chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Viral test negative, Vomiting
Clinical narrative: Patient developed low grade fever, fatigue, aches 11/14/23.  Morning of 11/15/23 acutely confused, vomited multiple times.  Sent to ED 11/15/23: CT head, MRI brain negative, labs, UA, chest x-ray without abnormal finding. Viral pathogen testing negative.  Dx with delirium, improved with time.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: glenohumeral joint pain limited range of motion unable to lift arm above shoulder level
Age: 82.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature decreased, Chills, Insomnia, Nausea, SARS-CoV-2 test negative
Clinical narrative: Received phone call from patient's wife who stated that the evening of the 16th the patient started to have chills, nausea, vomiting, and difficulty sleeping. Patient's wife reported that patient had low body temperature (around 96 degrees). She reported that the patient continued to have these symptoms into the afternoon of the 17th as well. She reported that the patient tested negative for Covid. Shortly after our phone call I contacted the patient back (around 6 PM) and his wife informed me that the symptoms were starting to abate and the patient was feeling much better.
Age: 82.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Received phone call from patient's wife who stated that the evening of the 16th the patient started to have chills, nausea, vomiting, and difficulty sleeping. Patient's wife reported that patient had low body temperature (around 96 degrees). She reported that the patient continued to have these symptoms into the afternoon of the 17th as well. She reported that the patient tested negative for Covid. Shortly after our phone call I contacted the patient back (around 6 PM) and his wife informed me that the symptoms were starting to abate and the patient was feeling much better.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLU4, VARZOS
Symptoms: Blood glucose normal, Cold sweat, Dizziness, Hyperhidrosis, Peripheral coldness
Clinical narrative: about 5 minutes after receiving 3 shots, the patient was starting to feel dizzy, lightheaded, and starting sweating profusely.  felt patients hands and they were very cold and clammy.  it lasted for over 30 minutes.  patient stated she was seeing stars.  patient know her name, where she was and what day it was when asked, responded quickly, patient state she had some toast and some yogurt for breakfast
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLU4, VARZOS
Symptoms: Photopsia
Clinical narrative: about 5 minutes after receiving 3 shots, the patient was starting to feel dizzy, lightheaded, and starting sweating profusely.  felt patients hands and they were very cold and clammy.  it lasted for over 30 minutes.  patient stated she was seeing stars.  patient know her name, where she was and what day it was when asked, responded quickly, patient state she had some toast and some yogurt for breakfast
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Headache, Injection site pain, Pyrexia
Clinical narrative: High fever came and went (102.1, 102.2, 102.6, 100.3) starting at 2am (still symptomatic at 11pm) Stomach discomfort/unsettled but no diarrhea  Pain at injection site almost immediately after administration which persisted, but no axillary lymphadenopathy  Extreme headache and joint pain (hips, right hand ring finger and middle finger)
Age: 78.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Eryethema at injection site 4 inches by 3 inches that was raised and extremely itchy and hot
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Chills and muscle pain.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Urticaria
Clinical narrative: 2 weeks post booster shot I've started to experience persistent hives that itch intensely, cause a red rash, and worsen at night. I have never previously suffered from hives or skin sensitivity or any allergies. Oral antihistamines seem to be helping but the itching is very intense, especially on hands and soles of the feet.
Age: 60.0
Sex: F
Vaccine: FLUR4, PPV, VARZOS
Symptoms: Unevaluable event
Clinical narrative: Unknown
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Blood culture negative, C-reactive protein normal, Culture urine negative, Procalcitonin, Pyrexia
Clinical narrative: Patient exposed to sibling with viral illness and developed fever 10/5/2023 that resolved on its own. Patient seen for Health Maintenance exam on 11/7/2023 with normal exam. Patient developed fever on the evening of 11/7/2023 and seen in Emergency Department and admitted for observation
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Erythema, Injection site erythema, Injection site swelling
Clinical narrative: 11/10/2023 evening arm soreness. next day 11/11-chills,nausea,backache took tylenol, sunday 11/12 nausea, backache muscle cramps, arm still sore and red monday 11/13 still having nausea, arm red and swollen at injection site general itching both arms, stomach and back-taking benadryl
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea, Pain in extremity, Pruritus
Clinical narrative: 11/10/2023 evening arm soreness. next day 11/11-chills,nausea,backache took tylenol, sunday 11/12 nausea, backache muscle cramps, arm still sore and red monday 11/13 still having nausea, arm red and swollen at injection site general itching both arms, stomach and back-taking benadryl
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Skin ulcer
Clinical narrative: Developed Ulcer in shoulder  referred pt to wound care
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC20
Symptoms: Cellulitis, Vaccination site erythema
Clinical narrative: DX: Cellulitis. Left upper medial leg with approx 4cmx4cm area of erythema surrounding most medial vaccine injection site. Treated with po abx, Augmentin 400mg 15mls, 3mls BID x 7 days.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Diarrhoea, Headache, Injection site pain, Nausea
Clinical narrative: fainted; Chills; soreness at injection site; headache; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Nov2023 at 15:15 as dose 1, single (Lot number: HH7595) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Covid prior vaccination. The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 11Nov2023 at 04:00, outcome "recovered" (Nov2023); DIARRHOEA (non-serious) with onset 11Nov2023 at 04:00, outcome "recovered" (Nov2023), described as "diarrhea"; SYNCOPE (medically significant) with onset 11Nov2023 at 04:00, outcome "recovered" (Nov2023), described as "fainted"; HEADACHE (non-serious) with onset 11Nov2023 at 04:00, outcome "recovered" (Nov2023); VACCINATION SITE PAIN (non-serious) with onset 11Nov2023 at 04:00, outcome "recovered" (Nov2023), described as "soreness at injection site". Therapeutic measures were not taken as a result of syncope, chills, vaccination site pain, headache, diarrhoea. Clinical course: Chills, soreness at injection site, headache, chills (nothing out of ordinary) but in middle of night had diarrhea and fainted. Patient had no other vaccine in four weeks. Patient had never fainted in her life. She had not Covid tested post vaccination and she had no known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: fainted; Chills; soreness at injection site; headache; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Nov2023 at 15:15 as dose 1, single (Lot number: HH7595) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Covid prior vaccination. The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 11Nov2023 at 04:00, outcome "recovered" (Nov2023); DIARRHOEA (non-serious) with onset 11Nov2023 at 04:00, outcome "recovered" (Nov2023), described as "diarrhea"; SYNCOPE (medically significant) with onset 11Nov2023 at 04:00, outcome "recovered" (Nov2023), described as "fainted"; HEADACHE (non-serious) with onset 11Nov2023 at 04:00, outcome "recovered" (Nov2023); VACCINATION SITE PAIN (non-serious) with onset 11Nov2023 at 04:00, outcome "recovered" (Nov2023), described as "soreness at injection site". Therapeutic measures were not taken as a result of syncope, chills, vaccination site pain, headache, diarrhoea. Clinical course: Chills, soreness at injection site, headache, chills (nothing out of ordinary) but in middle of night had diarrhea and fainted. Patient had no other vaccine in four weeks. Patient had never fainted in her life. She had not Covid tested post vaccination and she had no known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Diarrhoea, Headache, Syncope, Vaccination site pain
Clinical narrative: fainted; Chills; soreness at injection site; headache; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Nov2023 at 15:15 as dose 1, single (Lot number: HH7595) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Covid prior vaccination. The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 11Nov2023 at 04:00, outcome "recovered" (Nov2023); DIARRHOEA (non-serious) with onset 11Nov2023 at 04:00, outcome "recovered" (Nov2023), described as "diarrhea"; SYNCOPE (medically significant) with onset 11Nov2023 at 04:00, outcome "recovered" (Nov2023), described as "fainted"; HEADACHE (non-serious) with onset 11Nov2023 at 04:00, outcome "recovered" (Nov2023); VACCINATION SITE PAIN (non-serious) with onset 11Nov2023 at 04:00, outcome "recovered" (Nov2023), described as "soreness at injection site". Therapeutic measures were not taken as a result of syncope, chills, vaccination site pain, headache, diarrhoea. Clinical course: Chills, soreness at injection site, headache, chills (nothing out of ordinary) but in middle of night had diarrhea and fainted. Patient had no other vaccine in four weeks. Patient had never fainted in her life. She had not Covid tested post vaccination and she had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Heart pain; Booster really made me sick / I got very sick; Head and neck issue; Head and neck issue; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received bnt162b2 (BNT162B2), on 28Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 81 years intramuscular, in right 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: bnt162b2 (dose 1, single; lot number: EL3246), administration date: 06Jan2021, for COVID-19 immunisation; bnt162b2 (dose 2, single; lot number: EL9261), administration date: 29Jan2021, for COVID-19 immunisation. The following information was reported: MALAISE (non-serious), outcome "not recovered", described as "Booster really made me sick / I got very sick"; ANGINA PECTORIS (medically significant), outcome "unknown", described as "Heart pain"; HEAD DISCOMFORT (non-serious), MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown" and all described as "Head and neck issue". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of angina pectoris. Therapeutic measures were not taken as a result of malaise, head discomfort, musculoskeletal discomfort. Clinical course: The patient reported that she had been sick for one year. In December (unspecified year), she got very sick, she tested negative for COVID, but she had been so sick on and off, she hadn't had a good day since then. Now, she had heart pain (she doesn't know when it started), she had to have a cardiac cap, she had to have 2 stents in there and she had a head and neck issue, before but was just like arthritis. Everything that she had before blossomed into major problem and she just doesn't know what it was. Her allergist told her it was long hold COVID. She wouldn't know how to find what it is because her doctor doesn't want to talk about it. She doesn't know of her doctors were afraid to help her or they just don't know what to do. The patient knows there was something wrong, she was so healthy. She had been working for 5 days a week and it has been she had not done 5 times a year, it just makes her angry. She took the Pfizer COVID-19 shot. She had the 1st vaccine on 06Jan2021, the 2nd one on 29Jan2021, and then in 28Nov2021 she had the Pfizer booster shot. The booster really made her sick.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300366122 same patient and vaccine; different dose and event;
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Head discomfort, Malaise, Musculoskeletal discomfort, SARS-CoV-2 test
Clinical narrative: Heart pain; Booster really made me sick / I got very sick; Head and neck issue; Head and neck issue; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received bnt162b2 (BNT162B2), on 28Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 81 years intramuscular, in right 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: bnt162b2 (dose 1, single; lot number: EL3246), administration date: 06Jan2021, for COVID-19 immunisation; bnt162b2 (dose 2, single; lot number: EL9261), administration date: 29Jan2021, for COVID-19 immunisation. The following information was reported: MALAISE (non-serious), outcome "not recovered", described as "Booster really made me sick / I got very sick"; ANGINA PECTORIS (medically significant), outcome "unknown", described as "Heart pain"; HEAD DISCOMFORT (non-serious), MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown" and all described as "Head and neck issue". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of angina pectoris. Therapeutic measures were not taken as a result of malaise, head discomfort, musculoskeletal discomfort. Clinical course: The patient reported that she had been sick for one year. In December (unspecified year), she got very sick, she tested negative for COVID, but she had been so sick on and off, she hadn't had a good day since then. Now, she had heart pain (she doesn't know when it started), she had to have a cardiac cap, she had to have 2 stents in there and she had a head and neck issue, before but was just like arthritis. Everything that she had before blossomed into major problem and she just doesn't know what it was. Her allergist told her it was long hold COVID. She wouldn't know how to find what it is because her doctor doesn't want to talk about it. She doesn't know of her doctors were afraid to help her or they just don't know what to do. The patient knows there was something wrong, she was so healthy. She had been working for 5 days a week and it has been she had not done 5 times a year, it just makes her angry. She took the Pfizer COVID-19 shot. She had the 1st vaccine on 06Jan2021, the 2nd one on 29Jan2021, and then in 28Nov2021 she had the Pfizer booster shot. The booster really made her sick.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300366122 same patient and vaccine; different dose and event;
Sex: F
Vaccine: HPV9
Symptoms: Adverse event
Clinical narrative: unknown side effects; This spontaneous report was received from a physician and refers to a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were unknown.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml intramuscularly (strength not reported; lot #, expiration date, unknown by reporter), for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus.   After the administration, on an unknown date, the patient experienced unknown side effects (adverse event). Medical attention was sought. It was unknown whether treatment was given for the adverse event. At the time of this report, the outcome of the adverse event was unknown.  The causal relationship between the adverse event and the suspect vaccine was unknown.
Age: 59.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Expired product administered
Clinical narrative: no symptoms or side effects reported/No additional AE/No PQC; a PNEUMOVAX 23 prefilled syringe was administered after expiration to a patient today, 25-OCT-2023; This spontaneous report has been received from a medical assistant and refers to a 59-year-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.  On 25-OCT-2023, the patient was vaccinated with an expired second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection 0.5 milliliter intramuscularly (IM) as prophylaxis (anatomical location of vaccination was not provided; lot number W007035 has been verified to be valid, expiration date 20-OCT-2023) (conflicting information, lot number also reported as UT8076JA) (expired product administered). No symptoms or side effects were reported. There were no previous temperature excursions on the vaccine.
Sex: U
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: she also mentioned that she has a friend around the same age that also had a titer done in the past which showed no immunity to at least 1 of the viruses despite being vaccinated.; This spontaneous report was received from a company representative and refers to an adult patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) (dose, route of administration, anatomical location, lot #, and expiration date were not provided).   On an unknown date, the patient got Measles, Mumps and Rubella (MMR) titer test that showed no immunity to at least 1 of the viruses despite being vaccinated (Antibody test negative). Outcome of the events was unknown.  Causality assessment was not provided.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2311USA000494:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The nurse is reporting that a patient received improperly stored vaccine.; This spontaneous report was received from a nurse and refers to a patient of a not reported age or gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-OCT-2023, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, lot #x019553, expiration date: 19-JAN-2025, administered for prophylaxis (strength, vaccination scheme and route of administration were not provided) following a temperature excursion of -9.2 degrees Celsius (C) for 1 hour 7 minutes and -11.2C for 31 minutes, it was stated that no previous temperature excursions occurred. No additional adverse event was reported.
Sex: M
Vaccine: RV5
Symptoms: Regurgitation
Clinical narrative: HCP called to report an AE regarding the ROTATEQ vaccine. HCP reported that the patient regurgitated the ROTATEQ vaccine. HCP provided limited pertinent information and had no further clarifications. Request case 02504635 filed. Permission to contact; This spontaneous report was received from a Physician and refers to a 2-month-old male. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with Rotavirus Vaccine, Pentavalent (ROTATEQ), (strength, dose, frequency and units were not provided), administered Orally for prophylaxis (lot # 1965643 has been verified to be a valid lot number with the expiration date as 05-OCT-2024; anatomical location were not provided)  The causal relationship between the event and rotavirus Vaccine, Pentavalent (ROTATEQ), was unknown.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; reports expired dose of PNEUMOVAX 23 (pfs) was administered to a patient; This spontaneous report as received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 14-NOV-2023, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection (0.5 mL, lot #W019533 was valid for formulation pre-filled syringe, expiration date was reported as 30-SEP-2023, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used). Product had not experienced any temperature excursions through the date of administration. No additional adverse event (AE) reported (No adverse event). No product quality complaint (PQC).
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects reported; expired dose of ROTATEQ that was administered to a patient; This spontaneous report as received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 14-NOV-2023, the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral solution (lot #1879866, expiration date 30-OCT-2023, exact dose and route of administration were not provided) for prophylaxis (Expired vaccine used). No side effects reported. Vaccine never had any temperature excursions. No additional adverse event (AE)/product quality complaint (PQC) (No adverse event).
Age: 14.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: inadvertent administration of PROQUAD to a 14-year-old patient who was scheduled to receive only MMR-II; administration of PROQUAD to a 14-year-old; No additional AE; This spontaneous report was received from a nurse, referring to 14-year-old male patient. Information regarding the patient's historical condition, concurrent condition and concomitant medication was not provided. Patient's historical vaccines included varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II).  On 13-NOV-2023, the patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection (exact dose, lot #, expiration date, route of administration and anatomical location were not provided) instead of M-M-R II for prophylaxis (Wrong vaccine used, Inappropriate age at vaccine administration). No additional adverse event (AE)/product quality complaint (PQC).
Sex: U
Vaccine: MMRV
Symptoms: Peripheral swelling, Rash, Rash erythematous, Skin warm
Clinical narrative: developed a rash in the right arm in the right arm that was red; swollen right arm; warm to the touch; developed a rash in the right arm in the right arm that was red; This spontaneous report was received from a consumer and refers to a 4-year-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-NOV-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, administered subcutaneously for prophylaxis (strength, lot #, and expiry date were not provided).  On an unknown date, the patient recovered from the events. On 07-NOV-2023 (also reported as 8 hours after vaccination), the patient experienced developed a rash in the right arm in the right arm that was red, swollen, and warm to the touch. The reporter states that the area was still red but the rash is gone and the "problem was resolved". There was no spread of the rash and the patient did not need any urgent care.  The causal relationship betweenall adverse events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was unknown.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Medical assistant called to report that a patient was administered an expired dose of ROTATEQ. Caller stated the dose expired on 10/16/2023 and was administered on 11/15/2023.; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 15-NOV-2023, the patient was vaccinated with expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 1 dose, administered orally, lot # 1879870, expiration date 16-OCT-2023 (exact dose for not reported) for prophylaxis. Reporter stated that vaccine was not involved in any temperature excursions. No additional adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No averse event; HCP called to report T/E for GARDASIL 9. HCP stated 2 patients inadvertently patient received GARDASIL 9 during the T/E.   GARDASIL 9 was administered on 10/31/2023 and it was the 1st dose for the patient.  AE case filed # 02508287.  No other informa; This spontaneous report was received from a nurse refers to a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-OCT-2023, the patient was vaccinated with the first improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #1957405, expiration date: 11-NOV-2025 (exact dose, route of administration and anatomical location were not reported) for prophylaxis.    On 26-OCT-2023 and 27-OCT-2023, administered dose of vaccine was exposed to the temperature excursion of -2.04 degrees Celsius for 2 hours, -1.61 degrees Celsius for 1 hour and 30 minutes, -1.56 degrees Celsius for 45 minutes, -1.04 degrees Celsius for 30 minutes, -0.82 degrees Celsius for 1 hour and 15 minutes, -1.21 degrees Celsius for 1 hour and 15 minutes (product storage error). There were no additional adverse events reported (no adverse event).
Age: 64.0
Sex: U
Vaccine: PNC13, PPV
Symptoms: No adverse event, Product confusion, Wrong product administered
Clinical narrative: No additional adverse event; HCP meant to administer Pnuemovax 23 and instead administered prevnar 13; HCP meant to administer Pnuemovax 23 and instead administered prevnar 13; This spontaneous report has been received from other health professional concerning to a 64-year-old patient of unknown gender and ethnicity. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter.  On 14-NOV-2023, the health care professional (HCP) was supposed to administer pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 mL, but instead administered pneumococcal vaccine conj 13v (CRM197) (PREVNAR 13) as prophylaxis (formulation, dose, route of administration, scheme, lot number and expiration date were not provided) (product confusion/ wrong product administered). No adverse effects, no additional adverse event or product quality complain (PQC) were reported.
Sex: F
Vaccine: VARCEL
Symptoms: Deafness, Immunisation reaction
Clinical narrative: Hearing loss 6 weeks after varivax; This spontaneous report has been received from a physician, via a MR from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 1806USA001202 original legal case), concerning a currently 68-year-old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.   On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (strength, dose, route, lot# and expiration date were not reported) for prophylaxis.        On an unknown date, 6 weeks after varicella virus vaccine live (Oka/Merck) (VARIVAX), the patient experienced reaction of hearing loss (Deafness), which was a side effect of this vaccine. Outcome of deafness was unknown.   The causality between varicella virus vaccine live (Oka/Merck) (VARIVAX) and the event was related.  Upon internal review, deafness was determined to be medically significant.  This is one of two reports regarding the same patient.; Sender's Comments:  US-009507513-1806USA001202:
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered, Product storage error
Clinical narrative: Five doses of the Jynneos vaccine were administered beyond-use date; The Jynneos doses were stored in the fridge beyond the eight weeks; Case reference number US-BN-2023-001739 is a spontaneous case report initially received from a physician (reference number: EUBAV23-1815) on 01-Nov-2023 and concerns five patients of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified dates, five patients were vaccinated with a dose of Jynneos (batch number: FDP00020) at an unknown dose, route or site of administration, for unknown indication. As reported, the five doses of Jynneos were administered beyond-use date, the doses were stored in the fridge beyond the eight weeks and there were five patients involved (explicitly coded as 'expired vaccine used' and 'product storage error').  At the time of this initial report, it was unknown if the patient experienced any adverse event due to Jynneos vaccine.  Additional information received on 01-Nov-2023 included local case ID.; Reporter's Comments: This case concerns five patients (of unknown demographics) vaccinated with doses of Jynneos stored in the fridge beyond the eight weeks and beyond-use date which is considered as expired vaccine used and product storage error. Expired product administered and product storage error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Jynneos vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: This case concerns five patients (of unknown demographics) vaccinated with doses of Jynneos stored in the fridge beyond the eight weeks and beyond-use date which is considered as expired vaccine used and product storage error. Expired product administered and product storage error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Jynneos vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Gave a HEPLISAV-B Vaccine on 05/17/2023 But Wrote Expiration Date in January 2023; Initial Report Received on 19-Jun-2023  A retail pharmacist reported that a 22-year-old female patient (race and ethnicity unknown) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and allergies at the time of vaccination were reported as unknown. Medications at the time of vaccination were not reported.  On 17-May-2023, the patient received an expired dose of HEPLISAV-B vaccine (Lot # 941389, expiration date Jan-2023 and NDC # 43528000305) intramuscularly (injection site not reported) at a retail pharmacy. The actual expiration date was unknown. The reporter denied any adverse effects.  No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Dizziness, Fall, Pyrexia, Tinnitus
Clinical narrative: On the evening of 11-9-2023, I went in to store to get the updated Moderna Covid19 vaccine as well as my annual flu shot. My appointment was scheduled at 5pm. I received my vaccinations some time after my arrival as I had to check in, wait, pay, etc. My brother had come along with me to receive his updated vaccinations as well and he went first, then me. Exact time of my vaccination is unknown to me but was after 5pm and before 6pm. We went home and watched a movie and my right arm, which received the Covid19 injection was feeling sore. Next morning, 11-10-2023, I woke up around 7:30am and was getting out of bed to feed my cats. I nearly fell over as my body pulled to the left due to extreme dizziness. I tried to take a few steps toward my bedroom door but was so dizzy I had to lie back down in bed. I also had some fever, but the fever was not unexpected as it was how I reacted to previous Covid19 vaccinations; the extreme dizziness was another matter altogether. After lying there for a little while, I sat back up and waited for the spinning feeling to level off. I was still dizzy, but not falling over anymore, so I went to feed my cats and then laid back down and went back to sleep. Later in the day, I woke back up and was no longer dizzy but still had the slight fever. The following morning, 11-11-2023, I woke up with no dizziness and my fever was gone, but I now had a ringing, buzzing sound in both of my ears. I waited to file this report to see if the ringing would subside, but it has not as of now, 11-18-2023. The ringing is tolerable and not very noticeable to me when I am engaged in doing something such as talking to someone, shopping, watching a movie, etc., but becomes quite bothersome and prevalent when I am alone doing something quietly (reading, computer work, etc.) It is especially intrusive and loud when I am trying to fall asleep at night and is preventing me from falling to sleep well.  I am hoping this situation somehow resolves itself in the future, but unfortunately for now I continue to have the ringing, buzzing sound in both of my ears.
Sex: M
Vaccine: RVX
Symptoms: Respiratory symptom, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Vaccination failure
Clinical narrative: Suspected vaccination failure; Respiratory syncytial virus infection; upper respiratory symptoms; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a adult male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: Respiratory syncytial virus infection) and upper respiratory symptom (Verbatim: upper respiratory symptoms). The outcome of the vaccination failure was unknown and the outcome of the respiratory syncytial virus infection and upper respiratory symptom were not reported.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and upper respiratory symptom to be related to RSV vaccine.  It was unknown if the company considered the vaccination failure, respiratory syncytial virus infection and upper respiratory symptom to be related to RSV vaccine.   Additional Information: GSK Receipt Date- 07-NOV-2023 The patient age was over 60. The reporter reported that the patient got a RSV vaccine, the brand of vaccine was unconfirmed.  The patient got adult RSV within a few days of reporting he got the RSV vaccine.  The patient was confirmed to had RSV (Respiratory syncytial virus infection) by PCR test.  The reporter reported that the patient had a upper respiratory symptoms but did not report lower respiratory symptoms. The reporter would inquire of the pharmacy where he was vaccinated which brand of RSV vaccine he received. This case was considered as suspected vaccination failure as details regarding time to onset confirming respiratory syncytial virus infection were unknown at the time of reporting. This case had been linked to US2023AMR155718, reported by the same reporter, for a different patient. The reporter did not agree to follow up from GlaxoSmithKline.; Sender's Comments:  US-GSK-US2023AMR155718:Patient 2
Sex: F
Vaccine: RVX
Symptoms: Respiratory symptom, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Vaccination failure
Clinical narrative: Suspected vaccination failure; Respiratory syncytial virus infection; Upper respiratory symptom; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a adult female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: Respiratory syncytial virus infection) and upper respiratory symptom (Verbatim: Upper respiratory symptom). The outcome of the vaccination failure was unknown and the outcome of the respiratory syncytial virus infection and upper respiratory symptom were not reported.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and upper respiratory symptom to be related to RSV vaccine.   It was unknown if the company considered the vaccination failure, respiratory syncytial virus infection and upper respiratory symptom to be related to RSV vaccine.   Additional Information: GSK Receipt Date- 07-NOV-2023 The patient age was over 60. The reporter reported that the patient got a RSV vaccine, the brand of vaccine was unconfirmed.  The patient got adult RSV within a few days of reporting he got the RSV vaccine.  The patient was confirmed to had RSV (Respiratory syncytial virus infection) by PCR test.  The reporter reported that the patient had a upper respiratory symptoms but did not report lower respiratory symptoms. The reporter would inquire of the pharmacy where he was vaccinated which brand of RSV vaccine he received. This case was considered as suspected vaccination failure as details regarding time to onset confirming respiratory syncytial virus infection were unknown at the time of reporting. This case had been linked to US2023AMR155714, reported by the same reporter, for a different patient. The reporter did not agree to follow up from GlaxoSmithKline.; Sender's Comments:  US-GSK-US2023AMR155714:Patient 2
Sex: U
Vaccine: MNQ
Symptoms: Product lot number issue
Clinical narrative: Maladministration; This non-serious case was reported by a nurse via sales rep and described the occurrence of product lot number issue in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced product lot number issue (Verbatim: Maladministration). The outcome of the product lot number issue was unknown.   Additional Information: GSK Receipt Date: 16-JUN-2023 The reporter asked the timeframe for Menveo to go to fully liquid as he/she was working through an error in one of their clinics. The private doses would be available to order in July, others would be 4 to 6 weeks behind and hopefully that would help the back-to-school season. The reporter asked if they knew about the extra lot numbers on the current supply of Menveo.  A picture was shared of a vial, a staff had been voicing confusion on which lot number they were to be using for documentation. Not only did they have the lot number from the diluent, 2 different numbers on the vial with the powder as well.  They discussed that they should always use the one that matches the one on the box, but unfortunately some of their clinics did not order by the box from the pharmacy.  Not sure why there would be 2 different lot numbers on one vial, and asked if moving forward with the new formulation of being fully liquid if that was going to perhaps be corrected. The fully liquid Menveo would have just one lot number so it should be much less confusing. Both the mix version & the fully liquid version would be available on the order screen so they may have to make sure the hospital understood which one they want & orders it properly.  The reporter consented to follow up. The vial had multiple batch numbers, which led to product lot number issue.
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Fatigue, Headache, Impaired work ability, Inflammation, Pain
Clinical narrative: itching on side torso bilaterally; blotchy rash; developed hives on her torso; entire trunk felt inflamed; bad headache; fatigue; achy; missed work; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included HEPATITIS B VACCINE (HEPLISAV B) for prophylaxis.   Previously administered products included Allergy injection. Concurrent medical conditions included allergic to dogs.   On 30-AUG-2023, the patient received Shingrix and HEPLISAV B. On 31-AUG-2023, 1 days after receiving Shingrix, the patient experienced headache (Verbatim: bad headache), fatigue (Verbatim: fatigue), pain (Verbatim: achy) and activities of daily living impaired (Verbatim: missed work). In OCT-2023, the patient experienced pruritus (Verbatim: itching on side torso bilaterally), blotchy rash (Verbatim: blotchy rash), hives (Verbatim: developed hives on her torso) and inflammation localized (Verbatim: entire trunk felt inflamed). The patient was treated with ibuprofen (Advil) and benadryl (nos) (Benadryl). The outcome of the headache, fatigue, pain and activities of daily living impaired were resolving and the outcome of the pruritus, blotchy rash, hives and inflammation localized were not reported.   It was unknown if the reporter considered the headache, fatigue, pain, activities of daily living impaired, pruritus, blotchy rash, hives and inflammation localized to be related to Shingrix.     It was unknown if the company considered the headache, fatigue, pain, activities of daily living impaired, pruritus, blotchy rash, hives and inflammation localized to be related to Shingrix.   Additional Information: GSK receipt date: 08-NOV-2023 A woman received Heplisav and Shingrix and 3 days later she developed hives on her torso. As per primary care provider note on 31st October 2023, next day the patient suffered from bad headache, fatigue, achy and missed work however felt better next day, Advil helped. Three days later noted itching on side torso bilaterally, blotchy rash, looked like hives and entire trunk felt inflamed, Benadryl helped. The patient had allergy injections as a child, history of dog allergies, even had reaction to hypoallergenic dogs. There were no other medical notes documented between 30 August 2023 and 31 October 2023.
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Pruritus, Rash macular, Urticaria
Clinical narrative: itching on side torso bilaterally; blotchy rash; developed hives on her torso; entire trunk felt inflamed; bad headache; fatigue; achy; missed work; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included HEPATITIS B VACCINE (HEPLISAV B) for prophylaxis.   Previously administered products included Allergy injection. Concurrent medical conditions included allergic to dogs.   On 30-AUG-2023, the patient received Shingrix and HEPLISAV B. On 31-AUG-2023, 1 days after receiving Shingrix, the patient experienced headache (Verbatim: bad headache), fatigue (Verbatim: fatigue), pain (Verbatim: achy) and activities of daily living impaired (Verbatim: missed work). In OCT-2023, the patient experienced pruritus (Verbatim: itching on side torso bilaterally), blotchy rash (Verbatim: blotchy rash), hives (Verbatim: developed hives on her torso) and inflammation localized (Verbatim: entire trunk felt inflamed). The patient was treated with ibuprofen (Advil) and benadryl (nos) (Benadryl). The outcome of the headache, fatigue, pain and activities of daily living impaired were resolving and the outcome of the pruritus, blotchy rash, hives and inflammation localized were not reported.   It was unknown if the reporter considered the headache, fatigue, pain, activities of daily living impaired, pruritus, blotchy rash, hives and inflammation localized to be related to Shingrix.     It was unknown if the company considered the headache, fatigue, pain, activities of daily living impaired, pruritus, blotchy rash, hives and inflammation localized to be related to Shingrix.   Additional Information: GSK receipt date: 08-NOV-2023 A woman received Heplisav and Shingrix and 3 days later she developed hives on her torso. As per primary care provider note on 31st October 2023, next day the patient suffered from bad headache, fatigue, achy and missed work however felt better next day, Advil helped. Three days later noted itching on side torso bilaterally, blotchy rash, looked like hives and entire trunk felt inflamed, Benadryl helped. The patient had allergy injections as a child, history of dog allergies, even had reaction to hypoallergenic dogs. There were no other medical notes documented between 30 August 2023 and 31 October 2023.