chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
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) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies; Walnuts" (unspecified if ongoing). There were no concomitant medications. No Other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (02Jul2022) negative; (08Jul2022) positive; (Jul2022) negative, notes: for 5 days. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical courses: The patient received Paxlovid for COVID 19 Treatment, from 27Jun2022 to 02Jul2022. The patient tested negative on a rapid test on 02Jul after starting Paxlovid on 27Jun. She then tested negative for 5 days until testing positive on 08Jul. Symptoms all returned and feeling pretty bad.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
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 a contactable reporter(s) (Physician). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 11Aug2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 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: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "Allergy"; Rosuvastatin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included COVID 19 Treatment with Paxlovid from 28Jul2022 to 03Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 52.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "allergies: shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of covid-19.  Clinical course: it was reported that event COVID 19 Treatment was treated with Paxlovid from 01Jul2022 to 06Jul2022.   Follow-up attempts are completed. No further information is expected.
Age: 30.0
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 31-year-old male patient received BNT162b2 (BNT162B2), on 06Oct2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient received Paxlovid from 27Jun2022 to 01Jul2022 for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 02Apr2021 as dose 2, single (Lot number: EP7533), in left arm and on 24Oct2021 as dose 3 (booster), single (Lot number: 30155BH) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sesame Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (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: Unknown Results. Therapeutic measures were taken as a result of covid-19.  Clinical course: Paxlovid treatment was started from 01Jul2022 to 06Jul2022.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: had another bells palsy after the first Pfizer booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-017831.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing); "covid 19", start date: Nov2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "bells palsy"; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: BELL'S PALSY (medically significant), outcome "unknown", described as "had another bells palsy after the first Pfizer booster". Caller said they initially took 2 Pfizer doses and 1 Pfizer booster. Caller reported getting bells palsy after the first Pfizer injection. Then they had another bells palsy after the first Pfizer booster. Now caller is at the second booster and it is Moderna. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200019699 same patient/drug/AE, different dose number;
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 71 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: "hbp" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim"; Levaquin, reaction(s): "Known allergies : Levaquin"; Cipro, reaction(s): "Known allergies : Cipro"; Erythromycin, reaction(s): "Known allergies :Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 48-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EL9266), on 10Mar2021 as dose 2, single (Lot number: EL3246) and on 23Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "Excessive daytime sleepiness" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "restless leg syndrome" (unspecified if ongoing). Concomitant medication(s) included: MIRAPEX; HORIZANT; TAMSULOSIN; OMEPRAZOLE; MODAFINIL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; CLARITINE; FLONASE [FLUTICASONE PROPIONATE]. Past drug history included: Meloxicam, reaction(s): "Known allergies: Meloxicam". The following information was reported: VACCINATION FAILURE (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: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid from 30Jun2022 to 04Jul2022.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 72-year-old male patient received BNT162b2 (BNT162B2), on 31Jan2021 as dose number unknown, single (Lot number: El9262), in right arm and on 21Feb2021 as dose number unknown, single (Lot number: En6198) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Cipro, reaction(s): "Allergy". There was no other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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, suspected covid-19. The patient received Paxlovid for COVID 19 Treatment from 01Jul2022 to 06Jul2022. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care.
Age: 57.0
Sex: M
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) from product quality group. The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: Gw0153), in left arm and on 06May2021 as dose 2, single (Lot number: Ew0168) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Nov2021 as dose 3 (booster), single (Lot number: 004f21a), in left arm and on 10Apr2022 as dose 4 (booster), single (Lot number: 005m21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes, well controlled" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: INSULIN; LISINOPRIL; IRON SUPPLEMENT WITH VIT C & HERBS; VITAMIN B-12. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid.
Age: 43.0
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) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster), single (Lot number: 330268D) at the age of 43 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Rispiradone" (unspecified if ongoing). Concomitant medication(s) included: ABILIFY; LAMOTRIGINE; CLONOPIN; FLEXERIL [CEFIXIME]. 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: Rebound Covid positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical courses: Adverse event: Rebound Covid positive post Paxlovid treatment on 06Jul2022 at 20:00. No treatment was received for the rebound. Other medication in 2 weeks product included Abilify, Lamotrigine, Klonopin, Flexeril
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2021 as dose 3 (booster), single (Lot number: fc3184), in left arm and on 04Apr2022 as dose 4 (booster), single (Lot number: fp4554), 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: "Type 2 diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Treatment of COVID-19; (unspecified date) Negative, notes: covid home test came our negative; (08Jul2022) Positive, notes: home test was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Macule, Pruritus, Vaccination site rash
Clinical narrative: fourth shot gave a rash around injection site; got huge patches on abdomen; itchy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), 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. Vaccination history included: BNT162b2 (DOSE: 01, Route of Admin: Intramuscular), administration date: 20Feb2021, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "Autoimmune disorder", "Drug allergy", "Injection site itching", "Injection site reaction"; BNT162b2 (DOSE: 02, Route of Admin: Intramuscular), administration date: 13Mar2021, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "Autoimmune disorder", "Drug allergy", "Injection site itching", "Injection site reaction"; Astrazeneca covid-19 vaccine (DOSE: 03 (Booster dose), Route of Admin: Intramuscular), for COVID-19 Immunization. The following information was reported: VACCINATION SITE RASH (non-serious), outcome "unknown", described as "fourth shot gave a rash around injection site"; MACULE (non-serious), outcome "unknown", described as "got huge patches on abdomen"; PRURITUS (non-serious), outcome "unknown", described as "itchy".  Additional information: The patient had two Covid-19 injections, and said injections threw her into an autoimmune disorder. The physician prescribed HUMIRA. She was injecting into abdomen. She had an allergic reaction to HUMIRA. Her first three shots went fine; the fourth shot gave her a rash around injection site. After the fourth injection, she got huge patches on her abdomen, they were itchy, and each injection made it worse and worse. Patient then had two AstraZeneca injections simultaneously without any side effects. Patient was prescribed RINVOQ at the time of report. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: 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 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2021 as dose number unknown, single (Batch/Lot number: unknown), in Feb2021 as dose number unknown, single (Batch/Lot number: unknown), in Sep2021 as dose number unknown, single (Batch/Lot number: unknown) and in Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "hashimotos thyroid disease" (unspecified if ongoing). Concomitant medication(s) included: TRESIBA; NOVOLIN 30R [INSULIN]; LEVOTHYROXINE; PANTOPRAZOLE; ALBUTEROL [SALBUTAMOL]. 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: Unknown results; Positive, notes: rebound with symptoms worse than the original. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 27Jun2022 to 02Jul2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID positive; COVID positive; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 at 18:00 as dose 1, single (Lot number: EL9269), in left arm, on 02Mar2021 as dose 2, single (Lot number: EN6206), in left arm, on 06Oct2021 at 13:30 as dose 3 (booster) single (Lot number: FF2590), in left arm and on 19Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FJ9943) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "seasonal allergy" (unspecified if ongoing); "auto immune angio edema" (unspecified if ongoing); "glaucoma" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY; METOPROLOL; CALTRATE [CALCIUM CARBONATE]; D3; VITAMIN C [ASCORBIC ACID]. Past drug history included: Metoprolol, reaction(s): "Minor cardiac pvc's", notes: Minor cardiac pvc's (metoprolol). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jun2022) Positive; (29Jun2022) Negative; (30Jun2022) Negative; (01Jul2022) Negative; (02Jul2022) Negative; (08Jul2022) Positive, notes: Tested twice on 08Jul2022. Both immediately Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Addition information: Start date of treatment for COVID-19 was 24Jun2022. Stop date of treatment for COVID-19 was 29Jun2022. Paxlovid rebound- return of COVID symptoms 5-8 days after first negative test. (First negative test and last day of paxlovid 5 day caourse are same). 3 consecutive days of negative tests to follow. Initial COVID positive on 22Jun2022. 1st dose paxlovid 24Jun2022 in pm. Last dose paxlovid 29Jun2022 in am. Negative tests 29Jun2022; 30Jun2022; 01Jul2022; 02Jul2022; new mild symptoms may have started as early as 01Jul2022. Or as late as 06Jul2022. Cold symptoms with mild congestion and intermittent cough due to raw throat more apparent on 07Jul2022. Tested twice on 08Jul2022. Both immediately Positive. Slight fever and headache with some congestion on 08Jul2022. I am in the throes of it now.; Sender's Comments: The contribution of the suspect drug to the onset of "COVID positive" cannot be ruled out since drug efficacy varies from one patient to another and affected by different factors.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 37-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 17Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing). There were no concomitant medications (No other medication in 2 weeks). Past drug history included: Meloxicam, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. 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 included Paxlovid.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 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: "Depression" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO. 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: Unknown results; Positive, notes: positive COVID test for 4 days (so far). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine lot unknown reason: Unable to locate or read the details. The patient Anti-viral details: Product: COVID 19 Treatment, Treatment start date: 23Jun2022, Treatment stop date: 27Jun2022, Indication: Treatment of COVID-19. The patient did not had any known allergies. Other medication on 2 weeks product: Lexapro.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EN5318) and on 24Feb2021 as dose 2, single (Lot number: EN6203) at the age of 32 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 01Jan2022 as dose 3 (booster), single (Lot number: D68h21a) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension"; "chronic migraines"; "chronic pain"; "chronic fatigue"; "possible gerd"; "chronic sinus infections". There were no concomitant medications. Past drug history included: Thyme, reaction: "Known allergies: Thyme". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: Positive test 30Jun; Positive test 30Jun; 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 65-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 24May2021 as dose 2, single (Lot number: LR2613), in left arm, on 06Oct2021 as dose 3 (booster), single (Lot number: FF2588), in left arm and on 05May2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: Other medical history: HTN (Hypertension), controlled. Otherwise good physical condition. Concomitant medication(s) included: ATORVASTATIN, start date: Jan1999; LISINOPRIL, start date: Jan2009; TESTOSTERONE, start date: Jan2011; CLARITIN [LORATADINE], start date: Jan2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Jun2022, outcome "not recovered" and all described as "Positive test 30Jun". The patient underwent the following laboratory tests and procedures: Oxygen saturation: (unspecified date) >94, notes: Both of us have remained afebrile, with good pulse oximetry >94; SARS-CoV-2 test: (30Jun2022) positive, notes: After positive test 30Jun, started 5-day course Paxlovid; (05Jul2022) negative, notes: At end of 5-day course 05Jul I tested negative; (10Jul2022) positive, notes: Retested and it had returned to covid-positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Appeared to be Covid rebound. Original Sx (symptoms) onset 29Jun2022, mild bronchitis with exhale wheezing, mild fatigue, a febrile. Positive test 30Jun2022. On 10Jul2022, patient woke up with mild bronchitis again, this time with a mild productive cough with forced expiration wheezing. The retropharyngeal irritation was not present. Afebrile still. Not much fatigue really. Retested and it had returned to covid-positive. One other thing to note: my housemate also turned covid-positive 5 days after I did. Not sure if it is the same strain, but we were probably exposed together. (Housemate is completing a 5-day course of Paxlovid today, but remains covid-positive but otherwise asymptomatic. Both of us have remained afebrile, with good pulse oximetry >94).  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 at 18:00 as dose 1, single (Lot number: EN6198), in left arm, on 22Mar2021 at 18:00 as dose 2, single (Lot number: ER8727), in left arm, on 13Dec2021 at 12:00 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 14May2022 at 12:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies: Walnuts/Pecans" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19: received Paxlovid for COVID 19 Treatment from 24Jun2022 to 29Jun2022.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; GABAPENTIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient did not have any allergies. Patient received Paxlovid from (27Jun2022 to 01Jul2022) as a result of treatment for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to  all the reported events Drug ineffective , COVID-19 cannot be completely excluded based on temporal association and known drug safety profile
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 30 , in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Cephalosporin" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO, start date: 01Jan2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 at 16:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 08Apr2021 at 15:30 as dose 2, single (Batch/Lot number: unknown), in left arm, on 20Oct2021 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 13May2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALBUTEROL SULFATE, start date: 29Jun2022, stop date: 03Jul2022; LATANOPROST, start date: May2014.  The following information was reported: VACCINATION FAILURE (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: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received product "Paxlovid (Anti-viral)" as COVID-19 treatment. Treatment start date was 29Jun2022 and treatment stop date was 03Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
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 70-year-old male patient received BNT162b2 (BNT162B2), on 25Apr2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 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: "pacemaker" (unspecified if ongoing); "high BP" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN CALCIUM; LISINOPRIL; HYDROCHLOROTHIAZIDE. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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; Positive, notes: test positive 5 days after negitive test. Cough and congestion no fever. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Known allergies: none. He received Paxlovid treatment for COVID-19 (from 27Jun2022 to 01Jul2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tue 28Jun2022 was my first positive test/Sun 26Jun2022 I started feeling a little off/Mon 27Jun2022 I developed a cough and fever.; Tue 28Jun2022 was my first positive test/Sun 26Jun2022 I started feeling a little off/Mon 27Jun2022 I developed a cough and fever.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 [booster], single (Lot number: 30125BA), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 28Jun2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant) with onset 28Jun2022, outcome "unknown" and all described as "Tue 28Jun2022 was my first positive test/Sun 26Jun2022 I started feeling a little off/Mon 27Jun2022 I developed a cough and fever.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jun2022) Positive, notes: Tue 28Jun2022 was my first positive test; (03Jul2022) Negative, notes: Sun 03Jul2022 I tested negative; (04Jul2022) Negative, notes: Mon 04Jul2022 I tested negative; (08Jul2022) Positive, notes: I just tested positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient didn't received other medication in 2 weeks. Treatment start date-28Jun2022, Treatment stop date-04Jul2022. Other medical history reported as None.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment/Drug ineffective; COVID 19 Treatment; 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 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 at 15:00 as dose 3 (booster), single (Lot number: FP8891) and on 25Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic asthma" (unspecified if ongoing). Concomitant medication(s) included: AZITHROMYCIN, start date: 29Jun2022, stop date: 03Jul2022; ALEMBIC TELMISARTAN, start date: 29Jun2022, stop date: 03Jul2022. Past drug history included: Codeine, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "COVID 19 Treatment/Drug ineffective"; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) Positive, notes: COVID symptoms returned worse than before treatment with fever on 8Jul22. Therapeutic measures were taken as a result of drug ineffective, covid-19. The vaccine received reported as yes. Other medication in 2weeks reported as yes. Anti viral details was Product reported as COVID 19 Treatment as Paxlovid. Treatment start date was 29Jun2022. Treatment stop date was 04Jul2022. Indication was treatment of COVID-19. Other medication in 2weeks product was Azithromycin. Other medication in 2weeks brand was Alembic. Other medication in 2weeks start date was 29Jun2022. Other medication in 2weeks stop date was 03Jul2022. Adverse event start date was 08Jul2022. Adverse event start time was 12:00 AM. Patient recovered was not recovered. Treatment ae was no.
Age: 65.0
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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, Vaccine brand unknown and Vaccine lot unknown: False, Vaccine dose number unknown: False), on 17Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 07Apr2021 as dose 2, single (Lot number: EW0153), in left arm and on 20Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart Murmur Since Birth" (unspecified if ongoing), notes: No underlying conditions; "borderline high blood pressure" (unspecified if ongoing), notes: No underlying conditions; "misc surgeries" (unspecified if ongoing), notes: No underlying conditions. There were no concomitant medications in 2weeks. The following information was reported: VACCINATION FAILURE (medically significant) with onset 22Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 22Apr2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Apr2022) Positive; (24Apr2022) Negative; (02May2022) Positive; (04May2022) Negative; (05May2022) Negative; (06May2022) Negative; (07May2022) Negative; (08May2022) Negative; (09May2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Adverse event: Recurrence of COVID-19 symptoms on Day 19: runny nose, sinus pressure, fatigue. Day 0 of mild COVID symptoms 22Apr2022; tested positive 23Apr2022; started Paxlovid 23Apr2022; still-mild symptoms resolved 24Apr2022; tested neg 25Apr2022; symptoms recurred 02May2022; tested pos 04May2022-09May2022; tested neg 10May2022; symptoms resolved by 13May2022. Rebound symptoms significantly worse (though still clinically mild) than initial Day 0-2.  Known allergies: No. Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 23Apr2022, Treatment stop date: 27Apr2022, Lot number: FY8914, Indication: Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 69-year-old male patient received BNT162b2 (BNT162B2), on 04Oct2021 at 10:30 as dose number unknown, single (Lot number: FD8448) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Apr2022 at 10:30 as dose number unknown, single (Batch/Lot number: unknown), in left arm 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), SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical information: It was reported that Other medication in 2weeks: No. Anti-viral details: Product=COVID 19 Treatment, Brand=Pfizer, Treatment start date=29Jun2022, Treatment stop date=04Jul2022, Indication=Treatment of COVID-19. Adverse event: Cough, congestion, runny nose, and rundown feeling. Adverse event, Adverse event start date: 07Jul2022. Ae resulted in: None of the above. If patient: recovered: Recovering. If treatment ae: No. Known allergies: No. Other medical history: No.
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 71-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Plavix, notes: Taking plavix and statin.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: still test positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details product COVID 19 Treatment, brand  Paxlovid, treatment start date 30Jun2022, treatment end date 04Jul2022, other medication details: other medication in 2 weeks product Cipro, start date 29Jun2022, stop date 06Jul2022, other medical history: Taking plavix and statin. Symptoms never completely abated but even stronger returned after finishing Paxlovid, still test positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.