after receiving a [Pfizer] booster.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP. The reporter is the patient.  A 30-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing), notes: Covid once after receiving my [Pfizer] initial shots. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got Covid once after receiving my [Pfizer] initial shots and once again after receiving a [Pfizer] booster.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  Clinical course: patient thought it was targeted towards everyone, which is sketchy to me because I think that only people at risk of serious illness should be getting boosted. I am a healthy person who got Covid once after receiving my [Pfizer] initial shots and once again after receiving a [Pfizer] booster. I would not have got the booster if I had not been required by my university. I think boosters are a scam by the  companies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Alexithymia, Confusional state
Clinical narrative: Bizarre behaviour; Confusion; inability to express themselves; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 97-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunisation. The following information was reported: CONFUSIONAL STATE (non-serious) with onset Dec2022, outcome "unknown", described as "Confusion"; ALEXITHYMIA (non-serious) with onset Dec2022, outcome "unknown", described as "inability to express themselves"; ABNORMAL BEHAVIOUR (non-serious) with onset 17Dec2022, outcome "unknown", described as "Bizarre behaviour".  Additional information: The patient got an injection on Wednesday of the Bivalent (Pfizer covid bivalent vaccine) last Wednesday and on the date of this report she was experiencing some real bizarre behavior.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I got a test and it was positive and I had my vaccines; got a test and it was positive and I had my vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: I got a test and it was positive and I had my vaccines (clarified as Pfizer COVID 19 vaccine) and before I had my vaccine, the first time I got it I did not feel anything. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "I got a test and it was positive and I had my vaccines"; COVID-19 (medically significant), outcome "unknown", described as "got a test and it was positive and I had my vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: I just took the test, my test is negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that consumer stated three days ago, may be a week ago, he got a cold you know continue working then my wife told me, you might have a corona so go get a test. I got a test and it was positive and had my vaccines (clarified as Pfizer COVID 19 vaccine) and before had my vaccine, the first time I got it I did not feel anything. Patient was treated with Paxlovid. Patient took the test again, test was negative. Patient was taking Paxlovid for two and half days and asked can I stop this since adverse event occurred due to use of Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 8.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Body height, Chest pain, Condition aggravated, Off label use, Pain in extremity
Clinical narrative: He got his flu shot at the same time as he got the covid bivalent yesterday; He got his flu shot at the same time as he got the covid bivalent yesterday; He said, it's mostly his arm but little bit on his chest near his arm like upper left part of his chest; Arm being sore; soreness got worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 8-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Dec2022 as dose 3 (booster), single (Lot number: GK1657) at the age of 8 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 17Dec2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Optic nerve glioma" (unspecified if ongoing), notes: Optic nerve glioma. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single; LOT# FK5618), administration date: 17Nov2021, when the patient was 7-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, single; LOT#: FK5618), administration date: 13Dec2021, when the patient was 7-year-old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Dec2022, outcome "recovering", described as "Arm being sore"; CHEST PAIN (non-serious) with onset Dec2022, outcome "unknown", described as "He said, it's mostly his arm but little bit on his chest near his arm like upper left part of his chest"; CONDITION AGGRAVATED (non-serious) with onset Dec2022, outcome "recovering", described as "soreness got worse"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 17Dec2022, outcome "unknown" and all described as "He got his flu shot at the same time as he got the covid bivalent yesterday". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chest pain, pain in extremity, condition aggravated.  Additional information: Medical Conditions was reporter as None like that but he does have a, he has a, an Optic nerve glioma (captured as provided) that is currently disabled and that's his medical condition. Regular Medications was just the multivitamins (not specifically clarified hence not captured in tab). No lab Work. So he complained about his arm being sore, kind of right away. And then he said the soreness got worse, instead of later in the evening and when he woke up this morning, but it has gotten better since then. He said, it's mostly his arm but little bit on his chest near his arm like upper left part of his chest. No treatment received.