chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory disorder, SARS-CoV-2 test
Clinical narrative: respiratory; sore throat; ear infection; congestion; cough; cough progressively worsened and became productive; low grade fever; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 15-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2022 as dose 3 (booster), single (Lot number: FL3209) at the age of 15 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DOXYCYCLINE taken for acne. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Site of injection: L. arm (Left Arm), Covid-19 Vaccine name: Pfizer, Batch/Lot number: EW0167), administration date: 17May2021, when the patient was 14-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Site of injection: L. arm (Left Arm), Covid-19 Vaccine name: Pfizer, Batch/Lot number: EW0191), administration date: 09Jun2021, when the patient was 14-year-old, for COVID-19 Immunization. The following information was reported: COUGH (non-serious) with onset 09May2022, outcome "unknown"; PRODUCTIVE COUGH (non-serious) with onset 09May2022, outcome "unknown", described as "cough progressively worsened and became productive"; PYREXIA (non-serious) with onset 09May2022, outcome "unknown", described as "low grade fever"; NASAL CONGESTION (non-serious) with onset 18May2022, outcome "unknown", described as "congestion"; EAR INFECTION (non-serious) with onset 20May2022, outcome "unknown"; RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "respiratory"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: It was unknown whether patient have Sars-CoV2 antibodies at diagnosis. The patient was not hospitalized. The patient was not admitted to an intensive care unit. The patient did not display clinical signs at rest indicative of severe systemic illness. Patient had cough and sore throat during initial 10 days. Cough progressively worsened and became productive week of 09May2022. One day of low grade fever. Congestion began 18May2022 and ear infection documented 20May2022. Patient's outcome with Covid-19 was recovering. It was unknown from how many days from SARS-CoV2 diagnosis did it take before the SARS-CoV2 antigen test became negative. The patient was not a smoker/former smoker. The patient was taking other medication routinely prior to the event being reported which included: MVI, Doxycycline 50 mg 2 tab QD for acne. The patient did not have any pre-existing disease worsened during the SARS-CoV2 infection. The patient had not been treated with immunomodulating or immunosuppressing medication or received any other vaccines around the time of covid-19 vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: Pregnant :YES/Patient last menstrual period date: 08Nov2021; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "no" (unspecified if ongoing). Date of last menstrual period: 08Nov2021. The patient is expected to deliver a baby(s) on 15Aug2022. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Vaccine dose number=1,, Vaccine brand=Pfizer / BioNTech,, Vaccine brand unknown=False,, Vaccine administration date=May2021, Vaccine lot unknown=True,, Vaccine lot unknown_reason=Not available/provided to reporter at the time of report completion,, Vaccine dose number unknown=False,), administration date: May2021, when the patient was 35 years old, for COVID-19 Immunization; Bnt162b2 (Vaccine dose number=2,, Vaccine brand=Pfizer / BioNTech,, Vaccine brand unknown=False,, Vaccine administration date=Jun2021, Vaccine lot unknown=True,, Vaccine lot unknown_reason=Not available/provided to reporter at the time of report completion,, Vaccine dose number unknown=False,), administration date: Jun2021, when the patient was 35 years old, for Covid-19 immunization. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 08Nov2021, outcome "unknown", described as "Pregnant :YES/Patient last menstrual period date: 08Nov2021". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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), Program ID: Unknown. The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "I had the Covid back in 2020", start date: 2020 (unspecified if ongoing), notes: I had the Covid back in 2020. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "She already had the vaccine and she got Covid again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) positive, notes: tested yesterday and I had a positive result. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical Course: "She is calling with regards of the Covid where she already had the vaccine and she got Covid again". When clarified the concern, consumer stated, "Yes, I really I did want to know, because it did not say whether it is me. I had the Covid back in 2020. I had very bad. I was on the vent and everything. I got well from it and tested yesterday, and I had a positive result. I am fully vaccinated with booster, and I have an appointment to get the next booster shot next month. I wasn't not sure whether this medication was for somebody like me who is fully vaccinated and already had Covid at one time, severely. So, I don't know whether I am really going to be severe again and I do have underlying conditions. But with me being fully vaccinated and 'boostered' do I need take this medication? Is this medication for someone like me or is it someone who has not been 'boostered' or vaccinated, for them"? No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
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 30-year-old male patient received BNT162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster), single at the age of 29 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Rebound, notes: COVID-19 rebound after completing treatment. Therapeutic measures were taken as a result of covid-19, drug ineffective.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID with home test kit on 28May2022; Tested positive for COVID with home test kit on 28May2022; 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 54-year-old male patient received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 05Feb2021 as dose 2, single (Lot number: EL3248), in left arm and on 02Dec2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 54 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "diabetes mellitus (Type 2)" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "diastasis recti" (unspecified if ongoing), notes: diastasis recti; "Known allergies: sulfa" (unspecified if ongoing), notes: Known allergies: yes - sulfa, sulfamethoxazole, penicillins; "Known allergies: penicillins" (unspecified if ongoing), notes: Known allergies: yes - sulfa, sulfamethoxazole, penicillins. The patient's concomitant medications were not reported. Past drug history included: Sulfamethoxazole, reaction(s): "Known allergies: sulfamethoxazole,", notes: Known allergies: yes - sulfa, sulfamethoxazole, penicillins. The following information was reported: VACCINATION FAILURE (medically significant) with onset 28May2022, outcome "unknown", COVID-19 (medically significant) with onset 28May2022, outcome "recovering" and all described as "Tested positive for COVID with home test kit on 28May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Sep2021) Negative, notes: Nasal Swab; (18May2022) Negative, notes: Nasal Swab; (28May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Investigation result: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EL3248 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 EL3248, FF8841 fill lot EL3231, FF8835 and the formulated drug product lot EL3224, FA9156. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. An elderly female patient received BNT162b2 (BNT162B2), on 11Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 01Feb2021 as dose 2, single (Lot number: EL3249), in left arm and on 29Nov2021 as dose 3 [booster], single (Lot number: F48027 (as reported)), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "Breast Cancer (remission)" (unspecified if ongoing); "Pulmonary Embolism" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE, stop date: 10May2022; ASPIRIN 81, stop date: 10May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22May2022, outcome "recovering" and all described as "I got Covid again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test (COVID-19 test): (22May2022) Positive. Therapeutic measures (Monoclonal Infusion Therapy) were taken as a result of drug ineffective, Covid-19. Additional information: The patient started the Pfizer COVID-19 treatment from 10May2022 to 14May2022 then reported that on day 13, the patient got COVID again after taking the pills. On 02Jun2022, investigation results concluded that: The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot EL3246 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 EL3246, fill lot EL3229, and the formulated drug product lot EL3222. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 32-year-old male patient received BNT162b2 (BNT162B2), on 22Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 32 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: DAYQUIL, start date: 16May2022, stop date: 18May2022.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: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Other medication was provided within 2 weeks of vaccination. Paxlovid was given as a treatment form 17May2022 to 22May2022 for Covid-19. Investigational results reported: This is a notification generated from the gQTS system. As part of the simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS. AE Ref No. Unknown. Product Description (CR): Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1, Lot- (CR): FH8027. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FH8027 was investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FH8027, fill lot FH4340, and the bulk formulated drug product FH4348. 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. No follow-up attempts are possible. No further information is expected.
Age: 54.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pre diabetes" (unspecified if ongoing). No known allergies. There were no concomitant medications received in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment start date: 23May2022 and stop date- 28May2022. The patient was joyous, happy mood, energetic, lack of fever, euphoria, friendliness and talkative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52-year-old male patient received BNT162b2 (BNT162B2), on 14Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (COVID-19 VACCINE MODERNA), on 14Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing); "Gout" (unspecified if ongoing); "fatty liver" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: Pravachol; Zetia; Allopurinol. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Patient did take other medication in 2 weeks. Patient took Paxlovid as treatment for COVID-19 and treatment start date was 18May2022, and stop date was 22May2022. Covid was rebound 3 days after finishing Paxlovid. Symptoms (fever, aches, congestion) and positive test. The rapid home tests had been very light after Paxlovid and are now dark. Adverse events start date was 26May2022 and was not recovered without treatment. 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
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 02May2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 08Mar2021 as dose 1, single (Lot number: 001A21A), in right arm, on 05Apr2021 as dose 2, single (Lot number: 026821A), in left leg and on 23Aug2021 as dose 3 (booster), single (Lot number: 026821a), in right 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 24May2022, outcome "not recovered" 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; (24May2022) COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Pfizer Paxlovid. Conclusion of Previously Completed Investigation: 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 FK9893. 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. A Regulatory Authority (site withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. A Regulatory Authority 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: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 35-year-old male patient received BNT162b2 (BNT162B2), on 15Nov2021 at 20:30 as dose 3 (booster), single (Lot number: FH8027) at the age of 35 years for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 11Feb2021 at 19:00 as dose 1, single (Lot number: 015M20A) and on 11Mar2021 at 15:00 as dose 2, single (Lot number: 036A21A) for Covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "asthma" (unspecified if ongoing); "ulcerative colitis" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: Dextroamphetamine [Dexamphetamine]; Mesalamine Delayed Release; Mometasone Furoate; Fexofenadine HCL; Vitamin D [Vitamin D Nos]; Deplin [Calcium Levomefolate]; Dextroamphetamine [Dexamphetamine], stop date: 19May2022. Past drug history included: Ritalin, reaction(s): "Known allergies: Ritalin"; Zyrtec, reaction(s): "Known allergies: Zyrtec"; Cipro, reaction(s): "Known allergies: Cipro". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) positive; (26May2022) Negative; (27May2022) Negative; (28May2022) positive. Therapeutic measures were taken with Paxlovid as a result of drug ineffective, Covid-19. Clinical information: Patient received Other medication in 2 weeks included Multivitamin 2/D. Patient developed COVID-19 symptoms on 19May2022, tested positive on 20May2022, and started treatment with Paxlovid. Patient symptoms stopped and tested negative on 26May2022 and 27May2022. Patient symptoms returned and tested positive on 28May2022. Patient received Covid-19 treatment from 20May2022 to 22May2022. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FH8027 was investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FH8027, fill lot FH4340, and the bulk formulated drug product FH4348. A complaint sample was not returned. No related quality issues were identified during the investigation. There was 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 possible. No further information is expected.
Age: 65.0
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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 at 14:00 as dose 1, single (Lot number: EL9262), in left arm, on 12Feb2021 at 13:00 as dose 2, single (Lot number: EN 6201), in left arm and on 24Sep2021 at 13:00 as dose 3 (booster), single (Lot number: 30145B19), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing), notes: Other medical history: Allergies. There were no concomitant medications. 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: Negative, notes: Tested positive after 5 negative days; Positive, notes: Tested positive after 5 negative days. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: patient received anti viral Treatment as Paxlovid. for Covid-19. Start date of treatment is 17May2022 and treatment stop date is 22May2022. Upon follow up product complaint conclusion was added. Conclusion: As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to Unknown. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EN6201, 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 EN6201, fill lot EN5333, and the formulated drug product lot EN5322. 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. When more than one investigation is found in the family, the Conclusion field could result in repeating rows for the CR in the table. If the Conclusion is blank in the table above, then the investigation record is likely an Offline Contractor Investigation and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record. No follow up attempts are possible, no further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient received Paxlovid for COVID 19 Treatment; Patient received Paxlovid for COVID 19 Treatment; This is a spontaneous report received from a contactable healthcare professional (HCP) from product quality group. The reporter is the patient. A 53-year-old male patient received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history was not reported. Patient did not receive other medication in 2 weeks. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. It was reported that patient received Paxlovid for COVID-19 treatment from 19May2022 to 234May2022. Outcome of the events was unknown.   Product Quality Group provided investigational results on 01Jun2022 for Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1 (Lot#: FF8841): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FF8841 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 FF8841, fill lot FF8835, and the formulated drug product lot FA9156. 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 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: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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: "heart disease" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; ELIQUIS; LISINOPRIL. 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 were taken as a result of drug ineffective, covid-19 with paxlovid.  Additional information: I felt better taking paxlovid but got covid again 6 days after last dose. Treatment: Anti-viral details: [{product=COVID 19 Treatment, brand=Paxlovid, treatment start date=16May2022, treatment stop date=20May2022, indication=Treatment of COVID-19}]. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medication details: (other medication in 2weeks product=Eliquis, Lisinipril and Atavastin)   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01Apr2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 06Sep2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Apr2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Immunoglobulin A defficiency" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive any other medication in 2weeks. The patient recovered and tested negative with minor ongoing symptoms. After several days, on day 9 of start of symptoms, symptoms returned, and she began testing positive again. She was on day 18 of isolation. Doctor was unsure of rebound and considered it a severe case base on symptoms of continuing. She was asked to isolate for 21 days instead of the original 5/10.The patient received treatment Paxlovid from 11May2022 to 16May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 28.0
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) (Other HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 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: "Cavernous hemangioma" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "Known allergies: Spinach" (unspecified if ongoing); "Known allergies: Avocado" (unspecified if ongoing). 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 were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2 weeks. Patient was treated with Paxlovid from 25May2022 for 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: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 31-year-old [non-pregnant] adult female received COVID-19 immunization with the first dose of a COVID-19 VACCINE (manufacturer unknown, unspecified formulation; batch/lot and expiry information not provided) as a single dose via unspecified route on an unspecified date; and the second dose of BNT162B2 (solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route on 13Apr2021 (at 30-years-old). The patient had no relevant medical history and denied any known allergies or any other medications within two weeks of the vaccine. On an unspecified date in May2022, the patient experienced COVID-19. There was no laboratory testing reported. Treatment for the event included nirmatrelvir tablets; ritonavir tablets (PAXLOVID) from 17May2022 through 21May2022.  The outcome of the event was recovering.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 56-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 at 12:30 as dose 1, single (Lot number: EP6955), in left arm, on 07Apr2021 at 12:00 as dose 2, single (Lot number: EP6955), in left arm and on 16Oct2021 at 13:00 as dose 3 (booster), single (Lot number: FH8020) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Moderate persistent Asthma (well controlled)" (unspecified if ongoing); "Allergic rhinitis" (unspecified if ongoing); "Hyperlipemia" (unspecified if ongoing); "Laryngopharyngeal reflux (LPR)" (unspecified if ongoing); "Allergic to tropical fruits -pineapple, kiwi" (unspecified if ongoing); "Allergic to pollen" (unspecified if ongoing); "season allergies" (unspecified if ongoing). Concomitant medication(s) included: FAMOTIDINE, start date: Mar2022; MONTELUKAST, start date: May2022; SIMVASTATIN, start date: Mar2022, stop date: 25May2022; FLUTICASONE, start date: Apr2022; DULERA, start date: Apr2022; ALBUTEROL HFA, start date: Apr2022. Past drug history included: Azithromycin, reaction(s): "Drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient received treatment with Paxlovid (Lot number: FY8914) from 26May2022 to 27May2022 for treatment of COVID-19.  Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EP6955 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 EP6955, fill lot EP6954, and the formulated drug product lot EP6953. 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.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 at 08:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 08Apr2021 at 08:45 as dose 2, single (Batch/Lot number: unknown), in left arm and on 15Dec2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SERTRALINE; DICLOFENAC; CLARITINE; VITAMIN C [ASCORBIC ACID].  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: The patient has no known allergies. The patient took other medication in 2weeks. The patient was also taking multivitamin. Anti viral details: Product was COVID 19 Treatment, Brand was Paxlovid, Treatment start date was 24May2022, Treatment stop date was 28May2022, Indication was Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody 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) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06May2022 at 10:45 as dose number unknown, single (Lot number: FK9895) at the age of 70 years intramuscular, 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), 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 antibody test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not received any other medication in 2 weeks. Patient received Paxlovid from 18May2022 to 23May2022 for the treatment of COVID-19.   This is a notification generated from the system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in a Regulatory Authority.   Conclusion of Previously Completed Investigation: 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 FK9895. 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. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. A Regulatory Authority 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.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Influenza like illness, Nasal congestion
Clinical narrative: Achiness; Fatigue; Headache; Nasal congestion; Felt fluish; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jan2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 06Feb2021 at 09:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 10Sep2021 at 17:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Apr2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "ductal atypic" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN, start date: 19Feb2022. Past drug history included: Codeine, reaction(s): "known allergies: codeine", notes: known allergies: codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12May2022, outcome "recovered" (21May2022) and all described as "Treatment of COVID-19"; PAIN (non-serious), outcome "unknown", described as "Achiness"; FATIGUE (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; NASAL CONGESTION (non-serious), outcome "unknown"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Felt fluish ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (12May2022) Positive, notes: I tested positive for Covid on 12May2022,; (20May2022) Negative, notes: tested negative beginning 20May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19, pain, fatigue, headache, nasal congestion, influenza like illness. The patient received other medication and a 5 day course of paxlovid (from 12May2022 to 17May2022) as 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 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: Achiness; Fatigue; Headache; Nasal congestion; Felt fluish; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jan2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 06Feb2021 at 09:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 10Sep2021 at 17:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Apr2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "ductal atypic" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN, start date: 19Feb2022. Past drug history included: Codeine, reaction(s): "known allergies: codeine", notes: known allergies: codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12May2022, outcome "recovered" (21May2022) and all described as "Treatment of COVID-19"; PAIN (non-serious), outcome "unknown", described as "Achiness"; FATIGUE (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; NASAL CONGESTION (non-serious), outcome "unknown"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Felt fluish ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (12May2022) Positive, notes: I tested positive for Covid on 12May2022,; (20May2022) Negative, notes: tested negative beginning 20May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19, pain, fatigue, headache, nasal congestion, influenza like illness. The patient received other medication and a 5 day course of paxlovid (from 12May2022 to 17May2022) as 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 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.