chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Live birth
Clinical narrative: IATROGENIC HYPOTENSION 11/29/2022 MATERNAL DELIVERY OUTCOME, SINGLETON BIRTH, LIVEBORN
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Caesarean section, Delivery, High risk pregnancy, Ileus, Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA 4/2023 SUPERVISION HIGH RISK PREGNANCY, HX OF CESAREAN SECTION, SECOND TRIMESTER ADULT OBSTRUCTIVE SLEEP APNEA 4/2023 CESAREAN DELIVERY ADULT OBSTRUCTIVE SLEEP APNEA 4/2023 PREECLAMPSIA, UNSPECIFIED, IN CHILDBIRTH ADULT OBSTRUCTIVE SLEEP APNEA 4/27/2023 ILEUS ADULT OBSTRUCTIVE SLEEP APNEA 4/27/2023 SMALL BOWEL OBSTRUCTION
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pre-eclampsia, Small intestinal obstruction
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA 4/2023 SUPERVISION HIGH RISK PREGNANCY, HX OF CESAREAN SECTION, SECOND TRIMESTER ADULT OBSTRUCTIVE SLEEP APNEA 4/2023 CESAREAN DELIVERY ADULT OBSTRUCTIVE SLEEP APNEA 4/2023 PREECLAMPSIA, UNSPECIFIED, IN CHILDBIRTH ADULT OBSTRUCTIVE SLEEP APNEA 4/27/2023 ILEUS ADULT OBSTRUCTIVE SLEEP APNEA 4/27/2023 SMALL BOWEL OBSTRUCTION
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphthous ulcer, Lip ulceration, Mouth ulceration, Tonsillar ulcer
Clinical narrative: Onset of many apthous ulcer in bilateral buccal mucosa and inside of top and bottom lip, and 1 lesion on base of right tonsil
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Skin warm
Clinical narrative: pt stated arm feels hot to the touch and red, has been this way for about a week
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patients are was slightly warm to touch with minimal swelling and redness.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Pt given vaccine in the morning on 8/22  to her left arm and waited in the store for >15min following vaccine and returned to pharmacy to make purchase and report that she felt "fine".  On 8/24 at 10:30a she return to the pharmacy to report that she had a bad muscle pain in her the arm of the injection and muscle ache across her trunk/torso the following morning and took ibuprofen 200mg twice that day. She also presented her left  arm to show and rash across the upper arm that was ~1-2 inch  below the injection; she said it was a little itchy the previous day, sore, and warm. She added there was "bump" in the middle the rash but it was now gone. The Rph on duty asked if it could be a related to a bug bite but she said she didn't think so.  Later that day the patient went to her PCP's office for a walk-in appt and saw nurse. She said the provider told her to apply cold compress and continue ibu and not to get the 2nd dose for the vaccine.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Pt given vaccine in the morning on 8/22  to her left arm and waited in the store for >15min following vaccine and returned to pharmacy to make purchase and report that she felt "fine".  On 8/24 at 10:30a she return to the pharmacy to report that she had a bad muscle pain in her the arm of the injection and muscle ache across her trunk/torso the following morning and took ibuprofen 200mg twice that day. She also presented her left  arm to show and rash across the upper arm that was ~1-2 inch  below the injection; she said it was a little itchy the previous day, sore, and warm. She added there was "bump" in the middle the rash but it was now gone. The Rph on duty asked if it could be a related to a bug bite but she said she didn't think so.  Later that day the patient went to her PCP's office for a walk-in appt and saw nurse. She said the provider told her to apply cold compress and continue ibu and not to get the 2nd dose for the vaccine.
Age: 0.75
Sex: F
Vaccine: DTAP, HEP
Symptoms: Extra dose administered
Clinical narrative: Patient administered vaccines Dtap and Hep B.  Patient is up to date on vaccines. Vaccines administered not needed.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness
Clinical narrative: Approxiamtely three mins after patient received the MCV4 (Menquadfi) vaccine he c/o of feeling dizzy. At that time we propped his feet up in the chair, placed cool cloths on neck and face and turned on a cool fan. BP was check @2:29pm. 85/47 P-68. Patient was given a soda and some peanut butter crackers. Patients BP was checked again @2:32pm 96/57 P-64. BP was checked again @2:35pm 102/60 P-68. After 10 mins, patient stated that he was feeling better. No longer experiencing any dizziness. Advised grandmother to wait in the lobby an additional 15 mins for patient to be monitored and after that he can go. Also advised gandmother to get patient something to eat when they leave as patient stated that he had not had anything to eat all day.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Rash, Rash macular, Skin warm
Clinical narrative: Mom reported a rash the entire front of arm with red blotchy edges, warm to touch. Mom reported she administered Benadryl with a positive effect and rash cleared up and did not return.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Epstein-Barr virus infection, General physical health deterioration, Incomplete course of vaccination
Clinical narrative: See patients' response on first half of form.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 7.0
Sex: F
Vaccine: COVID19-2, HEP, IPV, MMRV, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Report made within hours of discovering error. Parent will be contacted to notified to monitor for potential side effects or concerns. None reported at the time of this report
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past it's expiration date. We contacted Moderna, the mfg who performed an analysis of lot #043H22A. They determined "the vaccine administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of administration."
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past it's expiration date. We contacted Moderna, the mfg who performed an analysis of lot #043H22A. They determined "the vaccine administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of administration."
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Chest discomfort
Clinical narrative: Chest tightness
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past it's expiration date. We contacted Moderna, the mfg who performed an analysis of lot #043H22A. They determined "the vaccine administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of administration."
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Anaemia, Basophil count, Basophil percentage, Blood creatinine normal, Blood glucose normal
Clinical narrative: pt developed nodular and painful bumps on her legs and hands, she also had a headache and dizziness. At the time of her ER visit she was found to be anemic, which could account for her dizziness.  The lump went away and returned on 8/24/23, and appear to be erythema nordosum
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blood urea nitrogen/creatinine ratio, Blood urea normal, Culture throat, Culture urine, Dizziness
Clinical narrative: pt developed nodular and painful bumps on her legs and hands, she also had a headache and dizziness. At the time of her ER visit she was found to be anemic, which could account for her dizziness.  The lump went away and returned on 8/24/23, and appear to be erythema nordosum
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Eosinophil count, Eosinophil percentage increased, Full blood count, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: pt developed nodular and painful bumps on her legs and hands, she also had a headache and dizziness. At the time of her ER visit she was found to be anemic, which could account for her dizziness.  The lump went away and returned on 8/24/23, and appear to be erythema nordosum
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Headache, Influenza virus test negative, Lip swelling, Lymphocyte count, Lymphocyte percentage
Clinical narrative: pt developed nodular and painful bumps on her legs and hands, she also had a headache and dizziness. At the time of her ER visit she was found to be anemic, which could account for her dizziness.  The lump went away and returned on 8/24/23, and appear to be erythema nordosum
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Mean cell haemoglobin concentration decreased, Mean cell haemoglobin decreased, Mean cell volume decreased, Mean platelet volume normal, Monocyte count
Clinical narrative: pt developed nodular and painful bumps on her legs and hands, she also had a headache and dizziness. At the time of her ER visit she was found to be anemic, which could account for her dizziness.  The lump went away and returned on 8/24/23, and appear to be erythema nordosum
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Monocyte percentage, Neutrophil count, Neutrophil percentage, Peripheral swelling, Platelet count increased
Clinical narrative: pt developed nodular and painful bumps on her legs and hands, she also had a headache and dizziness. At the time of her ER visit she was found to be anemic, which could account for her dizziness.  The lump went away and returned on 8/24/23, and appear to be erythema nordosum
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Protein total normal, Red blood cell count normal, Red cell distribution width increased, SARS-CoV-2 test negative, White blood cell count
Clinical narrative: pt developed nodular and painful bumps on her legs and hands, she also had a headache and dizziness. At the time of her ER visit she was found to be anemic, which could account for her dizziness.  The lump went away and returned on 8/24/23, and appear to be erythema nordosum
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past it's expiration date. We contacted Moderna, the mfg who performed an analysis of lot #043H22A. They determined "the vaccine administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of administration."
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past it's expiration date. We contacted Moderna, the mfg who performed an analysis of lot #043H22A. They determined "the vaccine administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of administration."
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past it's expiration date. We contacted Moderna, the mfg who performed an analysis of lot #043H22A. They determined "the vaccine administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of administration."
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past it's expiration date. We contacted Moderna, the mfg who performed an analysis of lot #043H22A. They determined "the vaccine administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of administration."
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past it's expiration date. We contacted Moderna, the mfg who performed an analysis of lot #043H22A. They determined "the vaccine administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of administration."
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Syncope
Clinical narrative: Upon administration of second vaccine, HPV, patient stated he was lightheaded and had a syncopal episode. Assisted patient on laying on bed, patient was alert within seconds and instructed to lay with knees bent. Patient sat up within 5 minutes and given water. Patient was observed by mother and nurses. Patient stated he wanted to go home and it was determined that he was able to ambulate on his own. He was accompanied outside walking by mother. Patient's color was back to normal and was alert and oriented.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past it's expiration date. We contacted Moderna, the mfg who performed an analysis of lot #043H22A. They determined "the vaccine administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of administration."
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past it's expiration date. We contacted Moderna, the mfg who performed an analysis of lot #043H22A. They determined "the vaccine administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of administration."
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past it's expiration date. We contacted Moderna, the mfg who performed an analysis of lot #043H22A. They determined "the vaccine administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of administration."
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: No adverse events reported.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: left upper arm swollen, hot, itchy and painful
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: No adverse event reported.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Hepatitis B surface antibody negative; Literature Report.  This literature marketed report has been received from authors of a published literature article, title as stated above, referring to a 52 patients of unknown age and gender.   On an unspecified date, the patients were vaccinated with Hepatitis B Vaccine (Recombinant) (manufacturer unknown) (strength, dose, frequency, route of administration, lot# and expiration date were not reported).  On an unspecified date, revaccination was recommended for the patients due to they were hepatitis-B non-immune (hepatitis B surface antibody negative).  The authors considered the hepatitis B surface antibody negative to be related to Hepatitis B Vaccine (Recombinant) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past it's expiration date. We contacted Moderna, the mfg who performed an analysis of lot #043H22A. They determined "the vaccine administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of administration."
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past it's expiration date. We contacted Moderna, the mfg who performed an analysis of lot #043H22A. They determined "the vaccine administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of administration."
Age: 10.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Erythema, Oropharyngeal pain, Swelling face
Clinical narrative: Mom informed me (on 8/24/2023) that he had swollen, red cheeks as well as a sore throat about 24 hours after his vaccines. She gave him benadryl and felt that helped his symptoms. Took him to the ED on 6/2- in the evening. symptoms resolved 48 hours after receiving vaccine.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Balance disorder, Gait disturbance, Gait inability, Laboratory test
Clinical narrative: Felt fine that day the 24th , felt sick on the 25th and collapsed at work on the 26th. I was taken to the hospital by ambulance. I was "out of it" for 5 days. Was discharged along with a lot of other pts because the hospital had to take a bunch of pt from another hospital. I couldn't walk or balance. It was months before I could walk steadily again. Indeterminate cause. Ended up with atrial fibrillation and I have a Waxman patch put in. 2 Weeks later my PCP tried to give me another shot and I said no.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Medical device implantation, Syncope
Clinical narrative: Felt fine that day the 24th , felt sick on the 25th and collapsed at work on the 26th. I was taken to the hospital by ambulance. I was "out of it" for 5 days. Was discharged along with a lot of other pts because the hospital had to take a bunch of pt from another hospital. I couldn't walk or balance. It was months before I could walk steadily again. Indeterminate cause. Ended up with atrial fibrillation and I have a Waxman patch put in. 2 Weeks later my PCP tried to give me another shot and I said no.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Facial pain, Herpes simplex, Magnetic resonance imaging head, Musculoskeletal pain
Clinical narrative: Starting in June of 2021 I had developed a tick like rash on my left arm.  It was not a tick.  That summer I had pins and needs in my hands. I received the Moderna booster on December 28, 2021.  The rashes developed into MRSA and HSV1 on my upper lip.  Following that MRSA event, I developed nerve pain in the back of my left thigh which traveled to my bottom buttocks both sides.  I had nerve pain in my face which has continued.  I have seen a neurologist who has done test after test and all have been normal with the exception of the past MRSA infection.  We have no explanation for my nerve damage.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nerve injury, Neuralgia, Oral herpes, Pain in extremity, Paraesthesia
Clinical narrative: Starting in June of 2021 I had developed a tick like rash on my left arm.  It was not a tick.  That summer I had pins and needs in my hands. I received the Moderna booster on December 28, 2021.  The rashes developed into MRSA and HSV1 on my upper lip.  Following that MRSA event, I developed nerve pain in the back of my left thigh which traveled to my bottom buttocks both sides.  I had nerve pain in my face which has continued.  I have seen a neurologist who has done test after test and all have been normal with the exception of the past MRSA infection.  We have no explanation for my nerve damage.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Spinal X-ray, Staphylococcal infection
Clinical narrative: Starting in June of 2021 I had developed a tick like rash on my left arm.  It was not a tick.  That summer I had pins and needs in my hands. I received the Moderna booster on December 28, 2021.  The rashes developed into MRSA and HSV1 on my upper lip.  Following that MRSA event, I developed nerve pain in the back of my left thigh which traveled to my bottom buttocks both sides.  I had nerve pain in my face which has continued.  I have seen a neurologist who has done test after test and all have been normal with the exception of the past MRSA infection.  We have no explanation for my nerve damage.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, IPV, MMR, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Student received 2 doses of Polio on the same time.  Unknown reaction.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Musculoskeletal chest pain, Poor quality sleep, Urticaria
Clinical narrative: Didn't sleep well, Large welt on my right shoulder. Also have a sharp stabbing pain on back on upper part of my rib cage that also is a welt.  I took Benadryl, doctors instructions.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: kinrix was given to patient under 4 years old. symptoms and reaction unknown
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, Product storage error
Clinical narrative: Nurse reported MMRII was administered after improper storage; MMRII Lot: U022983 Exp: 07/22/2023; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On 03-AUG-2023, the patient was vaccinated with improperly stored and also expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 1 dose, recombinant Human albumin (rHA) lot # U022983 with expiration date 22-JUL-2023, for prophylaxis (strength and route of administration were not provided). The vaccine was exposed to a temperature of 51°F for 1 hour. No previous temperature excursion was reported.
Age: 88.0
Sex: F
Vaccine: COVID19-2
Symptoms: Confusional state, Dyspnoea, Fatigue, Pain
Clinical narrative: 08/23/2023 at 15:10 had increased confusion, temp 99.3, SOB with 02 sats 88% on R/A. applied 02 at 2 liters.  At 15:30 c/o fatigued, and body aches.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 26.0
Sex: M
Vaccine: RAB
Symptoms: Dry mouth, Lip swelling, Mouth swelling, Rhinorrhoea, Swelling face
Clinical narrative: Symptom onset approximately 5pm on 8/19/23: red/swollen face, mouth, and lips, runny nose, oral dryness and tongue swelling. Treatment: SOLU-Medrol IV push 125 mg, diphenhydramine IV push 50 mg, famotidine IV push 20 mg. Observed 2 hours and symptoms resolved.
Age: 26.0
Sex: M
Vaccine: RAB
Symptoms: Swollen tongue
Clinical narrative: Symptom onset approximately 5pm on 8/19/23: red/swollen face, mouth, and lips, runny nose, oral dryness and tongue swelling. Treatment: SOLU-Medrol IV push 125 mg, diphenhydramine IV push 50 mg, famotidine IV push 20 mg. Observed 2 hours and symptoms resolved.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: I had given the pt the 5-11 year covid shot and not the 12+ one. I thought the pt was 11 years old. I got confused with his age. So I gave him with 5 -11 yr one and realized when I was charting it before the end of the day. . Pt did not show signs of symptoms when I was thier in the room with
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: pt was given kinrix at 4 month, symptoms and reactions unknown.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, MENB
Symptoms: Dizziness, Fatigue, Hypotension, Injection site pain, Migraine
Clinical narrative: - Adverse events started that day with dizziness and pain at injection site. -Other adverse events that quickly came about include migraines, dizzy spells, nausea/vomitting, faint spells, blood pooling, extreme fatigue, low blood pressure, and tachycardia (all of which continously got worse). - After two years of trying to find my diagnosis, I was found to have P.O.T.S. in 2021. Treatments included increased salt and water, beta blockers, multiple medications to help with symptoms, IV infusions, herbal medicine, compression stockings, etc. However, none of these treatments stop or prevent the symptoms I face daily. Most of the medications I was put on increased my symptoms or gave me new ones.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, MENB
Symptoms: Nausea, Syncope, Tachycardia, Vomiting
Clinical narrative: - Adverse events started that day with dizziness and pain at injection site. -Other adverse events that quickly came about include migraines, dizzy spells, nausea/vomitting, faint spells, blood pooling, extreme fatigue, low blood pressure, and tachycardia (all of which continously got worse). - After two years of trying to find my diagnosis, I was found to have P.O.T.S. in 2021. Treatments included increased salt and water, beta blockers, multiple medications to help with symptoms, IV infusions, herbal medicine, compression stockings, etc. However, none of these treatments stop or prevent the symptoms I face daily. Most of the medications I was put on increased my symptoms or gave me new ones.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Sex: F
Vaccine: HPV9
Symptoms: Skin laceration, Syringe issue
Clinical narrative: the patient receiving the injection was not injured/No further AE details; Registered Nurse called to report a PQC for GARDASIL 9. HCP reports that a Medical Assistant, who is a repeat device user was given a patient a GARDASIL 9 injection and was pushing the last bit of the dose into the patient when the barrel of the syri; Registered Nurse called to report a PQC for GARDASIL 9. HCP reports that a Medical Assistant, who is a repeat device user was given a patient a GARDASIL 9 injection and was pushing the last bit of the dose into the patient when the barrel of the syri; This spontaneous report was received from Other Health Professional and refers to a 27-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 16-AUG-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml/once, lot #W026151, expiration date: 20-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided).  On 16-AUG-2023, registered nurse called to report a PQC for GARDASIL 9. HCP reports that a Medical Assistant, who is a repeat device user was given a patient a GARDASIL 9 injection and was pushing the last bit of the dose into the patient when the barrel of the syringe shattered into multiple pieces. RN reports that the MA was injured and received a cut from one of the shattered pieces of glass on her right middle finger. RN reports that the MA was able to be treated with topical antibiotics and a band aide and did not require stitches. RN reports that the patient receiving the injection was not injured, and the full dose was given. PQC filed: 02453005 /No further AE details.
Age: 34.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: The caller said the patient's first dose of GARDASIL 9 was administered on 12/29/2022 (lot and expiration date unknown).; no other AE; Customer called to report an AE for GARDASIL 9. The caller said that a pregnant patient received GARDASIL 9 on 8/1/2023. The caller said this was the patient's second dose of GARDASIL 9. The caller said the patient's first dose of GARDASIL 9 was ad; This spontaneous report was received from Other and refers to a 35-year-old female patient (pregnant, LMP 10-JUL-2023).  The patient's medical history included  human papillomavirus infection, and rhinitis allergic. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 29-DEC-2022, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 01-AUG-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 2nd dose, lot #w014479, expiration date: 16-DEC-2024, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, customer called to report an AE for GARDASIL 9. The caller said that a pregnant patient received GARDASIL 9 on 8/1/2023. The caller said this was the patient's second dose of GARDASIL 9. The caller said the patient's first dose of GARDASIL 9 was administered on 12/29/2022 (lot and expiration date unknown). Confirmed with caller no other AE occurred. Case number provided. (Vaccine exposure during pregnancy, Vaccine exposure before pregnancy). AE letter sent to prescriber. No other AE. No PQC. At the time of reporting, the outcome of the events was not known. The action taken with GARDASIL 9 regarding events was reported as Not Applicable.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No adverse event; Medical Tech calls to report vaccine given during an excursion.; This spontaneous report was received from other health professional referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.    On 16-AUG-2023, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status rHA) (lot # W038815 which was determined to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date not reported, but upon internal validation established as 04-JUN-2024; strength, dose and route were not reported; one time) was given during an excursion to the patient (product storage error).
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Nurse reported pediatric patient received adult dose of VAQTA. See additional AE cases 02457006 and 02457034/no PQC.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.     On 22-AUG-2023 the pediatric patient was vaccinated with adult dose of hepatitis a vaccine, inactivated (VAQTA) lot # W023489 and expiration date 27-DEC-2023 for prophylaxis (exact dose, dose number, route and site of administration were not provided) (product administered to patient of inappropriate age).
Sex: M
Vaccine: TYP
Symptoms: Abdominal discomfort, Abdominal pain, Nausea, Vomiting
Clinical narrative: Upset stomach; Abdominal pain; Vomiting; Nausea; A spontaneous report was received from a nurse on 31JUL2023 regarding a 26-year-old male patient who had "upset stomach" (PT: Abdominal discomfort), "nausea" (PT: Nausea), "vomiting" (PT: Vomiting) and "abdominal pain" (PT: Abdominal pain) following the administration of oral Vivotif capsule (typhoid vaccine live oral Ty21A; lot number: 3003830, expiry date: FEB2024) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  On an unknown date, the patient took the first dose of Vivotif. Reportedly, after 7 hours of administration of the first dose the patient had an upset stomach and nausea and after 8 hours of administration the patient experienced abdominal pain and vomiting. No fever was reported. Subsequently, the patient decided to discontinue the vaccine and was given a typhoid injection before leaving for the trip.  The outcome of the reported events was unknown at the time of this report.  The action taken with Vivotif with respect to the reported events was withdrawn.  No additional information was reported.  Company comment: It was reported that a patient received Vivotif and after 7 hours of administration of the first dose the patient had an upset stomach (abdominal discomfort) and nausea. Then at 8 hours after administration the patient experienced abdominal pain and vomiting. Considering the case information, the role of Vivotif cannot be ruled out and the causality of abdominal discomfort, nausea, abdominal pain, and vomiting is assessed as possible. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient received Vivotif and after 7 hours of administration of the first dose the patient had an upset stomach (abdominal discomfort) and nausea. Then at 8 hours after administration the patient experienced abdominal pain and vomiting. Considering the case information, the role of Vivotif cannot be ruled out and the causality of abdominal discomfort, nausea, abdominal pain, and vomiting is assessed as possible. The case is considered non serious as per medical assessment.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose was 2 years ago not received 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 10th March 2020 received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first dose was 2 years ago not received 2nd dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 16-AUG-2023 A pharmacist intern reported that a patient received their first dose was 2 years ago from reporting. The reporter wanted to know late second dose of Shingrix and the efficacy data for one dose only. Till the time of reporting the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. This case was linked with US2023111553 with same reporter. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2023111553:secand case created for second patient
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: pt had last vaccine 1/30/23. Greater than 6 month; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on 30th January 2023).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: pt had last vaccine 1/30/23. Greater than 6 month). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 16 August 2023 The patient had last vaccine on 30th Jan 2023, it was greater than 6 months. The reporter asked if they would need to restart the series over. Till the time of reporting the patient did not received 2nd dose of shingrix which led to incomplete course of vaccination.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus
Clinical narrative: Painful shot; itching in the arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: Painful shot) and itchy upper limbs (Verbatim: itching in the arm). The outcome of the pain and itchy upper limbs were resolved.   It was unknown if the reporter considered the pain and itchy upper limbs to be related to Shingrix.     It was unknown if the company considered the pain and itchy upper limbs to be related to Shingrix.   Additional Information: GSK receipt date: 17-Aug-2023 and 19-Aug-2023 The patient had the first Shingrix shot and was a painful shot. After couple weeks, the patient developed severe itching in the arm and went on for 2 to 3 weeks and now only slightly itches and it was manageable. The patient was very concerned about this side effect and asked that have you gotten any other complaints like that. The patient did not know for sure if it was caused by the shot, but it seems to radiate from the site of the injection.  Neither the primary care provider or dermatologist knows the answer and suggested the patient contact the company to see if they had this problem with any other patients. If they could provide information, it will help her to decide whether to get the second shot. The caller was not sure the patient will get the second Shingrix vaccine.  The patient would like to know if anyone else has had this happen.  Gave medical information number for health care professional to call but the patient declined to provide health care professional contact information.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain
Clinical narrative: injection site redness; injection site pain; Injection was administered Subquetanious; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: injection site redness), injection site pain (Verbatim: injection site pain) and intramuscular formulation administered by other route (Verbatim: Injection was administered Subquetanious). The outcome of the injection site erythema and injection site pain were not reported and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site erythema and injection site pain to be related to Shingrix.   Additional Information: GSK receipt date: 17-AUG-2023 The reporter stated that injection was administered Subquetanious, causing injection site redness and pain. The patient received Shingrix via subquetanously, which led to intramuscular formulation administered by other route. The reporter agree to follow up to GlaxoSmithKline (GSK).
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: i got my shots they hurt a little; my arm was very sore for about 3 or 4 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: i got my shots they hurt a little) and pain in arm (Verbatim: my arm was very sore for about 3 or 4 days). The outcome of the pain was not reported and the outcome of the pain in arm was resolved (duration 4 days).   It was unknown if the reporter considered the pain and pain in arm to be related to Shingrix.     It was unknown if the company considered the pain and pain in arm to be related to Shingrix.   Additional Information: Receipt date: 20-AUG-2023 This case was reported by patient via interactive digital media. The patient received first and second dose of vaccination. The patient got her shots they hurt a little but there worth, her arm was very sore for about 3 to 4 days.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: August 10th the patient was administered  a 3rd dose of the hepatitis vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number A32BB, expiry date 10-AUG-2025) for prophylaxis.   Concomitant products included HEPATITIS VACCINE, NOS (HEPATITIS VACCINE). Family history included hepatitis b carrier.   On 10-AUG-2023, the patient received the 3rd dose of Pediarix. On 10-AUG-2023, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: August 10th the patient was administered  a 3rd dose of the hepatitis vaccine).  The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-AUG-2023 The reporter was the parent (father) of a 2-month infant. Parent reported, that the mother of the child was a Hepatitis B carrier. Infant was given the 1st dose of the Hepatitis vaccine at birth and Parent reports that on August 10th the patient was administered a 3rd dose of the hepatitis vaccine (Pediarix), which led to Inappropriate age at vaccine administration.  Parent did not consent to follow up with HCP.
Sex: U
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: pharmacist calling to report a Menveo vaccine was given to a child less then 10 years of age; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a child 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 age at vaccine administration (Verbatim: pharmacist calling to report a Menveo vaccine was given to a child less then 10 years of age). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date 16 August 2023: The pharmacist calling to report a Menveo vaccine was given to a child less then 10 years of age. No other information was known at this time.  The reporter consented to follow up.  The patient less than 10 year old received menveo which led to inappropriate age at vaccine administration.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: experiencing a red circle; raised bump around injection site right deltoid; Expired BEXSERO vaccine was administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number M7455, expiry date 31-DEC-2022) for prophylaxis.   On 15-AUG-2023, the patient received Bexsero (injection, right deltoid). On 15-AUG-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired BEXSERO vaccine was administered). On 16-AUG-2023, the patient experienced injection site erythema (Verbatim: experiencing a red circle) and injection site swelling (Verbatim: raised bump around injection site right deltoid).     The outcome of the injection site erythema and injection site swelling were not resolved and the outcome of the expired vaccine used was unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site erythema and injection site swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16 August 2023: The reporter was the mother of patient.   The mother stated that the doctor's office called and notified her that the BEXSERO vaccine that they administered to her son  was expired.  Expired BEXSERO vaccine was administered on 15 August 2023 in his right deltoid by a Medical assistant.   The mother stated that the doctor wanted to re-vaccinate when their next BEXSERO shipment come in this week.  The reporter was not sure if this was safe and called today to question re-administration.  Medical information phone number and case number given to reporter for her physicians reference.   The patient who received expired vaccine was experiencing a red circle and a raised bump around injection site right deltoid 1 day after administration that had not resolved.   The reporter consented to follow up. The patient received expired dose of vaccine which led to expired vaccine used.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: inappropriate dose; inappropriate dose/12 month old female patient received an adult dose (1ml) of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 12-month-old female patient who received HAV (Havrix adult) (batch number PB5JA, expiry date 14-FEB-2025) for prophylaxis.   On 16-AUG-2023, the patient received Havrix adult 1 ml. On 16-AUG-2023, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: inappropriate dose) and overdose (Verbatim: inappropriate dose/12 month old female patient received an adult dose (1ml) of Havrix). The outcome of the adult product administered to child and overdose were unknown.   Additional Information: GSK receipt date 16 August 2023: The practice manager reported that a 12 month old patient received an adult dose (1ml) of Havrix. No symptoms reported. The reporter Consented to follow up via mail. The Vaccine Administration Facility was the same as Primary Reporter. The 12 month old patient received an adult dose (1ml) of Havrix, which led to adult product administered to child and overdose.