chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Foetal cystic hygroma
Clinical narrative: Miscarriage at 13 weeks gestation due to fetal cystic hygroma; Miscarriage at 13 weeks gestation due to fetal cystic hygroma; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) was exposed to bnt162b2 (BNT162B2), transplacental, administration details for the mother: on 18Dec2020 at 10:00 as dose 1, single (Lot number: EK5730) and on 08Jan2021 at 10:00 as dose 2, single (Lot number: EL3246) for covid-19 immunisation. The mother of the patient was 32 years old. The mother was 13 weeks pregnant at the event onset. The mother's relevant medical history and concomitant medications were not reported. The mother was vaccinated at a hospital.  The following information was reported: FOETAL CYSTIC HYGROMA (death, medically significant), EXPOSURE DURING PREGNANCY (death, medically significant), outcome "fatal" and all described as "Miscarriage at 13 weeks gestation due to fetal cystic hygroma". Therapeutic measures were taken as a result of foetal cystic hygroma. The patient date of death was 03Mar2021. Reported cause of death: "Miscarriage at 13 weeks gestation due to fetal cystic hygroma". No autopsy was performed. Additional information: On 03Mar2021, the mother experienced a miscarriage at 13 weeks gestation due to fetal cystic hygroma.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up (10Oct2023): This is a follow-up report to notify that this case 2021288616 was submitted to the Agency trading partners with the 2020516672 of case 202300324023. Case 202300324023 is going to be resubmitted to confirm information and case 2021288616 is considered invalid and corresponding information is re-entered under this new manufacturer report number 202300324023.; Sender's Comments: Based on the information provided,  a causal association between reported events and suspect BNT162B2 cannot be excluded. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-2020516672 Mother case;; Reported Cause(s) of Death: Miscarriage at 13 weeks gestation due to fetal cystic hygroma; Miscarriage at 13 weeks gestation due to fetal cystic hygroma
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), 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. No known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 26Sep2023 to 01Oct2023. Clinical course: the patient received COVID-19 Vaccine (Pfizer/Biontech brand) on "15Aug2020" (as reported).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300324048 same patient, different vaccine/event;
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Felt bad the day after shot; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "COVID-19"; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "COVID-19"; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "COVID-19"; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt bad the day after shot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Dose #3: Moderna, dose #4: Pfizer; 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 41-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna (Dose 3, left arm, vaccine administration time: 12:00 PM,), administration date: 10Sep2022, for COVID-19 immunization; Covid-19 vaccine (Primary series, manufacturer unknown), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 01Oct2023, outcome "not recovered" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Dose #3: Moderna, dose #4: Pfizer". Therapeutic measures were taken as a result of covid-19, vaccination failure which includes paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE], start date: Feb2021, stop date: 10Oct2023. Past drug history included: Keflix, reaction(s): "Known allergies: Keflix". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Sep2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negetive, notes: rebound Covid - test positive again after testing negative 3 days ago; Positive, notes: rebound Covid - test positive again after testing negative 3 days ago. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).  The information on the batch/lot number for bnt162b2 omi xbb.1.5 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 drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.
Age: 78.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Interchange of vaccine products, Laboratory test, Swollen tongue
Clinical narrative: Interchange of vaccine product; My tongue was all swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   78-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 78 years intramuscular, in arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 05Oct2023 as unk, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for blood pressure abnormal. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for covid-19 immunization; Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), for covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Interchange of vaccine product"; SWOLLEN TONGUE (non-serious), outcome "unknown", described as "My tongue was all swollen". The events "interchange of vaccine product" and "my tongue was all swollen" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of interchange of vaccine products, swollen tongue.  Additional information: Patient got vaccinated on saturday morning at 5:30 in the morning, she went to the hospital because her tongue was all swollen, in the hospital she received some medication to bring the swelling of her tongue down: dexamethasone (Intent: Treatment), Benadryl (Intent: Treatment) and Reglan (Intent: Treatment) for her stomach. She didn't take medicines anymore because she did not stay in the hospital. She had 3 Pfizer shots and 1 Moderna shot since the year 2021 and she never had a reaction.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 4 (booster), single (Lot number: G49694) and on 25Apr2023 as dose 5 (booster), single (Lot number: GJ3268) for covid-19 immunisation; bnt162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL9262), on 02Feb2021 as dose 2, single (Lot number: EL9266) and on 16Apr2022 as dose 3 (booster), single (Lot number: FJ9943) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "Sulpha" (unspecified if ongoing), notes: Known allergies: Sulpha. The patient's 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 measure taken as a result of drug ineffective, covid-19 included administration of Paxlovid.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 4 (booster), single (Lot number: G49694) and on 25Apr2023 as dose 5 (booster), single (Lot number: GJ3268) for covid-19 immunisation; bnt162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL9262), on 02Feb2021 as dose 2, single (Lot number: EL9266) and on 16Apr2022 as dose 3 (booster), single (Lot number: FJ9943) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "Sulpha" (unspecified if ongoing), notes: Known allergies: Sulpha. The patient's 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 measure taken as a result of drug ineffective, covid-19 included administration of Paxlovid.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive day 9. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 02Oct2023 to 06Oct2023. The information on the batch/lot number for bnt162b2 omi xbb.1.5 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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 24.0
Sex: F
Vaccine: COVID19, FLUX, COVID19, FLUX
Symptoms: Bone pain, Brain fog, Fatigue, Headache, Interchange of vaccine products
Clinical narrative: bone aches (back/ribs/arms); brain fog; congestion; fatigue; Mainly muscle aches (back/ribs/arms).; headache; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 at 11:30 as dose 1, single (Lot number: HF9275) at the age of 24 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 09Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for influenza immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: johnson & johnson (Dose Number: 1, Batch No: 041A21A, Site: Arm Left, Time: 12:00 PM, ROA: Intramuscular), administration date: 01Apr2021, when the patient was 22-year-old, for COVID-19 immunization; moderna (Dose Number: 2, Batch No: 017F21A, Site: Arm Left, Time: 12:00 PM, ROA: Intramuscular), administration date: 29Oct2021, when the patient was 22-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 09Oct2023 at 11:30, outcome "unknown"; MYALGIA (non-serious) with onset 09Oct2023 at 20:00, outcome "recovered" (Oct2023), described as "Mainly muscle aches (back/ribs/arms)."; BONE PAIN (non-serious) with onset 09Oct2023 at 20:00, outcome "recovered" (Oct2023), described as "bone aches (back/ribs/arms)"; BRAIN FOG (non-serious) with onset 09Oct2023 at 20:00, outcome "recovered" (Oct2023); NASAL CONGESTION (non-serious) with onset 09Oct2023 at 20:00, outcome "recovered" (Oct2023), described as "congestion"; FATIGUE (non-serious) with onset 09Oct2023 at 20:00, outcome "recovered" (Oct2023); HEADACHE (non-serious) with onset 09Oct2023 at 20:00, outcome "recovered" (Oct2023). Therapeutic measures were not taken as a result of bone pain, brain fog, nasal congestion, fatigue, myalgia, headache.  Additional information: Reported that, Mainly muscle and bone aches (back/ribs/arms). Also, headache and brain fog, congestion, and fatigue. The patient had no known allergies.
Age: 24.0
Sex: F
Vaccine: COVID19, FLUX, COVID19, FLUX
Symptoms: Myalgia, Nasal congestion
Clinical narrative: bone aches (back/ribs/arms); brain fog; congestion; fatigue; Mainly muscle aches (back/ribs/arms).; headache; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 at 11:30 as dose 1, single (Lot number: HF9275) at the age of 24 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 09Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for influenza immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: johnson & johnson (Dose Number: 1, Batch No: 041A21A, Site: Arm Left, Time: 12:00 PM, ROA: Intramuscular), administration date: 01Apr2021, when the patient was 22-year-old, for COVID-19 immunization; moderna (Dose Number: 2, Batch No: 017F21A, Site: Arm Left, Time: 12:00 PM, ROA: Intramuscular), administration date: 29Oct2021, when the patient was 22-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 09Oct2023 at 11:30, outcome "unknown"; MYALGIA (non-serious) with onset 09Oct2023 at 20:00, outcome "recovered" (Oct2023), described as "Mainly muscle aches (back/ribs/arms)."; BONE PAIN (non-serious) with onset 09Oct2023 at 20:00, outcome "recovered" (Oct2023), described as "bone aches (back/ribs/arms)"; BRAIN FOG (non-serious) with onset 09Oct2023 at 20:00, outcome "recovered" (Oct2023); NASAL CONGESTION (non-serious) with onset 09Oct2023 at 20:00, outcome "recovered" (Oct2023), described as "congestion"; FATIGUE (non-serious) with onset 09Oct2023 at 20:00, outcome "recovered" (Oct2023); HEADACHE (non-serious) with onset 09Oct2023 at 20:00, outcome "recovered" (Oct2023). Therapeutic measures were not taken as a result of bone pain, brain fog, nasal congestion, fatigue, myalgia, headache.  Additional information: Reported that, Mainly muscle and bone aches (back/ribs/arms). Also, headache and brain fog, congestion, and fatigue. The patient had no known allergies.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: interchange of vaccine products; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 78-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 10:30 as dose 5 (booster), single (Lot number: GU2524), in left arm and on 24Apr2023 at 10:30 as dose 6 (booster), single (Lot number: GL2042) at the age of 78 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 21Jan2021 at 14:30 as dose 1, single (Lot number: EL2349), in left arm, on 12Feb2021 at 15:15 as dose 2, single (Lot number: EL9269), in left arm, on 03Sep2021 at 10:30 as dose 3 (booster), single (Lot number: FC3182), in left arm and on 26May2022 at 13:15 as dose 4 (booster), single (Lot number: FJ4991), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Sep2023 at 15:30 as dose number 7 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "CML" (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing); "Sulfa" (unspecified if ongoing); "PCN allergy" (unspecified if ongoing). Concomitant medication(s) included: SPRYCEL, start date: Oct2017; ZETIA; ESTRACE; LASIX [FUROSEMIDE]; KCL; MINOXIDIL; ALLEGRA [FEXOFENADINE HYDROCHLORIDE]. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; 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: (28Sep2023) Positive; (04Oct2023) Negative; (06Oct2023) Negative; (08Oct2023) Positive; (10Oct2023) Positive; (11Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid treatment from 28Sep2023 to 03Oct2023 for COVID-19.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 33.0
Sex: F
Vaccine: UNK
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 33-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 20Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE 4 (BOOSTER), SINGLE, {vaccine brand=Pfizer / BioNTech, vaccine administration date=07Sep2022,, vaccine lot number=GH9694, vaccine location=Left arm}), administration date: 07Sep2022, when the patient was 32-year-old, for COVID-19 immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, vaccine brand=Pfizer / BioNTech, vaccine administration date=17Oct2021,, vaccine lot number=FF2593,), administration date: 17Oct2021, when the patient was 31-year-old, for COVID-19 immunization; bnt162b2 (DOSE 2, SINGLE, vaccine brand=Pfizer / BioNTech, vaccine administration date=17Mar2021,,  vaccine lot number=EP7534, vaccine location=Left arm), administration date: 17Mar2021, when the patient was 30-year-old, for COVID-19 immunization; bnt162b2 (DOSE 1, SINGLE, vaccine brand=Pfizer / BioNTech, vaccine administration date=24Feb2021,, vaccine lot number=EN6198, vaccine location=Left arm}), administration date: 24Feb2021, when the patient was 30-year-old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment information: Paxlovid from 24Sep2023 to 29Sep2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 5 (booster), single (Lot number: GJ3277), in left arm and on 13Jul2023 as dose 6 (booster), single (Lot number: GH9702) at the age of 65 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 19May2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: ER8729), in left arm, on 30Apr2021 as dose 2, single (Lot number: EW0173), in left arm and on 21Nov2021 as dose 3 (booster), single (Lot number: FH8030), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: a week of not feeling good every single time I receive the Pfizer COVID vaccine; 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 61-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: MALAISE (non-serious), outcome "unknown", described as "a week of not feeling good every single time I receive the Pfizer COVID vaccine".  Additional information : Caller stated she had already reported her side effects when she first got the Pfizer COVID shots and did not want to report again. Caller stated, "It was a week of not feeling good every single time I receive the Pfizer COVID vaccine." Caller was calling in asking if the new shot will not have a side effect. Caller mentioned that when she took the last booster shot a couple of years ago, it gives a terrible side effect. The patient stated she went to the website and could not find side effects to the new Pfizer COVID vaccine for 12 years of age and older as it was still talking about the old shot. The caller had a side effect with the booster shot that she took a couple of years ago.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300318222 Same patient, event, Different drug dose number.;
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 41-year-old male patient received bnt162b2 (BNT162B2), on 24Sep2021 as dose 3 (booster), single (Lot number: 3013458A) at the age of 39 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid treatment start date: 01Oct2023, end date: 06Oct2023) were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; 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 drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202300323668 same patient/reporter, different drug/event;
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: left leg DVT in two spots of her leg; This is a spontaneous report received from non-contactable reporter (Consumer or other non-HCP).   A 40-year-old female patient received bnt162b2 (BNT162B2 NOS), in 2022 as dose number unknown, single (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEEP VEIN THROMBOSIS (medically significant) with onset 2022, 48 hrs after the suspect product(s) administration, outcome "unknown" described as "left leg DVT in two spots of her leg." The Pfizer sales representative stated, "I just had somebody report today that 40 years old, she was not on a birth control a year ago after receiving the Pfizer Vaccine, about 48 hours later, left leg DVT in two spots of her leg." When asked if Vaccine name is Pfizer COVID-19 Vaccine, Pfizer sales representative stated, "I guess, I just know it was a COVID Vaccine. I was taking for granted, I guess she did not say it was the Pfizer just COVID Vaccine. I was thinking, it was Pfizer, I guess they are talking about the Pfizer." Reason for no lot number of COVID Vaccine: Caller does not have the product with them at the time of call.  No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive for COVID again; I tested positive for COVID again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 5 (booster), single (Lot number: GH9693) 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "History (decades ago) of thyroid ca" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Oct2023, outcome "not recovered" and all described as "I tested positive for COVID again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Positive; (Oct2023) Negative, notes: tested negative twice this week. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 61.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: NSAIDs" (unspecified if ongoing), notes: Known allergies: NSAIDs. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, 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 76-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 01:00 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN, start date: 01May2018; ATORVASTATIN, start date: 01May2018, stop date: 10Oct2023; ADDERALL, start date: 01May2018, stop date: 10Oct2023; TAMSULOSIN, start date: 01Jun2021, stop date: 10Oct2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown), 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: "Crohns disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID Treatment). The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 (vaccination failure); COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 33 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 06Apr2021 as dose 2, single (Lot number: ER8734), in left arm and on 20Nov2021 as dose 3 (booster), single (Lot number: FG3527), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Peanut allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "Allergy". The following information was reported: COVID-19 (medically significant) with onset Sep2023, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset Sep2023, outcome "unknown", described as "COVID-19 (vaccination failure)". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was treated with nirmatrelvir, ritonavir (PAXLOVID), from 29Sep2023 to 03Oct2023.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN POTASSIUM, start date: 27Dec2022 (ongoing); RALOXIFENE (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  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-202300321150 same patient/drug, different dose/AE;
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Vaccine booster failed to prevent Covid19 infection. I tested positive on 08Oct with flu-like symptoms.; Vaccine booster failed to prevent Covid19 infection. I tested positive on 08Oct with flu-like symptoms.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 at 11:30 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Oct2023, outcome "recovering" and all described as "Vaccine booster failed to prevent Covid19 infection. I tested positive on 08Oct with flu-like symptoms.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no other vaccine in four weeks and no other medications in two weeks. The patient stated that the vaccine booster failed to prevent Covid-19 infection. He tested positive on 08Oct2023 with flu-like symptoms. Therapy for the event included Albuterol inhaler to suppress cough. The patient did not have covid prior vaccination. The patient was covid tested post vaccination. The patient had no known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based upon the available information, the reported events DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Oct2023 are deemed associated to the administration of COMIRNATY.   The impact of this report on the benefit risk profile of the Pfizer product and 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: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: COVID-19, Drug ineffective, EGFR status assay, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna x2 + 2 Moderna boosters, + Pfizer bivalent; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 74-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 13:00 as dose 5 (booster), single (Lot number: GJ2524) at the age of 74 years, in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "compromised renal fxn eGFR about 60" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline"; Doxycycline, reaction(s): "known allergies: doxycycline"; Oxycodone, reaction(s): "known allergies: oxycodone"; Hydrocodone, reaction(s): "known allergies: hydrocodone". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Sep2022 at 13:00, outcome "unknown", described as "Moderna x2 + 2 Moderna boosters, + Pfizer bivalent"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Sep2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: EGFR status assay: (unspecified date) 60; SARS-CoV-2 test: (28Sep2023) Positive, notes: Positive COVID antigen test 28Sep2023 and 03Oct2023; (03Oct2023) Positive, notes: Positive COVID antigen test 28Sep2023 and 03Oct2023; (05Oct2023) Negative, notes: Negative antigen test 05Oct and 07Oct2023; (07Oct2023) Negative, notes: Negative antigen test 05Oct and 07Oct2023; (11Oct2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid).; 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 drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.
Sex: F
Vaccine: COVID19, FLUX, PNC13, PNC20
Symptoms: Pain
Clinical narrative: She was in acute, major pain from her shoulders to her toes..lasting 5 to 7 minutes then slowly went away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation; for immunisation; pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation; for immunisation; influenza vaccine (INFLUENZA), as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine moderna (her previous COVID shots were moderna, DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization.  The following information was reported: PAIN (non-serious), outcome "recovered", described as "She was in acute, major pain from her shoulders to her toes..lasting 5 to 7 minutes then slowly went away".  The reporter considered "she was in acute, major pain from her shoulders to her toes..lasting 5 to 7 minutes then slowly went away" associated to device constituent of pneumococcal 13-val conj vac (dipht crm197 protein) and pneumococcal 20-val conj vac (dipht crm197 protein). Causality for "she was in acute, major pain from her shoulders to her toes..lasting 5 to 7 minutes then slowly went away" was determined associated to device constituent of pneumococcal 13-val conj vac (dipht crm197 protein) and pneumococcal 20-val conj vac (dipht crm197 protein).  Additional information: My mother just received her covid vaccine along with the flu and pneumonia vaccines at the (pharmacy name) in (city name), (state name). Covid in left arm and others in the right. Within 5 to 7 minutes. She was in acute, major pain from her shoulders to her toes. lasting 5 to 7 minutes then slowly went away. She has never had a reaction like this. her previous COVID shots were moderna. what are other concerns should I be watching for? There is no redness or heat to the injection sites.  The information on the batch/lot number for bnt162b2, pneumococcal 13-val conj vac (dipht crm197 protein), pneumococcal 13-val conj vac (dipht crm197 protein) , pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein) has been requested and will be submitted if and when received.