chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood culture, Blood lactate dehydrogenase, Blood lactic acid, Blood pressure decreased, Blood thyroid stimulating hormone
Clinical narrative: Began having feelings of back pain, abdominal pain, and chest pain. After about two weeks, began vomiting and having diarrhea along with the lingering body pains. Went to the emergency room were I passed out for an extended period of time, blood pressure dropped to 50/40, required 8L of oxygen to maintain appropriate oxygen saturations, and heart rate was 185. I was transferred to the Trauma Wing of the emergency room in order to receive the care required. Received 6 bags of IV Sodium Chloride during this time as well as numerous medical tests and exams. Eventually, it was determined that I had fluid in my heart, impacting my hears ability to beat properly. I was diagnosed at that time with a Pericardial Effusion, Pleural Effusion, and Cardiac Tamponade. I had to undergo an emergency Pericardiocentesis in order to drain the fluid. Approximately 300cc of serous fluid was drained from my pericardium and a pericardial catheter was put in place to continue draining excess fluid. After this procedure I was transferred to the Critical Care Unit where the catheter remained in place for two days. Once this catheter was removed, I was transferred to the Intensive Care Unit for closer care. I remained within the hospital for about 5 days before discharge.
Age: 25.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood triglycerides, Borrelia test, C-reactive protein, Cardiac tamponade, Catheterisation cardiac
Clinical narrative: Began having feelings of back pain, abdominal pain, and chest pain. After about two weeks, began vomiting and having diarrhea along with the lingering body pains. Went to the emergency room were I passed out for an extended period of time, blood pressure dropped to 50/40, required 8L of oxygen to maintain appropriate oxygen saturations, and heart rate was 185. I was transferred to the Trauma Wing of the emergency room in order to receive the care required. Received 6 bags of IV Sodium Chloride during this time as well as numerous medical tests and exams. Eventually, it was determined that I had fluid in my heart, impacting my hears ability to beat properly. I was diagnosed at that time with a Pericardial Effusion, Pleural Effusion, and Cardiac Tamponade. I had to undergo an emergency Pericardiocentesis in order to drain the fluid. Approximately 300cc of serous fluid was drained from my pericardium and a pericardial catheter was put in place to continue draining excess fluid. After this procedure I was transferred to the Critical Care Unit where the catheter remained in place for two days. Once this catheter was removed, I was transferred to the Intensive Care Unit for closer care. I remained within the hospital for about 5 days before discharge.
Age: 25.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chest X-ray, Chest pain, Computerised tomogram, Computerised tomogram abdomen, Coxsackie virus test
Clinical narrative: Began having feelings of back pain, abdominal pain, and chest pain. After about two weeks, began vomiting and having diarrhea along with the lingering body pains. Went to the emergency room were I passed out for an extended period of time, blood pressure dropped to 50/40, required 8L of oxygen to maintain appropriate oxygen saturations, and heart rate was 185. I was transferred to the Trauma Wing of the emergency room in order to receive the care required. Received 6 bags of IV Sodium Chloride during this time as well as numerous medical tests and exams. Eventually, it was determined that I had fluid in my heart, impacting my hears ability to beat properly. I was diagnosed at that time with a Pericardial Effusion, Pleural Effusion, and Cardiac Tamponade. I had to undergo an emergency Pericardiocentesis in order to drain the fluid. Approximately 300cc of serous fluid was drained from my pericardium and a pericardial catheter was put in place to continue draining excess fluid. After this procedure I was transferred to the Critical Care Unit where the catheter remained in place for two days. Once this catheter was removed, I was transferred to the Intensive Care Unit for closer care. I remained within the hospital for about 5 days before discharge.
Age: 25.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Culture urine, Cytology, Diarrhoea, Echocardiogram, Echovirus test
Clinical narrative: Began having feelings of back pain, abdominal pain, and chest pain. After about two weeks, began vomiting and having diarrhea along with the lingering body pains. Went to the emergency room were I passed out for an extended period of time, blood pressure dropped to 50/40, required 8L of oxygen to maintain appropriate oxygen saturations, and heart rate was 185. I was transferred to the Trauma Wing of the emergency room in order to receive the care required. Received 6 bags of IV Sodium Chloride during this time as well as numerous medical tests and exams. Eventually, it was determined that I had fluid in my heart, impacting my hears ability to beat properly. I was diagnosed at that time with a Pericardial Effusion, Pleural Effusion, and Cardiac Tamponade. I had to undergo an emergency Pericardiocentesis in order to drain the fluid. Approximately 300cc of serous fluid was drained from my pericardium and a pericardial catheter was put in place to continue draining excess fluid. After this procedure I was transferred to the Critical Care Unit where the catheter remained in place for two days. Once this catheter was removed, I was transferred to the Intensive Care Unit for closer care. I remained within the hospital for about 5 days before discharge.
Age: 25.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Electrocardiogram, Electroencephalogram, Epstein-Barr virus test, Full blood count, Glycosylated haemoglobin
Clinical narrative: Began having feelings of back pain, abdominal pain, and chest pain. After about two weeks, began vomiting and having diarrhea along with the lingering body pains. Went to the emergency room were I passed out for an extended period of time, blood pressure dropped to 50/40, required 8L of oxygen to maintain appropriate oxygen saturations, and heart rate was 185. I was transferred to the Trauma Wing of the emergency room in order to receive the care required. Received 6 bags of IV Sodium Chloride during this time as well as numerous medical tests and exams. Eventually, it was determined that I had fluid in my heart, impacting my hears ability to beat properly. I was diagnosed at that time with a Pericardial Effusion, Pleural Effusion, and Cardiac Tamponade. I had to undergo an emergency Pericardiocentesis in order to drain the fluid. Approximately 300cc of serous fluid was drained from my pericardium and a pericardial catheter was put in place to continue draining excess fluid. After this procedure I was transferred to the Critical Care Unit where the catheter remained in place for two days. Once this catheter was removed, I was transferred to the Intensive Care Unit for closer care. I remained within the hospital for about 5 days before discharge.
Age: 25.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: HIV test, Hepatitis viral test, Imaging procedure, Intensive care, Lipase
Clinical narrative: Began having feelings of back pain, abdominal pain, and chest pain. After about two weeks, began vomiting and having diarrhea along with the lingering body pains. Went to the emergency room were I passed out for an extended period of time, blood pressure dropped to 50/40, required 8L of oxygen to maintain appropriate oxygen saturations, and heart rate was 185. I was transferred to the Trauma Wing of the emergency room in order to receive the care required. Received 6 bags of IV Sodium Chloride during this time as well as numerous medical tests and exams. Eventually, it was determined that I had fluid in my heart, impacting my hears ability to beat properly. I was diagnosed at that time with a Pericardial Effusion, Pleural Effusion, and Cardiac Tamponade. I had to undergo an emergency Pericardiocentesis in order to drain the fluid. Approximately 300cc of serous fluid was drained from my pericardium and a pericardial catheter was put in place to continue draining excess fluid. After this procedure I was transferred to the Critical Care Unit where the catheter remained in place for two days. Once this catheter was removed, I was transferred to the Intensive Care Unit for closer care. I remained within the hospital for about 5 days before discharge.
Age: 25.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Loss of consciousness, Metabolic function test, Pain, Parvovirus B19 test, Pericardial drainage
Clinical narrative: Began having feelings of back pain, abdominal pain, and chest pain. After about two weeks, began vomiting and having diarrhea along with the lingering body pains. Went to the emergency room were I passed out for an extended period of time, blood pressure dropped to 50/40, required 8L of oxygen to maintain appropriate oxygen saturations, and heart rate was 185. I was transferred to the Trauma Wing of the emergency room in order to receive the care required. Received 6 bags of IV Sodium Chloride during this time as well as numerous medical tests and exams. Eventually, it was determined that I had fluid in my heart, impacting my hears ability to beat properly. I was diagnosed at that time with a Pericardial Effusion, Pleural Effusion, and Cardiac Tamponade. I had to undergo an emergency Pericardiocentesis in order to drain the fluid. Approximately 300cc of serous fluid was drained from my pericardium and a pericardial catheter was put in place to continue draining excess fluid. After this procedure I was transferred to the Critical Care Unit where the catheter remained in place for two days. Once this catheter was removed, I was transferred to the Intensive Care Unit for closer care. I remained within the hospital for about 5 days before discharge.
Age: 25.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pericardial effusion, Pleural effusion, Respiratory pathogen panel, Rheumatoid factor, Troponin
Clinical narrative: Began having feelings of back pain, abdominal pain, and chest pain. After about two weeks, began vomiting and having diarrhea along with the lingering body pains. Went to the emergency room were I passed out for an extended period of time, blood pressure dropped to 50/40, required 8L of oxygen to maintain appropriate oxygen saturations, and heart rate was 185. I was transferred to the Trauma Wing of the emergency room in order to receive the care required. Received 6 bags of IV Sodium Chloride during this time as well as numerous medical tests and exams. Eventually, it was determined that I had fluid in my heart, impacting my hears ability to beat properly. I was diagnosed at that time with a Pericardial Effusion, Pleural Effusion, and Cardiac Tamponade. I had to undergo an emergency Pericardiocentesis in order to drain the fluid. Approximately 300cc of serous fluid was drained from my pericardium and a pericardial catheter was put in place to continue draining excess fluid. After this procedure I was transferred to the Critical Care Unit where the catheter remained in place for two days. Once this catheter was removed, I was transferred to the Intensive Care Unit for closer care. I remained within the hospital for about 5 days before discharge.
Age: 25.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Ultrasound abdomen, Ultrasound biliary tract, Vomiting
Clinical narrative: Began having feelings of back pain, abdominal pain, and chest pain. After about two weeks, began vomiting and having diarrhea along with the lingering body pains. Went to the emergency room were I passed out for an extended period of time, blood pressure dropped to 50/40, required 8L of oxygen to maintain appropriate oxygen saturations, and heart rate was 185. I was transferred to the Trauma Wing of the emergency room in order to receive the care required. Received 6 bags of IV Sodium Chloride during this time as well as numerous medical tests and exams. Eventually, it was determined that I had fluid in my heart, impacting my hears ability to beat properly. I was diagnosed at that time with a Pericardial Effusion, Pleural Effusion, and Cardiac Tamponade. I had to undergo an emergency Pericardiocentesis in order to drain the fluid. Approximately 300cc of serous fluid was drained from my pericardium and a pericardial catheter was put in place to continue draining excess fluid. After this procedure I was transferred to the Critical Care Unit where the catheter remained in place for two days. Once this catheter was removed, I was transferred to the Intensive Care Unit for closer care. I remained within the hospital for about 5 days before discharge.
Age: 1.17
Sex: M
Vaccine: MMRV
Symptoms: Device connection issue, Exposure via skin contact, Underdose
Clinical narrative: While giving this vaccine the syringe and the needle completely disengaged while RN administering dose resulting in a non-standard administration. RN noticed liquid running down thigh and when patient was picked up there was a wet spot greater than a half dollar on the sheet below this left thigh.  RN supervisor and District vaccine coordinator notified, and decision made to re vaccinate client in 28 days after research done on CDC, ACIP and Immunize.org obtained.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Blood test, Chest pain, Computerised tomogram, Headache, Injection site swelling
Clinical narrative: Could not lift arm or sleep on it, swollen hot in shot area,nausea, fever chills, swollen ankles, chest pain! headache, wheezing.  It is December, I?m just starting to feel better.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Injection site warmth, Joint swelling, Mobility decreased, Nausea, Pyrexia
Clinical narrative: Could not lift arm or sleep on it, swollen hot in shot area,nausea, fever chills, swollen ankles, chest pain! headache, wheezing.  It is December, I?m just starting to feel better.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Sleep disorder, Wheezing, X-ray
Clinical narrative: Could not lift arm or sleep on it, swollen hot in shot area,nausea, fever chills, swollen ankles, chest pain! headache, wheezing.  It is December, I?m just starting to feel better.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Per patient she has been feeling mild light-headed/intermittent arm soreness since receiving the vaccine. When reporting symptoms to her doctor, she discovered she received a prior dose of the COVID vaccine at her annual check up in August. Per patient she was unaware that she was receiving that particular vaccine at her PCP visit.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event reported. Patient did ok no side effects.  Was told to report due to vaccination for less than 12 year old for 12+ Comirnaty.
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Extra dose administered
Clinical narrative: Pt was new to the health department clinic. Mother presented with a immunization record.  Vaccines given at visit based off of the record mom brought to clinic and the mother stating the child had not been anywhere else to get vaccines via translation. The state system forecaster was not looked up by clerical staff nor nursing staff prior to giving vaccine. Pt had received Hep A #1 and flu vaccine at Medical Clinic on 9/17/2024 resulting in extra dose of both vaccines given to pt.
Age: 60.0
Sex: F
Vaccine: COVID19, FLU3, TDAP
Symptoms: Abscess limb, Acute kidney injury, Sepsis
Clinical narrative: R arm abscess, sepsis, AKI
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site pain, SARS-CoV-2 test
Clinical narrative: Soreness at injection sight
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Client given pediatric booster dose instead of adult booster dose.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Ophthalmic migraine, Photopsia, Visual acuity tests, Vitreous floaters
Clinical narrative: Had sudden onset of an arced flashing, sparkling light in my right eye field of view  that gradually over 5 to 10 minutes moved off towards the upper right corner of my field of vision. This was followed by a headache. Because I have had several issues with eye floaters in the past I thought it was my retina partially separating. After 3 hours of testing at the  vision urgent care it was determined that it was an ocular migraine. I have never had one of these before.
Age: 77.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Approximately 1 week after vaccination, her arm became red, swollen, and hot to touch. As of 12/13 (10 days post vaccination) it is cleared up.
Age: 16.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient given wrong vaccination. No adverse effects noted.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was administered HEP B (Lot #MD9SL, exp 12-08-26) in error by Registered Nurse. Tdap was ordered by provider. Nurse administered HEP B in error. Patient remained in the office for over an hour after incident, patient experienced no adverse symptoms while in the office. Patient reported feeling well upon leaving the office. Follow up call was made to patient on 12-13-24, patient denied any abnormal symptoms.
Age: 87.0
Sex: M
Vaccine: COVID19, PNC20
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient states that within a couple of days his right arm had limited range of motion and hurt when he did move it. His PCP recommended that the patient talk to the pharmacy, which happened today, 12/13/2024, almost 2 months after the injections.
Age: 0.17
Sex: M
Vaccine: HIBV, PNC20, PNC21, RV1
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient received RSV Beyfortus 100mg/ml. He should have received 50mg/ml due to current weight of 8lb 15.5oz on 12/10/24. Patient has not had adverse reactions. Administered on 12/10/24 but error was noted on 12/13/24 when inventory was complete.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Gait disturbance, Injection site swelling
Clinical narrative: swelling at site of vaccine. trouble walking swelling spreading
Age: 16.0
Sex: M
Vaccine: FLU3, MENB, MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events. Patient has no complaints. Fluzone, Menquadfi and Bexero were all given on 12/2/2024 and, inadvertently, were all given again on 12/12/2024.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 12 year old male DOB 01/xx/20xx   Accompanied by his mother came to an off-site IZ clinic on 12/13/2024.    He has previously received: Pediarix  -7/9/2012  Pediarix 8/20/2012 Pediarix 11/9/2012 DTap 7/16/2013 Kinrix 8/14/2018 Today he was due for Tdap, but was given Dtap instead.  Supervisor notified.  Mother called and message left for return call to state health center.  Public Health physician notified.
Age: 53.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Accidently given early
Age: 75.0
Sex: F
Vaccine: DF
Symptoms: Influenza virus test negative, SARS-CoV-2 test negative, Viral upper respiratory tract infection
Clinical narrative: Vaccine was administered over 6 weeks ago  so current symptoms probably not related to the vaccine but just a virus causing an upper respiratory infection.
Age: 1.33
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Parent was told to come back for a 2nd 2024 dose of Flu vaccine; dose was administered before it was realized patient did not need a 2nd flu vaccine for 2024
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Dizziness and light headedness
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered expired Novavax. Patient reports no adverse events at this time. Manufacturer was contacted and informed pharmacy to fill out VAERS form
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Nausea, Vomiting
Clinical narrative: Employee was given 2nd dose of Hep B Vaccine on 12/12/2024 ( 1st dose was given on 11/13/2024). Employee reports noticing redness, swelling, warmth to injection site the morning of 12/13/2024 and also began experiencing nausea/vomiting upon waking.  No other symptoms noted. Employee applied icepack to area for 20 minutes at  4pm on 12/13/2024. Pain, swelling,  redness and nausea continue.
Age: 56.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: injection site redness (with suspicion of cellulitis), soreness
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Streptococcus test
Clinical narrative: Ear ache
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: NO adverse events.  Only malaise/tiredness side effects for couple of days
Age: 12.0
Sex: M
Vaccine: COVID19, HEP, IPV
Symptoms: Cough, Erythema, Pain, Throat irritation
Clinical narrative: 15:35 Mother reported patient having "pain" and requested post the 15 minute monitoring post vaccination.  Upon nurse assessment, bilateral "redness" noted on patients cheeks and patient complaining of "itchy throat and cough".  Emergency cart brought to bedisde immediately.  15:40 Mother, brother, certified interpreter, FNP and nurse at bedside. 25 mg of Children's Benadryl PO given to patient with constant pulse oximetry assessment. Nurse remained at bedside with patient. No hives noted on inspection. 15:42  pulse oximeter reads 98 % room air, 114 heart rate bpm. Mother in agreeance, no distress noted at this time. Patient smiling, remains alert and oriented.  It was determined by provider that no epi pen was needed at this time. 15:55 vital signs collected by CNA per nurse, blood pressure 112/72, 99% room air, 104 bpm heart rate, temporal temperature 99.2 degrees F.  Patient states "no more itchiness in throat and feels better." Mother states has epi pen at home and with teachback educated on allergic reactions, symptoms, treatment, benadryl dosing, when to seek emergency medical care and how to follow up with patient's pediatrician at clinic. Mother requests to discharge stating "needs to be at work."  Per FNP ok for patient to discharge at this time, post observation. 16:00 Patient left clinic stable condition.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Inflammation, Injection site erythema, Pain
Clinical narrative: Erythema at injection site.  Educated patient on watching if redness continues to spread outside of marking. -Ice pack was applied in clinic.  Recommended that she continue to ice the area 15 minutes on and 15 minutes off at a time. -Also recommended that she take ibuprofen to help with pain and inflammation.
Age: 26.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Exposure during pregnancy, Pain, Pyrexia, Vomiting
Clinical narrative: Pregnant due date 1/7/2025. Had a fever, chills, vomiting, and sore body
Age: 28.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered
Clinical narrative: The patient received a second flu shot for this season, having received the flu shot for the first time on 8/16/24. I spoke to the patient and they have not experienced any side effects due to this.
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No symptoms reported; inadvertent concomitant administration of PROQUAD and MMRII; This spontaneous report was received from a nursel and referred to a 12-month-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 29-OCT-2024, the patient was inadvertent concomitant administrated of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin [rHA]) (PROQUAD) injection, 0.5 milliliter, lot #Y010247, expiration date: 30-NOV-2025, administered for prophylaxis (strength, anatomical site of administration and route of administration were not provided); and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) injection, 0.5 milliliter, lot #X019104, expiration date: 16-JUL-2025, administered for prophylaxis (strength, anatomical site of administration and route of administration were not provided) (accidental overdose). No symptoms reported (no adverse event).
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reported that PROQUAD was administered to patients as HCP reported that VFC coordinator had given them the "ok" to administer the vaccines based on the excursion.; This spontaneous report was received from an other health professional (licensed practical nurse [LPN]) and refers to a unknown number of patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On 21-NOV-2024, the patients were adminstered with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection, 0.5 milliliter, valid lot # Y013584 expiration date: 03-FEB-2026, administered for prophylaxis (strength, lot #, and route of administration were not provided), which underwent temperature excursion (product storage error) with temperature excursion (high) of 6.0 Fahrenheit (F), duration of 2 hours 0 minutes and 0 seconds. No additional adverse (AE) event was reported (no adverse event).  The report was considered as non-valid due to multiple patients without identifiers.  Follow up information was received from primary reporter on 10-DEC-2024 concerning a 4-year-old male patient. In initial report, identifiable patient was missing, the case became valid on that day (10-DEC-2024).   This was the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) administered to the patient, anatomical location was illegibly reported. The vaccine was administered at public health clinic/ hospital by trained health care professional.   It was reported malfunction of thermometer without change in freezer temperature. The data logger read incorrectly. The medication error (previously reported) occurred at point of storage in clinical practice. It was tested back up data logger and temperature was within normal limits (WNL). The vaccine were examined and remained frozen, as well as the color/ appearance of the vaccine remained as usual. The back up logger continued to read WNL. The vaccines were safe and administered as usual. Measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) remained in proper condition, was instructed to continue to give. The vaccine did not need to be returned.; Sender's Comments:  US-009507513-2412USA004512:
Age: 12.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Administered after being improperly stored; This spontaneous report was received from a medical assistant referring to a 12-year-old patient.  The patient's medical history concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On 02-DEC-2024, the patient was vaccinated with the improperly stored vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection, 0.5 milliliter, lot #Y009982, expiration date: 24-NOV-2025, administered by health professional for prophylaxis (strength, and route of administration were not provided) (product storage error). On an unknown date, this vaccine was exposed to temperature excursion (TE). No adverse effects were reported (no adverse event).
Sex: M
Vaccine: VARCEL
Symptoms: Arthralgia, Herpes zoster, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: nasal congestion; sore throat; a 13-year-old male developed shingles; This spontaneous report was received from a Company Representative referring to a 13-year-old male patient.  The patient's medical history, concurrent conditions, Concomitant therapies, and drug reactions/allergies were not reported.  On 08-DEC-2012, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered by health professional for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 09-DEC-2016, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered by health professional for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 12-NOV-2024, the patient was diagnosed with shingles. He developed rash on the left shoulder that didn't cross midline but developed on chest. He had an achy red shoulder with bumps, a little itchy painful. He was treated with acyclovir. He also had slight fever, nasal congestion, and sore throat. It took about 3 weeks for shingles to go away, so on approximately 03-DEC-2024, the patient recovered from the event of shingles. At the time of reporting, the outcome of nasal congestion and sore throat was not known.   The causal relationship regarding the reported events to varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.  Lot # is being requested and will be submitted if received.
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: nasal congestion; sore throat; a 13-year-old male developed shingles; This spontaneous report was received from a Company Representative referring to a 13-year-old male patient.  The patient's medical history, concurrent conditions, Concomitant therapies, and drug reactions/allergies were not reported.  On 08-DEC-2012, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered by health professional for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 09-DEC-2016, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered by health professional for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 12-NOV-2024, the patient was diagnosed with shingles. He developed rash on the left shoulder that didn't cross midline but developed on chest. He had an achy red shoulder with bumps, a little itchy painful. He was treated with acyclovir. He also had slight fever, nasal congestion, and sore throat. It took about 3 weeks for shingles to go away, so on approximately 03-DEC-2024, the patient recovered from the event of shingles. At the time of reporting, the outcome of nasal congestion and sore throat was not known.   The causal relationship regarding the reported events to varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.  Lot # is being requested and will be submitted if received.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reported that PROQUAD was administered to patients as HCP reported that VFC coordinator had given them the "ok" to administer the vaccines based on the excursion.; This spontaneous report was received from an other health professional (licensed practical nurse [LPN]) and refers to a 4-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-NOV-2024, the patient was vaccinated with the fist dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection, 0.5 milliliter, anatomical location was illegibly reported, valid lot # Y013584 expiration date: 03-FEB-2026, administered for prophylaxis (strength, and route of administration were not provided), which underwent temperature excursion (product storage error) with temperature excursion (high) of 6.0 Fahrenheit (F), duration of 2 hours 0 minutes and 0 seconds. No additional adverse (AE) event was reported (no adverse event). The vaccine was administered at public health clinic/ hospital by trained health care professional.   It was reported malfunction of thermometer without change in freezer temperature. The data logger read incorrectly. The medication error occurred at point of storage in clinical practice. The back up data logger read correctly and temperature was within normal limits (WNL). The vaccine were examined and remained frozen, as well as the color/ appearance of the vaccine remained as usual. The back up logger continued to read WNL. The vaccines were safe and administered as usual. The vaccine did not need to be returned.; Sender's Comments:  US-009507513-2411USA009579:
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: patient received a 3rd dose; This non-serious case was reported by a nurse via patient support programs and described the occurrence of extra dose administered in a female patient who received HAV (Havrix) (batch number A3x2k, expiry date 07-SEP-2026) for prophylaxis.   Previously administered products included Havrix (Patient received 1st dose of Havrix on 26-OCT-2020) and Havrix (Patient received 2nd dose of Havrix on 28-APR-2021). Concomitant products included salbutamol sulfate (Albuterol).   On 14-NOV-2024, the patient received the 3rd dose of Havrix. On 14-NOV-2024, an unknown time after receiving Havrix, the patient experienced extra dose administered (Verbatim: patient received a 3rd dose). The outcome of the extra dose administered 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: 14-NOV-2024 and 15-NOV-2024 Reporter reported an adverse event for Havrix. Patient had been provided two previous doses 1st dose on 26-OCT-2020 and 2nd dose on 28-APR-2024 and the provider inquired of providing the patient with a third dose. Patient received a 3rd dose on 14Nov2024, which led to extra dose administered.
Age: 11.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 11 year old man who received Kinrix; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID;PERTUSSIS VACCINE ACELLULAR 5-COMPONENT;TETANUS VACCINE TOXOID (ADACEL).   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 11 year old man who received Kinrix). The outcome of the inappropriate age at vaccine administration 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: 15-NOV-2024 Other HCP reported about 11 year old man who received Adacel and Kinrix. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Reporter stated that patient received Adacel and Kinrix with no reported adverse event which led to inappropriate age at vaccine administration. Reportedly, they wanted to know if there are any serious adverse event they should look out for.
Sex: F
Vaccine: RSV
Symptoms: Cough, Malaise, Nasal disorder
Clinical narrative: cough; Nasal disorder; has not felt well; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of cough in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Dupixent.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced cough (Verbatim: cough), nasal disorder (Verbatim: Nasal disorder) and unwell (Verbatim: has not felt well). The outcome of the cough, nasal disorder and unwell were unknown.   It was unknown if the reporter considered the cough, nasal disorder and unwell to be related to Arexvy.     It was unknown if the company considered the cough, nasal disorder and unwell to be related to Arexvy.   Additional Information: GSK Receipt Date: 15-NOV-2024 In November 2020, the patient started taking Dupixent (strength 300 mg12ml) Solution for injection 300 mg Q W subcutaneous for prurigo nodularis and atopic dermatitis, unspecified.  On an unknown date in September 2024, the patient received Arexvy. In September 2024 the patient developed a non-serious event had not felt well, received antibiotics, cough pills and nasal spray that did not help (cough) (nasal disorder). It was reported patient received Arexvy vaccine last month and had not felt well since, patient went to urgent care and received antibiotics, cough pills and nasal spray that did not help, no further information known or given, unknown if specialist and is aware. Corrective treatment antibiotics, cough pills and nasal spray was received for the events (had not felt well, received antibiotics, cough pills and nasal spray that did not help). At time of reporting, the outcome was unknown for the event had not felt well, received antibiotics, cough pills and nasal spray that did not help.
Sex: U
Vaccine: RVX
Symptoms: Dizziness
Clinical narrative: dizziness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of dizziness in a 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 dizziness (Verbatim: dizziness). The outcome of the dizziness was not resolved.   It was unknown if the reporter considered the dizziness to be related to RSV vaccine.     It was unknown if the company considered the dizziness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 15-NOV-2024 This case was reported by a patient's friend via interactive digital media. The patient still had dizziness after getting her RSV jab. The case was linked with case US2024AMR144409, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR144409:same reporter
Age: 7.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received Havrix early second dose; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of drug dose administration interval too short in a 7-year-old male patient who received HAV (Havrix Junior) (batch number C24B9, expiry date 06-MAY-2026) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact (Havrix junior).   On 12-NOV-2024, the patient received Havrix Junior. On 12-NOV-2024, an unknown time after receiving Havrix Junior, the patient experienced drug dose administration interval too short (Verbatim: patient received Havrix early second dose). The outcome of the drug dose administration interval too short 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: Follow up information received on 15-NOV-2024 The other health professional reported that the 7 year-old patient received Havrix early second dose. The patient received second dose of Havrix shorter than the recommended interval which led to shortening of vaccination schedule. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 52.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Chills, Fatigue, Headache, Pyrexia, Rash
Clinical narrative: headache; fatigue; chills; Fever; Rash under the left arm pit area; This non-serious case was reported by a other health professional via sales rep and described the occurrence of rash in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On 25-JUN-2024, the patient received the 1st dose of Shingrix (injection, right arm). On 08-NOV-2024, the patient received INFLUENZA VACCINE. On 08-NOV-2024, 136 days after receiving Shingrix, the patient experienced rash (Verbatim: Rash under the left arm pit area). On an unknown date, the patient experienced headache (Verbatim: headache), fatigue (Verbatim: fatigue), chills (Verbatim: chills) and fever (Verbatim: Fever). The outcome of the rash was not resolved and the outcome of the headache, fatigue, chills and fever were unknown.   It was unknown if the reporter considered the rash, headache, fatigue, chills and fever to be related to Shingrix.     It was unknown if the company considered the rash, headache, fatigue, chills and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-NOV-2024 The reporter was the administrator of a medical office and was also the patient. The reporter was a female patient that received the first dose of Shingrix vaccine on 25 June 2024. The reporter stated that she got vaccinated at that medical facility and was administered the vaccine in the right arm. The Lot number/Expiration date were unknown. Two weeks ago she had fever, chills, fatigue, and headache. The patient was tested for FLU and for COVID and both test results were negative. On 08 November 2024, she received a Flu vaccine. It was unknown the manufacturing company of the vaccine, and the arm of the injection site in which it was administered. On 08 November 2024, she noticed a rash which was located under the left arm pit area. The patient stated that the rash had not resolved.  The patient reported that she had not yet received the 2nd dose of Shingrix. It was unknown if the reporter considered the rash to be related to Flu vaccine.  No additional information or event was reported.
Sex: F
Vaccine: MENB
Symptoms: Occupational exposure to product, Product colour issue
Clinical narrative: vaccine leaked onto her ungloved fingers; Product Complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of occupational exposure via skin contact with product in a female patient who received Men B NVS (Bexsero) (batch number 52N4S, expiry date 30-NOV-2027) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced occupational exposure via skin contact with product (Verbatim: vaccine leaked onto her ungloved fingers) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the occupational exposure via skin contact with product and pharmaceutical product complaint were 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: 13-NOV-2024 When the healthcare professional was inspecting the consistency of one suspect syringe, and trying to remove the bubble, vaccine leaked onto her ungloved fingers which led to occupational exposure via skin contact with product. The reporter was the HCP (medical assistant), an experienced Bexsero user.  1 Confirmed that all operations were performed appropriately before the defect was discovered. 2 All 10 pre-filled syringes in that newly opened Bexsero box had an unusual appearance and large bubbles.  3 The first time box was opened, during preparation.  4 The suspect product was not administered. 5 Bexsero pre-filled syringes were involved in the complaint. The suspension was cloudier than normal, clumpy, gelatinous, sticky, and slimy. The large bubble was half the size of the liquid in the syringe (about 0.25ml). The bubble can't be removed. There was also a brown, dried, liquid stain on the outside of the box. No evidence of leak or discoloration inside the box. The vaccine was cloudier, gelatinous, sticky, slimy, and clumpy compared to other Bexsero batches. No any visible damage was present on the syringe.  There was no any temperature excursions during storage. The product was not at room temperature when particle observed. When the healthcare professional was inspecting the consistency of one suspect syringe, and trying to remove the bubble, vaccine leaked onto her ungloved fingers which led to occupational exposure via skin contact with product and inadvertent exposure to vaccine. Pictures were taken of the discoloration on the box and of the suspect syringes. The box and all ten syringes are available for return to GSK. The reporter provided consent to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received third dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number 93ET2, expiry date 23-OCT-2026) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 13-DEC-2022 (lot 559H5)) and Shingrix (2nd dose received on 17-FEB-2023 (lot 5L3HB)).   On 13-NOV-2024, the patient received the 3rd dose of Shingrix. On 13-NOV-2024, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Patient received third dose of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 13-NOV-2024 The reporter is a pharmacist. The patient received third dose of Shingrix on 13-Nov-2024 which led to extra dose administered. The healthcare professional stated that she looked in her states vaccine registry and noted Shingrix dose number 1 lot 559H5 was given on 13-Dec-2022.  No second dose was noted in the state registry. Therefore, The healthcare professional gave a dose of Shingrix on 13-Nov-2024.  The healthcare professional reported when she was doing computer documentation for the vaccine dose given on that day, she noted that a dose (second dose) of Shingrix LOT 5L3HB was given to patient on 17-Feb-2023 at a different location.
Sex: F
Vaccine: VARZOS
Symptoms: Occupational exposure to product
Clinical narrative: occupational exposure to product; exposure via eye contact; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while preparing product for administration in a female patient who received Herpes zoster (Shingrix) (batch number 4x7ZJ, expiry date 06-APR-2026) for prophylaxis.   On 13-NOV-2024, the patient received Shingrix. On 13-NOV-2024, an unknown time after receiving Shingrix, the patient experienced occupational exposure while preparing product for administration (Verbatim: occupational exposure to product) and exposure via eye contact (Verbatim: exposure via eye contact). The outcome of the occupational exposure while preparing product for administration and exposure via eye contact were unknown.   Additional Information: GSK Receipt Date: 13-NOV-2024 Pharmacist reported her immunize colleague administer Shingrix vaccine to a patient. However, while she was pulling up the adjuvant a drop got into her eye before mixing the vaccine which led to occupational exposure to product and exposure via eye contact. The vaccine Administration Facility was the same as Primary Reporter.