chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19, 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) (Physician). 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 08Aug2023 as dose 6 (booster), single (Lot number: GK0928) at the age of 67 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sick sinus syndrome" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing), notes: Known allergies: Sulfa allergy; "Gluten sensitivity" (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 Sep2023, outcome "recovered" (Oct2023) and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment from 27Sep2023 to 02Oct2023. Clinical Course: Symptoms had fully resolved as of about 3 days into first Paxlovid treatment did not have access to retest at that time.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported event Drug ineffective and COVID 19 cannot be ruled out.    ,Linked Report(s) : US-PFIZER INC-202300328852 same patient, different drug and event (Paxlovid case);
Age: 46.0
Sex: F
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 46-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10May2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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 was not reported. There were no concomitant medications. 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 were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.
Age: 25.0
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) (Other HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 14Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 25 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 drug ineffective, covid-19 with Paxlovid from 04Oct2023 to 08Oct2023 (Lot number GJ3916).  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to 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-202300329586 same patient, different drug and different event;
Age: 72.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose 5 (booster), single (Lot number: Gh9703) at the age of 72 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EN5318), in right arm, on 24Feb2021 as dose 2, single (Lot number: EN6203), in right arm, on 14Oct2021 as dose 3 (booster), single (Lot number: Ff2593), in right arm and on 31May2022 as dose 4 (booster), single (Lot number: FM9992), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 04Oct2023 to 08Oct2023. Clinical course: Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300329587 same patient, different drug and different event;
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; vaccine brand other=Moderna; vaccine administration date=Oct/2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Batch/Lot number: unknown) and in Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "former rheumatoid arthritis" (unspecified if ongoing); "chronic pain" (unspecified if ongoing); "allergy-induced asthma" (ongoing); "high blood pressure" (ongoing); "Possibly penicillin and sulfas" (unspecified if ongoing); "Possibly penicillin and sulfas" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM, start date: May2013; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: Feb2018. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Oct2022, outcome "unknown", described as "vaccine brand other=Moderna; vaccine administration date=Oct/2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Oct2023) Positive, notes: two Binax brand tests. Therapeutic measures were taken as a result of drug ineffective, Covid-19 with PAXLOVID from 04Oct2023 to 09Oct2023.  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-202300328896 same patient, different drug and event;
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Lot number: GJ6739), in left arm and on 04Jun2023 as dose 6 (booster), single (Lot number: GJ3268) at the age of 71 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 18Mar2021 as dose 2, single (Lot number: EN6208), in left arm, on 17Jun2021 as dose 3 (booster), single (Lot number: 20125BA), in left arm and on 23Apr2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Celiac" (unspecified if ongoing); "Dermatitis herpetiformis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "slightly high cholesterol" (unspecified if ongoing), notes: slightly high; "Overweight" (unspecified if ongoing); "recurring Vertigo" (unspecified if ongoing), notes: recurring; "Known allergies: Several, too many to list" (unspecified if ongoing), notes: Known allergies: Several, too many to list. 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 "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Oct2023) Positive; (Oct2023) Positive; (15Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 01Oct2023 to 05Oct2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300329903 Same patient, different vaccine dose/event;
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 46-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Jun2023 as dose 4 (booster), single (Lot number: GJ3268) at the age of 45 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: "Asthma" (unspecified if ongoing); "Metabolic Syndrome X" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Prediabetes" (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 "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 03Oct2023 to 07Oct2023.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 3 (booster), single (Lot number: GH9694) at the age of 48 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP6955), in left arm and on 19Apr2021 as dose 2, single (Lot number: EW0153), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Pre-diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Certain adhesives (bandages) cause a topical reaction" (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 03Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Oct2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with PAXLOVID from 04Oct2023 to 09Oct2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300329602 same  patient/reporter, different drug/AE;
Age: 58.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Arthralgia, Chills, Fatigue, Myalgia
Clinical narrative: chills; fatigue; severe muscle pain generally; severe joint pain in the left hip; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 58-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 11Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Hip replacement" (unspecified if ongoing); "IV Contrast" (unspecified if ongoing), notes: known allergies: IV Contrast. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, unknown manufacturer), 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. The following information was reported: CHILLS (non-serious) with onset 12Oct2023, outcome "recovering"; FATIGUE (non-serious) with onset 12Oct2023, outcome "recovering"; ARTHRALGIA (non-serious) with onset 12Oct2023, outcome "recovering", described as "severe joint pain in the left hip"; MYALGIA (non-serious) with onset 12Oct2023, outcome "recovering", described as "severe muscle pain generally". Therapeutic measures were not taken as a result of chills, fatigue, myalgia, arthralgia.  Additional information: On 12Oct2023, the patient felt chills, fatigue, severe muscle pain generally, severe joint pain in the left hip. No fever. The patient was not tested for COVID post vaccination.  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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: sore arm; fever; chills; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 at 15:30 as dose 1, single (Lot number: HF9275) at the age of 56 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHILLS (non-serious) with onset 13Oct2023 at 01:30, outcome "not recovered"; PYREXIA (non-serious) with onset 13Oct2023 at 01:30, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset 13Oct2023 at 01:30, outcome "not recovered"; PAIN IN EXTREMITY (non-serious) with onset 13Oct2023 at 01:30, outcome "not recovered", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, pyrexia, chills, headache.  Additional information: there was no other vaccine in four weeks, no other medications in two weeks. No covid prior vaccination, no covid tested post vaccination.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Illness, Peripheral swelling
Clinical narrative: arm became extremely swollen; Arm hot to the touch; Exactly one week after I received the vaccine, I started to feel sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 12:00 as dose 1, single (Lot number: HH7595) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sarcoidosis" (unspecified if ongoing); "breast cancer" (unspecified if ongoing); "melanoma" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE. Past drug history included: Taxotere, reaction(s): "Known allergies: Taxotere". Vaccination history included: Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, All others have been Moderna.), for COVID-19 immunisation. The following information was reported: FEELING HOT (non-serious) with onset 05Oct2023 at 16:00, outcome "not recovered", described as "Arm hot to the touch"; PERIPHERAL SWELLING (non-serious) with onset 05Oct2023 at 16:00, outcome "not recovered", described as "arm became extremely swollen"; ILLNESS (non-serious) with onset Oct2023, 1 week after the suspect product(s) administration, outcome "not recovered", described as "Exactly one week after I received the vaccine, I started to feel sick". The events "arm became extremely swollen", "arm hot to the touch" and "exactly one week after i received the vaccine, i started to feel sick" required emergency room visit. Therapeutic measures were not taken as a result of peripheral swelling, feeling hot, illness.  Additional information: Patient arm became extremely swollen, and hot to the touch and patient felt sick for several days. Exactly one week after patient received the vaccine, Patient started to feel sick. Patient went to urgent care and was still ill. This was patients first Pfizer vaccine and all others have been Moderna.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300329590 same patient, drug and different events;
Age: 34.0
Sex: M
Vaccine: COVID19, FLUC3
Symptoms: Arthralgia, Back pain, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Extreme pain in left shoulder; upper back pain on left side; left arm pain; numbness and tingling in fingers of left hand; numbness and tingling in fingers of left hand; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 18:00 as dose 1, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 11Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. There were no concomitant medications. 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 (BOOSTER) Completed, Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (BOOSTER) Completed, Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 12Oct2023, outcome "not recovered", described as "Extreme pain in left shoulder"; PAIN IN EXTREMITY (non-serious) with onset 12Oct2023, outcome "not recovered", described as "left arm pain"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 12Oct2023, outcome "not recovered" and all described as "numbness and tingling in fingers of left hand"; BACK PAIN (non-serious) with onset 12Oct2023, outcome "not recovered", described as "upper back pain on left side". The events "extreme pain in left shoulder", "upper back pain on left side", "left arm pain" and "numbness and tingling in fingers of left hand" required physician office visit. Therapeutic measures were taken as a result of arthralgia, back pain, pain in extremity, hypoaesthesia, paraesthesia. Additional information: Treatment for adverse events was diclofenac.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2 (BNT162B2 NOS), on 06Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (Oct2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Negative, notes: two days after testing negative via antigen test; (Oct2023) Positive, notes: tested positive for covid via antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 02Oct2023 to 07Oct2023. Clinical course: Patient had no known allergies.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300330419 same patient, different drug/AE;
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 29May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "known allergies: Augmentin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid from 02Oct2023 to 06Oct2023.  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-202300329595 same patient, different drug/AE;
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: Mild arm pain; Pfizer Bivalent/14-OCT-2023; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 47-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2023 at 15:45 as dose 5 (booster), single (Lot number: 4665) intramuscular, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 14Oct2023 as dose 1, single (Batch/Lot number: unknown), in left arm for influenza immunisation. The patient didn't receive bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)). The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Known allergies: Acetaminophen" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 14Oct2023 at 15:45, outcome "unknown", described as "Pfizer Bivalent/14-OCT-2023"; PAIN IN EXTREMITY (non-serious) with onset 14Oct2023 at 19:00, outcome "not recovered", described as "Mild arm pain". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Patient did not receive any other vaccine in four weeks. Patient received various Rx and OTC medications in two weeks. Patient did not had covid prior vaccination. Patient did not test for covid-19 post vaccination. The vaccine facility type was Pharmacy or Drug Store.  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-202300330651 same reporter/product/events; different patient;US-PFIZER INC-202300330662 same reporter/product; different patient;
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 44 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: Ep7533), on 27Apr2021 as dose 2, single (Lot number: EW0171), in left arm and on 25Oct2021 as dose 3 (booster), single (Lot number: 300308D), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Uterine fibroids" (unspecified if ongoing); "Migraines with aura but no headache..aura but no headache." (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Allergy: Amoxicillin". 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 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 03Oct2023 to 08Oct2023. Patient felt better days after taking paxlovid.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300329598 same patient, different drug and different event.;
Age: 12.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: Moderate arm pain; Product=COVID 19, / Brand=Pfizer, / Is bivalent=True, / Administration date=14Oct2023; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2023 at 15:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 12 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 14Oct2023 as dose 1, single (Batch/Lot number: unknown), in left arm. The patient didn't receive bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)). The patient's relevant medical history included: "Migraines" (unspecified if ongoing), notes: Other medical history: Migraines. There were no concomitant medications. 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. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 14Oct2023, outcome "not recovered", described as "Moderate arm pain"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 14Oct2023, outcome "unknown", described as "Product=COVID 19, / Brand=Pfizer, / Is bivalent=True, / Administration date=14Oct2023". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient received his Comirnaty and Influenza vaccinations on 14Oct2023, and a few hours later on 14Oct2023 the arm pain was reported.     The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, 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-202300330630 same reporter/product/events; different patient;US-PFIZER INC-202300330662 same reporter/product, different patient, with similar events;
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Arthralgia, Fatigue, Myalgia, Pain in extremity, Wrong product administered
Clinical narrative: Pfizer Bivalent/14Oct2023; Mild-to-moderate arm pain; Mild-to-moderate arthralgia; Mild-to-moderate myalgia; Moderate fatigue; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2023 at 15:30 as dose 5 (booster), single (Lot number: 4665) intramuscular, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 14Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm for influenza immunisation. The patient didn't receive bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)). The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "seasonal allergy" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: LEVOXYL; NEXIUM [ESOMEPRAZOLE SODIUM]; DYMISTA. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2; Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3 (Booster); Manufacturer Unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 4 (Booster); Manufacturer Unknown), for COVID-19 immunisation. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 14Oct2023 at 15:30, outcome "unknown", described as "Pfizer Bivalent/14Oct2023"; PAIN IN EXTREMITY (non-serious) with onset Oct2023, outcome "not recovered", described as "Mild-to-moderate arm pain"; ARTHRALGIA (non-serious) with onset Oct2023, outcome "not recovered", described as "Mild-to-moderate arthralgia"; MYALGIA (non-serious) with onset Oct2023, outcome "not recovered", described as "Mild-to-moderate myalgia"; FATIGUE (non-serious) with onset Oct2023, outcome "not recovered", described as "Moderate fatigue". Therapeutic measures were not taken as a result of pain in extremity, arthralgia, myalgia, fatigue.  Additional information: covid did not occur prior vaccination. Covid not tested post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300330651 same reporter/product; different patient;US-PFIZER INC-202300330630 same reporter/product; different patient;
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Malaise, Sinus disorder, Suspected COVID-19
Clinical narrative: tested positive for COVID in Aug2023/Felt like had Covid again after receiving the vaccine; tested positive for COVID in Aug2023/Felt like had Covid again after receiving the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 72-year-old male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 07Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years intramuscular for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "AFib" (ongoing), notes: Diagnosed before 2007, but had cardioversion in 2007; "sinus and congestion issues in the fall" (unspecified if ongoing); "Covid-19", start date: Aug2023 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization; Pneumonia vaccine, for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 07Oct2023, outcome "unknown" and all described as "tested positive for COVID in Aug2023/Felt like had Covid again after receiving the vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Positive.  Additional information: it was reported that the patient had Covid again after receiving the vaccine. After patient got vaccine thought had COVID again, but patient did not. The event lasted until a couple of days ago, feeling better. Lasted 8 to 10 days. Patient said some of the people at work felt like that too, no further details provided. The patient had COVID-19 vaccine 12 plus, adult new formulation because it had had been over 9 months and figured coming into season again and doesn't want COVID at his age. It was further mentioned that the patient tested positive for COVID-19 in Aug2023. Patient had sinus and congestion issues in the fall. Patient didn't test at that time, then 2 days later was getting worse, clearly had COVID, didn't get a positive COVID test until 2 days after caller did. Patient had lingering sinus things. Clarified and confirmed had prior Pfizer COVID vaccines, had first 2 doses and then a booster and maybe another booster. Confirmed all doses were the Pfizer COVID vaccine. NDC numbers, lot numbers, expiration dates were unknown as the reporter did not have products or information at time of call. Had sinus problems every Sep, which was part of the delay in patient going to urgent care when tested positive for COVID in Aug2023.   The information on the batch/lot number for bnt162b2 omi xbb.1.5, bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: vaccine brand other=Moderna/vaccine, administration date=12Nov2021, vaccine brand=Pfizer / BioNTech/vaccine, administration date=12Nov2021/Interchange of vaccine products; 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 59-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 16Apr2021 as dose 2, single (Lot number: ER8721), in left arm and on 12Nov2021 as dose 3 (booster), single (Lot number: 320308D), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 4 (booster), single (Lot number: 060A22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient took 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 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand other=Moderna/vaccine, administration date=12Nov2021, vaccine brand=Pfizer / BioNTech/vaccine, administration date=12Nov2021/Interchange of vaccine products". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (start date 05Oct2023, stop date 09Oct2023).  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300330560 same patient, different drug/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Wrong product administered
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Wrong vaccine administered; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 1, single (Lot number: GH9697), in left arm for covid-19 immunisation. The patient didn't receive bnt162b2 (BNT162B2). The patient's relevant medical history included: "Known allergies: sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 28Oct2022, outcome "unknown", described as "Wrong vaccine administered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Oct2023) Negative; (unspecified date) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 05Oct2023 to 10Oct2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300330546 same patient, different SD/AE;
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 74-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 at 02:00 as dose 1, single (Lot number: HD9835) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Depression" (unspecified if ongoing); "HLP" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient has no known allergies. Anti viral COVID 19 treatment Paxlovid, started from 05Oct2023 to 10Oct2023.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05May2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 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 was not reported. Concomitant medication(s) included: CRESTOR, start date: 01Dec2020, stop date: 04Oct2023; PROZAC, start date: 02Sep2017, stop date: 03Oct2023. Past drug history included: Sulfonylurea, reaction(s): "Drug Allergier:sulfonylurea". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received COVID-19 antiviral treatment with Paxlovid form 04Oct2023 to 09Oct2023, 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.; 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: 39.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Pain, Poor quality sleep
Clinical narrative: fatigue; moderate body aches; Poor sleep for the one night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 at 14:00 as dose 1, single (Lot number: HF9275) at the age of 39 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 10Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for 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 Number: 05 (Booster), Manufacture: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 04 (Booster), Manufacture: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 03 (Booster), Manufacture: Unknown), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization Series Completed, Manufacture: Unknown), for COVID-19 immunization. The following information was reported: POOR QUALITY SLEEP (non-serious) with onset 10Oct2023 at 23:00, outcome "recovered" (Oct2023), described as "Poor sleep for the one night"; FATIGUE (non-serious) with onset 11Oct2023 at 23:00, outcome "recovered" (Oct2023); PAIN (non-serious) with onset 11Oct2023 at 23:00, outcome "recovered" (Oct2023), described as "moderate body aches". Therapeutic measures were not taken as a result of poor quality sleep, fatigue, pain.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: constant headache/ it was like on and off and now it is a steady headache; 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 68-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: NORVASC taken for cardiovascular disorder. The following information was reported: HEADACHE (non-serious) with onset Oct2023, outcome "not recovered", described as "constant headache/ it was like on and off and now it is a steady headache". Therapeutic measures were taken as a result of headache. Additional information: NDC number of Comirnaty: 00069-2362-10. Patient would like to know if he should visit a doctor after experiencing headaches following the vaccination of Comirnaty 2023-2024 formula for 12 years and older. The headache started out slowly and just became a constant headache. He had an mRNA COVID shot about 2 and a half weeks prior. He was having a headache that, it just started like 4 days prior, and it was like on and off and became a steady headache. He started taking ibuprofen (MOTRIN) and then he stopped and he went and he got bare aspirin that thin out his blood because he was reading on here about blood clots and he was hoping that isn't it.   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: Asthenia, Cough, Diarrhoea, Malaise, Oropharyngeal pain
Clinical narrative: Diarrhea; Coughing; Coughed all night; Sore throat; I am a sick person; I started to feel sick; I feel very weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 06Oct2023 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: COUGH (non-serious) with onset Oct2023, outcome "unknown", described as "Coughing; Coughed all night"; DIARRHOEA (non-serious) with onset Oct2023, outcome "unknown", described as "Diarrhea"; ILLNESS (non-serious) with onset Oct2023, outcome "unknown", described as "I am a sick person; I started to feel sick"; ASTHENIA (non-serious) with onset Oct2023, outcome "unknown", described as "I feel very weak"; OROPHARYNGEAL PAIN (non-serious) with onset Oct2023, outcome "unknown", described as "Sore throat".  Additional information: Patient had the shot for COVID (Pfizer COVID-19 vaccine) on the 6th of this month and started to feel sick and then had diarrhea and coughing and coughed all night and had a sore throat. Patient felt very weak and wanted to know what can be done for this.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.