chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Lateral flow test was positive/lingering cough, my head/nasal congestion returned with runny nose, worsening cough, and 100.3 temperature; Lateral flow test was positive/lingering cough, my head/nasal congestion returned with runny nose, worsening cough, and 100.3 temperature; This is a spontaneous report received from a contactable consumer from product quality group. The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Oct2021 as dose 3 (booster), single (Lot number: 32030BD) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as [dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26May2022, outcome "recovering" and all described as "Lateral flow test was positive/lingering cough, my head/nasal congestion returned with runny nose, worsening cough, and 100.3 temperature". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: After 2 negative lateral flow tests; Positive, notes: Lateral flow test was positive; Body temperature: 100.3. Therapeutic measures were taken as a result of drug ineffective, covid-19. No other medication received in 2weeks. Conclusion of previously completed investigation: The complaint for a Lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot 32030BD was investigated. The investigation included reviewing incoming quality and manufacturing batch records, deviation investigations, an analysis of the complaint history for the reported lot and product type and final release assay testing. This product is received as pre-formulated bulk and is manufactured, labeled and packaged by Pfizer. The final scope was determined to be lot 32030BD. No quality issues were identified during the investigation. There is no impact on product quality. An was not issued for the complaint. No regulatory notifications were held as a result of this complaint. The complaint condition of lack of 6706206 6690013 effect was not confirmed, therefore the root cause cannot be attributed to manufacture or vendor processes. The root cause was not determined to be manufacture or vendor related as incoming quality component testing and the results of all analytical tests performed at the time of lot release confirmed that the batch met potency specifications. No corrective or preventative actions are required as the complaint condition was not determined to be manufacture or vendor related and there are quality systems in place to detect defects prior any lot being released to the market. No further investigation required.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 22Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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 results. Therapeutic measures taken as a result of the event included paxlovid from 16May2022 to 20May2022.   Product Quality provided investigational results on 01Jun2022 for BNT162b2: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 7142695 (see File attachment in this investigation record) The complaint for "PFIZER- BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FM9992. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a 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 26Apr2021 as dose number unknown, single (Lot number: EN6198) at the age of 67 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Acute sinus infection with positive Covid result" (unspecified if ongoing), notes: Acute sinus infection with positive, Covid result. Concomitant medication(s) included: PRAVASTATIN, start date: 02Jan2006, stop date: 11May2022 (lot: 35802170003, also reported as APOTEX); OMEPRAZOLE, start date: 03Jan2005, stop date: 15May2022(lot: 36036227450003, also reported as Dr. Private); VITAMIN D NOS, start date: 02Jan2012 (lot: 108180, also reported as Unknown Molecular Products); MAGNESIUM, start date: 01Jan2020 (lot: 250180, also reported as 250180). 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: Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional information: On 01Jun2022 the product quality group reported investigation results. It was concluded that: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EN6198 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 EN6198, fill lot EN5330, and the formulated drug product lot EN5319. 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. Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event Drug ineffective and Covid-19 cannot be completely excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I have COVID; I have COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID: (005570). The reporter is the patient.  An 81-year-old female patient received BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 29Jul2021 as dose 2, single (Lot number: EN5318), in left arm, on 07Sep2021 as dose 3 (booster), single (Lot number: FE3592, Expiration Date: 04Oct2021), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FK9893, Expiration Date: 17Jun2022) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "breast cancer" (unspecified if ongoing), notes: anastrozole 1mg for breast cancer 2 years ago. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "I have COVID". The patient underwent the following laboratory tests and procedures: Body temperature: (2022) 101 and 102; SARS-CoV-2 test: (unspecified date) Negative, notes: she tested negative and she had to test negative; (unspecified date) Positive, notes: did a home test an d the test was positive; (2022) Positive, notes: had a PCR and that was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The patient reported that she have COVID and took Paxlovid fir 5 days. The patient have been vaccinated and double boosted and have had a relapse of symptoms after 10 days with fever, congestion and body aches.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Covid 19 Treatment; Covid 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group.  An adult female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH MRNA COVID-19 VACCINE), on 30Dec2020 as dose 1, single (Lot number: EL1284), on 20Jan2021 as dose 2, single (Lot number: EL9262) and on 17Aug2021 as dose 3 (booster), single (Lot number: EW0191) for covid-19 immunisation. The patient's relevant medical history included: "SLE" (unspecified if ongoing); "Sjogrens" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL, start date: 23May2022; IBUPROFEN, start date: 23May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Based on product investigation results, 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.  Based on product investigation results, the complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot EL9262 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 EL9262, fill lot EL9253, and the formulated drug product lot EL9244. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. 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.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event Drug ineffective and Suspected Covid 19 cannot be completely excluded.
Age: 71.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Apr2022 as dose 4 (booster), single (Lot number: 048L21A), in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history was not reported. The patient had no known allergies. There were no concomitant medications. Other medication in 2 weeks was reported as no. 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: Positive, notes: Rapid Covid-19 antigen test was positive. Therapeutic measures were taken as a result of covid-19. Anti-viral details: product: COVID 19 Treatment, Brand: Pfizer.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2020 at 11:00 as dose 1, single (Lot number: EH9899), in right arm, on 07Jan2021 at 16:00 as dose 2, single (Lot number: EH9899), in right arm and on 30Sep2021 at 17:00 as dose 3 (booster), single (Lot number: FE3592) at the age of 57 years, in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTRADIOL. 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: (25May2022) Negative, notes: Tested negative on 25May; (27May2022) Positive, notes: Tested positive again on 27May. Therapeutic measures were taken as a result of vaccination failure, covid-19.  clinical course: Felt much better on 24May. Tested negative on 25May. Started feeling sick again on 26May. Tested positive again on 27May.  Information from Product Complaint Team, provided from division agency includes conclusion of Investigation for lot# EH9899 and lot# FE3592 respectively.Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot# EH9899 and lot# FE3592 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# EH9899 and lot# FE3592 , fill lot EH9783, FF2553, and the formulated drug product lot EH9782, FA9141 respectively. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Cardiac disorder
Clinical narrative: my heart has become weaker and to the point that last week; two week from now, I got a pacemaker;  I have had bypass surgery, I had stent; my heart has become weaker and to the point that last week; two week from now, I got a pacemaker;  I have had bypass surgery, I had stent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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: "bypass surgery" (unspecified if ongoing); "stent" (unspecified if ongoing); "pacemaker" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (medically significant), ASTHENIA (non-serious), outcome "unknown" and all described as "my heart has become weaker and to the point that last week; two week from now, I got a pacemaker;  I have had bypass surgery, I had stent". Therapeutic measures were taken as a result of cardiac disorder, asthenia.  Clinical course : Consumer stated, "Just curiosity, more than any kind, we have taken three of the Pfizer COVID-19 shots, very thankful for those to be out, but at the same time in the last couple of years my heart has become weaker and to the point that last week; two week from now, I got a pacemaker now, I have had bypass surgery, I had stent but it seems that in the  last couple of years other things happening related to my heart and I am not trying to do anything other than to wave a little flag and saying this is happening to me and if it is of any help to Pfizer, to know this and to follow up on it with my heart doctor. I would be more than glad to give information." When probed vaccine name: Consumer stated, "It is the COVID-19 shot. I do have my record so." When probed if consumer wants Pfizer to follow up with doctor: Consumer stated, "If that is the best time for you to do. I am trying to make Pfizer aware of this and if it is something that you have seen and heard about  then yes. I would like for you to follow up with my doctor to see if they can help and prove the drug in the future. You know that thing." Consumer was informed about the role of Pfizer Drug Safety and Pfizer medical information department and offered the number.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: testes positive for covid after; testes positive for covid after; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA 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: "Interchange of vaccine" (not ongoing), notes: 1st, 2nd (moderna vaccines) and boosted from Pfizer . The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "testes positive for covid after". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Call was answered by consumer (patient wife). Consumer does not wish to be contacted any further. Reporter also stated "Both she and her husband have been vaccinated with 1st, 2nd (moderna vaccines) and boosted from Pfizer and both tested positive for covid after. They are fine now. They also took Paxlovid and it helped to recover faster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : 202200650609 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chills, Drug ineffective, Lethargy
Clinical narrative: Tested positive on antigen test. Received Pfizer booster in Oct2021; Tested positive on antigen test. Received Pfizer booster in Oct2021; Experienced fever 102, chills and lethargic; Experienced fever 102, chills and lethargic; Experienced fever 102, chills and lethargic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 46-year-old female patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive on antigen test. Received Pfizer booster in Oct2021"; LETHARGY (non-serious), PYREXIA (non-serious), CHILLS (non-serious), outcome "unknown" and all described as "Experienced fever 102, chills and lethargic". The patient underwent the following laboratory tests and procedures: Body temperature: 102; SARS-CoV-2 test: positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Tested positive on antigen test. Received Pfizer booster in Oct2021; Tested positive on antigen test. Received Pfizer booster in Oct2021; Experienced fever 102, chills and lethargic; Experienced fever 102, chills and lethargic; Experienced fever 102, chills and lethargic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 46-year-old female patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive on antigen test. Received Pfizer booster in Oct2021"; LETHARGY (non-serious), PYREXIA (non-serious), CHILLS (non-serious), outcome "unknown" and all described as "Experienced fever 102, chills and lethargic". The patient underwent the following laboratory tests and procedures: Body temperature: 102; SARS-CoV-2 test: positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Benign neoplasm of thyroid gland, Fatigue, Pain
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4410179-00. A 61-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, (booster) single (Batch/Lot number: unknown) at the age of 60 years intramuscular, as dose 2, single (Batch/Lot number: unknown) and on 01Apr2021 as dose 1, single (Batch/Lot number: unknown) intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BENIGN NEOPLASM OF THYROID GLAND (medically significant), outcome "recovered", described as "had 50 percent of thyroid removed it was benign"; FATIGUE (medically significant), outcome "recovered"; PAIN (medically significant), outcome "recovered", described as "body soreness". The action taken for adalimumab was unknown. Clinical Information: It was unknown if patient was enrolled in a Covid-19 vaccine trial. Causality assessment for the events fatigue and body soreness by vaccine BNT162B2 was reported to be possible. Regulatory Authority opinion is the event of THYROID BENIGN is not assessable. Regulatory Authority's opinion is that there is no reasonable possibility that the events of VACCINE CAUSED FATIGUE and VACCINE CAUSED BODY SORENESS are related to HUMIRA (ADALIMUMAB). The reporter's assessment of the causal relationship of "had 50 percent of thyroid removed it was benign", "fatigue" and "body soreness" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. 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 available information in the case, the causal association between the events Benign neoplasm of thyroid gland, Fatigue, General body pain and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). An 11-year-old male patient received BNT162b2 (BNT162B2), on 27May2022 at 06:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 11 years intramuscular for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown; Route of administration: unknown), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown; Route of administration: unknown), for COVID-19 Immunization. The following information was reported: MIGRAINE (non-serious) with onset 27May2022 at 22:00, outcome "recovered" (May2022), described as "Child got a migraine about 16 hours after receiving his booster (3rd dose) of the vaccine.". Therapeutic measures were taken as a result of migraine. Additional information: Child got a migraine about 16 hours after receiving his booster (3rd dose) of the vaccine. He took Tylenol and felt better after about an hour. The previous doses did not result in a headache. The patient did not test positive for COVID-19 prior or since having had the vaccine. 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: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Lot number: el0142), in left arm, on 15Jan2021 as dose 2, single (Lot number: el3247), in right arm and on 28Sep2021 as dose 3 (booster), single (Lot number: ff8839) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: antigen positive since symptoms unto present. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient did not have any other medication in 2 weeks. The patient started Paxlovid on 17May2022 for Covid-19 and stopped the treatment on 22May2022.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 28Dec2020 as dose 1, single (Lot number: EK5730), in right arm, on 19Jan2021 as dose 2, single (Lot number: EL1283), in right arm and on 07Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Benign prostatic hyperplasia" (unspecified if ongoing); "allergies to Sulfa" (unspecified if ongoing); "allergies to penicillin" (unspecified if ongoing); "Allergy to iodine" (unspecified if ongoing); "Allergy to shell fish" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN; FISH OIL; VITAMIN D3. 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. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, covid-19 and the suspect drug BNT162B2 cannot be excluded.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 71 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: "Asthma" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing), notes: high blood pressure; "herniated disc L4" (unspecified if ongoing), notes: herniated disc L4. Concomitant medication(s) included: AMLODIPINE BESYLATE, start date: 01Jan2022, stop date: 01Jun2022. 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.  Additional information: Report about covid treatment: Yes. Reporter type: Patient. If vaccine received: Yes. Other medication in 2weeks: Yes.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: vacciantion faliure; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 20Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: SUMATRIPTAN; VENLAFAXINE; MELATONIN; AREDS 2 VISUAL ADVANTAGE; TRAZODONE. Vaccination history included: moderna coviD-19 vaccine (Dose: 1, Lot # 025A21A), administration date: 01Mar2021, for covid-19 immunization; moderna coviD-19 vaccine (Dose: 2, Lot# 028A21A), administration date: 29Mar2022, for covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "vacciantion faliure"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Unknown results. Therapeutic measures were taken as a result of covid-19.  Clinical information: The patient received other medications in 2 weeks, anti viral details are for covid-19 treatment Paxlovid with start date 25may2022 and stop date was 29may2022 for the treatment of covid-19. positive antigen test on following negative antigen test.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Fatigue, Headache, Nasal congestion
Clinical narrative: Positive COVID test; Positive COVID test; fatigue; nasal congestion; runny nose; headache; loss of sense of smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 35-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: ER8731), in left arm and on 27Apr2021 as dose 2, single (Lot number: EW0167) at the age of 34 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "diabetes" (unspecified if ongoing). Concomitant medication(s) included: TRULICITY; LEVOMIR; METFORMIN; JARDIANCE; ROSUVASTATIN; LOSARTAN. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 31May2022, outcome "recovering" and all described as "Positive COVID test"; FATIGUE (non-serious) with onset 31May2022, outcome "recovering"; HEADACHE (non-serious) with onset 31May2022, outcome "recovering"; ANOSMIA (non-serious) with onset 31May2022, outcome "recovering", described as "loss of sense of smell"; NASAL CONGESTION (non-serious) with onset 31May2022, outcome "recovering"; RHINORRHOEA (non-serious) with onset 31May2022, outcome "recovering", described as "runny nose". The events "positive covid test", "fatigue", "nasal congestion", "runny nose", "headache" and "loss of sense of smell" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Positive, notes: covid test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of covid-19, vaccination failure, fatigue, nasal congestion, rhinorrhoea, headache, anosmia.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID test; Positive COVID test; fatigue; nasal congestion; runny nose; headache; loss of sense of smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 35-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: ER8731), in left arm and on 27Apr2021 as dose 2, single (Lot number: EW0167) at the age of 34 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "diabetes" (unspecified if ongoing). Concomitant medication(s) included: TRULICITY; LEVOMIR; METFORMIN; JARDIANCE; ROSUVASTATIN; LOSARTAN. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 31May2022, outcome "recovering" and all described as "Positive COVID test"; FATIGUE (non-serious) with onset 31May2022, outcome "recovering"; HEADACHE (non-serious) with onset 31May2022, outcome "recovering"; ANOSMIA (non-serious) with onset 31May2022, outcome "recovering", described as "loss of sense of smell"; NASAL CONGESTION (non-serious) with onset 31May2022, outcome "recovering"; RHINORRHOEA (non-serious) with onset 31May2022, outcome "recovering", described as "runny nose". The events "positive covid test", "fatigue", "nasal congestion", "runny nose", "headache" and "loss of sense of smell" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Positive, notes: covid test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of covid-19, vaccination failure, fatigue, nasal congestion, rhinorrhoea, headache, anosmia.
Age: 34.0
Sex: F
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 product quality group. The reporter is the patient. A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN5318) and on 23Feb2021 as dose 2, single (Lot number: EN5318) at the age of 34 years for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient had no Covid prior vaccination. There were no concomitant medications. The patient had no other vaccine in four weeks and no other medications in two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" and all described as "COVID-19 breakthrough infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, Covid-19. Patient was not feeling great at the end of last week through the weekend so was focused on resting. Her case was mild so in her head she was thinking the vaccine was doing what it is supposed to!
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: ep6965), in right arm, on 06Apr2021 as dose 2, single (Lot number: ER2789), in right arm and on 20Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 50 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30May2022 at 13:00, outcome "recovered" (2022) and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical Course: Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.; 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL3247), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6203), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: EW0186), in left arm and on 04May2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 57 years, in left arm, all intramuscular for Covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Anxiety/Depression" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; ATORVASTATIN; PRISTIQ; METFORMIN; AMLODIPINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31May2022 at 09:00, outcome "not recovered" and all described as "Had a positive COVID test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (31May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, Covid-19. Clinical Information: Reporter stated, Age group as adult (18-64 Years). Current age is reported 47, Patient received More than 3 doses, No other vaccine in four weeks, Other medications in two weeks was Losartan, Atorvastatin, Pristiq, Metformin, Amlodipine. Adverse event reported as, Had a positive COVID test. Experiencing congestion, sore throat, knee joint pain and leg muscle pain, Adverse event started on 31May2022, 09:00 AM, patient was Not recovered, No treatment AE, No Covid prior vaccination, Covid tested post vaccination. Covid test type post vaccination was Nasal Swab, Covid test name post vaccination was reported as Unknown, Covid tested on 31May2022 and Covid test result was Positive. Known allergies reported as, Sulfa and Other medical history was Diabetes, High Blood Pressure, Anxiety/Depression. No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: infected with COVID-19; infected with COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 31-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) at the age of 30 years for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The patient was infected with COVID-19 as he tested positive in a covid test via nasal swab on 27May2022 at 6pm. The patient did not had Covid prior to vaccination. The patient did not receive treatment for the event of covid-19. The outcome of the event was recovering. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Bone neoplasm, Hypersomnia
Clinical narrative: a swollen lump on my left collar bone; I was in bed for about 5 days sleeping 18-24 hours a day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSOMNIA (non-serious) with onset Mar2021, outcome "unknown", described as "I was in bed for about 5 days sleeping 18-24 hours a day"; BONE NEOPLASM (non-serious) with onset Mar2021, outcome "unknown", described as "a swollen lump on my left collar bone". Additional information: The patient reported that, On 07Mar2021 he took his first vaccine and was in bed for about 5 days sleeping 18-24 hours a day and a swollen lump on his left collar bone. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
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 56-year-old male patient received BNT162b2 (BNT162B2), on 20Dec2021 at 19:00 as dose 3 (booster), single (Lot number: 33033BD) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Tetracycline, reaction(s): "known allergy: tetracycline"; Dexamethasone, reaction(s): "known allergy:dexamethasone"; Clindamycin, reaction(s): "known allergy:clindamycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information: The patient received vaccine. The patient did not received any other medication in 2 weeks. The patient took anti-viral for COVID-19 treatment brand=Paxlovid, treatment start date=20May2022, treatment stop date=24May2022,and lot number=GA2268. Adverse event: When retired to bed, bright flash of light occurs (like when lightening occurs in nature at night) that wakes the patient up at least 4-5 times a night, only to find that there is no lightening or flash. This began the day the patient started Paxlovid. Have reported to PCP. Adverse event start date: 20May2022. Adverse event start time: 23:00 . If patient recovered: Not recovered. If treatment ae: Unknown  No follow-up attempts are possible. No further information is expected.