chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
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.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: Rebound of covid symptoms on 25May2022 after completing paxlovid on 20May2022 with floridly positive antigen test; (22May2022) negative, notes: Rebound of covid symptoms on 25May2022 after completing paxlovid on 20May2022 with floridly positive antigen test after being faint/negative the 3 days prior to rebound symptoms; (22May2022) faint, notes: Rebound of covid symptoms on 25May2022 after completing paxlovid on 20May2022 with floridly positive antigen test after being faint/negative the 3 days prior to rebound symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Known allergies: No. The patient received treatment (Conservative/supportive management) drug Paxlovid with start date 16May2022 and stop date 20May2022 for the indication of Treatment of COVID-19.  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 between the reported events: "Drug ineffective", "COVID-19" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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: Blood test, Body temperature, COVID-19, Drug ineffective, Magnetic resonance imaging
Clinical narrative: He received  3 shots of Pfizer vaccine (agent was not able to clarify if that was covid vaccine ) but stated he still got covid.; He received  3 shots of Pfizer vaccine (agent was not able to clarify if that was covid vaccine ) but stated he still got covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster) , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "stage 3 lung Cancer/stage 3B lung", start date: 1995 (unspecified if ongoing); "trachea cancer/trachea cancer necrosis", start date: 1995 (unspecified if ongoing), notes: inoperable; "no muscle mass", start date: 1999 (unspecified if ongoing); "could not walk", start date: 1999 (unspecified if ongoing); "skin cancer/skin necrosis" (unspecified if ongoing); "skin necrosis" (unspecified if ongoing); "voice was not clear/does not have "a lot of voice"" (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 20May2022, outcome "unknown" and all described as "He received  3 shots of Pfizer vaccine (agent was not able to clarify if that was covid vaccine ) but stated he still got covid.". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) Unknown results; Body temperature: (unspecified date) 99; (unspecified date) 104; (unspecified date) 102; (May2022) 102; (May2022) 97-98; Magnetic resonance imaging: (unspecified date) Unknown results; SARS-CoV-2 test positive: (20May2022) Positive; Ultrasound scan: (unspecified date) Unknown results; Urine analysis: (unspecified date) Unknown results; X-ray: (unspecified date) Unknown results. Therapeutic measures were taken as a result of covid-19 included Paxlovid tablet from 20May2022 to 24May2022 3 in the morning and 3 at night, 1 white tablet and 2 light pink with each dose.  Clinical course: Patient received 3 shots of the Pfizer Covid vaccine and he still got Covid. He took PAXLOVID for covid and his last dose was last night. PAXLOVID helped with fever from 102 to now its 97-98 degrees but he still had body aches, shoulder pain and neck  pain across the base of the neck, his fever gotten better but he had no energy. He still did not feel 100% better yet. He stated PAXLOVID did not help with the aches and pain in the body, shoulder and neck, he has that form covid time," part of the covid". Patient was coughing a lot during the conversation. He felt somewhat better but not a lot. Patient was a veteran and a cosmetologist.   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: SARS-CoV-2 test positive, Ultrasound scan, Urine analysis, X-ray
Clinical narrative: He received  3 shots of Pfizer vaccine (agent was not able to clarify if that was covid vaccine ) but stated he still got covid.; He received  3 shots of Pfizer vaccine (agent was not able to clarify if that was covid vaccine ) but stated he still got covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster) , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "stage 3 lung Cancer/stage 3B lung", start date: 1995 (unspecified if ongoing); "trachea cancer/trachea cancer necrosis", start date: 1995 (unspecified if ongoing), notes: inoperable; "no muscle mass", start date: 1999 (unspecified if ongoing); "could not walk", start date: 1999 (unspecified if ongoing); "skin cancer/skin necrosis" (unspecified if ongoing); "skin necrosis" (unspecified if ongoing); "voice was not clear/does not have "a lot of voice"" (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 20May2022, outcome "unknown" and all described as "He received  3 shots of Pfizer vaccine (agent was not able to clarify if that was covid vaccine ) but stated he still got covid.". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) Unknown results; Body temperature: (unspecified date) 99; (unspecified date) 104; (unspecified date) 102; (May2022) 102; (May2022) 97-98; Magnetic resonance imaging: (unspecified date) Unknown results; SARS-CoV-2 test positive: (20May2022) Positive; Ultrasound scan: (unspecified date) Unknown results; Urine analysis: (unspecified date) Unknown results; X-ray: (unspecified date) Unknown results. Therapeutic measures were taken as a result of covid-19 included Paxlovid tablet from 20May2022 to 24May2022 3 in the morning and 3 at night, 1 white tablet and 2 light pink with each dose.  Clinical course: Patient received 3 shots of the Pfizer Covid vaccine and he still got Covid. He took PAXLOVID for covid and his last dose was last night. PAXLOVID helped with fever from 102 to now its 97-98 degrees but he still had body aches, shoulder pain and neck  pain across the base of the neck, his fever gotten better but he had no energy. He still did not feel 100% better yet. He stated PAXLOVID did not help with the aches and pain in the body, shoulder and neck, he has that form covid time," part of the covid". Patient was coughing a lot during the conversation. He felt somewhat better but not a lot. Patient was a veteran and a cosmetologist.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: First positive test was on 05May2022; First positive test was on 05May2022; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 66-year-old male patient received BNT162b2 (BNT162B2), on 13Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing), notes: Other medical history: Coronary artery disease. Concomitant medication(s) included: METFORMIN; ATORVASTATIN; CARVEDILOL; CLOPIDOGREL; FINASTERIDE; PERINDOPRIL. Past drug history included: Piroxicam, reaction(s): "Known allergies: piroxicam", notes: Known allergies: piroxicam. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 05May2022, outcome "unknown", COVID-19 (medically significant) with onset 05May2022, outcome "not recovered" and all described as "First positive test was on 05May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05May2022) positive; (20May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: First positive test was on 05May. Started Paxlovid and completed it and felt better. Developed COVID symptoms again on 19May. Had another positive test on 20May.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.
Age: 64.0
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) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 06:30 PM as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 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: "lymphoma" (unspecified if ongoing), notes: Other medical history: lymphoma/follicular/DLBCL/HEP B carrier; "follicular" (unspecified if ongoing), notes: Other medical history: lymphoma/follicular/DLBCL/HEP B carrier; "DLBCL" (unspecified if ongoing), notes: Other medical history: lymphoma/follicular/DLBCL/HEP B carrier; "HEP B carrier" (unspecified if ongoing), notes: Other medical history: lymphoma/follicular/DLBCL/HEP B carrier; "Known allergies: Cat scan iodine" (unspecified if ongoing), notes: Known allergies: Cat scan iodine. Concomitant medication(s) included: VEMLIDY, start date: Jan2020, stop date: May2022. 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: (22May2022) negative; (25May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: The patient received Other medication in 2 weeks.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 29Dec2020 at 10:00 as dose 1, single (Lot number: EH9899), in left arm, as dose 2, single (Lot number: EL1283), in left arm and on 09Oct2021 at 14:15 as dose 3 (booster), single (Lot number: FF2589) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidaemia" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR, start date: Jan2020, stop date: 25May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Conclusion of Previously Completed Investigation: The complaint for 'Lack of Effect' of the PFIZER BIONTECH COVID-19 VACCINE lot FF2589, EL1283 and EH9899 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 FF2589, fill lot FF2558, and the bulk formulated drug product lot FE5318. The final scope included the reported finished goods lot EL1283, fill lot EL1281, and the formulated drug product lot EL1279. The final scope included the reported finished goods lot EH9899, the formulated drug product lot EH9782. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Batch and lot tested and found within specifications checked in product tab.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 69-year-old male patient received BNT162b2 (BNT162B2), on 31Jan2021 as dose 1, single (Batch/Lot number: unknown), on 23Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "hepatic steatosis" (unspecified if ongoing). Concomitant medication(s) included: FAMOTIDINE oral; PANTOPRAZOLE oral; ROSUVASTATIN oral, start date: 11May2022; LOSARTAN oral. Past drug history included: No, reaction(s): "Allergy".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: UNKNOWN. 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.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Drug ineffective and Covid 19 cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: Exposure during pregnancy, White blood cell count, White blood cell count abnormal
Clinical narrative: the baby was born without the white stuff. The baby was hospitalized and eventually discharged; a pregnant mom received a COVID-19 vaccine while pregnant where the baby was born without the white stuff; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), 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: WHITE BLOOD CELL COUNT ABNORMAL (hospitalization), outcome "unknown", described as "the baby was born without the white stuff. The baby was hospitalized and eventually discharged"; EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "a pregnant mom received a COVID-19 vaccine while pregnant where the baby was born without the white stuff". The patient underwent the following laboratory tests and procedures: White blood cell count: without the white stuff.  Clinical course: It was reported that a pregnant mom received a COVID-19 vaccine while pregnant where the baby was born without the white stuff. The baby was hospitalized and eventually discharged. They did not know if it was the Pfizer and Moderna COVID-19 vaccine.  Optional Information: Was given very limited info about this occupancy and the person reporting, had very little info on this event. They were not sure if this was the pfizer/BioNTech or Moderna COVID-19 vaccine. Event took place after use of product.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 38.0
Sex: M
Vaccine: 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).  A 39-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in May2021 as dose 2, single (Batch/Lot number: unknown), in right arm and in Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reportedly the patient was taking paxlovid and noted that he had a very bad taste in his mouth. He described it as metallic and felt most prominent on roof of mouth.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, 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) from product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 at 13:00 as dose 1, single (Lot number: EN6199), in left arm, on 25Mar2021 at 15:00 as dose 2, single (Lot number: EP6955), in left arm, on 10Sep2021 at 15:00 as dose 3 (booster), single (Lot number: FC3183), in left arm and on 07Apr2022 at 04:00 as dose 4 (booster), single (Lot number: F63527) at the age of 67 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course included No other medications in two weeks. No known allergies. Treatment for Covid-19 included Paxlovid.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot(s) EN6199, EP6955, FC3183 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(s) EN6199, EP6955, FC3183 fill lot(s) EN5331, EP6954, EY0555 and the formulated drug product lot(s) EN5320, EP6953, EP8657. 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
Symptoms: Blood glucose decreased
Clinical narrative: blood sugar has dropped; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 84-year-old male patient received BNT162b2 (COMIRNATY), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: BLOOD GLUCOSE DECREASED (non-serious), outcome "unknown", described as "blood sugar has dropped". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Reporter's 84 year old Diabetic brother in law also got the Pfizer Covid19 2nd booster vaccine on Monday and said that his blood sugar has dropped since getting it. Reporter is asking if this is a side effect of the booster vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 29.0
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 non-contactable reporter(s) (Physician). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL; IBUPROFEN; SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]. 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.  Clinical course: vaccine received and other medication with in in 2weeks received. No Known allergies  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive test; positive test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: Em6201), in left arm, on 24Mar2021 as dose 2, single (Lot number: Er2613), in right arm and on 07Oct2021 as dose 3 (booster), single (Lot number: Ff2589) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Immunodeficiency" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course included anti viral product: COVID 19 Treatment, brand was Pfizer Paxlovid, treatment from 12May2022 to 17May2022, indication was treatment of COVID-19. Conclusion: 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 FF2589, fill lot FF2558, and the bulk formulated drug product lo FE5318 and lot ER2613, fill lot EP8678, and the formulated drug product lot EP8565 and lot ER2613, fill lot EP8678, and the formulated drug product lot EP8565. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: vaccination failure; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jan2021 at 13:30 as dose 1, single (Lot number: EL3302) intramuscular, in left arm, on 03Feb2021 at 08:00 as dose 2, single (Lot number: EL8482), in left arm and on 24Aug2021 at 12:30 as dose 3 (booster), single (Lot number: FC3183) at the age of 67 years intramuscular, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Apr2022 at 11:00 as dose 4 (booster), single (Lot number: 002M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Peniciliin" (unspecified if ongoing); "HTN" (unspecified if ongoing); "DM" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN, start date: May2009; PANTOPRAZOLE, start date: May2006; FEXOFENADINE, start date: May1997; FLUTICASONE, start date: May1999; DOXYCYCLINE; ESTRING, start date: May2013. The following information was reported: COVID-19 (medically significant) with onset May2022, outcome "recovered", described as "COVID 19 Treatment"; VACCINATION FAILURE (medically significant) with onset May2022, outcome "recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Product investigation report received from product quality group on 25May2022. The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot FC3183 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 FC3183, fill lot EY0555, and the bulk formulated drug product lot EP8657. 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.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jul2021 as dose 1, single (Batch/Lot number: unknown), on 01Sep2021 as dose 2, single (Batch/Lot number: unknown) and on 15Jul2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing). Concomitant medication(s) included: PROPANOLOL [PROPRANOLOL], start date: Mar2022; ASPIRIN [ACETYLSALICYLIC ACID]. Past drug history included: Ppd, reaction(s): "Known allergies: PPD". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" (May2022) and all described as "COVID 19 Treatment". Paxlovid treatment start date was 04May2022 and treatment stop date was 09May2022 for treatment of COVID-19. Covid symptoms and a positive rapid test occurred after Paxlovid treatment and a negative rapid test. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: rapid test; Negative, notes: rapid test. 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 reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EL9265), on 22Feb2021 as dose 2, single (Lot number: EN6198), in left arm, on 24Sep2021 as dose 3 (booster), single (Lot number: EW0191), in left arm and on 05Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CRESTOR, start date: 07Aug2018; DULOXETINE, start date: Feb2012; AMABELZ, start date: Feb2019. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Positive, notes: Recurrence of Covid positive test, 3 days after a negative test following Paxlovid treatment; Negative, notes: Recurrence of Covid positive test, 3 days after a negative test following Paxlovid treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. clinical course : Anti viral product for COVID 19 Treatment, brand-Paxlovid, treatment start date-08May2022, treatment stop date-12May2022, indication-Treatment of COVID-19. Recurrence of Covid positive test, 3 days after a negative test following Paxlovid treatment. Symptoms are headache and fatique. This is a notification generated from the system. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lots FM0698, EW0191, EN6198 , EL9265 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 and products  type. The final scope included the reported finished goods lots FM0698, EW0191, EN6198 , EL9265 , fill lot EP8738, and bulk formulation lot EP8619. fill lot EN5330, and the formulated drug product lot EN5319, fill lot EL9256, and the formulated drug product lot EL9247.  A complaint samples  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.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: testing positive with COVID-19; testing positive with COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Birth Control" (unspecified if ongoing). Concomitant medication(s) received in 2 weeks included: AVIANE taken for contraception, start date: 01Jan2018; SPIRONOLACTONE, start date: 01Jan2020. Past drug history included: Aleve, reaction(s): "Known allergies: Aleve". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "testing positive with COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (May2022) Negative, notes: I tested negative on day 8, pcr and rapid; (16May2022) Positive, notes: testing positive again on day 12. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated with Paxlovid, treatment start date=11May2022, treatment stop date=16May2022. The patient was vaccinated, boosted and took Paxlovid upon symptom onset/testing positive with COVID-19. She tested negative on day 8, PCR and rapid, and felt much better. She began testing positive again on day 12. By day 13 symptoms returned - congestion, cough, stomach issues, etc. She was on day 14 and still feeling sick.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter (Physician).  A 47-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), on 07Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "migraine" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing); "Shellfish allergy" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE oral, start date: 18Mar2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (16May2022) negative, notes: Rebound Covid-19 infection 1 week later after testing negative on 16May. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid to treat vaccination failure, covid-19. Treatment start date: 12May2022, 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: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 42.0
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) (Physician). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Dec2020 as dose 1, single (Batch/Lot number: unknown), on 08Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 10Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: MERCAPTOPURINE, start date: 01Jan2000; ZOLOFT, start date: 13Oct2021. Past drug history included: Asacol, reaction(s): "known allergies Asacol", notes: known allergies Asacol. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2022, outcome "recovered" (01Apr2022) 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; (19Mar2022) Negative, notes: negative rapid antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Patient took Paxlovid from 14Mar2022 to 19Mar2022 for COVID 19 Treatment. Details were reported for Other medication in 2weeks product. Adverse event: Started paxlovid on day 1 of symptoms (fever, fatigue, sore throat, muscle aches). Near immediate improvement in all symptoms within 24-48 hours of starting paxlovid. Had a negative rapid antigen test in last day of taking paxlovid. 48 hours after stopping paxlovid had sore throat, cough, congestion. Not severe but lasted 4-7 days.  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 to product and the suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Lot number: EW0175) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (1st dose, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (2nd dose, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (unspecified date) Negative; (unspecified date) Unknown Results, notes: COVID 19 Treatment; (May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID treatment).
Age: 44.0
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 a contactable reporter(s) (Physician) from product quality group.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2021 at 12:00 as dose 1, single (Lot number: El1284), in left arm and on 27Jan2021 at 12:00 as dose 2, single (Lot number: El1282) at the age of 44 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Sep2021 at 12:00 as dose 3 (booster), single (Lot number: 009c21a), in right arm for covid-19 immunisation. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) positive, notes: On 19May2022 he got sick again, tested positive by antigen again; (25May2022) positive, notes: He finished on 25May2022. He is still testing positive for COVID antigen; (unspecified date) Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 (PAXLOVID treatment). Subsequently, the product quality complaint group via CITI reported that Conclusion: the complaint for Lack of Effect with the product for the COVID-19 Vaccine was investigated. The investigation included review of manufacturing records, analytical results at the time of lot release, retained reference samples, deviations, and complaint lot history trends. The final scope was limited to include the reported finished goods lot EL1284, fill lot EL1282, the bulk formulated drug product lot EL1280. No returned complaint sample was received. All deviation investigations performed during the manufacturing process of the lot were reviewed. The conclusion of all investigations confirmed there was no quality issue which would affect the quality of the lot. No root cause or CAPA were identified as the complaint was not confirmed.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 70.0
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) (Other HCP).  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "GERD" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "asthmatic bronchitis" (unspecified if ongoing); "lichen planus" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; PANTOPRAZOLE. Past drug history included: Actifed, reaction(s): "Known allergies"; Diclofenac, reaction(s): "Known allergies"; Voltaren, reaction(s): "Known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Positive, notes: 10 days after completing Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 including oral Paxlovid from 10May2022 to 15May2022. The patient had symptoms of rhinorrhea, positive rapid antigen test 10 days after completing Paxlovid treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.