chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: getting COVID-19 infection; getting COVID-19 infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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. Vaccination history included: Flu vaccine (DOSE NUMBER UNKNOWN, SINGLE; UNKNOWN MANUFACTURER  feeling sick with flu symptoms for one month after getting the flu vaccine), for Flu vaccination, reaction(s): "flu/ feeling sick with flu symptoms". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "getting COVID-19 infection".  Clinical course: This female consumer reported receiving two injections for the primary series of the Pfizer covid-19 monovalent and then later a booster dose of the Pfizer covid-19 monovalent. She did not report on what dates. The consumer reported recently getting COVID-19 infection. The consumer stated she had been prescribed Zithromax 500 mg every other day to take by her doctor. She did not say why the Zithromax 500 mg was prescribed. The consumer stated her ex-husband and his girlfriend received the Pfizer covid-19 vaccines and later got COVID-19. The consumer did not report when and how many of the Pfizer covid-19 vaccinations her ex-husband or the girlfriend of her ex-husband received. The consumer mentioned she had a flu vaccine in the past (manufacturer not specified), after just getting over the flu, and she experienced feeling sick with flu symptoms for one month after getting the flu vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021152706 same patient, same product, different dose and event;US-PFIZER INC-2021329876 same patient, same product, different dose and event;US-PFIZER INC-202101587543 same patient, same product, different dose and event;
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heterozygous Familial Hypercholesterolemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course details: The patient received treatment with Paxlovid on 04Feb2023 and stopped on 09Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got COVID-19; got COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2 NOS), 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got COVID-19".  Additional information: The consumer stated her ex-husband and his girlfriend received the Pfizer covid-19 vaccines and later got COVID-19. The consumer did not report when and how many of the Pfizer covid-19 vaccinations her ex-husband or the girlfriend of her ex-husband received.   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: Drug ineffective, Suspected COVID-19
Clinical narrative: got COVID-19; got COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got COVID-19".  Clinical course: The reporter stated her ex-husband and his girlfriend received the Pfizer covid-19 vaccines and later got COVID-19. The reporter did not report when and how many of the Pfizer covid-19 vaccinations her ex-husband or the girlfriend of her ex-husband received.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid; Covid; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4272717 (Abbvie).  A 50-year-old female patient received BNT162b2 (BNT162B2), on 15Jun2021 as dose 1, single (Batch/Lot number: unknown) and on 18Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at 40 mg (40 mg (citrate free), every 2 weeks), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "covid" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Causalities: The reporter's causality for the event(s) of Covid with Adalimumab Solution for Injection was Not Provided. The reporter's causality for the event(s) of Covid with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not ProvidedAbbVie's opinion was that the causality for the event(s) of Covid respiratory infection with Adalimumab Solution for Injection was Not Provided. companies opinion was that the causality for the event(s) of Covid with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided Assessment Results: - Humira 40MG/0.4ML - COVID-19, Market Authorization Holder (MAH)- COVID-19, Non-Health Care Professional, Global Introspection, Not ReportedPfizer/BioNtech Covid-19 Vaccine - COVID-19, Market Authorization Holder (MAH.  Pfizer/BioNtech Covid-19 Vaccine - COVID-19, Non-Health Care Professional, Global Introspection, Not Reported  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / Suspected COVID-19 cannot be ruled out,Linked Report(s) : US-PFIZER INC-202300069763 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;US-PFIZER INC-PV202300029663 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 at 10:00 as dose 5 (booster), single (Lot number: GJ6738) 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Cancer" (unspecified if ongoing); "Penicillin" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "Known allergies: Procaine" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Metformin, start date: 15Jun1998; Januvia, start date: 01Jun2016.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I was tested positive for Covid-19 first time. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medication in 2 weeks was reported as yes. The patient was tested positive for Covid-19 first time and received Anti-viral COVID 19 Treatment with Paxlovid from 09Feb2023 to 13Feb2023 with Lot number # 660050.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 73 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Remote treatment for lung cancer" (unspecified if ongoing), notes: Other medical history: Remote treatment for lung cancer; "NSCLC" (unspecified if ongoing), notes: Other medical history: NSCLC. There were no concomitant medications. Patient had no known allergies.  The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "not recovered", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (10Feb2023) Negative, notes: Antigen test one day after completion of the 5 day treatment course was Negative; (15Feb2023) Positive, notes: Mild symptoms continued and 5 days later a repeat antigen test was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 from 04feb2023 to 09Feb2023. Clinical course: The reporter stated that Covid Rebound. Antigen test one day after completion of the 5 day treatment course was Negative. Mild symptoms continued and 5 days later a repeat antigen test was positive.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and  Covid 19 cannot be ruled out.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing); "Other medical history: mild COPD" (unspecified if ongoing), notes: Other medical history: mild COPD. The patient took concomitant medications. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid from 02Feb2023 to 06Feb2023. Clinical course: The name of the concomitant drug was reported as unknown, and administration period was from Jul2005 to Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 14:15 as dose 3 (booster), single (Lot number: GH9703) at the age of 70 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: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "type 2 diabetes" (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". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: If vaccine received: Yes, Other medication in 2 weeks: Yes. Antiviral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 02Feb2023, Treatment stop date: 06Feb2023, Lot number=NDC: 00069-1085-30, Indication: Treatment of COVID-19  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: have Covid disease after 5 Pfizer immunization shots; have Covid disease after 5 Pfizer immunization shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and on 17Nov2022 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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. No known allergies. There were no concomitant medications.No other vaccine in four weeks or other medications in two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Feb2023 at 12:00, outcome "recovering" and all described as "have Covid disease after 5 Pfizer immunization shots". The event "have covid disease after 5 pfizer immunization shots" required physician office visit. Physician medical provider prescribed Paxlovid.The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300070780 Same reporter /drug/event ,different patient;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: have Covid disease after 5 Pfizer immunization shots; have Covid disease after 5 Pfizer immunization shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) reporting for her husband.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "have Covid disease after 5 Pfizer immunization shots". The event "have covid disease after 5 pfizer immunization shots" required physician office visit. Physician medical provider prescribed Paxlovid. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300070772 Same reporter /drug/event ,different patient;
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid; covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CLL" (unspecified if ongoing); "known allergies Penicillin" (unspecified if ongoing), notes: known allergies Penicillin. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient received other medication in 2 weeks. The anti viral details COVID 19 treatment of Paxlovid started from 06Feb2023 to10Feb2023.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15May2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 31May2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 29Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 25May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications in 2 weeks. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Feb2023) negative, notes: tested negative; (15Feb2023) Positive, notes: 04:00. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 02Feb2023 to 07Feb2023. Clinical course: It was reported that, all symptoms resolved and tested negative for COVID by day 5 of the Paxlovid treatment. However, one week after completed treatment, symptoms had returned and tested positive for COVID again.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300071028 same patient/vaccine, diff dose/event;
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Fatigue
Clinical narrative: minor heart stitches; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 16Jun2021 as dose 1, single (Lot number: FC3095) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ANGINA PECTORIS (medically significant), outcome "unknown", described as "minor heart stitches"; FATIGUE (non-serious), outcome "unknown".  Clinical course: The patient had first 2 vaccinations in 2021 and had passed without much incident. The patient did have minor heart stitches and fatigue but these complaints were not that severe.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; Moderna, Dose Number: 4, 5 ; Pfizer/BioNTech, Dose Number: 1, 2, 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: El9266), in left arm, on 11Mar2021 as dose 2, single (Lot number: En6207), in left arm and on 21Sep2021 as dose 3 (booster), single (Lot number: 20ff2589) at the age of 65 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Jul2022 as dose 4 (booster), single (Lot number: 013822A), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 11Oct2022 as dose 5 (booster), single (Lot number: As7145B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Enlarged prostrat" (unspecified if ongoing); "known allergies: Bactria meloxicam" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Jul2022, outcome "unknown", described as "Moderna, Dose Number: 4, 5 ; Pfizer/BioNTech, Dose Number: 1, 2, 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Feb2023, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Feb2023) Positive. Therapeutic measures were taken with Paxlovid as a result of drug ineffective, covid-19.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, 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 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 12:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Feb2021 at 12:15 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04Mar2021 at 12:15 as dose 2, single (Batch/Lot number: unknown), in left arm, on 08Oct2021 at 12:15 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 06May2022 at 12:15 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thalesemia Minor" (unspecified if ongoing). The patient had no known allergy. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 03Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Moderna/ Dose #4: Moderna/ Dose #5: Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 73 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Jan2021 as dose 1, single (Lot number: 041L204), in left arm, on 22Feb2021 as dose 2, single (Lot number: 004M20A), in left arm, on 27Oct2021 as dose 3 (booster), single (Lot number: 011D21A), in left arm and on 12Apr2022 as dose 4 (booster), single (Lot number: 027121A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "breast cancer surgery", start date: Nov2019 (unspecified if ongoing); "known allergies: lactose intolerance" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN, start date: Jan2020. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Sep2022, outcome "unknown", described as "Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Moderna/ Dose #4: Moderna/ Dose #5: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Feb2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Feb2023) Positive, notes: Day 8 tested positive with Faint Line; (14Feb2023) Positive, notes: Day 10 stronger nasal & Upper throat & upper back discomfort, tested positive strong line. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 10:00 as dose 6 (booster), single (Lot number: G53277) at the age of 56 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: 01Sep2022, stop date: 06Feb2023; ANASTROZOLE, start date: 11Jan2021, stop date: 06Feb2023. 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: (unspecified date) Positive, notes: COVID 19 Treatment; (Feb2023) Positive, notes: Positive COVID antigen tests. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand=Pfizer / BioNTech, Vaccine, dose number=3, vaccine administration date=01Oct2021; vaccine brand other=Moderna, Vaccine dose number=4, vaccine administration date=28Jun2022; 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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9261), on 18Feb2021 as dose 2, single (Lot number: EM9809) and on 01Oct2021 as dose 3 (booster), single (Lot number: 3D135BA) at the age of 65 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Jun2022 as dose 4 (booster), single (Lot number: 059A22A) and on 02Dec2022 as dose 5 (booster), single (Lot number: 043H22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "RLS/PLMD" (unspecified if ongoing); "RLS/PLMD" (unspecified if ongoing). Concomitant medication(s) included: FORTEO, start date: 24May2021. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Jun2022, outcome "unknown", described as "Vaccine brand=Pfizer / BioNTech, Vaccine, dose number=3, vaccine administration date=01Oct2021; vaccine brand other=Moderna, Vaccine dose number=4, vaccine administration date=28Jun2022"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Other medication in 2 weeks: Yes. Anti-viral details: product=COVID 19 Treatment, brand=Paxlovid, treatment start date=08Feb2023, treatment stop date=13Feb2023, lot number=unknown, indication=Treatment of COVID-19, Return of symptoms 2 days after taking Paxlovid. Known allergies: No.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Moderna, Dose Number: 1, 3 ; Pfizer/BioNTech, Dose Number: 4; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 11Apr2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Jan2021 as dose 1, single (Lot number: 037k20a), in left arm and on 26Oct2021 at 10:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE, also reported as "037cz1a"), on 24Feb2022 at 13:30 as dose 2, single (Lot number: 001a21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "known allergies: sulfa antibiotics" (unspecified if ongoing); "known allergies:shrimp shells" (unspecified if ongoing); "bronchitis" (unspecified if ongoing), notes: bronchitis secondary to colds and flu; "colds" (unspecified if ongoing); "flu" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Apr2022 at 13:15, outcome "unknown", described as "Moderna, Dose Number: 1, 3; Pfizer/BioNTech, Dose Number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 includes COVID 19 Treatment of PAXLOVID from 06Feb2023 to 10Feb2023.  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, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Lot number: FJ5682), 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: "Diabetic" (unspecified if ongoing); "known allergies Statins" (unspecified if ongoing), notes: known allergies Statins. 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". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 31Jan2023 to 04Feb2023.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8732), in left arm, on 14Apr2021 as dose 2, single (Lot number: EW0162), in left arm and on 10Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes - several foods" (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 30Jan2023, outcome "recovered" (09Feb2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jan2023) Positive; (09Feb2023) negative; (14Feb2023) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had Paxlovid rebound COVID symptoms. Tested positive for COVID 30Jan2023. Took Paxlovid 31Jan2023 to 04Feb2023. Felt better, then got sick again 07Feb2023 with COVID symptoms. Re-tested negative for COVID 09Feb2023 and 14Feb2023. Still sick as of 16Feb2023. Patient had other medication (Digestive Probiotic, Expectorant, DayQuil/Nyquil, Pseudoephedrine) within 2 weeks of Paxlovid therapy.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech, Dose Number: 3; Moderna, Dose Number: 4; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 at 13:00 as DOSE 1, SINGLE (batch/lot number: unknown), administered in the left arm; on 14Apr2021 at 13:00 as DOSE 2, SINGLE (batch/lot number: unknown), administered in the left arm; and on 05Nov2021 at 14:00 as DOSE 3 (BOOSTER), SINGLE (batch/lot number: unknown) at the age of 44 years, administered in the  left arm for COVID-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 04May2022 at 14:00 as DOSE 4 (BOOSTER), SINGLE (batch/lot number: unknown), administered in the left arm and on 09Sep2022 at 15:45 as DOSE 5 (BOOSTER), SINGLE (batch/lot number: unknown), administered in the left arm for COVID-19 immunization. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "Known allergy: stone fruits" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Demerol, reaction: "Known allergies: Demerol." The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04May2022 at 14:00, outcome "unknown" described as "Pfizer / BioNTech, Dose Number: 3; Moderna, Dose Number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19." The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of Drug ineffective, Covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 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: "Born prematurely" (unspecified if ongoing); "asthma" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "depression" (unspecified if ongoing); "known allergies:some antibiotics (both mild/hives)" (unspecified if ongoing), notes: known allergies:some antibiotics (both mild/hives); "known allergies:some antibiotics (both mild/hives)" (unspecified if ongoing), notes: known allergies:some antibiotics (both mild/hives). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". 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: Negative, notes: tested negative for covid with an at home test; Positive, notes: at-home covid test and it was positive. Therapeutic measures were taken as a result of drug ineffective, 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, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19; COVID 19; Moderna, Dose Number: 3, 4, 5 ; Pfizer/BioNTech, Dose Number: 1, 2; 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 18Apr2021 at 12:00 as dose 1, single (Lot number: EW0164), in right arm and on 19May2021 at 15:00 as dose 2, single (Lot number: ER8736) at the age of 49 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Nov2021 at 15:00 as dose 3 (booster), single (Lot number: 65F21A), in right arm, on 14Apr2022 at 14:00 as dose 4 (booster), single (Lot number: x17L21A), in right arm and on 11Oct2022 at 14:00 as dose 5 (booster), single (Lot number: 05302244), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid disease" (unspecified if ongoing); "overweight" (unspecified if ongoing); "Known allergies: Amaranth, buckwheat" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Mar1996; LIOTHYRONINE SOD., start date: Feb2000; MONTELUKAST SODIUM, start date: 05Jan2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021 at 15:00, outcome "unknown", described as "Moderna, Dose Number: 3, 4, 5 ; Pfizer/BioNTech, Dose Number: 1, 2"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of the covid-19 which included PAXLOVID taken from 03Feb2023 to 07Feb2023.
Sex: U
Vaccine: MENB
Symptoms: Seizure
Clinical narrative: seizure; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A patient (no qualifiers provided) received meningococcal group b Rlp2086 (TRUMENBA), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "unknown". It was reported that patient had a seizure right away after Trumenba.  The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.; Sender's Comments: Based on the temporal relationship, the association between the event seizure with TRUMENBA can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product 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: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 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: "Known allergies: Curry" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Pituitary adenoma" (unspecified if ongoing); "Irritable bowel syndrome" (unspecified if ongoing); "Major depressive disorder" (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 "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid treatment from 01Feb2023 to 06Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Laboratory test
Clinical narrative: COVID; COVID; 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 57-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Jan2023 as dose 4 (booster), single (Lot number: GJ6796) at the age of 57 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Apr2021 as dose 1, single (Lot number: ER8729), as dose 2, single (Lot number: EW0172) and on 13Jan2022 as dose 3 (booster), single (Lot number: FL3198) for covid-19 immunisation. The patient's relevant medical history included: "cold induced asthma" (unspecified if ongoing); "upper respiratory it moves to her chest/upper respiratory thing", start date: Jun2019 (unspecified if ongoing). Concomitant medication(s) included: DULERA taken for asthma, respiratory disorder; LEVALBUTEROL [LEVOSALBUTAMOL] taken for respiratory disorder, start date: Jun2019; PRILOSEC [OMEPRAZOLE] (ongoing); PROBIOTIC [BIFIDOBACTERIUM LACTIS]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: Lab test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300072419 same patient, different vaccine dose/events.;