chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
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 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Sep2021 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 19Apr2022 at 16:00 as dose 2, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "uterine cancer" (unspecified if ongoing), notes: other medical history: Cancer/ chemo treatment ended 7, years for uterine cancer; "other medical history: Cancer/ chemo treatment" (unspecified if ongoing), notes: other medical history: Cancer/ chemo treatment ended 7, years for uterine cancer. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other medication in 2weeks product Over counter vitamins and Various brands on 01Jun2022 and 07Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Mar2021 as dose 1, single (Lot number: ER8734), in left arm, on 18Apr2021 as dose 2, single (Lot number: EW0170), in left arm, on 18Nov2021 as dose 3 (booster), single (Lot number: FH8028), in left arm and on 25Apr2022 as dose 4 (booster), single (Lot number: FP4564), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: GABAPENTIN; DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE. 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: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had no known allergies. Other medication in 2 weeks product: Gabapentin, Dorzolamide hydrochloride Timolol maleate. Anti viral details for COVID 19 Treatment included Paxlovid (lot number: GA6260) from 09Jul2022 to 13Jul2022.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Corneal transplant
Clinical narrative: corneal transplant; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 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 (Caller states that she completed the first two doses of the Pfizer Covid 19 vaccine, DOSE 1, Single), for COVID-19 immunization; Bnt162b2 (Caller states that she completed the first two doses of the Pfizer Covid 19 vaccine, DOSE 2, Single), for COVID-19 immunization. The following information was reported: CORNEAL TRANSPLANT (medically significant) with onset 11Jul2022, outcome "unknown". Therapeutic measures were taken as a result of corneal transplant.  Clinical course: Question: Caller states that she completed the first two doses of the Pfizer Covid 19 vaccine, and also already took her first booster. Caller is scheduled to take her second booster on 09Aug but is concerned since she just had her corneal transplant on 11Jul and is now taking Prednisolone because of it. Caller states that Prednisolone is an anti-rejection medication and is worried because the vaccine targets foreign bodies. Caller is asking if it was safe for her to take the dose of the Pfizer Covid 19 vaccine on August, or if it would be better to delay it about 1 to 2 months later. During the phone call received, the patient stated, "I just signed up for my second Pfizer COVID booster, um, in August and it, I just have a medical type question. I have recently had a corneal transplant on 1 eye. My question is the COVID vaccine goes after different antibodies or foreign objects in the body. Does that, would that have an impact on a corneal transplant?. I need to know if it's safe to get the vaccine after, you know, within a month of getting a corneal transplant. Since that has a donor transplant. "Note: The patient's date of birth was not provided on the phone call. Note: The reporter's address and phone number were not provided on the phone call. The following information was not provided during the call: Patient gender.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cervical dystonia" (unspecified if ongoing). There were no concomitant medications. No other medication in 2 weeks. There was no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Adverse event: 1-very bad med taste that does not go away. 2-I am on my 3rd day and should be feeling better, yet I am not better and have new symptoms. Paxlovid was taken as treatment for COVID-19, treatment started on 18Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 60 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cancer history" (unspecified if ongoing); "all gerd reflux med" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codiene, reaction(s): "Allergy"; Z pak, reaction(s): "Allergy". 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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19 including PAXLOVID (Lot number: 1918528A) on 16Jul2022 to 20Jul2022.  The lot number for BNT162b2, was not provided and will be requested during follow-up.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Glomerular filtration rate, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6202), in left arm, on 18Mar2021 as dose 2, single (Lot number: ER2613), in left arm, on 26Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 13Jun2022 at 13:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Reduced kidney function as a result of kidney donation in 2004, Latest GFR 49" (unspecified if ongoing), notes: Reduced kidney function as a result of kidney donation in 2004, Latest GFR 49; "Reduced kidney function as a result of kidney donation in 2004, Latest GFR 49" (unspecified if ongoing), notes: Reduced kidney function as a result of kidney donation in 2004, Latest GFR 49; "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Suphedrine, reaction(s): "Known allergies: Suphedrine".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Glomerular filtration rate: (unspecified date) 49, notes: Reduced kidney function as a result of kidney donation in 2004, Latest GFR 49; SARS-CoV-2 test: (unspecified date) Unknown Result; (08Jul2022) Negative, notes: Rebound of COVID after previously testing negative. Negative test July 8, 2022; (10Jul2022) Positive, notes: July 10; tested positive July 10; (18Jul2022) Positive, notes: Retest July 18 also positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Fatigue, Glomerular filtration rate, Pain in extremity, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6202), in left arm, on 18Mar2021 as dose 2, single (Lot number: ER2613), in left arm, on 26Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 13Jun2022 at 13:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Reduced kidney function as a result of kidney donation in 2004, Latest GFR 49" (unspecified if ongoing), notes: Reduced kidney function as a result of kidney donation in 2004, Latest GFR 49; "Reduced kidney function as a result of kidney donation in 2004, Latest GFR 49" (unspecified if ongoing), notes: Reduced kidney function as a result of kidney donation in 2004, Latest GFR 49; "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Suphedrine, reaction(s): "Known allergies: Suphedrine".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Glomerular filtration rate: (unspecified date) 49, notes: Reduced kidney function as a result of kidney donation in 2004, Latest GFR 49; SARS-CoV-2 test: (unspecified date) Unknown Result; (08Jul2022) Negative, notes: Rebound of COVID after previously testing negative. Negative test July 8, 2022; (10Jul2022) Positive, notes: July 10; tested positive July 10; (18Jul2022) Positive, notes: Retest July 18 also positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 12Mar2021 as dose 2, single (Lot number: EN6206), in left arm and on 18Jan2022 as dose 3 (booster), single (Lot number: FJ1614) at the age of 26 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jul2022, outcome "not recovered" and all described as "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jul2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had not received any other vaccine in four weeks. Patient had not experienced COVID prior to vaccination and Covid was tested post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100974734 Same reporter and product, different dose;
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN, start date: 02Jan2018; HYDROXYZINE. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: it was reported that patient received vaccine. Patient received other medication in 2 weeks. Patient received treatment for suspected covid-19 with Anti-viral, Brand as Paxlovid, treatment Start Date on 09Jul2022 and Stop Date on 13Jul2022. Began feeling worse after starting Paxlovid. Discontinued Wellbutrin and hydroxyzine. It was asked if Interaction between drugs. Covid rebound symptoms 19Jul2022 after being completely recovered. Symptoms seem worse than original Covid symptoms 08Jul2022. Before taking Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest X-ray, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Chest X-ray: which came back OK, notes: They did a chest X-ray, which came back OK; SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.Patient received treatment with Paxlovid, treatment start date: 06Jul2022, treatment stop date: 10Jul2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Presyncope
Clinical narrative: Lightheaded/ dizzy; near syncope; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 39-year-old female patient received BNT162b2 (BNT162B2), on 19Jul2022 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Interstitial cystitis" (unspecified if ongoing), notes: Other medical history: Interstitial cystitis. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 20Jul2022, outcome "recovering", described as "Lightheaded/ dizzy"; PRESYNCOPE (non-serious) with onset 20Jul2022, outcome "recovering", described as "near syncope". It was unknown if therapeutic measures were taken as a result of dizziness, presyncope.  Additional Information: The patient had no known allergies. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any vaccine within four weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 05Jan2021 at 12:00 as dose 1, single (Lot number: EH9899), in right arm, on 26Jan2021 at 12:00 as dose 2, single (Lot number: EL7262), in right arm, on 01Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF8839), in right arm and on 01Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "heart attack", start date: 2010 (unspecified if ongoing); "possible slight iodine sensitivity" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE, start date: 01Jan2020; ROSUVASTATIN, start date: 01Jan2020; HYDROCHLOROTHIAZIDE, start date: 01Jan2020. The following information was reported: VACCINATION FAILURE (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: Unknown results; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient received Other medication in 2weeks.Anti-viral details: product=COVID 19 Treatment, brand=Paxlovid, treatment start date=08Jul2022, treatment stop date=14Jul2022, lot number=GC9447, indication=Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Batch/Lot number: unknown), on 05Feb2021 as dose 2, single (Batch/Lot number: unknown), on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 07Jun2022 as dose 4, (booster) single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jul2022) Positive; (13Jul2022) Negative; (14Jul2022) Negative; (15Jul2022) Negative; (18Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: Employee tested positive for COVID on 07Jul2022 and took Paxlovir for 5 days. Tested negative on day 7, 8 and 9 and symptoms improved. symptoms returned on day 12 and employee tested positive again. symptoms are much worse now that when originally diagnosed.   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 plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), on 23Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; LATUDA; LAMOTRIGINE; DICYCLOMINE; PANTOPRAZOLE. The following information was reported: VACCINATION FAILURE (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: Unknown Result. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Anti-viral COVID 19 Treatment Paxlovid. Treatment start date was 07Jul2022 and Treatment stop date was 11Jul2022. Symptoms came back in full about a week after treatment.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Dec2020 as dose 1, single (Batch/Lot number: unknown), on 21Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 12Nov2021 as unk, single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient had no Known allergies. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 04Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jul2022) positive; (09Jul2022) negative; (16Jul2022) positiive. Therapeutic measures were taken as a result of covid-19, vaccination failure. The patient tested positive on 04Jul2022, started Paxlovid from 04Jul2022 evening to 09Jul2022 morning. Then tested negative from 09Jul2022 to 13Jul2022. But I started covid symptom again and tested positive again from 16Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: Her friend lost hearing on her right ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 19Jul2022 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history included: "Brain tumor" (unspecified if ongoing); "Muscle disease" (unspecified if ongoing), notes: Muscle disease; "Migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DEAFNESS (medically significant) with onset 20Jul2022, outcome "unknown", described as "Her friend lost hearing on her right ear".  Clinical information: Caller is calling on behalf of her girlfriend. Her friend got the first dose of Pfizer COVID-19 Vaccine. Her friend lost hearing on her right ear. She wants information on this in relation to the vaccine. She mentioned that her friend has brain tumor and muscle disease and is on her way now to the ER. She also mentioned of migraine. Consumer calling regarding COVID-19 vaccination, the first one. They are aware of body aches and possible fever, but her girlfriend lost her hearing in her right ear. Her girlfriend is on her way to the emergency room, they just want to know how severe. Her girlfriend has a brain tumor and a muscle disease and stuff like that. She received the vaccine yesterday and lost her hearing today. Her primary care doctor, Dr. withheld, doesn't know about this. It was done at withheld, withheld. Her girlfriend is going to withheld in withheld on withheld to the emergency room. She thinks the address is withheld but is not sure. Just put withheld Hospital. A pharmacist gave the COVID-19 vaccine. Caller declines completing the report and requests transfer to Medical Information.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EN6200), in right arm, on 17Mar2021 as dose 2, single (Lot number: EP7534), in right arm and on 16Dec2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "Known allergies: Raw fruits" (unspecified if ongoing); "Known allergies: Shell fish" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing); "Stroke", start date: 2020 (unspecified if ongoing); "Cerebral Vasospasm" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "occasional Vertigo" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Contact Dermatitis" (unspecified if ongoing); "Hyperprolactinemia" (unspecified if ongoing); "Pituitary Microadenoma" (unspecified if ongoing); "Adrenal Insufficiency" (unspecified if ongoing); "Sjogren's" (unspecified if ongoing); "Factor V Leiden" (unspecified if ongoing). Concomitant medication(s) included: HYDROCORTISONE; HYDROXYCHLOROQUINE; AMITRIPTYLINE HCL; VALACICLOVIR; CYCLOBENZAPRINE; GABAPENTIN; OMEPRAZOLE; DICLOFENAC SODIUM; FAMOTIDINE; ZOFRAN [ONDANSETRON]; RESTASIS; CABERGOLINE; SUCRALFATE; PSYLLIUM HUSK [PLANTAGO OVATA HUSK]; CALCIUM MAGNESIUM ZINC [CALCIUM;MAGNESIUM;ZINC]; ELDERBERRY [RUBUS IDAEUS LEAF;SAMBUCUS NIGRA FLOWER;SAMBUCUS NIGRA FRUIT]; ECHINACEA; MELATONIN; SULFACLEANSE; EVENING PRIMROSE; VITAMIN D3. Past drug history included: Known allergies: triptans, reaction(s): "Allergy"; Known allergies: citric acid, reaction(s): "Allergy". 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: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient reported about Covid-19 treatment. Patient received other medication in 2weeks, concomitant medications reported. Anti viral details reported as patient took Paxlovid for COVID 19 treatment, from 07Jul2022 to 12Jul2022 (Lot number: 1917018A).
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jul2022) negative, notes: after testing negative one day after completion; (19Jul2022) positive, notes: positive antigen test 6 days after completion of the course of antivirals. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication details: other medication in 2weeks product Birth control, Other medication in 2weeks marlissa, other medication in 2weeks, start date 01Jun2022, other medication in 2weeks stop date 20Jul2022. Recurrence of original symptoms and positive antigen test 6 days after completion of the course of antivirals after testing negative one day after completion.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: ER2613), on 11Apr2021 as dose 2, single (Lot number: EW0151), on 18Oct2021 as dose 3 (booster), single (Lot number: Fe3590) and on 05May2022 at 17:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 51 years for covid-19 immunization. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing); "Known allergies: food" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Adverse event- Rebound Covid 5 days after finishing Paxlovid. Confirmed with rapid test. Symptoms include sore throat, runny nose, and headache.Other medical history- Type 2 Diabetes well controlled; not overweight  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "obesity with prediabetes" (unspecified if ongoing); "obesity with prediabetes" (unspecified if ongoing); "fatty liver" (unspecified if ongoing); "chronic herpes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) Positive; (20Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 includes Paxlovid from 08Jul2022 to 13Jul2022.  Clinical Course: Patient has received other medication in 2 weeks.  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 known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 17Feb2021 at 09:00 as dose 1, single (Lot number: EL8982), in left arm, on 10Mar2021 at 09:00 as dose 2, single (Lot number: EL9269), in right arm and on 04Oct2021 as dose 3 (booster), single (Lot number: Ff2589) at the age of 67 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (unspecified date) Positive; (20Jul2022) Positive, notes: Now on 20Jul I'm still Covid positive with symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received Anti-viral COVID 19 Treatment which start date was 06Jul2022 and stop date was 11Jul2022. After taking the 5 day regimen of Paxlovid and having a negative test, 4 days later he started with fever and other symptoms and a positive Covid test. Now on 20Jul he still felt Covid positive with symptoms. Adverse event start date was 15Jul2022 at 06:00 AM which was not recovered. No other medication in 2 weeks. No Known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 63-year-old male patient received BNT162b2 (BNT162B2), on 12Sep2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: Other medical history: HTN; "Hyperlipidemia" (unspecified if ongoing), notes: Other medical history: hyperlipidemia; "elevated PSA" (unspecified if ongoing), notes: Other medical history: elevated PSA. The patient took concomitant medications. Past drug history included: Lisinopril, reaction(s): "known allergies: Lisnopril". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient had started with anti-viral treatment for COVID 19 on 10Jul2022 and stopped treatment on 15Jul2022. The patient had Rebound Symptoms with the anti-viral treatment on 18Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE) and COVID-19 cannot be ruled out.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 29Apr2022 at 16:15 as dose number (unknown), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: it was reported that, Patient received Paxlovid treatment for COVID 19,Treatment start date: 11Jul2022,Treatment stop date: 15Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 at 11:00 as dose 1, single (Lot number: EL9266), in right arm, on 10Mar2021 at 11:00 as dose 2, single (Lot number: EN6206), in right arm, on 08Sep2021 at 12:00 as dose 3 (booster), single (Lot number: 3013538A), in right arm and on 13Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9896) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Macrodantin, reaction(s): "known allergies: Macrodantin", notes: known allergies: Macrodantin. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", described as "COVID-19 Treatment"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Lot number: EW0183), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE, start date: 07Sep2016; LEVOTHYROXINE, start date: 05Mar2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received oral antiviral drug paxlovid from 09Jul2022 to 14Jul2022 for the treatment of COVID-19. No known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: irritation in the throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 6-year-old male patient received BNT162b2 (BNT162B2), on 19Jul2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 6 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROAT IRRITATION (non-serious) with onset Jul2022, outcome "unknown", described as "irritation in the throat".  Additional information: Received the Pfizer COVID-19 vaccine yesterday and one day later he shows irritation in the throat, she wants to know if this could be due to the vaccination.  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: Chills, Vomiting
Clinical narrative: vomiting; chills; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I have coronary artery disease." (unspecified if ongoing), notes: I have coronary artery disease. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "vomiting up a storm"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization.  The following information was reported: VOMITING (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown". Additional information: Caller stated that she was violently sick throwing up. She was up all night and vomiting with the vaccine, every time I take it, this is what happens. I am a HCP myself. Caller stated, "I took the second booster, wasn't expecting a reaction, but I always get, vomiting. Why is this happening? My husband had the vaccines and was fine. It's just me". Caller stated, the "First time I didn't vomit, the second dose I was vomiting up a storm, the first and second booster I was vomiting and chills". Caller just received the last booster yesterday, "I was okay in the beginning and started vomiting about. I received the vaccine at 1:30pm and started vomiting at 11PM and it lasted all night until about 8 or 9AM, I was up every hour on the hour vomiting.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in right arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID; METFORMIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Procedure to get heart in sync; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: CARDIAC DISORDER (medically significant), outcome "unknown", described as "Procedure to get heart in sync".  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: Cardiac pacemaker insertion
Clinical narrative: Pacemaker; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: CARDIAC PACEMAKER INSERTION (medically significant), outcome "unknown", described as "Pacemaker". Clinical course: There have been five of us on one floor that have had heart issues after receiving the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.