chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
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 a Consumer or other non HCP. A 25-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 25 years for covid-19 immunisation. The patient's relevant medical history included: "Crohn's Disease" (unspecified if ongoing). Concomitant medication(s) included: INFLIXIMAB taken for crohn's disease. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4, manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 5, manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 6, manufacturer Unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (28Jan2024) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jan2024) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with PAXLOVID from 25Jan2024 until 30Jan2024.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Jan2024 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation. Patient had no known allergies. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset Jan2024, outcome "recovered" (2024), described as "COVID 19 Treatment". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19 included Paxlovid from 23Jan2024 to 28Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 39.0
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 Consumer or other non HCP.  A 39-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obese BMI 38" (unspecified if ongoing), notes: Obese BMI 38. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2024) Positive, notes: positive test 2-3 days after lasted Paxlovid dose. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: the patient was treated with Paxlovid from 25Jan2024 to 30Jan2024 for Covid-19.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 47-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Nov2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Brca2+" (unspecified if ongoing); "obstructive sleep apnea" (unspecified if ongoing); "Hx of suspected pneumonia" (unspecified if ongoing); "Norco, lexapro allergy" (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 Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid 25Jan2024 to 29Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Age: 78.0
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 a Consumer or other non HCP.  A 78-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 78 years, in left arm for covid-19 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; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 6; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included PAXLOVID from 18Jan2024 to 23Jan2024. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 68.0
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 Consumer or other non HCP.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jun2021 as dose 1, single (batch/lot number: ER2613), in right arm, on 06Jul2021 as dose 2, single (batch/lot number: ER2613), in right arm and on 28Dec2021 as dose 3 (booster), single (batch/lot number: 33036BD) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Meniere's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ampicillin, reactions: "allergies"; Vicodin, reactions: "allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "not recovered" and all described as "treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2024) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 22Jan2024 to 26Jan2024.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 70-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Clindamycin, Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid treatment from 22Jan2024 to 26Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID: 200250.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6206), on 26Mar2021 as dose 2, single (Lot number: ER2613), on 08Dec2021 as dose 3 (booster), single (Lot number: FE3594) and on 23May2022 as dose 4 (booster), 0.3 ml single (Lot number: FM9992) at the age of 71 years, in arm for covid-19 immunisation. The patient received dose 4 in her arm, she didn't recall which one, typically she used left arm. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure abnormal; FENOFIBRATE taken for blood cholesterol abnormal; CENTRUM [MINERALS NOS;VITAMINS NOS] taken for vitamin supplementation. The patient had been taking CENTRUM forever, she had always taken vitamins. The patient reported that her LISINOPRIL was like 5mg or something small, she had been taking it for 100 years, for years. At night, the patient took FENOFIBRATE. She thought that it might be like 5 or 10, she was not sure. The patient had been taking it forever. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovering" and all described as "Covid". The patient had Covid on Oct2023 (near end of month) and up until then she had all Pfizer vaccines, 2 initial ones and a total of 4 shots. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Tested herself. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient took PAXLOVID and hopefully made Covid-19 less than it would have been. The patient got better.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400032817 Same patient, different drug and event;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  An adult 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 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; 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 25Jan2024 to 29Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 70.0
Sex: M
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 Consumer or other non HCP.  An elderly male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jan2024) Negative; (03Feb2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient took Paxlovid for treatment of COVID-19 from 25Jan2024 to 29Jan2024. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a consumer. A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: El1283), in left arm, on 02Feb2021 as dose 2, single (Lot number: En5318), in left arm and on 30Aug2021 as dose 3 (booster), single (Lot number: Sc3181) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune disorder" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). Concomitant medication included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE], start date: Feb2004, stop date: Feb2024; HCTZ, start date: Feb1997, stop date: Jan2024; DIOVAN, start date: Feb1997, stop date: 02Feb2024; GLUCOSAMINE, start date: Feb1987, stop date: 02Feb2024; FIBERCON, start date: Feb1987, stop date: 02Feb2024; COLACE, start date: Feb1987, stop date: 02Feb2024; ROSUVASTATIN, start date: Sep2019, stop date: Feb2024; VITAMIN D NOS, start date: Feb2009, stop date: Feb2024; and Hormone replacement therapy (HRT) started in Feb2004 and stopped on 02Feb2024. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Oct2023 at 10:00 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 and concomitant medications were not reported. Past drug history included: Neomycin, reaction(s): "Allergy". 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 Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 33-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 and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 27Jan2024 to 31Jan2024. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "allergies: Macadamia nuts" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN, start date: 01Jun2023. 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 26Jan2024 to 30Jan2024.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Moderna spikevax /Dose Number: 6 and Pfizer / BioNTech/Dose Number: 5; COVID-19; COVID-19; This is a spontaneous report received from an Other HCP.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 5 (booster), single (Lot number: 0J3277) at the age of 72 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Sep2023 as dose 6 (booster), single (Lot number: 203F23A) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single) and as dose 4 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing); "Known allergies: cephalosporins" (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 Jan2024, outcome "unknown" and all described as "COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna spikevax /Dose Number: 6 and Pfizer / BioNTech/Dose Number: 5". Therapeutic measures were taken as a result of interchange of vaccine products, drug ineffective, covid-19 which included Paxlovid administration from 25Jan2024 to 30Jan2024.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2, BNT162B2 OMI BA.4-5 cannot be fully excluded.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 18Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 08Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pre-Diabetes" (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 Jan2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 in which patient received Paxlovid on 22Jan2024 to 27Jan2024.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 will be requested and submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Nurse.  A 68-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Type 2 DM" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE; Primary Immunization series complete, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid administration from 18Jan2024 to 22Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 at 13:15 as dose 1, single (Batch/Lot number: unknown) at the age of 66 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Covid-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 treated with Paxlovid from 22Jan2024 to 27Jan2024. Additional information: The patient has no known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Nov2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ulcerative colitis" (unspecified if ongoing); "rheumatoid arthritis" (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 Immunization; Covid-19 vaccine (Dose 2, Single; Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 3 (Booster), Single; Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid treatment from 23Jan2024 to 27Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19; COVID 19; vaccine brand other=Moderna, vaccine administration date=31Mar2022/ vaccine brand=Pfizer / BioNTech, vaccine administration date= 16Sep2022; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 69 years, in left arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Feb2021 as dose 1, single (Lot number: 011M20A), in left arm, on 15Mar2021 as dose 2, single (Lot number: 012A), in left arm, on 22Oct2021 as dose 3 (booster), single (Lot number: 011F21a), in left arm, on 31Mar2022 as dose 4 (booster), single (Lot number: 027L21A), in left arm, on 08Apr2023 as dose 6 (booster), single (Lot number: AS7185B), in left arm and on 23Oct2023 as dose 7 (booster), single), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medications included: SERTRALINE, start date: 15Nov2023; ATORVASTATIN, start date: 11Apr2006, stop date: 26Jan2024; L-TRYPTOPHAN, start date: 02Jan2018; MAGTEIN, start date: 14Apr2023; CENTRUM SILVER WOMEN 50+, start date: 02Jan1989; ALLER TEC, start date: 26Apr2019. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Sep2022, outcome "unknown", described as "vaccine brand other=Moderna, vaccine administration date=31Mar2022/ vaccine brand=Pfizer / BioNTech, vaccine administration date= 16Sep2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 treated with Paxlovid from 27Jan2024 to 01Feb2024.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; vaccine brand other: Moderna; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 at 11:00 as dose 1, single (Lot number: EL9262), in left arm, on 18Feb2021 at 12:00 as dose 2, single (Lot number: EN6200), in left arm and on 29Sep2021 at 16:00 as dose 3 (booster), single (Lot number: 30145BA) at the age of 74 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Apr2022 at 15:00 as dose 4, (booster) single (Lot number: 005M21A), in left arm, on 29Sep2022 at 12:00 as dose 5, (booster) single (Lot number: AS7164B), in left arm, on 01May2023 at 14:00 as dose 6, (booster) single (Lot number: 059F22A), in left arm and on 09Oct2023 at 13:00 as dose 7, (booster) single (Lot number: 8058492), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "known allergies: Hay fever, cats" (unspecified if ongoing); "known allergies: Hay fever, cats" (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 "unknown" and all described as "COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand other: Moderna". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid taken from 22Jan2024 to 26Jan2024.  No follow-up attempts are possible.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 48-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 17:15 as dose 1, single (batch/lot number: unknown) at the age of 48 years, in left arm for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer / Biontech (dose 4 (booster), batch/lot number GH9694, vaccine location left arm), administration date: 11Sep2022, when the patient was 47-year-old, for Covid-19 Immunization; Pfizer / Biontech (dose 3 (booster), batch/lot number FF8839, vaccine location right arm), administration date: 08Oct2021, when the patient was 46-year-old, for Covid-19 Immunization; Pfizer / Biontech (dose 2,  batch/lot number EW0150, vaccine location left arm), administration date: 07Apr2021, when the patient was 45-year-old, for Covid-19 Immunization; Pfizer / Biontech (dose 1, batch/lot number EN6207, vaccine location left arm), administration date: 17Mar2021, when the patient was 45-year-old, 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 which included Paxlovid from 26Jan2024 to 31Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; vaccine brand=Pfizer / BioNTech, vaccine administration date=19Oct2022/ vaccine brand other=Moderna, vaccine administration date=20Apr2022; This is a spontaneous report received from a Consumer or other non HCP.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Mar2021 as dose 1, single), in left arm, on 17Apr2021 as dose 2, single), in right arm, on 20Oct2021 as dose 3, single), in left arm and on 20Apr2022 as dose 4, single), in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), on 17Oct2023 at 13:00 as dose 6 (booster), single), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing); "inflammation" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing). Concomitant medication(s) included: SUBOXONE, start date: 11Mar2015; LASIX [FUROSEMIDE], start date: 12Sep2018. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Oct2022, outcome "unknown", described as "vaccine brand=Pfizer / BioNTech, vaccine administration date=19Oct2022/ vaccine brand other=Moderna, vaccine administration date=20Apr2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". It was unknown if 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 will be requested and submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 5 (booster), single (batch/lot number: Oj5346), in left arm and on 24Aug2023 at 13:15 as dose 6 (booster), single (batch/lot number: GKO928) at the age of 60 years, in left arm for covid-19 immunization; BNT162b2 (BNT162B2), on 12Apr2021 as dose 1, single (batch/lot number: Er8737), in left arm, on 04May2021 as dose 2, single (batch/lot number: unknown), in left arm, on 03Dec2021 as dose 3 (booster), single (batch/lot number: 3203080), in left arm and on 18Jun2022 as dose 4 (booster), single (batch/lot number: FM0173), in left arm for covid-19 immunization. The patient's relevant medical history included: "penicillin allergy" (unspecified if ongoing); "many miscellaneous food allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Lethargy, Pain, Pyrexia, Vaccination site swelling
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 5 (booster), single (batch/lot number: Oj5346), in left arm and on 24Aug2023 at 13:15 as dose 6 (booster), single (batch/lot number: GKO928) at the age of 60 years, in left arm for covid-19 immunization; BNT162b2 (BNT162B2), on 12Apr2021 as dose 1, single (batch/lot number: Er8737), in left arm, on 04May2021 as dose 2, single (batch/lot number: unknown), in left arm, on 03Dec2021 as dose 3 (booster), single (batch/lot number: 3203080), in left arm and on 18Jun2022 as dose 4 (booster), single (batch/lot number: FM0173), in left arm for covid-19 immunization. The patient's relevant medical history included: "penicillin allergy" (unspecified if ongoing); "many miscellaneous food allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 66.0
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 Consumer or other non HCP.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Sep2023 at 01:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (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 "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid treatment from 23Jan2024 to 27Jan2024.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Nov2023 as dose 1, single (Lot number: HG2649) at the age of 73 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Arrhythmia" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (dose number unknown (booster), single; lot number: GH9694; site: right arm), administration date: 22Sep2022, when the patient was 72-year-old, for COVID-19 immunization; COVID-19 vaccine (primary immunization series completed; 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 which included Paxlovid from 23Jan2024 to 28Jan204 (lot number: 00069-0345-30 [as reported]). Additional information: The patient has no known allergies. The patient has other medications in 2 weeks.  No follow-up attempts are possible.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "sjogrens" (unspecified if ongoing); "neurofibromatosos" (unspecified if ongoing); "lipomatosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "known allergies: aspirin", notes: known allergies: buprofen; Ibuprofen, reaction(s): "known allergies: buprofen". Vaccination history included: moderna (DOSE 4, (BOOSTER) SINGLE, vaccine location=Left arm), administration date: 20Apr2022, when the patient was 76-year-old, for COVID-19 Immunization; moderna (DOSE 3, (BOOSTER) SINGLE, vaccine location=Left arm), administration date: 28Oct2021, when the patient was 75-year-old, for COVID-19 Immunization; moderna (DOSE 1, SINGLE, vaccine lot number=031L20A, vaccine location=Left arm), administration date: 03Feb2021, when the patient was 74-year-old, for COVID-19 immunization; Moderna (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: on first day of testing positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid from 27Jan2024 to 31Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Nov2023 as dose 1, single (Batch/Lot number: unknown), in left leg for covid-19 immunisation. The patient's relevant medical history included: "Mild Asthma" (unspecified if ongoing); "Afib" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER), Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 in which patient received Paxlovid from 23Jan2024 to 27Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: RSV
Symptoms: Asthenia, Influenza like illness, Myalgia
Clinical narrative: muscle pain; weakness; flu-like symptoms; This is a spontaneous report received from an Other HCP from a sales representative.  A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "recovered", described as "muscle pain"; ASTHENIA (non-serious), outcome "recovered", described as "weakness"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu-like symptoms". It was unknown if therapeutic measures were taken as a result of myalgia, asthenia, influenza like illness.  Additional information: Patient experienced muscle pain, weakness, flu-like symptoms for 24 hours following vaccination. No other vaccine given on the same day.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for covid/three vaccine on the Pfizer already and got COVID; tested positive for covid/three vaccine on the Pfizer already and got COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, lot number unknown), for COVID-19 immunization; Bnt162b2 (DOSE 2, lot number unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for covid/three vaccine on the Pfizer already and got COVID". The patient tested positive for COVID and she called the doctor and was prescribed PAXLOVID and it costs (dollar) 1700. She had three vaccine on the Pfizer already. She mentioned it is expensive and she cannot afford it.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Coma, Paralysis
Clinical narrative: severe weakness, total body paralysis, and coma
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: Raching heart rate - 100 to 115 - getting alerts from Apple Watch
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: patient presented at pharmacy with a complaint that her right arm since receiving her vaccine 1/11 has been painful and itchy at the site of injection
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Pain, Pain in jaw, Peripheral swelling, Pyrexia, Rash erythematous
Clinical narrative: The symptoms started the next day on 2/3/24,  patient felt achy and developed a low grade fever.  Patient came in on Tuesday, 2/6/24 4 pm and left arm developed a red rash, and hot to the touch ane was swollen.  She also mentioned that when yawning, her jaw area was sore.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Skin warm
Clinical narrative: The symptoms started the next day on 2/3/24,  patient felt achy and developed a low grade fever.  Patient came in on Tuesday, 2/6/24 4 pm and left arm developed a red rash, and hot to the touch ane was swollen.  She also mentioned that when yawning, her jaw area was sore.
Age: 75.0
Sex: M
Vaccine: FLUA4, PNC20, RSV
Symptoms: Vision blurred
Clinical narrative: PATIENTS WIFE CALLED AND REPORTED HER HUSBAND HAD BLURRY VISION
Age: 60.0
Sex: M
Vaccine: HEPAB, VARZOS
Symptoms: Ear pain, Headache, Injection site rash, Pyrexia, Rash
Clinical narrative: Painful red bump developed well below injection site approximately 3 inches long and elliptical in shape two days after injection. Fever and headache were reported as well. Patient also experienced a severe earache
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: On 01/16/24 reported left hand numbness immediately following COVID monovalent injection and on this date left pinky continues to be numb. Full range of motion, baseline hand grasp and sensation. No visible abnormalities noted to administration site indicated by resident. Dr. was updated on concerns and reports "No orders. Would recommend follow up in clinic."
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received vaccine that was 8 days beyond the 30 days from which the Spikevax (NDC:80777-0102-93) vaccine was thawed from freezing temperatures. Pharmacy followed up with the patient shortly after to explain event that occurred. Patient states they were not currently experiencing any current adverse events.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Endoscopy normal, Sensation of foreign body, Throat tightness, X-ray normal
Clinical narrative: A feeling of something stuck in my throat that gradually worsened over the course of a few weeks, culminating in an event where I had to go to the emergency room due to a restricted airway.
Age: 10.0
Sex: M
Vaccine: FLU4, HEP, HEPA, VARCEL
Symptoms: Cough, Oropharyngeal pain, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient's family reports the patient has began having a cough and sore throat accompanied with a itching pink rash on his face stomach and legs on 2/3/24.  The family states they took the patient to the emergency department and were told some signs were to be expected and given an antihistamine, Benadryl which did seem to help. The family states he was discharged the same day and able to recover at home.