chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: Blood bicarbonate normal, Blood bilirubin decreased, Blood calcium normal, Blood chloride normal, Blood creatinine decreased
Clinical narrative: Full body hives, purple hands, feet, mouth, lethargy, cough and vomiting developed within 30 mins of vaccine administration on 5/1/24. Mom took patient to emergency department. In the ER patient was given intramuscular epinephrine, intravenous fluids, Benadryl, and solu-medrol. Patient was then admitted to in patient pediatric floor for observation where he stayed overnight until he was discharged mid-day on 5/2/24.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: Blood glucose increased, Blood osmolarity normal, Blood pH normal, Blood potassium normal, Blood sodium decreased
Clinical narrative: Full body hives, purple hands, feet, mouth, lethargy, cough and vomiting developed within 30 mins of vaccine administration on 5/1/24. Mom took patient to emergency department. In the ER patient was given intramuscular epinephrine, intravenous fluids, Benadryl, and solu-medrol. Patient was then admitted to in patient pediatric floor for observation where he stayed overnight until he was discharged mid-day on 5/2/24.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: Blood urea nitrogen/creatinine ratio increased, Blood urea normal, C-reactive protein normal, Carbon dioxide decreased, Chest X-ray normal
Clinical narrative: Full body hives, purple hands, feet, mouth, lethargy, cough and vomiting developed within 30 mins of vaccine administration on 5/1/24. Mom took patient to emergency department. In the ER patient was given intramuscular epinephrine, intravenous fluids, Benadryl, and solu-medrol. Patient was then admitted to in patient pediatric floor for observation where he stayed overnight until he was discharged mid-day on 5/2/24.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: Cough, Eosinophil count normal, Eosinophil percentage, Globulins decreased, Glomerular filtration rate
Clinical narrative: Full body hives, purple hands, feet, mouth, lethargy, cough and vomiting developed within 30 mins of vaccine administration on 5/1/24. Mom took patient to emergency department. In the ER patient was given intramuscular epinephrine, intravenous fluids, Benadryl, and solu-medrol. Patient was then admitted to in patient pediatric floor for observation where he stayed overnight until he was discharged mid-day on 5/2/24.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: Granulocyte percentage, Haematocrit normal, Haemoglobin normal, Immature granulocyte count, Lethargy
Clinical narrative: Full body hives, purple hands, feet, mouth, lethargy, cough and vomiting developed within 30 mins of vaccine administration on 5/1/24. Mom took patient to emergency department. In the ER patient was given intramuscular epinephrine, intravenous fluids, Benadryl, and solu-medrol. Patient was then admitted to in patient pediatric floor for observation where he stayed overnight until he was discharged mid-day on 5/2/24.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: Lymphocyte count increased, Lymphocyte percentage, Mean cell haemoglobin concentration decreased, Mean cell haemoglobin decreased, Mean cell volume decreased
Clinical narrative: Full body hives, purple hands, feet, mouth, lethargy, cough and vomiting developed within 30 mins of vaccine administration on 5/1/24. Mom took patient to emergency department. In the ER patient was given intramuscular epinephrine, intravenous fluids, Benadryl, and solu-medrol. Patient was then admitted to in patient pediatric floor for observation where he stayed overnight until he was discharged mid-day on 5/2/24.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: Mean platelet volume normal, Monocyte count increased, Monocyte percentage, Neutrophil count increased, Neutrophil percentage
Clinical narrative: Full body hives, purple hands, feet, mouth, lethargy, cough and vomiting developed within 30 mins of vaccine administration on 5/1/24. Mom took patient to emergency department. In the ER patient was given intramuscular epinephrine, intravenous fluids, Benadryl, and solu-medrol. Patient was then admitted to in patient pediatric floor for observation where he stayed overnight until he was discharged mid-day on 5/2/24.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: PCO2 decreased, PO2 increased, Platelet count increased, Platelet morphology normal, Protein total normal
Clinical narrative: Full body hives, purple hands, feet, mouth, lethargy, cough and vomiting developed within 30 mins of vaccine administration on 5/1/24. Mom took patient to emergency department. In the ER patient was given intramuscular epinephrine, intravenous fluids, Benadryl, and solu-medrol. Patient was then admitted to in patient pediatric floor for observation where he stayed overnight until he was discharged mid-day on 5/2/24.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: Red blood cell count normal, Red cell distribution width normal, Skin discolouration, Urticaria, Vomiting
Clinical narrative: Full body hives, purple hands, feet, mouth, lethargy, cough and vomiting developed within 30 mins of vaccine administration on 5/1/24. Mom took patient to emergency department. In the ER patient was given intramuscular epinephrine, intravenous fluids, Benadryl, and solu-medrol. Patient was then admitted to in patient pediatric floor for observation where he stayed overnight until he was discharged mid-day on 5/2/24.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: White blood cell count increased
Clinical narrative: Full body hives, purple hands, feet, mouth, lethargy, cough and vomiting developed within 30 mins of vaccine administration on 5/1/24. Mom took patient to emergency department. In the ER patient was given intramuscular epinephrine, intravenous fluids, Benadryl, and solu-medrol. Patient was then admitted to in patient pediatric floor for observation where he stayed overnight until he was discharged mid-day on 5/2/24.
Age: 1.17
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Vaccine was administered to patient on 4/11/24 and on 4/25/24- no symptoms after either injection
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Asthenia, Decreased activity, Dizziness, Injection site pain
Clinical narrative: Initially, there was some soreness at the injection sight accompanied with some dizziness as well. However, pain started 4/27/24 in the right elbow and radiated up the arm into the shoulder and shoulder blade and across the back to the spine. The pain was debilitating at first and limited motion and activity as well. As of this writing, the pain is limited to the elbow, shoulder and shoulder blade with it's severity changing from day to day and not always diminishing.
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Mobility decreased, Musculoskeletal pain, Pain, Spinal pain
Clinical narrative: Initially, there was some soreness at the injection sight accompanied with some dizziness as well. However, pain started 4/27/24 in the right elbow and radiated up the arm into the shoulder and shoulder blade and across the back to the spine. The pain was debilitating at first and limited motion and activity as well. As of this writing, the pain is limited to the elbow, shoulder and shoulder blade with it's severity changing from day to day and not always diminishing.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Head discomfort
Clinical narrative: Patient experienced head pressure and chest tightening. No coughing on the 1st day. Patient felt normal on Day 7.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: After administration this nurse noted vaccine had actually expired on 5/4/2024. Patient was informed via phone call and was understanding. Informed he would need to receive another dose that was not expired as expired dose may not be effective. Verbalized understanding and stated he was unable to come back today but next time he was in town he would stop in for another dose. Expired vaccines were removed from stock.
Age: 18.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: The vaccine was outdated with expiration date of 02 march 2024
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest discomfort, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: I am having on and off issues with my heart after this vaccine,  I felt heaving breathing and heart palpitations a little after taking this vaccine, now I have having those same issues more frequently, this week it happen to me twice.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: I am having on and off issues with my heart after this vaccine,  I felt heaving breathing and heart palpitations a little after taking this vaccine, now I have having those same issues more frequently, this week it happen to me twice.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fall
Clinical narrative: Resident received COVID vaccine 5/7/2024 a.m. Resident fell out of wheelchair on same day 5/7/2024 at 3:00 p.m. Resident had no other symptoms and no obvious injuries from event. Resident does have history of falls.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Migraine, Nervous system disorder
Clinical narrative: Joint pain, migraines, nerve issues.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Arthralgia, Hypoaesthesia, Myalgia, Pain, Pain in extremity
Clinical narrative: Noted the night she received the vaccines the right arm started hurting. Prior to this she had no shoulder pain. She worked that evening and next at nursing home and did a lot of moving. She didn't note any troubles with this. Over the week the constant tenderness seemed to get better. However, she has continued to note isolated instances such as throwing a ball/reaching up for something/pulling up her pants will cause more pain in the right shoulder.  The pain is sharp and feels deep within the muscle. Gets better when not moving in those patterns. She has noted that if she raises her arm above head for too long and then relaxes it it seems to feel numb/tingling down the whole arm for about 30-60 seconds.  Otherwise there is no ongoing numbness, weakness, tingling.  She has not tried anything to relieve symptoms aside from heating 1 time.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Paraesthesia, Tenderness
Clinical narrative: Noted the night she received the vaccines the right arm started hurting. Prior to this she had no shoulder pain. She worked that evening and next at nursing home and did a lot of moving. She didn't note any troubles with this. Over the week the constant tenderness seemed to get better. However, she has continued to note isolated instances such as throwing a ball/reaching up for something/pulling up her pants will cause more pain in the right shoulder.  The pain is sharp and feels deep within the muscle. Gets better when not moving in those patterns. She has noted that if she raises her arm above head for too long and then relaxes it it seems to feel numb/tingling down the whole arm for about 30-60 seconds.  Otherwise there is no ongoing numbness, weakness, tingling.  She has not tried anything to relieve symptoms aside from heating 1 time.
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired on 5/7/2024- No reported side effects
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired 5/7/2024- No adverse effects noted
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Influenza like illness, Peripheral swelling, Rash
Clinical narrative: initially patient experienced flu-like symptoms, upset stomach. after a week patient developed swelling in both limps and rash on left leg
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 69.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: Patient noticed a slight itchy sensation from left deltoid on Tues. 5/07/24, days after vaccination on 5/03/24.  Stated the area was sore and after a week, what appears to be a pink rash slowly started to spread from the area of vaccination. Today, patient presented to the pharmacy stating the area is now very itchy (and is using hydrocortisone 1% OTC) and the pink area is not approximately 2 inches in diameter.  Advised to try diphenhydramine 25 mg OTC every 6 hours and report to his MD if there is no improvement in 48 hours.
Age: 18.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Headache, Injection site pain, Injection site swelling
Clinical narrative: Small headache within minutes after injection. Next day, slight swelling (vaccine not absorbed?) and pain if pressure is applied to injection site. Symptoms have persisted for 4 days without improvement.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Pain in extremity, Peripheral swelling, Pruritus, Skin exfoliation
Clinical narrative: Patient said her she had pain in her arm immediately, and by the end of the night it was like a hard golf ball and was protruding.  She said her right cheek as also swollen, but no impaired speech.  Now she still has itching and the skin is peeling in the area.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Patient said her she had pain in her arm immediately, and by the end of the night it was like a hard golf ball and was protruding.  She said her right cheek as also swollen, but no impaired speech.  Now she still has itching and the skin is peeling in the area.
Age: 13.0
Sex: M
Vaccine: HPV9, MENB, TDAP
Symptoms: Unevaluable event
Clinical narrative: Meningitis B given at age 13
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 1.25
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired on 5/8/2024 but administered on 5/9/2024. No adverse reactions noted.
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Confusional state, Culture, Fall, Swelling, Urine analysis
Clinical narrative: Resident received COVID vaccine on 5/7/2024. At approximately 3:30 PM on the same day, he had an unwitnessed fall. Resident has history of falls and confusion. No obvious signs of injury were noted, but on 5/9/2024 at approximately 1:00 PM, a nurse noted a soft lump on his right lateral neck. No further signs of injury or adverse events.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 54.0
Sex: F
Vaccine: YF
Symptoms: Chest discomfort, Throat irritation, Wheezing
Clinical narrative: Pt reported to health department in person an hour after vaccine was given. Pt complaint of wheezing, itching to back of throat, and chest tightness. Pt states she drove to health department with her partner after symptoms began and that she also took 2 Benadryl. No obvious signs of distress was witnessed by this nurse. No auditory wheezing was heard. Pt AOx3 and pt was speaking calmly and without difficulty. Pt was told to report to the emergency room at hospital which is across the street for treatment. Called pt at 3pm to check on patient status. Pt reported she did not go to the emergency room, but went to "an urgent care" instead. Pt states she is in the waiting room about to be called back, and that she is beginning to feel better with symptoms beginning to improve.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness
Clinical narrative: Patient received Hep A vaccine and had no react. Then patient received MMR. After receiving vaccine, he began to feel dizzy. The pharmacist grabbed him a water and patient stated that the water made him feel better although he still felt dizzy. The pharmacist asked the patient if they would like us to call a parent. The patient suggested that they would like us to call the parents. The parents arrived and, in the meantime the pharmacist had a technician call 911. The fireman arrived and assessed the patient. The parents arrived and they walked the patient out to the ambulance. The patient left with mom and dad and NOT with the ambulance.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: On 5/7/24 significant pain to right arm injection site occurring at night, on 5/8/24 right arm injection site area red, swollen, itchy and painful. On 5/10/24, 5cm x 8cm dark red area on right arm around injection site, area warm to touch, tender and hard. Hives noted in red area, c/o itchiness and pain.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: On 5/7/24 significant pain to right arm injection site occurring at night, on 5/8/24 right arm injection site area red, swollen, itchy and painful. On 5/10/24, 5cm x 8cm dark red area on right arm around injection site, area warm to touch, tender and hard. Hives noted in red area, c/o itchiness and pain.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient's arm is red and swollen on most of the upper deltoid area leading down to the elbow. It is warm to touch. Patient did not take anything to help as she thought the swelling would go down eventually. Patient will follow up with her physician after taking Benadryl to help the swelling.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Blood albumin, Blood magnesium, Fall, Full blood count
Clinical narrative: Resident received COVID vaccine on 5/7/2024. The same day 5/7 at approximately 6:30 PM, resident had unwitnessed fall -- resident stated she slid from the edge of her bed. She also has some generalized weakness. No obvious signs of injury and no other side effects or adverse events noted.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Metabolic function test, Vitamin B12
Clinical narrative: Resident received COVID vaccine on 5/7/2024. The same day 5/7 at approximately 6:30 PM, resident had unwitnessed fall -- resident stated she slid from the edge of her bed. She also has some generalized weakness. No obvious signs of injury and no other side effects or adverse events noted.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I have tinnitus now, happened right after receiving Pfizer booster
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Patient has had redness with mild swelling just inferior the the injection site that started a couple days after the injection and continues to worsen. Also some headaches and nausea as well. Conservative treatment.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaemia, Aspiration bone marrow, Biopsy bone marrow, Chills, Feeding disorder
Clinical narrative: fever/chills/severe muscle body pain/heavy sweats/ headache/total muscle weakness/legs could barely hold me up/nausea could not eat/never recovered from muscle problems etc Full year to begin to recover. Never back to my normal to this day.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Hyperhidrosis, Infusion, Laboratory test abnormal, Muscular weakness
Clinical narrative: fever/chills/severe muscle body pain/heavy sweats/ headache/total muscle weakness/legs could barely hold me up/nausea could not eat/never recovered from muscle problems etc Full year to begin to recover. Never back to my normal to this day.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: fever/chills/severe muscle body pain/heavy sweats/ headache/total muscle weakness/legs could barely hold me up/nausea could not eat/never recovered from muscle problems etc Full year to begin to recover. Never back to my normal to this day.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Patient still having arm pain after 4 months, usually mild but does become severe
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Immediately post vaccination patient developed lump and swelling at injection site. The area is tender and red. After 20 minutes of observation the redness has decreased but swelling as remained.
Age: 1.0
Sex: M
Vaccine: DTPPVHBHPB, HEPA, MMR, PNC20, VARCEL
Symptoms: Bell's palsy, Facial paralysis
Clinical narrative: Pt had vaccines on Thursday afternoon, woke up in his home on Friday morning with a drooping face.  Mom called with concerns,  mom was told to bring him in immediately.  Dr saw him and diagnosed Bells Palsyna
Age: 50.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: given adolescent vaccine to an adult
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Abdominal discomfort, Arthralgia, Erythema, Headache, Myalgia
Clinical narrative: Localized swelling, redness and pain (started quarter sized and grew to egg sized before receding over 3 days). Also had low grade fever, headache, nausea, upset stomach, muscle and joint aches for 24-48hrs
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Nausea, Pain, Pyrexia, Swelling
Clinical narrative: Localized swelling, redness and pain (started quarter sized and grew to egg sized before receding over 3 days). Also had low grade fever, headache, nausea, upset stomach, muscle and joint aches for 24-48hrs
Age: 6.0
Sex: M
Vaccine: DTAP, DTAPHEPBIP, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given 2 Dtap on the same day. Notified the patient legal guard. no reaction noted at this time.
Age: 85.0
Sex: F
Vaccine: RSV
Symptoms: Injection site reaction, Neuralgia
Clinical narrative: She complained of nerve pain in the upper left arm for a couple of months now.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt was given vaccine 6 days past expiration date. No symptoms from pt.
Sex: F
Vaccine: HPV9
Symptoms: Chills, Diarrhoea, Fatigue, Myalgia, Pyrexia
Clinical narrative: Approximately 3 hours after the injection I experienced a fever of 102, chills, muscle aches, fatigue and diarrhea.; Approximately 3 hours after the injection I experienced a fever of 102, chills, muscle aches, fatigue and diarrhea.; Approximately 3 hours after the injection I experienced a fever of 102, chills, muscle aches, fatigue and diarrhea.; Approximately 3 hours after the injection I experienced a fever of 102, chills, muscle aches, fatigue and diarrhea.; Approximately 3 hours after the injection I experienced a fever of 102, chills, muscle aches, fatigue and diarrhea.; This spontaneous report was received from a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-APR-2024 (reported as yesterday), the patient received second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  Approximately 3 hours after the injection on 09-APR-2024, the patient experienced a fever of 102 (unit not reported), chills, muscle aches, fatigue and diarrhea. These symptoms had all resolved on 10-APR-2024 (as of this morning, less than 24 hours after injection). The patient did not experience any adverse events (AEs) with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No additional AE reported. The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding all events was not applicable.  The causal relationship between all events and diarrhea. and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; however the second dose administered on 6/5/2023 was considered "not supported."; Caller reporting temperature excursion. Initial dose that was administered to patient on 5/5/2023 was considered "supported,"; This spontaneous report was received from an office manager, referring to a patient of unknown gender and age. The patient's pertinent medical history, concurrent condition, concomitant therapies, drug reaction and allergies were not reported.  On 05-MAY-2023, the patient was vaccinated with the initial dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 ml, lot # W018824 has been verified to be a valid lot number, expiration date reported and validated as 14-JUN-2024, for prophylaxis (strength and route of administration were not provided), which was considered "supported", after undergoing a temperature excursion (product storage error). Temperature excursion as following: -14 degree Celsius (C) to -10 C for 168 hours and -10 C up to 8 C (-6 C) for 48 hours. On 05-JUN-2023, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 ml, lot # W018824 has been verified to be a valid lot number, expiration date reported and validated as 14-JUN-2024, for prophylaxis (strength and route of administration were not provided), which was considered "not supported", after undergoing a temperature excursion (product storage error). Temperature excursion as following: -10 C up to 8 C (-6 C) for 792 hours. There was no previous temperature excursion. No additional adverse event (AE) was reported (no adverse event).
Age: 28.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: HCP reporting delayed vaccination for GARDASIL 9.  First dose - 2/14/2023 and second dose 1/9/2024.  No adverse effects reported. No additional information provided.; HCP reporting delayed vaccination for GARDASIL 9.  First dose - 2/14/2023 and second dose 1/9/2024.  No adverse effects reported. No additional information provided.; This spontaneous report has been received from a nurse, referring to a 28 years old female patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 14-FEB-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, strength, lot number and expiration date were unknown) for prophylaxis. On 09-JAN-2024, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  (dose: 0.5 milliliter, lot # X014788 with expiration date: 07-MAR-2025, route and strength were unknown) for prophylaxis (inappropriate schedule of product administration). Operator Of Device was a health professional. No adverse effects reported. No additional information provided.   First dose lot# is being requested and will be submitted if received.
Sex: F
Vaccine: HEP, HEP
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: 18 year-old female patient non-immune to hep B in pregnancy; the medication error occurred at prescribing; no adverse event; On 3/8/2024 an 18 Year old patient was given an adult dose of 1.0MLs of RECOMBIVAX HB. HCP reports no signs or symptoms have been reported by the patient; This spontaneous report was received from registered nurse and refers to an 18-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions included  immunodeficiency. Concomitant therapies were not reported.  On 05-FEB-2024, the patient started therapy with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 0.5 milliliter, lot #X011082, expiration date: 01-OCT-2025, administered intramuscularly (strength, and indication were not provided). On 08-MAR-2024, the patient started therapy with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 1 milliliter, lot #X025237, expiration date: 17-MAY-2026, administered intramuscularly (strength, and indication were not provided)(Overdose). On 03-JAN-2024, Pregnancy test showed 179.095 (units not provided), and AB0/RH showed 0 positive. On 08-MAR-2024, MOADD showed negative. At the time of reporting, the patient was pregnant (Exposure during pregnancy). The medication error occured at prescription (Product prescribing error). No additional adverse events.  Due to illegible document not all laboratory tests were added and no full information from the document was added in narrative section and at tabs.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event, Product dose omission issue
Clinical narrative: No additional AE; a patient who missed their dose of GARDASIL 9. Patient received their first dose of GARDASIL 9 on 27MAR2023 and their second dose of GARDASIL 9 on 10JAN2024.; This spontaneous report was received from Consumer and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-MAR-2023, the patient was vaccinated with the first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided). On 10-JAN-2024, the patient was vaccinated with the second dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided). It was reported missed dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Inappropriate schedule of product administration).  No additional adverse event (AE) provided.  Lot numbers are being requested and will be submitted if available.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; HCP called for TE evaluation of VAQTA.; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 29-APR-2024, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection for prophylaxis (lot #x025342, expiration date: 12-MAY-2025; strength, dose and route of administration were not provided). The vaccine had TE evaluation; it was a not supported excursion (product storage error). The patient had no adverse event.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller reporting temperature excursion and a dose was administered.; No additional AE; This spontaneous report was received from medical assistant and referred to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient received a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #2014790, expiration date: 22-APR-2026, administered for prophylaxis (strength, dose and route of administration were not provided) after temperature excursion of 10.76 degrees Fahrenheit for 13 hours 50 minutes and 10.69 degrees Fahrenheit for 8 hours 21 minutes (Product storage error). There was no previous temperature excursion. No additional adverse event reported (No adverse event).
Age: 0.58
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No other AE and no PQC; HCP reporting a 7 month old patient was inadvertently administered the GARDASIL 9 Vaccine on 04/04/2024 instead of the Pneumonia vaccine at another facility; HCP reporting a 7 month old patient was inadvertently administered the GARDASIL 9 Vaccine on 04/04/2024 instead of the Pneumonia vaccine at another facility; This spontaneous report was received from a physician regarding to a 7-month-old patient of unspecified gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 04-APR-2024, the patient was inadvertently administered with human papilloma virus (HPV) rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (product administered to patient of inappropriate age), instead of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection or pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (reported as "the pneumonia vaccine") at another facility (wrong product administered) (strengths, dose, dose numbers, frequencies, routes of administration, anatomical injection sites, lot numbers and expiration dates were not provided) for prophylaxis.  Health care professional (HCP) was unable to provide further information, as this was administered by another HCP. Physician did confirm there was no misuse or missed dose to report for the pneumonia vaccine. No symptoms reported and no additional details provided. No other adverse event (AE) and no product quality complaint (PQC) (no adverse event).
Age: 35.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: No side effects reported; Consumer called to report an AE of behalf of his wife. Caller advised his wife had a appointment today at the OBGYN and she was supposed to get a vaccine for a tetanus shot, however she was administered GARDASIL 9 (HPV vaccine) instead. Once the HCP; vaccine administered intervenous in arm; Gardasil 9 administered during pregnancy; This spontaneous prospective pregnancy report was received from the patient's husband referring to a 35-year-old female patient. The patient's historical medications, medical history and concurrent conditions were not reported. Concomitant therapies included paracetamol (TYLENOL).      The patient became pregnant with last menstrual period (LMP) of 30-NOV-2023. On 06-MAY-2024, when the patient was 27 weeks of pregnancy, was vaccinated by accident with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intravenous for prophylaxis (exposure during pregnancy and incorrect route of product administration) instead of receiving tetanus vaccine toxoid(TETANUS-VACCIN) (wrong product administered). The patient's estimated date of delivery (EDD) would be 05-SEP-2024. The pregnancy outcome was unknown. No adverse event was reported.  Lot # is being requested and will be submitted if received.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; Physician assistant reported 12 month old patient was accidently administered a dose of ROTATEQ. The first dose of ROTATEQ was administered on June 26 2023, whenever patient was about two months old. The second dose was accidently administered today,; This spontaneous report was received from a physician assistant referring to a 12-month-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.     On 26-JUN-2023, when the patient was 2 months old, was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral (dose, lot number and expiration date not reported) and on 06-MAY-2024, the patient received by accident a second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral, lot number X023404, expiration date 18-MAY-2025 for prophylaxis (inappropriate schedule of product administration). No adverse event was reported.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Medical assistant called to report an excursion.; This spontaneous report was received from a medical assistant, referring to a patient of unknown gender and age. The patient's medical history, concurrent condition and concomitant therapies were not reported.  On 11-APR-2024, the patient was administered of measles, mumps, and rubella (Wistar Ra 27-3) virus vaccine, live (M-M-R II), recombinant human albumin (rHA) injection, lot # X020654 has been verified to be a valid lot number, expiration date reported and validated as 21-OCT-2024 for prophylaxis (strength, dose, frequency, and route of administration were not provided) and varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, lot # X006582 is an invalid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX), expiration date reported as 07-MAR-2025 after undergoing a temperature excursion (product storage error). Temperature excursion was as following: the vaccine was stored under 7.9 Fahrenheit (F)/6 F up to 14 F for 38 minutes. Previous temperature excursion included 6.3 F / 6 F to 14 F for 13 hours. No additional adverse event (AE)/ product quality concern (PQC) was reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2404USA007180:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Medical assistant called to report an excursion.; This spontaneous report was received from a medical assistant, referring to a patient of unknown gender and age. The patient's medical history, concurrent condition and concomitant therapies were not reported.  On 13-APR-2024, the patient was administered of measles, mumps, and rubella (Wistar Ra 27-3) virus vaccine, live (M-M-R II) injection, lot # K020654 is an invalid lot number for measles, mumps, and rubella (Wistar Ra 27-3) virus vaccine, live (M-M-R II), expiration date reported as 24-OCT-2024 for prophylaxis (strength, dose, frequency, and route of administration were not provided) and varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, lot # K006982 is an invalid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX), expiration date reported as 07-MAR-2025 after undergoing a temperature excursion (product storage error). Temperature excursion was as following: the vaccine was stored under 7.9 Fahrenheit (F)/6 F up to 14 F for 38 minutes. Previous temperature excursion included 6.3 F / 6 F to 14 F for 13 hours. No additional adverse event (AE)/ product quality concern (PQC) was reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2404USA007180:
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Head injury, Loss of consciousness, Syncope
Clinical narrative: loss consciousness; syncopal episode minutes after; he fell and hit his head; he fell and hit his head; This spontaneous report has been received from a patient's mother, referring to a 11-year-old male patient. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On 07-MAY-2024, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot# and expiry date were not reported), administered for prophylaxis.  On the same day, minutes after vaccination, he had a syncopal episode. He fell and hit his head and loss consciousness momentarily. The healthcare professional checked on him and kept him for observation for a few more minutes. He seemed fine after. He had not received any treatment for the events.  At the time of reporting, the patient had recovered from all the events.  Causality assessment was not provided.  Upon internal review, the events of syncope and loss of consciousness were determined to be medically significant.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: PNC15, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse called to report TE where products have been administered to patients. No Additional AE/PQC.        ?    Names of vaccines involved (including lot/exp) VAXELIS (PREFFILED SYRINGE):  u7767ba exp: 05/26/2026 VAXNEUVANCE: x019438 exp: 11/07/2025; No additional AE; This spontaneous report was received from Other Health Professional and refers to a currently 8 months patient of unknow gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with improperly store dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot # reported as x019438, expiration date reported as 07-NOV-2025; and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection (strength, and route of administration were not provided), lot # reported as u7767ba, expiration date reported as 26-MAY-2026; both were administered for prophylaxis. The doses were exposed to a temperature excursion of 9.85 Celsius degrees for 30 mins, no previous excursion. At the reporting time, the patient had not presented any adverse reaction.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; an outbreak again on my hairline on my forehead; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: an outbreak again on my hairline on my forehead). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt date: 03-MAY-2024 The patient self-reported. He/she received the two shots of shingrix 8 years ago and had an outbreak again on his/her hairline on my forehead. The reporter wanted to know should he/she get another two shots. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: M
Vaccine: RVX
Symptoms: Death
Clinical narrative: the vaccine and he died; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced unknown cause of death (Verbatim: the vaccine and he died) (serious criteria death and GSK medically significant). The reported cause of death was unknown.   It was unknown if the reporter considered the unknown cause of death to be related to RSV vaccine.     It was unknown if the company considered the unknown cause of death to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 08-MAY-2024 This case was reported by a patient's relative via interactive digital media. The patient was in the initial trial for the RSV vaccine and he died.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: it still hurts alot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included shingles (suffering from this illness).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: it still hurts alot). The outcome of the pain was not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 30-APR-2024 This case was reported by a patient via  interactive digital media. The patient asked that what was shingles as the patient was suffering from this illness. The patient had a vaccination and it still hurts a lot anyway and the doctor told him/her that he/she had to wait 6 months for the next vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: very painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 18-APR-2024, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: very painful). The outcome of the pain was resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 30-APR-2024 This case was reported by a patient via interactive digital media. They gave it to patient two years ago and on Thursday 18 they gave the vaccine. The patient reported that the reaction was very painful but it only lasts less than 24 hours and the patient felt well. Follow-up was not possible as no contact details were available.
Sex: F
Vaccine: RSV
Symptoms: Injection site nodule
Clinical narrative: nodule at the injection site; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site nodule in a 81-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site nodule (Verbatim: nodule at the injection site). The outcome of the injection site nodule was unknown.   It was unknown if the reporter considered the injection site nodule to be related to Arexvy.     It was unknown if the company considered the injection site nodule to be related to Arexvy.   Additional Information: GSK Receipt Date: 29-APR-2024 The health care professional reported that a patient developed a nodule at the injection site of Arexvy vaccine. The patient date of birth and initial were not available. The reporter consent to follow up.