chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Skin infection
Clinical narrative: Patient was seen by a physician and determined she likely caught a skin infection originating from her injection site, 12/13/23
Age: 74.0
Sex: M
Vaccine: MENB, MMR
Symptoms: Wrong patient
Clinical narrative: Incorrect patient r/t similar patient name and situation; doctor notified
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Peripheral swelling, Swelling
Clinical narrative: Pt noted swelling to R clavicle the even after administration. The next day, she noted swelling to the R posterior hand.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema
Clinical narrative: PATIENT REPORTED REDNESS AT INJECTION SITE AND THAT THE REDNESS WAS SPREADING TO UPPER ARM AREA. NO PAIN REPORTED CURRENTLY. PATIENT SAYS THE REDNESS AREA IS GETTING LARGER. TRIED TO CONTACT PATIENT TO SEE IMPROVEMENT OR WORSENING OF SYMTPS TODAY, BUT NO ANSWER. PATIENT WAS DIRECTED TO DISCUSS WITH PHYSICIAN FOR TREATMENT.
Age: 24.0
Sex: F
Vaccine: HEPAB, HPV9, MMR, TD, VARCEL
Symptoms: Erythema, Induration, Lip swelling, Pruritus, Rash
Clinical narrative: patient contacted Immunization clinic program assistant (who interpreted the phone call from patient) to RN. Patient states that on Friday, December 15, 2023 pt started experiencing potential reactions post vaccinations (vaccinations received yesterday around 1:35PM on Thursday December 14, 2023). Patient reports at around 10:00AM on Friday, December 15, 2023, pt  was experiencing a rash to her shoulders and arms, redness to the face, itching of the neck (Interpreting program assistant verified that patient did NOT have itching  or swelling in her throat), and patient had a swollen and hardened top upper lip. Program assistant verified with patient, on the phone, that the patient was NOT having any difficulty swallowing, breathing, or speaking. RN instructed pt to seek immediate medical attention, by going to the Emergency Room/Urgent Care Immediately, so that she may get help and potential treatment. Program assistant interpreted this strong recommendation and encouragement to the patient on the phone. Patient verbalized understanding to RN's recommendation to seek immediate medical attention.  At this time patient has not contacted clinic back to discuss outcomes or treatment.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Cardiac murmur, Inflammation, Infusion, Laboratory test normal
Clinical narrative: Adverse reaction was on the Moderna booster, 10/23/2022, now I have a heart murmur had a cardiac work up 1-2 years did not have murmur. Unexplained  moderate/ severe inflammation around ankles/calves, diagnosed with anemia, all previous labs negative for anemia, glocoma, muscle loss, memory loss
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Adverse reaction was on the Moderna booster, 10/23/2022, now I have a heart murmur had a cardiac work up 1-2 years did not have murmur. Unexplained  moderate/ severe inflammation around ankles/calves, diagnosed with anemia, all previous labs negative for anemia, glocoma, muscle loss, memory loss
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 54.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age, Product prescribing error
Clinical narrative: Vaccine administration error - accidentally prescribed and administered Arexvy vaccine for patient under at 60
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site paraesthesia
Clinical narrative: Patient is experiencing pain/tingling around the sight of injection and has been for the last 17 days. Her dr has put her on gabapentin to see if it helps. She has yet to start that medication
Age: 58.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Arexvy vaccine accidentally ordered and administer early (prior to age 60)
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt given Fluzone HD QID instead of Fluzone QID PF. At follow up (~6 hours later) patient did not report any side effects.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort
Clinical narrative: Discomfort to Right upper extremity .  Discomfort progressing over 8 day span.  Saw PCP in office on day 8 after injection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash on the injection site.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received Fluzone in October 2023 and then requested it again on 12/15/23 and it was administered. No complication or adverse effects.
Age: 1.92
Sex: M
Vaccine: HEPA
Symptoms: Condition aggravated, Cough, Eczema, Hypersensitivity, Inflammation
Clinical narrative: Going by the notes from the time of injection. Unknown manufacture or injection site. Constant coughing and unknown inflammation caused eczma outbreak, coughing and increased allergies.
Age: 1.92
Sex: M
Vaccine: HEPA
Symptoms: Laboratory test
Clinical narrative: Going by the notes from the time of injection. Unknown manufacture or injection site. Constant coughing and unknown inflammation caused eczma outbreak, coughing and increased allergies.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Malaise, Pyrexia
Clinical narrative: I was contacted by the Community Health Worker at the facility that patient was experiencing fever, malaise, tiredness, and decreased appetite.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Breath holding, Nervousness, Presyncope
Clinical narrative: Patient had a vasovagal reaction dur to being nervous and held breath.
Age: 83.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Blood creatinine normal, Blood thyroid stimulating hormone normal, C-reactive protein normal, Full blood count normal
Clinical narrative: I'v got a question about the RSV shot that I got at your office around 6 weeks ago.  The shot was very painful when given. My arm was very sore for two days. The soreness then moved from my right shoulder to my left shoulder. I have been having pain in my body ever since then.  The pain has moved from my shoulders down to my hands.  Asper cream seems to help but the pain keeps coming back.  I went to the Doctor and she checked me out even had blood test done, but could find nothing wrong.  The pain is not as bad now, but still there. Have been taking Tylenol. Have you had any problems from other patients taking that shot? The pain also is in my backside and the back of my legs. Hopeful for your help..
Age: 83.0
Sex: M
Vaccine: RSV
Symptoms: Immediate post-injection reaction, Injection site pain, Liver function test normal, Metabolic function test normal, Pain
Clinical narrative: I'v got a question about the RSV shot that I got at your office around 6 weeks ago.  The shot was very painful when given. My arm was very sore for two days. The soreness then moved from my right shoulder to my left shoulder. I have been having pain in my body ever since then.  The pain has moved from my shoulders down to my hands.  Asper cream seems to help but the pain keeps coming back.  I went to the Doctor and she checked me out even had blood test done, but could find nothing wrong.  The pain is not as bad now, but still there. Have been taking Tylenol. Have you had any problems from other patients taking that shot? The pain also is in my backside and the back of my legs. Hopeful for your help..
Age: 83.0
Sex: M
Vaccine: RSV
Symptoms: Pain in extremity, Red blood cell sedimentation rate normal
Clinical narrative: I'v got a question about the RSV shot that I got at your office around 6 weeks ago.  The shot was very painful when given. My arm was very sore for two days. The soreness then moved from my right shoulder to my left shoulder. I have been having pain in my body ever since then.  The pain has moved from my shoulders down to my hands.  Asper cream seems to help but the pain keeps coming back.  I went to the Doctor and she checked me out even had blood test done, but could find nothing wrong.  The pain is not as bad now, but still there. Have been taking Tylenol. Have you had any problems from other patients taking that shot? The pain also is in my backside and the back of my legs. Hopeful for your help..
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Malaise, Pyrexia
Clinical narrative: I received a report from the Community Health Worker that patient was experiencing fever, malaise, tiredness and decreased appetite after receiving the vaccines.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Condition aggravated, Dizziness, Laboratory test, Syncope
Clinical narrative: Patient received the vaccine around 11 am in the morning. At 3am the following day, the patient had gotten up to go the bathroom and felt dizzy and that her afib had kicked in. As she was walking to her bed, she collapsed and was then transported to ER / Hospital for observation.
Age: 58.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event noted; required to complete per guidance by medical director
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5, UNK
Symptoms: Extra dose administered
Clinical narrative: Patient received Beyfortus 0.5 mL on 11/1/2023. He was accidentally given an additional dose of Beyfortus (1.0 mL) on 12/15/2023.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Eye movement disorder, Nystagmus
Clinical narrative: Developed nystagmus, shaking of the eyes just after we ll visit with vaccines. Still occurring no treatment available
Age: 65.0
Sex: F
Vaccine: COVID19, PPV, TDAP
Symptoms: Ageusia, Anosmia, Headache, Pyrexia, Unresponsive to stimuli
Clinical narrative: CLIENT STATED SHE HAD TO RECIEVE EMERGENCY SERVICES AFTER BEING UNRESPONSIVE ON 11/06/23.  FEVER, LOST OF SMELL AND TASTE FOR OVER 25 DAYS ALSO A HEADACHE
Age: 9.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever, sore arm
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Brain fog, Diarrhoea, Dizziness
Clinical narrative: Accelerated heart rate, dizziness, brain fog, diarrhea, anxiety beginning 10/06/21.  Still experiencing these symptoms in intervals except anxiety.  Severe head pain from neck-up the back-to forehead beginning late November 2021.   Appearance of psoriasis lesions March 2022 along with numbness in legs, severe radiating pain in right side of torso, right shoulder and right arm, arthritis pain in fingers and knees.  Long term prognosis to be determined.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: Accelerated heart rate, dizziness, brain fog, diarrhea, anxiety beginning 10/06/21.  Still experiencing these symptoms in intervals except anxiety.  Severe head pain from neck-up the back-to forehead beginning late November 2021.   Appearance of psoriasis lesions March 2022 along with numbness in legs, severe radiating pain in right side of torso, right shoulder and right arm, arthritis pain in fingers and knees.  Long term prognosis to be determined.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Accelerated heart rate, dizziness, brain fog, diarrhea, anxiety beginning 10/06/21.  Still experiencing these symptoms in intervals except anxiety.  Severe head pain from neck-up the back-to forehead beginning late November 2021.   Appearance of psoriasis lesions March 2022 along with numbness in legs, severe radiating pain in right side of torso, right shoulder and right arm, arthritis pain in fingers and knees.  Long term prognosis to be determined.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGEREATED
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Adenovirus test, Alanine aminotransferase increased, Ascites, Aspartate aminotransferase increased
Clinical narrative: Pt presents to ER on 11/24/23 with fatigue, jaundice, N/V, found to have acute hepatitis of unclear etiology.   Patient reports that starting 1 day before Halloween, she noted decreased energy associated with nausea and metallic taste in her mouth.  In the days after she noted mild jaundice starting on her chest and worsening acholic stools with mild abdominal pain associated with cough.  She subsequently noted progressively worsening jaundice diffusely as well as constipation, sore throat, and decreased appetite.    She went to urgent care and took a course of amoxicillin from 11/5 to 11/12, and a small amount of acetaminophen in this period (total of 10 to 12 pills over 2 weeks) She reports minimal alcohol use, last 3 weeks prior.   Regarding sick contacts, she had traveled mid October, whereby 1 friend was vaguely sick however quickly recovered, no symptoms of note that she recalls, no questionable ingestions of raw food, no foreign travel.    Due to the above progressive symptoms, she presented for evaluation.  started on NAC, given vitamin K x 3 days, and diagnostic workup notable for HVPG 15 and liver biopsy with suggestive but not classic findings of AIH, started on steroids 11/28, also bactrim started.    1.5 liter (L) therapeutic paracentesis performed, no SBP, low prot ascites identified.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Biopsy liver abnormal, Blood alkaline phosphatase increased, Blood bilirubin increased, Cholecystectomy
Clinical narrative: Pt presents to ER on 11/24/23 with fatigue, jaundice, N/V, found to have acute hepatitis of unclear etiology.   Patient reports that starting 1 day before Halloween, she noted decreased energy associated with nausea and metallic taste in her mouth.  In the days after she noted mild jaundice starting on her chest and worsening acholic stools with mild abdominal pain associated with cough.  She subsequently noted progressively worsening jaundice diffusely as well as constipation, sore throat, and decreased appetite.    She went to urgent care and took a course of amoxicillin from 11/5 to 11/12, and a small amount of acetaminophen in this period (total of 10 to 12 pills over 2 weeks) She reports minimal alcohol use, last 3 weeks prior.   Regarding sick contacts, she had traveled mid October, whereby 1 friend was vaguely sick however quickly recovered, no symptoms of note that she recalls, no questionable ingestions of raw food, no foreign travel.    Due to the above progressive symptoms, she presented for evaluation.  started on NAC, given vitamin K x 3 days, and diagnostic workup notable for HVPG 15 and liver biopsy with suggestive but not classic findings of AIH, started on steroids 11/28, also bactrim started.    1.5 liter (L) therapeutic paracentesis performed, no SBP, low prot ascites identified.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cholecystitis, Constipation, Cough, Cytomegalovirus test negative, Decreased appetite
Clinical narrative: Pt presents to ER on 11/24/23 with fatigue, jaundice, N/V, found to have acute hepatitis of unclear etiology.   Patient reports that starting 1 day before Halloween, she noted decreased energy associated with nausea and metallic taste in her mouth.  In the days after she noted mild jaundice starting on her chest and worsening acholic stools with mild abdominal pain associated with cough.  She subsequently noted progressively worsening jaundice diffusely as well as constipation, sore throat, and decreased appetite.    She went to urgent care and took a course of amoxicillin from 11/5 to 11/12, and a small amount of acetaminophen in this period (total of 10 to 12 pills over 2 weeks) She reports minimal alcohol use, last 3 weeks prior.   Regarding sick contacts, she had traveled mid October, whereby 1 friend was vaguely sick however quickly recovered, no symptoms of note that she recalls, no questionable ingestions of raw food, no foreign travel.    Due to the above progressive symptoms, she presented for evaluation.  started on NAC, given vitamin K x 3 days, and diagnostic workup notable for HVPG 15 and liver biopsy with suggestive but not classic findings of AIH, started on steroids 11/28, also bactrim started.    1.5 liter (L) therapeutic paracentesis performed, no SBP, low prot ascites identified.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Epstein-Barr virus test negative, Exposure to communicable disease, Faeces pale, Fatigue
Clinical narrative: Pt presents to ER on 11/24/23 with fatigue, jaundice, N/V, found to have acute hepatitis of unclear etiology.   Patient reports that starting 1 day before Halloween, she noted decreased energy associated with nausea and metallic taste in her mouth.  In the days after she noted mild jaundice starting on her chest and worsening acholic stools with mild abdominal pain associated with cough.  She subsequently noted progressively worsening jaundice diffusely as well as constipation, sore throat, and decreased appetite.    She went to urgent care and took a course of amoxicillin from 11/5 to 11/12, and a small amount of acetaminophen in this period (total of 10 to 12 pills over 2 weeks) She reports minimal alcohol use, last 3 weeks prior.   Regarding sick contacts, she had traveled mid October, whereby 1 friend was vaguely sick however quickly recovered, no symptoms of note that she recalls, no questionable ingestions of raw food, no foreign travel.    Due to the above progressive symptoms, she presented for evaluation.  started on NAC, given vitamin K x 3 days, and diagnostic workup notable for HVPG 15 and liver biopsy with suggestive but not classic findings of AIH, started on steroids 11/28, also bactrim started.    1.5 liter (L) therapeutic paracentesis performed, no SBP, low prot ascites identified.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatectomy, Hepatic necrosis, Hepatic venous pressure gradient, Hepatitis, Herpes simplex test negative
Clinical narrative: Pt presents to ER on 11/24/23 with fatigue, jaundice, N/V, found to have acute hepatitis of unclear etiology.   Patient reports that starting 1 day before Halloween, she noted decreased energy associated with nausea and metallic taste in her mouth.  In the days after she noted mild jaundice starting on her chest and worsening acholic stools with mild abdominal pain associated with cough.  She subsequently noted progressively worsening jaundice diffusely as well as constipation, sore throat, and decreased appetite.    She went to urgent care and took a course of amoxicillin from 11/5 to 11/12, and a small amount of acetaminophen in this period (total of 10 to 12 pills over 2 weeks) She reports minimal alcohol use, last 3 weeks prior.   Regarding sick contacts, she had traveled mid October, whereby 1 friend was vaguely sick however quickly recovered, no symptoms of note that she recalls, no questionable ingestions of raw food, no foreign travel.    Due to the above progressive symptoms, she presented for evaluation.  started on NAC, given vitamin K x 3 days, and diagnostic workup notable for HVPG 15 and liver biopsy with suggestive but not classic findings of AIH, started on steroids 11/28, also bactrim started.    1.5 liter (L) therapeutic paracentesis performed, no SBP, low prot ascites identified.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Jaundice, Nausea, Oropharyngeal pain, Paracentesis
Clinical narrative: Pt presents to ER on 11/24/23 with fatigue, jaundice, N/V, found to have acute hepatitis of unclear etiology.   Patient reports that starting 1 day before Halloween, she noted decreased energy associated with nausea and metallic taste in her mouth.  In the days after she noted mild jaundice starting on her chest and worsening acholic stools with mild abdominal pain associated with cough.  She subsequently noted progressively worsening jaundice diffusely as well as constipation, sore throat, and decreased appetite.    She went to urgent care and took a course of amoxicillin from 11/5 to 11/12, and a small amount of acetaminophen in this period (total of 10 to 12 pills over 2 weeks) She reports minimal alcohol use, last 3 weeks prior.   Regarding sick contacts, she had traveled mid October, whereby 1 friend was vaguely sick however quickly recovered, no symptoms of note that she recalls, no questionable ingestions of raw food, no foreign travel.    Due to the above progressive symptoms, she presented for evaluation.  started on NAC, given vitamin K x 3 days, and diagnostic workup notable for HVPG 15 and liver biopsy with suggestive but not classic findings of AIH, started on steroids 11/28, also bactrim started.    1.5 liter (L) therapeutic paracentesis performed, no SBP, low prot ascites identified.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pathology test, Vomiting
Clinical narrative: Pt presents to ER on 11/24/23 with fatigue, jaundice, N/V, found to have acute hepatitis of unclear etiology.   Patient reports that starting 1 day before Halloween, she noted decreased energy associated with nausea and metallic taste in her mouth.  In the days after she noted mild jaundice starting on her chest and worsening acholic stools with mild abdominal pain associated with cough.  She subsequently noted progressively worsening jaundice diffusely as well as constipation, sore throat, and decreased appetite.    She went to urgent care and took a course of amoxicillin from 11/5 to 11/12, and a small amount of acetaminophen in this period (total of 10 to 12 pills over 2 weeks) She reports minimal alcohol use, last 3 weeks prior.   Regarding sick contacts, she had traveled mid October, whereby 1 friend was vaguely sick however quickly recovered, no symptoms of note that she recalls, no questionable ingestions of raw food, no foreign travel.    Due to the above progressive symptoms, she presented for evaluation.  started on NAC, given vitamin K x 3 days, and diagnostic workup notable for HVPG 15 and liver biopsy with suggestive but not classic findings of AIH, started on steroids 11/28, also bactrim started.    1.5 liter (L) therapeutic paracentesis performed, no SBP, low prot ascites identified.
Age: 15.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood glucose normal, Face injury, Fall, Lip haemorrhage, Lip injury
Clinical narrative: Occurred right after appt this evening when walking out of exam room. Mother reports he was walking down hallway with MA on one side and mother on the other side when he suddenly fell down with face hitting the door to utility room, grazing his bottom outer lip. Patient was supervised immediately by one MD, two NPs, and one MA. He was taken into a room to lay down, feet elevated. VS stable. Glucose finger stick 110. Incident report created and risk management notified immediately. Outer lip cleaned, direct pressure placed, bleeding controlled. Patient was able to recover from symptoms 30 min later after rest and was accompanied outside to car by medical provider. Patient advised to come back next day for further evaluation and since this is the second incident for syncope.
Age: 15.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Occurred right after appt this evening when walking out of exam room. Mother reports he was walking down hallway with MA on one side and mother on the other side when he suddenly fell down with face hitting the door to utility room, grazing his bottom outer lip. Patient was supervised immediately by one MD, two NPs, and one MA. He was taken into a room to lay down, feet elevated. VS stable. Glucose finger stick 110. Incident report created and risk management notified immediately. Outer lip cleaned, direct pressure placed, bleeding controlled. Patient was able to recover from symptoms 30 min later after rest and was accompanied outside to car by medical provider. Patient advised to come back next day for further evaluation and since this is the second incident for syncope.
Age: 0.42
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Resident ordered flu vaccine one month too early for 5 month old mistaking the appointment type as the 6mo well child follow up instead of the actual appointment type of failure to thrive. Flulaval administered at 5mo instead of 6mo. Patient will be receiving a restart of the series and has already had a correction dose on 12/12/23. No adverse effects noted.
Age: 27.0
Sex: M
Vaccine: HEPA
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out briefly while sitting in the waiting room after getting the vaccine. Patient was promptly given attention and came to pretty quick. Patient was advised to elevate legs on another chair and sit for a while for observation. Patient was given water and supervised patient while he was sitting in the waiting room. After 45 minutes of observation, patient was all back to normal, he felt good, breathing good, not dizzy. Advised patient to definitely call his doctor and let them know what happened. Patient was with his mom, so they both said he was ok to go after 45 minutes of observation.  Advised patients mother to observe him the rest of the day and call 911 if any emergencies.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU4, VARCEL
Symptoms: Culture throat, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient received Varicella in right arm, DTaP and FLU in left arm near each other. Mom reports patient developed fever and redness around injection sites within 24 hours. She treated fever with Tylenol, patient came in for exam - local red/swelling reaction is evident at injection sites. Due to prior visit with abnormal throat findings, swabbed for strep culture to rule out cause of fever. Mom instructed to keep treating if fever persists and to come in if fever persists. Will converse with parents over next week on status of patient and reactions.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Haematochezia, Mucous stools, Occult blood positive
Clinical narrative: Patient noted to have blood and mucus in stool (with positive hemoccult). Spontaneous resolution
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives, in one area, similar to location. Many people have shingles rash. Right side, mid back
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pruritus, Injection site rash, Pruritus, Rash
Clinical narrative: Itching and rash in arm at injection site. Some itching and rash on rest of body. Left shoulder and back itching and rash went away . Started on 12/8/23 and it has been getting worse for the past few days.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Injection site reaction, Peripheral swelling, Pruritus, Rash
Clinical narrative: Itching and rash in arm at injection site. Some itching and rash on rest of body. Left shoulder and back itching and rash went away . Started on 12/8/23 and it has been getting worse for the past few days.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Scab, Skin exfoliation
Clinical narrative: Itching and rash in arm at injection site. Some itching and rash on rest of body. Left shoulder and back itching and rash went away . Started on 12/8/23 and it has been getting worse for the past few days.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Haemorrhage, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: Itching and rash in arm at injection site. Some itching and rash on rest of body. Left shoulder and back itching and rash went away . Started on 12/8/23 and it has been getting worse for the past few days.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Psoriasis, Skin exfoliation, Skin fragility
Clinical narrative: Itching and rash in arm at injection site. Some itching and rash on rest of body. Left shoulder and back itching and rash went away . Started on 12/8/23 and it has been getting worse for the past few days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: on day 2 following the vaccination, she has redness and swelling about 1 inch around the injection site.  Pharmacist recommended cool compressed and benadryl as needed. Recommended if situation worsens, to seek medical attention.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: 2cmx4cm discoloration/bruise lasted 3 weeks
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was to receive RSV vaccine, but Shingrix vaccine was administered. No ADRs were reported or observed.
Age: 61.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Hypersensitivity, Pharyngeal swelling, Urticaria
Clinical narrative: 12/12/23 2:25PM: Fluzone Quad and Comirnaty administered 12/13/23 8:30PM: Hives, throat swelling 12/13/23 9:00PM: Went to emergency department - BP was 189/118 and fever of 99.6 degrees. Patient was treated via IV for severe allergic reaction. ED staff were unsure it was connected to vaccinations given the 24+ hour delay between administration and reaction.  12/13/23 11PM: Discharged from ED
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Mouth swelling, Stomatitis
Clinical narrative: RN trying to help peer administered vaccine as she noted patient had flag for allergy to pork.  Pt was asymptomatic until a little after 1 hour of observation when she complained of some mouth irritation. PA noted slight swelling on buccal surface of R side of mouth . VSS through out. Prescribed home with certirizine  to take at home. and ER precautions regarding GI upset and further exacerbation of symptoms given.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse called and reported that a dose of VARIVAX was administered to a patient after a temperature excursion. Caller stated the dose was administered on 10/2/2023 and the product had 1 temperature excursion prior being administered. Caller stated pat; This spontaneous report was received from a nurse and referred to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported.  The varicella virus vaccine live (oka/merck) (VARIVAX) had a temperature excursion under 10 degree Fahrenheit for 1 hour 15 minutes. On 02-OCT-2023, the patient was vaccinated with the improper stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #W031810 was verified as a valid lot number , expiration date was reported as 15-OCT-2024 but upon internal validation established as 05-OCT-2024, administered for prophylaxis (strength, anatomical site of administration and route of administration were not provided) (product storage error). The patient had not reported any symptoms or additional adverse events (no adverse event). It was reported that there was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2311USA006506: US-009507513-2311USA006232: US-009507513-2311USA006797:
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product quality issue, Product storage error
Clinical narrative: No side effects or issues were reported with the administration of the MMR II to the patient.  Please ref; A HCP called to report a TE for MMR II that resulted in an outcome that was not supported and was also administered to a patient on 12/11/2023.; This spontaneous report has been received from a nurse referring a 1-year-old patient of unknown gender. The patient's concurrent conditions and medical history. Concomitant medications included sterile diluent.    On 11-DEC-2023, the patient was vaccinated with an improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), subcutaneous Injection, at a dose of 0.5 milliliter (mL), once, lot number W007180 with expiration date: 01-MAR-2024 that has been verified to be valid, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided) (product storage error).   On an unknown date, the vaccine had a temperature excursion of 65.3 F, for a time range between of 10 hours 29 minutes 0 seconds. No additional adverse events or product quality complaint were reported. No previous temperature excursion reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product quality issue, Product storage error
Clinical narrative: No additional AEs were reported; The healthcare worker is reporting that a patient received improperly stored vaccine.; This spontaneous report has been received from Other Health Professional referring a patient of unknown age and gender. The patient's concurrent conditions and medical history. Concomitant medications included sterile diluent.    On 20-NOV-2023, the patient was vaccinated with 1 improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), Injection, lot number w017551 with expiration date: 01-JUN-2024 that has been verified to be valid, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided) (product storage error).   On an unknown date, the vaccine had a temperature excursion of 17.6 F, for a time range between of 11 hours 59 minutes. No additional adverse events or product quality complaint were reported. No previous temperature excursion reported.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Underdose
Clinical narrative: There were no adverse side effects; A physician called to report that a dose of MMR II administered to a 12 month old patient today (12/12/2023) was incomplete.  The caller stated that the patient was moving around and the child did not receive the full dose as recommended.  The caller; This spontaneous report was received from a physician and refers to a 12-month-old patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 12-DEC-2023 the patient was vaccinated with incomplete dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (exact dose, dose number, route and site of administration, lot number and expiration date were not provided).  Other suspect therapies included sterile diluent (STERILE DILUENT) (accidental underdose and no adverse event).
Sex: U
Vaccine: FLUN4
Symptoms: Death
Clinical narrative: COMMENT SEEN ON SOCIAL MEDIA POST NOTING DEATH OF CHILD FROM THE FLU AFTER RECEIVING FLUMIST TO BE PROTECTED; A spontaneous report has been received from a consumer concerning a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    On an unknown date, the patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number Unknown) once/single administration, via nasal route.    An unknown administered FLUMIST QUADRIVALENT.    On an unknown date, a comment was seen on social media post noting death of child from the flu after receiving flumist to be protected (Preferred term: Influenza).    Action taken with Flumist Quadrivalent was not applicable.    It was not known whether an autopsy was performed and the cause of death was unknown.    The reporter assessed the event of comment seen on social media post noting death of child from the flu after receiving flumist to be protected as serious due to fatal outcome.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Minor correction on 14-Dec-2023: Null flavors for event added for event onset date and All Reporters. Reporter Name (Vaccination Facility) in association with the Primary Suspect product on the Product and Dosing Tab selected as unknown.; Sender's Comments: Fatal event of influenza is not listed in the company core data sheet of Q/LAIV. Due to limited information on date of administration and indication of Q/LAIV, onset date of the event, patient's demographics, relevant medical history, circumstances surrounding the event, clinical course and treatment details, aetiological and diagnostic workup (complete blood panel, infectious work-up, imaging studies), concurrent diseases, concomitant medications, risk factors, the evaluation did not find evidence to suggest a causal relationship between the fatal event and Q/LAIV.; Reported Cause(s) of Death: COMMENT SEEN ON SOCIAL MEDIA POST NOTING DEATH OF CHILD FROM THE FLU AFTER RECEIVING FLUMIST TO BE PROTECTED
Sex: F
Vaccine: RSV
Symptoms: Atrial fibrillation, Condition aggravated, Heart rate increased, Heart rate irregular
Clinical narrative: Fast irregular heart rate; Fast irregular heart rate; Atrial fibrilation; This serious case was reported by a consumer and described the occurrence of atrial fibrillation in a 73-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3H477) for prophylaxis.   The patient's past medical history included atrial fibrillation (last episode was in early 2023). Concurrent medical conditions included hypertension. Concomitant products included diltiazem and losartan.   On 30-NOV-2023, the patient received Arexvy .5 ml. On 08-DEC-2023, 8 days after receiving Arexvy, the patient experienced atrial fibrillation (Verbatim: Atrial fibrilation) (serious criteria GSK medically significant). On an unknown date, the patient experienced heart rate increased (Verbatim: Fast irregular heart rate) and heart rate irregular (Verbatim: Fast irregular heart rate). The patient was treated with warfarin and flecainide acetate (Flecainide). The outcome of the atrial fibrillation was resolving and the outcome of the heart rate increased and heart rate irregular were resolved.   It was unknown if the reporter considered the atrial fibrillation, heart rate increased and heart rate irregular to be related to Arexvy.  It was unknown if the company considered the atrial fibrillation, heart rate increased and heart rate irregular to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-DEC-2023 This report was submitted via the online direct entry reporting system. The patient had Flecainide 50 mg tablet on hand in case of occurrence so the patient took 1 tablet after 2 hours of monitoring symptoms. The patient experienced fast irregular heart rate. It resolved by bedtime.
Sex: F
Vaccine: RVX
Symptoms: Middle ear effusion, Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected vaccination failure; fluid behind her ear drums; RSV infection; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: RSV infection) and fluid in middle ear (Verbatim: fluid behind her ear drums). The outcome of the vaccination failure was unknown and the outcome of the respiratory syncytial virus infection was resolved (duration 2 weeks) and the outcome of the fluid in middle ear was not resolved.   The reporter considered the vaccination failure, respiratory syncytial virus infection and fluid in middle ear to be possibly related to RSV vaccine.     The company considered the vaccination failure, respiratory syncytial virus infection and fluid in middle ear to be possibly related to RSV vaccine.   Additional Information: GSK Receipt Date-04-DEC-2023 This case was reported by a patient via interactive digital media. The reporter reported that the patient had a reaction to the RSV vaccine and said it was like she had RSV for two weeks. The patient still had a fluid behind her ear drums. The patient was given nose spray. The follow-up could not be possible as no contact details were available. The reporter thought that the event might had been related to product/device. This case was considered as suspected vaccination failure since occurrence of RSV LRTD, but no laboratory testing was reported.
Sex: U
Vaccine: FLU3, RSV
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: multiple years of afib; This serious case was reported by a consumer via regulatory authority and described the occurrence of atrial fibrillation in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Influenza vaccine inact split 3v (Fluzone high dose) for prophylaxis.   The patient's past medical history included artificial cardiac pacemaker user. Concomitant products included lansoprazole, famotidine, montelukast sodium (Montelukast), simvastatin and amlodipine.   On an unknown date, the patient received Arexvy and Fluzone high dose. On an unknown date, an unknown time after receiving Arexvy, the patient experienced atrial fibrillation (Verbatim: multiple years of afib) (serious criteria GSK medically significant). The patient was treated with amiodarone. The outcome of the atrial fibrillation was not reported.   It was unknown if the reporter considered the atrial fibrillation to be related to Arexvy.     It was unknown if the company considered the atrial fibrillation to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-Nov-2023 Patient reported that after multiple years of afib controlled on a pacemaker, patient had an event following reception of Arexvy and Fluzone HD vaccine on same date and was informed that pacemaker intervention was no longer viable and initiated on amiodarone.  It was unknown if the reporter considered the atrial fibrillation to be related to Fluzone high dose.  Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: RSV
Symptoms: Arthralgia
Clinical narrative: Aching joints; This non-serious case was reported by a consumer via sales rep and described the occurrence of joint pain in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 24-OCT-2023, the patient received the 1st dose of Arexvy (unknown arm). On 24-OCT-2023, less than a day after receiving Arexvy, the patient experienced joint pain (Verbatim: Aching joints). On 25-OCT-2023, the outcome of the joint pain was resolved (duration 1 day).   It was unknown if the reporter considered the joint pain to be related to Arexvy.     It was unknown if the company considered the joint pain to be related to Arexvy.   Additional Information: GSK receipt date: 06-DEC-2023 The report was submitted in language by GlaxoSmithKline employee via the online direct entry reporting system. The other non-healthcare professional was family member. The reporter did not consent to contact.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: possible only liquid component administered; possible only liquid component administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 06-NOV-2023, the patient received Menveo. On 06-NOV-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: possible only liquid component administered) and inappropriate dose of vaccine administered (Verbatim: possible only liquid component administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: RA Receipt Date: 07-DEC-2023 The nurse reported that patient received the liquid only component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. It was not known if the patient received only diluent. The reporter consented to follow up via email. This case was linked with US2023AMR172682 and US2023AMR172681, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR172682:Original Case : US2023171742 US-GSK-US2023AMR172681:Original Case : US2023171742
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: did not dilute the vaccine used the diluent like it was the vaccine; She used the diluent like it was the vaccine.; This non-serious case was reported by a nurse via patient support programs and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: did not dilute the vaccine used the diluent like it was the vaccine) and inappropriate dose of vaccine administered (Verbatim: She used the diluent like it was the vaccine.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: RA Receipt Date: 07-DEC-2023 The reporter reported that medication error involving three patients but no side effects. She advised that the medical assistant did not dilute the vaccine. The reporter reported that she used the diluent like it was the vaccine. The reporter did not know which of three patients only received the diluent which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter asked when the patients could be revaccinated. They attempted to transfer her to the Medical information line but she disconnected. The reporter denied to follow-up.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Arthritis
Clinical narrative: I am having joint pain; I have arthritis; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a 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 joint pain (Verbatim: I am having joint pain) and arthritis (Verbatim: I have arthritis). The outcome of the joint pain was not resolved and the outcome of the arthritis was not reported.   It was unknown if the reporter considered the joint pain and arthritis to be related to Arexvy.     It was unknown if the company considered the joint pain and arthritis to be related to Arexvy.   Additional Information: GSK receipt date: 04-DEC-2023 The case was received from the patient via interactive digital media. The patient was having joint pain and had arthritis. The patient felt that the vaccine triggered.