chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report from a contactable consumer. The reporter is the patient. A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single at the age of 27 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single and as dose 2, single for covid-19 immunisation. The patient's relevant medical history included: "papillary necrosis"; "known allergies to penicillin, sulfa, shellfish". 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 "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included PAXLOVID since 16May2022 to 20May2022.  Rebound case - tested positive again 29May (9 days after last dose).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (other HCP) and from Product Quality Group. The reporter is the patient. A 53-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), on 14Jan2021 as dose 1, single (lot number EL3247), in left arm; on 04Feb2021 (also reported as 04Feb2022) as dose 2, single (lot number EL3247), in left arm and; on 03Dec2021 as dose 3 (booster), single (lot number FJ8757) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medications included: MAGNESIUM ACETATE start date: 01Feb2019, stop date: 25May2022; VITAMIN D3 start date: 01Jun2019, stop date: 25May2022; BAYER ASPIRIN stop date: 25May2022 and; multivitamin stop date: 25May2022. The following information was reported: VACCINATION FAILURE (medically significant) and COVID-19 (medically significant), outcome "unknown" and described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure and covid-19 which included Paxlovid taken since 25May2022.  Product Quality Group provided investigational results on 31May2022 for BNT162b2. Conclusion: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FJ8757 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 FJ8757, fill lot FJ1608, and formulated drug product lot FK2442. 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.  Product Quality Group provided investigational results on 31May2022 for BNT162b2. Conclusion: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EL3247 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 EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Menstrual cycle/ Period was disrupted and was over 50 days long; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FH8030), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, LOT NUMBER: ER8727, Anatomical Location: left arm), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, LOT NUMBER: ER8729, Anatomical Location: left arm), for COVID-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "Menstrual cycle/ Period was disrupted and was over 50 days long". Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: The patient was not administered other vaccine in four weeks. The patient did not have covid prior vaccination. The patient was not tested COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Sleep disorder due to general medical condition, insomnia type
Clinical narrative: 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8732) at the age of 62 years, in left arm, on 14Apr2021 as dose 2, single (Lot number: ER8729), in left arm and on 29Nov2021 as dose 3 (booster), single (Lot number: FJ1620), in left arm for covid-19 immunization. The patient's relevant medical history included: "Seasonal allergy to pollens" (unspecified if ongoing); "osteoporosis (no medicines yet)" (unspecified if ongoing), notes: osteoporosis (no medicines yet). Concomitant medication(s) included: CALCIUM. Past drug history included: Thimerosal, reaction(s): "known allergies: thimerosal", notes: known allergies: thimerosal. The following information was reported: RASH (non-serious) with onset 2021, outcome "unknown", described as "Torso rash over front and back a few days after vaccine, like a mild sunburn - difficult to wear certain clothing."; SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE (non-serious) with onset 2021, outcome "unknown", described as "making sleep and activities difficult"; ERYTHEMA (non-serious) with onset 2021, outcome "unknown", described as "redness"; PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "terrible itching". Therapeutic measures were taken as a result of pruritus. Additional information: Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccine within 4 weeks of vaccination. Post vaccination, the patient had not been tested for COVID-19. Concomitant product included vit D supplements. All the reported events following third dose occurred on 01Dec2021, and recovered on an unknown date. Torso rash over front and back a few days after vaccine, like a mild sunburn difficult to wear certain clothing. After redness goes away, terrible itching for days - making sleep and activities difficult. Happened after each vaccine. 3rd time, The patient took Benadryl after itching started - but it made no difference at all. She had a 4th shot (2nd booster) on 28May2022 (Moderna) - torso rash again even though she suppressed fever with NSAIDs this time. Took Zyrtec. Rash progressed anyway. Still red. Even though not a 'serious' effect, it could be serious because will lead to vaccine hesitancy or reluctance in the future for her. Pharmacist advised for next time to start antihistamine a few days before vaccine to allow more time for antihistamine to work. The patient will not be going through this 4 times a year given that the 4th dose has debatable benefit anyway, had she known she would get this rash again, She would have skipped the 4th dose and waited until fall.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Lacrimation increased
Clinical narrative: my left eye was swollen and watering throughout the morning; my left eye was swollen and watering throughout the morning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Drug Allergy" (unspecified if ongoing), notes: Reaction: Allergy. Concomitant medication(s) included: LOSARTAN. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot Number: FJ1611), administration date: 19Nov2021, when the patient was 65-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot number: EW0179), administration date: 03May2021, when the patient was 64-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE, Lot number: EW0151), administration date: 12Apr2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: EYE SWELLING (non-serious), LACRIMATION INCREASED (non-serious) all with onset 15May2022 at 05:00, outcome "recovered" (16May2022) and all described as "my left eye was swollen and watering throughout the morning". Therapeutic measures were not taken as a result of eye swelling, lacrimation increased. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. By early afternoon it had cleared up somewhat and was back to normal the next day. Report is assessed as non-serious.
Age: 48.0
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). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 15Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 28Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "Ms" (unspecified if ongoing); "epilepsy" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL, start date: 01Jan1994. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.The patient was treated with Anti viral Product Paxlovid, Treatment start date: 14May2022 and Treatment stop date: 18May2022,  indicated for treatment of COVID-19.  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: Epistaxis, Nausea
Clinical narrative: nose bleeds; nausea; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team, Program ID:   An 83-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for Covid-19 immunization. The following information was reported: EPISTAXIS (non-serious), outcome "unknown", described as "nose bleeds"; NAUSEA (non-serious), outcome "unknown".  Additional information: Patient had frequent nose bleeds and constant nausea following the second shot.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EM9809) at the age of 50 years, in left arm, on 26Feb2021 as dose 2, single (Lot number: EN6198) at the age of 51 years, in right arm, on 21Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 51 years, in left arm and on 20May2022 at 12:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies Sulfa" (unspecified if ongoing); "known allergies Mold" (unspecified if ongoing). The patient took concomitant medications: UP&UP (Women's Multivitamins, Probiotic Gummies) from Sep2019 to 01Jun2022. 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: Indication: Covid-19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid (Lot number: GA6206) from 31May2022 to 01Jun2022 for covid-19.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Rash pruritic
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EM9809) at the age of 50 years, in left arm, on 26Feb2021 as dose 2, single (Lot number: EN6198) at the age of 51 years, in right arm, on 21Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 51 years, in left arm and on 20May2022 at 12:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies Sulfa" (unspecified if ongoing); "known allergies Mold" (unspecified if ongoing). The patient took concomitant medications: UP&UP (Women's Multivitamins, Probiotic Gummies) from Sep2019 to 01Jun2022. 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: Indication: Covid-19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid (Lot number: GA6206) from 31May2022 to 01Jun2022 for covid-19.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2022 at 08:30 as dose 4 (booster), single (Lot number: FK9895) at the age of 67 years, in right 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: "ARDS" (unspecified if ongoing); "SCA" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Allergy: Sulfa" (unspecified if ongoing); "Allergy: penicillin" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: May2020, stop date: 13May2022. Past drug history included: Oxicodone, reaction(s): "Known allergies: oxicodone"; Codeine, reaction(s): "Known allergies: codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Anti viral details: product: COVID 19 Treatment brand: Pfizer, treatment start date: 15May2022, treatment stop date: 19May2022 Indication: Treatment of COVID-19
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Off label use, SARS-CoV-2 test
Clinical narrative: Contracting COVID confirmed by multiple at home tests; Contracting COVID confirmed by multiple at home tests; dose 4 (booster); dose 4 (booster); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: AI8028) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DILTIAZEM; HYDROCHLOROTHIAZIDE; PAXIL [PAROXETINE HYDROCHLORIDE].  The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 21Apr2022, outcome "unknown" and all described as "dose 4 (booster)"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 23May2022, outcome "recovered" and all described as "Contracting COVID confirmed by multiple at home tests". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23May2022) Positive, notes: Contracting COVID confirmed by multiple at home tests; (30May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19, drug ineffective.  Follow up information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Condition aggravated, Food allergy
Clinical narrative: anaphylactic reaction to first dose of the COVID-19 Pfizer vaccine; tomato allergy has become increasingly sensitive, and developed new allergies to other foods; tomato allergy has become increasingly sensitive, and developed new allergies to other foods; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Tomato" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylactic reaction to first dose of the COVID-19 Pfizer vaccine"; FOOD ALLERGY (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "tomato allergy has become increasingly sensitive, and developed new allergies to other foods". The events "anaphylactic reaction to first dose of the covid-19 pfizer vaccine" and "tomato allergy has become increasingly sensitive, and developed new allergies to other foods" required emergency room visit.  Addition inoraamtion: Patient experienced anaphylactic reaction to first dose of the COVID-19 Pfizer vaccine. Ever since the described event, the patient's tomato allergy has become increasingly sensitive, and developed new allergies to other foods. Covid prior vaccination was unknown. Covid tested post vaccination was unknown.  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: Mild symptoms of Covid; Mild symptoms of Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 7-year-old male patient received BNT162b2 (BNT162B2), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29May2022, outcome "recovering" and all described as "Mild symptoms of Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) positive, notes: Nasal Swab. The patient had mild symptoms of Covid: fever, congestion. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 13Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 18Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 19Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "ALLERGY" (unspecified if ongoing), notes: known allergies: Yes. There were no concomitant medications reported as, the patient did not receive other medications within two weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid started from 18May2022 to 22May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). An 11-year-old male patient received BNT162b2 (BNT162B2), on 28Nov2021 at 13:00 as dose 1, single (Lot number: FK5127) at the age of 10 years intramuscular, in left arm for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 22May2022, outcome "unknown", described as "Armpit swollen"; AXILLARY PAIN (non-serious) with onset 22May2022, outcome "unknown", described as "Armpit swollen and pain"; AXILLARY MASS (non-serious) with onset 22May2022, outcome "unknown", described as "lump under armpit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, axillary pain, axillary mass. Additional information: It was reported that no specific relevant test for thromboembolic events with thrombocytopenia. Event required the initiation of new medication/other treatment/ procedure and the same were occurred at 1 and 2nd dose, but less severe. No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: PNC20
Symptoms: Syringe issue
Clinical narrative: one of the pre-filled syringes break at the top, the glass part/we went to fold the plastic protective of the needle and the whole top of the prefilled syringe broke off; The initial case was missing the following minimum criteria: [no adverse event]. Upon receipt of follow-up information on [02Jun2022], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team and product quality group.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: FJ2604, Expiration Date: 30Jun2023) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "one of the pre-filled syringes break at the top, the glass part/we went to fold the plastic protective of the needle and the whole top of the prefilled syringe broke off". Additional information: Caller states: We were about to administer a PREVNAR 20 dose to a patient and I had one of the pre-filled syringes break at the top, the glass part. We put our syringe, our-like syringe that you screw on onto it and before we went to inject the patient we went to fold the plastic protective of the needle and the whole top of the prefilled syringe broke off. Caller clarified the patient that was intended to receive this dose was not administered this pre-filled syringe.   No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: indication=Treatment of COVID-19; indication=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 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2021 at 13:15 as dose 1, single (Lot number: EW0150), in left arm, on 01May2021 at 13:15 as dose 2, single (Lot number: EW0176), in left arm and on 22Nov2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 25 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (25May2022) Negative; (31May2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical Course: Anti viral details: Product COVID 19 Treatment, Paxlovid, she took 5 day course of paxlovid starting Wednesday afternoon 18May2022 through Monday morning 23May2022 for moderate COVID. Symptoms improved 20May and she tested negative Wednesday 25May On 28May she had a slight sore throat, 30May she became congested, 31May she had cooled mucus and tested positive for COVID again. Symptoms are more minor than initial infection.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Muscle spasms, Pain, Thrombosis
Clinical narrative: left leg is hurting more and burning more, very good burning sensation, probably where the clots are; now both legs are cramping and aching; now both legs are cramping and aching; left leg is hurting more and burning more, very good burning sensation, probably where the clots are; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 14Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 60 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1, NDC number, lot number, expiration date: ER6213, Dose and route: Unknown), administration date: 18Mar2021, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "Caller's legs have been cramping"; BNT162b2 (Dose: 2, NDC number, lot number, expiration date: EW0153, Dose and route: Unknown), administration date: 08Apr2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "2 blood clots in 1 leg", "Caller's legs have been cramping". The following information was reported: THROMBOSIS (non-serious), BURNING SENSATION (non-serious), outcome "unknown" and all described as "left leg is hurting more and burning more, very good burning sensation, probably where the clots are"; MUSCLE SPASMS (non-serious), PAIN (non-serious), outcome "unknown" and all described as "now both legs are cramping and aching". The events "left leg is hurting more and burning more, very good burning sensation, probably where the clots are" required physician office visit. Therapeutic measures were taken as a result of thrombosis, muscle spasms, pain, burning sensation.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body mass index, Condition aggravated, Eosinophil count, Eosinophil count increased, Hypereosinophilic syndrome
Clinical narrative: vaccinated participant reported an increase in eosinophil count or eosinophil-related symptoms; vaccinated participant reported an increase in eosinophil count or eosinophil-related symptoms; vaccinated participant reported an increase in eosinophil count or eosinophil-related symptoms; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypereosinophilic syndrome" (ongoing). Concomitant medication(s) included: PREDNISONE. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation. The following information was reported: EOSINOPHIL COUNT INCREASED (hospitalization, medically significant), HYPEREOSINOPHILIC SYNDROME (hospitalization, medically significant), CONDITION AGGRAVATED (hospitalization, medically significant), all with latency 2 weeks after the suspect product(s) administration, outcome "unknown" and all described as "vaccinated participant reported an increase in eosinophil count or eosinophil-related symptoms". The patient underwent the following laboratory tests and procedures: Body mass index: Unknown results; Eosinophil count: increase in eosinophil count or eosinophil-related, notes: symptoms; SARS-CoV-2 antibody test: Unknown results. Therapeutic measures were taken as a result of eosinophil count increased, hypereosinophilic syndrome, condition aggravated. Additional information: only 1 case did this lead to a change in Hypereosinophilic syndromes therapy (a transient increase in prednisone dose 2 weeks after the second dose of the Pfizer vaccine).  The reporter considered "vaccinated participant reported an increase in eosinophil count or eosinophil-related symptoms" related to BNT162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of clinically significant exacerbation of HES requiring alteration of therapy cannot be fully excluded, considering the temporal relationship.  More immunological and biomolecular evidence would be needed to explore the plausible physiopathologic mechanism between the vaccination and the event occurrence.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test
Clinical narrative: vaccinated participant reported an increase in eosinophil count or eosinophil-related symptoms; vaccinated participant reported an increase in eosinophil count or eosinophil-related symptoms; vaccinated participant reported an increase in eosinophil count or eosinophil-related symptoms; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypereosinophilic syndrome" (ongoing). Concomitant medication(s) included: PREDNISONE. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation. The following information was reported: EOSINOPHIL COUNT INCREASED (hospitalization, medically significant), HYPEREOSINOPHILIC SYNDROME (hospitalization, medically significant), CONDITION AGGRAVATED (hospitalization, medically significant), all with latency 2 weeks after the suspect product(s) administration, outcome "unknown" and all described as "vaccinated participant reported an increase in eosinophil count or eosinophil-related symptoms". The patient underwent the following laboratory tests and procedures: Body mass index: Unknown results; Eosinophil count: increase in eosinophil count or eosinophil-related, notes: symptoms; SARS-CoV-2 antibody test: Unknown results. Therapeutic measures were taken as a result of eosinophil count increased, hypereosinophilic syndrome, condition aggravated. Additional information: only 1 case did this lead to a change in Hypereosinophilic syndromes therapy (a transient increase in prednisone dose 2 weeks after the second dose of the Pfizer vaccine).  The reporter considered "vaccinated participant reported an increase in eosinophil count or eosinophil-related symptoms" related to BNT162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of clinically significant exacerbation of HES requiring alteration of therapy cannot be fully excluded, considering the temporal relationship.  More immunological and biomolecular evidence would be needed to explore the plausible physiopathologic mechanism between the vaccination and the event occurrence.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 77.0
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) (Physician). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 77 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no known allergies. The patient's relevant medical history included: "BPH" (unspecified if ongoing); "s/p AVR" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; ASPIRIN [ACETYLSALICYLIC ACID]; TAMSULOSIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19.   Clinical course: From 20May2022 to 25May2022, the patient was treated with Paxlovid for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 24-May-2022/Result: Positive; 24-May-2022/Result: Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: ER2613), on 28Apr2021 as dose 2, single (Lot number: EW016) and on 16Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 22 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Patient did not had covid prio vaccination nor tested post vaccination. Patient had no known allergies.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24May2022, outcome "recovered" and all described as "24-May-2022/Result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jul2021) Positive, notes: Covid test type post vaccination=Nasal swab; (24May2022) Positive, notes: Covid test type post vaccination=Nasal swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 54-year-old male patient received BNT162b2 (BNT162B2), on 21Jul2021 at 09:00 as dose 1, single (Lot number: FC3183), in left arm and on 20Aug2021 at 09:30 as dose 2, single (Lot number: FA7484) at the age of 53 years, in left arm for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21May2022, outcome "unknown" and all described as "21May2022 Nasal swab: positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test (21May2022) Positive. Clinical course: The patient did not receive any other vaccine in four weeks. The patient did not had Covid prior vaccination. No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Paranasal sinus discomfort, Sinus congestion, Throat irritation
Clinical narrative: Scratchy throat; sinus pressure; sinus pressure and congestion; achy; tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 11Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: 301308A; Anatomical Location: Left arm), administration date: 25Aug2021, when the patient was 62-year-old; Covid-19 vaccine (DOSE 1, MANFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: THROAT IRRITATION (non-serious) with onset 23May2022, outcome "recovered with sequelae", described as "Scratchy throat"; PAIN (non-serious) with onset 23May2022, outcome "recovered with sequelae", described as "achy"; PARANASAL SINUS DISCOMFORT (non-serious) with onset 23May2022, outcome "recovered with sequelae", described as "sinus pressure"; SINUS CONGESTION (non-serious) with onset 23May2022, outcome "recovered with sequelae", described as "sinus pressure and congestion"; FATIGUE (non-serious) with onset 23May2022, outcome "recovered with sequelae", described as "tired". Therapeutic measures were taken as a result of throat irritation, paranasal sinus discomfort, sinus congestion, pain, fatigue.  Additional information: The patient had no known allergies. It was unknown if patient received any medication within two weeks of vaccination. Therapeutic measures were taken as a result of the events which included treatment with Paxlovid from 24May2022 to 29May2022.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown), on 11Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 01Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Transgender female-to-male" (unspecified if ongoing), notes: Transgender female-to-male; "Trigeminal neuralgia" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL oral, start date: 19Nov2021; BUSPIRONE oral, start date: 01Mar2021; BUPROPIONE SANDOZ oral; TESTOSTERONE. The following information was reported: DRUG INEFFECTIVE (medically significant), 9 days after the suspect product(s) administration, outcome "not recovered", 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: (unspecified date) Unknown Results, notes: Treatment of COVID-19; (02Jun2022) Positive, notes: Rapid antigen and PCR positive; (02Jun2022) Positive, notes: Rapid antigen and PCR positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Vaccine and other medication received in 2weeks of vaccination.  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 known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she has tested Positive for Covid and she did take the Pfizer vaccine; she took the other vaccine last year; she has tested Positive for Covid and she did take the Pfizer vaccine; she took the other vaccine last year; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 30-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 29 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "unknown" and all described as "she has tested Positive for Covid and she did take the Pfizer vaccine; she took the other vaccine last year". The events "she has tested positive for covid and she did take the pfizer vaccine; she took the other vaccine last year" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: When my symptoms returned I tested positive using an at home antigen test.; When my symptoms returned I tested positive using an at home antigen test.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 at 13:30 as dose 1, single (Lot number: EI9264), in left arm, on 16Feb2021 as dose 2, single (Lot number: EI9266), in left arm and on 22Sep2021 at 13:00 as dose 3 (booster), single (Lot number: FC3184) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 05Apr2022 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL / NORETHINDRONE ACETATE; ALEVE, start date: 01Apr2022; FLONASE [FLUTICASONE PROPIONATE], start date: 01Mar2020; LEVALBUTEROL TARTRATE HFA; FLOVENT HFA; BIOTIN; UBIQUINOL. Past drug history included: Torradol, reaction(s): "known allergies Torradol", notes: known allergies Torradol; Morphine, reaction(s): "known allergies Morphine", notes: known allergies Morphine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "When my symptoms returned I tested positive using an at home antigen test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: While on the Paxlovid I tested negative twice using an at home antigen test; (unspecified date) Negative, notes: While on the Paxlovid I tested negative twice using an at home antigen test; (May2022) Positive, notes: When my symptoms returned I tested positive using an at home antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Information: COVID 19 Treatment reported as Paxlovid, Treatment started on 18May2022 and stop date was 22May2022, Indication was reported as Treatment of COVID-19. Adverse event was reported as, 7 days after last dose of Paxlovid cough, runny nose, scratchy throat, slight nausea and general feeling of malaise returned. While on the Paxlovid patient tested negative twice using an at home antigen test. When symptoms returned patient tested positive using an at home antigen test.  No follow-up attempts are possible. No further information is expected.