chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Culture urine positive, Nausea, Pain
Clinical narrative: aching; chills/teeth were chattering; nausea; fever; 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.  An 80-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cystocele" (unspecified if ongoing), notes: scheduled to have urogynecologic surgery on 24Oct. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, has been having recurrent urinary tract infections and has had one 10Jul, 12Sep and 27Sep.), administration date: Jun2023, for COVID-19 immunization, reaction(s): "urinary tract infection"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, have been from Pfizer and the most she got from them was a sore arm.), administration date: Jun2023, for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, have been from Pfizer and the most she got from them was a sore arm), for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 2, SINGLE, have been from Pfizer and the most she got from them was a sore arm.), for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 1, SINGLE, have been from Pfizer and the most she got from them was a sore arm.), for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: CHILLS (non-serious) with onset 05Oct2023, outcome "not recovered", described as "chills/teeth were chattering"; PYREXIA (non-serious) with onset 05Oct2023, outcome "recovering", described as "fever"; NAUSEA (non-serious) with onset 05Oct2023, outcome "not recovered"; PAIN (non-serious) with onset 09Oct2023, outcome "not recovered", described as "aching". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Additional information: On Thursday, 05Oct2023, the patient experienced chills, nausea and then a fever of 103 F.  On Friday morning, she had a fever of 101 F in the morning and later on it was better and over the weekend she was fine. On 09Oct2023, she then experienced chills, her teeth were chattering and she was aching and then had a fever again of 101.8 F.  She took an extra strength Tylenol and her temp has been normal to low grade since. The patient had another urine test and the culture showed gram positive bacteria which the doctor thinks was just contaminant and does not think it was causing the fever.    The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: aching; chills/teeth were chattering; nausea; fever; 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.  An 80-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cystocele" (unspecified if ongoing), notes: scheduled to have urogynecologic surgery on 24Oct. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, has been having recurrent urinary tract infections and has had one 10Jul, 12Sep and 27Sep.), administration date: Jun2023, for COVID-19 immunization, reaction(s): "urinary tract infection"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, have been from Pfizer and the most she got from them was a sore arm.), administration date: Jun2023, for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, have been from Pfizer and the most she got from them was a sore arm), for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 2, SINGLE, have been from Pfizer and the most she got from them was a sore arm.), for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 1, SINGLE, have been from Pfizer and the most she got from them was a sore arm.), for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: CHILLS (non-serious) with onset 05Oct2023, outcome "not recovered", described as "chills/teeth were chattering"; PYREXIA (non-serious) with onset 05Oct2023, outcome "recovering", described as "fever"; NAUSEA (non-serious) with onset 05Oct2023, outcome "not recovered"; PAIN (non-serious) with onset 09Oct2023, outcome "not recovered", described as "aching". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Additional information: On Thursday, 05Oct2023, the patient experienced chills, nausea and then a fever of 103 F.  On Friday morning, she had a fever of 101 F in the morning and later on it was better and over the weekend she was fine. On 09Oct2023, she then experienced chills, her teeth were chattering and she was aching and then had a fever again of 101.8 F.  She took an extra strength Tylenol and her temp has been normal to low grade since. The patient had another urine test and the culture showed gram positive bacteria which the doctor thinks was just contaminant and does not think it was causing the fever.    The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Urinary tract infection
Clinical narrative: recurrent urinary tract infections; sore arm; 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.  An 80-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jun2023 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cystocele" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, All of her previous 4 covid vaccines and boosters, the last one in June 2023, have been from Pfizer and the most she got from them was a sore arm.), for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 2, SINGLE, All of her previous 4 covid vaccines and boosters, the last one in June 2023, have been from Pfizer and the most she got from them was a sore arm.), for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 3(BOOSTER), SINGLE, All of her previous 4 covid vaccines and boosters, the last one in June 2023, have been from Pfizer and the most she got from them was a sore arm.), for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "unknown", described as "sore arm"; URINARY TRACT INFECTION (non-serious) with onset 10Jul2023, outcome "unknown", described as "recurrent urinary tract infections". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: All of her previous 4 covid vaccines and boosters, the last one in June 2023, have been from Pfizer and the most she got from them was a sore arm.  She has been having recurrent urinary tract infections and has had one July 10, September 12 and September 27th.    The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; 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.  An 80-year-old female patient received bnt162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Additional information: All of her previous 4 covid vaccines and boosters, the last one in Jun2023, have been from Pfizer and the most she got from them was a sore arm..   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-202300324950 Same reporter, Patient / Different AE, Vaccine Dose;US-PFIZER INC-202300325059 Same reporter, Patient / Different AE, Vaccine Dose;US-PFIZER INC-202300325060 Same reporter, Patient / Different AE, Vaccine Dose;US-PFIZER INC-202300325057 Same reporter, Patient / Different AE, Vaccine Dose;US-PFIZER INC-202300325070 Same reporter, Patient / Different AE, Vaccine Dose;US-PFIZER INC-202300325071 Same reporter, Patient / Different AE, Vaccine Dose;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; 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.  An 80-year-old female patient received bnt162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cystocele" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  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: Pain in extremity
Clinical narrative: sore arm; 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.  An 80-year-old female patient received bnt162b2 (COMIRNATY), as dose 1, 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Additional information: All of her previous 4 Covid vaccines and boosters, the last one in Jun2023, have been from Pfizer and the most she got from them was a sore arm.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Body temperature, Inflammation, Pain
Clinical narrative: joint pain that radiates up and down the arm; joint pain that radiates up and down the arm; inflammation in my right hand and right wrist; inflammation in my right hand and right wrist; Sensation in my right hand at rest; Slightly swollen; fever; 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 23-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 16:30 as dose 1, 0.3 ml single (Lot number: HG4628) at the age of 23 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "Functional gastrointestinal disorders" (unspecified if ongoing); "Kawasaki disease", start date: 2006 (unspecified if ongoing), notes: Diagnosis date of Kawasaki disease was 2006; "mild congestion" (unspecified if ongoing); "Sacralization", start date: 2015 (unspecified if ongoing), notes: Diagnosis date: 2015. I have a fused L5 in vertebrate in my back. Concomitant medication(s) included: SYMBICORT. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: SENSORY DISTURBANCE (non-serious) with onset 2023, outcome "unknown", described as "Sensation in my right hand at rest"; SWELLING (non-serious) with onset 2023, outcome "unknown", described as "Slightly swollen"; PYREXIA (non-serious) with onset 2023, outcome "recovered" (2023), described as "fever"; INFLAMMATION (non-serious), ARTHRITIS (non-serious) all with onset 2023, outcome "unknown" and all described as "inflammation in my right hand and right wrist"; ARTHRALGIA (non-serious), PAIN (non-serious) all with onset 2023, outcome "unknown" and all described as "joint pain that radiates up and down the arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, pain, sensory disturbance, swelling, pyrexia.  Additional Information: Patient was having joint pain in right hand and right wrist. She had an x-ray done and it came back fine. She had a lot of inflammation in her right hand and right wrist. She was feeling fine before the vaccine and she had done nothing to injure her right hand and wrist and was wondering if it was a side effect. She read that joint pain was a side effect and asked whether had there been any reports of joint pain in the hand and wrist. She was taking the Symbicort inhaler, it was not really dose it was 2-3 days. She was just prescribed Meloxicam 15 milligrams. No family history relevant to adverse event reported.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sensory disturbance, Swelling, X-ray
Clinical narrative: joint pain that radiates up and down the arm; joint pain that radiates up and down the arm; inflammation in my right hand and right wrist; inflammation in my right hand and right wrist; Sensation in my right hand at rest; Slightly swollen; fever; 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 23-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 16:30 as dose 1, 0.3 ml single (Lot number: HG4628) at the age of 23 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "Functional gastrointestinal disorders" (unspecified if ongoing); "Kawasaki disease", start date: 2006 (unspecified if ongoing), notes: Diagnosis date of Kawasaki disease was 2006; "mild congestion" (unspecified if ongoing); "Sacralization", start date: 2015 (unspecified if ongoing), notes: Diagnosis date: 2015. I have a fused L5 in vertebrate in my back. Concomitant medication(s) included: SYMBICORT. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: SENSORY DISTURBANCE (non-serious) with onset 2023, outcome "unknown", described as "Sensation in my right hand at rest"; SWELLING (non-serious) with onset 2023, outcome "unknown", described as "Slightly swollen"; PYREXIA (non-serious) with onset 2023, outcome "recovered" (2023), described as "fever"; INFLAMMATION (non-serious), ARTHRITIS (non-serious) all with onset 2023, outcome "unknown" and all described as "inflammation in my right hand and right wrist"; ARTHRALGIA (non-serious), PAIN (non-serious) all with onset 2023, outcome "unknown" and all described as "joint pain that radiates up and down the arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, pain, sensory disturbance, swelling, pyrexia.  Additional Information: Patient was having joint pain in right hand and right wrist. She had an x-ray done and it came back fine. She had a lot of inflammation in her right hand and right wrist. She was feeling fine before the vaccine and she had done nothing to injure her right hand and wrist and was wondering if it was a side effect. She read that joint pain was a side effect and asked whether had there been any reports of joint pain in the hand and wrist. She was taking the Symbicort inhaler, it was not really dose it was 2-3 days. She was just prescribed Meloxicam 15 milligrams. No family history relevant to adverse event reported.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain, Pyrexia
Clinical narrative: Mild fever; bodyaches; chills; weakness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 34-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 at 13:30 as dose 1, single (Batch/Lot number: unknown) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "history of TB" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, start date: 20Sep2023, stop date: 20Sep2023. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 11Oct2023 at 01:00, outcome "recovering", described as "Mild fever"; PAIN (non-serious) with onset 11Oct2023 at 01:00, outcome "recovering", described as "bodyaches"; CHILLS (non-serious) with onset 11Oct2023 at 01:00, outcome "recovering"; ASTHENIA (non-serious) with onset 11Oct2023 at 01:00, outcome "recovering", described as "weakness". Therapeutic measures were not taken as a result of pyrexia, pain, chills, asthenia.  Additional information: It was reported that the patient received other vaccination (flu vaccine) and medication (multivitamin once a day) in two weeks. The patient was not tested COVID prior or post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "CAD" (unspecified if ongoing); "known allergies: sulphides" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as COVID 19 treatment .  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna/ Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). 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 14Sep2022 as dose 5 (booster), single (Lot number: 652529) at the age of 71 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EL9267), on 09Mar2021 as dose 2, single (Lot number: EN6199) and on 25Sep2021 as dose 3 (booster), single (Lot number: 30145BA) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 033K21-2A) and on 28Apr2023 as dose 6 (booster), single (Lot number: 045H22A) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Apr2022, outcome "recovered", described as "Moderna/ Interchange of vaccine products"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" (Oct2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 29Sep2023 to 03Oct2023 for treatment of COVID-19. Patient tested negative for covid on day after the course of Paxlovid and again 2 days later. Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300325158 Same patient, different drug/events;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive for Covid; I tested positive for Covid; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown) and as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I did not take my allergy medication" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Oct2023, outcome "unknown" and all described as "I tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Oct2023) Positive; (Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Caller stated that she had 6 of vaccines very pleased with them, lined up in (withheld), (Country name) lined up to get number 7 she was the one who wears the googles, the gloves, the mask, she was a full time flight attendant, she had been very good, not even close to Covid. Last Monday 02Oct2023 she tested positive for Covid, called the (withheld) health, the nurse called the pharmacy and within an hour and a half she testing positive she had Paxlovid, excellent, she knew it was government healthcare but it worked when they did not want you to get sick, so from Monday 02Oct2023 until the 6th Friday, she took her Paxlovid, she did not take her allergy medication the pharmacist recommend she did not take the two together, and all those days she tested herself everyday because she worked for an airline and she had plenty of (inaudible) Saturday, Sunday, Monday, Tuesday she tested negative so she was really happy. She woke up this morning, runny nose, fever 98.6, hands are cold, runny nose and a horrible sinus. She thought my allergies are back, but she thought because she was only taking the pills for 4 days. She tested herself, she was positive, is this unusual to have a rebound after taking Paxlovid for 5 days. and should she started taking it again.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300327166 Same patient/vaccine; different dose/events;US-PFIZER INC-202300325049 Same reproter/patient; different drug/events;
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Vaccine failure to prevent COVID19 infection; tested positive on 11Oct with symptoms (flu-like).; Vaccine failure to prevent COVID19 infection; tested positive on 11Oct with symptoms (flu-like).; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 12:00 as dose 1, single (Lot number: HGH628) at the age of 63 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Oct2023 at 10:00, outcome "not recovered" and all described as "Vaccine failure to prevent COVID19 infection; tested positive on 11Oct with symptoms (flu-like).". Clinical course details: the patient had no Covid prior vaccination and tested for Covid after vaccination. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Oct2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: Joint pain; Slight headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, 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: ARTHRALGIA (non-serious) with onset 11Oct2023, outcome "unknown", described as "Joint pain"; HEADACHE (non-serious) with onset 11Oct2023, outcome "unknown", described as "Slight headache".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 06Apr2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "total hip replacement" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID Treatment). The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Memory impairment, Reading disorder, Road traffic accident
Clinical narrative: I could not find the store like I was confused; I didn't remember/ I just forgot; I couldn't read; I got into a car accident; fatigue/the vaccine somehow made me tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, 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: CONFUSIONAL STATE (non-serious), outcome "unknown", described as "I could not find the store like I was confused"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "I didn't remember/ I just forgot"; READING DISORDER (non-serious), outcome "unknown", described as "I couldn't read"; ROAD TRAFFIC ACCIDENT (non-serious), outcome "unknown", described as "I got into a car accident"; FATIGUE (non-serious), outcome "unknown", described as "fatigue/the vaccine somehow made me tired".  Additional information: The patient felt fine, but the pharmacist did not give the patient a list of any of the side effects that could happen and they did not make the patient to sit and wait 15 minutes. The patient went home for few minutes, and felt fine. So, then the patient drove to the store and couldn't find the store like the patient was confused, to how to get there and then the patient does not go to that store very often. So, the patient just said maybe just forgot or something and then when came out of the store. The patient was fine in the store, felt okay and put all the groceries in the car and then got into a car accident in the parking lot of the store. Then after that the police came and the patient could not figure out how did, could not find and figure how to get in driver's license registration and insurance like the patient could not read, the patient did not remember. The patient was wondering if the vaccine somehow made the patient tired or confused that either it caused to have an accident or not to be unable to figure out how to get to the store and how to find ID that was needed or whatever. Does it caused confusion or fatigue or something or not at all.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history included: "Fruit allergy" (unspecified if ongoing), notes: Strawberries, kiwi. The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Allergy:Cipro". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID Treatment). No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 62-year-old male patient received bnt162b2 (BNT162B2 NOS), on 01Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "IBS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, patient received Paxlovid from  01Oct2023 to 05Oct2023.. The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Fevers; chill; nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: PYREXIA (non-serious), outcome "unknown", described as "Fevers"; CHILLS (non-serious), outcome "unknown", described as "chill"; NAUSEA (non-serious), outcome "unknown".  Additional Information: It was reported that patient had Fevers and chill and nausea with the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Chills; Headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose1, 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: CHILLS (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown", described as "Headaches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: He then came back with Covid; He then came back with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 78-year-old male patient 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 included: "hypertension/high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "He then came back with Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient stated he was planning to visit his grandkids and better to come up first week of Sept. He doesn't want to leave until he was vaccinated. He called and was told he can get the shot 15Aug2023. And so, he ended up getting the booster. He then came back with Covid, he did have Paxlovid and needed to go around with N95 mask. He added he got his first shot of Covid, got tested and was clean. He wanted to know what was given to him that's why he called Pfizer to check when was the new vaccine released. He was told he cannot get a flu shot or get a test. He said had they told him it was an old vaccine version, he would have waited and rescheduled his trip. He also mentioned he did not get into the Facility till May 2014. He said he has hypertension/high blood pressure but Facility turned him down and said it was not bad enough. And so he quit Facility and moved his medical.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Jan2023 as dose 6 (booster), single (Lot number: 6L0446) at the age of 56 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "On hormone therapy replacement" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, Paxlovid was administered from 25Sep2023 to 29Sep2023.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Jan2023 as dose 6 (booster), single (Lot number: 6L0446) at the age of 57 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, Paxlovid was administered from 27Sep2023 to 01Oct2023.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 at 17:00 as dose 5 (booster), single (Lot number: GH6739) at the age of 64 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 04Jun2022 at 10:00 as dose 4 (booster), single (Lot number: FM7553), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Underactive thyroid" (unspecified if ongoing); "Osteporosis" (unspecified if ongoing); "light plague carotid artery" (unspecified if ongoing); "Known allergies: Acromycin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Aug2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure, managed. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE, start date: 15Nov2022; ATORVASTATIN, start date: 19Jul2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Oct2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Aug2023 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, the patient received paxlovid from  04Oct2023 to 09Oct2023.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 71-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19, Paxlovid administered from 19Sep2023 to 24Sep2023. 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 bnt162 vaccines in this patient cannot be completely excluded.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Jul2023 as dose number 4 (booster), single (Batch/Lot number: unknown) at the age of 65 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; levothyroxine (LEVOTHYROXINE), since 01Jan2016 (Batch/Lot number: unknown). 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 2023, outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Course of events:  Patient received COVID 19 anti viral treatment with Paxlovid form 01Oct2023 to 05Oct2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.