chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
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 44-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: ER2613) and on 10Apr2021 as dose 2, single (Lot number: EW0153) at the age of 43 years for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 27Dec2021 as dose 3 (booster), single (Lot number: 030H21B), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "MS; HX colon cancer stage IIB" (unspecified if ongoing); "tree fruit (mild) allergy" (unspecified if ongoing); "MS; HX colon cancer stage IIB" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN, start date: 01Feb2022; LORAZEPAM, start date: 01Jan2012; TYLENOL; ADVIL [IBUPROFEN]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment/ Positive Antigen test on day 13". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: On Day 10, with no fever and other symptoms abated, I tested negative on an antigen at home test; Positive, notes: Day 13 (today) I took an antigen at home and it is positive. I have the same symptoms as yesterday. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical information: Patient did have receive other medication in 2 weeks, product for COVID-19 Treatment, brand: Paxlovid, treatment start date 29May2022, treatment stop date 02Jun2022, lot number (PAA183750/GA6206), indication: Treatment of COVID-19. Adverse event: Covid rebound. On Day 10, with no fever and other symptoms abated, He tested negative on an antigen at home test. On Day 11, he noticed some congestion, on Day 12 it was a runny nose and chest congestion with a minor cough. Still no fever. Day 13 (today) he took an antigen at home and it is positive. He have the same symptoms as yesterday. adverse event start date: 08Jun2022.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 52-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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 drug ineffective, covid-19.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Limb discomfort, Musculoskeletal discomfort
Clinical narrative: Each of us had a Covid infection with light to no symptoms; Each of us had a Covid infection with light to no symptoms; None of us have had any issues with our necks or arms up to this year from Previous issue; None of us have had any issues with our necks or arms up to this year from Previous issue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "neck diagnosis issue" (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 "Each of us had a Covid infection with light to no symptoms"; MUSCULOSKELETAL DISCOMFORT (non-serious), LIMB DISCOMFORT (non-serious), outcome "unknown" and all described as "None of us have had any issues with our necks or arms up to this year from Previous issue". Therapeutic measures were taken as a result of musculoskeletal discomfort, limb discomfort.  Clinical course: Severe Pain in left neck and left arm. 3 male employees at a office of 24 are experiencing the same symptoms. The only thing we all have in common is the Pfizer shots. we are of different ethnicity's and age. We each have a past neck diagnosis issue from over 10 years ago. None of us have had any issues with our necks or arms up to this year from Previous issue. Seems like to much of a coincidence that it's not either a side effect of the vaccine or a side effect of Covid. Each of us had a Covid infection with light to no symptoms. The symptoms are ongoing with health care being administered with PT. Ae treatment: Ongoing neck and arm treatment. If covid tested post vaccination: Yes. Known allergies: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200824355 same product/event, different patient;
Age: 70.0
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) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 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: "hyperthyroidism" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 09Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 09Jun2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: rapid; (09Jun2022) Positive. Therapeutic measures were not taken as a result of covid-19.  Clinical information: The patient had other medication in 2weeks. The patient had no known allergies. The patient had rebound infection- tested positive on 09Jun2022 after previous negative rapid test. Symptoms reoccurred 08Jun2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
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) (Consumer or other non-HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 01Jan2022 as dose 1, single (Batch/Lot number: unknown), in right arm and on 07Mar2022 as dose 2, single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine; Demerol, reaction(s): "Known allergies: Demerol", notes: Known allergies: Demerol.  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 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 Information: Anti-viral details: Product: Covid 19 Treatment. Brand was Paxlovid. Treatment start date was 06Jun2022. Treatment stop date was 10Jun2022. Lot number was FX4447. Indication was Treatment of Covid-19. Taking Paxlovid within a couple hours patient had a very bitter taste on the back of the tongue. Almost like tasting alum. This subsided within 6 - 8 hours, but re-occurs with the next dose taken. This sensation had increased over the course of the week's dosages. This adverse event started at 06Jun2022 at 09:30 PM.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2021 at 14:00 as dose 3 (booster), single (Lot number: Fj1611) at the age of 61 years intramuscular, 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: "Graves' disease" (unspecified if ongoing); "Allergy: Peanut" (unspecified if ongoing), notes: known allergies Slight allergy to peanuts. Concomitant medication(s) included: SYNTHROID, start date: 09Dec2019, stop date: 10Jun2022. 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, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Investigational results were received on 13Jun2022. This is a notification generated from the gQTS system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q1215 and/or Q1252. Refer to the below table for details: Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot FJ1611 was investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FJ1611, fill lot FH4344 and the bulk formulated drug product FJ8502. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Age: 28.0
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 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 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: "Clinically isolated syndrome" (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 "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 treatment with Paxlovid from 09Jun2022.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient. A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22May2022 at 10:30 as dose 4 (booster), single (Lot number: FK9894) at the age of 68 years, in left arm for Covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL, start date: 01May2002; CELEBREX, start date: 08Jan2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: The patient received other medication in 2 weeks. Product-COVID 19 Treatment, Brand-Paxlovid, Treatment start date- 01Jun2022, Treatment stop date- 06Jun2022, Indication: Treatment of COVID-19. The patient received other medication in 2 weeks product=Estradiol Patch, start date=01May2002, Celebrex, start date=08Jan2018. Adverse event: Covid Rebound-developed nasal congestion, mild chest congestion, body aches, fatigue and headache, event start date: 10Jun2022, event start time: 07:00 AM. The patient had no Known allergies: no. The patient other medical history: osteoarthritis, osteoporosis. No follow-up attempts possible. No further information expected. Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and Covid-19 and BNT162B2.
Age: 51.0
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 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 02Apr2022 as dose 2, single at the age of 51 years, in left 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: "Pcos" (unspecified if ongoing), notes: Polycystic ovary syndrome. 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; Positive, notes: Rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: patient received Paxlovid for COVID 19 Treatment. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in May2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MESTINON. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jun2022) Positive, notes: Return of symptoms and positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 31Aug2021 at 14:00 as dose 3 (booster), single (Lot number: EW0167) at the age of 62 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) Positive, notes: I tested positive for Covid-19 on 29May2022; (08Jun2022) Positive, notes: I tested positive for Covid-19 again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient tested positive for Covid-19 on 29May2022 and was immediately prescribed Paxlovid by his doctor (Patient is healthy and do not take any medications). Patient completed the treatment 03Jun (morning), and was recuperating well. On 08Jun2022, patient felt fatigued and a scratchy throat. Patient tested positive for Covid-19 again. Currently, 10Jun, patient have a runny nose, slight cough and feel tired.  Investigational report: Conclusion: The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot EW0167 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EW0167, fill lot EP8698, and the formulated drug product lot EP8595. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EN5318), in left arm, on 22Feb2021 as dose 2, single (Lot number: EN6200), in left arm, on 13Sep2021 as dose 3 (booster), single (Lot number: 30130BA), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Early kidney disease" (unspecified if ongoing); "sulpha" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received Paxlovid as COVID 19 treatment.
Age: 41.0
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 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 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 "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (01Jun2022) Negative, notes: I tested negative on 01Jun; (10Jun2022) Positive, notes: Now on 10Jun I tested positive again. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: No Other medication in 2weeks. No treatment received. No Known allergies. No Other medical history. The lot number for the vaccine  BNT162b2 (COMIRNATY), was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 25Mar2021 as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "Non-Hodgkins Lymphoma" (unspecified if ongoing), notes: remission for 10 Years. 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". Therapeutic measures were taken as a result of drug ineffective, covid-19. No other medications were received in two weeks. Anti-viral details: Paxlovid for treatment of COVID-19 from 25May2022 to 30May2022. The patient was vaccinated with JJ Mar2021 and received Pfizer booster Nov2021.No known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Lot number: el3248), in right arm, on 03Feb2021 as dose 2, single (Lot number: en5218), in right arm and on 23Aug2021 as dose 3 (booster), single (Lot number: fl3187) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Metformin, reaction(s): "Known allergies: Metformin"; Codeine, reaction(s): "Known allergies: Codeine"; Ropinirole, reaction(s): "Known allergies: Ropinirole". No Other medication in 2weeks. The patient was treated for COVID-19 from 21May2022 to 25May2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 38.0
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 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years, 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 included: "Asthma" (unspecified if ongoing); "Reaction similar to stevens Johnson" (unspecified if ongoing), notes: Reaction similar to stevens Johnson syndrome (experienced 10 years ago with lamictal). Concomitant medication(s) included: MUCINEX, start date: 06Jun2022; SUDAFED 12 HOUR, start date: 06Jun2022. Past drug history included: Lamictal, reaction(s): "Allergy", notes: known allergies: Lamictal. 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. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included Paxlovid 09Jun2022 to 10Jun2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Six weeks later I tested positive 29May, Started 5 day Paxlovid series same day (second time Paxlovid) Today, 13 days later still testing positive; Six weeks later I tested positive 29May, Started 5 day Paxlovid series same day (second time Paxlovid) Today, 13 days later still testing positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), in Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 83 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: "psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: ENBREL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Six weeks later I tested positive 29May, Started 5 day Paxlovid series same day (second time Paxlovid) Today, 13 days later still testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (13Apr2022) negative; (29May2022) positive; (10Jun2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. The vaccine Lot was unknown as it was not available/provided to reporter at the time of report completion. Patient received other medication in 2weeks: Enbrel and Paxlvoid. Patient was Home test positive. He started taking Paxlovid. On second day a hospital test was negative. I continued and finished 5 day series. Paxlovid was started on 12Apr2022 to 16Apr2022. Six weeks later he tested positive 29May at 12:00 AM, Started 5 day Paxlovid series same day (second time Paxlovid). Today, 13 days later still testing positive. Symptoms not problem for me that I know of.   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: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Covid positive after vaccine; Covid positive after vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Pharmacist).  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: SUSPECTED COVID-19 (non-serious), DRUG INEFFECTIVE (non-serious), outcome "unknown" and all described as "Covid positive after vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 50 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1,single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: BYSTOLIC, start date: 01Jan2021; GEMTESA, start date: 01Jan2022; SINGULAIR, start date: 01Jan2021. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED 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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Patient received antiviral treatment for COVID-19. No known allergies and no other medical history.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19 despite having 3 doses of the Pfizer vaccine; tested positive for Covid-19 despite having 3 doses of the Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid-19 despite having 3 doses of the Pfizer vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Patient age group is elderly (65+ Years). Patient was tested positive for Covid-19 despite having 3 doses of the Pfizer vaccine. Patient was doing well, very mild symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: 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. A 49-year-old male patient received BNT162b2 (BNT162B2), on 19Feb2021 at 13:00 as dose 1, single (Lot number: EL3248), in left arm, on 10Mar2021 at 13:00 as dose 2, single (Lot number: EL3248), in left arm and on 15Nov2021 at 13:00 as dose 3 (booster), single (Lot number: FH8028) at the age of 48 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Shellfish allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 08Jun2022, outcome "not recovered", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID-19 symptoms started on 08Jun2022. Tested positive on 10Jun2022.". The event "Covid-19 symptoms started on 08Jun2022. tested positive on 10Jun2022." required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (10Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Patient did not take other vaccine in four weeks. Patient did not take other medications in two weeks. AE treatment include Paxlovid. Patient did not have Covid prior vaccination. Patient had Covid test post vaccination. Covid test type post vaccination was nasal Swab. No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Limb discomfort, Peripheral swelling
Clinical narrative: Slight swelling, Discomfort and burning sensation in under arm; Slight swelling, Discomfort and burning sensation in under arm; Slight swelling, Discomfort and burning sensation in under arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jun2022 at 16:45 as dose 3 (booster), single (Lot number: FP4554) at the age of 42 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Borderline ITP" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN [CLARITHROMYCIN]; TYLENOL; MOTRIN [IBUPROFEN]. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: FC3183), administration date: 24Aug2021, when the patient was 41-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: Ew0198), administration date: 03Aug2021, when the patient was 41-year-old, for Covid-19 Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), LIMB DISCOMFORT (non-serious), BURNING SENSATION (non-serious) all with onset 11Jun2022 at 11:00, outcome "recovering" and all described as "Slight swelling, Discomfort and burning sensation in under arm". Therapeutic measures were not taken as a result of peripheral swelling, limb discomfort, burning sensation.  Additional Information: facility type was vaccine Public Health Clinic/Veterans. Patient did not received any other vaccine in four weeks .Patient received other medications in two weeks was Multi vitamin, Claritin, Tylenol, Motrin. Slight swelling, Discomfort and burning sensation in under arm. Patient has no COVID prior vaccination. Patient was not tested COVID post vaccination. known allergies was unknown.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Gastrooesophageal reflux disease, Migraine, Nausea, Pain
Clinical narrative: Nausea; migraines; fever; cough; pain; swelling; reflux; The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received. 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 11Jun2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: EXCEDRIN ASPIRIN FREE; TYLENOL; ADVILCAPS; IBUPROFEN. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 08:00 AM), administration date: 06Jun2021, for Covid-19 immunisation; BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 17May2021. The following information was reported: NAUSEA (non-serious) with onset 11Jun2022 at 20:00, outcome "unknown"; COUGH (non-serious) with onset 11Jun2022 at 20:00, outcome "unknown"; PYREXIA (non-serious) with onset 11Jun2022 at 20:00, outcome "unknown", described as "fever"; MIGRAINE (non-serious) with onset 11Jun2022 at 20:00, outcome "unknown", described as "migraines"; PAIN (non-serious) with onset 11Jun2022 at 20:00, outcome "unknown"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset 11Jun2022 at 20:00, outcome "unknown", described as "reflux"; SWELLING (non-serious) with onset 11Jun2022 at 20:00, outcome "unknown". Therapeutic measures were not taken as a result of nausea, migraine, pyrexia, cough, pain, swelling, gastrooesophageal reflux disease. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: Nausea; migraines; fever; cough; pain; swelling; reflux; The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received. 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 11Jun2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: EXCEDRIN ASPIRIN FREE; TYLENOL; ADVILCAPS; IBUPROFEN. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 08:00 AM), administration date: 06Jun2021, for Covid-19 immunisation; BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 17May2021. The following information was reported: NAUSEA (non-serious) with onset 11Jun2022 at 20:00, outcome "unknown"; COUGH (non-serious) with onset 11Jun2022 at 20:00, outcome "unknown"; PYREXIA (non-serious) with onset 11Jun2022 at 20:00, outcome "unknown", described as "fever"; MIGRAINE (non-serious) with onset 11Jun2022 at 20:00, outcome "unknown", described as "migraines"; PAIN (non-serious) with onset 11Jun2022 at 20:00, outcome "unknown"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset 11Jun2022 at 20:00, outcome "unknown", described as "reflux"; SWELLING (non-serious) with onset 11Jun2022 at 20:00, outcome "unknown". Therapeutic measures were not taken as a result of nausea, migraine, pyrexia, cough, pain, swelling, gastrooesophageal reflux disease. 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, 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 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), solution for injection, on 11Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 04Mar2021 at 16:30 as dose 2, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 17Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 06Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment; Negative, notes: sound of Covid quickly after paxlovid and quarantining for 5 days from onset of symptoms then testing negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: sound of Covid quickly after Paxlovid and quarantining for 5 days from onset of symptoms then testing Negative. Got head cold starting about 4 days later. May have been that her husband had a rebound (as he had Started paxlovid 1 day before me) and she caught it from him. Unsure. He definitely brought the original virus to their house.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Lot number: 301SSBA) at the age of 66 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment (Paxlovid) from 10Jun2022 to an unspecified date in Jun2022. patient previously received a COVID-19 Vaccine.
Age: 44.0
Sex: F
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 contactable reporter(s) (Physician). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Oct2021 at 10:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 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: "Autoimmune disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Chest X-ray: Unknown results; SARS-CoV-2 test: Unknown results, notes: On an unknown date the patient was tested for Covid and result was unknown as per best understandings; Unknown results, notes: Rebound Covid after paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Treatment of adverse event was done by: Added inhalers, chest X-ray, Tylenol, steroids. Patient had no known allergies.  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 vaccination failure (LOE) cannot be ruled out.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 10Nov2021 as dose 3 (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: "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ammonia, reaction(s): "Known Allergies: Ammonia when inhaled", notes: ammonia when inhaled. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.