chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Flank pain, Hydronephrosis, Ovarian cyst, Pyelonephritis
Clinical narrative: test positive; test positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 as dose 4 (booster), 0.3 ml single (Lot number: GJ3274) at the age of 36 years intramuscular, in left deltoid for covid-19 immunisation; bnt162b2 (BNT162B2), on 19Mar2021 as dose 1, 0.3 ml single (Lot number: ER2613), in left arm, on 09Apr2021 as dose 2, 0.3 ml single (Lot number: EW0158), in left deltoid and on 10Dec2021 as dose 3 (booster), 0.3 ml single (Lot number: FJ8757), in left deltoid, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Mar2023, outcome "unknown" and all described as "test positive". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (24Mar2023) positive; SARS-CoV-2 test: (21Feb2022) Detected; (24Mar2023) positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300135086 same patient/vaccine, different dose and event;
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Renal atrophy, Renal impairment, Renal scan, Scan
Clinical narrative: test positive; test positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 as dose 4 (booster), 0.3 ml single (Lot number: GJ3274) at the age of 36 years intramuscular, in left deltoid for covid-19 immunisation; bnt162b2 (BNT162B2), on 19Mar2021 as dose 1, 0.3 ml single (Lot number: ER2613), in left arm, on 09Apr2021 as dose 2, 0.3 ml single (Lot number: EW0158), in left deltoid and on 10Dec2021 as dose 3 (booster), 0.3 ml single (Lot number: FJ8757), in left deltoid, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Mar2023, outcome "unknown" and all described as "test positive". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (24Mar2023) positive; SARS-CoV-2 test: (21Feb2022) Detected; (24Mar2023) positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300135086 same patient/vaccine, different dose and event;
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound kidney
Clinical narrative: test positive; test positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 as dose 4 (booster), 0.3 ml single (Lot number: GJ3274) at the age of 36 years intramuscular, in left deltoid for covid-19 immunisation; bnt162b2 (BNT162B2), on 19Mar2021 as dose 1, 0.3 ml single (Lot number: ER2613), in left arm, on 09Apr2021 as dose 2, 0.3 ml single (Lot number: EW0158), in left deltoid and on 10Dec2021 as dose 3 (booster), 0.3 ml single (Lot number: FJ8757), in left deltoid, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Mar2023, outcome "unknown" and all described as "test positive". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (24Mar2023) positive; SARS-CoV-2 test: (21Feb2022) Detected; (24Mar2023) positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300135086 same patient/vaccine, different dose and event;
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Nasopharyngeal swab, SARS-CoV-2 test, Vaccination failure
Clinical narrative: test positive; test positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 as dose 4 (booster), 0.3 ml single (Lot number: GJ3274) at the age of 36 years intramuscular, in left deltoid for covid-19 immunisation; bnt162b2 (BNT162B2), on 19Mar2021 as dose 1, 0.3 ml single (Lot number: ER2613), in left arm, on 09Apr2021 as dose 2, 0.3 ml single (Lot number: EW0158), in left deltoid and on 10Dec2021 as dose 3 (booster), 0.3 ml single (Lot number: FJ8757), in left deltoid, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Mar2023, outcome "unknown" and all described as "test positive". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (24Mar2023) positive; SARS-CoV-2 test: (21Feb2022) Detected; (24Mar2023) positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300135086 same patient/vaccine, different dose and event;
Age: 66.0
Sex: F
Vaccine: COVID19, 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 67-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Mar2023 as dose 5 (booster), 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), 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: "Known allergies: Penicillin" (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 "recovered" (Oct2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Positive; (Oct2023) Negative; (Oct2023) Negative; (Oct2023) Negative; (Oct2023) Negative; (Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment from 16Oct2023 to 21Oct2023.   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: 69.0
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 69-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 at 13:00 as dose 1, single (Lot number: HG4680) at the age of 69 years, in right arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Sulfur drugs" (unspecified if ongoing), notes: known allergies: Sulfur drugs. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative; (19Oct2023) Negative, notes: on day seven. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: After taking Paxlovid for five days (from 12Oct2023 to 17Oct2023), patient home tested negative on day seven. About three day later, she started sneezing and draining again and home tested positive and negative. She was feeling a little better but still stuffed up and tired. She had night sweats too.    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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: unable to walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received bnt162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EL9269, Expiration Date: 31May2021) at the age of 74 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: GAIT INABILITY (non-serious) with onset 2021, outcome "unknown", described as "unable to walk".  Additional information: Reporter stated that got the first Pfizer Covid vaccine 06Feb2021, second one on 02Mar2021 and got the booster on 05Nov2021. About four weeks after the first vaccine she was unable to walk; has muscle weakness in left leg. Has been like that for 2.5 years. Was wondering if it was going to get any better. Has been to so many doctors, they do not know anything and are not talking as much.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300337515 Same patient/vaccine, different vaccine dose/event;US-PFIZER INC-202300348118 Same patient/vaccine, different vaccine dose/event;
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: muscle weakness in her left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received bnt162b2 (BNT162B2), on 02Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: bnt162b2 (Batch/lot number: EL9269), administration date: 06Feb2021, when the patient was 74-year-old, for COVID-19 Immunization, reaction(s): "unable to walk". The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 07Apr2021, outcome "not recovered", described as "muscle weakness in her left leg". The event "muscle weakness in her left leg" required physician office visit. Therapeutic measures were not taken as a result of muscular weakness. Additional information:  Patient got the first Pfizer Covid vaccine 06Feb2021, second one on 02Mar2021 and got the booster on 05Nov2021. About four weeks after the first vaccine she was unable to walk; has muscle weakness in left leg since 07Apr2021. Patient had been like that for 2.5 years (as of ). Patient was wondering if it was going to get any better. She had been to so many doctors, they did not know anything and were not talking as much. No investigations were performed.    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-202300348112 Same patient/vaccine, different vaccine dose (dose 1)/event;US-PFIZER INC-202300337515 Same patient/vaccine, different vaccine dose (Comirnaty (2023-2024 Formula))/event;
Sex: F
Vaccine: COVID19
Symptoms: Periarthritis
Clinical narrative: experiencing moderate to severe frozen shoulder syndrome; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 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 and concomitant medications were not reported. Vaccination history included: Bnt162b2 (I have only received Pfizer vaccines and have received every shot offered since 2020 by Pfizer), for Covid-19 Immunization. The following information was reported: PERIARTHRITIS (non-serious), outcome "unknown", described as "experiencing moderate to severe frozen shoulder syndrome". Clinical course: The reporter stated, "Can you please provide me with the side effect profile of all Covid-19 vaccines and boosters. I have only received Pfizer vaccines and have received every shot offered since 2020 by Pfizer. I am experiencing moderate to severe frozen shoulder syndrome".    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: 44.0
Sex: F
Vaccine: 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 contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: METFORMIN. Vaccination history included: COVID-19 vaccine (dose 1, single; manufacturer unknown), for COVID-19 immunization; COVID-19 vaccine (dose 2, single; manufacturer unknown), for COVID-19 immunization; COVID-19 vaccine (dose 3 (booster), single; manufacturer unknown), for COVID-19 immunization; COVID-19 vaccine (dose 4 (booster), single; manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, COVID-19 which included Paxlovid (lot number: GK2916) starting on 25Oct2023.  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: UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Paxlovid taken after vaccine.; Paxlovid taken after vaccine.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), 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 "Paxlovid taken after vaccine.". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, COVID-19, Drug ineffective, Heart rate increased
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; Immediate rapid heart beat and increased blood pressure; Immediate rapid heart beat and increased blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 22Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Irritated Bowel" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; CARVEDILOL; SIMVASTATIN. The following information was reported: HEART RATE INCREASED (non-serious), BLOOD PRESSURE INCREASED (non-serious) all with onset 21Jan2022, outcome "recovered" and all described as "Immediate rapid heart beat and increased blood pressure"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jan2022, outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19?:Yes". The events "immediate rapid heart beat and increased blood pressure" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) increased; Heart rate irregular: (unspecified date) Immediate rapid heartbeat; SARS-CoV-2 test: (unspecified date) Negative, notes: Covid test type post vaccination: Nasal Swab; (21Jan2022) positive. Therapeutic measures were taken as a result of heart rate increased, blood pressure increased: treatment with fluids. The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, SARS-CoV-2 test
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; Immediate rapid heart beat and increased blood pressure; Immediate rapid heart beat and increased blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 22Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Irritated Bowel" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; CARVEDILOL; SIMVASTATIN. The following information was reported: HEART RATE INCREASED (non-serious), BLOOD PRESSURE INCREASED (non-serious) all with onset 21Jan2022, outcome "recovered" and all described as "Immediate rapid heart beat and increased blood pressure"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jan2022, outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19?:Yes". The events "immediate rapid heart beat and increased blood pressure" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) increased; Heart rate irregular: (unspecified date) Immediate rapid heartbeat; SARS-CoV-2 test: (unspecified date) Negative, notes: Covid test type post vaccination: Nasal Swab; (21Jan2022) positive. Therapeutic measures were taken as a result of heart rate increased, blood pressure increased: treatment with fluids. The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: 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) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 64 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received COVID-19 Treatment from 12Oct2023 to 16Oct2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), in Jul2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received COVID-19 treatment from 13Oct2023 to 17Oct2023. No known allergies.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Sep2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: lactose and egg intolerant" (unspecified if ongoing), notes: Known allergies: lactose and egg intolerant; "Known allergies: lactose and egg intolerant" (unspecified if ongoing), notes: Known allergies: lactose and egg intolerant. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1), for COVID-19 immunization; Covid-19 vaccine (Dose: 2), for COVID-19 immunization; Covid-19 vaccine (Dose: 3 (Booster)), for COVID-19 immunization; Covid-19 vaccine (Dose: 4 (Booster)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 05Oct2023, outcome "recovered", COVID-19 (medically significant) with onset 05Oct2023, outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Oct2023) Positive, notes: for the very first time; (13Oct2023) Negative. The patient tested positive for COVID-19 for the very first time on 06Oct2023. Her symptoms started the day before. They were fairly mild but still didn't feel well and had multiple cold-like symptoms. The patient started Paxlovid that evening and finished my last dose the morning of 11Oct2023. She started feeling like 50% better within a couple days of starting and felt completely better and tested negative by 13Oct2023. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was used as COVID-19 treatment from 06Oct2023 to 11Oct2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 at 09:30 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VICKS DAYQUIL [PARACETAMOL;PSEUDOEPHEDRINE HYDROCHLORIDE], start date: 16Oct2023, stop date: 18Oct2023. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: 3 days after testing negative (with no symptoms); Positive, notes: positive antigen tests on Day 9. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included paxlovid from 16Oct2023 to 21Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 12:00 as dose 5 (booster), 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: "Arteriosclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Thimerosal, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (DOSE NUMBER 4 (BOOSTER), SINGLE, Brand: Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER 3 (BOOSTER), SINGLE, Brand: Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER 2, SINGLE, Brand: Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER 1, SINGLE, Brand: Unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 15Oct2023 at 02:00, outcome "not recovered", COVID-19 (medically significant) with onset 15Oct2023 at 02:00, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Oct2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: patient experienced full symptoms again of covid and tested positive again on rapid antigen test . Fever 101.5, headache, cough, chills myalgia. Symptoms are on day 5 and still fever and aches. taking tylenol. getting rest.  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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 12May2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing); "Sulfa antibiotics." (unspecified if ongoing), notes: Known allergies: Sulfa antibiotics. 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 "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 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Experiencing incredible joint and muscle pain and it is not going away; Experiencing incredible joint and muscle pain and it is not going away; 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 patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 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: ARTHRALGIA (non-serious), MYALGIA (non-serious), outcome "not recovered" and all described as "Experiencing incredible joint and muscle pain and it is not going away".  Additional information: After patient would said a week later, patient had been experiencing incredible joint and muscle pain and it is not going away. Patient added this was not lifestyle. It was affecting reporter's quality of life."  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: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose #1: Pfizer/ Dose #2: Pfizer/ Dose #3: Pfizer/ Dose #4: Moderna/ Dose #5: Moderna; 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 male patient received bnt162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8732), in left arm, on 14Apr2021 as dose 2, single (Lot number: EW0161), in left arm and on 18Oct2021 as dose 3 (booster), single (Lot number: 320308D) at the age of 47 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Mar2022 as dose 4 (booster), single (Lot number: 048L21A), in left arm and on 15Sep2022 as dose 5 (booster), single (Lot number: AS7145B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "known allergies: sulfa drugs" (unspecified if ongoing); "known allergies: cashews, Peanuts, tree nuts" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Zithromax, reaction(s): "known allergies: Zithromax". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Mar2022, outcome "unknown", described as "Dose #1: Pfizer/ Dose #2: Pfizer/ Dose #3: Pfizer/ Dose #4: Moderna/ Dose #5: Moderna"; 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, notes: product- COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 14Oct2023 to 18Oct2023.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 75-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose 1, single (Lot number: HM7595) at the age of 75 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: product=COVID 19 Treatment, brand=Pfizer; Treatment start date=15Oct2023; Treatment stop date=19Oct2023; indication=Treatment of COVID-19.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Headache
Clinical narrative: daily headaches which happen multiple times day and night; vivid dreams; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Oct2023 at 15:00 as dose 1, single (Lot number: HH7595) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "bronchial asthma when ill with a cold" (unspecified if ongoing), notes: bronchial asthma when ill with a cold; "bronchial asthma when ill with a cold" (unspecified if ongoing), notes: bronchial asthma when ill with a cold; "Latex allergy" (unspecified if ongoing). Concomitant medication(s) included: FLU, on 01Sep2023 as dose number unknown, single; RSV VACCINE, on 01Sep2023 as dose number unknown, single. Past drug history included: Vicodin, reaction(s): "Drug allergy"; Floxin, reaction(s): "Drug allergy". Vaccination history included: Moderna (had Moderna in the past with no side effects), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 15Oct2023, outcome "not recovered", described as "daily headaches which happen multiple times day and night"; ABNORMAL DREAMS (non-serious) with onset 15Oct2023, outcome "not recovered", described as "vivid dreams". Therapeutic measures were not taken as a result of headache, abnormal dreams. Additional information: Patient stated "I have been getting daily headaches which happen multiple times day and night as well as vivid dreams, these all started about a week after the Covid vaccine. I had Moderna in the past with no side vaccine."
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid and put on Paxlovid; tested positive for Covid and put on Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  An 81-year-old female patient received bnt162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6200) and on 17Mar2021 as dose 2, single (Lot number: EN6207) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "kidney disease", start date: 2018 (ongoing); "thyroid" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "heart burn acid reflux" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE taken for gastrooesophageal reflux disease; LOSARTAN taken for blood pressure measurement (ongoing); LEVOTHYROXINE taken for thyroid disorder (ongoing); NEBIVOLOL taken for palpitations; DULOXETINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "tested positive for Covid and put on Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19, patient took Paxlovid from 21Oct2023 to 25Oct2023 .
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; 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 male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 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: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 23Oct2023, outcome "unknown" and all described as "COVID-19". Clinical course: Patient and his wife had taken all of the COVID-19 vaccines produced by Pfizer. They took the most current vaccine two weeks ago. Two days ago they contracted COVID-19 and were surprised to have contracted the virus with the current vaccine.  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: Linked Report(s) : US-PFIZER INC-202300349536 same reporter/vaccine/event, different patient;
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: when they gave her the Pfizer Covid Vaccine shot that day, it bled.; pain, it started at the injection site; pain in her hand, and arm; 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.  An 84-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 84 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE HAEMORRHAGE (non-serious), 1 day after the suspect product(s) administration, outcome "unknown", described as "when they gave her the Pfizer Covid Vaccine shot that day, it bled."; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain, it started at the injection site"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in her hand, and arm".  Additional information: The patient reported that when they gave her the Pfizer Covid Vaccine shot that day, it bled. And the nurse apparently told her that she's never had that bleed before but she's developed pain her arm and it started at the injection site but now it run and travelled to her hand and she said that it was very painful and she wanted to know if that could be a side effect of the vaccination. She added she did not know if it was from that or not (the vaccine), but it was very painful down into her hand.  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: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects reported; HCP calling to report AE for patient who received improperly stored VARIVAX on 10OCT2023. No side effects reported. No other medical information known. Operator of Device was a Healthcare Professional. HCP permission to contact obtained. See addition; This spontaneous report was received from the nurse and referred to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 10-OCT-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X007372, expiration date: 12-MAR-2025, administered for prophylaxis (strength, and route of administration were not provided) which improperly stored by a healthcare professional (temperature showed -9.9 C for 12 minutes, there were previous temperature excursion showed -8.8 C for 14 minutes; -13.1 C for 11 minutes). No side effects reported (no adverse event).; Sender's Comments:  US-009507513-2310USA007934:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pyrexia, Respiratory tract congestion
Clinical narrative: chest stuff [Respiratory tract congestion]; chills; fever; aches in joints ankles and knees; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT CONGESTION (chest stuff [Respiratory tract congestion]), CHILLS (chills), PYREXIA (fever) and ARTHRALGIA (aches in joints ankles and knees) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 4782591) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 30-Jan-2023, the patient started UPADACITINIB (RINVOQ) (Oral use) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 11-Oct-2023, the patient experienced RESPIRATORY TRACT CONGESTION (chest stuff [Respiratory tract congestion]), CHILLS (chills), PYREXIA (fever) and ARTHRALGIA (aches in joints ankles and knees). At the time of the report, RESPIRATORY TRACT CONGESTION (chest stuff [Respiratory tract congestion]), CHILLS (chills), PYREXIA (fever) and ARTHRALGIA (aches in joints ankles and knees) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.       No Concomitant and treatment medications were reported.
Age: 81.0
Sex: M
Vaccine: UNK
Symptoms: Discomfort, Injection site pain
Clinical narrative: The night was annoying for him with the discomfort and had to endure this through the night; a little more reaction than normal as well; injection site pain; This spontaneous case was reported by a patient and describes the occurrence of DISCOMFORT (The night was annoying for him with the discomfort and had to endure this through the night), IMMUNISATION REACTION (a little more reaction than normal as well) and INJECTION SITE PAIN (injection site pain) in an 81-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Cardiovascular disorder. Previously administered products included for Product used for unknown indication: Flu shot (3 weeks ago) in October 2023. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Drug allergy (Statin).    On 25-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced DISCOMFORT (The night was annoying for him with the discomfort and had to endure this through the night), IMMUNISATION REACTION (a little more reaction than normal as well) and INJECTION SITE PAIN (injection site pain). The patient was treated with PARACETAMOL (TYLENOL) in October 2023 for Pain, at an unspecified dose and frequency. At the time of the report, DISCOMFORT (The night was annoying for him with the discomfort and had to endure this through the night) and INJECTION SITE PAIN (injection site pain) was resolving and IMMUNISATION REACTION (a little more reaction than normal as well) outcome was unknown.            No concomitant medication was reported.
Age: 66.0
Sex: F
Vaccine: FLUX, RSV
Symptoms: Cough, Wheezing
Clinical narrative: wheezing; coughing; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP).  A 66-year-old female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 26Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years for immunisation; for immunisation; treprostinil sodium (REMODULIN), first regimen (Batch/Lot number: unknown) at 0.05 ug/kg (0.050 ug/kg) and second regimen since Apr2021 (ongoing) (Batch/Lot number: unknown), all intravenous for pulmonary arterial hypertension; influenza vaccine (INFLUENZA VACCINE), on 26Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Pulmonary arterial hypertension" (ongoing). Concomitant medication(s) included: TADALAFIL. The following information was reported: COUGH (medically significant) with onset Sep2023, outcome "unknown", described as "coughing"; WHEEZING (medically significant) with onset Sep2023, outcome "unknown". The events "wheezing" and "coughing" required emergency room visit. She stated that her symptoms were not severe enough to go to the ER (emergency room) and wanted to knew if there is anything she could take. She was advised that there was nothing over the counter, but her MD (physician) could possibly prescribe something. The action taken for treprostinil sodium was dosage not changed.  The reporter did not provide causality for the events of cough and wheezing with IV Remodulin. The reporter's causality for the events of cough and wheezing with flu vaccine and RSV vaccine was considered to be possibly related.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported events wheezing and cough were related to the suspect product, however based on the temporal association possible causal association cannot be exclucde
Sex: U
Vaccine: UNK
Symptoms: Acute febrile neutrophilic dermatosis
Clinical narrative: Recurrent giant cellulitis-like Sweet syndrome induced by SARS-CoV-2 Pfizer-BioNTech mRNA vaccine; This is a literature report.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), 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: ACUTE FEBRILE NEUTROPHILIC DERMATOSIS (medically significant), outcome "unknown", described as "Recurrent giant cellulitis-like Sweet syndrome induced by SARS-CoV-2 Pfizer-BioNTech mRNA vaccine".; Sender's Comments: As there is limited information in the case provided, the causal association between the event acute febrile neutrophilic dermatosis and the suspect product BNT162B2 OMI XBB.1.5 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product 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.