chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash pustular, Wrong product administered
Clinical narrative: Developed raised itchy raised red pustule lesions 3-4 new lesions per day. Went to doctor to be seen because the lesions hurt deeply into the tissue.; Developed raised itchy raised red pustule lesions 3-4 new lesions per day. Went to doctor to be seen because the lesions hurt deeply into the tissue.; Dose Number: 1 (Bivalent); This is a spontaneous report received from contactable reporter(s) (Nurse). 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 28Oct2022 at 10:45 as dose 1, single (Lot number: Gj3275) at the age of 39 years, in left arm for covid-19 immunization. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing); "known allergies: latex" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Flu vaccine, for Immunization, reaction(s): "known allergies: flu vaccine". The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 28Oct2022 at 10:45, outcome "unknown", described as "Dose Number: 1 (Bivalent)"; RASH PUSTULAR (medically significant), PRURITUS (medically significant) all with onset 06Nov2022 at 16:00, outcome "recovering" and all described as "Developed raised itchy raised red pustule lesions 3-4 new lesions per day. Went to doctor to be seen because the lesions hurt deeply into the tissue.". The event "developed raised itchy raised red pustule lesions 3-4 new lesions per day. went to doctor to be seen because the lesions hurt deeply into the tissue." required physician office visit and emergency room visit. Therapeutic measures were taken as a result of rash pustular, pruritus.  Clinical course: Additional information: If other vaccine in four weeks: No. Other medication in two weeks: No. Facility type vaccine was Workplace clinic. No other vaccine in four weeks and other medication in two weeks. covid tested post vaccination: Unknown. Treatment provided was Acyclovir. Developed raised itchy raised red pustule lesions 3-4 new lesions per day. Went to doctor to be seen because the lesions hurt deeply into the tissue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported events.-WRONG PRODUCT ADMINISTERED ,RASH PUSTULAR ,PRURITUS 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness of the upper arm where the injection site occurred; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness of the upper arm where the injection site occurred". 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-202201296760 same patient/event, different vaccine doses/event;US-PFIZER INC-202201296759 same patient/event, different vaccine doses/event.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Apr2021 as dose 1, single (Lot number: EW0175), in left arm, on 12Nov2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 13Apr2022 as dose 3 (booster), single (Lot number: FK9895), in left arm and on 08Nov2022 as dose 5 (booster), single (Lot number: ER8737) at the age of 58 years for covid-19 immunisation; BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 14:00 as dose 4 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation.  The patient's relevant medical history included: "COPD" (unspecified if ongoing); "Heart" (unspecified if ongoing), notes: Heart; "Known allergies: Pickles" (unspecified if ongoing), notes: Known allergies: Pickles; "Known allergies: Bees" (unspecified if ongoing), notes: Known allergies: Bees. Concomitant medication(s) included: ALLERTEC [CETIRIZINE HYDROCHLORIDE], start date: Apr2017; CARVEDILOL, start date: Jan2006; CLOPIDOGREL AUROBINDO, start date: Jan2006; LAMOTRIGINE, start date: Jan2004; ROSUVASTATIN, start date: Jan2018. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient received concomitantly multivitamin from Jan2017. No treatment received for the event. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy bone, Blood test, Body height, Pain in extremity, Platelet count
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 21Dec2021 as dose 3 (booster), single (Lot number: 33130BA) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "medical condition with the lungs", start date: 2017 (ongoing), notes: has oxygen for that and that was stable; "paralyzed lung" (unspecified if ongoing), notes: stable; "Wheelchair" (ongoing); "has oxygen" (unspecified if ongoing), notes: the lungs that he had already in 2017 and has oxygen for that and that was stable. There were no concomitant medications. Past drug history included: Sertraline, start date: Jun2021, for depression; Hydroxizine, notes: low dose. Vaccination history included: BNT162b2 (Dose: 2, Lot number: lot EW01), administration date: 14Jun2021, when the patient was 66-year-old, for Covid-19 immunization, reaction(s): "sore arm"; BNT162b2 (Dose: 1, Lot number: ER8737), administration date: 24May2021, when the patient was 66-year-old, for Covid-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The previous other three covid vaccine didn't do anything to him. He always gets his blood drawn and they check everything especially with him going to the (name withheld) and he was fine with the other vaccines and had three other covid vaccines that were Pfizer as caller states later in the call and he had no symptoms with those and only had a sore arm for all four doses of the vaccine but the sore arm only lasted for the first 24 hours with the first three vaccines and then he was good.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Scan, Weight
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 21Dec2021 as dose 3 (booster), single (Lot number: 33130BA) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "medical condition with the lungs", start date: 2017 (ongoing), notes: has oxygen for that and that was stable; "paralyzed lung" (unspecified if ongoing), notes: stable; "Wheelchair" (ongoing); "has oxygen" (unspecified if ongoing), notes: the lungs that he had already in 2017 and has oxygen for that and that was stable. There were no concomitant medications. Past drug history included: Sertraline, start date: Jun2021, for depression; Hydroxizine, notes: low dose. Vaccination history included: BNT162b2 (Dose: 2, Lot number: lot EW01), administration date: 14Jun2021, when the patient was 66-year-old, for Covid-19 immunization, reaction(s): "sore arm"; BNT162b2 (Dose: 1, Lot number: ER8737), administration date: 24May2021, when the patient was 66-year-old, for Covid-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The previous other three covid vaccine didn't do anything to him. He always gets his blood drawn and they check everything especially with him going to the (name withheld) and he was fine with the other vaccines and had three other covid vaccines that were Pfizer as caller states later in the call and he had no symptoms with those and only had a sore arm for all four doses of the vaccine but the sore arm only lasted for the first 24 hours with the first three vaccines and then he was good.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 10Jun2022 at 13:15 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: "Hypertension-1" (unspecified if ongoing), notes: Hypertension-1. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient taking any other medications/products within 2 weeks of starting COVID-19 treatment: No. Other medication in 2weeks: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
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 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Batch/Lot number: unknown), on 20Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer" (unspecified if ongoing); "prostate removed" (unspecified if ongoing). Concomitant medication(s) included: SILDENAFIL, start date: 30Oct2022, stop date: 30Oct2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. COVID 19 Treatment included Paxlovid from 03Nov2022 to 08Nov2022  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: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Coordination abnormal, Dizziness, Feeling abnormal, Feeling drunk, Gait disturbance
Clinical narrative: Head was spinning light headed within one hour; Head was spinning light headed within one hour; Then as I drove home altitude 5300 foot elevation I was drunk without the alcohole; stumbling; coordination was way off, impaired; I had brain fog; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 at 15:15 as dose 4 (booster), single (Lot number: GJ3275) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart deviated septum," (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacturer unknown), for Covid-19 Immunization; Bnt162b2 (DOSE 3, SINGLE; Lot number: Fh8028; Anatomical location: left arm), for Covid-19 Immunization. The following information was reported: VERTIGO (non-serious), DIZZINESS (non-serious) all with onset 13Nov2022 at 16:00, outcome "recovered" (Nov2022) and all described as "Head was spinning light headed within one hour"; FEELING ABNORMAL (non-serious) with onset 13Nov2022 at 16:00, outcome "recovered" (Nov2022), described as "I had brain fog"; FEELING DRUNK (non-serious) with onset 13Nov2022 at 16:00, outcome "recovered" (Nov2022), described as "Then as I drove home altitude 5300 foot elevation I was drunk without the alcohole"; COORDINATION ABNORMAL (non-serious) with onset 13Nov2022 at 16:00, outcome "recovered" (Nov2022), described as "coordination was way off, impaired"; GAIT DISTURBANCE (non-serious) with onset 13Nov2022 at 16:00, outcome "recovered" (Nov2022), described as "stumbling". Therapeutic measures were not taken as a result of vertigo, dizziness, feeling drunk, gait disturbance, coordination abnormal, feeling abnormal.  Additional information: Head was spinning light headed within one hour. Then as he drove home altitude 5300 foot elevation he was drunk without the alcohol stumbling coordination was way off, impaired and he had brain fog. Nothing made sense of his symptoms from the vaccine. No made sense of his symptoms from the vaccine. No other symptoms, lasted 24 hours. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive other vaccines within 4 weeks prior to the vaccination. The patient did not receive other medications within 2 weeks. The patient's known allergies were reported as none. AEs did not result in physician office visit or emergency room visit.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Head was spinning light headed within one hour; Head was spinning light headed within one hour; Then as I drove home altitude 5300 foot elevation I was drunk without the alcohole; stumbling; coordination was way off, impaired; I had brain fog; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 at 15:15 as dose 4 (booster), single (Lot number: GJ3275) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart deviated septum," (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacturer unknown), for Covid-19 Immunization; Bnt162b2 (DOSE 3, SINGLE; Lot number: Fh8028; Anatomical location: left arm), for Covid-19 Immunization. The following information was reported: VERTIGO (non-serious), DIZZINESS (non-serious) all with onset 13Nov2022 at 16:00, outcome "recovered" (Nov2022) and all described as "Head was spinning light headed within one hour"; FEELING ABNORMAL (non-serious) with onset 13Nov2022 at 16:00, outcome "recovered" (Nov2022), described as "I had brain fog"; FEELING DRUNK (non-serious) with onset 13Nov2022 at 16:00, outcome "recovered" (Nov2022), described as "Then as I drove home altitude 5300 foot elevation I was drunk without the alcohole"; COORDINATION ABNORMAL (non-serious) with onset 13Nov2022 at 16:00, outcome "recovered" (Nov2022), described as "coordination was way off, impaired"; GAIT DISTURBANCE (non-serious) with onset 13Nov2022 at 16:00, outcome "recovered" (Nov2022), described as "stumbling". Therapeutic measures were not taken as a result of vertigo, dizziness, feeling drunk, gait disturbance, coordination abnormal, feeling abnormal.  Additional information: Head was spinning light headed within one hour. Then as he drove home altitude 5300 foot elevation he was drunk without the alcohol stumbling coordination was way off, impaired and he had brain fog. Nothing made sense of his symptoms from the vaccine. No made sense of his symptoms from the vaccine. No other symptoms, lasted 24 hours. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive other vaccines within 4 weeks prior to the vaccination. The patient did not receive other medications within 2 weeks. The patient's known allergies were reported as none. AEs did not result in physician office visit or emergency room visit.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: knows about 4 or 5 patients who got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version; knows about 4 or 5 patients who got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "knows about 4 or 5 patients who got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version".  Clinical course: The reporter stated that she knows about 4 or 5 patients who got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version.  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: Linked Report(s) : US-PFIZER INC-202201300085 similar report from same reporter;US-PFIZER INC-202201300196 similar report from same reporter;US-PFIZER INC-202201300195 similar report from same reporter;US-PFIZER INC-202201300197 similar report from same reporter;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Knows about 4 or 5 patients who got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version; Knows about 4 or 5 patients who got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 "Knows about 4 or 5 patients who got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version".  Clinical information: Dose/Dosage Form: Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), 12 years - 15/15 mcg per dos Lot Number Unknown Reason: Complainant does not have the product with them at the time of call. During the call she (reporter) stated that she knew about 4 or 5 patients who got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version, she believed that this vaccine might not be matching the current COVID variant "that is out there". Caller declined to make a safety report since she did not want to report something on behalf of other patients.  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: Linked Report(s) : US-PFIZER INC-202201300085 Similar report from same reporter;US-PFIZER INC-202201300194 similar report from same reporter;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: knows about 4 or 5 patients who got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version; knows about 4 or 5 patients who got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 "knows about 4 or 5 patients who got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: she knows about 4 or 5 patients who got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version.  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: Linked Report(s) : US-PFIZER INC-202201300085 similar report from same reporter;US-PFIZER INC-202201300194 similar report from same reporter;
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test, Vertigo
Clinical narrative: Vertigo; Dizziness; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 17:00 as dose 3 (booster), single (Lot number: GH9694) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Macrobid, reaction(s): "drug allergy". Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EK5730), administration date: 17Dec2020, when the patient was 40-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot Number: EK5730), administration date: 07Jan2021, when the patient was 40-year-old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 09Nov2022, outcome "recovering"; VERTIGO (non-serious) with onset 09Nov2022, outcome "recovering". The events "vertigo" and "dizziness" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vertigo, dizziness.  Additional information: The patient was treated with Anti-histamine, physical therapy. The patient did not have COVID prior vaccination. The patient had not tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Ear pain, Lacrimation increased, Nasal congestion
Clinical narrative: red and watery eyes; red and watery eyes; cough; nasal congestion; earache; lack of appetite; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 4-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2022 at 15:30 as dose 1 (maroon cap), single (Lot number: FT9142) at the age of 4 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: COUGH (non-serious) with onset 10Nov2022 at 18:00, outcome "recovering"; EAR PAIN (non-serious) with onset 10Nov2022 at 18:00, outcome "recovering", described as "earache"; DECREASED APPETITE (non-serious) with onset 10Nov2022 at 18:00, outcome "recovering", described as "lack of appetite"; NASAL CONGESTION (non-serious) with onset 10Nov2022 at 18:00, outcome "recovering"; OCULAR HYPERAEMIA (non-serious), LACRIMATION INCREASED (non-serious) all with onset 10Nov2022 at 18:00, outcome "recovering" and all described as "red and watery eyes". The events "red and watery eyes", "cough", "nasal congestion", "earache" and "lack of appetite" required emergency room visit. Therapeutic measures were taken as a result of ocular hyperaemia, lacrimation increased, ear pain. Additional Information: The patient did not receive other vaccines within four weeks prior to COVID vaccine. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Ear infection was treated with Amoxicillin. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: red and watery eyes; red and watery eyes; cough; nasal congestion; earache; lack of appetite; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 4-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2022 at 15:30 as dose 1 (maroon cap), single (Lot number: FT9142) at the age of 4 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: COUGH (non-serious) with onset 10Nov2022 at 18:00, outcome "recovering"; EAR PAIN (non-serious) with onset 10Nov2022 at 18:00, outcome "recovering", described as "earache"; DECREASED APPETITE (non-serious) with onset 10Nov2022 at 18:00, outcome "recovering", described as "lack of appetite"; NASAL CONGESTION (non-serious) with onset 10Nov2022 at 18:00, outcome "recovering"; OCULAR HYPERAEMIA (non-serious), LACRIMATION INCREASED (non-serious) all with onset 10Nov2022 at 18:00, outcome "recovering" and all described as "red and watery eyes". The events "red and watery eyes", "cough", "nasal congestion", "earache" and "lack of appetite" required emergency room visit. Therapeutic measures were taken as a result of ocular hyperaemia, lacrimation increased, ear pain. Additional Information: The patient did not receive other vaccines within four weeks prior to COVID vaccine. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Ear infection was treated with Amoxicillin. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: 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 53-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Overdose, Pain in extremity, Product preparation error
Clinical narrative: overdosed with the Covid 19 orange cap Bivalent booster they received, it was undiluted; overdosed with the Covid 19 orange cap Bivalent booster they received, it was undiluted; sore arm/arms were sore (more than with previous doses); sore arm/arms were sore (more than with previous doses); felt tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the parent.  A 6-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (orange cap; booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "sore arm"; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "sore arm"; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: FATIGUE (non-serious) with onset 2022, outcome "not recovered", described as "felt tired"; PAIN IN EXTREMITY (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 2022, outcome "not recovered" and all described as "sore arm/arms were sore (more than with previous doses)"; PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 28Oct2022, outcome "unknown" and all described as "overdosed with the Covid 19 orange cap Bivalent booster they received, it was undiluted".  Additional information: The caregiver reported that her two kids were overdosed with the Covid 19 orange cap Bivalent booster they received on 28Oct2022, it was undiluted. It's been 2 weeks and their arms were sore (more than with previous doses) and they felt tired. She had seen on the news that this happened to other kids. She was wondering why Pfizer was not doing the single dose of the vial already diluted and was concerned about that. She wanted to make sure her kids have no adverse effect from that. She was told by the HCP that it should be fine; just more reactogenicity. They got in touch with the CDC.  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: Linked Report(s) : US-PFIZER INC-202201300448 same reporter, events and suspect product; different patient;
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Overdose, Pain in extremity, Product preparation error
Clinical narrative: sore arm more than before with previous doses/arms were sore (more than with previous doses)/sore arm; sore arm; felt tired; The mother called and said that her kids were overdosed with Pfizer covid 19 Bivalent last 28Oct which was not diluted; The mother called and said that her kids were overdosed with Pfizer covid 19 Bivalent last 28Oct which was not diluted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the parent.  An 8-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (orange cap; booster), single (Batch/Lot number: unknown) at the age of 8 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; MANUFACTURER UNKNOWN), for Covid-19 immunization, reaction(s): "sore arm"; Covid-19 vaccine (Dose 2; MANUFACTURER UNKNOWN), for Covid-19 immunization, reaction(s): "sore arm"; Covid-19 vaccine (Dose 3; MANUFACTURER UNKNOWN), for Covid-19 immunization, reaction(s): "sore arm". The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 28Oct2022, outcome "unknown" and all described as "The mother called and said that her kids were overdosed with Pfizer covid 19 Bivalent last 28Oct which was not diluted"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "sore arm more than before with previous doses/arms were sore (more than with previous doses)/sore arm"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "sore arm"; FATIGUE (non-serious), outcome "not recovered", described as "felt tired". Additional information: The patient's mother reported that two of her kids received the Covid 19 orange cap Bivalent booster on 28Oct2022, it was not diluted. The kids had a sore arm more than before with previous doses and felt tired. It has seen on the news that this happened to other kids. The mother was wondering why Pfizer is not doing the single dose of the vial already diluted. She wanted to make sure her kids have no adverse effect from that. The HCP told her that it should be fine; just more reactogenicity. They got in touch with the CDC.  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: Linked Report(s) : US-PFIZER INC-202201300442 same reporter, events and suspect product; different patient;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: The patients got COVID 2 weeks later; The patients got COVID 2 weeks later; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team, Program ID.  A 9-year-old male patient received BNT162b2 (BNT162B2), on 11Nov2021 as dose 1 (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "The patients got COVID 2 weeks later". Clinical course: Caller, a pediatrician, reported that the patient received first dose of Pfizer covid-19 monovalent vaccine on 11Nov2021 and then got covid two weeks later and did not come back in for the 2nd dose. Caller stated she saw the patients on 11Nov2022 and gave them Pfizer covid-19 for ages 5-11 monovalent vaccine. Caller asked is this the 2nd primary dose or should she repeat the dose. NDC number, batch/lot number, expiry date: Not provided. Caller was going to call the patients back but called Pfizer first to try to figure out if they need to restart the series.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information. 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,Linked Report(s) : US-PFIZER INC-202201300797 Same reporter/product/event, different patient;
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Eye pain, Eye pruritus, Eye swelling, Eyelid margin crusting
Clinical narrative: eye redness; chronic eye tearing; eye soreness; eye itchiness; swollen eyes and eyelids; swollen eyes and eyelids; waking up with eyes crusty; dry eyes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04May2021 at 10:00 as dose 2, single (Lot number: EW0171) at the age of 55 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "Highly allergic to shellfish" (unspecified if ongoing); "pollen allergy/grass pollen allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; ARMOUR THYROID. Past drug history included: Erythromycin, reaction(s): "Known allergies: erythromycin". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EW0161, Administration time: 10:00 AM, Vaccine location: Left arm), administration date: 13Apr2021, when the patient was 55-year-old, for COVID-19 Immunization. The following information was reported: LACRIMATION INCREASED (non-serious) with onset 17May2021 at 06:00, outcome "not recovered", described as "chronic eye tearing"; DRY EYE (non-serious) with onset 17May2021 at 06:00, outcome "not recovered", described as "dry eyes"; EYE PRURITUS (non-serious) with onset 17May2021 at 06:00, outcome "not recovered", described as "eye itchiness"; OCULAR HYPERAEMIA (non-serious) with onset 17May2021 at 06:00, outcome "not recovered", described as "eye redness"; EYE PAIN (non-serious) with onset 17May2021 at 06:00, outcome "not recovered", described as "eye soreness"; EYE SWELLING (non-serious), SWELLING OF EYELID (non-serious) all with onset 17May2021 at 06:00, outcome "not recovered" and all described as "swollen eyes and eyelids"; EYELID MARGIN CRUSTING (non-serious) with onset 17May2021 at 06:00, outcome "not recovered", described as "waking up with eyes crusty". The events "eye redness", "chronic eye tearing", "eye soreness", "eye itchiness", "swollen eyes and eyelids", "waking up with eyes crusty" and "dry eyes" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of ocular hyperaemia, lacrimation increased, eye pain, eye pruritus, eye swelling, swelling of eyelid, eyelid margin crusting, dry eye.  Additional information: Two weeks after receiving her second Pfizer COVID-19 vaccine, the patient began experiencing eye issues that she had not experienced in her entire life, including: chronic tearing, soreness, itchiness, swollen eyes and eyelids, and waking up with eyes crusty. The patient received eye drops for dry eyes and allergy medications. She stated she had never had eye issues. The patient received her third Pfizer COVID-19 monovalent vaccine on 03Jan2022 at 10:00 AM in the left arm.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Ocular hyperaemia, SARS-CoV-2 test, Swelling of eyelid
Clinical narrative: eye redness; chronic eye tearing; eye soreness; eye itchiness; swollen eyes and eyelids; swollen eyes and eyelids; waking up with eyes crusty; dry eyes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04May2021 at 10:00 as dose 2, single (Lot number: EW0171) at the age of 55 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "Highly allergic to shellfish" (unspecified if ongoing); "pollen allergy/grass pollen allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; ARMOUR THYROID. Past drug history included: Erythromycin, reaction(s): "Known allergies: erythromycin". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EW0161, Administration time: 10:00 AM, Vaccine location: Left arm), administration date: 13Apr2021, when the patient was 55-year-old, for COVID-19 Immunization. The following information was reported: LACRIMATION INCREASED (non-serious) with onset 17May2021 at 06:00, outcome "not recovered", described as "chronic eye tearing"; DRY EYE (non-serious) with onset 17May2021 at 06:00, outcome "not recovered", described as "dry eyes"; EYE PRURITUS (non-serious) with onset 17May2021 at 06:00, outcome "not recovered", described as "eye itchiness"; OCULAR HYPERAEMIA (non-serious) with onset 17May2021 at 06:00, outcome "not recovered", described as "eye redness"; EYE PAIN (non-serious) with onset 17May2021 at 06:00, outcome "not recovered", described as "eye soreness"; EYE SWELLING (non-serious), SWELLING OF EYELID (non-serious) all with onset 17May2021 at 06:00, outcome "not recovered" and all described as "swollen eyes and eyelids"; EYELID MARGIN CRUSTING (non-serious) with onset 17May2021 at 06:00, outcome "not recovered", described as "waking up with eyes crusty". The events "eye redness", "chronic eye tearing", "eye soreness", "eye itchiness", "swollen eyes and eyelids", "waking up with eyes crusty" and "dry eyes" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of ocular hyperaemia, lacrimation increased, eye pain, eye pruritus, eye swelling, swelling of eyelid, eyelid margin crusting, dry eye.  Additional information: Two weeks after receiving her second Pfizer COVID-19 vaccine, the patient began experiencing eye issues that she had not experienced in her entire life, including: chronic tearing, soreness, itchiness, swollen eyes and eyelids, and waking up with eyes crusty. The patient received eye drops for dry eyes and allergy medications. She stated she had never had eye issues. The patient received her third Pfizer COVID-19 monovalent vaccine on 03Jan2022 at 10:00 AM in the left arm.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Off label use, Oropharyngeal pain, Product use issue
Clinical narrative: Headache; sore throat; other vaccine same dateproduct=Influenza Vaccine, other vaccine same date vaccinedate=14Nov2022; other vaccine same dateproduct=Influenza Vaccine, other vaccine same date vaccinedate=14Nov2022; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 at 11:00 as dose 3 (booster), single (Lot number: GK1647) at the age of 12 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 14Nov2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PROBIOTICS. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: FL2757, Location of injection: Arm Left), administration date: 02Aug2022, when the patient was 11-year-old, for COVID-19 immunization, reaction(s): "Inappropriate schedule of vaccine administered"; BNT162b2 (Dose Number: 1, Batch/Lot No: FL8095, Location of injection: Arm Left), administration date: 14Jan2022, when the patient was 11-year-old, for Covid-19 immunization, reaction(s): "Inappropriate schedule of vaccine administered".  The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 14Nov2022 at 11:00, outcome "unknown" and all described as "other vaccine same dateproduct=Influenza Vaccine, other vaccine same date vaccinedate=14Nov2022"; HEADACHE (non-serious) with onset 14Nov2022 at 16:00, outcome "not recovered"; OROPHARYNGEAL PAIN (non-serious) with onset 14Nov2022 at 16:00, outcome "not recovered", described as "sore throat". Therapeutic measures were taken as a result of headache, oropharyngeal pain.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201301482 same patient, different dose number and events;
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 13:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 72 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Jan2021 at 15:45 as dose 1, single (Lot number: EL9261), in right arm, on 24Feb2021 as dose 2, single (Lot number: EL6201), in right arm, on 02Oct2021 at 14:00 as dose 3 (booster), single (Lot number: FF8841), in right arm and on 08Apr2022 at 10:30 as dose 4 (booster), single (Lot number: FJ9943), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma; "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "hiatal hernia" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Negative, notes: 2 negative rapid antigen tests 48 hrs; (Nov2022) Positive again; (Nov2022) Negative, notes: 2 negative rapid antigen tests 48 hrs. Therapeutic measures were taken as a result of vaccination failure, covid-19: Paxlovid from 01Nov2022 to 06Nov2022.