chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Hypoaesthesia, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Peripheral numbness feet, legs; tingling in hands; right foot/leg and fingers were affected and right leg worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20May2022 at 10:30 as dose 4 (booster), single (Lot number: FJ4991) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pancreatic carcinoma" (unspecified if ongoing); "known allergies: Shellfish" (unspecified if ongoing); "Physical therapy" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VIT D3; ASPIRIN [ACETYLSALICYLIC ACID]; PANTOPRAZOLE. Vaccination history included: BNT162b2 (other vaccine same date product=Covid pfizer,, other vaccine same date lot number=FF2588,, other vaccine same date vaccine date=20May2022,, other vaccine same date dose number=3,, other vaccine same date vaccine location=Right arm), administration date: 20May2022, for covid-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious), outcome "not recovered", described as "Peripheral numbness feet, legs"; PARAESTHESIA (non-serious), outcome "not recovered", described as "tingling in hands"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "right foot/leg and fingers were affected and right leg worse". The events "peripheral numbness feet, legs", "tingling in hands" and "right foot/leg and fingers were affected and right leg worse" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypoaesthesia, paraesthesia, condition aggravated.  Additional information: Peripheral numbness feet, legs and tingling in hands. Started after first dose but didn't equate it with vaccine until after the most recent booster. Initially in left foot/leg only about two three weeks after shot. A week after the 4th booster my right foot/leg and fingers were affected and right leg worse. Then connected the dots from beginning. No other vaccines in four weeks.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
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 65-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2021 at 12:45 as dose 1, single (Lot number: ER8733), in left arm, on 15Apr2021 at 14:00 as dose 2, single (Lot number: EW0169), in left arm and on 31Jan2022 at 12:30 as dose 3 (booster), single (Lot number: FM0698) at the age of 65 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 "recovered" (13Jun2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: I tested positive once again using a home antigen test; (unspecified date) Positive, notes: I tested positive once again; (unspecified date) Negative, notes: I tested negative using home antigen test; (08Jun2022) Negative, notes: home antigen test is now negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: COVID-19 rebound--after I completed the Paxlovid treatment all symptoms of Covid-19 were gone and I tested negative using home antigen test. 6 days after initial recovery there was a recurrence of Covid-19 symptoms and I tested positive once again using a home antigen test. Symptoms were fairly mild--low grade fever of 99.5°F, sore throat & cough, low energy. Symptoms cleared up within 5 days & home antigen test is now negative. No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL9261), in left arm, on 19Feb2021 as dose 2, single (Lot number: EN6200), in left arm, on 08Oct2021 as dose 3 (booster), single (Lot number: 30125BA), in left arm and on 05May2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Moderate hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Mar2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (04Jun2022) Negative; (11Jun2022) Positive; (13Jun2022) Positive; (unspecified date) Negative; (27May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received anti-viral product for COVID 19 Treatment, brand Pfizer, treatment start date: 27May2022, treatment stop date: 01Jun2022. The patient had a rebound of COVID-19 after testing negative with a rapid test. The patient contracted COVID from a colleague on 24May2022. The patient began to feel symptoms on 26May. The patient tested positive with a rapid test on 27May and was prescribed Paxlovid which he began to take the evening of 27May. The patient did not miss any treatments. The patient tested every day and was negative on 04Jun. His moderate symptoms also had disappeared. Moderate symptoms returned on June 8, and tested positive again on 11Jun. the patient still positive as of 13Jun.
Age: 64.0
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) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8737), in right arm and on 25Apr2021 as dose 2, single (Lot number: EW071) at the age of 64 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Nov2021 as dose 3 (booster), single (Lot number: 067F21A), in right arm and on 07Apr2022 at 12:00 as dose 4 (booster), single (Lot number: 027L21A), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Product investigation summary concluded the complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot ER8737 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 ER8737, fill lot EW3426, and the formulated drug product lot EP8586. 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 needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever; aches; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Route of Administration: Intramuscular), for COVID-19 Immunization; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Route of Administration: Intramuscular), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 13Jun2022, outcome "recovering", described as "Fever"; PAIN (non-serious) with onset 13Jun2022, outcome "recovering", described as "aches"; CHILLS (non-serious) with onset 13Jun2022, outcome "recovering". It was unknown if therapeutic measures were taken as a result of pyrexia, pain, chills.   Additional Information: The age group pf patient was 18-64 Years.   It was unknown If there was other vaccine in fourweeks, If covid prior vaccination and if covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19/Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 at 08:00 as dose 1, single (Lot number: EN6206), in left arm, on 07Apr2021 at 08:00 as dose 2, single (Lot number: ER8737), in left arm, on 08Oct2021 at 15:00 as dose 3 (booster), single (Lot number: FF2590), in right arm and on 15Apr2022 at 15:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR, start date: 01Jan2018. The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered", described as "COVID-19/Vaccination failure"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Day 11 my cough has come back with some shortness of breath not previously experienced and still testing positive with much darker line on the Antigen test; Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The report about covid treatment. Other medication in 2weeks reported as yes. Anti viral details reported as product was COVID 19 Treatment. Brand name was Pfizer. Treatment start date was 04Jun2022, treatment stop date was 09Jun2022. Indication reported as treatment of COVID-19. other medication in 2weeks product was Lipitor. other medication in 2weeks start date was 01Jan2018. Adverse event was day 11 patient cough has come back with some shortness of breath not previously experienced and still testing positive with much darker line on the Antigen test. Patient recovered was recovering and treatment AE was no.    No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Pain, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: runny nose; sore throat; body ache; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 27-year-old female patient received BNT162b2 (BNT162B2), on 04Nov2021 as dose 3 (booster), single (Lot number: EL0140) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: pfizer covid vaccine (Dose Number: 2, Batch/Lot No: EL3302), administration date: 21Feb2021, when the patient was 26-year-old, for COVID-19 Immunization; pfizer covid vaccine (Dose Number: 1, Batch/Lot No: EL0140), administration date: 12Jan2021, when the patient was 26-year-old, for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 12Jun2022, outcome "not recovered", described as "body ache"; RHINORRHOEA (non-serious) with onset 12Jun2022, outcome "not recovered", described as "runny nose"; OROPHARYNGEAL PAIN (non-serious) with onset 12Jun2022, outcome "not recovered", described as "sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of rhinorrhoea, oropharyngeal pain, pain.  Additional information: The patient did not have COVID prior vaccination. COVID was tested post vaccination.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: runny nose; sore throat; body ache; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 27-year-old female patient received BNT162b2 (BNT162B2), on 04Nov2021 as dose 3 (booster), single (Lot number: EL0140) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: pfizer covid vaccine (Dose Number: 2, Batch/Lot No: EL3302), administration date: 21Feb2021, when the patient was 26-year-old, for COVID-19 Immunization; pfizer covid vaccine (Dose Number: 1, Batch/Lot No: EL0140), administration date: 12Jan2021, when the patient was 26-year-old, for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 12Jun2022, outcome "not recovered", described as "body ache"; RHINORRHOEA (non-serious) with onset 12Jun2022, outcome "not recovered", described as "runny nose"; OROPHARYNGEAL PAIN (non-serious) with onset 12Jun2022, outcome "not recovered", described as "sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of rhinorrhoea, oropharyngeal pain, pain.  Additional information: The patient did not have COVID prior vaccination. COVID was tested post vaccination.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Pain, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: COVID positive; COVID positive; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: EL0140), on 21Feb2021 as dose 2, single (Lot number: EL3302) and on 04Nov2021 as dose 3 (booster), single (Lot number: EL0140) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 12Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 12Jun2022, outcome "not recovered" and all described as "COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19. Clinical information: Facility type vaccine: pharmacy or drug store. The patient had not received other vaccine in four weeks of vaccination. The patient had not received other medications in two weeks of vaccination. Patient had not covid prior vaccination. The patient covid tested post vaccination. Adverse event: COVID positive, runny nose, sore throat, body ache.; 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: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID positive; COVID positive; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: EL0140), on 21Feb2021 as dose 2, single (Lot number: EL3302) and on 04Nov2021 as dose 3 (booster), single (Lot number: EL0140) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 12Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 12Jun2022, outcome "not recovered" and all described as "COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19. Clinical information: Facility type vaccine: pharmacy or drug store. The patient had not received other vaccine in four weeks of vaccination. The patient had not received other medications in two weeks of vaccination. Patient had not covid prior vaccination. The patient covid tested post vaccination. Adverse event: COVID positive, runny nose, sore throat, body ache.; 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: 42.0
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) (Nurse) from product quality group. The reporter is the patient. A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2022 as dose 2, single (Lot number: EL9266), in left arm and on 18May2022 as dose 3 (booster), single (Lot number: FM0173) at the age of 42 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: "Autoimmune disorder" (unspecified if ongoing); "known allergies: Lime" (unspecified if ongoing), notes: known allergies: Lime. Concomitant medication(s) included: HUMIRA; CELEBREX. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Patient received Paxlovid from 31May2022 to 05Jun2022 for the treatment of COVID-19. 2 days after completion patient started experiencing worsening symptoms like first few days following Covid diagnosis. Extreme nausea, headache and body aches during treatment. Sender's Comments: Considering the nature of the reported events and product profile, a causal role of the suspect BNT162B2 cannot be denied for the reported events.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Postural orthostatic tachycardia syndrome
Clinical narrative: I developed Postural Orthostatic Tachycardia; Dysautonomia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunization. The patient's relevant medical history included: "allergies" (unspecified if ongoing); "Allergy to gold" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Titanium dioxide, reaction(s): "known allergies titanium dioxide". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: Apr2021, when the patient was 47 years old, for Covid-19 immunization. The patient was neither diagnosed with covid-19 prior vaccination, nor been tested with covid post vaccination. The following information was reported: AUTONOMIC NERVOUS SYSTEM IMBALANCE (disability) with onset May2021, outcome "recovering", described as "Dysautonomia"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (disability) with onset May2021, outcome "recovering", described as "I developed Postural Orthostatic Tachycardia". The events "i developed postural orthostatic tachycardia" and "dysautonomia" required physician office visit. The patient stated that she has been symptomatic for a year. Therapeutic measures were taken as a result of postural orthostatic tachycardia syndrome, autonomic nervous system imbalance by change in diet and a specific exercise program.  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: Poor quality product administered, Product administration error
Clinical narrative: received the Pfizer-COVID-19 vaccine gray cap and it was left out of the fridge for 48 hours; received the Pfizer-COVID-19 vaccine gray cap and it was left out of the fridge for 48 hours; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 44-year-old male patient 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: PRODUCT ADMINISTRATION ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "received the Pfizer-COVID-19 vaccine gray cap and it was left out of the fridge for 48 hours".  Additional information: NDC number of Covid 19 vaccine; Grey Cap was not provided. The reporter was looking for clarification related to GSOP form sent previously, for a Pfizer Covid vaccine gray top, temperature excursion, and subsequent inadvertent vaccination of a 44 year old patient. The reporter confirmed the previous information that the online recommendations say, 'Revaccinate the patient immediately', but like to confirm that information. The reporter said they accidentally administered a dose from a vial that had been left out for 48 hours, so well past the window, they are wondering what to do next. The guidelines online, he believed, said that the patient should get a new dose immediately; asks if this was accurate. The reporter declined to complete the safety report, as he does not have the patient there at this time and there was no adverse event for the patient.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, 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) from product quality.  An 84-year-old male patient received BNT162b2 (BNT162B2), on 05Oct2021 at 16:00 as dose 3 (booster), single (Lot number: FF2590) at the age of 84 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: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL oral taken for hypertension, start date: 01Jan2018. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 including oral paxlovid (Lot number: 69530) from 10Jun2022. Investigation results received from product quality group on 14Jun2022, Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot FF2590 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FF2590, fill lot FF2559, and the bulk formulated drug product lot FE5320. 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. Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Eye infection, Eye irritation
Clinical narrative: irritation in outer upper corner of left eye; eye infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46-year-old male patient received BNT162b2 (BNT162B2), on 02Jun2022 at 16:00 as dose 2, single (Lot number: FJ4991) at the age of 46 years, in left arm for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single, Batch/Lot No: FM0173, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 06May2022, when the patient was 46-year-old, for Covid-19 Immunization. The following information was reported: EYE INFECTION (non-serious) with onset 03Jun2022 at 08:00, outcome "not recovered"; EYE IRRITATION (non-serious) with onset 03Jun2022 at 08:00, outcome "not recovered", described as "irritation in outer upper corner of left eye". The events "irritation in outer upper corner of left eye" and "eye infection" required physician office visit. Therapeutic measures were taken as a result of eye irritation, eye infection. Additional information: The patient had no other vaccine in four weeks and no other medications in two weeks. Day after dose 2, irritation in outer upper corner of left eye. over the next 5 days irritation persisted and developed an eye infection. Doctor or other healthcare professional office/clinic visited. The patient was treated with .prescription of antibiotics. The Patient did not have covid prior vaccination and was not tested for covid post vaccination. No Known allergies and no other medical history.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Body mass index, 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 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 as dose 3(booster) , single (Lot number: FP4554) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 09Nov2021 as dose 2, single (Lot number: 048C21A), in left arm for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 19Mar2021 as dose 1, single (Lot number: 1805020), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BMI" (unspecified if ongoing); "Sulpher based antibotics" (unspecified if ongoing). The patient's concomitant medications were not reported. 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: Body mass index: (unspecified date) High; SARS-CoV-2 test: (09Jun2022) Positive; (13Jun2022) Positive; (02Jun2022) Negative; (03Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 as dose 3(booster) , single (Lot number: FP4554) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 09Nov2021 as dose 2, single (Lot number: 048C21A), in left arm for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 19Mar2021 as dose 1, single (Lot number: 1805020), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BMI" (unspecified if ongoing); "Sulpher based antibotics" (unspecified if ongoing). The patient's concomitant medications were not reported. 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: Body mass index: (unspecified date) High; SARS-CoV-2 test: (09Jun2022) Positive; (13Jun2022) Positive; (02Jun2022) Negative; (03Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.
Age: 45.0
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 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 30Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Nov2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Interchange of vaccine" (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 "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for 15 days. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Anti-viral Product for COVID-19 Treatment, Brand Paxlovid, treatment start date 01Jun2022, treatment stop date 05Jun2022. Patient tested positive for 15 days still have symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Hypersensitivity, Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: tested Ag positive 09Jun2022; tested Ag positive 09Jun2022; sx mild ST and congestion allergies 08Jun; sx mild ST and congestion allergies 08Jun; sx mild ST and congestion allergies 08Jun; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 24-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3247), on 18Feb2021 as dose 2, single (Lot number: EL3247) and on 11Jan2022 as dose 3 (booster), single (Lot number: FF2589) at the age of 24 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious), NASAL CONGESTION (non-serious), HYPERSENSITIVITY (non-serious) all with onset 08Jun2022, outcome "unknown" and all described as "sx mild ST and congestion allergies 08Jun"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jun2022, outcome "unknown" and all described as "tested Ag positive 09Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jun2022) Positive, notes: COVID test post vaccination COVID test type post vaccination=Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, oropharyngeal pain, nasal congestion, hypersensitivity. 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 between the event, vaccination failure and Covid 19 and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: tested Ag positive 09Jun2022; tested Ag positive 09Jun2022; sx mild ST and congestion allergies 08Jun; sx mild ST and congestion allergies 08Jun; sx mild ST and congestion allergies 08Jun; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 24-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3247), on 18Feb2021 as dose 2, single (Lot number: EL3247) and on 11Jan2022 as dose 3 (booster), single (Lot number: FF2589) at the age of 24 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious), NASAL CONGESTION (non-serious), HYPERSENSITIVITY (non-serious) all with onset 08Jun2022, outcome "unknown" and all described as "sx mild ST and congestion allergies 08Jun"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jun2022, outcome "unknown" and all described as "tested Ag positive 09Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jun2022) Positive, notes: COVID test post vaccination COVID test type post vaccination=Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, oropharyngeal pain, nasal congestion, hypersensitivity. 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 between the event, vaccination failure and Covid 19 and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Age: 50.0
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 contactable reporter(s) (Nurse). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 19Feb2021 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 50 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: "Pneumonia", start date: Aug2020 (unspecified if ongoing), notes: Pneumonia Aug2020, 2015; "COVID19", start date: Aug2020 (unspecified if ongoing); "Tinnitus", start date: Aug2020 (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". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event, Drug ineffective and Covid 19 and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Headache, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Nurse). A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EL3247), on 06Apr2021 as dose 2, single (Lot number: EL3247) and on 08Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 45 years for Covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jun2022, outcome "unknown" and all described as "PCR"; DYSPNOEA (non-serious), HEADACHE (non-serious), SNEEZING (non-serious), COUGH (non-serious) all with onset 10Jun2022, outcome "unknown" and all described as "SX of SOB HA sneezing and coughing". The events "PCR" and "SX of SOB has sneezing and coughing" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jun2022) Positive, notes: COVID test type post vaccination: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, Covid-19, dyspnoea, headache, sneezing, cough. Device timestamp: 13Jun2022. 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 between the event, vaccination failure and Covid 19 and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing, Vaccination failure
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Nurse). A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EL3247), on 06Apr2021 as dose 2, single (Lot number: EL3247) and on 08Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 45 years for Covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jun2022, outcome "unknown" and all described as "PCR"; DYSPNOEA (non-serious), HEADACHE (non-serious), SNEEZING (non-serious), COUGH (non-serious) all with onset 10Jun2022, outcome "unknown" and all described as "SX of SOB HA sneezing and coughing". The events "PCR" and "SX of SOB has sneezing and coughing" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jun2022) Positive, notes: COVID test type post vaccination: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, Covid-19, dyspnoea, headache, sneezing, cough. Device timestamp: 13Jun2022. 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 between the event, vaccination failure and Covid 19 and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Age: 59.0
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) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 03May2022 at 04:30 as dose 4 (booster), single (Lot number: FM9992) at the age of 59 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). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course- The patient previously received a COVID-19 Vaccine. There was list of other medications the patient received within 2 weeks of vaccination. Device Date: 13Jun2022  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 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: "high blood pressure" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; HYDROCHLOROTHIAZIDE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "recovered" (12Jun2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. No known allergies reported for the patient. 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: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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 infection". 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: Question: Caller was a patient also calling on behalf of her husband. Both have completed the 5-day treatment of Paxlovid and they were planning to get the second booster dose of Pfizer-BioNTech COVID-19 Vaccine this month (June). She wanted to know if they should wait some time after completing the Paxlovid treatment and before receiving the dose of the vaccine. There is no specific information on the timing of vaccination after the Paxlovid treatment. However, there is information about getting a dose of the vaccine after a diagnosis of COVID-19 infection. Caller also wanted to know if we had information about the COVID-19 rebound effect after the Paxlovid treatment. Pfizer cannot assess causality between the Paxlovid treatment and the COVID-19 rebound effect yet. At this time, there is no information regarding this topic described in the Prescribing Information or other resources from Pfizer. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (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 2, single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing). Concomitant medication(s) included: TRI-SPRINTEC. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Indication: No known allergies. Treatment of COVID-19 with Brand Paxlovid. Treatment started date from 31May2022 to 05Jun2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.