chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested + PCR and neg CXR; tested + PCR and neg CXR; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EL3247), on 16Mar2021 as dose 2, single (Lot number: EL3247) and on 10Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "recovering" and all described as "tested + PCR and neg CXR". The events "tested + pcr and neg cxr" required physician office visit. The patient underwent the following laboratory tests and procedures: Chest X-ray: (18May2022) Negative, notes: 18May2022 tested +PCR and neg CXR; SARS-CoV-2 test: (18May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Treatment ae: Unknown. It was unknown whether the patient had covid prior vaccination. She tested covid post vaccination.  Clinical information: Adverse event: attended a funeral 14May2022, then sx cough, moderate aches, congestion and chills on 16May2022 and on 18May2022 she tested positive PCR and negative CXR.  Investigation results: This was 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.  Lot (CR): EL3247 and FF2589: Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the Pfizer-BioNTech covid-19 vaccine lot EL3247 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 EL3247, fill lot EL3230, and the formulated drug product lot EL3223 and FE5318. A complaint sample was not returned, and photographs were not received. 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; 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.
Age: 32.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 19Mar2021 as dose 2, single (Lot number: ER2613), in left arm and on 15Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Inflammatory bowel disease" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: MESALAMINE taken for inflammatory bowel disease, start date: 23Jun2019. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", 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: Positive, notes: I tested positive and became symptomatic again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  As of 26May2022, the product quality group providing investigation results 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 EN6200 (for dose 1), fill lot EN5332, and the formulated drug product lot EN5321. The final scope included the reported finished goods lot ER2613 (for dose 2), fill lot EP8678, and the formulated drug product lot EP8565. The final scope included the reported finished goods lot FF2593 (for dose 3), fill lot FF5584, and formulated drug product lot FA9147 respectively. A complaint sample was not returned, and photographs were not received. 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.
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 (Other HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 05Nov2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history, known allergies. 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: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid to treat drug ineffective, covid-19. Treatment start date: 10May2022, treatment stop date: 16May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The contribution of the suspect drug to the onset of event drug ineffective cannot be ruled out since drug efficacy varies from one patient to another and affected by different factors.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive Covid; positive Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 23Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "Borderline anemic" (unspecified if ongoing), notes: Borderline anemic; "Dose Number: 2,1; Pfizer / BioNTech/ Dose Number: 3; Moderna" (not ongoing), notes: Dose Number: 2,1; Pfizer / BioNTech/ Dose Number: 3; Moderna. Concomitant medication(s) included: OMEGA 3 SELECT; PROBIOTICS; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]; CALCIUM; PRESERVISION AREDS 2. The following information was reported: VACCINATION FAILURE (medically significant) with onset 11May2022, outcome "unknown", COVID-19 (medically significant) with onset 11May2022, outcome "recovered with sequelae" and all described as "positive Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) Positive; (16May2022) Positive, notes: barely testing positive (whisper of a line) and feeling much better; (17May2022) Positive, notes: barely testing positive (whisper of a line) and feeling much better; (18May2022) Positive, notes: 30 seconds dark red line; (24May2022) Negative; (25May2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course included Anti-viral details: product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 11May2022, treatment stop date: 15May2022. Other medication in 2weeks product: Omega-3s. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. 25May- tested negative again, still have some congestion, cough, fatigue, cloudy head.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Dose Number: 1,2,3; COVID 19 Treatment; Dose Number: 1,2,3; 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 40-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 16Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient did not have known allergies. Other medication in 2 weeks were None. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Dose Number: 1,2,3; COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound of COVID symptoms and positive RAT 7 days after completion of Paxlovid course (14 days after first positive RAT). Positive RAT for next 6 days. Negative RAT on day 7 from rebound (day 21 from initial positive RAT); Negative, notes: Negative RAT on day 7 from rebound (day 21 from initial positive RAT); Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid was given to the patient for covid-19 treatment on 01May2022 and stopped on 06May2022. Adverse event start date was provided as 14May2022. Rebound of COVID symptoms and positive RAT 7 days after completion of Paxlovid course (14 days after first positive RAT). Positive RAT for next 6 days. Negative RAT on day 7 from rebound (day 21 from initial positive RAT). Symptoms mostly resolved around day 5-6 after start of rebound; with lingering cough and intermittent fatigue remaining today (day 25 from first positive RAT; day 11 from rebound).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: tested positive for Covid on 14May2022; tested positive for Covid on 14May2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown), on 06Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing). Concomitant medication(s) included: CYCLOBENZAPRINE; PROPRANOLOL; IUD NOS; MIRENA; AJOVY [FREMANEZUMAB]. Past drug history included: Prilosec otc, reaction(s): "Known allergies: Prilosec OTC".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14May2022, outcome "not recovered" and all described as "tested positive for Covid on 14May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (14May2022) Positive; (21May2022) Negative; (25May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional Information:Adverse event: Initially tested positive for Covid on 14May2022. Started Paxlovid 15May2022, treatment stopped on 19May2022, Lot number=FX4466. Tested negative 21May2022. Runny nose and slightly irritated throat 25May (almost imperceptible but took a test anyway). Tested positive 25May.Adverse event country. Adverse event start date: 25May2022.Adverse event start time: 07:00 AM. Ae resulted in: None of the above. If patient recovered: Not recovered. If treatment ae: No. Known allergies: Prilosec OTC. Other medical history: Migraine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
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). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2022 as dose 4 (booster), single (Lot number: ???) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: COVID test  x 2 rapid antigen test from 2 different manufacturers; (May2022) Positive, notes: COVID test  x 2 rapid antigen test from 2 different manufacturers. Therapeutic measures were taken as a result of covid-19. The patient did not have ant known allergies.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 26Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 19Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; SYNTHROID. Past drug history included: Keflex, reaction(s): "known allergies: Keflex"; Bacteria ds, reaction(s): "Known allergies: Bacteria DS". The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, suspected Covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative, notes: Got positive after about 2 weeks of getting a negative result; (23May2022) Positive, notes: Got positive after about 2 weeks of getting a negative result. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course information: It was reported that the patient had no known allergies and the patient was not taking any other medications in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 33-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 09Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, 1 year 1 month 15 days after the suspect product(s) administration, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Negative, notes: Symptoms improved and rapid COVID test negative on 20May; (24May2022) Positive, notes: Recurrence of COVID symptoms with positive rapid COVID test 24May concerning for COVID rebound after Paxlovid. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 45.0
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) (Other HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Nov2021 as dose 3 (booster), single (Lot number: Ew0196) at the age of 45 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: "Cyclic vomiting syndrome" (unspecified if ongoing); "migraine" (unspecified if ongoing); "known allergies: Chocolate" (unspecified if ongoing), notes: known allergies: Chocolate. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) Positive, notes: Return of positive antigen test after testing negative; (May2022) Negative, notes: Return of positive antigen test after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient got Paxlovid treatment from 03May2022 to 07May2022. Metallic taste Return of fever, fatigue, cough, and muscle aches after symptoms had resolved with treatment Return of positive antigen test after testing negative.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He had 4 COVID-19 vaccine shots from Pfizer and got COVID-19; He had 4 COVID-19 vaccine shots from Pfizer and got COVID-19; 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "He had 4 COVID-19 vaccine shots from Pfizer and got COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Paxlovid Rebound symptoms of COVID-19, she already has the 4 doses of the Pfizer COVID-19 vaccine. Got COVID-19 virus two and a half weeks after getting second booster dose of COVID-19 Vaccine. Her husband took Paxlovid and he's fine. He had 4 COVID-19 vaccine shots from Pfizer and got COVID-19. Responded well from Paxlovid. Positive for COVID-19 after 4 doses of Pfizer COVID-19 Vaccines.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 38-year-old patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) 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), SUSPECTED 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. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  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, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Saliva lab test positive for COVID-19; Saliva lab test positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 06May2022 at 12:15 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 21Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "heart disease" (unspecified if ongoing); "short colon" (unspecified if ongoing), notes: short colon; "Interchange of vaccine products" (unspecified if ongoing), notes: Vaccine: Pfizer BioNTech, Dose number: 4 and 3/Vaccine: Moderna, Dose number: 2 and 1. The patient took concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "not recovered" and all described as "Saliva lab test positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21May2022) Positive; (09May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported that patient also received that Paxlovid from 11May2022 to 16May2022 of unknown lot number for the indication of treatment of COVID-19 and patient received several per & otc of various brand on 01Jan2015 of unknown lot number.  Clinical course: Adverse event Saliva lab test positive for COVID-19 09May2022, 1 day after symptoms started. Started Paxlovid 11May2022, 2 days later. Patient felt much better by 16May2022, on 8th day. On 21May2022 again had COVID symptoms, home-test positive.  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: Herpes ophthalmic, Ophthalmological examination, Slit-lamp examination, Visual acuity tests
Clinical narrative: Recurrence of Herpetic Keratitis; This is a literature report.  A 52-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "herpetic keratitis of the right eye" (unspecified if ongoing); "herpes simplex virus (HSV) stromal keratitis", start date: 1992, stop date: 2019. The patient's concomitant medications were not reported. Past drug history included: Prednisolone acetate, stop date: 2017, for herpetic keratitis, notes: 1% topical; Trifluridine for herpetic keratitis, notes: topical; Acyclovir for antiviral prophylaxis, notes: oral; Valacyclovir for antiviral prophylaxis, notes: oral. Vaccination history included: Bnt162b2 (DOSE 1), administration date: Mar2021, for covid-19 immunization; Zostavax varicella zoster vaccine, administration date: Mar2020, for varicella zoster. The following information was reported: HERPES OPHTHALMIC (medically significant), 24 hrs after the suspect product(s) administration, outcome "recovering", described as "Recurrence of Herpetic Keratitis". The patient underwent the following laboratory tests and procedures: Ophthalmological examination: two weeks after the initial symptoms and was found, notes: to have 20/40 visual acuity in the right eye with patchy stromal haze and confluent punctate epithelial erosions along the inferior cornea; the patient presented to our clinic and vision had, notes: declined to 20/60 with new nummular opacities at multiple stromal levels. Sector iris stromal atrophy was noted; Slit-lamp examination: depicting corneal stromal haziness, notes: and sectoral iris atrophy(right eye); Visual acuity tests: 20/40, notes: right eye; 20/60, notes: vision had declined; 20/30, notes: stabilized. Therapeutic measures were taken as a result of herpes ophthalmic. Clinical Course included for relevant history herpes simplex virus (HSV) stromal keratitis: 3-4 episodes of reactivation/year until 2010; decreased to 1 episode of reactivation every other year with last episode in 2019.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 40.0
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 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "GAD" (unspecified if ongoing); "overweight" (unspecified if ongoing); "known allergies: penicililin" (unspecified if ongoing), notes: known_allergies penicililin. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (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. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: If vaccine received Yes. Other medication in 2weeks No. Anti viral details product=COVID 19 Treatment, brand=Pfizer, treatment start date=16May2022, treatment stop date=21May2022, covid vaccine details vaccine brand=Pfizer / BioNTech, vaccine brand unknown=False, vaccine administration date=22Oct2021, vaccine dose number=3, vaccine dose number unknown=False, vaccine location=Left arm, adverse event Experiencing a paxlovid rebound. As of now, my symptoms are: congestion, chills, no fever, and stomach cramps.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: EW0158), in left arm, on 20Apr2021 as dose 2, single (Lot number: EW0169), in left arm, on 08Nov2021 as dose 3 (booster), single (Lot number: FH2087), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "implanted amplatzer cribriform to close PFO from a few TIA's" (unspecified if ongoing), notes: implanted amplatzer cribriform to, close PFO from a few TIA's. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (17May2022) Negative, notes: 1st dose paxlovid 12May pm finishing 17May am and tested negative that morning (day 6); (24May2022) Positive, notes: on 24May symptoms returned and I tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 56-year-old male patient received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Lot number: EW0191) at the age of 55 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 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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Negative; (23May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid start on 12May2022 and stop date on 16May2022. Last dose of Pax was 16May2022. Negative home antigen on 20May2022. Patient felt fine then recurrence of sneezing,  congestion, fatigue on 22May2022and tested positive on 23May and outcome was recovered.No treatment, Known allergies and Other medical history.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: Tinnitus; Occasional ringing; Arm is really hurting; Hearing a hissing sound in my ears; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 18Nov2021 as dose 3 (booster), single (Lot number: FH8028) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1), administration date: 21Mar2021, for COVID-19 Immunization; BNT162b2 (Dose 2, And it started from a pain in my arm and a little bit of fatigue.), administration date: 28Mar2022, for COVID-19 immunization, reaction(s): "pain in my arm", "little bit of fatigue". The following information was reported: TINNITUS (non-serious) with onset Nov2021, outcome "unknown", described as "Hearing a hissing sound in my ears"; PAIN IN EXTREMITY (non-serious) with onset 18Nov2021, outcome "unknown", described as "Arm is really hurting"; TINNITUS (non-serious), outcome "unknown"; TINNITUS (non-serious), outcome "unknown", described as "Occasional ringing".  No follow-up attempts are possible. No further information is expected.
Age: 53.0
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 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 at 12:00 as dose 1, single (Lot number: EN6207), in left arm, on 16Apr2021 at 12:00 as dose 2, single (Lot number: EW0169), in left arm, on 20Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 31Mar2022 at 12:00 as dose 4 (booster), single (Lot number: FJ9943) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "melanoma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin". 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: (May2022) Negative, notes: 1 week after testing negative on PCR; (May2022) Positive, notes: Tested positive again (rapid) on 5th day; (unspecified date) Unknown results; (May2022) Positive, notes: tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 55.0
Sex: M
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) (Physician).  A 55-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive antigen test after negative 5 days, after completion of paxlovid; Negative, notes: positive antigen test after negative 5 days, after completion of paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient. A 57-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), on 05Apr2021 as dose 1, single (lot number unknown), in left arm; on 26Apr2021 as dose 2, single (lot number unknown), in left arm; on 25Oct2021 as dose 3 (booster), single (lot number unknown), in left arm and; on 30Mar2022 as dose 4 (booster), single (lot number unknown) at the age of 56 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) and SUSPECTED COVID-19 (medically significant), outcome "unknown" and described as "COVID-19". The patient underwent the following laboratory tests and procedures: covid 19: unknown results. Therapeutic measures were taken as a result of drug ineffective and suspected covid-19 which included Paxlovid taken from 13May2022 to 18May2022 for the treatment of covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 67-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 27Jan2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 17Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic kidney disease" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Iodine, reaction(s): "Known allergies: Iodine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 03Apr2022 at 11:00 as dose number unknown, single (Lot number: IM0698) at the age of 47 years, in left arm for covid-19 immunisation. The patient's family history included: "Hear disease history on patient father and brothers" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Positive; (25May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not receive any other medication in 2 weeks. Rebound of Covid 19. Tested positive on 25May2022. Symptoms never went completely away since patient originally tested positive on 09May2022. COVID 19 Treatment included Paxlovid, Treatment start date: 09May2022, Treatment stop date: 14May2022. No known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bursitis, Chills, Fatigue, Joint range of motion decreased
Clinical narrative: Had immediate injection site pain which progresses to limited range of motion and pain in left shoulder.; Had immediate injection site pain which progresses to limited range of motion and pain in left shoulder.; Had immediate injection site pain which progresses to limited range of motion and pain in left shoulder.; By 8pm experienced all over myalgia and fatigue and chills.; By 8pm experienced all over myalgia and fatigue and chills.; By 8pm experienced all over myalgia and fatigue and chills.; bursitis; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), on 24May2022 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing). Concomitant medication(s) included: CELEXA [CITALOPRAM HYDROBROMIDE] oral; ESTRADIOL; PROGESTERONE. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: MYALGIA (non-serious), FATIGUE (non-serious), CHILLS (non-serious) all with onset May2022, outcome "recovering" and all described as "By 8pm experienced all over myalgia and fatigue and chills."; VACCINATION SITE PAIN (non-serious), ARTHRALGIA (non-serious) all with onset May2022, outcome "recovering" and all described as "Had immediate injection site pain which progresses to limited range of motion and pain in left shoulder."; JOINT RANGE OF MOTION DECREASED (non-serious) with onset May2022, outcome "not recovered", BURSITIS (non-serious) with onset May2022, outcome "not recovered" and all described as "bursitis". Therapeutic measures were taken as a result of vaccination site pain, joint range of motion decreased, arthralgia, myalgia, fatigue, chills, bursitis.  Additional information: Took 1000mg acetaminophen and hydrated. Symptoms resolved slightly by morning however bursitis in should persists with limited range of motion.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.