chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; 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 35-year-old female patient (pregnant) received bnt162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: FR8730), in left arm and on 16Apr2021 as dose 2, single (Lot number: FR8735) at the age of 32 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Nov2021 as dose 3 (booster), single (Lot number: 021C21A), in left arm for covid-19 immunisation. Date of last menstrual period: 24Aug2023. The patient was 8 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 30May2024. 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 "recovered" (17Oct2023) and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Positive; (17Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300336044 same reporter/patient with different drug/AE;US-PFIZER INC-202300336168 same reporter/patient/drug with different AE;
Sex: M
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION HCL, start date: 10May2023. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin. 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 08Oct2023 to 12Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300336079 same reporter/patient with different drug/AE;
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). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm, as dose 4 (booster), single (Batch/Lot number: unknown), in left leg and as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), in Apr2022 as dose 1, single (Batch/Lot number: unknown), in left arm and in Jun2022 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "No" (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 with paxlovid from 14Oct2023 to 18Oct2023. Clinical course: After 4 days of finishing treatment with Paxlovid and testing negative for Covid 19, patient got Covid rebound, had covid symptoms and tested positive.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300336301 same reporter/patient with different drug/AE;
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Sep2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (Oct2023) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 11Oct2023 to 15Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335934 same patient, different drug/AE.;
Age: 28.0
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Aug2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 28 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 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 12Oct2023 to 17Oct2023. Clinical course: Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300336307 Same patient, different product, different dose/event;
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Fatigue; Nausea; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "asthma" (unspecified if ongoing); "cholesterol high" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: RSV VACCINE taken for immunisation, start date: 10Oct2023, stop date: 10Oct2023; FLU [INFLUENZA VACCINE] taken for influenza immunisation, start date: 26Sep2023, stop date: 26Sep2023; LISINOPRIL; CHLORTHALIDONE; ROSUVASTIN. Past drug history included: Ciprofaxen, reaction(s): "Drug allergy"; Phenobarbital, reaction(s): "Drug allergy". 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), MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 18Oct2023, outcome "recovered" (Oct2023); HEADACHE (non-serious) with onset 18Oct2023, outcome "recovered" (Oct2023); NAUSEA (non-serious) with onset 18Oct2023, outcome "recovered" (Oct2023). Therapeutic measures were not taken as a result of fatigue, nausea, headache.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
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) (Physician). The reporter is the patient.  A 55-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. 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. 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. Clinical Course: Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events drug ineffective and Covid-19 and the use of suspect product cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202300336312 same reporter/patient; different drug/events;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 13Jan2023 as dose number unknown, single (Batch/Lot number: unknown), 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 2023, outcome "recovered" (2023) and all described as "covid-19". Therapeutic measures were taken as a result of drug ineffective, Covid-19 with Paxlovid from Oct2023 to Oct2023.  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-202300335935 same patient, different drug/AE;
Age: 41.0
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic inflammatory demyelinating polyradiculoneuropathy" (unspecified if ongoing), notes: CIDP. The patient's concomitant medications were not reported. 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; Covid-19 vaccine (Dose 5 (booster); Manufacturer unknown), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 12Oct2023 to 16Oct2023. . No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300336370 same patient, different drug and event;
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 59-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies: sulfa drugs" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing); "Allergies: corn, eggs" (unspecified if ongoing); "Allergies: dairy" (unspecified if ongoing). The patient's concomitant medications were not reported. 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. 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 (Paxlovid) were taken as a result of drug ineffective, covid-19 from 12Oct2023 to 15Oct2023.  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-202300335938 same patient, different drug/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunisation. 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 (Paxlovid treatment start date: 11Oct2023, sop date: 16Oct2023) 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335922 same patient different drug /event;
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore Arm; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 72-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 09:30 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (ongoing), notes: several different pills in the morning; "Compromised immune system" (ongoing). The patient took concomitant medications. Vaccination history included: Moderna (Dose Number Unknown, Single), for COVID-19 IMMUNISATION, reaction(s): "tired", "got sore arm from all the other covid shot". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "unknown", described as "Sore Arm"; FATIGUE (non-serious) with onset 2023, outcome "unknown", described as "tired".  Additional Information: Reporter did not had a compromised immune system but her husband does, he had ulcerative colitis (Intent: Medical History) and he never got affected by the shot other than a sore arm so this was what she found so absurd. Just a sore arm. He had gotten on the Friday before at 9:30 in the morning. He was 5, she did not know if he was 5'10 or 5'11 and he was probably like 200 pounds. He got sore arm from all the other covid shot so it was not anything really different and he was tired. His was all Moderna also with myself. This was the only Pfizer shot he got.  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-202300333443 same reporter/drug, different AE/patient;US-PFIZER INC-202300334050 same reporter/drug, different AE/patient;
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (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), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of Covid-19; (Oct2023) Negative; (19Oct2023) Positive, notes: Tested negative and then after 2 days started having symptoms and tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 08Oct2023 to 13Oct2023 for Treatment of COVID-19.   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: 49.0
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) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Jun2023 at 16:00 as dose 5 (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), 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: "Thyroid cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  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: Linked Report(s) : US-PFIZER INC-202300336618 same patient, different dose/event;
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 03Oct2023 at 10:30 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "History of pre diabetes, controlled" (unspecified if ongoing), notes: other medical history: History of pre diabetes, controlled. Concomitant medication(s) included: METFORMIN, start date: 01Mar2019 (ongoing). Past drug history included: Erythromycin, reaction(s): "known allergies: Erythromycin", notes: known allergies: Erythromycin. Vaccination history included: moderna covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE , Anatomical location: Right arm), administration date: 01May2023, when the patient was 73-year-old, for covid-19 immunization; moderna covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE , Anatomical location: Left arm), administration date: 26Sep2022, when the patient was 72-year-old, for covid-19 immunization; moderna covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Anatomical location: Left arm), administration date: 22Apr2022, when the patient was 72-year-old, for covid-19 immunization; moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Anatomical location: Left arm), administration date: 03Dec2021, when the patient was 71-year-old, for covid-19 immunization; moderna covid-19 vaccine (DOSE 2, SINGLE, Anatomical location: Left arm), administration date: 30Mar2021, when the patient was 71-year-old, for covid-19 immunization; moderna covid-19 vaccine (DOSE 1, SINGLE, Anatomical location: Left arm), administration date: 02Mar2021, when the patient was 71-year-old, for covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective and covid-19 with Paxlovid on 08Oct2023.  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: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 40 years for COVID-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Nasal allergies" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Oct2023) Negative; (19Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Additional information: The patient was treated with Paxlovid from 09Oct2023 to 14Oct2023. The patient's symptoms seemed to improve and on 16Oct2023 she tested negative. She thought she was done with COVID-19 but then on 19Oct2023 she woke up sounding much more congested and coughing more and when she tested herself there was a faint positive line.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, single (Lot number: 4680) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other vaccine and medication in 2 weeks. Paxlovid was taken as treatment for COVID -19 from 10Oct2023 to 14Oct2023
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID on 22Oct2023; Tested positive for COVID on 22Oct2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 at 10:45 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 19Sep2023 as dose number unknown, single; ESTRADIOL; NASONEX. Past drug history included: Bactrim, reaction(s): "known allergies: Bactrim". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Oct2023 at 10:00, outcome "recovering" and all described as "Tested positive for COVID on 22Oct2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Oct2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 49.0
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). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies". 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 including Paxlovid from 13Oct2023 to 17Oct2023.  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: 62.0
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 a non-contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Sep2023 as dose 1, single (Lot number: HH7595) at the age of 62 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Dust" (unspecified if ongoing); "Known allergies: Bananas" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (dose 1, single; manufacturer unknown), for COVID-19 immunisation; COVID-19 vaccine (dose 2 single; manufacturer unknown), for COVID-19 immunisation; COVID-19 vaccine (dose 3 (booster), single; manufacturer unknown), for COVID-19 immunisation; COVID-19 vaccine (dose 4 (booster), single; manufacturer unknown), for COVID-19 immunisation; COVID-19 vaccine (dose 5 (booster), single; manufacturer unknown), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Oct2023) Negative; (Oct2023) Negative; (Oct2023) Positive. Therapeutic measures were taken as a result of vaccination failure, COVID-19. Additional information: The patient was treated with Paxlovid from 15Oct2023 to 20Oct2023. After 2 negative tests, runny nose returned and a positive test.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
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 17May2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 73 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), outcome "unknown" and all described as "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, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; 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)), 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. The following information was reported: DIZZINESS (non-serious), outcome "not recovered".  Additional Information: It was reported that patient had vaccine over 2 weeks ago and wanted to know if dizziness was a result of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis, Malaise
Clinical narrative: generalized malaise; had an inflamed lymph node on the same side where the vaccine was received for 5 days; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  An adult female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 immunization; Covid-19 vaccine (Dose 2), for COVID-19 immunization; Covid-19 vaccine (Dose 3), for COVID-19 immunization; Covid-19 vaccine (Dose 4), for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "recovered", described as "generalized malaise"; LYMPHADENITIS (non-serious), outcome "recovered", described as "had an inflamed lymph node on the same side where the vaccine was received for 5 days". It was unknown if therapeutic measures were taken as a result of malaise, lymphadenitis. Additional information: patient took 1000mg of TYLENOL after receiving the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Within seconds of receiving 4th dose of vaccine right arm swelled up; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "recovered", described as "Within seconds of receiving 4th dose of vaccine right arm swelled up". The event "within seconds of receiving 4th dose of vaccine right arm swelled up" required physician office visit. Therapeutic measures were not taken as a result of peripheral swelling.  Additional information: The suspect vaccine patient received was not bivalent.  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: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation; bnt162b2 (BNT162B2), in Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Known allergies: No. Concomitant medication(s) included: FLONASE [MOMETASONE FUROATE], start date: Mar2022, stop date: 15Oct2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Oct2023) Negative; (23Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 15Oct2023 to 19Oct2023 for COVID 19 Treatment. After a full course of Paxlovid tested negative on 21Oct2023 and positive on 23Oct2023 with symptoms similar to a cold (sneeze, runny nose).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 62-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Dec2022 as dose 3 (booster), single (Lot number: CSJ6738) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High sensitivity Pneumonitis", start date: 2022 (ongoing), notes: High sensitivity Pneumonitis Diagnosed last year. 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, She only had the sore arm right after receiving the covid shot. It lasted like 3 days. It was hard to lift the first day. It happened with both doses.), for Covid-19 Immunization, reaction(s): "Sore arm". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Dec2022, outcome "recovered", described as "Sore arm".  Additional information: While reporting on her husband, caller said that she had a sore arm after receiving the vaccine. She only had the sore arm right after receiving the covid shot. It lasted like 3 days. It was hard to lift the first day. It happened with both doses. She has completely recovered from the sore arm. It only lasted for like 3 days or so. That was the only side effect she had. Caller does not know the exact date of her sore arm.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue
Clinical narrative: extremely tired; metallic taste; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 85-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 85 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "moderately high blood pressure" (ongoing), notes: diagnosed when she was about 40 years old. There were no concomitant medications. Vaccination history included: Bnt162b2 (all her prior doses are by Pfizer, dose number unknown), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 23Oct2023, outcome "not recovered", described as "extremely tired"; DYSGEUSIA (non-serious) with onset 23Oct2023, outcome "recovering", described as "metallic taste". Therapeutic measures were not taken as a result of dysgeusia.  Additional information: Since patient felt at her age and got all the other vaccines and should have the new COVID vaccine, injection in upper left arm. She does not know the name of the COVID shot she got today, just knows that it was by Pfizer since all her prior doses are by Pfizer. She has her old vaccine cards but they did not give her a new vaccine card for today's COVID shot. Patient received the most recent Pfizer COVID-19 vaccine on 23Oct2023. Patient reported that she had a metallic taste after receiving the vaccine and wanted to know if that was a normal side effect to experience? Patient also reported that she was extremely tired 2 hours after the vaccine, and asked if that was a normal side effect? She had an adverse effect from the COVID shot she just had. She is not sure but it is definitely not life threatening, clarifies the adverse effect is that she got a very strong metallic taste in her mouth within 15 minutes of getting the shot, it was immediate. Outcome for metallic taste in her mouth: still ongoing but not as bad as it was. She is also insanely tired, which started about 2 hours after the shot, outcome is the same. She does not think she is going to die, feels like she has to go to sleep now. The metallic taste will eventually go away, it has to go away and will not stay with her forever. It is unpleasant. She does not know if it has ever been reported or if it is coincidental.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: felt pretty bad with it, just felt tired, or whatever; felt pretty bad with it, just felt tired, or whatever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 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: FATIGUE (non-serious), FEELING ABNORMAL (non-serious) all with onset 2023, outcome "unknown" and all described as "felt pretty bad with it, just felt tired, or whatever".  Additional information: The reporter stated that he did talk to his brother-in-law (patient) and stated that he has the same shot, didn't have the reaction the reporter had but the patient felt pretty bad with it, he just felt tired, or whatever.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: A golf ball size swelling in armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 multivalent nos (COVID-19 VACCINE MULTIVALENT NOS MANUFACTURER UNKNOWN), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: SWELLING (non-serious), outcome "recovered", described as "A golf ball size swelling in armpit". It was unknown if therapeutic measures were taken as a result of swelling.  Additional information: After receiving the Covid-19 Vaccine (unsure of the manufacturer and believes it was the bivalent formulation; also reported as "Vaccine, is bivalent: False"), the patient had a golf ball size swelling in armpit for about a week after receiving the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: 3 in welt at injection site. Raised, red and warm and itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Oct2023 at 17:00 as dose 1, single (Lot number: HH7595) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "latex allergy" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: OLMESARTAN; OXCARBAZEPINE; VAGIFEN; ASPIRIN [ACETYLSALICYLIC ACID]. Past drug history included: Morphine, reaction(s): "Allergies: morphine"; Tramadol, reaction(s): "Allergies: tramadol". Vaccination history included: Flu shot, for Immunization, reaction(s): "Allergies: flu shot"; 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), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION SITE URTICARIA (non-serious) with onset 20Oct2023 at 15:00, outcome "not recovered", described as "3 in welt at injection site. Raised, red and warm and itchy". Therapeutic measures were not taken as a result of vaccination site urticaria.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Chills, Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: Tiredness; Chills; Fever; Nauseous; Vomiting; This is a spontaneous report received from a contactable reporter (consumer).  A male patient received BNT162B2 OMI XBB.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation; varicella zoster vaccine (VARICELLA ZOSTER VACCINE), on 20Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 20Oct2023, outcome "not recovered", described as "Tiredness"; CHILLS (non-serious) with onset 20Oct2023, outcome "not recovered"; PYREXIA (non-serious) with onset 20Oct2023, outcome "not recovered", described as "Fever"; NAUSEA (non-serious) with onset 20Oct2023, outcome "not recovered", described as "Nauseous";  VOMITING (non-serious) with onset 20Oct2023, outcome "not recovered". Additional information: The reporter stated, "my boyfriend had a the Pfizer shot yesterday, COVID shot yesterday but he also had a shingles shot too but he has had tiredness, he has chills, fever, nauseous, vomiting and it still has not gone away. Is there anything that I can do? It has been 24 hours. Is there anything we can do?" He also has a fever and vomiting really yesterday and chills. Product details (LOT#, NDC#, UPC# and expiration date) and pharmacy details could not be probed as the reporter hung up the call abruptly. Thus, limited information was available over the call.  The information on the batch/lot number for BNT162B2 OMI XBB.1.5 has been requested and will be submitted if and when received.