chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment/Tested positive on 18May2022/Retested for Covid on 29May2022 and it was positive; COVID 19 Treatment/Tested positive on 18May2022/Retested for Covid on 29May2022 and it was positive; This is a spontaneous report received from 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 23Feb2021 as dose 1, single (Lot number: EN6202), in right arm, on 16Mar2021 as dose 2, single (Lot number: ER2013), in right arm, on 24Sep2021 as dose 3 (booster), single (Lot number: FF2587), in right arm and on 24Feb2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Rhumatoid Arthritis", start date: 1999 (unspecified if ongoing); "Known allergies: Yes, multiple allergies" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "sleep issues" (unspecified if ongoing), notes: for 5+ years; "Diaviticulitis" (unspecified if ongoing), notes: severe Diaviticulitis resulting in surgery to remove 12" of lower large intestines 4 1/2 years ago; "seasonal allergies" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: OLUMIANT, start date: 01Mar2020, stop date: 17May2022; FEXOFENADINE, start date: 01Dec2021, stop date: 29May2022; LIVALO, start date: 01Mar2020, stop date: 29May2022; SYNTHROID, start date: 01Jan2017, stop date: 29May2022; METOPROLOL, start date: 01Jan2017, stop date: 29May2022; OMEPRAZOLE, start date: 01Jan2020, stop date: 29May2022; ATOMOXETINE, start date: 01Jan2007, stop date: 29May2022; BUPROPION, start date: 01Nov2021, stop date: 29May2022; TRAZODONE, start date: 01May2020, stop date: 17May2022; COQ10 [UBIDECARENONE], start date: 01Jan2017, stop date: 29May2022; OMEGA 3 FISH OIL [FISH OIL], start date: 01Jan1996, stop date: 29May2022; L-LYSINE [LYSINE HYDROCHLORIDE], start date: 01Jan2017, stop date: 29May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18May2022, outcome "unknown" and all described as "COVID 19 Treatment/Tested positive on 18May2022/Retested for Covid on 29May2022 and it was positive". Patient stated that she tested positive on 18May2022 and started Paxlovid that day. On 24May2022, she tested negative. On evening of 27May2022, she began with coughing and sinus drainage. On 29May2022, she was retested for Covid and it was positive. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) Positive; (24May2022) Negative; (29May2022) Positive. Therapeutic measures were taken as a result of vaccination failure covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Nasopharyngitis, Suspected COVID-19
Clinical narrative: had 2 Pfizer vaccines and the booster vaccine of Pfizer and she just got COVID; had 2 Pfizer vaccines and the booster vaccine of Pfizer and she just got COVID; just got like a cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  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. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "had 2 Pfizer vaccines and the booster vaccine of Pfizer and she just got COVID"; NASOPHARYNGITIS (non-serious) with onset May2022, outcome "unknown", described as "just got like a cold".  Clinical course: Caller calling about her daughter have received two of your vaccine plus the booster and she got COVID, 3 days ago and wanted to find out this is for her daughter, the medication that they are giving people, who are they giving that medication to, the Pfizer medication. Reporter stated, she doesn't know the name of the medication, you know when they get COVID. just want to know my daughter had 2 Pfizer vaccines and the booster vaccine of Pfizer and she just got COVID and there is a medication that they are giving people when they get sick with COVID but it's supposedly for high-risk people, don't what the name of it is. caller don't know the name, it's the COVID medication (As reporter was unsure about the name of medication hence Suspect captured as per verbatim for MI query).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Apr2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 07May2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 28Nov2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "CVID" (unspecified if ongoing), notes: other medical history: CVID; "Known Allergies: penicillin" (unspecified if ongoing), notes: Known Allergies: penicillin. There were no concomitant medications and also reported as no other medications in two weeks. Past drug history included: Neomicyn, reaction(s): "Known Allergies: Neomicyn", notes: Known Allergies: Neomicyn; Prednisone, reaction(s): "Known Allergies: Prednisone", notes: Known Allergies: Prednisone. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, suspected covid-19 included Paxlovid (Batch/lot number: GA1529) started on 25May2022 and stopped on 29May2022. Clinical course was reported as, For Paxlovid Extreme dry mouth, bad fatigue, dizziness, hotflashes, nightmares on 27May2022. No treatment received for symptoms and patient was not recovered from symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Infection, Macule
Clinical narrative: He had reaction to it; the reaction is bad; at first it was just a red circle and it was hot; it's been 8 days and it's turning, now it's getting infected and it's still red like bright red; He had reaction to it; the reaction is bad; at first it was just a red circle and it was hot; it's been 8 days and it's turning, now it's getting infected and it's still red like bright red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), on 20May2022 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: MACULE (non-serious), INFECTION (non-serious) all with onset May2022, outcome "not recovered" and all described as "He had reaction to it; the reaction is bad; at first it was just a red circle and it was hot; it's been 8 days and it's turning, now it's getting infected and it's still red like bright red".  Additional information: Reporter was calling on behalf of father. Patient had the Pfizer vaccine on the 20May2022, he had reaction to it. Reporter wanted to know what to do because the reaction was bad. At first the reaction was just a red circle and it was hot but it had been 8 days and it was turning and getting infected. It was bright red and it was getting infected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "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: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Off label use, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer BioNtech dose number 4; 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 64-year-old male patient received BNT162b2 (BNT162B2), on 15May2022 as dose 4 (booster), single (Lot number: fj4989) at the age of 64 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: "asthma" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing), notes: hypothyroid; "Known allergies: peanuts" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHROID. The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 15May2022, outcome "unknown" and all described as "Pfizer BioNtech dose number 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Positive, notes: 19May2022 positive home test; (24May2022) Negative, notes: 24May2022 Negative home test (Binax); (25May2022) Negative, notes: 25May2022 Negative home test (Binax); (29May2022) Positive, notes: 29May2022 same symptoms continuing - Positive home test (Quidel). Therapeutic measures were taken as a result of drug ineffective, covid-19, off label use, immunisation.  Clinical course information: Covid rebound after Paxlovid and on 18May2022, Covid symptoms started. On 19May2022, Positive home test (Binax), started Paxlovid. On 24May2022, Negative home test (Binax), still had runny nose, sore throat, diarrhea. On 25May2022, Negative home test (Binax) and on 29May2022, same symptoms continuing Positive home test (Quidel).  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 68-year-old male patient received BNT162b2 (BNT162B2), in Feb2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 68 years, in right arm, as dose number unknown (booster), single (Batch/Lot number: unknown), in right arm, as dose 2, single (Batch/Lot number: unknown) and as dose 1, 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: About 3 days later started having running nose and positive test; (May2022) Positive, notes: Runny nose and some congestion has continued day about day for now 4days. No other symptoms and am testing positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. Antiviral details: Product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 17May2022, Treatment stop date: 21May2022, Indication: Treatment of COVID-19. Adverse event: After about 3 days of Paxlovid symptoms went away. Finished treatment on 5 days. No symptoms. About 3 days later started having running nose and positive test. Runny nose and some congestions have continued day about day for now 4days. No other symptoms and am testing positive. It's been 12 days since I tested positive and got on Paxlovid 10 days ago. Was fully vaccinated with 2 boosters. This is clearly the rebound effect I've been reading about. Adverse event start date: 25May2022. If patient recovered: Recovering If treatment ae was no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 60-year-old male patient received BNT162b2 (BNT162B2), on 19Dec2020 at 13:00 as dose 1, single (Lot number: EH9899), in left arm and on 09Jan2021 at 18:15 as dose 2, single (Lot number: EJ1686) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19. Clinical course: Other medication in 2weeks No antiviral details product COVID 19 Treatment, brand Paxlovid, treatment start date 11May2022, treatment stop date 16May2022, indication Treatment of COVID-19, administrator route Oral.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Eye disorder, Eyelid pain, Lymphadenopathy, Magnetic resonance imaging
Clinical narrative: still can't see and her eyes have gotten terribly worse in the past year; states her eyesight feels like it is declining.; when she touches her eyelid hurts and feels like something is in her eye; swollen lymph node in her axillary region; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus", start date: 1992 (ongoing), notes: she does have a mild case of Lupus but is not on any treatment for it. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose number: 02, Anatomical location: Arm), administration date: 15Mar2021, for Covid-19 immunization; BNT162b2 (Dose number: 01, Anatomical location: Arm), administration date: 22Feb2021, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Dec2021, outcome "not recovered", described as "swollen lymph node in her axillary region"; EYE DISORDER (non-serious), outcome "unknown", described as "still can't see and her eyes have gotten terribly worse in the past year"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "states her eyesight feels like it is declining."; EYELID PAIN (non-serious), outcome "not recovered", described as "when she touches her eyelid hurts and feels like something is in her eye". The event "swollen lymph node in her axillary region" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient expected some soreness when she got the vaccine and was not sick or fatigued like everybody else was talking about and the patient had no symptoms. About eyesight she recalls she just sent her doctor a message said she wants to see an ophthalmologist and she had glasses but did not see and her eyes have gotten terribly worse in the past year or year and a half and she did not say if it was before or after her Pfizer Covid vaccines or when it started; Said her right eye when she touches her eyelid hurts and feels like something is in her eye and this was going and coming and she reached out to her doctor and hopes it was not a cataract but does not know what it was; said the eyelid pain was ongoing and about the same as when it began; states her eyesight feels like it was declining. Patient did not receive any prior vaccinations (within 4 weeks). Husband had fatigue after his Moderna vaccine.  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: Mammogram, Ultrasound scan, Visual impairment
Clinical narrative: still can't see and her eyes have gotten terribly worse in the past year; states her eyesight feels like it is declining.; when she touches her eyelid hurts and feels like something is in her eye; swollen lymph node in her axillary region; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus", start date: 1992 (ongoing), notes: she does have a mild case of Lupus but is not on any treatment for it. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose number: 02, Anatomical location: Arm), administration date: 15Mar2021, for Covid-19 immunization; BNT162b2 (Dose number: 01, Anatomical location: Arm), administration date: 22Feb2021, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Dec2021, outcome "not recovered", described as "swollen lymph node in her axillary region"; EYE DISORDER (non-serious), outcome "unknown", described as "still can't see and her eyes have gotten terribly worse in the past year"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "states her eyesight feels like it is declining."; EYELID PAIN (non-serious), outcome "not recovered", described as "when she touches her eyelid hurts and feels like something is in her eye". The event "swollen lymph node in her axillary region" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient expected some soreness when she got the vaccine and was not sick or fatigued like everybody else was talking about and the patient had no symptoms. About eyesight she recalls she just sent her doctor a message said she wants to see an ophthalmologist and she had glasses but did not see and her eyes have gotten terribly worse in the past year or year and a half and she did not say if it was before or after her Pfizer Covid vaccines or when it started; Said her right eye when she touches her eyelid hurts and feels like something is in her eye and this was going and coming and she reached out to her doctor and hopes it was not a cataract but does not know what it was; said the eyelid pain was ongoing and about the same as when it began; states her eyesight feels like it was declining. Patient did not receive any prior vaccinations (within 4 weeks). Husband had fatigue after his Moderna vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 08Apr2021 as dose 2, single (Lot number: EW0162), in left arm and on 14Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 42 years, in left arm for covid-19 immunisation.  The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "postpartum anxiety" (unspecified if ongoing); "vitamin D deficiency" (unspecified if ongoing), notes: ,; "seasonal allergies" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE; INFLECTRA [INFLIXIMAB]; VITAMIN D2; CLARITIN [CLARITHROMYCIN]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ALEVE; VENLAFAXINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive; (13May2022) Negative, notes: Home tests; (15May2022) Negative, notes: Home tests; (16May2022) Negative, notes: Home tests; (27May2022) Positive, notes: Home tests; (27May2022) Positive, notes: Home tests. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: Known allergies: No. Recurrence of COVID - initially tested positive on 07May2022. Treated with Paxlovid for 5 days and then tested negative with 2 at-home tests on 13May, one on 15May, and another on 16May. Started experiencing sore throat, hoarse voice and cough on 26May2022. Tested positive with two different brand at-home tests on 27May2022. Not recovered. No treatment.
Age: 57.0
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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2021 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; COVID-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), on 02Jan2022 at 14:30 as dose 2, single (Batch/Lot number: unknown), in left arm 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) all with onset May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (21May2022) negative, notes: I tested negative for covid 2 days after I finished my 5 days of Paxilovid; (26May2022) positive, notes: I tested positive five days after that. 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: 33.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Lot number: EW0153) at the age of 33 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Nov2021 as dose 3 (booster), single (Lot number: 066F21A), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Vaccine brand: Pfizer / BioNTech,, Vaccine lot number: EP7534,, DOSE 1, SINGLE, Vaccine location: Left arm), administration date: 17Mar2021, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Patient received treatment with Paxlovid from 25May2022.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, COVID-19, Gene sequencing, Investigation, Nasopharyngeal swab
Clinical narrative: fully vaccinated and boosted with the BNT162b2mRNA vaccine but one had been infected with and recovered from a SARS-CoV-2infection; fully vaccinated and boosted with the BNT162b2mRNA vaccine but one had been infected with and recovered from a SARS-CoV-2infection; This is a literature report for the following literature source(s): DOI:10.21203/rs.3.rs-1662783/v1.  A patient (no qualifiers provided) 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. The following information was reported: "VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "fully vaccinated and boosted with the BNT162b2mRNA vaccine but one had been infected with and recovered from a SARS-CoV-2infection". The patient underwent the following laboratory tests and procedures: Antibody test: unknown results; Gene sequencing: unknown results; Phenotypic analysis: unknown results; Nasopharyngeal swab: unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Authors next evaluated the susceptibility of the viral panel to the neutralizing antibody response in the plasma from the patient and two controls. Both controls were fully vaccinated and boosted with the BNT162b2mRNA vaccine (Pfizer-BioNTech), but one had been infected with and recovered from a SARS-CoV-2infection with symptom onset 3 days prior to the individual who experienced NM/r recrudescence. The average half maximal authentic virus neutralizing antibody concentrations (NT50) against BA.2 PRSD01, BA.1, and parental were, 1668, 1170 and 5239 respectively in the NM/r treated patient. These levels were 8.9, 7.1 and 2.1 times higher than the boosted control but 2.0, 1.7 and 2.6 times lower than the boosted and infected control. This study found that neither development of NM resistance or absence of neutralizing antibody were likely causes of the recrudescence. Although authors were unable to measure T cell responses or drug levels, authors feel the most likely possibility for the observed recrudescence is insufficient drug exposure.  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 information currently available, a lack of efficacy with BNT162B2 vaccine in this patient cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: fully vaccinated and boosted with the BNT162b2mRNA vaccine but one had been infected with and recovered from a SARS-CoV-2infection; fully vaccinated and boosted with the BNT162b2mRNA vaccine but one had been infected with and recovered from a SARS-CoV-2infection; This is a literature report for the following literature source(s): DOI:10.21203/rs.3.rs-1662783/v1.  A patient (no qualifiers provided) 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. The following information was reported: "VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "fully vaccinated and boosted with the BNT162b2mRNA vaccine but one had been infected with and recovered from a SARS-CoV-2infection". The patient underwent the following laboratory tests and procedures: Antibody test: unknown results; Gene sequencing: unknown results; Phenotypic analysis: unknown results; Nasopharyngeal swab: unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Authors next evaluated the susceptibility of the viral panel to the neutralizing antibody response in the plasma from the patient and two controls. Both controls were fully vaccinated and boosted with the BNT162b2mRNA vaccine (Pfizer-BioNTech), but one had been infected with and recovered from a SARS-CoV-2infection with symptom onset 3 days prior to the individual who experienced NM/r recrudescence. The average half maximal authentic virus neutralizing antibody concentrations (NT50) against BA.2 PRSD01, BA.1, and parental were, 1668, 1170 and 5239 respectively in the NM/r treated patient. These levels were 8.9, 7.1 and 2.1 times higher than the boosted control but 2.0, 1.7 and 2.6 times lower than the boosted and infected control. This study found that neither development of NM resistance or absence of neutralizing antibody were likely causes of the recrudescence. Although authors were unable to measure T cell responses or drug levels, authors feel the most likely possibility for the observed recrudescence is insufficient drug exposure.  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 information currently available, a lack of efficacy with BNT162B2 vaccine in this patient cannot be completely excluded.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pyrexia
Clinical narrative: 105.6 fever about 16 hours after vaccination; nausea; extreme headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28May2022 at 10:00 as dose number unknown (booster), single (Lot number: FP4554) at the age of 12 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 29May2022 at 02:30, outcome "recovered" (May2022), described as "105.6 fever about 16 hours after vaccination"; HEADACHE (non-serious) with onset 29May2022 at 02:30, outcome "recovered" (May2022), described as "extreme headache"; NAUSEA (non-serious) with onset 29May2022 at 02:30, outcome "recovered" (May2022). Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, nausea, headache.  Clinical information: Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not received any other medications the patient received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Seriousness criteria-Results in death/Seriousness criteria-Life threatening/Seriousness criteria-Caused/prolonged hospitalization/Seriousness criteria-Disabling/Incapacitating/Seriousness criteria-Congenital anomaly/birth defect all were reported as no.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Product administered to patient of inappropriate age
Clinical narrative: patient is a pediatric patient administered adult dose 30mcg 0.3 ml; swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  An 11-year-old female patient received BNT162b2 (COMIRNATY), as dose number unknown, 0.3 ml single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset May2022, outcome "unknown", described as "swollen lymph nodes"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "patient is a pediatric patient administered adult dose 30mcg 0.3 ml".  Additional information: patient is a paediatric patient administered adult dose 30mcg 0.3 ml Pfizer or Comirnaty should've received a paediatric dose now experiencing swollen lymph nodes and other side effects.   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: Therapeutic response unexpected
Clinical narrative: I did not wheeze or have any allergic issues at all; 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), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing), notes: I have had asthma all my life (cats and horses and dust). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I did not wheeze or have any allergic issues at all".  Additional information: Question: Hi, I have had asthma all my life (cats and horses and dust). I got two pfizer vaccines last year (no booster). I just got back from a family visit where I was around cats and smoke/cats all week. I did not wheeze or have any allergic issues at all. Please read the article below. Maybe the covid shots would HELP people with asthma? # Thanks - (name). Regulatory Authority: E- transmitting potential AE. Non Phone Case.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 22May2021 as dose 1, single (Lot number: EW0179), in right arm, on 18Jun2021 as dose 2, single (Lot number: EW0178), in right arm and on 06Jan2022 as dose 3 (booster), single (Lot number: FJ1611) at the age of 32 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep Apnea" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative, notes: Tested negative on COVID 19;(28May2022) Positive, notes: I was tested positive again on COVID 19. Therapeutic measures were taken as a result of covid-19. Clinical course: Anti viral Paxlovid was given from 21May2022 to 25May2022 for Treatment of COVID-19. After finishing taking Paxlovid, patient tested negative on COVID 19 but three days later he was tested positive again on COVID 19.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 29Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 57 years, in left arm for covid-19 immunization; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "dysthymia" (unspecified if ongoing). Concomitant medication(s) within 2 weeks of covid vaccine included: LEVOTHYROXINE oral; NP THYROID oral; BUPROPION oral. Past drug history included: Tetanus toxoid, reaction(s): "known allergies: Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19 with Paxlovid via oral route from 11May2022 to 15May2022 and had Rebound symptoms with positive Abbott rapid antigen test requiring re-isolation on 20May2022.; Sender's Comments: Based on the information in the case report, a causal association between reported events and suspect BNT162B2 is possible.
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03May2021 as dose number unknown, single (Lot number: ER8736) at the age of 36 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: I tested negative after finishing the Paxlovid treatment. Four days later I had a sore throat and had a positive COVID test again. It is 3 days later and I still have cold symptoms. No other medication in 2weeks.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), 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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR]; PANTOPRAZOLE; ESCITALOPRAM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19.  Additional information: Treatment with Paxlovid from 28May2022 to 29May2022 for COVID-19. No known allergies reported for the patient. Visit to the ER and given Benadryl. Device Date mentioned as 30May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 08Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27May2022) Positive, notes: Started with positive test. Therapeutic measures were taken as a result of covid-19, vaccination failure.  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: "Vaccination failure", "COVID-19" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Oct2021 as dose 3 (booster), single (Lot number: EW0191) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "history of juvenile rheumatoid arthritis" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "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. Anti-viral details product: COVID 19 treatment, brand: Paxlovid, treatment start date: 15May2022 and treatment stop date: 20May2022, indication: treatment of COVID-19. Started Paxlovid on day 2, symptoms cleared by day 6, returned on days 12-15 and counting. Device timestamp: 30May2022.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 02Apr2021 as dose 2, single (Lot number: ER8732), in left arm and on 05Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CLARITIN-D; OMEPRAZOLE; VITAMIN D [COLECALCIFEROL]; IBUPROFEN; ALPRAZOLAM. Past drug history included: Bactrim, reaction(s): "Known Allergies: Bactrim", notes: Known Allergies: Bactrim. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive; (May2022) Negative; (May2022) Positive, notes: Took a second and it was positive too. Therapeutic measures were taken as a result of covid-19. Treatment drug included Paxlovid from 18May2022 to 16May2022. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Rebound of Covid after taking Paxlovid. Took the 5 day treatment. Tested negative on day 8, symptoms improving (had been mild - mainly congestion, fatige, minimal cough, never had a fever). Day 13 work up with sinuses very congested and feeling generally crappy. Thinking patient might have sinus infection but also took a rapid test and it came up postive. Took a second and it was postive too.