chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARCEL
Symptoms: Flushing, Pain in extremity
Clinical narrative: Client states that after last appt for vaccinations she had redness & swelling of her L arm for about 2 days as well as a fever. Denied any SOB or itching. Client states that she managed symptoms at home with tylenol. Determined most likely cause was Varicella, isolated second dose to L arm today & had client wait for 15mins post vaccination. After about 10 minutes the client states that she felt flushed & had pain in her L arm. No SOB or itching. No visible redness or swelling, area not warm to the touch. Marked injection site with pen & instructed client to monitor for development of a rash. Cold compress given & education on pain management. Temp 98.1, O2 94%, heart rate 74bpm.
Age: 1.67
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: pt under age , no adverse reaction noted or observed
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, Posture abnormal
Clinical narrative: Resident had a heart attack in the dining room at the dinner table.  Resident was laughing and eating her meal, when she clutched her chest and slumped over the table.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Cough, Diabetic ketoacidosis, Dyspnoea, Fatigue
Clinical narrative: Hospitalized 3/16/23-3/23/23 nausea with vomiting, SOB, body aches, cough congestion, hypotension, tachycardia, respiratory failure with hypoxia, AKI, DKA, fatigue, malaise, PNA, hypomagnesemia,
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypomagnesaemia, Hypotension, Hypoxia, Malaise, Nausea
Clinical narrative: Hospitalized 3/16/23-3/23/23 nausea with vomiting, SOB, body aches, cough congestion, hypotension, tachycardia, respiratory failure with hypoxia, AKI, DKA, fatigue, malaise, PNA, hypomagnesemia,
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pneumonia, Respiratory failure, Respiratory tract congestion, Tachycardia
Clinical narrative: Hospitalized 3/16/23-3/23/23 nausea with vomiting, SOB, body aches, cough congestion, hypotension, tachycardia, respiratory failure with hypoxia, AKI, DKA, fatigue, malaise, PNA, hypomagnesemia,
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Hospitalized 3/16/23-3/23/23 nausea with vomiting, SOB, body aches, cough congestion, hypotension, tachycardia, respiratory failure with hypoxia, AKI, DKA, fatigue, malaise, PNA, hypomagnesemia,
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given to a patient younger than 4 years.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: pt under age, no adverse reaction noted or observed
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Culture wound negative, Injection site discharge, Injection site erythema, Injection site pustule, Injection site ulcer
Clinical narrative: Patient had received Tdap injection to the left deltoid on June 12.  She reports 1 week later noticed the area was erythematous and leaking of serous sanguinous fluid.  Patient is a medical assistant and had maintain the area clean with a gauze above it to absorb the fluid.  She sent pictures through Chart about 4 weeks later since she noticed the area was not improving in appearance.  On the phone yesterday when provider was following up with patient, she reported experiencing pus coming from the area for which she was recommended to come in for evaluation. Area did not have pus and wound culture showed normal flora.  Patient reports many years ago she had an erythema to area where Tdap was injected but no similar symptoms as reported now.  She currently denies any fever, pain, warmth, weakness in the arm, or tender lymph nodes in the elbows or armpits. In the area where she had the injection a clean based ulcer is noted measuring <0.5 mm in diameter.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fall, Femur fracture, Pneumonia
Clinical narrative: Hospitalized 3/31/23-4/12/23 fall, femur  fx, cough, SOB, PNA,
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Peripheral swelling
Clinical narrative: Patient's right arm became very swollen 07-25-2024 Mother advised to give Benadryl by nurse on 07-25-2024 Doctor advised to give Zyrtec on 07-26-2024 Doctor prescribed Keflex on 07-27-2024
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: The vial contents were not diluted and the patient got the 10mcgs instead of 3 mcg
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Hopsitalized 4/3/23-4/5/23 Diarrhea, body aches, fatigue, chest pain, SOB, hypotension, hypoxia, lightheadedness, respiratory failure
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Hypoxia, Pain, Respiratory failure
Clinical narrative: Hopsitalized 4/3/23-4/5/23 Diarrhea, body aches, fatigue, chest pain, SOB, hypotension, hypoxia, lightheadedness, respiratory failure
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Atrial fibrillation, Cough, Fall, Nausea
Clinical narrative: Hospitalized 4/15/24-4/18/24 weakness, fall, nausea with vomiting, a-fib, edema BLE, cough, sore throat, elevated troponin,
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Oropharyngeal pain, Troponin increased, Vomiting
Clinical narrative: Hospitalized 4/15/24-4/18/24 weakness, fall, nausea with vomiting, a-fib, edema BLE, cough, sore throat, elevated troponin,
Age: 11.0
Sex: M
Vaccine: MENB, MNQ, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt. was accidentally given Trumenba instead of HPV. He has had no reactions. He now has an altered vaccine schedule.
Age: 1.0
Sex: M
Vaccine: DTAPIPV, HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: pt was given the correct shot but incorrect age range, called pts mother, she stated nothing was different regarding pt, there was no side effects  . this was noticed 3 months later due to billing
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: After receiving the 2nd dose of Varivax, the patient woke up the next morning with severe swelling in her left arm down to her finger tips. Entire arm was painful and swollen including fingers.
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Patient was seen in clinic for newborn well visit 4 days after delivery. At this visit, provider was informed by parents that this infant was not offered the hepatitis B vaccine during his newborn nursery admission which is standard practice. Parents were not offered the vaccine and did not decline the vaccine while in the hospital. It was not offered so it was not given. Patient then received vaccine at office visit 7/25/24.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Chest pain, Cough, End stage renal disease, Headache
Clinical narrative: Hospitalized 5/1/23-5/4/23 cough, body aches, chest pain, fever with chills, elevated troponin, sore throat, headache, PNA, non-STEMI, ESRD,
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pneumonia, Pyrexia, Troponin increased
Clinical narrative: Hospitalized 5/1/23-5/4/23 cough, body aches, chest pain, fever with chills, elevated troponin, sore throat, headache, PNA, non-STEMI, ESRD,
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2, COVID19-2
Symptoms: Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Sore throat
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angle closure glaucoma, Autoimmune disorder, Detoxification, Dry eye, Electrocardiogram
Clinical narrative: PFIZER #1 3/4/2021 PFIZER #2 3/25/2021 DEVELOPED DRY PAINFUL EYE CONDITION OVER MONTHS AND NEEDED STEROID EYE DROPS, DEVELOPED ACUTE ANGLE CLOSURE GLAUCOMA AND HAD EYE SURGERY, THEN DEVELOPED A HYPER SENTIVITY TO MOLD.  CLINICAL DIAGNOSIS IS COVID VACCINE INDUCED SJOGRENS WITH AUTOIMMUNITY.  TREATED WITH PROTOCOL.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye operation, Eye pain, Immunisation reaction, Laboratory test, Mycotic allergy
Clinical narrative: PFIZER #1 3/4/2021 PFIZER #2 3/25/2021 DEVELOPED DRY PAINFUL EYE CONDITION OVER MONTHS AND NEEDED STEROID EYE DROPS, DEVELOPED ACUTE ANGLE CLOSURE GLAUCOMA AND HAD EYE SURGERY, THEN DEVELOPED A HYPER SENTIVITY TO MOLD.  CLINICAL DIAGNOSIS IS COVID VACCINE INDUCED SJOGRENS WITH AUTOIMMUNITY.  TREATED WITH PROTOCOL.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sjogren's syndrome
Clinical narrative: PFIZER #1 3/4/2021 PFIZER #2 3/25/2021 DEVELOPED DRY PAINFUL EYE CONDITION OVER MONTHS AND NEEDED STEROID EYE DROPS, DEVELOPED ACUTE ANGLE CLOSURE GLAUCOMA AND HAD EYE SURGERY, THEN DEVELOPED A HYPER SENTIVITY TO MOLD.  CLINICAL DIAGNOSIS IS COVID VACCINE INDUCED SJOGRENS WITH AUTOIMMUNITY.  TREATED WITH PROTOCOL.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt to clinic for immunizations for school. Pt was due 2nd MMR on 6/5/24 and second varicella on 7/31/24. Nurse misread due date for 2nd varicella as 7/13/24 and administered Proquad vaccine before minimum valid date on report.
Age: 21.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt developed localized swelling and erythema around the area. Approx 10cm circle with mild induration. Patient states the area had been painful and itchy, but getting better. Patient states she was also achy yesterday, but no fever that she was aware of.
Age: 21.0
Sex: F
Vaccine: PNC20
Symptoms: Pain
Clinical narrative: Pt developed localized swelling and erythema around the area. Approx 10cm circle with mild induration. Patient states the area had been painful and itchy, but getting better. Patient states she was also achy yesterday, but no fever that she was aware of.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Stomatitis
Clinical narrative: Oral sores, Chest pain.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Red raised rash all over body.  See Attached.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chest discomfort, Chills, Erythema, Flushing
Clinical narrative: Patient presented to the pharmacy on 7/29 saying she received a Shingrix vaccine on Friday 7/26. She reports she got some arm tingles and feels inflammation into almost her breast area (maybe swollen lymph node?)--she says it almost feels like chest tightness but not pain. Her shoulder is also very sore. I double checked where her poke was and don't suspect SIRVA. She also reports she still has a headache, chills and body aches, which could be the immune response. She has some remaining flushing, redness/pink coloring around the injection site area and on her neck/face. The area is slightly itchy. I advised she could take an anti-inflammatory, try some ice and continue to monitor. Diphenhydramine could be used if the itchiness is bothersome. I also encouraged her to send a note in chart to her pcp and that I would submit a VAERS form in case more follow up is needed in the future.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Inflammation, Injection site erythema, Injection site pruritus, Pain
Clinical narrative: Patient presented to the pharmacy on 7/29 saying she received a Shingrix vaccine on Friday 7/26. She reports she got some arm tingles and feels inflammation into almost her breast area (maybe swollen lymph node?)--she says it almost feels like chest tightness but not pain. Her shoulder is also very sore. I double checked where her poke was and don't suspect SIRVA. She also reports she still has a headache, chills and body aches, which could be the immune response. She has some remaining flushing, redness/pink coloring around the injection site area and on her neck/face. The area is slightly itchy. I advised she could take an anti-inflammatory, try some ice and continue to monitor. Diphenhydramine could be used if the itchiness is bothersome. I also encouraged her to send a note in chart to her pcp and that I would submit a VAERS form in case more follow up is needed in the future.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Patient presented to the pharmacy on 7/29 saying she received a Shingrix vaccine on Friday 7/26. She reports she got some arm tingles and feels inflammation into almost her breast area (maybe swollen lymph node?)--she says it almost feels like chest tightness but not pain. Her shoulder is also very sore. I double checked where her poke was and don't suspect SIRVA. She also reports she still has a headache, chills and body aches, which could be the immune response. She has some remaining flushing, redness/pink coloring around the injection site area and on her neck/face. The area is slightly itchy. I advised she could take an anti-inflammatory, try some ice and continue to monitor. Diphenhydramine could be used if the itchiness is bothersome. I also encouraged her to send a note in chart to her pcp and that I would submit a VAERS form in case more follow up is needed in the future.
Age: 72.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Injection site induration, Injection site mass, Pain in extremity, Peripheral swelling
Clinical narrative: Patient had her injection on 7/25/24.  Her arm was sore that evening.  The next morning, her arm was red, swollen, and itchy. She has a hard lump at the injection site.  She applied ice, took tylenol, and applied benadryl cream. She came into the clinic today to report it.  The redness and swelling are decreasing.  She will continue supportive measures and call the clinic if symptoms worsen.
Age: 72.0
Sex: F
Vaccine: PNC20
Symptoms: Pruritus
Clinical narrative: Patient had her injection on 7/25/24.  Her arm was sore that evening.  The next morning, her arm was red, swollen, and itchy. She has a hard lump at the injection site.  She applied ice, took tylenol, and applied benadryl cream. She came into the clinic today to report it.  The redness and swelling are decreasing.  She will continue supportive measures and call the clinic if symptoms worsen.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Patient Fainted five minutes after shot given. Recovered shortly after.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cold sweat, Loss of consciousness, Pallor, Presyncope
Clinical narrative: Pt tolerated TDAP injection to L arm, Pt vasovagaled after receiving MCV to R arm. Pt became pale, clammy, passed out for  approx 1 minute. Placed supine, feet elevated, vs obtained. PT returned to responsiveness less, cold pack placed to neck. Staff stayed with pt and MOC for approx 15 minutes. Pt then escorted to immz waiting room to waiting for additional observation.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Diplegia, Electromyogram, Gait disturbance, Laboratory test
Clinical narrative: Patient developed Chronic Inflammatory Demyelinating Polyneuropathy with paraparesis in legs as well as gait problems, and neuropathic pain.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Nerve conduction studies, Neuralgia
Clinical narrative: Patient developed Chronic Inflammatory Demyelinating Polyneuropathy with paraparesis in legs as well as gait problems, and neuropathic pain.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Pain in extremity, Product administered at inappropriate site, Ultrasound scan abnormal
Clinical narrative: The hospital staff member administering my vaccine didn't inject me where I've received every other COVID shot (my upper arm). Instead, she jabbed the needle into my lower arm, about an inch above my elbow. On every subsequent visit with doctors in that hospital, and others, I've brought it up since  - due to the pain - I can no longer have my blood pressure taken on that arm. Every single one has stated that it wasn't supposed to be injected there. Finally, after fruitless efforts to get help, an RN sent me for a sonogram. It confirmed that I'd developed a focal avascular echogenic lesion in the precise location where the vaccine was incorrectly administered.
Age: 84.0
Sex: M
Vaccine: RSV, VARZOS
Symptoms: Abdominal X-ray, Agitation, Amnesia, Chest X-ray, Computerised tomogram abdomen
Clinical narrative: Confusion, memory loss, severe agitation, hallucinations
Age: 84.0
Sex: M
Vaccine: RSV, VARZOS
Symptoms: Computerised tomogram head, Computerised tomogram neck, Computerised tomogram thorax, Confusional state, Electrocardiogram
Clinical narrative: Confusion, memory loss, severe agitation, hallucinations
Age: 84.0
Sex: M
Vaccine: RSV, VARZOS
Symptoms: Electroencephalogram, Hallucination, Laboratory test, Lumbar puncture, Magnetic resonance imaging head
Clinical narrative: Confusion, memory loss, severe agitation, hallucinations
Age: 84.0
Sex: M
Vaccine: RSV, VARZOS
Symptoms: Positron emission tomogram, Sleep study, Ultrasound Doppler, X-ray of pelvis and hip
Clinical narrative: Confusion, memory loss, severe agitation, hallucinations
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 18 day old was incidentally given vaxelis instead of hep B. no adverse outcomes in regards to symptoms
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Brain fog, Memory impairment
Clinical narrative: brain fog: forgetfulness, couldn't remember names/events, kept repeating things, memory challenges
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: DUPLICATE VACCINE. SAME VACCINE RECEIVED 1/12/2024. NO ISSUES REPORTED
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Activated partial thromboplastin time, Differential white blood cell count, Full blood count, Injection site reaction, International normalised ratio
Clinical narrative: Petechial rash to BLE
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Petechiae, Prothrombin time
Clinical narrative: Petechial rash to BLE
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Coordination abnormal, Dizziness, Gait disturbance, Headache
Clinical narrative: One day after vaccine given on 7/18/24,, experienced severe flu symptoms (bad headache, sore joints, lethargy) starting 7/19/2024,  It lasted three days, with the extreme lethargy lasting four more days.  On July 26, 2024, experienced headache, dizziness  and loss of coordination, left leaning gait.  Went via ambulance to hospital where MRI done in ER showed stroke in thalamus region of brain.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Ischaemic cerebral infarction, Lethargy, Magnetic resonance imaging head abnormal, Thalamic stroke
Clinical narrative: One day after vaccine given on 7/18/24,, experienced severe flu symptoms (bad headache, sore joints, lethargy) starting 7/19/2024,  It lasted three days, with the extreme lethargy lasting four more days.  On July 26, 2024, experienced headache, dizziness  and loss of coordination, left leaning gait.  Went via ambulance to hospital where MRI done in ER showed stroke in thalamus region of brain.
Age: 44.0
Sex: M
Vaccine: HEPAB, MMRV
Symptoms: Wrong product administered
Clinical narrative: No adverse events aside from patient receiving MMRV in place of MMR
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid 19 Breakthrough infection
Age: 56.0
Sex: F
Vaccine: ADEN_4_7
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Pt states immunization area became red and swollen.She had a fever of101.3 and injection site was 104.8. After 2 days symptoms dissappated and fever diminished
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Zoster dermatomal rash on right shoulder appeared two days after vaccine administered. Treated with valacyclovir and lidocaine ointment.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Patient syncopal episode 20 + minutes after vaccination.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Blood donor, Cold sweat, Dizziness, Fatigue, Nausea
Clinical narrative: Donor completed a plasma donation of 843/880mL; During donation, donor had an AC depletion event. Donor called the center at approx. 2:00PM and reported feeling nausea, dizziness, cold sweats, and fatigue. Donor reported that he needs to hydrate more and that he ate two egg and cheese biscuits prior to donation. Donor reports that he drank two sports drinks and will drink Pedialyte when he reaches home.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: No reactions. Spoke to provider Dr., then called parents and spoke to father to let him know the situation. Scheduled an appt for patient to receive MMRV in 1 month.
Age: 70.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient stated the injection site became hot to the touch and was very swollen and discolored (red) and remained that way for several days after injection.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Redness down most of arm. In 4 days redness resided.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Administered after being improperly stored; This spontaneous report was received from a certified medical assistant, referring to a 2-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-JUN-2024, the patient started therapy with the second dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (dose: 0.5 milliliter, lot #X025342, expiration date: 12-MAY-2025, strength: 25/0.5 (units not provided), route was not reported) in left vastus lateralis for prophylaxis (Product storage error). No adverse effects were reported.  The suspect vaccine is available for return/evaluation. Current location of vaccine was refrigerator. The operation of vaccine was healthcare professional.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: PEDVAXHIB was inadvertently administered to a patient outside of the recommended interval; No additional AE; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, at age of 2 months, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), 1 dosage form (strength, dose number, route, lot#, expiration date and anatomical location were not provided) for prophylaxis, then at age of 4 months, the patient received another dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) and then at the age of 6 months on 05-JUL-2024, the patient received another dose (also reported as: "most recent") of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), therefore it was mentioned that the vaccine haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) was inadvertently administered outside of the recommended Interval (inappropriate schedule of product administration).  No adverse event reported.
Age: 0.5
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects reported.; HCP calling to report that 6 month old patient mistakenly received PNEUMOVAX 23.; This spontaneous report was received from a nurse and referred to a 6-month-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-JUL-2024, the 6-month-old patient was mistakenly vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), lot #X022827, (expiration date: 14-AUG-2025), administered for prophylaxis (strength, dose, and route of administration were not provided) (Product administered to patient of inappropriate age). No adverse effects were reported, no other information was provided. It was confirmed no product quality complaint (PQC) and no additional adverse event (AE) (No adverse event).
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improper storage of product in use; This spontaneous report was received from a medical assistant, referring to a 4-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On 31-MAY-2024, the patient was vaccinated with improperly stored vaccine of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot # X015245, expiration date: 22-NOV-2024, administered orally for prophylaxis (dose and strength not provided) by a health professional (product storage error). It was reported that the vaccine was exposed to a temperature excursion on 30-APR-2024 (temperature: 74.4 degrees Fahrenheit [F]; time frame: 72 hours [also reported as excursion for 3 days plus 23 hours; min: 39.02 F, max: 74.84 F]). There was no previous temperature excursion. It was reported that the call was done because of a "data logger". It was confirmed that there were no symptomatic adverse events (no adverse event).  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2407USA012957: US-009507513-2407USA013125: US-009507513-2407USA013127:
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Diplopia, Eye pain, Feeling drunk, Headache, Hypoaesthesia
Clinical narrative: Numbness/tingling both lower extremities; tingling both lower extremities; Spinning sensation,; drunk feeling; Headache behind eyes; Double vision; This serious case was reported by a physician via sales rep and described the occurrence of double vision in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number Yc5y7, expiry date 23-OCT-2024) for prophylaxis.   On 09-JAN-2023, the patient received the 2nd dose of Shingrix (left deltoid). On 15-AUG-2023, 218 days after receiving Shingrix, the patient experienced double vision (Verbatim: Double vision) (serious criteria disability and other: Other medically imp. condition). On an unknown date, the patient experienced hypoesthesia (Verbatim: Numbness/tingling both lower extremities), tingling of extremity (Verbatim: tingling both lower extremities), spinning sensation (Verbatim: Spinning sensation,), feeling drunk (Verbatim: drunk feeling) and headache (Verbatim: Headache behind eyes). The outcome of the double vision was resolving and the outcome of the hypoesthesia, tingling of extremity, spinning sensation, feeling drunk and headache were not reported.   The reporter considered the double vision to be related to Shingrix. It was unknown if the reporter considered the hypoesthesia, tingling of extremity, spinning sensation, feeling drunk and headache to be related to Shingrix.     The company considered the double vision to be unrelated to Shingrix. It was unknown if the company considered the hypoesthesia, tingling of extremity, spinning sensation, feeling drunk and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-JUL-2024 The physician reported that, the patient received a subsequent dose of Shingrix. The patient had multiple symptoms associated with adverse event.  The patient had Numbness/tingling below elbows to fingertips bilaterally worse on left. Numbness/tingling both lower extremities, spinning sensation, drunk feeling and double vision.  The patient had headache behind eyes, double vision.  The patient also complained of a drunk feeling. The reporter consented to follow up.; Sender's Comments: Diplopia is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Vertigo
Clinical narrative: Numbness/tingling both lower extremities; tingling both lower extremities; Spinning sensation,; drunk feeling; Headache behind eyes; Double vision; This serious case was reported by a physician via sales rep and described the occurrence of double vision in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number Yc5y7, expiry date 23-OCT-2024) for prophylaxis.   On 09-JAN-2023, the patient received the 2nd dose of Shingrix (left deltoid). On 15-AUG-2023, 218 days after receiving Shingrix, the patient experienced double vision (Verbatim: Double vision) (serious criteria disability and other: Other medically imp. condition). On an unknown date, the patient experienced hypoesthesia (Verbatim: Numbness/tingling both lower extremities), tingling of extremity (Verbatim: tingling both lower extremities), spinning sensation (Verbatim: Spinning sensation,), feeling drunk (Verbatim: drunk feeling) and headache (Verbatim: Headache behind eyes). The outcome of the double vision was resolving and the outcome of the hypoesthesia, tingling of extremity, spinning sensation, feeling drunk and headache were not reported.   The reporter considered the double vision to be related to Shingrix. It was unknown if the reporter considered the hypoesthesia, tingling of extremity, spinning sensation, feeling drunk and headache to be related to Shingrix.     The company considered the double vision to be unrelated to Shingrix. It was unknown if the company considered the hypoesthesia, tingling of extremity, spinning sensation, feeling drunk and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-JUL-2024 The physician reported that, the patient received a subsequent dose of Shingrix. The patient had multiple symptoms associated with adverse event.  The patient had Numbness/tingling below elbows to fingertips bilaterally worse on left. Numbness/tingling both lower extremities, spinning sensation, drunk feeling and double vision.  The patient had headache behind eyes, double vision.  The patient also complained of a drunk feeling. The reporter consented to follow up.; Sender's Comments: Diplopia is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Nausea
Clinical narrative: pain at injection site; Nausea; Fatigue; Tiredness; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included attention deficit hyperactivity disorder and allergy. Concomitant products included methylphenidate hydrochloride (Aptensio Xr) and montelukast sodium (Singulair).   On 18-JUL-2024, the patient received Shingrix. On 19-JUL-2024, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site), nausea (Verbatim: Nausea), fatigue (Verbatim: Fatigue) and tiredness (Verbatim: Tiredness). The outcome of the injection site pain, nausea, fatigue and tiredness were not resolved.   It was unknown if the reporter considered the injection site pain, nausea, fatigue and tiredness to be related to Shingrix.     It was unknown if the company considered the injection site pain, nausea, fatigue and tiredness to be related to Shingrix.   Additional Information: GSK receipt date: 19-JUL-2024 The symptoms was treated.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Intramuscular injection given for Priorix; This non-serious case was reported by a consumer via patient support programs and described the occurrence of subcutaneous injection formulation administered by other route in a 4-year-old male patient who received MMR (Priorix) (batch number L3229, expiry date 01-AUG-2024) for prophylaxis.   On 19-JUL-2024, the patient received Priorix (subcutaneous). On 19-JUL-2024, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Intramuscular injection given for Priorix). The outcome of the subcutaneous injection formulation administered by other route was not reported.   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: 19-JUL-2024 The vaccine was given intramuscular instead of subcutaneous which led to Subcutaneous injection formulation administered by other route.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: she just gave an Engerix-B vaccine to an adult patient, and realized after that it expired on July 12 2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 53-year-old female patient who received HBV (Engerix B adult) (batch number DZ747, expiry date 12-JUL-2024) for prophylaxis.   On 18-JUL-2024, the patient received the 3rd dose of Engerix B adult. On 18-JUL-2024, an unknown time after receiving Engerix B adult, the patient experienced expired vaccine used (Verbatim: she just gave an Engerix-B vaccine to an adult patient, and realized after that it expired on July 12 2024). 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: 18-JUL-2024 A pharmacist stated she just gave an Engerix-B vaccine to an adult patient, and realized after that it expired on 12 July 2024 which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: She experienced swelling at the injection site; pain at the injection site that lasted one month.; swelling in other areas of her upper left arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-FEB-2024, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 25-FEB-2024, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at the injection site that lasted one month.). On 26-FEB-2024, the patient experienced injection site swelling (Verbatim: She experienced swelling at the injection site). On an unknown date, the patient experienced peripheral swelling (Verbatim: swelling in other areas of her upper left arm). The outcome of the injection site swelling and peripheral swelling were resolved (duration 2 weeks) and the outcome of the injection site pain was resolved (duration 1 month).   It was unknown if the reporter considered the injection site swelling, injection site pain and peripheral swelling to be related to Shingrix.     It was unknown if the company considered the injection site swelling, injection site pain and peripheral swelling to be related to Shingrix.   Additional Information: GSK Receipt date: 19-JUL-2024 A reporter reported that a patient received her first Shingrix dose on 24 February 2024 and she experienced swelling at the injection site and other areas of her upper left arm that lasted about 2 weeks and pain at the injection site that lasted one month.
Age: 4.0
Sex: F
Vaccine: DTAP, DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: A dose of Pediarix and a dose of Infanrix were applied to a 4 year old patient on the same day.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 4-year-old female patient who received DTPa (Infanrix) (batch number 73SX2, expiry date 24-MAR-2026) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number X9EP5, expiry date 09-MAR-2026) for prophylaxis.   On an unknown date, the patient received Infanrix and Pediarix. On an unknown date, an unknown time after receiving Infanrix and Pediarix, the patient experienced overdose (Verbatim: A dose of Pediarix and a dose of Infanrix were applied to a 4 year old patient on the same day.). The outcome of the overdose 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: 19-JUL-2024 A dose of Pediarix and a dose of Infanrix were applied to the patient on the same day, which led overdose. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received a third dose of Shingrix by mistake; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Patient received a third dose of Shingrix by mistake). The outcome of the extra dose administered was not reported.   Additional Information: GSK Receipt Date: 19-JUL-2024 Healthcare professional reported a patient received a third dose of Shingrix by mistake which led to extra dose administered.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Extra dose administered
Clinical narrative: 3rd dose received; 2nd dose received; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 9994E, expiry date 30-JUN-2025) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 19-JUL-2024, the patient received the 3rd dose of Menveo. On 11-NOV-2022, the patient received the 2nd dose of Menveo. On 11-NOV-2022, not applicable after receiving Menveo and an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: 2nd dose received). On 19-JUL-2024, the patient experienced extra dose administered (Verbatim: 3rd dose received). The outcome of the extra dose administered and extra dose administered were not reported.   Additional Information: GSK Receipt Date: 19-JUL-2024 The caller reported that they administered on the day of reporting a dose of Menveo, and caller needed to know if this can cause any harm to the patient due this was the 3rd dose that the patient received. The caller said that this same patient already completed her vaccination schedule, and this happened when it was a pediatric patient, the 1st dose was administer on 23 December 2017 and the 2nd at 11 November 2022 which led to extra dose administered. When patient received this 3rd dose, the patient was already 18 years old.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: patient moved his arm, and most of the vaccine did not make it in the arm.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 43-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9935H, expiry date 03-JUL-2026) for prophylaxis.   On 19-JUL-2024, the patient received Boostrix. On 19-JUL-2024, an unknown time after receiving Boostrix, the patient experienced incomplete dose administered (Verbatim: patient moved his arm, and most of the vaccine did not make it in the arm.). The outcome of the incomplete 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: 19-JUL-2024 The pharmacist states they were administering Boostrix and the patient moved his arm, and most of the vaccine did not make it in the arm, which led incomplete dose administered. The reporter consented to follow up.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Vaccine administered after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a male patient who received Men B NVS (Bexsero) (batch number ZH7SN, expiry date 31-JAN-2027) for prophylaxis.   On 18-JUL-2024, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Vaccine administered after temperature excursion). The outcome of the incorrect storage of drug 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: 22-JUL-2024 Medical Assistant explained that patient received Bexsero doses that were exposed to a temperature excursion above the normal range (unknown maximum temperature) for 56 hours, which led to incorrect storage of drug. The case is linked with US2024091873, by same reporter.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Menveo lyophilized vial was reconstituted with a sterile diluent instead of the supplied CYW-135 conjugate; Menveo lyophilized vial was reconstituted with a sterile diluent instead of the supplied CYW-135 conjugate; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA986A, expiry date 31-OCT-2024) for prophylaxis.   On 19-JUL-2024, the patient received Menveo. On 19-JUL-2024, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo lyophilized vial was reconstituted with a sterile diluent instead of the supplied CYW-135 conjugate) and inappropriate dose of vaccine administered (Verbatim: Menveo lyophilized vial was reconstituted with a sterile diluent instead of the supplied CYW-135 conjugate). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-JUL-2024 The nurse reported Menveo lyophilized vial was reconstituted with a sterile diluent instead of the supplied CYW-135 conjugate, and the dose was administered to a patient, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. At the time of reporting, a repeat dose had not yet been administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: got COVID in December; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (got COVID in December) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 18-Dec-2023, the patient experienced COVID-19 (got COVID in December). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 19-Dec-2023 for COVID-19 treatment, at an unspecified dose and frequency. On 25-Dec-2023, COVID-19 (got COVID in December) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2023, SARS-CoV-2 test: Positive. On 25-Dec-2023, SARS-CoV-2 test: Negative.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were reported. The patient's wife reported that, the patient had 7 vaccinations. Tested positive for COVID on 18-Dec-2023 and started Paxlovid on 19-Dec-2023 and tested negative 6 days later. Both 6th and 7th vaccinations of the patient were of Moderna. All COVID tests were home tests.   This case was linked to US-MODERNATX, INC.-MOD-2024-755811 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-755811:Same reporter (Wife case)
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Got COVID after getting the Moderna COVID vaccine; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Got COVID after getting the Moderna COVID vaccine) in a 70-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got COVID after getting the Moderna COVID vaccine). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Got COVID after getting the Moderna COVID vaccine) outcome was unknown.            No concomitant medications were reported.  The patient reported that, he had been fine, since it's been a year since he took that Moderna shots. The patient thought that he took two Moderna, took that Paxlovid and then took a third shot of Moderna. Well, he had been good for the whole year.  The patient thought that the vaccinator put two vaccines, in the left one and one in the right. The patient had blood and then urine test and got six tests and would get results in a week.