chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Bone density decreased, Chest X-ray, Culture urine, Diagnostic procedure, Imaging procedure
Clinical narrative: 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), on 09Apr2022 at 15:00 as dose 3 (booster), single (Lot number: FK9894) at the age of 80 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic Lymphocytic Leukemia", start date: 18Sep2007 (ongoing); "Spinal stenosis", start date: 2015 (unspecified if ongoing); "chemotherapy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EW0164, Time of vaccination: 03:00 PM, Anatomical location: Upper Arm, Route of administration: Left muscle), administration date: 30Apr2021, when the patient was 79-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot Number:EW0185, Time of vaccination: 02:00 PM, Anatomical location: Upper Arm, Route of administration: Intramuscular), administration date: 02Jul2021, when the patient was 79-year-old, for Covid-19 immunization, reaction(s): "Inappropriate schedule of vaccine administered". The following information was reported: URINARY TRACT INFECTION (non-serious) with onset 2022, outcome "unknown", described as "UTI". The patient underwent the following laboratory tests and procedures: Bone density decreased: (2021) low; Chest X-ray: (2021) good; Culture urine: (2022) UTI, notes: 4 times in 2022; Diagnostic procedure: (2007) Unknown results; Imaging procedure: (2015) Spinal stenosis.  Additional Information: The patient was diagnosed with chronic lymphocytic leukaemia (CLL) 14 years ago, this was prior to the Covid vaccines. She stated that it can start and stop and come back. She had been on oral medication and it did not work with her, she then started back on chemo. She was confused because she did have another hip sample taken and one oncologist said she had stage 4 lymphoma and her doctor now said it was still just CLL. The patient had family history of high blood pressure, heart disease, cancer, stroke; relevant to adverse events. The patient did not take the 3rd dose in Dec2021 because she forgot. The patient received third booster in upper arm. The nurse who administered booster dose advised her to have other 2 doses on 19Sep2022 and Jan2023. The patient had leukemia and her oncologist told her that no one should have more than 4 doses at this time. The patient wanted to know if she needs to get 2 more booster shots or if she should not get more than 4 in her lifetime like her oncologist recommended. This report was not serious.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: 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), on 09Apr2022 at 15:00 as dose 3 (booster), single (Lot number: FK9894) at the age of 80 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic Lymphocytic Leukemia", start date: 18Sep2007 (ongoing); "Spinal stenosis", start date: 2015 (unspecified if ongoing); "chemotherapy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EW0164, Time of vaccination: 03:00 PM, Anatomical location: Upper Arm, Route of administration: Left muscle), administration date: 30Apr2021, when the patient was 79-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot Number:EW0185, Time of vaccination: 02:00 PM, Anatomical location: Upper Arm, Route of administration: Intramuscular), administration date: 02Jul2021, when the patient was 79-year-old, for Covid-19 immunization, reaction(s): "Inappropriate schedule of vaccine administered". The following information was reported: URINARY TRACT INFECTION (non-serious) with onset 2022, outcome "unknown", described as "UTI". The patient underwent the following laboratory tests and procedures: Bone density decreased: (2021) low; Chest X-ray: (2021) good; Culture urine: (2022) UTI, notes: 4 times in 2022; Diagnostic procedure: (2007) Unknown results; Imaging procedure: (2015) Spinal stenosis.  Additional Information: The patient was diagnosed with chronic lymphocytic leukaemia (CLL) 14 years ago, this was prior to the Covid vaccines. She stated that it can start and stop and come back. She had been on oral medication and it did not work with her, she then started back on chemo. She was confused because she did have another hip sample taken and one oncologist said she had stage 4 lymphoma and her doctor now said it was still just CLL. The patient had family history of high blood pressure, heart disease, cancer, stroke; relevant to adverse events. The patient did not take the 3rd dose in Dec2021 because she forgot. The patient received third booster in upper arm. The nurse who administered booster dose advised her to have other 2 doses on 19Sep2022 and Jan2023. The patient had leukemia and her oncologist told her that no one should have more than 4 doses at this time. The patient wanted to know if she needs to get 2 more booster shots or if she should not get more than 4 in her lifetime like her oncologist recommended. This report was not serious.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL1283), in left leg, on 05Feb2021 at 09:00 as dose 2, single (Lot number: EL9262), in right arm and on 28Sep2021 at 09:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CARVEDILOL (ongoing); LOSARTAN HCTZ (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Aug2022 at 06:00, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jul2022) Positive, notes: Tested positive for Covid 24Jul22; (07Aug2022) Positive, notes: 7Aug22 symptoms started again and just tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Urticaria
Clinical narrative: Acute Urticaria; terribly painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2 , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacture unknown), for Covid-19 Immunization. The following information was reported: URTICARIA (hospitalization), outcome "unknown", described as "Acute Urticaria"; PAIN (hospitalization), outcome "unknown", described as "terribly painful". The patient was hospitalized for urticaria, pain (hospitalization duration: 5 day(s)).  Clinical course:To Whom it may concern, upon receiving my second dose of the Pfizer Covid-19 Vaccine I had a terrible allergic reaction that caused Acute Urticaria and I was Hospitalized for over 5 days. It was terribly painful and traumatizing. Now I'm faced with having to receive a booster dose to be sure I'm able to withstand contracting the new Covid strains that are out.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 at 11:45 as dose 1, single (Lot number: EP7534), in left arm, on 09Apr2021 at 11:45 as dose 2, single (Lot number: EW0151), in left arm and on 18Jan2022 at 11:15 as dose 3 (booster), single (Lot number: FK9729) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: PROGESTERONE, start date: Jun2019; ESTRADIOL [ESTRADIOL VALERATE], start date: Jun2019; BENADRYL; CETIRIZINE HCL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" 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 vaccination failure, covid-19. Clinical course: Antiviral drug details reported as Paxlovid (Lot Number: GD5273) taken for covid-19 treatment from 01Aug2022 to 06Aug2022.
Sex: F
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Illness, Mass, Nervousness, Rash
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient. A female patient received BNT162b2 (BNT162B2), on 04Aug2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: MASS (non-serious) with onset 06Aug2022, outcome "unknown", described as "lump on her upper arm"; RASH (non-serious), outcome "unknown", described as "big rash; rash is got worse; it's under my breast, it's on my stomach, it's on my shoulders, under my armpit"; NERVOUSNESS (non-serious), outcome "unknown", described as "nervous"; ILLNESS (non-serious), outcome "unknown", described as "sick"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD". Additional information: She said that she got her booster last Thursday (as reported) and what happen was there was a lump on her upper arm and doubt there was the big rash. Reporter stated that the lump in the red circle was not with the injection site but she noticed that day, she thought it looked like she got like kind of the rash or something. The rash got worse, it's under her breast, on her stomach, shoulders, under her armpit. She wanted to know what on put on it because she doesn't want it there. Stated that she the booster. The reporter stated that she could call her doctor the mass general on Monday and see what they would say because that's where she got the vaccine and it's only up to street though (as reported), stated "once if she wanted to ordered me some I can get it". Further stated that she doesn't known if she should just try some BENADRYL or something. Stated that she just got nervous when she saw it because she had just got over and was sick the week before with her COPD and then she got this (as reported). Stated that she did not know what was wrong. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient. A 78-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: 301308A) 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): "had a rashes on her neck"; Flu (Caller stated she was able to get a flu, pneumonia, shingles shot and never had a reaction); Pneumonia (Caller stated she was able to get a flu, pneumonia, shingles shot and never had a reaction); Shingles (Caller stated she was able to get a flu, pneumonia, shingles shot and never had a reaction); Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "had a light pink rash on the neck". The following information was reported: RASH (non-serious), outcome "unknown"; RASH (non-serious), outcome "unknown", described as "the rash came back. It was deeper pink and more widespread". Therapeutic measures were taken as a result of rash, rash. Additional information: It was reported that, the reporter confirmed, her rashes didn't happen right away and didn't notice it the next day. She had no primary care physician and don't take any medication. She tried today and get her booster her pharmacist seemed very reluctant to administer the vaccine and advised to call Pfizer. She never had an allergy to anything and had no primary care physician/allergist. She was able to get a flu, pneumonia, shingles shot and never had a reaction until she took the Covid-vaccine. The reporter was seeking recommendation on what to do going forward. The reporter stated she and her husband were doing the best they could to be healthy. She exercises and walks 2 miles everyday and she was as healthy as she could be. She already got first and second Pfizer COVID-19 vaccine. She didn't actually notice after getting the first shot of the vaccine she had a rashes on her neck she already. She also got the booster shot, the first one and the same thing happened to her. When she got the first shot she did know anything happened. With the second shot, the next day, she had a light pink rash on the neck. Went to patient first, got steroids and it went away in couple days. With the first booster dose, she literally forgot about the previous rash, she went and got the booster dose and the rash came back. It was deeper pink and more widespread. Went to patient first, got steroids again and it went away in couple days. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid; Covid; 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 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jan2021 at 11:15 as dose 1, single (Lot number: EL9263), in right arm, on 14Feb2021 at 09:15 as dose 2, single (Lot number: EN6201), in right arm, on 18Aug2021 at 00:45 as dose 3 (booster), single (Lot number: PC3181), in right arm and on 26Feb2022 at 11:45 as dose 4 (booster), single (Lot number: FJ6369) at the age of 71 years, in right arm for covid-19 immunisation. The patient had no other medication in 2weeks and no known allergies. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Jul2022 at 16:00, outcome "recovering" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: tested positive with a rapid antigen test on 25Jul. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).  Additional information: I started having Covid symptoms on 24Jul; tested positive with a rapid antigen test on 25Jul, started Paxlovid on 25Jul2022.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old female patient (not pregnant) received COVID-19 Vaccine - Manufacturer Unknown, on 05Aug2022 as dose 2, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes; "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: covid19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Manufacturer unknown), administration date: 09Dec2021, when the patient was 55-year-old, for COVID-19 immunization. The following information was reported: ERYTHEMA (non-serious), PRURITUS (non-serious) all with onset 05Aug2022, outcome "not recovered" and all described as "Red area and itches". Therapeutic measures were taken as a result of erythema, pruritus. Additional Information: patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). A 10-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2 (orange cap), 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 (ORANGE CAP), SINGLE), for COVID-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 07Aug2022, outcome "recovering", described as "Sore throat"; RHINORRHOEA (non-serious) with onset 07Aug2022, outcome "recovering", described as "runny nose"; BODY TEMPERATURE INCREASED (non-serious) with onset 07Aug2022, outcome "recovering", described as "slightly elevated temperature". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of oropharyngeal pain, rhinorrhoea, body temperature increased. Additional information: The adverse events did not result in physician office visit or emergency room visit. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE; LISINOPRIL. Past drug history included: Rituximab, start date: Mar2022, for RA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Aug2022, outcome "unknown" and all described as "Tested positive for Covid using rapid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Aug2022) Positive, notes: positive for Covid using rapid test on 01Aug2022. Therapeutic measures were taken as a result of covid-19. Clinical course: The patient tested positive for Covid using rapid test on 01Aug2022. She started Paxlovid with evening dose on 02Aug2022. Took final dose of med on 07Aug2022 morning. Tested positive for Covid on 08Aug2022 so not a rebound case. Waiting to see if symptoms return. 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: Cerebrovascular accident
Clinical narrative: Also had stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 88-year-old female patient received BNT162b2 (BNT162B2), on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Apr2022 as dose 4 (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), administration date: 20Jan2021, for covid-19 immunisation; BNT162b2 (dose 2, single), administration date: 10Feb2021, for covid-19 immunisation. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 26Jun2022, outcome "unknown", described as "Also had stroke".  Clinical course: The patient also had stroke on 26Jun2022 after taking the same sequence of 4 shots (3 Pfizer, 1 Moderna).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 18Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), on 31Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 10Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No other Medication in 2 weeks. Past drug history included: Dilantin, reaction(s): "Known allergies: Dilantin", notes: Known allergies: Dilantin; Acetaminophen, reaction(s): "Known allergies: Acetaminophen", notes: Known allergies: Acetaminophen; Pseudoephedrine, reaction(s): "Known allergies: Pseudoephedrine", notes: Known allergies: Pseudoephedrine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Aug2022) Negative, notes: Tested negative on Day 8 with few symptoms; (05Aug2022) Positive, notes: Tested positive on Day 9 with recurrence of symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 28Jul2022 to 02Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 81-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 at 11:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25Feb2021 at 11:00 as dose 2, single (Lot number: EN 6201), in left arm and on 30Sep2021 at 11:00 as dose 3 (booster), single (Lot number: 30155 BA), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jul2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jun2022) negative, notes: tested negative on successive days about 2 days after taking the full Paxlovid regimen; (03Jul2022) positive, notes: three days later. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: dose 1 vaccination lot number: BL or EL 9269 (hard to read).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient. A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), on 09Jan2021 as dose 1, single (Lot number: 026L20A), in left arm, on 06Feb2021 as dose 2, single (Lot number: 026L20A), in right arm and on 22Oct2021 as dose 3 (booster), single (Lot number: C58521A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "migraines" (unspecified if ongoing); "mild IBS" (unspecified if ongoing). Concomitant medication(s) included: COQ10 [UBIDECARENONE], start date: 01Nov2015; VITAMIN D [VITAMIN D NOS], start date: 01Dec2017. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "recovered" (2022) and all described as "COVID-19"; DISEASE RECURRENCE (medically significant) with onset 15Jul2022, outcome "recovered with sequelae" (01Aug2022), described as "Rebound after treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: tested positive again; (unspecified date) Positive, notes: Treatment of COVID-19; (13Jul2022) Negative. Therapeutic measures were taken as a result of covid-19, drug ineffective, disease recurrence. Clinical course: Concomitant medication Coq10 was currently from Pharmacy. Patient experienced rebound after treatment. Patient received Paxlovid from 07Jul2022 to 12Jul2022 for treatment of COVID-19. Patient felt good and tested negative on 13Jul2022. On 14Jul2022, patient was the same. 15Jul2022 patient felt tired and 16Jul2022 and 17Jul2022 patient had no energy and bad headaches and tested positive again. On 17Jul2022 patient told covering doc it was good enough for patient and asked for a second round of Paxlovid which led to improvement in 48 hrs. 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 drug ineffectiveness, COVID-19 and Disease recurrence cannot be ruled out.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID: Unknown. The reporter is the patient. A 77-year-old male patient received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EN5318, Expiration Date: 31May2021), on 01Mar2021 as dose 2, single (Lot number: EN6205, Expiration Date: 30Jun2021) and on 16Dec2021 as dose 3 (booster), single (Lot number: FE3594, Expiration Date: Feb2022) at the age of 77 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: RAMIPRIL taken for blood pressure abnormal. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "tested positive for Covid, had Pfizer Covid vaccines and booster". Patient had a real bad cold and taking cough syrup. About 6 weeks from time of report, had symptoms and didn't know that it was Covid. Thought he had a summer cold and had headache and cough. It went away with the syrup. When it came back, he got nervous and went to a walk-in clinic and doctor prescribed PAXLOVID. No tests were done at the time. They gave him blood work within the past year and his kidneys were clear so it was ok for him to take this. The events "tested positive for Covid, had Pfizer Covid vaccines and booster" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) his kidneys were clear; SARS-CoV-2 test: (2022) Positive, notes: tested positive for Covid. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Irritable bowel syndrome, Lymph node pain, SARS-CoV-2 test, Weight
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 18-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 18 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "IBD" (unspecified if ongoing), notes: Was diagnosed with IBD but was totally symptom free at the time of taking the Pfizer vaccine. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Anatomical location: Arm Left), administration date: 24Mar2021, when the patient was 18-year-old, for Covid-19 immunization. The following information was reported: LYMPH NODE PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "6 lymph nodes under the left armpit and neck region"; IRRITABLE BOWEL SYNDROME (non-serious), outcome "unknown", described as "IBD flare". The events "ibd flare" and "6 lymph nodes under the left armpit and neck region" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of irritable bowel syndrome, lymph node pain. Additional information: The patient did not receive any prior vaccination. The patient was tested for covid post vaccination. It also triggered an approx. 6-week long IBD flare. Symptoms included loss of appetite, weight loss, and change in bowels. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient. A 78-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1 0.3 ML, SINGLE; Lot number: 301308A), for COVID-19 immunization, reaction(s): "had a rashes on her neck". The following information was reported: RASH (non-serious), outcome "unknown", described as "had a light pink rash on the neck". Therapeutic measures were taken as a result of rash. Additional information: It was reported that, the reporter confirmed, her rashes didn't happen right away and didn't notice it the next day. She had no primary care physician and don't take any medication. She tried today and get her booster her pharmacist seemed very reluctant to administer the vaccine and advised to call Pfizer. She never had an allergy to anything and had no primary care physician/allergist. She was able to get a flu, pneumonia, shingles shot and never had a reaction until she took the Covid-vaccine. The reporter was seeking recommendation on what to do going forward. The reporter stated she and her husband were doing the best they could to be healthy. She exercises and walks 2 miles everyday and she was as healthy as she could be. She already got first and second Pfizer COVID-19 vaccine. She didn't actually notice after getting the first shot of the vaccine she had a rashes on her neck she already. She also got the booster shot, the first one and the same thing happened to her. When she got the first shot she did know anything happened. With the second shot, the next day, she had a light pink rash on the neck. Went to patient first, got steroids and it went away in couple days. With the first booster dose, she literally forgot about the previous rash, she went and got the booster dose and the rash came back. It was deeper pink and more widespread. Went to patient first, got steroids again and it went away in couple days. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive/ appear to be asymptomatic; Tested positive/ appear to be asymptomatic; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 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: "High blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. The following information was reported: DRUG INEFFECTIVE (medically significant), ASYMPTOMATIC COVID-19 (medically significant) all with onset 19Jul2022, outcome "not recovered" and all described as "Tested positive/ appear to be asymptomatic". The patient underwent the following laboratory tests: SARS-CoV-2 test: (19Jul2022) Positive, notes: Tested positive on 19Jul2022; (31Jul2022) Negative, notes: and tested negative by the following Sunday; (07Aug2022) Positive, notes: I tested positive again on 07Aug2022. Therapeutic measures were taken as a result of drug ineffective, asymptomatic covid-19. Additional information: Tested positive on 19Jul2022 and started Paxlovid for 5 days from 21Jul2022 to 25Jul2022 and tested negative by the following Sunday. Then, I tested positive again on 07Aug2022. I appear to be asymptomatic, but I tested because my husband also tested positive one day before me. Patient has no known allergy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), on 03Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 83 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 19Oct2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 26Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Angina" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "thyroid under active" (unspecified if ongoing); "allergies" (unspecified if ongoing); "osteo arthritis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; DILTIAZEM; ESTRADIOL; LEVOTHROID; LIOTHYRONINE; NITROGLYCERIN; POTASSIUM CHLORIDE; PRADAXA; PRAVASTATIN. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Apr2022, outcome "unknown"; 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: Blood pressure measurement: High; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
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 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 29Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for COVID-19 immunization; 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 immunization. The patient's relevant medical history included: "high blood pressure under control with medication" (unspecified if ongoing), notes: high blood pressure under control with, medication. There were no concomitant medications. Past drug history included: Aspirin, reaction(s): "known allergies aspirin", notes: known allergies aspirin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: COVID-19 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient did not 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.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
Clinical narrative: Rebound of symptoms; 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 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 35 years 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 2022, outcome "unknown" and all described as "COVID-19"; DISEASE RECURRENCE (medically significant) with onset 09Aug2022, outcome "unknown", described as "Rebound of symptoms". Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 26Jul2022 to 31Jul2022. Therapeutic measures were not taken as a result of disease recurrence.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 11Jan2021 as dose 1, single (Lot number: ek4176), in left arm, on 01Feb2021 as dose 2, single (Lot number: el3247) and on 20Sep2021 as dose 3 (booster), single (Lot number: fc3184) at the age of 78 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Feb2022 as dose 4 (booster), single (Lot number: wtfou2jdia), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A 54-year-old female patient received BNT162b2 (BNT162B2), on 13Sep2021 as dose 1, single (Lot number: EC3182), in left arm and on 04Oct2021 as dose 2, single (Lot number: EF8839) at the age of 54 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No prior vaccinations within 4 weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Positive for Covid, had 2 Pfizer Covid vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: Result: positive; Unit: Not Provided. Therapeutic measures were as a result of vaccination failure, covid-19 included Paxlovid (Could be GA5101, BA5101 or DA5101) from 17May2022, with dosage: take 2 tablets nirmatrelvir, 1 ritonavir by mouth, together; 3 tablets morning, 3 tablets at night.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive again for COVID-19; Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from contactable consumer. The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EL3247), in left arm, on 01Mar2021 as dose 2, single (Lot number: ENG200), in right arm and on 30Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR; ESTRADIOL. The following information was reported: VACCINATION FAILURE (medically significant) with onset 06Apr2022, outcome "recovered" (14Apr2022), COVID-19 (medically significant) with onset 06Apr2022, outcome "recovered" (10Apr2022) and all described as "Tested positive for COVID-19"; DISEASE RECURRENCE (medically significant) with onset 21Apr2022, outcome "recovered" (24Apr2022), described as "Tested positive again for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Apr2022) Positive; (14Apr2022) Negative; (21Apr2022) Positive; (24Apr2022) Negative; (27Apr2022) Negative; (19May2022) Negative; (02Jun2022) Negative; (08Jun2022) Negative. Therapeutic measures were taken as a result of vaccination failure, COVID-19. Per clinical course, the patient had no known allergies. The patient tested positive for COVID-19 on 06Apr2022. The patient then began taking nirmatrelvir/ ritonavir (PAXLOVID) from 06Apr2022 to 10Apr022. The patient had tested negative for COVID-19 on 14Apr2022 and then tested positive again on 21Apr2022. Further, the patient tested negative for COVID-19 on 24Apr2022, 27Apr2022, 19May2022, 02Jun2022, and 08Jun2022. The patient was administered with the fourth (booster) dose with Moderna COVID-19 vaccine (Lot Number: 038A22A) on 24May2022 in right arm.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; BNT162b2 dose 1, dose 2, dose 3; COVID-19 VACCINE MODERNA dose 4; BNT162b2 dose 1, dose 2, dose 3; COVID-19 VACCINE MODERNA dose 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EK9262), in left arm, on 27Feb2021 as dose 2, single (Lot number: EN6203), in left arm and on 27Sep2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 67 years, in left arm for COVID-19 immunisation; COVID-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 21Apr2022 as dose 4 (booster), single (Lot number: 005M21A), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Hayfever" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "arthritis in many joints" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 21Apr2022, outcome "unknown" and all described as "BNT162b2 dose 1, dose 2, dose 3; COVID-19 VACCINE MODERNA dose 4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Jun2022, outcome "recovered" (28Jun2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jun2022) Positive; (30Jun2022) Negative; (02Jul2022) Negative. Therapeutic measures were taken as a result of vaccination failure, COVID-19 and included Paxlovid. Clinical course: Original symptoms started and positive 'CRP' test was done on 24Jun2022. Anti-viral details: COVID 19 Treatment (Paxlovid) was started from 25Jun2022 and stopped on 30Jun2022. Prior to rebound all fever and other symptoms were gone by 28Jun2022 and rapid antigen tests done on 30Jun2022 and on 02Jul2022 were negative.
Age: 70.0
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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Sep2021 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 27Apr2022 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "seasonal allergies" (unspecified if ongoing); "mild asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative following course of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 12Jul2022 to 17Jul2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.