chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Got covid on the 27Dec; Got covid on the 27Dec; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Oct2023 at 02:00 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "known allergies: soy Protein" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "restless leg" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphin, reaction(s): "known allergies: Morphin"; Norvasc, reaction(s): "known allergies:Norvasc"; Reglan, reaction(s): "known allergies: Reglan". Vaccination history included: moderna (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 02:00 AM), administration date: 09Mar2023, when the patient was 61-year-old, for COVID-19 immunization; moderna (DOSE 2, SINGLE, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 01:00 AM), administration date: 19Oct2022, when the patient was 61-year-old, for COVID-19 immunization; moderna (DOSE 1, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 01:45 AM), administration date: 08May2022, when the patient was 60-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Dec2023, outcome "not recovered" and all described as "Got covid on the 27Dec". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Dec2023) Positive; (06Jan2024) Positive; (06Jan2024) Positive. Clinical course: Got covid on the 27Dec2023 started taking paxlvoid On 30Dec2023 ,5 day dose,7 days later on 06Jan2024 tested positive on 2 Test for covid agian.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
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 72-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 6 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunization; 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 (Primary Immunization series complete; unknown manufacturer), 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". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical details: Patient received Paxlovid for COVID 19 Treatment from 04Jan2024 to 08Jan2024.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 48.0
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 48-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Nov2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 48 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 Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 treated with Paxlovid from 30Dec2023 to 04Jan2024. Additional information: No other medications in 2 weeks. The patient had no known allergies and no medical history.  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, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 48-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown, unable to locate or read the details), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep Apnea" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Adhd" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Patient had no known allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4 ; Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 ; Unknown Manufacturer), 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: 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 drug ineffective, covid-19. Patient received Paxlovid treatment from 01Jan2024 to 05Jan2024.  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: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Age: 67.0
Sex: M
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 67-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 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 Treatment". Therapeutic measures included paxlovid from 01Jan2024 to 06Jan2024 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.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single) 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 Dec2023, outcome "recovered" (Dec2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Negative, notes: Covid rebound after 8 days of testing negative. Therapeutic measures (Paxlovid treatment start date: 28Dec2023, stop date: 01Jan2024) were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 43-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "known allergies: Some antibiotics" (unspecified if ongoing); "known allergies: pineapple" (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 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 02Jan2024 to 06Jan2024.  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: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: interchange of vaccine products; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP .  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL3302), on 09Feb2021 as dose 2, single (Lot number: EL9261) and on 28Sep2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 67 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Apr2022 as dose 4 (booster), single (Lot number: 00M21A), on 13Sep2022 as dose 5 (booster), single (Lot number: As7148B), on 22May2023 as dose 6 (booster), single (Lot number: 019H22A), in left arm and on 18Sep2023 as dose 7 (booster), single (Lot number: 202F22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "migraine" (unspecified if ongoing); "adhesive" (unspecified if ongoing); "penicillin" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "fractures" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19, treatment was Paxlovid from 05Jan2024.  No follow-up attempts are possible.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine BNT162B2 in this patient cannot be completely excluded. ,Linked Report(s) : US-PFIZER INC-202400011647 same patient, same drug, different event, different dose;
Sex: U
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: severe pain in my lower back; This is a spontaneous report received from a Consumer or other non HCP.  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. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "severe pain in my lower back". Additional information: Medicinal Product Name as Reported by the Primary Source: COVID-19 Vaccine. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure, Viral test
Clinical narrative: tested positive for Covid/mucus in throat; tested positive for Covid/mucus in throat; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 57-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Oct2023 as dose 1, single (Lot number: HG6396, Expiration Date: Jan2025) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure", start date: 1999 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, lot: EJ1685), administration date: 23Dec2020, when the patient was 54-year-old, for covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, lot: EL3249), administration date: 13Jan2021, when the patient was 54-year-old, for covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, lot: 30135BA), administration date: 11Oct2021, when the patient was 54-year-old, for covid-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, lot: FK9894), administration date: 15Apr2022, when the patient was 55-year-old, for covid-19 immunization; moderna COVID-19 vaccine (DOSE 5 (BOOSTER), SINGLE), administration date: 28Sep2022, when the patient was 55-year-old, for covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jan2024, outcome "unknown" and all described as "tested positive for Covid/mucus in throat". The event "tested positive for covid/mucus in throat" required physician office visit. Therapeutic measures were taken as a result of vaccination failure, covid-19, treatment was Paxlovid from 10Jan2024. At first when tested Sunday (07Jan2024) came up negative, took 3 different brand Covid tests, all came back negative. Was thinking was having viral infection, had mucus in throat, did video visit with doctor to let know what patient was feeling. Doctor prescribed Zithromax, which patient clarified was the generic, azithromycin, manufacturer Aurobindo. Confirmed patient was prescribed azithromycin. So started taking azithromycin, have to take 2 pills first day, took that and stated it is not patient's first time taking that medication, takes once a year or once every 2 years. Mucus was stuck so could be bacteria, laying dormant brings it out. Tuesday (09Jan2024) started breaking up the mucus, getting it out after taking the 2 pills as prescribed Monday, the mucus started coming out. Then patient's friend sent text that a few people from worship have Covid, but patient stated on Sunday caller had 2 masks on, so wasn't exposed there. The patient took 3 more different name brand Covid tests, all came back positive. Reached out to doctors office, went in that evening got swabbed to be sure, tested negative for flu and then said positive for SARS virus, value positive abnormal.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: Nausea; vomiting; generally felt really bad; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  A 21-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 2, single), for COVID-19 immunization; Bnt162b2 (dose 1, single), for COVID-19 immunization. The following information was reported: NAUSEA (non-serious), outcome "recovered"; VOMITING (non-serious), outcome "recovered"; MALAISE (non-serious), outcome "recovered", described as "generally felt really bad". It was unknown if therapeutic measures were taken as a result of nausea, vomiting, malaise.  Additional information: Nausea, vomiting, and generally felt really bad for 2-3 days.  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: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Nausea, Pain
Clinical narrative: fever; did not want to eat; aches and pains; nausea; chills; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Dec2023 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (primary immunization series completed with booster/s), for COVID-19 immunisation; Flu vaccine (dose number unknown, Lot number: unknown), administration date: Nov2023, for immunisation. The following information was reported: PAIN (non-serious) with onset Dec2023, outcome "recovered" (29Dec2023), described as "aches and pains"; CHILLS (non-serious) with onset Dec2023, outcome "recovered" (29Dec2023); DECREASED APPETITE (non-serious) with onset Dec2023, outcome "recovered" (29Dec2023), described as "did not want to eat"; PYREXIA (non-serious) with onset Dec2023, outcome "recovered" (29Dec2023), described as "fever"; NAUSEA (non-serious) with onset Dec2023, outcome "recovered" (29Dec2023). Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, decreased appetite, pain. Additional information: NDC number of Comirnaty: 00069-2377-10. Patient received vaccine in which she had insignificant problems with (also described as minimal side effects). She got the vaccination in the afternoon, about 2:30 in the afternoon and then she woke up in the middle of the night. She had a very, a 102.4 (also 100.2) fever, which wasn't to the point where she needed to be hospitalized and she had chills and then what she did was just kept warm and drank water. She would 'muster' like she did not want to eat but it went away quickly. She had a fever and some aches and pains and nausea. She was nauseous and then in the morning, it was starting to go down, it's about a 100 and it goes 99, finally gone to 97.9, which was normal for her, so she was fine, new the next day and she was fine after that (it went away within 24 hours). Therapeutic measures were taken as a result of pyrexia, decreased appetite, pain: Patient took two aspirin.  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: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; did not want to eat; aches and pains; nausea; chills; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Dec2023 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (primary immunization series completed with booster/s), for COVID-19 immunisation; Flu vaccine (dose number unknown, Lot number: unknown), administration date: Nov2023, for immunisation. The following information was reported: PAIN (non-serious) with onset Dec2023, outcome "recovered" (29Dec2023), described as "aches and pains"; CHILLS (non-serious) with onset Dec2023, outcome "recovered" (29Dec2023); DECREASED APPETITE (non-serious) with onset Dec2023, outcome "recovered" (29Dec2023), described as "did not want to eat"; PYREXIA (non-serious) with onset Dec2023, outcome "recovered" (29Dec2023), described as "fever"; NAUSEA (non-serious) with onset Dec2023, outcome "recovered" (29Dec2023). Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, decreased appetite, pain. Additional information: NDC number of Comirnaty: 00069-2377-10. Patient received vaccine in which she had insignificant problems with (also described as minimal side effects). She got the vaccination in the afternoon, about 2:30 in the afternoon and then she woke up in the middle of the night. She had a very, a 102.4 (also 100.2) fever, which wasn't to the point where she needed to be hospitalized and she had chills and then what she did was just kept warm and drank water. She would 'muster' like she did not want to eat but it went away quickly. She had a fever and some aches and pains and nausea. She was nauseous and then in the morning, it was starting to go down, it's about a 100 and it goes 99, finally gone to 97.9, which was normal for her, so she was fine, new the next day and she was fine after that (it went away within 24 hours). Therapeutic measures were taken as a result of pyrexia, decreased appetite, pain: Patient took two aspirin.  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: Arthralgia, Joint range of motion decreased, Poor quality product administered, Product temperature excursion issue
Clinical narrative: letter states it was stored in temperatures outside the manufacturer recommended range.; letter states it was stored in temperatures outside the manufacturer recommended range.; pain in her hip; couldn't raise her left leg and had to use the ramp; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 as dose 1, single (Lot number: HD9876, Expiration Date: 31Oct2024), in arm for covid-19 immunisation. The patient's relevant medical history included: "has a little arthritis" (unspecified if ongoing); "Had left hip surgery" (unspecified if ongoing), notes: a year ago. The patient's concomitant medications were not reported. Vaccination history included: moderna (Dose 2; lot 045J21A), administration date: 08Dec2021, for COVID-19 immunisation; moderna (Dose 3; lot 002M21A), administration date: 12Apr2022, for COVID-19 immunisation; moderna (Dose 4; lot 0611221A), administration date: 27Oct2022, for COVID-19 immunisation; Johnson and johnson (Dose 1, lot: 1805025), administration date: Mar2021, for COVID-19 immunisation; Flu shot (allowed a week between each one. Took them at pharmacy), for Immunization; Pneumonia (allowed a week between each one. Took them at pharmacy), for Immunization; Respiratory shot vaccine, rvs (allowed a week between each one. Took them at pharmacy), for Immunization. The following information was reported: JOINT RANGE OF MOTION DECREASED (non-serious) with onset 2023, outcome "recovered", described as "couldn't raise her left leg and had to use the ramp"; ARTHRALGIA (non-serious) with onset 2023, outcome "recovered", described as "pain in her hip"; PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 17Oct2023, outcome "unknown" and all described as "letter states it was stored in temperatures outside the manufacturer recommended range.". Additional information: Patient got Comirnaty 12 plus vaccine on 17Oct2023. She got a letter from that it was improperly stored. Patient states the letter states it was stored in temperatures outside the manufacturer recommended range. In Nov2023 or Dec2023 went to eat out and couldn't raise her left leg and had to use the ramp. Had been stepping up on steps prior. Had pain in her hip and couldn't understand that. Has since gone away and can raise her leg. Didn't make anything of it. Couldn't understand what was going on started having hip pain, that is gone now. Not sure if it was a passing thing.
Sex: U
Vaccine: RSV, COVID19, COVID19, FLU4, PPV
Symptoms: Asthma, Atrial fibrillation, Dyspnoea, Heart rate increased, Laboratory test
Clinical narrative: Afib; wheezing in upper chest; shortness of breath; elevated heart rate when climbing stairs /walking as longer distance; have asthma when I have a respiratory issues; have asthma when I have a respiratory issues; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) 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 was not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "Afib"; WHEEZING (non-serious), outcome "unknown", described as "wheezing in upper chest"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "elevated heart rate when climbing stairs /walking as longer distance"; ASTHMA (non-serious), RESPIRATORY DISORDER (non-serious), outcome "unknown" and all described as "have asthma when I have a respiratory issues". It was reported that the patient took the RSV shot in Oct. The day after the shot the patient started wheezing in upper chest, shortness of breath, and elevated heart rate when climbing stairs /walking as longer distance. The patient had tests to determine what has caused this, but he/she was healthy. The patient has asthma when he/she have a respiratory issues and Afib which meds control. The patient feels this is a reaction from the vaccine. The patient was going on 90 more days. The patient's quality of life has diminished. Therapeutic measures were taken as a result of atrial fibrillation, respiratory disorder.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: U
Vaccine: RSV, COVID19, COVID19, FLU4, PPV
Symptoms: Quality of life decreased, Respiratory disorder, Wheezing
Clinical narrative: Afib; wheezing in upper chest; shortness of breath; elevated heart rate when climbing stairs /walking as longer distance; have asthma when I have a respiratory issues; have asthma when I have a respiratory issues; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) 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 was not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "Afib"; WHEEZING (non-serious), outcome "unknown", described as "wheezing in upper chest"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "elevated heart rate when climbing stairs /walking as longer distance"; ASTHMA (non-serious), RESPIRATORY DISORDER (non-serious), outcome "unknown" and all described as "have asthma when I have a respiratory issues". It was reported that the patient took the RSV shot in Oct. The day after the shot the patient started wheezing in upper chest, shortness of breath, and elevated heart rate when climbing stairs /walking as longer distance. The patient had tests to determine what has caused this, but he/she was healthy. The patient has asthma when he/she have a respiratory issues and Afib which meds control. The patient feels this is a reaction from the vaccine. The patient was going on 90 more days. The patient's quality of life has diminished. Therapeutic measures were taken as a result of atrial fibrillation, respiratory disorder.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: U
Vaccine: RSV, COVID19, COVID19, FLU4, PPV
Symptoms: Atrial fibrillation, Cough, Dysphonia, Dyspnoea, Exercise tolerance decreased
Clinical narrative: Afib; wheezing in upper chest; shortness of breath; elevated heart rate when climbing stairs /walking as longer distance; have asthma when I have a respiratory issues; have asthma when I have a respiratory issues; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) 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 was not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "Afib"; WHEEZING (non-serious), outcome "unknown", described as "wheezing in upper chest"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "elevated heart rate when climbing stairs /walking as longer distance"; ASTHMA (non-serious), RESPIRATORY DISORDER (non-serious), outcome "unknown" and all described as "have asthma when I have a respiratory issues". It was reported that the patient took the RSV shot in Oct. The day after the shot the patient started wheezing in upper chest, shortness of breath, and elevated heart rate when climbing stairs /walking as longer distance. The patient had tests to determine what has caused this, but he/she was healthy. The patient has asthma when he/she have a respiratory issues and Afib which meds control. The patient feels this is a reaction from the vaccine. The patient was going on 90 more days. The patient's quality of life has diminished. Therapeutic measures were taken as a result of atrial fibrillation, respiratory disorder.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: U
Vaccine: RSV, COVID19, COVID19, FLU4, PPV
Symptoms: Fatigue, Heart rate increased, Sleep disorder, Wheezing
Clinical narrative: Afib; wheezing in upper chest; shortness of breath; elevated heart rate when climbing stairs /walking as longer distance; have asthma when I have a respiratory issues; have asthma when I have a respiratory issues; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) 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 was not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "Afib"; WHEEZING (non-serious), outcome "unknown", described as "wheezing in upper chest"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "elevated heart rate when climbing stairs /walking as longer distance"; ASTHMA (non-serious), RESPIRATORY DISORDER (non-serious), outcome "unknown" and all described as "have asthma when I have a respiratory issues". It was reported that the patient took the RSV shot in Oct. The day after the shot the patient started wheezing in upper chest, shortness of breath, and elevated heart rate when climbing stairs /walking as longer distance. The patient had tests to determine what has caused this, but he/she was healthy. The patient has asthma when he/she have a respiratory issues and Afib which meds control. The patient feels this is a reaction from the vaccine. The patient was going on 90 more days. The patient's quality of life has diminished. Therapeutic measures were taken as a result of atrial fibrillation, respiratory disorder.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand Pfizer / BioNTech, vaccine dose number: 6; vaccine brand other: Moderna, vaccine dose number: 5; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05May2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Jan2021 as dose 1, single), on 15Feb2021 as dose 2, single), on 23Oct2021 as dose 3 (booster), single), on 19Apr2022 as dose 4 (booster), single) and on 21Sep2022 as dose 5 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "heart disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05May2023, outcome "recovered", described as "Vaccine brand Pfizer / BioNTech, vaccine dose number: 6; vaccine brand other: Moderna, vaccine dose number: 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" (Jan2024) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Negative, notes: I tested negative three times after 5-day treatment with Paxlovid; (Jan2024) Negative, notes: I tested negative three times after 5-day treatment with Paxlovid; (Jan2024) Negative, notes: I tested negative three times after 5-day treatment with Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 27Dec2023 to 31Dec2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Condition aggravated, Inflammation, Phlebitis, Urticaria
Clinical narrative: inflammation; inflammation in the veins/ veins bulging all over her body (especially her abdomen and legs); hair loss; itchy, itchy hives, kind of things etc.; made 'her mast cell' worse; This is a spontaneous report received from a Physician from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "parethesia on small areas in her body", start date: 2007 (unspecified if ongoing), notes: on and off; she can have years without anything (without sxs). The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine (dose number unknown, manufacturer unknown), for immunisation, reaction(s): "no adverse effect"; Shingles vaccine (dose number unknown, manufacturer unknown), for immunisation, reaction(s): "no adverse effect"; Pneumonia vaccine (dose number unknown, manufacturer unknown), for immunisation, reaction(s): "no adverse effect". The following information was reported: INFLAMMATION (non-serious), outcome "unknown"; PHLEBITIS (non-serious), outcome "unknown", described as "inflammation in the veins/ veins bulging all over her body (especially her abdomen and legs)"; ALOPECIA (non-serious), outcome "unknown", described as "hair loss"; URTICARIA (non-serious), outcome "unknown", described as "itchy, itchy hives, kind of things etc."; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "made 'her mast cell' worse".  Additional information: Patient mentioned that she would have had long COVID 3 years this March and had a "laundry list of symptoms". Patient reported headaches, inflammation, nausea, myalgia, hair loss, veins bulging all over her body (especially her abdomen and legs), inflammation in the veins. Her headache was only now less frequent. Sometimes she got the itchy, itchy hives, kind of things etc, but she did not know if that played a role. She had both Moderna and Pfizer COVID vaccines (switched to Pfizer from Moderna however unclear timeline of vaccine and COVID). Ten (10) days after receiving COVID vaccine (manufacturer unknown) she developed COVID; however, she only had headache and worsened tinnitus at that time and then in the summer, "all sorts of GI symptoms" were added. She also reported that every time she had a COVID vaccine, it made her "mast cell" worse.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400011938 same patient/drug, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Reports 10 days after receiving covid vaccine (unclear mfg ) she developed Covid; Reports 10 days after receiving covid vaccine (unclear mfg ) she developed Covid; This is a spontaneous report received from a Physician from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Reports 10 days after receiving covid vaccine (unclear mfg ) she developed Covid".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162B2 administration.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from 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 07Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Kown llergies: Sulfa" (unspecified if ongoing). The patient had no other medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 02Jan2024 to 06Jan2024.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 in this patient cannot be completely excluded.
Age: 59.0
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 59-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2023, outcome "recovered" (01Jan2024) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2023) Positive, notes: Rebound case Positive test on 26Dec, start Paxlovid 28Dec; (01Jan2024) Negative; (02Jan2024) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 28Dec2023 to Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 84.0
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.  An 85-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, single (Lot number: HF9275) at the age of 84 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2023, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included paxlovid from 31Dec2023 to 04Jan2024. Clinical course: Patient experienced fever, runny nose, fatigue, cough on 29Dec2023. Patient did not have known allergies.
Age: 55.0
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 55-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 14:30 as dose 1, single (Lot number: hh7595) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lyme Disease", start date: 1989 (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot no. EN6702, Anatomical location: Left arm), administration date: 16Mar2021, when the patient was 52-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot no. ER8733, Anatomical location: Left arm), administration date: 06Apr2021, when the patient was 52-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot no. FE3590, Anatomical location: Left arm), administration date: 15Oct2021, when the patient was 53-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot no. PM9992, Anatomical location: Left arm), administration date: 22Apr2022, when the patient was 53-year-old, for COVID-19 immunization; BNT162b2, BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Batch/Lot no. GH9693, Anatomical location: Left arm), administration date: 30Sep2022, when the patient was 54-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2024) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid treatment from 28Dec2023 to 02Jan2024. Clinical course: Patient denied for any known allergies.
Age: 45.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19, SARS-CoV-2 test, Streptococcus test, Vaccination failure
Clinical narrative: First time, had sore throat/tested positive for Covid, had 5 vaccines; First time, had sore throat/tested positive for Covid, had 5 vaccines; This is a spontaneous report received from a Nurse.  A 46-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 as dose 1, single (Lot number: HG4464) at the age of 45 years for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 12Oct2023 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Hypertension. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, LOT: EJ1685, NDC, EXP: Unknown), administration date: 22Dec2020, when the patient was 43-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, LOT:EJ1685, NDC, EXP: Unknown), administration date: 10Jan2021, when the patient was 43-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3(BOOSTER), LOT: FG3527, NDC, EXP: Unknown), administration date: 08Nov2021, when the patient was 43-year-old, for COVID-19 Immunization; BNT162b2, BNT162b2 omi (DOSE 4 (BOOSTER) , LOT: GJ6739, NDC, EXP: Unknown), administration date: 23Nov2022, when the patient was 44-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jan2024, outcome "unknown" and all described as "First time, had sore throat/tested positive for Covid, had 5 vaccines". First time, had sore throat, second day, sore throat, coughing. Third day, went to get Paxlovid. Thought maybe it was cold because it was cold season. They did test for strep and Covid, Covid was positive, Strep was negative. Clarified, strep test and Covid test were 05Jan2024. Never had Covid, this is first time testing positive for Covid. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jan2024) Positive, notes: Result: positive; Unit: Not Provided; Streptococcus test: (05Jan2024) Negative, notes: Result: negative; Unit: Not Provided. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 06Jan2024 to 10Jan2024.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162B2 administration.