chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid; covid; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 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: "CAD" (unspecified if ongoing), notes: other medical history: CAD. The patient had no known allergies. The patient took concomitant medications. 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: (unspecified date) Positive, notes: Treatment of COVID-19 Positive antigen test again; (31May2022) Positive, notes: Positive antigen test again on 31May2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. From 17May2022 to 22May2022, the patient was treated with Paxlovid. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid; covid; This is a spontaneous report received from a 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 04Feb2021 at 16:30 as dose 1, single (Batch/Lot number: unknown), in left arm and on 25Feb2021 at 16:30 as dose 2, single (Batch/Lot number: unknown) at the age of 40 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" 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 covid-19, drug ineffective.  Clinical course: If vaccine received: Yes, Other medications in two weeks: No. Anti-viral details: product=COVID 19 Treatment, Brand: Paxlovid, treatment start date=17May2022, treatment stop date=15May2022, Indication: Treatment of Covid-19, Known allergies: No, Other medical history: No  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59-year-old male patient received BNT162b2 (BNT162B2), on 31Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CRESTOR, stop date: 10May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: Paxlovid Induced Rebound Covid 7 days after testing negative; Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: The treatment has been received with Paxlovid, start date was 10May2022 and stop date was 15May2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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) (Other HCP). A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Test positive again after 2 negative test; Negative, notes: Test positive again after 2 negative test; Negative, notes: Test positive again after 2 negative test. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Anti-viral details: product: COVID-19 Treatment, treatment start date: 13May2022 and stop date: 18May2022, indication is used for treatment of COVID-19, administrator route=Oral Adverse event: Test positive again after 2 negative test. If patient received treatment is Unknown. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s): US-PFIZER INC-202200787479 Same patient, different product and event.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dysgeusia, Nausea
Clinical narrative: she had a really bad taste in her mouth (later stated as a "strong medicine taste"); nausea; stomachache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (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: Bnt162b2 (Lot number of the first booster shot: FK9894., DOSE NUMBER UNKNOWN,(BOOSTER), SINGLE), for covid-19 immunization; Covid-19 vaccine (Primary immunization completed, unknown manufacture.), for covid-19 immunization. The following information was reported: DYSGEUSIA (non-serious), outcome "not recovered", described as "she had a really bad taste in her mouth (later stated as a "strong medicine taste")"; NAUSEA (non-serious), outcome "not recovered"; ABDOMINAL PAIN UPPER (non-serious), outcome "not recovered", described as "stomachache".  Additional Information:  Caller received the 2nd booster shot of the Pfizer-BioNTech Covid 19 Vaccine on Friday and immediately she had a really bad taste in her mouth (later stated as a "strong medicine taste"). 3 hours later the patient had nausea and stomach-ache. Today was the 5th day and she still had it. Her main concern was the terrible taste in her mouth and wants to know if it could be possible that the vaccine went directly to her veins once she received the shot. The taste did not happened with the first booster and she did not think that it could be due to the swap of alcohol she made.  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: Aphasia, Feeling abnormal, Seizure
Clinical narrative: non-verbal and could not say he felt weird; He felt weird; Seizure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID:. The reporter is the parent. A male patient received BNT162b2 (BNT162B2), on 05Apr2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Autism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SEIZURE (medically significant) with onset 06Apr2022, outcome "unknown"; APHASIA (non-serious), outcome "unknown", described as "non-verbal and could not say he felt weird"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "He felt weird". Customer Verbatim: Hi, my son received your vaccine on 05Apr2022 and had a seizure on 06Apr2022, less than 24 hours of taking your vaccine. My son has Autism and has never in his life had a seizure. He is non-verbal and could not say he felt weird. You all need to tell people about this stuff before pushing it out to the public. Now, my son may have to deal with this additional hurdle for the rest of his life. I am going to tell every parent of disabled kids that I know. I regret giving this to my son. Do More Resear  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Fatigue, Inflammation, Muscle disorder
Clinical narrative: my entire body has been severely inflamed; suffer from occasional loss of arm movement; severe dizzy spells; body is alway in pain; mid lower back is in pain; severe fatigue; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 at 19:45 as dose 1, single (Lot number: Er8730) at the age of 34 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Morphine, reaction(s): "Allergy". The following information was reported: PAIN (disability) with onset 12Apr2021 at 12:00, outcome "not recovered", described as "body is alway in pain"; BACK PAIN (disability) with onset 12Apr2021 at 12:00, outcome "not recovered", described as "mid lower back is in pain"; INFLAMMATION (disability) with onset 12Apr2021 at 12:00, outcome "not recovered", described as "my entire body has been severely inflamed"; DIZZINESS (disability) with onset 12Apr2021 at 12:00, outcome "not recovered", described as "severe dizzy spells"; FATIGUE (disability) with onset 12Apr2021 at 12:00, outcome "not recovered", described as "severe fatigue"; MUSCLE DISORDER (disability) with onset 12Apr2021 at 12:00, outcome "not recovered", described as "suffer from occasional loss of arm movement". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Apr2022) Negative. Therapeutic measures were taken as a result of inflammation, muscle disorder, dizziness, pain, back pain, fatigue.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between BNT162B2  and the reported events  inflammation, muscle disorder, dizziness, pain, back pain, fatigue 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: my entire body has been severely inflamed; suffer from occasional loss of arm movement; severe dizzy spells; body is alway in pain; mid lower back is in pain; severe fatigue; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 at 19:45 as dose 1, single (Lot number: Er8730) at the age of 34 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Morphine, reaction(s): "Allergy". The following information was reported: PAIN (disability) with onset 12Apr2021 at 12:00, outcome "not recovered", described as "body is alway in pain"; BACK PAIN (disability) with onset 12Apr2021 at 12:00, outcome "not recovered", described as "mid lower back is in pain"; INFLAMMATION (disability) with onset 12Apr2021 at 12:00, outcome "not recovered", described as "my entire body has been severely inflamed"; DIZZINESS (disability) with onset 12Apr2021 at 12:00, outcome "not recovered", described as "severe dizzy spells"; FATIGUE (disability) with onset 12Apr2021 at 12:00, outcome "not recovered", described as "severe fatigue"; MUSCLE DISORDER (disability) with onset 12Apr2021 at 12:00, outcome "not recovered", described as "suffer from occasional loss of arm movement". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Apr2022) Negative. Therapeutic measures were taken as a result of inflammation, muscle disorder, dizziness, pain, back pain, fatigue.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between BNT162B2  and the reported events  inflammation, muscle disorder, dizziness, pain, back pain, fatigue 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough COVID infection; Breakthrough COVID infection; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 7-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Nov2021 as dose 1, single (Batch/Lot number: unknown) and on 11Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 7 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 01Jun2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Breakthrough COVID infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Age: 45.0
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) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose number 1, single (Lot number: EN6198), in left arm, on 17Mar2021 as dose number 2, single (Lot number: EP7534), in left arm and on 19Nov2021 as dose number 3 (booster), single (Lot number: FG3527) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "gout" (unspecified if ongoing). Concomitant medication(s) included: ALLOPURINOL; FISH OIL; VITAMIN C [ASCORBIC ACID]; ZINC. 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: (14May2022) positive, notes: which was Day 9 after initial positive test; (23May2022) positive, notes: Rebound infection of Covid-19, symptoms & positive antigen tests began again on 23May2022, 4 days after Paxlovid treatment ended. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Malignant melanoma, Therapeutic response unexpected
Clinical narrative: Melanoma; I found that your vaccinations helped me with this cancer... my cancer lesions on my legs/an unexpected benefit from the Pfizer-Biontech Covid19 vaccine; I have total of 6 injections; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 85-year-old male patient received BNT162b2 (BNT162B2), in May2022 as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Karposi's Sarcoma", start date: 1998 (ongoing), notes: Agent states the Caller was diagnosed with Karposi's Sarcoma in 1998.; "Lesion on his legs" (unspecified if ongoing), notes: Caller reports vaccines helped Karposi's Sarcoma cancer, it helped with the lesions on legs. There were no concomitant medications. Vaccination history included: BNT162b2 (1st vaccine. Expiry Dt: EL3302/unknown. Route, Location: not provided. Previous Doses: No), administration date: 22Jan2021, when the patient was 83-year-old, for Covid-19 immunization; BNT162b2 (2nd injection 1st Covid vaccine: Expiry Dt:EN6201/unknown. Route, Location not provided. Previous: 1), administration date: 12Feb2021, when the patient was 83-year-old, for Covid-19 immunization; BNT162b2 (1st injection 2nd Covid vaccine. Expiry Dt: FC3180/unknown. Location: not provided. previous: 2), administration date: 07Aug2021, when the patient was 84-year-old, for Covid-19 immunization; BNT162b2 (2nd injection 2nd Covid vaccine. Expiry Dt: FC3182/unknown. Location: not provided. previous: 3), administration date: 11Sep2021, when the patient was 84-year-old, for Covid-19 immunization; BNT162b2 (1st Covid booster:18Feb2022 (5 vaccine). FJ6369. Expire Dt: unknown. Time, Location: not provided.), administration date: 18Feb2022, when the patient was 84-year-old, for Covid-19 immunization.  The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2022, outcome "unknown", described as "I found that your vaccinations helped me with this cancer... my cancer lesions on my legs/an unexpected benefit from the Pfizer-Biontech Covid19 vaccine"; EXTRA DOSE ADMINISTERED (non-serious) with onset 2022, outcome "unknown", described as "I have total of 6 injections"; MALIGNANT MELANOMA (medically significant) with onset 2022, outcome "not recovered", described as "Melanoma".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 breakthrough infection; COVID-19 breakthrough infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 37-year-old male patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 05Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Nov2021 as dose 3 (booster), single (Lot number: 051F21A) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) 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 vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Developed COVID, tested positive; Developed COVID, tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 62-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: EP6955), on 17Apr2021 as dose 2, single (Lot number: EP6955) and on 19Jan2022 as dose 3 (booster), single (Lot number: FJ5682) at the age of 62 years, all intramuscular 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 01Jun2022, outcome "unknown" and all described as "Developed COVID, tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Positive, notes: Nasal swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies. Facility type vaccine: Public Health Clinic/Administration facility. Patient did not receive any other vaccines within 4 weeks or 2 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient tested positive for covid post vaccination. Covid test type post vaccination=Nasal swab, Covid test name post vaccination= BinaxNOW.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6198) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The consumer started Paxlovid on 05Feb2021 for Treatment of COVID-19 (lot number: el9265). The patient previously received a COVID-19 Vaccine. Device Date: 01Jun2022.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 antibody test, Suspected COVID-19
Clinical narrative: had covid; had covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 94-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 94 years for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism; PRAVASTINE taken for blood cholesterol increased; SERTRALINE taken for anxiety. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "had covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (May2022) Positive.  Clinical course: It was reported that after further discussion with reporter's 40-year-old daughter, her mom was no longer frightened. Reporter's daughter told her she had very similar sleep/dream disturbances after dose 4. They feel the problem was a side effect due to 4 dose and having had covid in May2022. They feel it was just the way her mom is 94-year old body reacted and that there was nothing wrong with the serum, as the same thing happened with her daughter who is 54-years younger and had her dose 4 in a clinic setting.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: tested positive for COVID on 23May; tested positive for COVID on 23May; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 30 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: "Birth control" (ongoing). Concomitant medication(s) included: JUNEL taken for contraception; FLONASE [FLUTICASONE PROPIONATE]; AZELASTINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23May2022, outcome "not recovered" and all described as "tested positive for COVID on 23May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (23May2022) Positive; (01Jun2022) Positive; SARS-CoV-2 test: (29May2022) Negative, notes: rapid antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient tested positive for COVID on 23May2022 and began paxlovid on 23May2022. She stopped after completing the full course of doses on 27May2022. Patient received antiviral treatment with paxlovid from 23May2022 to 27May2022 for COVID-19 event. On 29May2022, she tested negative on a rapid antigen test. On 01Jun2022 at 10:00 AM, patient symptoms have returned and tested positive with a rebound case. Patient did not received any treatment and not recovered after symptoms returned. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (23May2022) Positive; (01Jun2022) Positive; SARS-CoV-2 test: (29May2022) Negative, notes: rapid antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: contracting covid infection after receiving 3 doses of Pfizer vaccine; contracting covid infection after receiving 3 doses of Pfizer vaccine; 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contracting covid infection after receiving 3 doses of Pfizer vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown). The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. No follow-up attempts are possible. No further information is expected.  Additional information: The patient was not  taking any other medications/products within 2 weeks of starting COVID-19 treatment.The patient previously receive a COVID-19 Vaccine.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 14Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 32 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 24May2022, outcome "unknown", COVID-19 (medically significant) with onset 24May2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Positive, notes: First positive test and treatment began 24May; (30May2022) Negative, notes: Negative rapid tests on 30May; (31May2022) Negative, notes: Negative rapid tests on 30May and 31May; (01Jun2022) Positive, notes: Positive rapid test in 01Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had not received any other medication in 2weeks. Patient had no known allergies. Patient had received COVID 19 Treatment as Paxlovid from 24May2022 to 28May2022. 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 Q1215 and/or Q1252. Refer to the below table for details. AE Ref No. (CC): 202200789582: 7237006. Product-Description: Compound BNT162B2 COVID-19 Vaccine suspension for intramuscular 2ML multiple dose vial X 1, Lot-: FG3527. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the Pfizer-Biontech Covid-19 Vaccine lot FG3527 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 FG3527, fill lot FG3512, and the formulated drug product lot FJ8500. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. ID of Previously Completed Inv: 6577183, Link (Previously Investigated): 6573465
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative, notes: Tested negative within 6 days; (30May2022) Positive, notes: 5 days later tested positive again and symptoms returned. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The Paxlovid worked well, felt great within 24 hours. Tested negative within 6 days. 5 days later tested positive again and symptoms returned. The patient had no known allergies. The other medications received in 2 weeks was unknown.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Did you/the patient previously receive a COVID-19 Vaccine?: Yes. Known allergies: No  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive with a PCR test on 29May2022; I tested positive with a PCR test on 29May2022; 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 20Apr2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) 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: "Immune disorder" (unspecified if ongoing); "known allergies: nuts all nuts" (unspecified if ongoing), notes: known allergies: nuts all nuts. Concomitant medication(s) included: DAPSON, start date: Jan2021.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 29May2022, outcome "unknown", COVID-19 (medically significant) with onset 29May2022, outcome "not recovered" and all described as "I tested positive with a PCR test on 29May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (29May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Anti-viral Product for COVID-19 Treatment, Brand: Paxlovid, treatment start date 29May2022, treatment stop date 26May2022. the patient took other medications/products within 2 weeks of starting COVID-19 treatment. The patient tested positive with a PCR test on 29May2022, took Paxlovid then tested positive again and was much sicker than she was the first time she tested positive. Second time had a sinus infection as well and started a Zpac, she was now 4 days positive, her parents also experienced COVID rebound, and they were all exposed at the same wedding.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Results unknown, notes: Recurrent rapid COVID test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from an unspecified date to 29May2022 for the treatment of COVID-19. Patient had sore throat, rhinitis and cough 3 days after completing 5-day Paxlovid course.  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 Drug ineffective , covid-19 and the suspect drug BNT162B2 cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient was received vaccine. The patient was received other medication in 2 weeks. No known allergies. No treatment was received in response to the adverse events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive Covid-19 tests; positive Covid-19 tests; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 87-year-old female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Lot number: EL9262) and in Feb2021 as dose 2, single (Lot number: EL8266) at the age of 86 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), in Oct2021 as dose 3 (booster), single (Lot number: 301418A), in arm for covid-19 immunisation. The patient's relevant medical history included: "stable angina", start date: 2012 (unspecified if ongoing), notes: never had any reaction or anything from it in 20 years. The patient's concomitant medications were not reported. Vaccination history included: Flu shots, for Immunization, reaction(s): "arm gets a little sore after shots". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive Covid-19 tests". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course- Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): Had a flu shot, but she did not know when she got the flu shot in relation to the booster.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
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 41-year-old male patient received BNT162b2 (BNT162B2), on 09Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) Negative, notes: After completing a round of Paxlovid, I was symptom-free and tested negative on a rapid for two days; (27May2022) Negative, notes: After completing a round of Paxlovid, I was symptom-free and tested negative on a rapid for two days; (28May2022) Positive, notes: On the third day, I tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti-viral details: product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 20May2022, Treatment stop date: 25May2022, Indication: Treatment of COVID-19. Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment reported as yes. Did you/the patient previously receive a COVID-19 Vaccine reported as yes. On the third day, I tested positive again and began having symptoms again (fatigue and upper respiratory symptoms). Now, four days into the rebound, I am still testing positive and experiencing symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient contracted COVID after 2 boosters; Patient contracted COVID after 2 boosters; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) 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: "COPD" (unspecified if ongoing), notes: Other medical history: COPD; "EBV" (unspecified if ongoing), notes: Other medical history: EBV; "HTN" (unspecified if ongoing), notes: Other medical history: HTN; "HLD" (unspecified if ongoing), notes: Other medical history: HLD; "Hypothyroid" (unspecified if ongoing), notes: Other medical history: Hypothyroid. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Patient contracted COVID after 2 boosters". Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient took Oral Paxlovid as anti viral for Covid-19 Treatment. Paxlovid via orally started on 25May2022 and stop on 01Jun2022. She had not any no known Allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.