chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC20
Symptoms: Blood glucose decreased, Ear infection, Hypophagia, Lethargy, Oliguria
Clinical narrative: 5/22-5/25: Child had low grade fever, lethargy, not eating/drinking much per MOC. 5/26 child spiked 101 fever and was seen by PCP  5/27 child was brought to ER by MOC for fever 105 not dropping with medication, low urine output, lethargy, low BS. Child was dx with ear infection and stared on Amoxicillin. Administered IVF and fever reducing meds and child was discharged. 5/28 child's fever was better but still not eating/drinking. 5/29 child was sent via ambulance back to ER after broke out in facial rash, fever, lethargy, low UO. Per MOC ER administered benedryl and believed it to be a abx related rash. Kept child on amoxicillin. Rash described as red, raised, started on face and moved down body. Child was inpt x 3 days and sent home on 5/31. Fever, rash and lethargy have resolved.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC20
Symptoms: Pyrexia
Clinical narrative: 5/22-5/25: Child had low grade fever, lethargy, not eating/drinking much per MOC. 5/26 child spiked 101 fever and was seen by PCP  5/27 child was brought to ER by MOC for fever 105 not dropping with medication, low urine output, lethargy, low BS. Child was dx with ear infection and stared on Amoxicillin. Administered IVF and fever reducing meds and child was discharged. 5/28 child's fever was better but still not eating/drinking. 5/29 child was sent via ambulance back to ER after broke out in facial rash, fever, lethargy, low UO. Per MOC ER administered benedryl and believed it to be a abx related rash. Kept child on amoxicillin. Rash described as red, raised, started on face and moved down body. Child was inpt x 3 days and sent home on 5/31. Fever, rash and lethargy have resolved.
Age: 51.0
Sex: F
Vaccine: PNC21
Symptoms: Haemorrhage, Immediate post-injection reaction, Swelling
Clinical narrative: Pt had a lot of swelling and bleeding immediately after the vaccination. She did not have any signs of an allergic reaction. I called her one hour later and it was still swollen but no other symptoms.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Patient reported she Vomited afterwards
Age: 52.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Injection site rash, Injection site warmth, Pain in extremity
Clinical narrative: Patient came into pharmacy with complaint of pain in left arm with visible rash from shoulder to elbow. Pt reported that it started the day after the vaccine and only had pain which he treated with tylenol. Rash came about lunchtime next day and has been spreading towards elbow and it hot to touch and has some pain.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Bell's palsy, Facial paralysis, Facial paresis
Clinical narrative: Pt is G3P2 at 36w3d at time of vaccination. Pt began having facial droop/weakness about 7 hours after vaccination and was diagnosed with Bell's palsy.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia, Peripheral coldness
Clinical narrative: 5/30--pt received PCV21 in R deltoid. Pt notes both arms with intermittent numbness since Friday night and coldness in hands--no discoloration. Denies tingling or weakness--pt notes numbness resolved yesterday and per her research PCV21 can cause some numbness a few days after immunization.     Pt notes injection site tender to touch but no pain with movement. Redness noticed today, +warmth to touch. Oval shaped redness 3.5 x 2 inches. Denies red streaking, drainages, fevers, SOB, wheezing, swelling of face/lips/tongue
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Craniofacial fracture, Fall, Shoulder fracture, Wrist fracture
Clinical narrative: I was in town for the booster, we were exiting the expo for Christmas. I had been standing for a hour and all i could remember was exiting on the east side holding the door open with my right hand, i don't remember my head turning around or anything i woke up in an ambulance with them asking who should we contact. And then i kinda don't remember too much of anything until i was in the exam room , my glasses were knocked off my shoe was knocked off and it was on concrete and i had tripped over that concrete bumper and there was a brick wall behind it 2.5 feet away and i was laying between the both i had fallen on my left side. I broke my shoulder and my wrist and the left side of my face. I went to see a facial surgeon and my doctor and i got an eye exam done.
Age: 1.25
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Irritability
Clinical narrative: Raised red mark surrounding the injection. Very irritable the morning after the injection and days after
Age: 63.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Hypersomnia, Inflammation, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Hands and feet/ankles began hurting (stiff and painful) approximately 2 weeks after vaccination. My feet/ankles are mostly okay, but will stiffen up after sleep, rest, and walking).  Hands, and especially right hand, are inflamed.  I have been sleeping more, but more likely because of my back and sciatica pain.
Age: 67.0
Sex: M
Vaccine: HEPAB, VARZOS
Symptoms: Arthralgia, Headache, Ligament sprain, Lip blister, Pain in extremity
Clinical narrative: After receiving the shingles vaccine I developed blisters on my upper lip that were present for 2 days, My left wrist felt like it was sprained.  Mild Arthritis pain in thumbs and fingers became extreme pain, Constant headaches, still to this day.  My knees are both hurting ion the joints and I have NEVER had knee pain.  Plus I have episodes of itching, all over my body.  Especially at night and it wakes me up.
Age: 67.0
Sex: M
Vaccine: HEPAB, VARZOS
Symptoms: Pruritus
Clinical narrative: After receiving the shingles vaccine I developed blisters on my upper lip that were present for 2 days, My left wrist felt like it was sprained.  Mild Arthritis pain in thumbs and fingers became extreme pain, Constant headaches, still to this day.  My knees are both hurting ion the joints and I have NEVER had knee pain.  Plus I have episodes of itching, all over my body.  Especially at night and it wakes me up.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Dehydration, Diarrhoea, Erythema, Hypophagia, Lethargy
Clinical narrative: Chief Complaint Vomiting yellow-green bile for over 1.5 hours yesterday, lethargy, pallor, dehydration requiring ER visit and IV fluids  History of Present Illness Patient, an infant male with a recent history of adenovirus and parainfluenza 3 in early May, presents for follow-up after an emergency room visit and hospitalization due to acute vomiting and lethargy.  Yesterday, around 2:30 PM, while napping in his swing, patient began vomiting. The vomiting episodes occurred every 1-2 minutes, progressing from what appeared to be a mix of spit-up and vomit to yellow-green bile. The episodes continued until after 4 PM. Accompanying symptoms included pallor, lethargy, and refusal to nurse. Patient's mother reports he became pale, with his lips losing color, and he didn't smile. He was gagging, whimpering, and dry-heaving, with his face turning red during episodes. His grandmother noted he looked gray.  Due to the severity of symptoms, patient was taken to the emergency room where he received IV fluids, labs, and imaging studies. The ER pediatrician initially suspected a possible partial intussusception based on x-ray findings. Patient was transferred by ambulance to another hospital for further evaluation, where repeat scans were normal. He regained his color by 9 PM and stopped vomiting after 7 PM. He received IV fluids and was able to nurse before being discharged with instructions to follow up with the pediatrician.  Since discharge, patient has been tired but nursing normally. He hasn't had any solid foods. This morning at 11 AM, he had light brown diarrhea. The mother notes that patient had a slight fever from shots on Friday, but has no fever now. She also mentions that his stool on Saturday night was mucousy, which she attributes to the rotavirus vaccine. Today, patient appears pale with some nasal contractions.  The mother reports that patient had adenovirus and parainfluenza 3 in early May, which caused yellow diarrhea. She states he hasn't had any bloody or mucousy stools indicative of intussusception. The mother mentions that patient had avocado yesterday morning, which she suspects might be linked to his symptoms. Medical History - Emergency room visit and hospitalization for severe vomiting and dehydration - Adenovirus and parainfluenza 3 infections in early May - Vaccinations received, including rotavirus vaccine  Medications and Supplements - Rotavirus vaccine  - Administered Friday  - Side effect: Mucousy poop on Saturday night  Social History - Living Situation: Lives with parents - Diet: Exclusively breastfed, no solid foods introduced yet except for recent avocado trial - Caretaker Arrangement: Primary care provided by mother, grandmother involved in care  Review of Systems General: Positive for fatigue, lethargy, pallor. Negative for fever. HEENT: Positive for nasal contractions. Respiratory: Positive for whimpering. Gastrointestinal: Positive for vomiting, diarrhea. Negative for bloody stools.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Nasal congestion, Pallor, Pyrexia, Retching, Secretion discharge
Clinical narrative: Chief Complaint Vomiting yellow-green bile for over 1.5 hours yesterday, lethargy, pallor, dehydration requiring ER visit and IV fluids  History of Present Illness Patient, an infant male with a recent history of adenovirus and parainfluenza 3 in early May, presents for follow-up after an emergency room visit and hospitalization due to acute vomiting and lethargy.  Yesterday, around 2:30 PM, while napping in his swing, patient began vomiting. The vomiting episodes occurred every 1-2 minutes, progressing from what appeared to be a mix of spit-up and vomit to yellow-green bile. The episodes continued until after 4 PM. Accompanying symptoms included pallor, lethargy, and refusal to nurse. Patient's mother reports he became pale, with his lips losing color, and he didn't smile. He was gagging, whimpering, and dry-heaving, with his face turning red during episodes. His grandmother noted he looked gray.  Due to the severity of symptoms, patient was taken to the emergency room where he received IV fluids, labs, and imaging studies. The ER pediatrician initially suspected a possible partial intussusception based on x-ray findings. Patient was transferred by ambulance to another hospital for further evaluation, where repeat scans were normal. He regained his color by 9 PM and stopped vomiting after 7 PM. He received IV fluids and was able to nurse before being discharged with instructions to follow up with the pediatrician.  Since discharge, patient has been tired but nursing normally. He hasn't had any solid foods. This morning at 11 AM, he had light brown diarrhea. The mother notes that patient had a slight fever from shots on Friday, but has no fever now. She also mentions that his stool on Saturday night was mucousy, which she attributes to the rotavirus vaccine. Today, patient appears pale with some nasal contractions.  The mother reports that patient had adenovirus and parainfluenza 3 in early May, which caused yellow diarrhea. She states he hasn't had any bloody or mucousy stools indicative of intussusception. The mother mentions that patient had avocado yesterday morning, which she suspects might be linked to his symptoms. Medical History - Emergency room visit and hospitalization for severe vomiting and dehydration - Adenovirus and parainfluenza 3 infections in early May - Vaccinations received, including rotavirus vaccine  Medications and Supplements - Rotavirus vaccine  - Administered Friday  - Side effect: Mucousy poop on Saturday night  Social History - Living Situation: Lives with parents - Diet: Exclusively breastfed, no solid foods introduced yet except for recent avocado trial - Caretaker Arrangement: Primary care provided by mother, grandmother involved in care  Review of Systems General: Positive for fatigue, lethargy, pallor. Negative for fever. HEENT: Positive for nasal contractions. Respiratory: Positive for whimpering. Gastrointestinal: Positive for vomiting, diarrhea. Negative for bloody stools.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Vomiting
Clinical narrative: Chief Complaint Vomiting yellow-green bile for over 1.5 hours yesterday, lethargy, pallor, dehydration requiring ER visit and IV fluids  History of Present Illness Patient, an infant male with a recent history of adenovirus and parainfluenza 3 in early May, presents for follow-up after an emergency room visit and hospitalization due to acute vomiting and lethargy.  Yesterday, around 2:30 PM, while napping in his swing, patient began vomiting. The vomiting episodes occurred every 1-2 minutes, progressing from what appeared to be a mix of spit-up and vomit to yellow-green bile. The episodes continued until after 4 PM. Accompanying symptoms included pallor, lethargy, and refusal to nurse. Patient's mother reports he became pale, with his lips losing color, and he didn't smile. He was gagging, whimpering, and dry-heaving, with his face turning red during episodes. His grandmother noted he looked gray.  Due to the severity of symptoms, patient was taken to the emergency room where he received IV fluids, labs, and imaging studies. The ER pediatrician initially suspected a possible partial intussusception based on x-ray findings. Patient was transferred by ambulance to another hospital for further evaluation, where repeat scans were normal. He regained his color by 9 PM and stopped vomiting after 7 PM. He received IV fluids and was able to nurse before being discharged with instructions to follow up with the pediatrician.  Since discharge, patient has been tired but nursing normally. He hasn't had any solid foods. This morning at 11 AM, he had light brown diarrhea. The mother notes that patient had a slight fever from shots on Friday, but has no fever now. She also mentions that his stool on Saturday night was mucousy, which she attributes to the rotavirus vaccine. Today, patient appears pale with some nasal contractions.  The mother reports that patient had adenovirus and parainfluenza 3 in early May, which caused yellow diarrhea. She states he hasn't had any bloody or mucousy stools indicative of intussusception. The mother mentions that patient had avocado yesterday morning, which she suspects might be linked to his symptoms. Medical History - Emergency room visit and hospitalization for severe vomiting and dehydration - Adenovirus and parainfluenza 3 infections in early May - Vaccinations received, including rotavirus vaccine  Medications and Supplements - Rotavirus vaccine  - Administered Friday  - Side effect: Mucousy poop on Saturday night  Social History - Living Situation: Lives with parents - Diet: Exclusively breastfed, no solid foods introduced yet except for recent avocado trial - Caretaker Arrangement: Primary care provided by mother, grandmother involved in care  Review of Systems General: Positive for fatigue, lethargy, pallor. Negative for fever. HEENT: Positive for nasal contractions. Respiratory: Positive for whimpering. Gastrointestinal: Positive for vomiting, diarrhea. Negative for bloody stools.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness & swelling & some itching at injection site; itching that worsened over past 2 days
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstruation irregular
Clinical narrative: Before I was given any Covid vaccine, I had regularly monthly menstruation. So regular it started every 28 days and lasted 4 days. Every month. However, after receiving the vaccines my monthly menstruation completely stopped being regular, meaning I wasn?t menstruating monthly any longer. I went from monthly and regular to sporadic and maybe 3-4 times per year for the first year after the vaccine. The second year I menstruated no more than 3 times, the third and year post vaccine I had maybe 1 period. This year I menstruated one time for two days. This is concerning, not so much for me, but for younger people who are trying to have babies.
Age: 77.0
Sex: M
Vaccine: COVID19, TDAP
Symptoms: Back pain, Pain in extremity, Pyrexia
Clinical narrative: patient stated he was running a fever and his left arm and back were aching, he stated he took some tylenol and it temporarily relieves the symptoms. I advised patient to seek medication attention if his symptoms became severe, if he developed a rash, or developed shortness of breath
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pruritus
Clinical narrative: BODY WIDE PRUITITS 15 MINUTES POST VACCINES.  ITCHING RESOLVED WITHIN 24 HOURS AFTER VACCINE ADMINISTRATION.
Age: 15.0
Sex: F
Vaccine: HPV9, IPV, TDAP, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Other language speaking pt here with dad and sibling. Language line interpreter #463318 and #425625 used in succession during appt. During assessment of vaccines it was determined that Tdap, IPV, HPV and VAR were needed. LMP- 05/20/25. NKA. No sig med hx per pts dad. All vaccines administered IM. Upon entering vaccines into database, it was realized that pt was already complete with VAR and therefore received an extra dose. Dad made aware and instructed on s/s to watch out for-temp over 104.0, seizures, sob, lethargy. Also instructed if any concerns or issues develop to RTC or seek ER care. Dad stated via interpreter "That is fine". Pt  BP taken on L arm-118/78, pulse-83. Medical Executive Director contacted due to nature of incident and received instructions to make pt aware of s/s to watch for as stated above. Pt remained in clinic 30 min after vaccines were administered and stated via interpreter "I feel fine".
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Patient returned(06/05/2025) one month later to receive the Hep A vaccine, however, his lab shows positive titers for Hep A. Pt reported that after he received the Hep B vaccine on 05/05/2025, that "a few hours" later he began experiencing nausea vomiting and diarrhea. Patient was seen in the ED the next day for these symptoms. Patient reports today that his symptoms improved.
Age: 1.42
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given Havrix 13 days early and off schedule.
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Induration, Peripheral swelling, Tenderness
Clinical narrative: Patient came to the pharmacy to report that she had a severe localized reaction to Gardasil. She said that her arm is very swollen, tender, and hard to the touch. We advise her to apply cold compresses and referred to her doctor for evaluation.
Age: 39.0
Sex: M
Vaccine: COVID19, TDAP
Symptoms: Arthralgia, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: shoulder pain and declined ROM within 2 hours of shots and lasting over 4 weeks. limiting activities
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Joint swelling, Pain
Clinical narrative: Multiple arthralgias and multiple swollen joints. acute diarrhea, body pain. Started approx 24 hours after vaccination, causing intense pain.
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Swelling
Clinical narrative: pt presented with swelling and erythema.  No fever noted
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site rash, Injection site warmth
Clinical narrative: 1 day after the vaccine, a rash showed up on Left thigh near injection site It started to spread and has spread across her thigh, it's hot to touch. No fevers. Patient seen in office 3 days after vaccines given and diagnosed with cellulitis at injection site. patient started on cephalexin to treat infection
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Starting experiencing tingling in extremities (hands, and feet) yesterday.  Today (6-5-2025) starting experiencing tingling on tongue
Age: 55.0
Sex: F
Vaccine: HPV9, PNC20, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: patient stated that the same day she received the 3 vaccines she began experiencing itching, redness, and swelling in the area of her arm that the vaccines were given,...the area became larger after a 6 day time frame
Age: 21.0
Sex: F
Vaccine: HEP, HEP, HEP, HEP, HEPAB
Symptoms: Antibody test negative, Expired product administered, Incomplete course of vaccination
Clinical narrative: they got an antibody test and it came negative; incomplete course of vaccination; patients received an expire dose of Engerix-B; This non-serious case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 21-year-old female patient who received HBV (Engerix B) (batch number PE9G5, expiry date 19-MAY-2025) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis, HBV (Engerix B) for prophylaxis, HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On 28-MAY-2025, the patient received the 4th dose of Engerix B. The patient did not receive the 2nd dose of Twinrix, on an unknown date, the patient received the 3rd dose of Engerix B, the 2nd dose of Engerix B and the 1st dose of Engerix B. On 28-MAY-2025, an unknown time after receiving Engerix B and not applicable after receiving Twinrix, Engerix B, Engerix B and Engerix B, the patient experienced expired vaccine used (Verbatim: patients received an expire dose of Engerix-B). On an unknown date, the patient experienced therapy non-responder (Verbatim: they got an antibody test and it came negative) and incomplete course of vaccination (Verbatim: incomplete course of vaccination). The outcome of the therapy non-responder, expired vaccine used and incomplete course of vaccination were not applicable.   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: 28-MAY-2025 Nurse called and reported that one of their patients received an expire dose of Engerix-B, the vaccination date was 28-May-2025 and the vaccine was expired since 19-May-2025, which led to expired vaccine used. The patient had 3 doses a long time ago, so this was the 5th dose, they had 3 doses when they were a child, and then they were going to school, colleague, and they got an antibody test and it came negative, which led to Therapy non-responder. So they want attempt start over, so she had a Twinrix on 20-Apr-2025. Till the time of reporting the patient did not receive the second dose of Twinrix, which led to incomplete course of vaccination.
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, HEPA, HIBV, MENB, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Product Storage error with vaccine administration outside stability conditions / some patients got vaccinated with those products; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis, HBV (Engerix B) for prophylaxis, Hib (Hiberix) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis and DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patients received Bexsero, Boostrix, Engerix B, Hiberix, Havrix, Infanrix, Kinrix, Menveo and Pediarix. On an unknown date, an unknown time after receiving Bexsero, Boostrix, Engerix B, Hiberix, Havrix, Infanrix, Kinrix, Menveo and Pediarix, the patient experienced incorrect storage of drug (Verbatim: Product Storage error with vaccine administration outside stability conditions / some patients got vaccinated with those products). The outcome of the incorrect storage of drug was not applicable.   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: 02-JUN-2025 The Vaccine Administration Facility was the same as Primary Reporter. The Medical Assistant called to report about a below freezing temperature excursion and reactively mentioned that he/she not aware of this information and some patients got vaccinated with those products. According to Medical Assistant precision, multiple patients were vaccinated Bexsero, Boostrix, Engerix B, Hiberix, Havrix, Infanrix, Kinrix, Menveo and Pediarix which led to incorrect storage of drug. No specific information about vaccination date, vaccine detail and patient demographics were obtained in this call  No further information was obtained in this call.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Product Used; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HBV (Engerix B) (batch number D23D3, expiry date 15-MAR-2025) for prophylaxis.   On 02-JUN-2025, the patient received Engerix B. On 02-JUN-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired Product Used). The outcome of the expired vaccine used was not applicable.   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:03-JUN-2025 The reporter reported that administration of an expired dose of Engerix-B the day before reporting to a patient, which led to expired vaccine used. The reporter asked if there was any data on when to repeat the dose of Engerix-B. The reporter consented to follow up.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: Incorrect Preparation/nurses administered just the diluent portion; Incorrect Preparation/nurses administered just the diluent portion; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 41-year-old female patient who received MMR (Priorix) (batch number 32YB4, expiry date 01-DEC-2026) for prophylaxis.   On 02-JUN-2025, the patient received Priorix. On 02-JUN-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Incorrect Preparation/nurses administered just the diluent portion) and inappropriate dose of vaccine administered (Verbatim: Incorrect Preparation/nurses administered just the diluent portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   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: 03-JUN-2025 The reporter had one of our nurses administered just the diluent portion, missed to combine the vial, the powder and just wanted to know when they should try to re-administer the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (expiry date 31-MAR-2025) for prophylaxis.   On 02-JUN-2025, the patient received Arexvy. On 02-JUN-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date:03-JUN-2025 Pharmacist reported that a patient received Arexvy the day before reporting, which led to expired vaccine used. The reporter consented to follow up
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix + Late 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 female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 18-FEB-2021, the patient got the first 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: Shingrix + Late 2nd dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 03-JUN-2025 The pharmacist called to confirm if what a physician said was true. The physician said Shingrix should be restarted if more than 6 months had passed after the first dose. The reporter did not consent to follow-up. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired dose administered.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB030A, expiry date 30-APR-2025) for prophylaxis.   On 03-JUN-2025, the patient received Menveo. On 03-JUN-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Expired dose administered.). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 03-JUN-2025 The reporter had a patient received Menveo at the time of reporting, but it was expired, which led to expired vaccine used. They were wondering when we should revaccinate. The reporter consented to follow up by email.
Sex: F
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: A female patient around 50 years old received Havrix on 2018 and did not complete the series.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 50-year-old female patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (received one dose in 2018).   On an unknown date, the patient did not receive Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incomplete course of vaccination (Verbatim: A female patient around 50 years old received Havrix on 2018 and did not complete the series.). The outcome of the incomplete course of vaccination was not applicable.   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: 03-JUN-2025 The reporter called to report that a patient around 50 years old who received a dose of Havrix on 2018 and had not completed the dosing schedule for Havrix.  The reporter asked if she could get Twinrix. The reporter consented to follow up. Till the time of reporting, the patient did not receive the further dose of Havrix, which led to incomplete course of vaccination.
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Kinrix plus use as 4th Dtap; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate schedule of vaccine administered in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Kinrix plus use as 4th Dtap). The outcome of the inappropriate schedule of vaccine administered was not applicable.   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: 03-JUN-2025 Patient got Kinrix last year when she was behind on vaccine, still 5 years old and still behind on Dtap and polio which led to inappropriate schedule of vaccine administered. The reporter enquired could she do a 2nd Kinrix this year.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: now want to receive 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 male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2023 with batch number YC51Y7).   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: now want to receive 2nd dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 04-JUN-2025 The registered pharmacist wanted to know how to proceed with a patient that received the first dose of Shingrix back in 2023 and now wanted to receive the second dose. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expiration date was on 17 March 2025, and it was administered to a 22 year old; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received HBV (Engerix B) (batch number XS27B, expiry date 17-MAR-2025) for prophylaxis.   On 04-JUN-2025, the patient received the 1st dose of Engerix B. On 04-JUN-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: expiration date was on 17 March 2025, and it was administered to a 22 year old). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 04-JUN-2025 On 4 June 2025 a pharmacist of called to asked how to proceed after the administration of an expired dose of Engerix-B.  The expiration date was on 17th March 2025, and it was administered to a 22 year-old female patient on 4 June 2025, which led to Expired vaccine used. It was for the first dose.  The reporter was consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: One lady had neuropathy; This female subject of an unknown age was involved in an other study and received COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) for COVID-19 prophylaxis. The report describes a case of NEUROPATHY PERIPHERAL (One lady had neuropathy).     No Medical History information was reported.    On an unknown date, the subject received dose of COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (unknown route) 1 dosage form at an unspecified frequency. On an unknown date, the subject experienced NEUROPATHY PERIPHERAL (One lady had neuropathy) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (One lady had neuropathy) outcome was unknown.        The action taken with COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (Unknown) was unknown.   For COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (Unknown), the reporter did not provide any causality assessments.   ID was reported as DCP-0420-25. Regulatory Authority name was reported as mRNA-1083 Life Cycle Management Concept Evaluation.  Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2025-786903 (E2B Linked Report).       Most recent FOLLOW-UP information incorporated above includes: On 22-May-2025: Live follow up received that contains no new information. On 26-May-2025: Live follow up received that contains no new information. On 27-May-2025: Live follow up received that contains significant information includes added Regulatory Authority number and narrative was updated.; Reporter's Comments: The reporter causality for the event was not provided. The company causality was assessed conservatively as related to the vaccine in the context of limited information available. The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-786903:Female patient
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Syncope
Clinical narrative: I had a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine; I had a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine; This male subject of an unknown age was involved in an other study and received COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) for COVID-19 prophylaxis. The report describes a case of IMMUNISATION REACTION (I had a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine) and SYNCOPE (I had a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine).     No Medical History information was reported.   On an unknown date, the subject received dose of COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (unknown route) 1 dosage form at an unspecified frequency. On an unknown date, received dose of COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (unknown route) dosage was changed to 1 dosage form at an unspecified frequency. On an unknown date, the subject experienced IMMUNISATION REACTION (I had a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine) (seriousness criterion medically significant) and SYNCOPE (I had a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine) (seriousness criterion medically significant). At the time of the report, IMMUNISATION REACTION (I had a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine) and SYNCOPE (I had a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine) outcome was unknown.        For COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (Unknown), the reporter did not provide any causality assessments.   ID was reported as DCP-0420-25.  Regulatory Agency name was reported as mRNA-1083 Life Cycle Management Concept Evaluation.  Concomitant medication use information was not provided by reporter.  It was reported that there was a surgeon who had a horrible reaction. He collapsed during surgery after the vaccine, and he just did not want to take the vaccine. He had taken two doses and did not want to take it. The reporter thought that vaccine side effects were a significant issue as well.  Treatment medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2025-786903 (E2B Linked Report).       Most recent FOLLOW-UP information incorporated above includes: On 22-May-2025: Live follow up received that contains no new information. On 26-May-2025: Live follow up received that contains no new information. On 27-May-2025: Live follow up received that contains significant information includes ID number was added, and narrative was updated.; Reporter's Comments: Company comment: The causality for the events was not provided by the reporter and is assessed as related to the vaccine based on close temporal association, in the absence of alternative explanation. The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-786903:Master case
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersomnia
Clinical narrative: she had a headache and that she slept for a full day/couldn't think about doing much, other than sleeping; she had a headache and that she slept for a full day; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (she had a headache and that she slept for a full day/couldn't think about doing much, other than sleeping) and HEADACHE (she had a headache and that she slept for a full day) in a 79-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     The patient's past medical history included Open heart surgery (recent heart surgery - valve repair, maze procedure, atrial abutment (Sep-1993)) in September 1993, Heart valve operation (Recent heart surgery - valve repair) in September 1993 and Cox-Maze procedure (Maze procedure) in September 1993. Previously administered products included for Product used for unknown indication: Pfizer vaccine (previous vaccine dose). Past adverse reactions to the above products included No adverse effect with Pfizer vaccine. Concurrent medical conditions included Blood pressure high (high blood pressure (normal yesterday 26-May-2025)).    On 23-May-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. In May 2025, the patient experienced HYPERSOMNIA (she had a headache and that she slept for a full day/couldn't think about doing much, other than sleeping) and HEADACHE (she had a headache and that she slept for a full day). The patient was treated with Paracetamol (Tylenol) in May 2025 at an unspecified dose and frequency. In May 2025, HYPERSOMNIA (she had a headache and that she slept for a full day/couldn't think about doing much, other than sleeping) and HEADACHE (she had a headache and that she slept for a full day) had resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient received the Spikevax (2024-2025) vaccination early on Friday of last week (23-May-2025) and had a reaction to it. She had a headache and that she slept for a full day. After receiving her dose, she was unable to think about doing much, other than sleeping. The reporter denied any severe pain.  She had roughly 10 COVID vaccines, all Moderna except 1 Pfizer. She had contacted Moderna before, after receiving her first vaccine, as she experienced a really strange reaction but everything kind of settled itself. The reporter stated that it was not catastrophic, but just unusual. Patient did not recall what her reaction was. No other details provided.  It was unknown if the patient experienced any additional symptoms/events. Patient's reactions were resolved with a couple of Tylenol.   This case was linked to MOD-2021-049524 (Patient Link).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: feeling under the weather; headaches/she stated headaches mainly; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling under the weather) and HEADACHE (headaches/she stated headaches mainly) in a 72-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced MALAISE (feeling under the weather) and HEADACHE (headaches/she stated headaches mainly). At the time of the report, MALAISE (feeling under the weather) and HEADACHE (headaches/she stated headaches mainly) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       No concomitant medication was reported. The patient got weaker reaction. She had headaches mainly and felt under the weather. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-787139 (E2B Linked Report). This case was linked to MOD-2021-030965 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2025: Live Follow up contains significant information received: event verbatim updated for headaches, Outcome of event feeling under the weather updated to recovered from unknown and reference added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-787139:Mother case
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: had covid once in august 2022; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had covid once in august 2022) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. In August 2022, the patient experienced COVID-19 (had covid once in august 2022). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency. In 2022, COVID-19 (had covid once in august 2022) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Negative) tested negative twice.     The action taken with mRNA-1273 (Spikevax) (Intramuscular use) was unknown.       No concomitant medication was reported. The patient was scheduled to receive the Spikevax 24-25 vaccine; however, due to its expiration, he decided against taking it. He was advised to wait until the fall season for the new vaccine, as the previous version was no longer available. He had already received 7 doses and contracted COVID-19 once in August 2022. He mentioned that when he had COVID-19, it was on a Monday, and after visiting the doctor, he was prescribed a pill. Five days later, he recovered and tested negative twice. He reported experiencing no side effects, as he took Tylenol. Reporter causality was not reported.   Reporter did not allow further contact