chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Cryoglobulins, Dyspnoea, Echocardiogram, Electrocardiogram ambulatory
Clinical narrative: Near syncope, loss of balance, palpitations, weakness, SOB that began after the 1st dose and before the 2nd dose, however the symptoms worsened following the 2nd dose and persisted into the next year until present.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electromyogram, Free thyroxine index, HIV test, Heavy metal test, Hepatitis B virus test
Clinical narrative: Near syncope, loss of balance, palpitations, weakness, SOB that began after the 1st dose and before the 2nd dose, however the symptoms worsened following the 2nd dose and persisted into the next year until present.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hepatitis C virus test, Hepatitis viral test, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Metabolic function test
Clinical narrative: Near syncope, loss of balance, palpitations, weakness, SOB that began after the 1st dose and before the 2nd dose, however the symptoms worsened following the 2nd dose and persisted into the next year until present.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Presyncope, Protein total, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: Near syncope, loss of balance, palpitations, weakness, SOB that began after the 1st dose and before the 2nd dose, however the symptoms worsened following the 2nd dose and persisted into the next year until present.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sjogren's syndrome, Spirometry, Thyroxine, Tilt table test, Treponema test
Clinical narrative: Near syncope, loss of balance, palpitations, weakness, SOB that began after the 1st dose and before the 2nd dose, however the symptoms worsened following the 2nd dose and persisted into the next year until present.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tri-iodothyronine, Urine analysis, Vitamin B1, Vitamin B12, Vitamin B6
Clinical narrative: Near syncope, loss of balance, palpitations, weakness, SOB that began after the 1st dose and before the 2nd dose, however the symptoms worsened following the 2nd dose and persisted into the next year until present.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vitamin D
Clinical narrative: Near syncope, loss of balance, palpitations, weakness, SOB that began after the 1st dose and before the 2nd dose, however the symptoms worsened following the 2nd dose and persisted into the next year until present.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Influenza like illness, Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Patient received immunization for RSV (Arexvy) 1/12/2024. Patient presented 1/14/2024 stating her arm was still sore and had redness at the injection site. The site was warm to the touch and patient complained she felt run down or flulike, which was uncommon for her after an immunization. Advised the patient continue applying ice and use ibuprofen and/or acetaminophen for discomfort; to take photo of site today and compare in several days. If not getting better, see provider.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: General malaise and fatigue.  Extremely painful, red, swollen injection site.  Sore muscles and joints.  3 days later sudden pain and swelling of MCP (knuckles) of bilateral index fingers.  Joints iced.  swelling reduced 24-48 hours later.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Malaise, Myalgia
Clinical narrative: General malaise and fatigue.  Extremely painful, red, swollen injection site.  Sore muscles and joints.  3 days later sudden pain and swelling of MCP (knuckles) of bilateral index fingers.  Joints iced.  swelling reduced 24-48 hours later.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Condition aggravated, Fatigue, Headache, Postural orthostatic tachycardia syndrome
Clinical narrative: Headache, fatigue, sleeping, rash, brain fog, fainting spells due to increase in POTS symptoms.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Somnolence, Syncope
Clinical narrative: Headache, fatigue, sleeping, rash, brain fog, fainting spells due to increase in POTS symptoms.
Age: 86.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient came in to receive her second Shingrix shot. Upon checking pharmacy software records, it was confirmed that patient is due for her second  Shingrix shot. We successfully billed it to insurance and administered it. After receiving the shot patient asked what other shots does she need, and the State IMZ registry was checked and it was then that it was discovered that she had already had the shot 4 times before from different places. No adverse reaction at this time. Patient was made aware and report submitted.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity, Vaccination site mass
Clinical narrative: Pain in the left arm not resolved as of 01/14/2024, Patient feels a lump at the vaccine site and cannot use the arm to the full extent
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Blepharospasm, Fatigue, Headache, Joint stiffness
Clinical narrative: Muscle twitch or spasm of L eyelid started within days of vaccine (exact date unknown, but on 12/26 I noted in a log that I had a twitch for about 2 weeks). Twitch persists still, at time of this report. Saw eye doctor week of 1/7/2024. Treatment: none.  Also had symptoms the  day after the vaccine: fever 100.0, fatigue, joint stiffness, mild headache.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension
Clinical narrative: Patients reports getting a "funny little headache" a couple days after getting the shot and she is not usually someone who gets headaches. She went to her PCP who alerted her to the fact that her blood pressure was > 150/90. Patient was prescribed lisinopril at that visit and told to monitor her BP at home. She reports the BP consistently high at 150mmHg systolic for a few hours until she started her medication the next day when it went down to 110-120mmHg systolic range. A few days of taking the medication later, she reports her BP dropping to 99mmHg systolic so she skipped that day's dose and continued as normal the next day. Now, patient is scheduling a visit with a cardiologist so she can get checked properly. Patient has not been hospitalized for this reason at the time she reported to me.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Pt recieved vaccine from previously punctured vial that had been at room temperature for 11 days
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Balance disorder, Electroencephalogram abnormal, Generalised tonic-clonic seizure, Neurological symptom
Clinical narrative: 3 days after vaccination, pt started having "stroke like" symptoms per his mother. He was unable to speak and unsteady on his feet. She called 911. Paramedics ruled out stroke on site. Patient walked to ambulance very unsteady and proceeded to have a grand-mal seizure in the ambulance. Patient was taken to hospital, given anti seizure medication. He is seeking ongoing treatment for abnormal EEG with seizure activity of unknown cause by Hospital.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: After the vaccine, the patient felt pain in the arm which was attributed to normal post injection soreness. Patient reports shoulder pain that has lasted for a month after vaccine administration. Pain was severe enough that patient sought care in the emergency department and was prescribed hydrocodone-acetaminophen for pain.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes simplex, Pain in extremity, Pyrexia
Clinical narrative: Sore arm and 101 degree fever for 3 days. On the 7th day a Herpes HS-2 outbreak started. this is the 2nd time I have had a Herpes outbreak 1 week after receiving a Moderna Covid-19 vaccination.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia
Clinical narrative: Patient got her Arexvy shot on 12-30-2023 (Saturday) and then reported that her joints started aching on 01-01-2024 (Monday morning). She states that starting that Monday, her right side had been experiencing joint pain in places including her bottom, lower back, hip, knee, and feet - but all notably on the right hand side (even though the shot was injected on the opposite arm, left). It's of note that she does have arthritis and experiences joint pain fairly often, but she did say this was to a different degree, and the pain persisted. This joint pain on her right side continued until the night before Tuesday 01-09-2024. When she woke up on Tuesday 01-09-2024, she realized she didn't have the joint pain anymore. So, from 01-01-2024 AM to 01-08-2024 PM, she had right side joint pain and did slowly decrease over time until waking up 01-09-2024. As this joint pain persisted longer than 3-4 days, patient did contact her doctor and contacted us at the pharmacy to report what happened to her. At the time of typing this report up, she is assumed to be well.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired driving ability, Vision blurred
Clinical narrative: Patient experience extreme blurry vision starting the evening of the vaccination day and has not resolved yet. difficulty reading and driving
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: a week after vaccine he said that his ankles started itching really bad. small red bumps a few inches up his ankles, all arouund.
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Hyperhidrosis, Nausea, Vertigo
Clinical narrative: Mild vertigo first and second morning after vaccine.  Third morning, moderate to severe vertigo with nausea and diaphoresis.  Tomorrow will be day 4, so I don't know if symptoms will persist.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure during pregnancy, Term birth
Clinical narrative: Received vaccination at 7 and 10 weeks pregnant, carried infant to term at 40 weeks 1 day but infant was born with syndactyly of the 3rd and 4th digits of her right hand. Infant also small for gestational age. No family history of syndactyly or hand deformities. Will need surgery to correct anomaly.
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: The patient, aged 15, came in to get a COVID shot. She was accompanied by her mother and little brother who were also getting COVID shots. She was given the vaccine and asked to sit down while her mother received the shot. It was during this time that her mother and I noticed she had become pale and faint, to which she said she was feeling dizzy. She was made to lie down under observation for 30 minutes, but 15 minutes into the observation period, she said she felt better and wanted to sit up and drink fluid. She spent the rest of the 15 minutes sitting down and was given a drink. She was also sweating but before her observation period was over, her sweating had subsided. Following the incident, the protocol for responding to adverse events was implemented.
Age: 66.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Arthralgia, Musculoskeletal stiffness
Clinical narrative: Extreme shoulder pain and stiffness. No swelling or bruising. Has not gone to a medical doctor to be seen or treated.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Cardiac monitoring, Chest pain, Echocardiogram, Troponin
Clinical narrative: Cardiac reaction mostly resolved after 2 months
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site swelling
Clinical narrative: Swelling noted  around  injection site approximately 20 hours after vaccine administered. Marked with pen. Swelling persisted and increased about 3-4 inches from injection site after 48 hours. Diagnosed as cellulitis at urgent care facility and prescribed Bactrim for the next 7 days
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, DTAP, FLUX, HEP, PNC13, DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: Cardiac arrest, Cardiac death
Clinical narrative: cardiac arrest; resuscitation; This is a spontaneous report received from a Physician.  An 1-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 14Jan2020 as dose 1, single (Lot number: AL8457), in left leg for immunisation; influenza vaccine (FLU VACCINE VII), on 14Jan2020 as dose 1, single (Lot number: UT6647 JA), in right leg for immunisation; hepatitis B vaccine (HEPATITIS B VACCINE), on 14Jan2020 as dose 3, single (Lot number: R013540), in left leg for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP VACCINE), on 14Jan2020 as dose 4, single (Lot number: UJ058AB), in right leg for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ACETAMINOPHEN; TYLENOL. The following information was reported: CARDIAC ARREST (death) with onset 16Jan2020, outcome "fatal"; RESUSCITATION (death) with onset 16Jan2020, outcome "fatal". The patient date of death was 16Jan2020. Reported cause of death: "cardiac arrest", "resuscitation". It was not reported if an autopsy was performed.  Additional information: Patient arrived to hospital by EMS, CPR In progress. On arrival, patient had no spontaneous cardiac activity or respirations.  No follow-up attempts are possible.; Sender's Comments: There is not a reasonable possibility that the reported event related to the suspect product event most likely due to patient underlying contributory factors.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate.; Reported Cause(s) of Death: resuscitation; cardiac arrest
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, DTAP, FLUX, HEP, PNC13, DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: Cardiac arrest, Death, Respiratory arrest, Resuscitation
Clinical narrative: cardiac arrest; resuscitation; This is a spontaneous report received from a Physician.  An 1-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 14Jan2020 as dose 1, single (Lot number: AL8457), in left leg for immunisation; influenza vaccine (FLU VACCINE VII), on 14Jan2020 as dose 1, single (Lot number: UT6647 JA), in right leg for immunisation; hepatitis B vaccine (HEPATITIS B VACCINE), on 14Jan2020 as dose 3, single (Lot number: R013540), in left leg for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP VACCINE), on 14Jan2020 as dose 4, single (Lot number: UJ058AB), in right leg for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ACETAMINOPHEN; TYLENOL. The following information was reported: CARDIAC ARREST (death) with onset 16Jan2020, outcome "fatal"; RESUSCITATION (death) with onset 16Jan2020, outcome "fatal". The patient date of death was 16Jan2020. Reported cause of death: "cardiac arrest", "resuscitation". It was not reported if an autopsy was performed.  Additional information: Patient arrived to hospital by EMS, CPR In progress. On arrival, patient had no spontaneous cardiac activity or respirations.  No follow-up attempts are possible.; Sender's Comments: There is not a reasonable possibility that the reported event related to the suspect product event most likely due to patient underlying contributory factors.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate.; Reported Cause(s) of Death: resuscitation; cardiac arrest
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, DTAP, FLUX, HEP, PNC13, DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: Cardiac arrest, Death
Clinical narrative: cardiac arrest; resuscitation; This is a spontaneous report received from a Physician.  An 1-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 14Jan2020 as dose 1, single (Lot number: AL8457), in left leg for immunisation; influenza vaccine (FLU VACCINE VII), on 14Jan2020 as dose 1, single (Lot number: UT6647 JA), in right leg for immunisation; hepatitis B vaccine (HEPATITIS B VACCINE), on 14Jan2020 as dose 3, single (Lot number: R013540), in left leg for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP VACCINE), on 14Jan2020 as dose 4, single (Lot number: UJ058AB), in right leg for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ACETAMINOPHEN; TYLENOL. The following information was reported: CARDIAC ARREST (death) with onset 16Jan2020, outcome "fatal"; RESUSCITATION (death) with onset 16Jan2020, outcome "fatal". The patient date of death was 16Jan2020. Reported cause of death: "cardiac arrest", "resuscitation". It was not reported if an autopsy was performed.  Additional information: Patient arrived to hospital by EMS, CPR In progress. On arrival, patient had no spontaneous cardiac activity or respirations.  No follow-up attempts are possible.; Sender's Comments: There is not a reasonable possibility that the reported event related to the suspect product event most likely due to patient underlying contributory factors.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate.; Reported Cause(s) of Death: resuscitation; cardiac arrest
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 3 boosters
Age: 30.0
Sex: U
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 74.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: COVID-19
Clinical narrative: hospitalized with covid; fully vaccinated with 2 boosters
Age: 74.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 2 boosters
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported; RECOMBIVAX was administered after expiry; This spontaneous report was received from a licensed practical nurse (LPN) referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medications were not reported.  On 08-JAN-2024, the patient was vaccinated with an expired dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection (lot # w008704 has been verified to be a valid lot number for hepatitis B vaccine (recombinant), expiration date reported as 18-NOV-2023), administered by a health professional for prophylaxis (concentration and route of administration were not reported) (expired product administered). No additional adverse events (AEs) were reported. No further information was provided.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs or PQC reported; expired dose of GARDASIL 9 was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medications were not reported.  On 05-JAN-2024, the patient was vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (lot # U024832 has been verified to be a valid lot number for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast), expiration date reported as 09-DEC-2023; concentration not reported), 0.5 ml, administered intramuscularly by a health professional for prophylaxis (expired product administered). No other information was provided. No additional adverse events (AEs) or product quality complaints (PQC) were reported.
Age: 0.08
Sex: U
Vaccine: PNC15, RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no patient symptoms have been reported/No additional AE; Nurse called and reported ROTATEQ, VAXELIS (prefilled syringes), and VAXNEUVANCE involved in a temperature excursion have been administered to a patient since the excursion; This spontaneous report has been received from a nurse and refers to an 8-week-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was not provided.  It was reported that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, taken orally (lot number 1947621 has been verified to be valid, expiration date 02-MAY-2024), diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) injection, 1 dose (lot number U7536AA has been verified to be valid, expiration date 30-SEP-2025; route of administration and anatomical location of vaccination were not provided) and pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection, 1 dose (lot number X020316 has been verified to be valid, expiration date 18-OCT-2025; route of administration and anatomical location of vaccination were not provided), which were involved in a temperature excursion had been administered as prophylaxis to the patient on 13-DEC-2023 (product storage error).   The temperature of the vaccines administered was reported as 59.45 Fahrenheit (F) during a time frame of 18 hours and 30 minutes. The previous temperature excursions were reported as 53.29 F during a time frame of 1 hour and 45 minutes; and 49.73 F during a time frame of 1 hour.  No symptoms or additional adverse events had been reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2401USA006039:MSD US-009507513-2401USA006339:MSD US-009507513-2401USA005828:MSD US-009507513-2401USA005851:MSD US-009507513-2401USA006334:MSD US-009507513-2401USA005789:MSD US-009507513-2401USA005923:MSD US-009507513-2401USA006004:MSD US-009507513-2401USA005823:MSD US-009507513-2401USA006082:MSD US-009507513-2401USA005734:MSD
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Developed shingles multiple times/suspected vaccination failure; Developed shingles multiple times; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Developed shingles multiple times/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Developed shingles multiple times). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-JAN-2024 The physician reported that the patient developed shingles multiple times even if she had been vaccinated with Shingrix. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The reporter did not consent to follow up.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: female patient received an expired dose of Bexsero; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 05-JAN-2024, the patient received Bexsero. On 05-JAN-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: female patient received an expired dose of Bexsero). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-JAN-2024. The Health care professional on 08th January 2024 at the time of reporting reported that patient received an expired dose of Bexsero which led to expired vaccine used. The reporter declined to provide the initials of patient and was unable to provide further details. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Second dose of Shingrix more than 3 years after the first dose; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix more than 3 years ago from reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Second dose of Shingrix more than 3 years after the first dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 09-JAN-2024 The physician did not have exact age but stated that patient was in her 70s. The retired physician reported that the patient was asking him about getting a second dose of Shingrix more than 3 years after the first dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up via mail.
Age: 24.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Amniotic cavity infection, Antiphospholipid antibodies negative, Blood thyroid stimulating hormone normal, Cytogenetic analysis abnormal, Cytomegalovirus test negative
Clinical narrative: Patient presented to Labor and Delivery on 12/10 reporting no fetal movement. She was found to have experienced an intrauterine fetal demise at 34 weeks and 2 days gestation. Her labor was then induced and she experienced a vaginal birth of a deceased baby boy. The etiology was undetermined. The placenta appeared consistent with an abruption but there was no evidence of this prior and pathology on the placenta did not show an abruption. Placental pathology did show acute chorioamnionitis and she developed a fever immediately postpartum, so may  have developed this during the course of her induction.
Age: 24.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Cytomegalovirus test positive, Delivery, Drug screen negative, Exposure during pregnancy, Foetal death
Clinical narrative: Patient presented to Labor and Delivery on 12/10 reporting no fetal movement. She was found to have experienced an intrauterine fetal demise at 34 weeks and 2 days gestation. Her labor was then induced and she experienced a vaginal birth of a deceased baby boy. The etiology was undetermined. The placenta appeared consistent with an abruption but there was no evidence of this prior and pathology on the placenta did not show an abruption. Placental pathology did show acute chorioamnionitis and she developed a fever immediately postpartum, so may  have developed this during the course of her induction.
Age: 24.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Foetal hypokinesia, Glycosylated haemoglobin normal, Induced labour, Influenza A virus test negative, Influenza B virus test
Clinical narrative: Patient presented to Labor and Delivery on 12/10 reporting no fetal movement. She was found to have experienced an intrauterine fetal demise at 34 weeks and 2 days gestation. Her labor was then induced and she experienced a vaginal birth of a deceased baby boy. The etiology was undetermined. The placenta appeared consistent with an abruption but there was no evidence of this prior and pathology on the placenta did not show an abruption. Placental pathology did show acute chorioamnionitis and she developed a fever immediately postpartum, so may  have developed this during the course of her induction.
Age: 24.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Influenza virus test negative, Kleihauer-Betke test negative, Parvovirus B19 test negative, Pathology test, Platelet count normal
Clinical narrative: Patient presented to Labor and Delivery on 12/10 reporting no fetal movement. She was found to have experienced an intrauterine fetal demise at 34 weeks and 2 days gestation. Her labor was then induced and she experienced a vaginal birth of a deceased baby boy. The etiology was undetermined. The placenta appeared consistent with an abruption but there was no evidence of this prior and pathology on the placenta did not show an abruption. Placental pathology did show acute chorioamnionitis and she developed a fever immediately postpartum, so may  have developed this during the course of her induction.
Age: 24.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Premature separation of placenta, Puerperal pyrexia, Red blood cell count decreased, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: Patient presented to Labor and Delivery on 12/10 reporting no fetal movement. She was found to have experienced an intrauterine fetal demise at 34 weeks and 2 days gestation. Her labor was then induced and she experienced a vaginal birth of a deceased baby boy. The etiology was undetermined. The placenta appeared consistent with an abruption but there was no evidence of this prior and pathology on the placenta did not show an abruption. Placental pathology did show acute chorioamnionitis and she developed a fever immediately postpartum, so may  have developed this during the course of her induction.
Age: 24.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Toxoplasma serology, Toxoplasma serology negative, Treponema test negative, Urine protein/creatinine ratio normal, White blood cell count normal
Clinical narrative: Patient presented to Labor and Delivery on 12/10 reporting no fetal movement. She was found to have experienced an intrauterine fetal demise at 34 weeks and 2 days gestation. Her labor was then induced and she experienced a vaginal birth of a deceased baby boy. The etiology was undetermined. The placenta appeared consistent with an abruption but there was no evidence of this prior and pathology on the placenta did not show an abruption. Placental pathology did show acute chorioamnionitis and she developed a fever immediately postpartum, so may  have developed this during the course of her induction.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms reported; a patient who was inadvertently administered an expired dose of PNEUMOVAX23 (w/ no TEs); This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 15-DEC-2023, the patient was inadvertently vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 0.5 milliliter, expiration date: 20-OCT-2023 (strength, lot #, and route of administration were not provided), administered for prophylaxis (Expired product administered), not supported via post-expiry memo. No temperature excursion. No symptoms reported (No adverse event).
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; VAQTA that experienced TE on 9/28/2023 was administered to a patient 12/13/2023; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medications were not reported.  On 13-DEC-2023, the patient was vaccinated with improperly stored hepatitis A vaccine, inactivated (VAQTA) intramuscular injection (lot # W021491 has been verified to be a valid lot number for hepatitis A vaccine, inactivated, expiration date reported as 14-DEC-2023), dose was unknown, administered for prophylaxis (concentration and route of administration were not reported) (product storage error). It was reported that the vaccine had experienced a temperature excursion on 28-SEP-2023, it was stored at 8.56 degrees Celsius (C) for 1 hour. There was no previous temperature excursion. No additional adverse event (AE) details were reported.
Sex: M
Vaccine: RSV
Symptoms: Product preparation error
Clinical narrative: Arexvy was reconstituted with sterile water for injection instead of the adjuvant and administered to a patient; Arexvy was reconstituted with SWFI instead of the adjuvant and administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 62-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced wrong solution used in drug reconstitution (Verbatim: Arexvy was reconstituted with sterile water for injection instead of the adjuvant and administered to a patient) and inappropriate dose of vaccine administered (Verbatim: Arexvy was reconstituted with SWFI instead of the adjuvant and administered to a patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 09-JAN-2024 The pharmacist reported that Arexvy vaccine was reconstituted with SWFI (sterile water for injection) instead of the adjuvant and administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The HCP (health care professional) did not have any other details. The reporter consent to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Provide later.     On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       No concomitant and treatment medication were provided  Company Comment: This is a Spontaneous case reported by a consumer, concerning a female patient of unknown age, with no medical history reported, who experienced the expected and serious (due to medically significant) event of Myocarditis, which occurred on an unknown date related to an unspecified dose of SPIKEVAX NOS vaccine. Since no vaccination, nor event dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; Pharmacist reports VAQTA that experienced TE on 9/28/2023 was administered to a patient 11/8/2023. Please note product is now expired but was not expired on date of administration.  ?    Names of vaccines involved (including lot/exp) VAQTA  W021491; This spontaneous report was received from a pharmacist and referred to a patient of unknown age or gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reaction/allergies were not reported.   On 28-SEP-2023, hepatitis a vaccine, inactivated (VAQTA) experienced temperature excursion and reached the temperature of 8.56 degrees Celsius for 1 hour 0 minutes and 0 seconds. On 08-NOV-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #W021491, expiration date: 14-DEC-2023, administered for prophylaxis (dose was unknown; strength, anatomical location and route of administration were not provided) after the vaccine was involved in a temperature excursion (Product storage error).   At the time of reporting, the vaccine was expired but was not expired on date of administration. There was no previous temperature excursion. No additional adverse effect (AE) details were provided (no adverse event).  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2401USA005519:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Peripheral swelling, Vaccination failure
Clinical narrative: Caller reports she has had shingles, all mild cases, 4 times in total since receiving her second Shingrix vaccine/suspected vaccination failure; Caller reports she has had shingles, all mild cases, 4 times in total since receiving her second Shingrix vaccine; red swollen arm; red swollen arm; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles again in May of 2001, 1 month after her husband passed) and shingles (had a history of shingles with the last case being in June 2017 before she received the Shingrix vaccine.).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular, left arm) .5 ml and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Caller reports she has had shingles, all mild cases, 4 times in total since receiving her second Shingrix vaccine/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Caller reports she has had shingles, all mild cases, 4 times in total since receiving her second Shingrix vaccine), erythema of extremities (Verbatim: red swollen arm) and swelling arm (Verbatim: red swollen arm). The outcome of the vaccination failure was unknown and the outcome of the shingles, erythema of extremities and swelling arm were resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the company considered the erythema of extremities and swelling arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-JAN-2024 The patient reported that she received the Shingrix vaccine when it came out in fall of 2017.  The patient reported that after received her first Shingrix vaccine her left arm was red and swollen and then resolved. The patient reported that she had no reaction on her second Shingrix vaccine 2 months later.  The patient reported that she had shingles, all mild cases, 4 times in total since receiving her second Shingrix vaccine. The patient reported that she was just recovered from her last case this past week.  The patient wished she could get a booster of Shingrix.  This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch); Mild injection site redness; Mild injection site swelling; Mild muscle pain and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling) and MYALGIA (Mild muscle pain and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling) and MYALGIA (Mild muscle pain and no interference with activity). At the time of the report, VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling) and MYALGIA (Mild muscle pain and no interference with activity) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported.   Patient had experienced vaccination site pain, vaccination site erythema, vaccination site swelling and myalgia anytime during the 2 days after COVID-19 vaccination, which occurred on Thursday, Dec 21, 2023 and Friday, Dec 22, 2023.   The Database Subject ID was reported as 5471648.   The Health Authority Subject ID was reported as 44599-58077.   No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Patient no 36
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Myalgia, Pyrexia
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild injection site swelling; Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Mild muscle pain and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity) and ARTHRALGIA (Joint pain and no interference with activity). At the time of the report, VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity) and ARTHRALGIA (Joint pain and no interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: 100.4 to 101.2 degree Fahrenheit.         No concomitant medications were reported.  Patient had experienced the symptoms during the 2 days after COVID-19 vaccination, which occurred on Thursday, Dec 21, 2023, and Friday, Dec 22, 2023.  No treatment medications were reported.  The Subject ID was reported as 21378-97052 and the Agency Subject ID was reported as 5471817.   This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Master case