chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site discomfort, Injection site swelling, Injection site warmth, Pain, Pain in extremity
Clinical narrative: Day 3 post vaccination family called and reported hives to bilat knees and elbows. Right eye slight swelling / puffy. Recommended benadryl, hydrocortisone cream topically for itching.  Advised ER if worsening or symptoms of distress. Urgent care / extended care if benadryl not helping. Day 7 post vaccination family called and reported severe pain in Right Arm, had been giving benadryl daily x 1 week. Appointment scheduled at Extended Care (clinic after hours care). On exam reported the above and also: rash started 2 days after vaccinations, right arm pain, itching over joints and eye swelling x 6 days. Timeline: 8/9 vaccinated, 8/10 intense itching to groin, back, joints. Woke up with welts to knees, elbows, and swelling to bilat eyes. Took 2 benadryl in the afternoon that day and one before bed. Continued 1 benadryl daily x 6 days. On exam: Moderate swelling to bilat eyelids, right deltoid mildly swollen with some increased warmth, discomfort over deltoid when stretching arm across chest. Treatment: Benadryl 2 tabs that evening, then 1 tab every 8 hours as needed; Zyrtec 1 tab every AM for at least the next 1-2 weeks; Ibuprofen 2 tabs every 8 hours x 1 day, then as needed. Ice massage or cool pack to arm several times over next 24 hours. Follow up with PCP 1-2 weeks.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Periorbital swelling, Pruritus, Rash, Urticaria
Clinical narrative: Day 3 post vaccination family called and reported hives to bilat knees and elbows. Right eye slight swelling / puffy. Recommended benadryl, hydrocortisone cream topically for itching.  Advised ER if worsening or symptoms of distress. Urgent care / extended care if benadryl not helping. Day 7 post vaccination family called and reported severe pain in Right Arm, had been giving benadryl daily x 1 week. Appointment scheduled at Extended Care (clinic after hours care). On exam reported the above and also: rash started 2 days after vaccinations, right arm pain, itching over joints and eye swelling x 6 days. Timeline: 8/9 vaccinated, 8/10 intense itching to groin, back, joints. Woke up with welts to knees, elbows, and swelling to bilat eyes. Took 2 benadryl in the afternoon that day and one before bed. Continued 1 benadryl daily x 6 days. On exam: Moderate swelling to bilat eyelids, right deltoid mildly swollen with some increased warmth, discomfort over deltoid when stretching arm across chest. Treatment: Benadryl 2 tabs that evening, then 1 tab every 8 hours as needed; Zyrtec 1 tab every AM for at least the next 1-2 weeks; Ibuprofen 2 tabs every 8 hours x 1 day, then as needed. Ice massage or cool pack to arm several times over next 24 hours. Follow up with PCP 1-2 weeks.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dysphagia, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: PATIENT COMPLAINED OF SORE THROAT COULDNT SWALLOW FOR A DAY ,  HIGH FEVER/CHILLS, VERY CONGESTED AND POUNDING HEADACHE. SHE WENT URGENT CARE ON 8/15
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Respiratory tract congestion
Clinical narrative: PATIENT COMPLAINED OF SORE THROAT COULDNT SWALLOW FOR A DAY ,  HIGH FEVER/CHILLS, VERY CONGESTED AND POUNDING HEADACHE. SHE WENT URGENT CARE ON 8/15
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red area, raised, warm to touch, swelling,
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Metastases to central nervous system, Metastases to spine, Metastatic neoplasm, Neoplasm malignant
Clinical narrative: Turbo Cancer rapidly spread throughout her body, eventually winding up in her spine and brain and taking her life.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: pt was given 3rd dose of shingrx. was only suppose to get 2. no reaction happened and pt was informed.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: CHILD RECEIVED DTAP, POLIO AND HIB TOO EARLY. SHE GOT THE VACCINES AT AGED 3 YEARS, WHEN THEY WERE REALLY AT 4 YEARS OLD. NO SYMPTOMS OR PROBLEMS FOR THE CHILD PER PARENT. NOTIFIED MOM AND DID LET HER KNOW THAT CHILD WOULD NEED THIS SET OF VACCINES AT AGE 4.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Proquad administered along with a Varicella. No adverse reaction at this time.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Mom noticed last pm that her right leg was red warm and swollen.  Mom drew a perimeter around it and it has gotten bigger, more red, more warm, and harder to the touch.  She has not had a fever and is walking normally on it. She is not complaining of pain.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Blister, Culture wound, Injection site erythema, Injection site reaction, Injection site vesicles
Clinical narrative: Proquad and Kinrix both given in left thigh on 8/15. Mom noticed redness and blisters at injection site the following day. Evaled in office on 8/17. Doctor's note describes "left leg with large area of erythema with multiple small bullae". Given location of rash, thought to be related to Proquad injection site. Patient prescribed cephalexin and mupirocin to treat possible cellulitis.
Age: 56.0
Sex: F
Vaccine: FLUC3
Symptoms: Echocardiogram, Electrocardiogram, Laboratory test, Malaise, Somnolence
Clinical narrative: Patient described typical post vaccine symptoms of general malaise and sleepiness. By the third day, patient said she felt like she was having a panic or heart attack and was admitted to the hospital for further evaluation and testing. Has had cardiac issues in the past.
Age: 36.0
Sex: F
Vaccine: IPV, TYP, YF
Symptoms: Lymphadenopathy, Muscle contractions involuntary, Muscle twitching, Pain in jaw, Toothache
Clinical narrative: Patient reports left sided jaw/tooth pain that started one day after receiving YF and IPV vaccine. States it feels like nerves are twitching/fasciculating.  Has taken Motrin with relief of pain, but fasciculations have gotten worse over the last week. Has an appointment in one week with dentist. Also reports swollen gland on left side after receiving vaccine, but that has improved.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Abdominal X-ray, Abdominal discomfort, Abdominal distension, Abdominal pain, Intussusception
Clinical narrative: on 5/30 patient was  taken to  ER for guiac positive stool and abdominal pain; by that evening progressed to worsening of abdominal discomfort bloating  and distention. upon imaging showed ileocolic intussusception
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Occult blood positive, Ultrasound abdomen
Clinical narrative: on 5/30 patient was  taken to  ER for guiac positive stool and abdominal pain; by that evening progressed to worsening of abdominal discomfort bloating  and distention. upon imaging showed ileocolic intussusception
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site infection
Clinical narrative: (PRIVACY) called in to let us know Pt had a reaction to the Dtap vaccine she received on Tuesday, August 13, 2024. Mom said the side was red and went to clinic on 8/14/2024 and was told child had Cellulitis/ Tissue Infection, was prescribed Keflex. She did call our facility to let us know and sent in pictures.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Fall, Feeling abnormal, Feeling hot, Head injury, Hyperhidrosis
Clinical narrative: patient walked out of the immunization room and said he was feeling weird- vision blurred, warm and sweating.  Fell back on ground striking the back of his head.  Was very pale.  Mom sat him down on a bench. We have him ice packs and water. Sat for about 30 minutes and then felt better.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pallor, Vision blurred
Clinical narrative: patient walked out of the immunization room and said he was feeling weird- vision blurred, warm and sweating.  Fell back on ground striking the back of his head.  Was very pale.  Mom sat him down on a bench. We have him ice packs and water. Sat for about 30 minutes and then felt better.
Age: 1.42
Sex: M
Vaccine: DTAPIPV, MMR, PNC20
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There were no symptoms or signs to my knowledge
Age: 31.0
Sex: F
Vaccine: HEPA
Symptoms: Chills, Hyperhidrosis, Joint lock, Pyrexia, Vomiting
Clinical narrative: patient reported fever, chills, sweats, throwing up and her thumb joint locked up
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Exposure during pregnancy
Clinical narrative: I received the TDAP vaccine at 28 weeks pregnant as recommended. My expected due date is November 5, 2024. I have been pregnant one prior time with a healthy delivery of a baby. My pregnancy thus far has been uneventful. No chronic conditions. No concerning blood pressures or on all recommended testing. I received the vaccine on 28 weeks one day. About 20 minutes after the vaccination I began to experience hearing loss in my left ear. My environment had not changed after getting the vaccine. I do not take any other medication?s. I was seen urgently by ENT the next day and confirmed hearing loss.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: sore arm
Age: 83.0
Sex: F
Vaccine: TDAP
Symptoms: Arthropod bite, Asthenia, Fatigue, SARS-CoV-2 test negative
Clinical narrative: Client called the following week and said the rest of the day following her vaccine, she was very tired. She had a bug bite that afternoon. On the morning of 8/2/24, she felt very weak and had to lay down on the floor in the bathroom.  As the day went on, she gradually felt better.  She took a COVID test that day which was negative.  Her BP was OK. She has been drinking more fluids and electrolytes.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Interchange of vaccine products, Product administration error, Wrong product administered
Clinical narrative: Had already received engerix hepatitis B vaccine. Was erroneously given heplisav B instead of next engerix.  I was not the one who saw the patient, i reviewed the chart as she was coming for another visit. She did not come in but she discussed this with NP who originally made error on 8/14/24.
Age: 7.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: pt presented with catch up vaccines. Should have given pt Tdap per CDC recommendation, but instead gave pt Dtap per school nurse request as well as per Infanrix packagint (6 weeks to 7 years of age). Pt reported no adverse effect. advised parents to vaccinate pt Tdap around ages 10-11.
Age: 37.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: Patient phoned into pharmacy experiencing "splotchy" rash at injection site which is slightly warm to the touch.  Based on feedback with the patient during phone call, the rash appears consistent with erythema/injection site swelling noted in the Prevnar20 Prescribing Information.  This rash developed about 24 hours after vaccination, patient will monitor and seek additional medical treatment if necessary.  No other adverse events noted at this time.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Patient in clinic to receive final booster for Gardasil, however inadvertently received Hep B instead. No history of pt receiving Hep B previously. Pt to return later for correct booster(s).
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event other than the nurse gave the Comirnaty vaccine to an 11 tear old. Not supposed to give until 12 or older.
Age: 0.08
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Pt was given 2 doses of the PCV 20 at this visit
Age: 61.0
Sex: M
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: administered only diluent, no reconstituted vaccine component
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: The patient said she had an adverse reaction to a tetanus vaccine 10 years ago.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Per patient report, one hour after receiving the varicella vaccination (dose #2), she developed transient hives near the injection site, then all over her body.  She tried benadryl at home with limited relief.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Pediatric patient was given an adult dose.
Age: 1.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The child was too young for the vaccine.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash on Torso
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was given outside the timeframe recommended by the manufacturer.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient given Covid19 vaccine that had a beyond use date of 2/27/2024, no signs or symptoms at the time of injection
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was given outside the timeframe recommended by the manufacturer.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was given outside the timeframe recommended by the manufacturer.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Muscular weakness, Nodule, Pain in extremity
Clinical narrative: my left arm has been hurting for about 3 weeks and I been trying to figure out did I lift something wrong or anything, but I noticed I had a large knot in my arm still and I haven't gotten anymore vaccines other than the tdap. I can't carry anything with my left arm, I can't sleep on my left arm, I can't reach to my back and scratch with my left arm, it hurts badly
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Per pt: I woke up with a sunburn like rash that slightly iched on just my face and puffy feeling lips on Sunday morning.   Not sure if it could be from the Shingles vaccine but thought I should document it.  I wear sunscreen on my face and didn't have any sunburn on any other body part so pretty sure was not a true sunburn.  Applied Aloe and took benadryl and it is much better today.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Vaccine was given outside the timeframe recommended by the manufacturer. patient reports sore arm/fatigue x 2 days
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Oligomenorrhoea, Pain, Pyrexia
Clinical narrative: Flu like symptoms (fever, chills, body aches) and missed menstruation. Never had missed a period previously. Period was due that week of the vaccine and it never came.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Pyrexia
Clinical narrative: pt started with fever 102 for 2 days after kinrix. fevers have lasted for 7 days in total . mom concerned about 2nd dose of kinrix as pt hasn' been vaccinated before. Oldest sibling of pt had prolonged fever after Dtap vaccine, post vacccine encephalopathy
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Adult dose of Havrix was accidentally administered to patient instead of pediatric dose on 8/15/2024. Parent was notified 8/19/2024 and denied any localized or generalized adverse reactions.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Adult dose of Hepatitis A was accidentally administered to patient instead of pediatric dose.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pediatric child was given the Adult dose of Vaqta - Child had no adverse effects from the medication.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Asthenia, Blood glucose normal, Dizziness, Nausea, Syncope
Clinical narrative: At around 8:45 AM, patient received PCV20 vaccine after appointment with her PCP. Patient had syncopal episode shortly after vaccine administration.  Patient had symptoms of nausea, vomiting, dizziness, and weakness. Patient never lost consciousness but was fearful of moving so she remained seated on the ground while receiving treatment. Patient had normal vital signs throughout incident, including normal blood glucose. Patient was evaluated throughout the incident by her PCP and an urgent care physician, Dr. Patient received about 200 ml of normal saline prior to EMS arrival. Patient was advised to go to emergency room for further evaluation.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Vomiting
Clinical narrative: At around 8:45 AM, patient received PCV20 vaccine after appointment with her PCP. Patient had syncopal episode shortly after vaccine administration.  Patient had symptoms of nausea, vomiting, dizziness, and weakness. Patient never lost consciousness but was fearful of moving so she remained seated on the ground while receiving treatment. Patient had normal vital signs throughout incident, including normal blood glucose. Patient was evaluated throughout the incident by her PCP and an urgent care physician, Dr. Patient received about 200 ml of normal saline prior to EMS arrival. Patient was advised to go to emergency room for further evaluation.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: MMR II vaccine was administered IM instead of SQ per RN error.  Pt tolerated immunization well, no adverse reaction. RN realized error upon documentation and went to supervisor immediately.
Age: 8.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: DTaP administered in lieu of TDaP due to a clerical error. No noted adverse effects. Patient will be following up with clinic.
Age: 1.58
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient did not have an adverse reaction, patient a 2nd dose of varicella and hep a to soon , the patient received these injections 2 months apart
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product preparation error
Clinical narrative: No PQC/additional AE reported; After the vaccinations, I learned that it is crucial to shake the vaccine vial thoroughly before administering the injection. Unfortunately, the healthcare provider who gave me the injections did not perform this step.; I am writing to inquire about the correct administration of the Gardasil 9 vaccine; After the vaccinations, I learned that it is crucial to shake the vaccine vial thoroughly before administering the injection. Unfortunately, the healthcare provider who gave me the injections did not perform this step.; I am writing to inquire about the correct administration of the Gardasil 9 vaccine; This spontaneous report has been received by a consumer, regarding themselves, a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not provided.   On 01-JUN-2024, the patient was vaccinated with first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, frequency, route of administration, vaccination scheme, site of administration, lot #, and expiration date were not provided) as a prophylaxis. On 01-AUG-2024, the patient was vaccinated with second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, frequency, route of administration, vaccination scheme, site of administration, lot #, and expiration date were not provided) as a prophylaxis.    After the vaccinations, the patient learned that it was crucial to shake the vaccine vial thoroughly before administering the injection. Unfortunately, the healthcare provider who administrated the injections did not perform this step (product preparation issue onset dates: 01-JUN-2024 and 01-AUG-2024). The patient was concerned that this oversight may had compromised the vaccine's efficacy (product with quality issue administered onset dates: 01-JUN-2024 and 01-AUG-2024). No further information was provided. No adverse event was reported.   Lot # were being requested and will be submitted if received.
Sex: F
Vaccine: HPV9
Symptoms: Maternal exposure before pregnancy, Pregnancy
Clinical narrative: a patient who has started the GARDASIL 9 series but becomes pregnant; No additional AE; This spontaneous report was received from a Physician via a Company Representative and referred to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient became pregnant (Exposure during pregnancy). No additional adverse event. The patient's last menstrual period (LMP) estimated due date (EDD) was not reported. The pregnancy outcome was outcome pending. The fetal outcome was unknown.  Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 12-15 month old female patient received 2 doses of MMRII previously (dates unknown); Confirmed no other AE occurred; This spontaneous report has been received from a nurse concerning to a female patient (age reported as: 12-15 month). The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter.  On unspecified dates, the patient was vaccinated with the first and second doses of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) injection (strengths, doses, routes and anatomical locations of administration, lot numbers and expiration dates were not provided) administered as prophylaxis (inappropriate schedule of product administration). It was confirmed that no adverse event occurred.   This is one of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-2408USA004139:
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, Product colour issue
Clinical narrative: Before administration of Jynneos vaccine suspension was clear but not cloudy pale yellow; Before administration of Jynneos vaccine suspension was clear but not cloudy pale yellow; Jynneos vaccine was administered intramuscularly instead of subcutaneously; Case reference number US-BN-2024-002283 is a spontaneous case initially received from a pharmacist via Communications (reference number: USBAV24-1837) on 31-Jul-2024 and concerns a male patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (batch number: unknown), at an unknown dose, administered intramuscularly in unknown site of administration for monkeypox. As reported before administration of Jynneos vaccine suspension was clear but not cloudy pale yellow (explicitly coded as 'product discoloration', 'product administration error' and 'inappropriate route of vaccination').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 01-Aug-2024: included product quality complaint number (QE-011597).; Reporter's Comments: A male patient of unknown age was vaccinated with a dose of Jynneos, intramuscularly for monkeypox. As reported before administration of Jynneos vaccine suspension was clear but not cloudy pale yellow, which is considered as product discoloration, product administration error and inappropriate route of vaccination. It was unknown if the patient experienced any adverse event due to Jynneos. Product colour issue, product administration error and incorrect route of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product colour issue, product administration error and incorrect route of product administration are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age was vaccinated with a dose of Jynneos, intramuscularly for monkeypox. As reported before administration of Jynneos vaccine suspension was clear but not cloudy pale yellow, which is considered as product discoloration, product administration error and inappropriate route of vaccination. It was unknown if the patient experienced any adverse event due to Jynneos. Product colour issue, product administration error and incorrect route of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product colour issue, product administration error and incorrect route of product administration are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Induration
Clinical narrative: Patient received the Jynneos vaccine and experienced induration on arm; Case reference number US-BN-2024-002231 is a spontaneous case initially received from other health care professional via Communications (reference number: USBAV24-1732) on 22-Jul-2024 and concerns a male patient of unknown age.  The patient's medical history and concomitant medication were not provided.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (batch number: unknown), at an unknown dose, route and site of administration, for unknown indication.  On an unspecified date, unknown amount of time after the dose, the patient experienced induration on arm.  At the time of the initial report, the outcome for the event of induration was unknown, also stated as lasting five weeks.  The reporter assessed the event of induration as not related to Jynneos, while the causality assessment for the same event was not provided.  No further information was provided.; Reporter's Comments: A male patient experienced induration on arm, an unknown amount of time after vaccination with Jynneos, given at unspecified site, route or dose. Site unspecific induration is unlisted and unlabeled per the CCDS v7.0 and RA for Jynneos. Medical history was unknown. As reported, the symptom had been lasting for five weeks. Considering the lack of alternative etiology, the event is assessed as related.; Sender's Comments: A male patient experienced induration on arm, an unknown amount of time after vaccination with Jynneos, given at unspecified site, route or dose. Site unspecific induration is unlisted and unlabeled per the CCDS v7.0 and RA for Jynneos. Medical history was unknown. As reported, the symptom had been lasting for five weeks. Considering the lack of alternative etiology, the event is assessed as related.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; Burning; itching; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), burning sensation (Verbatim: Burning) and pruritus (Verbatim: itching). The outcome of the vaccination failure, shingles, burning sensation and pruritus were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and pruritus to be related to Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine. It was unknown if the company considered the shingles, burning sensation and pruritus to be related to Shingles vaccine.   Additional Information: GSK receipt date: 09-AUG-2024 This case was reported by a patient via interactive digital media. The patient stated that shingles gave horrible burning and itching twice. The patient could not even stand water. When patient got the vaccine, it did not work. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK Shingles vaccine.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of expired vaccine used in a 11-year-old female patient who received HBV (Engerix B pediatric) (batch number A9349, expiry date 19-APR-2024) for prophylaxis.   On 08-AUG-2024, the patient received the 1st dose of Engerix B pediatric .5 ml. On 08-AUG-2024, an unknown time after receiving Engerix B pediatric, the patient experienced expired vaccine used (Verbatim: Expired vaccine used). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-AUG-2024 The patient received expired Engerix-B pediatric, which led expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: wo weeks after my shot, it was on my face near my eye,; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of facial herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced facial herpes zoster (Verbatim: wo weeks after my shot, it was on my face near my eye,). The outcome of the facial herpes zoster was not reported.   It was unknown if the reporter considered the facial herpes zoster to be related to Shingles vaccine.     It was unknown if the company considered the facial herpes zoster to be related to Shingles vaccine.   Additional Information: GSK receipt date: 09-AUG-2024 This case was reported the patient via interactive digital media. The patient had the vaccine and two weeks after the shot, it was on the face near the eye, eye doctor gave eye drops to the patient. This is 1 of the 4 linked cases, by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: nothing stops the pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (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: nothing stops the pain). The outcome of the pain was not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-AUG-2024 This case was reported by patient itself. The patient had tried everything and nothing stops the pain. The patient had been vaccinated.
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: Patient got one twinrix shot on 2006 and then another on 2012; and hasn't got the third dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 47-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Previously administered products included twinrix (on 2006 received 1st dose).   On an unknown date, the patient received the 2nd dose of Twinrix and the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix and not applicable after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Patient got one twinrix shot on 2006 and then another on 2012) and incomplete course of vaccination (Verbatim: and hasn't got the third dose yet). The outcome of the drug dose administration interval too long was unknown and the outcome of the incomplete course of vaccination was not reported.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 09-AUG-2024 A reporter reported that a patient got one twinrix shot on 2006 and then another on 2012 and hadn't got the third dose yet.  The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of twinrix later than the recommended interval, which led to lengthening of the vaccine schedule. Till the time of reporting the patient had not received the 3rd dose of twinrix, which led to incomplete course of vaccination.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue, Single component of a two-component product administered
Clinical narrative: only the liquid portion of Menveo had been given the same day; only the liquid portion of Menveo had been given the same day; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 02-AUG-2024, the patient received Menveo. On 02-AUG-2024, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: only the liquid portion of Menveo had been given the same day) and inappropriate dose of vaccine administered (Verbatim: only the liquid portion of Menveo had been given the same day). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-AUG-2024 The other health professional reported that a dose of Menveo that had been adequately reconstituted after only the liquid portion of Menveo had been given the same day, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  The other health professional provided limited data on vaccine, patient and event.  The Vaccine Administration Facility was the same as Primary Reporter
Age: 9.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: an adult vaccine of Engerix-B was given to a 9-year-old patient; Overdose; 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 9-year-old female patient who received HBV (Engerix B) (batch number YY37B, expiry date 17-AUG-2026) for prophylaxis.   On 16-JUL-2024, the patient received Engerix B. On 16-JUL-2024, an unknown time after receiving Engerix B, the patient experienced adult product administered to child (Verbatim: an adult vaccine of Engerix-B was given to a 9-year-old patient) and overdose (Verbatim: Overdose). The outcome of the adult product administered to child and overdose were 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: 09-AUG-2024 An adult vaccine of Engerix-B was given to a 9-year-old patient, which led adult product administered to child and overdose. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Incorrect route of product administration
Clinical narrative: Maladministration of Bexsero via Parenteral Routes other than Intramuscular; This non-serious case was reported by a physician via call center representative and described the occurrence of intramuscular formulation administered by other route in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced intramuscular formulation administered by other route (Verbatim: Maladministration of Bexsero via Parenteral Routes other than Intramuscular). The outcome of the intramuscular formulation administered by other route 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: 09-AUG-2024 Doctor has a 17 year-old female patient who received Bexsero second dose below the muscle, it was an incorrect session which led to intramuscular formulation administered by other route. The case was linked with US2024098186, same reporter.; Sender's Comments:  US-GSK-US2024098186:Same reporter
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration, Laboratory test abnormal
Clinical narrative: got her second dose 11 days after first dose instead of 7 days; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX).   In AUG-2024, the patient received the 2nd dose of Twinrix. In AUG-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: got her second dose 11 days after first dose instead of 7 days). The outcome of the drug dose administration interval too long 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: 09-AUG-2024 Nurse was taking accelerated dosing schedule for Twinrix first Twinrix dose 29 July 2024. She had issue with the lab tests and were not very good and that's why she waited to get the second dose, but her labs were back to normal. Then got her second dose 11 days after first dose (instead of 7 days) and she was going on a plane 28th of August 2024 so she needed to take the third dose (third dose was within frame). The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: administered Shingrix first dose without mixing the vaccines ( without the powder)/ Maladministration of the AS01B Adjuvant of Shingrix Alone; administered Shingrix first dose without mixing the vaccines ( without the powder)/ Maladministration of the AS01B Adjuvant of Shingrix Alone; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number HH44K, expiry date 17-MAY-2026) for prophylaxis.   On 09-AUG-2024, the patient received the 1st dose of Shingrix. On 09-AUG-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administered Shingrix first dose without mixing the vaccines ( without the powder)/ Maladministration of the AS01B Adjuvant of Shingrix Alone) and inappropriate dose of vaccine administered (Verbatim: administered Shingrix first dose without mixing the vaccines ( without the powder)/ Maladministration of the AS01B Adjuvant of Shingrix Alone). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-AUG-2024 The nurse reported that one of her medical assistant administered 1st dose of Shingrix without mixing the vaccines (without the powder), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 4.0
Sex: M
Vaccine: HIBV
Symptoms: Extra dose administered
Clinical narrative: fifth dose of Hiberix was administered inadvertently to a 4-year-old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 4-year-old male patient who received Hib (Hiberix) (batch number 545JY) for prophylaxis.   Previously administered products included Hiberix (received 4 doses on an unknown date).   On 09-AUG-2024, the patient received the 5th dose of Hiberix. On 09-AUG-2024, an unknown time after receiving Hiberix, the patient experienced extra dose administered (Verbatim: fifth dose of Hiberix was administered inadvertently to a 4-year-old patient). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 09-AUG-2024 The nurse reported that, on the day of reporting a fifth dose of Hiberix was administered inadvertently to a 4 year old patient, which led to extra dose administered.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Expired dose administered.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-year-old female patient who received MMR (Priorix) (batch number L322P, expiry date 01-AUG-2024) for prophylaxis.   On 05-AUG-2024, the patient received Priorix. On 05-AUG-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: Expired dose administered.). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 09-AUG-2024 A nurse reported that a dose of Priorix that expired on 01 Aug 2024 was administered to a patient which led to expired vaccine administered.  The vaccine administration facility was the same as primary reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: the shingrix vaccine and we had a little miss out with the diluent vial; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 2KD99, expiry date 18-APR-2026) for prophylaxis.   On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: the shingrix vaccine and we had a little miss out with the diluent vial). The outcome of the inappropriate preparation of medication was unknown.   Additional Information: GSK Receipt Date: 09-AUG-2024 A pharmacist reported that he/she were reconstituting a Shingles, the shingrix vaccine and we had a little miss out with the diluent vial and so, he/she currently have one vial that had the power in it but he/she don't had the diluent to mix it are you able to provide me with a replacement.  The vaccine was not yet administered we're calling to have a diluent replacement and administer the dose complete.
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: LPN gave a pediatric dose of Engerix-B to an adult patient; LPN gave a pediatric dose of Engerix-B to an adult patient.; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 64-year-old female patient who received HBV (Engerix B pediatric) (batch number F5L5E, expiry date 11-APR-2025) for prophylaxis.   On 10-JUL-2024, the patient received the 2nd dose of Engerix B pediatric. On 10-JUL-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: LPN gave a pediatric dose of Engerix-B to an adult patient) and adult use of a child product (Verbatim: LPN gave a pediatric dose of Engerix-B to an adult patient.). The outcome of the underdose was unknown and the outcome of the adult use of a child product was not reported.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-AUG-2024 The nurse (Licensed practical nurse) gave a pediatric dose of Engerix-B to an adult patient, which led to underdose and adult use of a child product.  The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Extra dose administered, Heart rate increased
Clinical narrative: fast heartbeat; Extra dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of heartbeats increased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2023) and Shingrix (1st dose received in 2023).   On 08-AUG-2024, the patient received Shingrix and INFLUENZA VACCINE. On 08-AUG-2024, an unknown time after receiving Shingrix and an unknown time after receiving INFLUENZA VACCINE, the patient experienced extra dose administered (Verbatim: Extra dose). On 09-AUG-2024, the patient experienced heartbeats increased (Verbatim: fast heartbeat). The outcome of the heartbeats increased was not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the heartbeats increased to be related to Shingrix.     It was unknown if the company considered the heartbeats increased to be related to Shingrix.   Additional Information: GSK receipt date: 09-AUG-2024 The reporter was the patient. She received two doses of Shingrix last year (2023). She mistakenly received a third dose of Shingrix on 8 August 2024 along with her flu vaccine (manufacturer unknown) which led to extra dose administered. The next day (9 August 2024) she felt like her heartbeat was fast. Nothing else was reported. It was unknown if the reporter considered the heartbeats increased to be related to Influenza vaccine.