chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient. A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Aug2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 27Apr2022 at 11:00 as dose 5 (booster), single (Lot number: Fk9893) at the age of 44 years, in right arm for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 06Feb2021 at 14:00 as dose 1, single (Lot number: 012m20A), in right arm, on 06Mar2021 at 11:00 as dose 2, single (Lot number: 016m20A), in left arm and on 16Nov2021 at 13:00 as dose 4 (booster), single (Lot number: 065f21A), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Autoimmune-Sjogren's" (unspecified if ongoing); "Raynaud's disease" (unspecified if ongoing); "positive ANA" (unspecified if ongoing); "vestibular Migraines" (unspecified if ongoing), notes: I have vestibular Migraines. Concomitant medication(s) included: Hydroxychloroquine, start date: 14Oct2019; Effexor, start date: Jun2019. 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: Positive; Negative, notes: Antigen testing negative. Therapeutic measures were taken as a result of drug ineffective, Covid-19 included Paxlovid from 24Jun2022 to 28Jun2022. 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 between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, HIV test, 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 36-year-old male patient received BNT162b2 (BNT162B2), on 31Dec2021 as dose 3 (booster), single (Lot number: EW0191) and on 30Apr2022 as dose 4 (booster), single (Lot number: FJ5683) at the age of 35 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Apr2021 as dose 1, single (Lot number: 041B21A) and on 13May2021 as dose 2, single (Lot number: 041B21A) for covid-19 immunisation. The patient's relevant medical history included: "HIV positive" (unspecified if ongoing); "thalassemia minor" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Known allergies: Shrimp" (unspecified if ongoing). Concomitant medication(s) included: BIKTARVY.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment".  Pateint received Paxlovid from 28Jun2022 to 02Jul2022 (Lot number: 1916517A). Other medication in 2weeks product: Biktarvy (brand: Gilead, lot number: 031317). Completed Paxlovid rounds yesterday - 01Jul2022. Today 02Jul2022, patient was testing positive. Currently, patient had some stuffiness, sneezing, and random cough. No fever. The patient underwent the following laboratory tests and procedures: HIV test: (unspecified date) positive; SARS-CoV-2 test: (unspecified date) Unknown results; (02Jul2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 68.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old patient received BNT162b2 (BNT162B2), on 10Oct2021 as dose 3 (booster), single (Lot number: Fe3590) and on 11Apr2022 as dose 4 (booster), single (Lot number: Pj4989) at the age of 68 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: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa, codeine; "Glaucoma" (unspecified if ongoing), notes: Other medical history: Glaucoma. The patient's concomitant medications were not reported. Past drug history included: Known allergies: codeine, reaction(s): "Known allergies: codeine", notes: Known allergies: codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Apr2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Apr2022) Negative, notes: Neg antigen 25Apr2022; (28Apr2022) Positive, notes: positive antigen test on 28Apr2022. 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: 19Apr2022 Treatment stop date: 24Apr2022 Indication: Treatment of COVID-19. Adverse event: Last dose AM 24Apr2022. Neg antigen 25Apr2022 Symptoms began to return 28Apr2022 positive antigen test on 28Apr2022 symptoms containing for 4 - 5 days tried reporting to Pfizer at that time and was brushed off.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (2022) Negative, notes: tested negative for 5 days and then became positive again; (2022) Positive, notes: tested negative for 5 days and then became positive again. 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: UNKNOWN RESULTS. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment of Paxlovid for COVID-19 on 21Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown), in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: INSULIN taken for type 1 diabetes mellitus; HUMALOG taken for type 1 diabetes mellitus. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient received "COVID-19 Treatment" Paxlovid from 01Jul2022 to 03Jul2022, after vaccination with Pfizer/BioNTech COVID vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Ear discomfort, Eye pain, Headache, Myalgia
Clinical narrative: headaches; muscle aches; eye pain; clogged ears; sore throat; nasal congestion; nausea; heartburn; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jun2022 as dose 2, single (Batch/Lot number: unknown) at the age of 22 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "COVID-19" (unspecified if ongoing); "Allergy to nickel" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; JUNEL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: Unknown, Vaccine location: Left arm), for COVID-19 immunization. The following information was reported: EAR DISCOMFORT (non-serious) with onset 27Jun2022, outcome "not recovered", described as "clogged ears"; EYE PAIN (non-serious) with onset 27Jun2022, outcome "not recovered"; HEADACHE (non-serious) with onset 27Jun2022, outcome "not recovered", described as "headaches"; DYSPEPSIA (non-serious) with onset 27Jun2022, outcome "not recovered", described as "heartburn"; MYALGIA (non-serious) with onset 27Jun2022, outcome "not recovered", described as "muscle aches"; NASAL CONGESTION (non-serious) with onset 27Jun2022, outcome "not recovered"; NAUSEA (non-serious) with onset 27Jun2022, outcome "not recovered"; OROPHARYNGEAL PAIN (non-serious) with onset 27Jun2022, outcome "not recovered", described as "sore throat". Therapeutic measures were not taken as a result of headache, myalgia, eye pain, ear discomfort, oropharyngeal pain, nasal congestion, nausea, dyspepsia. Additional information: The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The facility type vaccine was pharmacy or drug store. On 27Jun2022 (also reported as  following week after receiving dose 2), the patient experienced headaches, muscle aches, eye pain, clogged ears, sore throat, nasal congestion, nausea, and heartburn. Prior to vaccination, the patient was diagnosed as COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nausea, Oropharyngeal pain
Clinical narrative: headaches; muscle aches; eye pain; clogged ears; sore throat; nasal congestion; nausea; heartburn; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jun2022 as dose 2, single (Batch/Lot number: unknown) at the age of 22 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "COVID-19" (unspecified if ongoing); "Allergy to nickel" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; JUNEL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: Unknown, Vaccine location: Left arm), for COVID-19 immunization. The following information was reported: EAR DISCOMFORT (non-serious) with onset 27Jun2022, outcome "not recovered", described as "clogged ears"; EYE PAIN (non-serious) with onset 27Jun2022, outcome "not recovered"; HEADACHE (non-serious) with onset 27Jun2022, outcome "not recovered", described as "headaches"; DYSPEPSIA (non-serious) with onset 27Jun2022, outcome "not recovered", described as "heartburn"; MYALGIA (non-serious) with onset 27Jun2022, outcome "not recovered", described as "muscle aches"; NASAL CONGESTION (non-serious) with onset 27Jun2022, outcome "not recovered"; NAUSEA (non-serious) with onset 27Jun2022, outcome "not recovered"; OROPHARYNGEAL PAIN (non-serious) with onset 27Jun2022, outcome "not recovered", described as "sore throat". Therapeutic measures were not taken as a result of headache, myalgia, eye pain, ear discomfort, oropharyngeal pain, nasal congestion, nausea, dyspepsia. Additional information: The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The facility type vaccine was pharmacy or drug store. On 27Jun2022 (also reported as  following week after receiving dose 2), the patient experienced headaches, muscle aches, eye pain, clogged ears, sore throat, nasal congestion, nausea, and heartburn. Prior to vaccination, the patient was diagnosed as COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 21Oct2021 as dose number unknown, single (Lot number: TE3590) and on 15Apr2022 as dose number unknown, single (Lot number: FJ4989) at the age of 68 years for covid-19 immunization. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing). The patient took other medication in 2weeks. Past drug history included: Codeine, reaction(s): "known allergies Codeine", notes: known allergies Codeine. 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 of Paxlovid  were taken from 08Jun2022 to 13Jun2022 as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19/COVID rebound with a thick black line on antigen test; Treatment of COVID-19/COVID rebound with a thick black line on antigen test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Dec2021 as dose 3 (booster), single (Lot number: FH8030), 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's relevant medical history and concomitant medications were not reported. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19/COVID rebound with a thick black line on antigen test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) a faint line; (Jul2022) thick black line. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: it was reported that Treatment of COVID-19 was started on 23Jun2022 and stopped on 28Jun2022. After starting to feel better and saw a faint line on an antigen test, experienced COVID rebound with a thick black line on antigen test and return of symptoms on 02Jul2022.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19/Rebound of positive Covid test; Treatment of COVID-19/Rebound of positive Covid test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: Er2613), on 15Apr2021 as dose 2, single (Lot number: Ew0157) and on 08Nov2021 as dose 3 (booster), single (Lot number: 301458a) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19/Rebound of positive Covid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jul2022) Positive, notes: Rebound of positive Covid test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: it was reported that Treatment of COVID-19 was stopped on 28Jun2022, patient experienced Rebound of positive Covid test on 03Jul2022.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, 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 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "diabetic" (unspecified if ongoing); "obese" (unspecified if ongoing); "hypertensive" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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 drug ineffective, suspected covid-19. From 19Jun2022 to 23Jun2022, the patient received nirmatrelvir; ritonavir (PAXLOVID) for treatment of COVID-19. On 28Jun2022 (on Tuesday),  the patient experienced a return of covid symptoms that were worse than before nirmatrelvir; ritonavir. Coughing and breathing problems were still an issue as of 02Jul2022. No medical help available due to holiday weekend.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19
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 73-year-old male patient received BNT162b2 (BNT162B2), on 03Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Covid rebounded on 03Jul2022 (tested positive). Symptoms: congested, no fever or chills, aches. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment of COVID-19 included Paxlovid from 20Jun2022 to 25Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: My lips and outer mouth area were very numb for about an hour after receiving the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08May2021 as dose 2, single (Lot number: EW0170) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfa drugs allergy" (unspecified if ongoing), notes: Known allergies: Yes, Amoxicillin, Sulfa drugs and Codeine; "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; "HRT" (unspecified if ongoing), notes: other medications the patient received within 2 weeks of vaccination:HRT & Thyroid Medications; "Thyroid" (unspecified if ongoing), notes: other medications the patient received within 2 weeks of vaccination:HRT & Thyroid Medications. The patient took concomitant medications. Past drug history included: Known allergies: amoxicillin, reaction(s): "Drug Allergy", notes: Known allergies: Yes, Amoxicillin, Sulfa drugs and Codeine; Known allergies: codeine, reaction(s): "Drug Allergy", notes: Known allergies: Yes, Amoxicillin, Sulfa drugs and Codeine. The following information was reported: HYPOAESTHESIA ORAL (non-serious) with onset 2021, outcome "recovering", described as "My lips and outer mouth area were very numb for about an hour after receiving the vaccine". Therapeutic measures were not taken as a result of hypoaesthesia oral.   Additional information: Patient did not receive any other vaccine in four weeks prior to the COVID vaccine. Other medications in two weeks included HRT [hormone replacement therapy] and thyroid medications. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid Positive Illness; Covid Positive Illness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL3247), on 23Feb2021 as dose 2, single (Lot number: EL3247) and on 08Jan2022 as dose 3 (booster), single (Lot number: FJ5682) at the age of 48 years for covid-19 immunisation. The patient relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jul2022, outcome "not recovered" and all described as "Covid Positive Illness". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jul2022) Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical Information: No other medications in two weeks and no other vaccination in four weeks. No covid prior vaccination. Tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EN5318), in right arm, on 24Feb2021 as dose 2, single (Lot number: EN5318), in right arm and on 05Nov2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 39 years, in right arm, all intramuscular for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jul2022, outcome "recovering" and all described as "COVID Infection diagnosed via rapid test on 03Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jul2022) Positive, notes: COVID test type post vaccination=Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, Covid-19.
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) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), as dose 1, 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 patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid (Treatment start date: 21Jun2022, Treatment stop date: 26Jun2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
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(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EW0151), in right arm, on 29Apr2021 as dose 2, single (Lot number: EW0175), in left arm and on 11Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: Wheat" (unspecified if ongoing); "Psoriatic arthritis" (unspecified if ongoing); "migraines" (unspecified if ongoing); "asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "interstitial cystitis" (unspecified if ongoing); "chronic pain" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: yes-amoxicillin, reaction(s): "Known allergies: Yes-Amoxicillin"; Known allergies: macrodantin, reaction(s): "Known allergies: macrodantin"; Known allergies: prochlorperazine, reaction(s): "Known allergies: prochlorperazine"; Known allergies: pyridium, reaction(s): "Known allergies: pyridium". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course was reported as, patient experienced a rebound case of COVID after completing the treatment of Paxlovid on 25Jun2022. Patient was treated with prednisone. She was not recovered from symptoms.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 12Jan2021 as dose 1, single (Lot number: EN6201), in left arm, on 05Mar2021 as dose 2, single (Lot number: EN6198), in left arm and on 05Nov2021 at 14:00 as dose 3 (booster), single (Lot number: FH8028) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ovarian cancer" (unspecified if ongoing); "glaucoma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "Age related macular degeneration" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid.
Age: 67.0
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 a 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 19Jan2021 as dose 1, single (Lot number: EL8982) at the age of 66 years, in right arm, on 09Feb2021 as dose 2, single (Lot number: EN9581) at the age of 66 years, in right arm, on 26Sep2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 67 years, in right arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "mild asthma" (unspecified if ongoing), notes: Mild asthma. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jun2022) Positive; (16Jun2022) Negative; (17Jun2022) Negative; (04Jul2022) Positive, notes: Home test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient did not have known allergies. Tested positive for COVID on 07Jun2022. Started Paxloid on 09Jun2022. Finished her last dose on 13Jun2022. Tested negative for COVID on 16Jun2022 and negative again on 17Jun2022. She was experiencing COVID mild symptoms on 03Jul2022 and she tested positive for COVID on 04Jul2022 using a home test. She have an appointment for a PCR test on 05Jul2022 at 7:15 am. Patient had received Anti-viral medication Paxloid as COVID 19 treatment and the treatment was started on Jun2022 and stopped on 13Jun2022.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL SULFATE] taken for asthma. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19". 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=03Jun2022, treatment stop date=08Jun2022, indication=Treatment of COVID-19]  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Vomiting
Clinical narrative: Stomach Pain; Vomiting; Diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 4-year-old male patient received BNT162b2 (BNT162B2), on 01Jul2022 at 17:45 as dose 1, single (Lot number: FL8095) at the age of 4 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Premature Birth" (unspecified if ongoing); "Pyloric Stenosis" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; CLARITINE; MELATONIN. The following information was reported: DIARRHOEA (non-serious) with onset 02Jul2022 at 01:15, outcome "not recovered", described as "Diarrhea"; ABDOMINAL PAIN UPPER (non-serious) with onset 02Jul2022 at 01:15, outcome "not recovered", described as "Stomach Pain"; VOMITING (non-serious) with onset 02Jul2022 at 01:15, outcome "not recovered". The events "stomach pain", "vomiting" and "diarrhea" required emergency room visit. Therapeutic measures were taken as a result of abdominal pain upper, vomiting, diarrhoea.  Additional information: Other medications in two weeks included Multivitamin, Vitamin C, Claritin 5mg, Meletonin. Treatment of adverse events was prescription of Zofran. The patient had no known allergies to medications, food, or other products. The patient did not receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 45.0
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 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 45 years, in left 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 had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) 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.  Patient received treatment with Paxlovid. Treatment start date: 01Jul2022, Lot number: Gc4762. indication: Treatment of 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: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
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 non-contactable reporter(s) (Physician). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing); "known allergies Shellfish" (unspecified if ongoing), notes: known allergies Shellfish. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Anti-viral product Paxlovid started on 16Jun2022 and ended on 20Jun2022, for COVID 19 Treatment. Reported Event included return of positive test. Cold symptoms. Asthma symptoms and start date was 22Jun2022.It was reported that the patient was recovering without treatment. Device Date: 04Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events, COVID 19, Drug Ineffective and BNT162B2 is considered possible.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested + with sore throat, body aches, headache, mild congestion.; Tested + with sore throat, body aches, headache, mild congestion.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19May2022 at 14:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 61 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (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 "Tested + with sore throat, body aches, headache, mild congestion.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (Jun2022) Positive; (Jul2022) 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: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A male patient received BNT162b2 (BNT162B2), in Apr2021 as dose number unknown, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "tested positive for Covid/Covid symptoms as being mild; sore throat and feeling tired". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Received a report on 02Jul22 from a family friend that tested positive for Covid-19 15 days ago. He received his last Pfizer vaccine Apr2021. He reported his Covid symptoms as being mild; sore throat and feeling tired. Sore throat symptom subsided after the first day of taking Paxlovid. He also reported experiencing diarrhea while taking Paxlovid. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 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 had no relevant medical history. There were no concomitant medications. 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: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient previously received COVID-19 vaccine. Patient did not took any other medication or product within two weeks of COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Age: 46.0
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 non-contactable reporter(s) (Physician). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Lot number: EW0180) at the age of 46 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: "Environmental allergies" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received other medication in 2 weeks included Flonase.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report, a causal association between reported events and suspect BNT162B2 cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation
Clinical narrative: Vaccine brand=Pfizer/BioNTech, vaccine administration date=26Mar2021; vaccine brand other=Johnson ,vaccine administration date=26Mar2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 2, single (Lot number: Fj1620) at the age of 62 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 26Mar2021 at 10:15 as dose 1, single (Lot number: 1805029), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing), notes: Type 2 diabetes. The patient's concomitant medications were not reported. The following information was reported: COVID-19 IMMUNISATION (non-serious) with onset 26Mar2021, outcome "unknown", described as "Vaccine brand=Pfizer/BioNTech, vaccine administration date=26Mar2021; vaccine brand other=Johnson ,vaccine administration date=26Mar2021".  Additional information: Patient took medications within 2 weeks of starting COVID-19 treatment and patient previously received a COVID-19 Vaccine.
Age: 65.0
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) (Physician). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 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: "diabetes" (unspecified if ongoing); "HTN" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE, start date: 01Nov2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated with Paxlovid. The patient was taking other medication Amlodipine within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  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 between the events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: experiencing temperature of 101; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A child patient received BNT162b2 (BNT162B2), on 02Jul2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious) with onset Jul2022, outcome "not recovered", described as "experiencing temperature of 101". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Child got the Pfizer Booster (Clarified as Pfizer Covid-19 vaccine) yesterday and is experiencing temperature of 101.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.