chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Electrocardiogram, Investigation, SARS-CoV-2 test
Clinical narrative: I have experienced a fluttering in my chest and some slight dizziness over the past year or so; I have experienced a fluttering in my chest and some slight dizziness over the past year or so; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2021 at 09:15 as dose 3 (booster), single (Lot number: FF2590) at the age of 66 years, in left arm for covid-19 immunisation.The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM), administration date: 24Mar2021, when the patient was 65-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6196, Location of injection: Arm Left, Vaccine Administration Time: 12:00 AM), administration date: 02Mar2021, when the patient was 65-year-old, for COVID-19 immunization. The following information was reported: CHEST DISCOMFORT (hospitalization), DIZZINESS (non-serious), outcome "unknown" and all described as "I have experienced a fluttering in my chest and some slight dizziness over the past year or so". The events "I have experienced a fluttering in my chest and some slight dizziness over the past year or so" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Electrocardiogram: (Dec2022) first degree AV block, notes: EKG showed a first degree AV block,; Tests: (Dec2022) slightly enlarged heard; SARS-CoV-2 test: (15Dec2022) Negative, notes: COVID test type post vaccination=Nasal Swab.  Clinical course: 2 days after receiving the last booster the patient suffered a series of fainting spells. The patient was hospitalized and underwent a battery of tests. The only thing found was a slightly enlarged heard. EKG showed a first-degree AV block, but nothing that they could definitely pinpoint as a cause of her syncope. The patient was currently on a heart monitor. There were no indications prior to these fainting spells that there might be a problem with her heart. The patient has experienced a fluttering in her chest and some slight dizziness over the past year or so, which she had attributed to hunger, dehydration etc. The patient had mentioned this to her Doctor at her yearly physical in October. The patient was to monitor and make a return visit should they become more prevalent. Other medications in two weeks: no, If Other vaccine in four weeks: No.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Dehydration, Dizziness, Hunger, SARS-CoV-2 test
Clinical narrative: I have experienced a fluttering in my chest and some slight dizziness over the past year or so; I have experienced a fluttering in my chest and some slight dizziness over the past year or so; hunger; dehydration; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jun2022 at 15:30 as dose 4 (booster), single (Lot number: FN2908) at the age of 66 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EN6196; , Anatomical site: Arm Left; vaccine administration Time: 12:00 AM), administration date: 02Mar2021, when the patient was 65-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE; Lot No: EN6203, Anatomical site: Arm Left; Vaccine Administration Time: 08:30 AM), administration date: 24Mar2021, when the patient was 65-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; , Lot Number: FF2590; Anatomical site: Arm Left, Vaccine Administration Time: 09:15 AM), administration date: 09Nov2021, when the patient was 65-year-old, for COVID-19 Immunization. The following information was reported: CARDIAC FLUTTER (medically significant), DIZZINESS (non-serious) all with onset 2022, outcome "unknown" and all described as "I have experienced a fluttering in my chest and some slight dizziness over the past year or so"; DEHYDRATION (non-serious) with onset 2022, outcome "unknown"; HUNGER (non-serious) with onset 2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Dec2022) Negative.  Additional Information: It was reported that the patient had experienced a fluttering in chest and some slight dizziness over the past year or so, which patient  had attributed to hunger and dehydration . The patient had mentioned this to doctor at yearly physical in Oct. The patient was to monitor and make a return visit should they become more prevalent.  The patient did not receive other vaccines within four weeks prior to COVID vaccine. The patient had no known allergies. The patient did not receive any medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201391908 same patient/drug, different dose/event;
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; dose #1: Moderna/ dose #2: Moderna / dose #3: Moderna / dose #4 Pfizer / dose #5 Moderna Bivalent; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 20Sep2022 as dose 5 (booster), single (Lot number: AS715B), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Jan2021 as dose 1, single (Lot number: 030L20A), in left arm, on 17Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 04Nov2021 as dose 3 (booster), single (Lot number: 026021A), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ROSUVASTATIN, start date: Jan2010, stop date: 09Dec2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Apr2022, outcome "unknown", described as "dose #1: Moderna/ dose #2: Moderna / dose #3: Moderna / dose #4 Pfizer / dose #5 Moderna Bivalent"; 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: (11Dec2022) strongly positive, notes: rapid antigen covid test; (16Dec2022) still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies and other medical history was None. Other medication in 2 weeks  was reported as Yes. Anti viral details was mentioned as Paxlovid, treatment start date as 10Dec2022, and treatment stop date as 07Dec2022, indication reported as Treatment of COVID-19. Sore throat and strongly positive rapid antigen covid test 4 days after completing 5 days of Paxlovid. Still testing positive with mild congestion five days later.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 26Sep2021 at 13:00 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 11May2022 at 13:00 as dose 4 (booster), single (Lot number: FJ4991) 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) 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) all with onset Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Dec2022) Negative, notes: Took Paxlovid for 5 days. Tested negative two days later; (Dec2022) Positive, notes: positive for Covid (again). Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 69.0
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 a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 5 (booster), single (Lot number: 6J2526) at the age of 69 years, in left arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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 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) all with onset Dec2022, outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive; (2022) Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid from 12Dec2022 to 17Dec2022.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: vaccine brand: Pfizer / BioNTech, vaccine brand other: Moderna; 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 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 46 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Jan2021 as dose 1, single (Lot number: 028L20A), in left arm, on 22Feb2021 as dose 2, single (Lot number: 023M20A), in left arm and on 03Nov2021 as dose 3 (booster), single (Lot number: 938906), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Peanuts" (unspecified if ongoing), notes: known allergies: Peanuts. The patient's concomitant medications were not reported. It was unknown if the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  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 16Sep2022, outcome "unknown", described as "vaccine brand: Pfizer / BioNTech, vaccine brand other: Moderna". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 09Dec2022 to 14Dec2022. The patient completed Paxlovid on day 7 and experienced rebound of symptoms on day 9. The symptoms included bad cold symptoms, nasal congestion, ear pain, sneezing, and headache.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID after COVID Vaccines; COVID after COVID Vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 30-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 3 (booster), single (Lot number: GT2524) at the age of 30 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 24May2021 as dose 1, single (Lot number: EW0178) and on 15Jun2021 as dose 2, single (Lot number: EW0196) for covid-19 immunisation.The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Restless legs" (unspecified if ongoing), notes: Restless legs; "Acid reflux" (unspecified if ongoing), notes: Acid reflux; "Depression" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension (ongoing); ROPINIROLE HCL taken for restless legs syndrome (ongoing); PANTOPRAZOLE taken for gastrooesophageal reflux disease (ongoing); FLUOXETINE taken for depression (ongoing). Past drug history included: Penicillin, reaction(s): "allergic to Penicillin", notes: allergic to Penicillin and has been since he was a child. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Nov2022, outcome "unknown" and all described as "COVID after COVID Vaccines". Therapeutic measures were taken as a result of vaccination failure, covid-19. which include paxlovid.  Clinical course: Caller states she thinks her son has been on Lisinopril for a year, Ropinirole HCL for 6 months, Pantoprazole for 3 months and Fluoxetine for 5-6 months, maybe longer.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID after COVID Vaccines; COVID after COVID Vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 3 (booster), single (Lot number: FD0809) at the age of 52 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Jun2021 as dose 1, single (Lot number: EW0178) and on 24Jun2021 as dose 2, single (Lot number: EW0180) for covid-19 immunisation. The patient's relevant medical history included: "Heart Stent placement", start date: 2016 (unspecified if ongoing), notes: Caller states that her husband had 2 stents placed in 2016 and one placed in 2017; "Heart Stent placement", start date: 2017 (unspecified if ongoing), notes: Caller states that her husband had 2 stents placed in 2016 and one placed in 2017; "Heart", start date: 2016 (unspecified if ongoing); "Heart", start date: 2017, stop date: 2018; "Blood pressure" (unspecified if ongoing); "Heartburn" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing), notes: Allergies; "Neuropathy in feet" (unspecified if ongoing), notes: Neuropathy in feet. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID] taken for cardiac disorder, start date: 2017 (ongoing); BREO ELLIPTA taken for asthma (ongoing); ESOMEPRAZOLE MAGNESIUM DIHYDRATE taken for dyspepsia (ongoing); EZETIMIBE taken for blood cholesterol (ongoing); FLUOXETINE HCL DAEWHA taken for depression (ongoing); FLONASE [FLUTICASONE PROPIONATE] taken for hypersensitivity (ongoing); GABAPENTIN taken for neuropathy peripheral (ongoing); INCRUSE ELLIPTA taken for asthma (ongoing); LISINOPRIL taken for blood pressure measurement (ongoing); NITROGLYCERIN taken for cardiac disorder, start date: 2016 (ongoing); PROAIR HFA taken for asthma (ongoing). Past drug history included: Brilinta, reaction(s): "allergic to the medication Brilinta", notes: Her husband is allergic to the medication Brilinta. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 07Nov2022, outcome "unknown" and all described as "COVID after COVID Vaccines". Caller denies any labs, testing, or treatments relevant to these events (as reported).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Moderna: dose 1-2, Pfizer / BioNTech: 3-5; 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 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 13:15 as dose 5 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Nov2021 at 15:30 as dose 3 (booster), single (Lot number: PH8030), in left arm and on 08Apr2022 at 17:00 as dose 4 (booster), single (Lot number: FR9894), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Feb2021 at 18:45 as dose 1, single (Lot number: 013M20A), in left arm and on 04Mar2021 at 16:30 as dose 2, single (Lot number: 040A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Cholesterol" (unspecified if ongoing); "Allergy to pollen" (unspecified if ongoing), notes: Allergies to pollen, fragrances, dust, etc.; "Allergy to fragrances" (unspecified if ongoing), notes: Allergies to pollen, fragrances, dust, etc.; "Allergy to dust" (unspecified if ongoing), notes: Allergies to pollen, fragrances, dust, etc.; "Recently got over ear infection" (unspecified if ongoing), notes: Recently got over ear infection; "Thyroid" (unspecified if ongoing), notes: Thyroid. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna: dose 1-2, Pfizer / BioNTech: 3-5". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received anti-viral treatment: Paxlovid.
Age: 58.0
Sex: F
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). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 58 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 included: "known allergies: Eggs" (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 "COVID-19". The patient received PAXLOVID from 23Dec2022 for the treatment of Covid-19.
Age: 62.0
Sex: U
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) (Physician). The reporter is the patient.  A 62-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 62 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 included: "HTN" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Insomnia" (unspecified if ongoing); "Allergic rhinitis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Cephalexin, reaction(s): "Known allergies: Cephalexin"; Celebrex, reaction(s): "Known allergies: Celebrex"; Sulfa, reaction(s): "Known allergies: Sulfa". 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: (24Dec2022) Negative, notes: On day 11 I was negative on a lateral flow home test. On day 12 I tested again prior to an event and was positive; (25Dec2022) Positive, notes: On day 11 I was negative on a lateral flow home test. On day 12 I tested again prior to an event and was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2, BNT162B2 OMI BA.4-5  to the drug ineffective (LOE) and Covid -19 cannot be ruled out.
Age: 67.0
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) (Physician) from product quality group. 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 19Sep2022 at 14:00 as dose 5 (booster), single (Lot number: FJ7145B) at the age of 67 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Mar2022 at 15:00 as dose 4 (booster), single (Lot number: Fm0698), 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: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: two negative tests on day 9 and 10; Negative, notes: two negative tests on day 9 and 10; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID from 08Dec2022 to 12Dec2022). Reporter considered the event non-serious.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out.
Age: 59.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: EWO150), in left arm, on 30Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 07Dec2021 as dose 3 (booster), single (Lot number: 33030BD), in left arm and on 29Jun2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "underactive thyroid" (unspecified if ongoing); "known allergies: Sensitive to some antibiotics" (unspecified if ongoing), notes: known allergies: Sensitive to some antibiotics. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. 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: received Treatment of COVID-19; received 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 69-year-old male patient received BNT162b2 (BNT162B2), on 11Jul2022 at 12:45 as dose 5 (booster), single (Lot number: Pf7150) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Nov2022 at 14:30 as dose 6 (booster), single (Lot number: 023h22a), 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). The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "received Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Dec2022) positive, notes: tested positive after 9 days of completing of stopping Poxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test negative, SARS-CoV-2 test positive, 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) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GJ5342), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EL3302), in left arm, on 01Apr2021 as dose 2, single (Lot number: ER8734), in left arm and on 08Oct2021 as dose 3 (booster), single (Lot number: FC3180), in left arm for covid-19 immunisation.  The patient's relevant medical history included: "sulfa drugs" (unspecified if ongoing), notes: Known allergies to Sulfa drugs. Concomitant medication(s) included: CALCIUM; ESCITALOPRAM, start date: 01Aug2021; ESTRADIOL vaginal, start date: 30Mar2022; FAMOTIDINE, start date: 01Jan2022; IRON, start date: 01Dec2021; VITAMIN K2 + D3 [COLECALCIFEROL;MENAQUINONE], start date: 01Nov2022. Past drug history included: Diflucan, reaction(s): "Known allergies: Diflucan". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test negative: (Dec2022) Negative, notes: antigen test 2 days after completing Paxlovid medication; SARS-CoV-2 test positive: (Dec2022) Positive, notes: antigen test 2 and 3 days after negative test (4 and 5 days after completing Paxlovid medication). Therapeutic measures were taken as a result of vaccination failure, covid-19.  Course of events. Patient received treatment with Paxlovid in Dec2022 for COVID-19 infection. Restart of mild symptoms after being fully asymptomatic upon completion of medication course.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech: dose#1-4, Moderna: dose#5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6202), as dose 2, single (Lot number: ER8732), on 04Oct2021 as dose 3 (booster), single (Lot number: FF2589) and on 10Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 76 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Sep2022 at 10:00 as dose 5 (booster), single (Lot number: AS7146B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies : Penicillin" (unspecified if ongoing), notes: Known allergies : Penicillin. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Sep2022 at 10:00, outcome "unknown", described as "Pfizer / BioNTech: dose#1-4, Moderna: dose#5"; 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: Negative, notes: Covid rebound 4 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Patient received Vaccine. Patient received other medication in 2 weeks. Antiviral details: Product: COVID-19 Treatment. Brand: Paxlovid. Treatment start date was 11Dec2022 and Treatment stop date was 16Dec2022. Indication: Treatment of COVID-19.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient. A 29-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (lot number FJ524) at the age of 29 years, in left arm for covid-19 immunisation; BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 17Mar2021 as dose 1, single (lot number EP7534), in left arm, on 08Apr2021 as dose 2, single (lot number EW0158), in left arm and on 05Nov2021 as dose 3 (booster), single (lot number FF2520), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient was healthy. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) and COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure and covid-19 which included Paxlovid.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 5 (booster), single (Lot number: Gj2524) at the age of 68 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15May2022 as dose 4 (booster), single (Lot number: Fj4989), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Statins allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 10:30 as dose 5 (booster), single (Lot number: 6h9703) at the age of 60 years, in right 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 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 42.0
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 contactable reporter(s) (Physician).  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), in Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, in Jan2021 as dose 2, single (Batch/Lot number: unknown), in right arm, in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and in Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing); "mild protein S deficiency" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ceclor, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Dec2022) positive; (16Dec2022) negative; (18Dec2022) negative; (19Dec2022) negative; (24Dec2022) positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 14Dec2022 to 19Dec2022. The patient experienced COVID rebound after Paxlovid. Tested positive on 13Dec2022 with minimal to no symptoms. Began Paxlovid on 14Dec2022, tested negative on 16Dec2022, 18Dec2022 and 19Dec2022 and had no symptoms. Began having fevers, chills, cough, tachycardia and diaphoresis on 24Dec2022. Tested positive again.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Vaccine brand: Pfizer/BioNTech; Vaccien administraton date: 15Sep2022; vaccine brand other=Moderna; vaccine administration date: 01Apr2022; This is a spontaneous report received from contactable reporter (Consumer) from product quality group. The reporter is the patient. A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: FW1331) at the age of 65 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 033K21-2A), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: FAMOTIDINE, start date: 14Jun2022, stop date: 13Dec2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Sep2022, outcome "unknown", described as "Vaccine brand: Pfizer/BioNTech; Vaccien administraton date: 15Sep2022; vaccine brand other=Moderna; vaccine administration date: 01Apr2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Dec2022) Positive, notes: with only symptom being runny nose; (14Dec2022) Positive, notes: but still testing positive through 14Dec2022 with no symptoms after 10Dec2022; (25Dec2022) Positive, notes: Retested (before gathering with family large group) and tested positive with no symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19 with isolation and Paxlovid. Additional information: The patient has no known allergies.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Pfizer / BioNTech: dose#4, Moderna: dose#1-4; 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 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 40 years, in left arm for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 27Feb2021 as dose 1, single (Lot number: 041L20A), on 27Mar2021 as dose 2, single (Lot number: 020B21A) and on 16Nov2021 as dose 3 (booster), single (Lot number: 039fzia), in left arm for covid-19 immunization. The patient had no relevant medical history. Concomitant medication(s) included: Vicks Dayquil/Nyquil; Gabapentin; Lamotrigine; Pristiq; Spironolactone; Zyrtec [Cetirizine Hydrochloride]. 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 15Oct2022, outcome "unknown", described as "Pfizer / BioNTech: dose#4, Moderna: dose#1-4". Therapeutic measures were not taken as a result of drug ineffective, covid-19.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; Dose 1,2,3 are Moderna vaccine and Dose 4,5 are Pfizer vaccine; 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 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 71 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03May2022 at 12:30 as dose 4 (booster), single (Lot number: FM0698), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Jan2021 as dose 1, single (Lot number: 0122L20A), in left arm, on 07Feb2021 as dose 2, single (Lot number: 012M20A), in right arm and on 24Oct2021 as dose 3 (booster), single (Lot number: 062E21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "seronegative rheumatoid arthritis" (unspecified if ongoing); "cancer" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Sep2022 at 12:00, outcome "unknown", described as "Dose 1,2,3 are Moderna vaccine and Dose 4,5 are Pfizer vaccine"; COVID-19 (medically significant), DRUG INEFFECTIVE (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, drug ineffective with Paxlovid from 12Dec2022 to 17Dec2022.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from product quality group. 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 12Sep2022 as dose 5 (booster), single (Lot number: Kph54) at the age of 68 years, in right arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: Fk9896), in right arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: El3247), in right arm, on 09Feb2021 as dose 2, single (Lot number: El9269), in right arm and on 31Aug2021 as dose 3 (booster), single (Lot number: Fc3183), in right arm 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". 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 with Paxlovid from 07Dec2022 to 12Dec2022.
Age: 76.0
Sex: U
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 76-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Nov2022 at 12:00 as dose 5 (booster), single (Lot number: GJ33275) at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2021 at 12:00 as dose 1, single (Lot number: EL9262), in left arm, on 14Feb2021 at 12:00 as dose 2, single (Lot number: EL9269), in left arm, on 11Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 22Aug2022 at 12:15 as dose 4 (booster), single (Lot number: FP7138), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HighBP" (unspecified if ongoing); "low Thyroid" (unspecified if ongoing), notes: low Thyroid; "gERD" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: Rebound Covid 3 days after testing  negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech/Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 08:00 as dose number unknown (booster), single (Lot number: GH9694) at the age of 81 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Jan2021 as dose number unknown, single (Lot number: 06620A) for covid-19 immunisation. The patient's relevant medical history included: "heart" (unspecified if ongoing), notes: other medical history: heart; "cml" (unspecified if ongoing), notes: other medical history: cml. The patient took concomitant medications within 2 weeks of vaccination. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant, life threatening) with onset 09Sep2022, outcome "unknown", described as "Pfizer / BioNTech/Moderna"; DRUG INEFFECTIVE (hospitalization, medically significant, life threatening), COVID-19 (hospitalization, medically significant, life threatening), outcome "unknown" and all described as "Treatment of COVID-19". The patient was hospitalized for interchange of vaccine products, drug ineffective, covid-19 (hospitalization duration: 2 day(s)). Clinical course: The patient experienced "full COVID", incessant cough, nausea, trouble breathing, headache chills. The adverse event resulted in Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was given treatment from 05Dec2022 to 10Dec2022. The patient has no known allergies. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of interchange of vaccine products, drug ineffective, covid-19.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 69 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Mar2022 as dose 4 (booster), single (Lot number: FJ6369), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6202), in right arm, on 17Mar2021 as dose 2, single (Lot number: EP6955), in right arm and on 23Aug2021 as dose 3 (booster), single (Lot number: FC3183), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune diseases" (unspecified if ongoing); "celiac" (unspecified if ongoing); "rheumatiod arthritis" (unspecified if ongoing); "lupus SLE" (unspecified if ongoing); "microscopic Lymphocytic colitis" (unspecified if ongoing); "degenerative disc disease in neck" (unspecified if ongoing); "known allergies Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient received PAXLOVID as treatment for Covid-19 from 15Dec2022 to 20Dec2022.