chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from an Other HCP.  A 39-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: "HTN" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received PAXLOVID as COVID-19 treatment from 10Feb2024 to 15Feb2024.  The lot number for BNT162b2 omi xbb.1.5, was not provided and will be requested during follow up.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded for event drug ineffective. This case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202400047585 Same patient, different drug and event;
Age: 66.0
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 Physician.  A 66-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Nov2023 as dose 1, single (Lot number: HH7595) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "Paget Disease on the bones" (unspecified if ongoing); "Known allergies: fish" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor". Vaccination history included: moderna (DOSE 5 (BOOSTER), SINGLE lot no. 060F22A), administration date: 07Oct2022, when the patient was 65-year-old, for COVID-19 immunization; moderna (DOSE 4 (BOOSTER), SINGLE lot no. 001M21A), administration date: 20Apr2022, when the patient was 64-year-old, for COVID-19 immunization; moderna (DOSE 3 (BOOSTER), SINGLE lot no. 01H21A), administration date: 10Dec2021, when the patient was 64-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE lot no. EL3248), administration date: 18Jan2021, when the patient was 63-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE lot no. EL1284), administration date: 18Dec2020, when the patient was 63-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19, patient took Paxlovid form 11Feb2024 to 15Feb2024.; 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: 1.58
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Medical Assistant called and relayed she is reporting a temperature excursion which occurred on December 30, 2022.  Caller relayed she is calling due to VFC inspection which noted temperature excursion and confirmed no expired vaccines were administe; This spontaneous report was received from a Medical Assistant and refers to a 19-months-old female patient. The patient did not have illness at the time of vaccination, no preexisting conditions, and no concomitant medications.       On 31-JAN-2023, the patient was vaccinated with an incorrect storage dose of Hepatitis A Vaccine, Inactivated (VAQTA), lot # W003118, expiration date 13-JUL-2023, for prophylaxis (dose, was not reported); also, route of administration was not reported, but the medical assistant stated generally they give vaccine in the legs. The vaccine reached a low temperature of 35.1F for 31 minutes and 30 seconds (product storage error). This incorrect storage was due to clinical practice error and the temperature excursion occurred because of a reading from a digital data logger. The patient did not experience any adverse events after receiving vaccine involved in a temperature excursion (no adverse event). Also, the patient did no required prescription drug treatments.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2402USA003949: US-009507513-2401USA006504: US-009507513-2402USA003951:
Sex: M
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called and relayed she is reporting a temperature excursion which occurred on December 30, 2022.  Caller relayed she is calling due to VFC inspection which noted temperature excursion and confirmed no expired vaccines were administe; No additional AE; This spontaneous report was received from a Medical Assistant and refers to a currently 2-year-old male patient. The patient did not have illness at the time of vaccination, no preexisting conditions, and no concomitant medications.       On unknown date, the patient was vaccinated with an incorrect storage doses of Hepatitis A Vaccine, Inactivated (VAQTA), lot # W003118, expiration date 13-JUL-2023, and incorrect storage dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot # U023829, expiration date 30-JUL-2023,  both vaccines for prophylaxis (quantity dose was not reported); also, route of administration was not reported, but the medical assistant stated generally they give vaccines in the legs. The vaccines reached a low temperature of 35.1F for 31 minutes and 30 seconds (product storage error). This incorrect storage was due to clinical practice error and the temperature excursion occurred because of a reading from a digital data logger. The patient did not experience any adverse events after receiving vaccines involved in a temperature excursion (no adverse event). Also, the patient did no required prescription drug treatments.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2402USA003949: US-009507513-2402USA003950: US-009507513-2401USA006504:
Age: 1.58
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect noted; HCP calling to report that patient received dose of VARIVAX during temp. excursion. No adverse effects noted.  No additional AE. No PQC.   Precautionary AE filed as assessment not completed due to HCP not having total time in each frozen range.  VARI; This spontaneous report was received from a medical assistant and refers to a 19 month old female patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.    On 31-JAN-2024, the patient was vaccinated with a single dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # X007373, expiration date:12-MAR-2025 (strength, route of administration, anatomical location not provided) as prophylaxis, which underwent a temperature excursion at 42.0 degree Fahrenheit (F) for 120 hours (product storage error). No previous excursions and no adverse effects were reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from an Other HCP.  A 63-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 right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Penicillin" (unspecified if ongoing); "Latex" (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 Feb2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid treatment from 05Feb2024 to 10Feb2024).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162b2 omi xbb.1.5 to the reported events drug ineffective and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache
Clinical narrative: spreading headaches every day; stress that started from one eye and went across her forehead; pressure headache/ pressure thing on the face; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An adult female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Feb2024 as dose 1, single (Batch/Lot number: unknown) intramuscular, 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: Flu vaccine, for immunization, reaction: "didn't get any side effects". The following information was reported: HEADACHE (non-serious) with onset Feb2024, outcome "not recovered", described as "spreading headaches every day"; HEAD DISCOMFORT (non-serious) with onset Feb2024, outcome "not recovered", described as "stress that started from one eye and went across her forehead; pressure headache/ pressure thing on the face". Therapeutic measures were taken as a result of headache, head discomfort.  Additional information: The patient took the Comirnaty vaccine exactly 1 week prior reporting. She had been experiencing spreading headaches every day since then. Over-the-counter (OTC) medications did not eliminate these headaches; they typically went away on its own. The patient tried Excedrin (it's a generic brand) that didn't work; she tried Aleve (lot number: NAA98KL), that didn't work, and she tried ibuprofen (lot number: 604905CF4 or 5LE0336), which didn't work. The patient also tried an unspecified medication (a generic brand similar to Excedrin; lot number: P136527). At the time of the report, she had the headache for 3 hours. It started at the eye level, then across the forehead and then down the other eye. She described that this was not a typical headache, because it hanged in there until it eventually goes away. She didn't wake up with it and it's not there by the evening, but it comes during the day, typically after breakfast. She wanted to know how long this side effect might last. The patient was referred to the healthcare providers (HCPs). The patient further stated that the headache had been up for couple of hours and then it would stop and then "it goes away when it goes away." She didn't know what was the pain medicine or over the counter pain medicine that's okay, because it took quite a while after a couple of hours and it's still there, but eventually, it's not there. Well, it had to be. The patient was fine before the vaccine. The patient stated that it was not the common headache. It's like the stress that started from one eye and went across her forehead. It's like her head was in a 'vice' and then, it's a pressure headache. It's not like the normal headache. The patient just wanted to know why, because she didn't get any side effects from a flu vaccine or anything else. But that was not the normal headache; that was a pressure thing on the face.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had the soreness in her arm for 2 days and she couldn't sleep on that side; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 68-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergic to eggs" (unspecified if ongoing), notes: she could not take the Flu shot because it is equal to being allergic to eggs. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; Manufacturer unknown), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "had the soreness in her arm for 2 days and she couldn't sleep on that side". Additional information: Patient additionally asked whether people allergic to eggs may take Prevnar 20 because it is relevant to causing Guillain-Barre. Patient added that her arm started hurting from getting the booster shot. Patient confirmed that she received the COVID-19 Booster shot that was manufactured by Pfizer. Patient stated that she just had the soreness in her arm for 2 days and she couldn't sleep on that side.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, RSV
Symptoms: Hypersensitivity
Clinical narrative: Taken APfizer covid-19 virulent vaccine and Abrysvo vaccine. She had an allergic reaction; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; 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: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Taken APfizer covid-19 virulent vaccine and Abrysvo vaccine. She had an allergic reaction".  Additional information: Caller is calling in regard the ABRYSVO vaccine. She is getting patch testing done by an allergist, so she does not know the specifics of the ingredients she is allergic to. She needs to know the exact components of the vaccine. She also said she is aware of the information in the Package Insert and she needs more detailed information than that. After hearing the response, she mentioned checking the tool for Thimerosal and Alcohol but it is not showing any complete list of the vaccine components. Caller is a patient who has taken both the Pfizer covid-19 virulent vaccine and Abrysvo vaccine. She had an allergic reaction. She wants to know the allergens in these vaccines. She is getting patch testing done by an allergist so she does not know the specifics of the ingredients she is allergic to. She needs to know the exact components. She also said she is aware of the information in the Package Insert and she needs more detailed information than that. After hearing the response, she mentioned checking the tool for Thimerosal and Alcohol but it is not showing any complete list of the vaccine components.  The information on the batch/lot number for BNT162b2 omi xbb.1.5, rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
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 80-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Lot number: Hg4628) for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacture unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacture unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Manufacture unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (Booster), Manufacture 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 Treatment". Therapeutic measures were taken as a result of vaccination failure and covid-19 with paxlovid on 10Feb2024.
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 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2023 as dose number unknown, single (Lot number: GH9702), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. No known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 11Feb2024 to 15Feb2024.
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Infantile vomiting, Lethargy, Pallor, Presyncope, Pyrexia
Clinical narrative: fever; threw up; became lethargic; almost passed out in high chair; Face and body turned pale white; wrong vaccine administered; This is a spontaneous report received from a Consumer or other non HCP.  A 6-month-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Feb2024 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 6 months intramuscular, in right leg for covid-19 immunisation. The patient didn't receive BNT162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)). The patient had no relevant medical history. Concomitant medication(s) included: TDAP taken for immunisation, on 20Feb2024 as dose number unknown, single; INFLUENZA VACCINE taken for influenza immunisation, on 20Feb2024 as dose number unknown, single, sanofi; ROTAVIRUS VACCINE taken for immunisation, on 20Feb2024 as dose number unknown, single; PREVNAR taken for immunisation, on 20Feb2024 as dose number unknown, single; VAXELIS taken for immunisation, on 20Feb2024 as dose number unknown, single; BEYFORTUS taken for immunisation, on 20Feb2024 as dose number unknown, single; VITAMIN D [VITAMIN D NOS]; GERBER SOOTHE; MYLICON. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 20Feb2024 at 12:00, outcome "unknown", described as "wrong vaccine administered"; PALLOR (medically significant) with onset 20Feb2024 at 16:45, outcome "recovering", described as "Face and body turned pale white"; PRESYNCOPE (medically significant) with onset 20Feb2024 at 16:45, outcome "recovering", described as "almost passed out in high chair"; LETHARGY (medically significant) with onset 20Feb2024 at 16:45, outcome "recovering", described as "became lethargic"; PYREXIA (medically significant) with onset 20Feb2024 at 16:45, outcome "recovering", described as "fever"; INFANTILE VOMITING (medically significant) with onset 20Feb2024 at 16:45, outcome "recovering", described as "threw up". The events "fever", "threw up", "became lethargic", "almost passed out in high chair" and "face and body turned pale white" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of pyrexia, infantile vomiting, lethargy, presyncope, pallor. Clinical course: Approximately 5 hrs post administration, patient threw up and became lethargic/almost passed out in high chair. Face and body turned pale white followed by passing a stool. Recovered after 2-3 hours (still lethargic and fever). Called urgent care and doctor advised to provide liquid + monitoring. Patient was normal as of 8am the following day.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: fever; threw up; became lethargic; almost passed out in high chair; Face and body turned pale white; wrong vaccine administered; This is a spontaneous report received from a Consumer or other non HCP.  A 6-month-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Feb2024 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 6 months intramuscular, in right leg for covid-19 immunisation. The patient didn't receive BNT162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)). The patient had no relevant medical history. Concomitant medication(s) included: TDAP taken for immunisation, on 20Feb2024 as dose number unknown, single; INFLUENZA VACCINE taken for influenza immunisation, on 20Feb2024 as dose number unknown, single, sanofi; ROTAVIRUS VACCINE taken for immunisation, on 20Feb2024 as dose number unknown, single; PREVNAR taken for immunisation, on 20Feb2024 as dose number unknown, single; VAXELIS taken for immunisation, on 20Feb2024 as dose number unknown, single; BEYFORTUS taken for immunisation, on 20Feb2024 as dose number unknown, single; VITAMIN D [VITAMIN D NOS]; GERBER SOOTHE; MYLICON. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 20Feb2024 at 12:00, outcome "unknown", described as "wrong vaccine administered"; PALLOR (medically significant) with onset 20Feb2024 at 16:45, outcome "recovering", described as "Face and body turned pale white"; PRESYNCOPE (medically significant) with onset 20Feb2024 at 16:45, outcome "recovering", described as "almost passed out in high chair"; LETHARGY (medically significant) with onset 20Feb2024 at 16:45, outcome "recovering", described as "became lethargic"; PYREXIA (medically significant) with onset 20Feb2024 at 16:45, outcome "recovering", described as "fever"; INFANTILE VOMITING (medically significant) with onset 20Feb2024 at 16:45, outcome "recovering", described as "threw up". The events "fever", "threw up", "became lethargic", "almost passed out in high chair" and "face and body turned pale white" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of pyrexia, infantile vomiting, lethargy, presyncope, pallor. Clinical course: Approximately 5 hrs post administration, patient threw up and became lethargic/almost passed out in high chair. Face and body turned pale white followed by passing a stool. Recovered after 2-3 hours (still lethargic and fever). Called urgent care and doctor advised to provide liquid + monitoring. Patient was normal as of 8am the following day.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: RSV
Symptoms: Blood pressure increased, Heart rate increased, Hypoacusis
Clinical narrative: having some symptoms in which her blood pressure and heart rate is going higher than normal.; having some symptoms in which her blood pressure and heart rate is going higher than normal.; don't hear as fast as I used to; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 82-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 01Feb2024 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: HYPERTENSION (non-serious), HEART RATE INCREASED (non-serious), outcome "unknown" and all described as "having some symptoms in which her blood pressure and heart rate is going higher than normal."; HYPOACUSIS (non-serious), outcome "unknown", described as "don't hear as fast as I used to". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypoacusis. Additional information: Caller was 82 years old who got an RSV vaccine last 01Feb2024. After getting the RSV vaccine caller is having some symptoms in which her blood pressure and heart rate is going higher than normal. Caller is unsure about the specific RSV vaccine she received as she was unable to confirm the manufacturer with the pharmacy. The caller is seeking advice on what steps to take next or where to seek further assistance. Upon further discussion question confirmed. Caller asked if she should just talk to her provider. Caller did mention "I am 82 years old and don't hear as fast as I used to" she also stated that she has to adjust her hearing aid to hear much better.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Nov2023 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 and concomitant medications were not reported. Patient had no known allergies. 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 Feb2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 10Feb2024 to 15Feb2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from an Other HCP.  A 42-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Scleroderma" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE NUMBER UNKNOWN, SINGLE, Anatomical Location: Arm Left), administration date: 03Oct2022, when the patient was 40-year-old, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 09Feb2024 to 13Feb2024.  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: 61.0
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 Nurse.  A 62-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "depression" (unspecified if ongoing); "b12 folate deficiency" (unspecified if ongoing); "Known allergies: Cillins" (unspecified if ongoing); "immunosuppressed" (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 12Feb2024, outcome "recovered" (19Feb2024) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Feb2024) Positive, notes: Tested positive with symptoms; (19Feb2024) Negative, notes: negative for covid 19Feb asymptomatic. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included paxlovid from 12Feb2024 to 16Feb2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Age: 50.0
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 51-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 as dose 1 , single at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypogammaglobulinemia" (unspecified if ongoing); "PCOS" (unspecified if ongoing). The patient had not known allergies. Concomitant medication(s) included: ACETYL L-CARNITINE [ACETYLCARNITINE HYDROCHLORIDE], start date: Jan2021; BENADRYL, start date: Jan2017; BREO ELLIPTA, start date: Jun2023; CUVITRU, start date: May2017; DHEA, start date: Jan2017; DICYCLOMINE, start date: Jan2023; D-RIBOSE, start date: Jan2021; ESTRADIOL, start date: Feb2021; IRON, start date: Jan2017; OMEGA 3 [FISH OIL], start date: Jan2017; OZEMPIC, start date: May2023; PANTOPRAZOLE, start date: Jan2023; PODIAPN, start date: Jan2017; PROGESTERONE, start date: Jan2017; MELATONIN, start date: Jan2021; MELOXICAM, start date: Feb2020; METFORMIN, start date: Jan2017; NEBIVOLOL, start date: Jan2017; NALTREXONE, start date: Jan2017; TERAZOSIN, start date: Jan2017; TRIAMTERENE, start date: Jan2017; TESTOSTERONE, start date: Jan2017; VITAMIN C [ASCORBIC ACID], start date: Jan2021; VITAMIN D3 K2, start date: Jan2017; ZINC, start date: Feb2023. Vaccination history included: comirnaty (DOSE 1; Lot number: EL3247), administration date: 27Jan2021, when the patient was 48-year-old, for Covid-19 immunization; comirnaty (DOSE 2; Lot number: EL9269), administration date: 20Feb2021, when the patient was 48-year-old, for Covid-19 immunization; comirnaty (DOSE 3 (BOOSTER); Lot number: FE3592), administration date: 06Oct2021, when the patient was 48-year-old, for Covid-19 immunization; comirnaty (DOSE 4 (BOOSTER); Lot number: FJ6369), administration date: 23Mar2022, when the patient was 49-year-old, for Covid-19 immunization; comirnaty (DOSE 5 (BOOSTER); Lot number: GH9702), administration date: 28Oct2022, when the patient was 49-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Feb2024, outcome "recovered" (Feb2024) and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19 starting on 06Feb2024 until 10Feb2024.
Age: 68.0
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 Consumer or other non HCP.  A 69-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Sep2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 3 (booster), at 12:00 PM, Vaccine location=Left arm), administration date: 15Sep2022, when the patient was 67-year-old, for COVID-19 immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 1, Unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Feb2024, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Feb2024) Positive, notes: home tests. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid immediately for 5 days.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
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 52-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Dec2023 at 14:00 as dose 1, single (Lot number: Hm7010), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidaemia" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: 01Aug2023, stop date: 09Feb2024; MOUNJARO, start date: 15Dec2023, stop date: 04Feb2024. Vaccination history included: j&j (DOSE 1, SINGLE, Vaccine administration time: 13:00, Vaccine lot number: 202A21A, Vaccine location: Left arm), administration date: 10Apr2021, for COVID-19 Immunization; BNT162b2 (DOSE 2 (BOOSTER), SINGLE, Vaccine administration time: 14:00, Vaccine lot number=FH 820, Vaccine location=Right arm), administration date: 28Oct2021, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Vaccine administration time: 15:00, Vaccine lot number: I fj 4991, Vaccine location: Right arm), administration date: 15Apr2022, for COVID-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Vaccine administration time: 12:00, Vaccine lot number: I. GH9702, Vaccine location: Right arm), administration date: 21Nov2022, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Feb2024, outcome "recovered" (19Feb2024) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Feb2024) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Paxlovid from 12Feb2024 to 16Feb2024 for the treatment of COVID-19. After completion of the 5 day Paxlovid patient was improving for the next 3 days and tested negative home antigen test on that 3rd day (day 11 of symptoms).   No follow-up attempts are possible.
Age: 33.0
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 33-year-old male 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 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna (DOSE 4 (BOOSTER), SINGLE; Vaccine location: Left arm), administration date: 21Oct2022, when the patient was 32-year-old, for COVID-19 Immunization; moderna (DOSE 3 (BOOSTER), SINGLE; Vaccine location: Left arm), administration date: 29Nov2021, when the patient was 31-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE; Vaccine location: Left arm), administration date: 26Jan2021, when the patient was 30-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 1, SINGLE; Vaccine location: Left arm), administration date: 05Jan2021, when the patient was 30-year-old, 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". Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid as treatment from 12Feb2024 to 16Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 55.0
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 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 01Sep2023 as dose number unknown, single at the age of 55 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Having my second session with Covid. I have had 4 Pfizer shots in 2022-2023; Having my second session with Covid. I have had 4 Pfizer shots in 2022-2023; This is a spontaneous report received from a Consumer or other non HCP. A 76-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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: "Covid-19" (unspecified if ongoing), notes: 76 years old and having second session with Covid. 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 "Having my second session with Covid. I have had 4 Pfizer shots in 2022-2023". Therapeutic measures were taken as a result of drug ineffective, covid-19.Clinical information: The patient is 76 years old and having a second session with Covid. The patient has had 4 Pfizer shots in 2022-2023. The patient has been on Paxlovid for 2 days now and why does the medicine leave a bad taste in the mouth.  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.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Contusion, Erythema, Pruritus
Clinical narrative: Bruising, itchy, flat reddened area >2cm
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Vaccine administered at a Pharmacy clinic on 01/26/24. First complaint of urticaria on trunk, sides, back and down back of legs occurred on 02/20/24. Patient did not connect recent vaccine to reaction until receiving a V-Safe follow up text for check in on 02/23/24. Course of treatment was Prednisone 20mg BID for 4 days then 20mg once daily for 3 days. Patient currently taking Fexofenadine 180mg every morning, Cetirizine 10mg every evening, Montelukast 10mg every evening.
Age: 43.0
Sex: U
Vaccine: COVID19, FLUN4
Symptoms: Arthralgia, Fatigue, Muscle spasms, Neuropathy peripheral
Clinical narrative: fatigue (ongoing), arthralgias (resolved), muscle spasms and neuropathy in both feet (still ongoing)
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Malaise, Pyrexia
Clinical narrative: Fever of 103.5F and general malaise upon waking up on 2/24/24
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: patient says his right arm hurt the next day, hand is tingly, weak arm, hard to lift up all the way
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Extreme Tinnitus in both ears began about 3 days after vaccination and has persisted to this date nearly 3 years later
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Skin discolouration
Clinical narrative: Patient got a vaccine on 2/19/24 and said that a day or so after it, he started having a rash that started near his knees and now has it in more areas of his body. He is very itchy and has been using hydrocortisone cream for it and taking Benadryl at night. The rash isn?t raised, just has some discoloration. He said he scheduled an appt with a dermatologist on Tuesday (in a few days).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody positive, Blood culture negative, Blood urine present, C-reactive protein
Clinical narrative: Patient develped low grade fever (99-100 degrees) and fatigue on 01/10/2024.  Found to be have a positive ANA and positive anti-RNP antibodies indicating autoimmune disease. Patient developed COVID-19 symtpoms on January 20th, 2024 by NAAT and rapid test, with subsequent COVID-19 rebound on January 29th, 2024.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Culture urine negative, Fatigue, Rheumatoid factor negative, SARS-CoV-2 test positive
Clinical narrative: Patient develped low grade fever (99-100 degrees) and fatigue on 01/10/2024.  Found to be have a positive ANA and positive anti-RNP antibodies indicating autoimmune disease. Patient developed COVID-19 symtpoms on January 20th, 2024 by NAAT and rapid test, with subsequent COVID-19 rebound on January 29th, 2024.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Synovial fluid analysis abnormal
Clinical narrative: Patient develped low grade fever (99-100 degrees) and fatigue on 01/10/2024.  Found to be have a positive ANA and positive anti-RNP antibodies indicating autoimmune disease. Patient developed COVID-19 symtpoms on January 20th, 2024 by NAAT and rapid test, with subsequent COVID-19 rebound on January 29th, 2024.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Alanine aminotransferase increased, Anger, Angiogram pulmonary abnormal, Angiopathy
Clinical narrative: I received 2 Moderna vaccines (3/25/21 and 4/27/21) with no serious side effects. I received the Pfizer booster on 12/3/21 and within 2 days developed a serious headache and stiff neck that did not go away with OTC pain relievers. I traveled home 12/11-12/12. During this time I began having severe stomach pains and was seen in the emergency room on 12/15/21. The main finding was very elevated liver enzymes. ALT and AST. Over the course of the next 6 months, I was diagnosed with autoimmune hepatitis. I also had a reactivation of EBV, VZ, Cytomegalovirus, and HSV 1. I continue to have extremely high levels of antibodies to each to. I was referred to a neurologist after developing neurological symptoms. I have been told I have a vaccine injury and this has caused autoimmune antibody-mediated small fiber neuropathy and other demyelinating occurrences. I have also developed tachycardia, digestive issues,  and dental problems. I have had CT scans, MRIs, and heart tests, including echocardiogram, blood vessel ultrasound, calcium scoring, and have an upcoming echo stress test. In addition to tachycardia, I have developed cardiovascular symptoms such as weakened blood vessels and bruising. The hepatitis has improved but resulted in a non-diet-related large increase in cholesterol. I am currently on low dose naltrexone, pregabalin, and atorvastatin, as well as a low-dose anti-anxiety medication and valcyclovir. The anxiety comes from the constant health problems and limitations and fear that I will never regain my health as it was prior to this vaccine booster. I am not an anti-vaxxer. I am a biology professor and got vaccinated because vaccines prevent disease. This vaccine, however, has markedly changed my life. I have very bad weeks, with massive inflammation and inability to carry out daily activities. I continue to have neurological symptoms including balance problems and numbness in my extremities. I have better weeks when I am hopeful I will feel well again. I have spent my savings paying for tests, imaging, and specialists. I was unable to work because of this for 8 months and am now financially struggling. I have now gone back to work part time, as I cannot afford not to. I am angry that I trusted that this vaccine was safe and beneficial to my health. I will continue to try to feel better - get the recommended medical tests and take the prescribed medications that have been given me. But, I have lost faith in both the vaccine program and the medical professionals in their ability to treat the vaccine injured. They acknowledge that I was vaccine injured, but admit that they do not know how to treat me. In fact, I have been advised by my doctors to get no vaccines at this time, which leaves me susceptible to influenza, shingles, and pneumonia. This was a health disaster for me. Thank you.