chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Injection site bruising, Injection site discolouration, Injection site pain, Injection site reaction
Clinical narrative: Patient had soreness in injection area and woke up next morning of July 17 with red rash around site and  bruising at site.  After awaiting for it to get better, the rash spread some and area very sore with movement of arm and injection site was warm to touch.  The injection was received on Tuesday  7-16-24 and I called the office on the following Friday and was told to put ice on area and take Tylenol.  On Monday 7-22-24 I was seen by the Doctor because bruise had turned yellow and was still surrounded by the red itchy rash.  I have also had some slight light headed feeling as well.  The Doctor reassured me that I would be fine after a few days and recommended ice for 20 minutes in evening and take Tylenol.  Today it has been a week since the injection and the area is still red and  a little itchy.  I just wanted to let this program know so you would be aware of the reaction.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site warmth, Pain, Rash erythematous, Rash pruritic
Clinical narrative: Patient had soreness in injection area and woke up next morning of July 17 with red rash around site and  bruising at site.  After awaiting for it to get better, the rash spread some and area very sore with movement of arm and injection site was warm to touch.  The injection was received on Tuesday  7-16-24 and I called the office on the following Friday and was told to put ice on area and take Tylenol.  On Monday 7-22-24 I was seen by the Doctor because bruise had turned yellow and was still surrounded by the red itchy rash.  I have also had some slight light headed feeling as well.  The Doctor reassured me that I would be fine after a few days and recommended ice for 20 minutes in evening and take Tylenol.  Today it has been a week since the injection and the area is still red and  a little itchy.  I just wanted to let this program know so you would be aware of the reaction.
Age: 27.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: At time of injection: Burning pain at injection site. The morning after injection: hard raised bump approx 3" diameter around injection site (tender to the touch), muscular deltoid pain on injection side.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dyskinesia, Mydriasis, Pallor, Posture abnormal, Unresponsive to stimuli
Clinical narrative: 2:25 PM. As I was removing the 3rd needle from the client's arm, he slumped forward, his L arm jerked into a 90 degree angle, both legs started having slight jerking movements. I shook his L shoulder and he couldn't answer me nor move  for about 30 seconds. He then raised his head-both eyes completely dilated & he asked what happened-very pale lips. We had him lean forward again & gave him 4 oz of ginger ale to drink (no food since cereal this AM). BP at 2:33 was 101/87. HR 61. He continued to talk to us, sipped the ginger ale & by 2:40, he was able to stand & walk w/o stumbling. He waited another 15 minutes with his father and then left the HD. I advised his father to seek a medical exam as this is the first time he has experienced these symptoms. Father says there is a family hx of not tolerating shots well.
Age: 1.42
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: PHN gave dose of Hep A to one year old. Hep A dose was supposed to be given. Vaccine was administered at 3:20, and the error was noticed at 3:30. PHN notified supervisor, email was sent to state and family was notified. PHN discussed with family the side effects to look out for. Health department initiated protocol and will continue to follow the required steps.
Age: 6.0
Sex: F
Vaccine: TD
Symptoms: Wrong product administered
Clinical narrative: Td given instead of Dtap.  Patient has previously received 3 of 5 required Dtap doses.  Patient tolerated vaccine well. VIS given. Advised parents of possible side effects. Name of otc meds for soreness and/or fever given. on call nurse notified, supervisor notified.  Patient is a refugee and case manager was notified.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No Adverse
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Interchange of vaccine products
Clinical narrative: Pt received second dose of Men B but it was a different Brand than the first dose so is not valid and will need another dose in 6 months to be complete.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Altered state of consciousness, Glassy eyes, Pallor, Syncope, Tremor
Clinical narrative: Patient left the building with her mother immediately following vaccine administration after being instructed to wait 15 minutes. Mother returned to office saying patient was fainting. When observed, patient was conscious but was glass eyed, pale, slightly trembling, and non- verbal. Mother stated patient hadn?t eaten anything since 8:00pm yesterday, July 22, 2024. Patient slowly regained complete awareness and ability to speak. Was alert and oriented X4. Motor skills okay. Symptoms lasted less than 5 minutes. Totally recovered within 15 minutes of symptom onset.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No Adverse
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Vaccine error, injection given as IM rather than SQ.  GSK called to find out next steps.  Research cited during call states that immunogenicity and reactions very similar regardless of IM or SQ injection and repeat of the vaccine is not needed.  There was no adverse reaction for the patient and patient has been notified.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: NO ADVERSE REACTIONS NOTED. VACCINE ADMINISTERED OUSIDE OF TIME FRAME RECOMMENDED BY THE MANUFACTUREER.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reactions noted. vaccine administered outside of time frame recommended by the manufacturer
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: On 7/22/2024, this 19 year old patient was administered a Hep A vaccine indicated for ages 12 months through 18 years.  Patient had no adverse reaction from this vaccine
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Tdap administered to 5 yr old child. No signs or symptoms of adverse effects.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reaction. vaccine was administered outside the timeframe recommended by the manufacturer.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reactions. vaccine administered outside of timeframe recommended by the manufacturer.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Feeling of body temperature change, Hyperhidrosis, Tremor
Clinical narrative: PATIENT CAME BACK YESTERDAY TO ASK FOR A PROOF OF VACCINATION TO SUBMIT TO EMPLOYER. HE SAID AFTER ABOUT 12 HOURS LATER AFTER RECIEVING VACCINE, HE FELT HOT AND COLD, SWEATING, CHILL, SHAKING, JOINT PAIN. THOSE SYMPTOMS WERE LAST FOR ABOUT 3 DAYS. TODAY, HE CAME BACK AND SAID IT'S BETTER NOW. HE VISITED A LOCAL URGENT CARE AND THEY SAID HE MAY HAVE ALLERGIC REACTION TO ONE OF THOSE COMPONENTS OF THE VACCINE.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse reactions noted. Vaccine was administered outside the timeframe recommended by the manufacturer.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Apnoeic attack, Choking, Cyanosis, Oral administration complication, Underdose
Clinical narrative: Patient ingested half of vaccine aliquot, appeared to choke on the liquid and became apneic and cyanotic around mouth for 10 seconds. Spontaneously started breathing again with normal O2 sat following a few back blows and suctioning. Patient observed in ED following episode and discharged home after a couple of hours.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Nurse called to report a 4 month old was administered ROTATEQ on 6/25/2024, that expired on 6/21/2024. Nurse confirmed no symptoms or side effects reported. Expired dose of ROTATEQ was supported by the post expiry memo. No additional AE/no PQC.; This spontaneous report has been received from a nurse, referring to a 4-month-old patient of unknown gender. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not reported.  On 25-JUN-2024, the patient was vaccinated with expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 mL, once, lot# 1947648, expiry date 21-JUN-2024, for prophylaxis (route of administration and anatomical location were not reported) (expired product administered). No symptoms or side effects reported (no adverse event).
Sex: M
Vaccine: VARCEL
Symptoms: Central venous catheterisation, Ophthalmic herpes zoster
Clinical narrative: "was on IV everything" because the shingles involved the nerves around his eye; This spontaneous report was received from company representative on 14-JUL-2024 and refers to a male patient who is un his 20's. The patient's medical history was not reported. The patient's concurrent conditions included inflammatory bowel disease. Concomitant medications included adalimumab (HUMIRA).   On an unknown date (reported as he was a child), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for immunisation (strength, dose description, lot #, expiry date, and route of administration were not provided) (reported as chickenpox vaccine).  On an unknown date, was recently hospitalized at the Hospital for shingles and "was on IV everything" because the shingles involved the nerves around his eye (ophthalmic herpes zoster). He was discharged from the hospital after 5 days with a peripherally inserted central catheter (PICC) line to continue IV therapy. At the time of the report, the outcome of ophthalmic herpes zoster was not reported. The action taken with the suspect vaccine regarding the event was not applicable.  The causal relationship between ophthalmic herpes zoster and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported. Upon internal review,ophthalmic herpes zoster was determined to be medically significant.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No addtional AE; improper storage product in use; This spontaneous report was received from a medical assistant and refers to a 4-year-old male patient.  The patient's pertinent medical history and drug reactions/allergies and concomitant medication were not reported.  On 05-JUN-2024, the patient  was vaccinated with improper storage first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, lot #w028734, expiration date: 08-SEP-2024, administered in the right arm for prophylaxis (strength, dose and route of administration were not provided); first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # X018954, expiration date: 13-JUL-2025, administered in the right arm for prophylaxis (strength, dose and route of administration were not provided); and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX), lot #5AY2J, expiration date: 10-JUN-2024, administered in the left arm for prophylaxis (strength, dose, formulation, and route of administration were not provided) at the private doctor's office/hospital (Product storage error). The temperature excursion occurred as a result of a reading from a Digital Data Logger. No prior temperature excursions but multiple current temperature excursions. It was reported that 16 different excursions began on 22-APR-2024 but were identified "last week" between 10-JUN-2024 to 14-JUN-2024. No additional adverse event (AE) was reported (No adverse event).  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2406USA005882:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse event; HCP states patient received 1st GARDASIL 9 on 10/18/2022 and 2nd vaccine on 7/17/2024.  No other information provided.  No additional AEs or PQC reported.  DDP not sent as HCP declined.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 18-OCT-2022, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided). On 17-JUL-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) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided). No additional adverse events or product quality complaints reported (inappropriate schedule of product administration and no adverse event).
Age: 1.0
Sex: F
Vaccine: MMR, PNC20, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; Improper storage of product in use; This spontaneous report was received from medical assistant and refers to an 1-year-old female patient. No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided  On 13-MAY-2024, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, lot #w035041, expiration date: 24-MAY-2024 (upon internal review, it was determined to be a valid lot number) administered for prophylaxis (strength, dose, and anatomical route of administration were not provided); varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #x010531, expiration date: 11-APR-2025 (upon internal review, it was determined to be a valid lot number) administered for prophylaxis (strength, dose, and anatomical route of administration were not provided); and pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) (strength, formulation, lot #, expiry date, anatomical route of administration, and indication were not provided).  It was reported that the vaccines were administered following as temperature excursion (temperature and previous temperature excursions were not reported) (product storage error). No additional adverse events.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2406USA005882:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; Improper storage of product in use; This spontaneous report was received from medical assistant and refers to a 4-year-old female. No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided  On 26-APR-2024, the patient was vaccinated with improperly stored doses measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, lot #W035041, expiration date: 24-MAY-2024, (upon internal review, it was determined to be a valid lot number) administered for prophylaxis (strength, dose, and anatomical route of administration were not provided); varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X010531, expiration date:11-APR-2025, (upon internal review, it was determined to be a valid lot number) administered for prophylaxis (strength, dose, and anatomical route of administration were not provided); and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX) lot number 5AY2J (strength, formulation, expiry date, route of administration, and indication were not provided).  It was reported that the vaccines were administered following as temperature excursion (temperature and previous temperature excursions were not reported) (product storage error). No additional adverse events.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2406USA005882:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: super painful; Suspected vaccination failure; shingles; 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. In JUN-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). On an unknown date, the patient experienced pain (Verbatim: super painful). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain 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 and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-JUL-2024 This case was reported by a consumer via interactive digital media. The patient stated that, he/she was vaccinated, and he/she have had shingles for a month now (at the time of reporting), super painful. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK drug Shingles vaccine
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: patients often experience headache following Shingrix vaccination; This non-serious case was reported by a other health professional via sales rep and described the occurrence of headache in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: patients often experience headache following Shingrix vaccination). The outcome of the headache was resolved.   The reporter considered the headache to be related to Shingrix.     The company considered the headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-JUL-2024 The medical assistant stated that the patients often experience headache following Shingrix vaccination. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: my arm is sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13-JUL-2024, the patient received Shingles vaccine. In JUL-2024, less than a week after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: my arm is sore). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JUL-2024 The patient self-reported this case. The patient just got his/her Shingles vaccine yesterday (prior to reporting day) and his/her arm was sore.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Improper storage; This non-serious case was reported by a physician via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix) (batch number br2gd, expiry date 16-MAY-2025) for prophylaxis.   On an unknown date, the patient received Havrix .5 ml. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: Improper storage). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 17-JUL-2024 Healthcare professional called to report Havrix has been administered to patients following being improperly stored which led to incorrect storage of drug. Caller was unsure how many patients and did not have patient information. No further information was provided. No Additional adverse event, no PQC.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Inappropriate schedule of product administration, Somnolence
Clinical narrative: Tiredness; wanted to sleep all day; 2nd dose received late; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes simplex, shingles and shingles. Previously administered products included Shingrix (received 1st dose 4 years ago).   On 07-JUL-2024, the patient received the 2nd dose of Shingrix. On 07-JUL-2024, less than a day after receiving Shingrix, the patient experienced tiredness (Verbatim: Tiredness), sleepiness (Verbatim: wanted to sleep all day) and drug dose administration interval too long (Verbatim: 2nd dose received late). The outcome of the tiredness was resolved and the outcome of the sleepiness was not reported and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the tiredness and sleepiness to be related to Shingrix.     It was unknown if the company considered the tiredness and sleepiness to be related to Shingrix.   Linked case(s) involving the same patient:  US2024084972   Additional Information: GSK Receipt Date: 08-JUL-2024 The reporter was the patient. She received her first dose of Shingrix about 4 years ago. In March 2024, and again in May 2024, she had shingles on her buttock. She recovered from shingles about two weeks ago. She had her second dose of Shingrix day before reporting and was tired and wanted to sleep all day. Nothing else was reported. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. For tolerance of 1st dose refer case US2024084972.; Sender's Comments:  US-GSK-US2024084972:Same patient
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: patient received 3 doses of Havrix; This non-serious case was reported by a physician via sales rep and described the occurrence of extra dose administered in a 16-year-old male patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (On an unknown date, received first dose) and Havrix (On an unknown date, received second dose).   On 06-JUL-2024, the patient received the 3rd dose of Havrix. On 06-JUL-2024, an unknown time after receiving Havrix, the patient experienced extra dose administered (Verbatim: patient received 3 doses of Havrix). The outcome of the extra dose administered 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: 07-JUL-2024 Reporter reported that the patient received 3rd dose of Havrix instead of 2 doses, which led to extra dose administered. Reporter asked to be sent an email on how to explain to the patient's parent medically about receiving 3 doses of Havrix. No additional details provided, no to lot number and expiration date or previous dates of Havrix vaccines as it was unknown if administered at the same clinic. Reporter would like any data on the maladministration of a 3rd dose of Havrix to a patient.
Age: 30.0
Sex: F
Vaccine: HEP, HEP, HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Early 3rd dose of Engerix-B adult; Late 2nd dose of Engerix-B adult; Early 2nd dose of Havrix; 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 short in a 30-year-old female patient who received HBV (Engerix B adult) (batch number 7352x, expiry date 02-AUG-2026) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) (batch number 7mh25, expiry date 07-DEC-2025) for prophylaxis and HAV (Havrix) (batch number ahavb554aa) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE INACT (HAVRIX) and HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B ADULTO).   On 06-MAY-2024, the patient received the 3rd dose of Engerix B adult. On 06-FEB-2024, the patient received the 2nd dose of Engerix B adult. On 31-MAY-2012, the patient received the 2nd dose of Havrix. On 31-MAY-2012, not applicable after receiving Engerix B adult and Engerix B adult and an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: Early 2nd dose of Havrix). On 06-FEB-2024, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose of Engerix-B adult). On 06-MAY-2024, the patient experienced drug dose administration interval too short (Verbatim: Early 3rd dose of Engerix-B adult). The outcome of the drug dose administration interval too short, drug dose administration interval too long and drug dose administration interval too short 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-JUL-2024 The other health professional (medical assistant) reported that, a patient received 1st dose of Havrix on 26-APR-2012 with lot number ahavc532aa and received 2nd dose of Havrix earlier than the recommended interval which led to shortening of vaccination schedule. The patient received 1st dose of Engerix B adult on 25-APR-2012 and received 2nd dose of Engerix B adult longer than the recommended interval which led to lengthening of vaccination schedule and further the patient received 3rd dose of Engerix B adult earlier than the recommended interval which led to shortening of vaccination schedule. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: they administered Shingrix reconstituted with sterile diluent instead of the approved adjuvant; administered Shingrix reconstituted with sterile diluent instead of the approved adjuvant; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 2P5E9, expiry date 18-APR-2026) for prophylaxis.   On 02-JUL-2024, the patient received Shingrix. On 02-JUL-2024, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: they administered Shingrix reconstituted with sterile diluent instead of the approved adjuvant) and inappropriate dose of vaccine administered (Verbatim: administered Shingrix reconstituted with sterile diluent instead of the approved adjuvant). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 09-JUL-2024 The nurse reported that they administered Shingrix reconstituted with sterile diluent instead of the approved adjuvant which led to, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered  The reporter consented to the follow up.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: 4 year old male patient was administered a dose of Priorix on 04Jun2024 from lot number 3247X, which had an expiration date of 11May2024.; 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 4-year-old male patient who received MMR (Priorix) (batch number 3247X, expiry date 11-MAY-2024) for prophylaxis.   On 04-JUN-2024, the patient received the 2nd dose of Priorix. On 04-JUN-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: 4 year old male patient was administered a dose of Priorix on 04Jun2024 from lot number 3247X, which had an expiration date of 11May2024.). 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-JUL-2024 The reporter was a medical assistant. The reporter reported that a patient was administered an expired dose of Priorix, wich led to expired vaccine sued. At the time of reporting, a repeat dose had not been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Vision blurred
Clinical narrative: lightheaded; blur vision; This non-serious case was reported by a consumer via call center representative and described the occurrence of light headedness in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of musculoskeletal stiffness (1st dose received in MAR-2024).   In MAY-2024, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced light headedness (Verbatim: lightheaded) and blurred vision (Verbatim: blur vision). The outcome of the light headedness was resolved and the outcome of the blurred vision was resolving.   It was unknown if the reporter considered the light headedness and blurred vision to be related to Shingrix.     It was unknown if the company considered the light headedness and blurred vision to be related to Shingrix.   Linked case(s) involving the same patient:  US2024085126   Additional Information: GSK Receipt Date: 09-JUL-2024 The patient reports that the 2nd dose was administered at the end of May 2024 and felt lightheaded and had blur vision. The patient reports that the blur vision has improved but has not resolved. The reporter consented for follow up was not requested.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Wrong diluent used; Wrong diluent used; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a specified number of patients 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 wrong solution used in drug reconstitution (Verbatim: Wrong diluent used) and inappropriate dose of vaccine administered (Verbatim: Wrong diluent used). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 10-JUL-2024 The reporter administered a dose of Shingrix to a patient and only the powder was used along with a sterile diluent, not the adjuvant that comes with the Shingrix which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. It was unclear which one of 4 patients was given a Shingrix vaccine with just the powder and a sterile diluent. It was recommended that the patient who did not receive the adjuvant be revaccinated as we did not know which patient out of the 4 did not receive the full dose, what was the risk or effect of administering an extra dose of Shingrix to the 3 who did receive the whole dose of Shingrix.
Age: 0.75
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a staff member gave Kinrix to a 38 week, 1 day old infant, instead of Pediarix; The infant had 2 doses of Dtap previously and this would have been the 3rd.; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 38-week-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   Previously administered products included Dtap and Dtap.   On 10-JUL-2024, the patient received Kinrix. On 10-JUL-2024, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: a staff member gave Kinrix to a 38 week, 1 day old infant, instead of Pediarix) and inappropriate age at vaccine administration (Verbatim: The infant had 2 doses of Dtap previously and this would have been the 3rd.). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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: 10-JUL-2024 Executive director of nursing states that today, a staff member gave Kinrix to a 38 week, 1 day old infant, instead of Pediarix, which led inappropriate age at vaccine administration and wrong vaccine administered. The reporter reported this suspect would have been the 3rd dose. The patient was 15 lbs, 12 oz (7.144 kg), 25 inches long with a body mass index (BMI) of 17.72.  The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix early second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number ly93m, expiry date 09-JUN-2026) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 29-JUN-2024, the patient received the 2nd dose of Shingrix. On 29-JUN-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Shingrix early second dose). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 12-JUL-2024 The patient received 2nd dose of Shingrix earlier than recommended interval, which led to shortening of vaccination schedule.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination, Product dose omission issue
Clinical narrative: missed the second 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 58-year-old female patient who received HAB (Twinrix adult) for prophylaxis.   Previously administered products included Twinrix adult (received 1st dose on 23rd January 2024).   On an unknown date, the patient did not receive the 2nd dose of Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult, the patient experienced incomplete course of vaccination (Verbatim: missed the second dose). The outcome of the incomplete course of vaccination 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: 12-JUL-2024 Pharmacist had patient that got a first Twinrix dose on January and missed the second dose, which led to incomplete course of vaccination. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up. The case is linked with US2024087713, by same reporter.; Sender's Comments:  US-GSK-US2024087713:SAme reporter/Different patient
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: reconstituted with sterile water diluent instead of the supplied AS01B adjuvant; reconstituted with sterile water diluent instead of the supplied AS01B adjuvant; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-JUL-2024, the patient received Shingrix. On 11-JUL-2024, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with sterile water diluent instead of the supplied AS01B adjuvant) and inappropriate dose of vaccine administered (Verbatim: reconstituted with sterile water diluent instead of the supplied AS01B adjuvant). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 12-JUL-2024 Pharmacist reported that a provider contacted her regarding a dose of Shingrix that was reconstituted with sterile water diluent that comes with MMR vaccine instead of the supplied AS01B adjuvant which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. The dose was administered to a patient on 11 July 2024. The reporter did not have the dose lot number / expiration date information. The reporter did not have any patient specific information. At the time of call, a repeat dose had not been administered.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: gave a patient an expired Energix-B adult vaccine; 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 52-year-old female patient who received HBV (Engerix B adult) (batch number 25K3M, expiry date 02-JUN-2024) for prophylaxis.   On 12-JUL-2024, the patient received Engerix B adult. On 12-JUL-2024, an unknown time after receiving Engerix B adult, the patient experienced expired vaccine used (Verbatim: gave a patient an expired Energix-B adult vaccine). 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: 12-JUL-2024 The reporter work for a family practice.  One of the employees gave a patient an expired Energix-B adult vaccine, which led to expired vaccine used. The reporter wanted to check on the efficacy of this vaccine as it was expired. Consented to follow up.
Sex: F
Vaccine: MENB
Symptoms: Erythema, Injection site bruising
Clinical narrative: Bruise around the injection site was normal, as any vaccine; pink red lines that looks like the lymph ducts/ 4 straight lines; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 23-year-old female patient who received Men B NVS (Bexsero) (batch number 2X955, expiry date 31-JAN-2026) for prophylaxis.   On 29-JUN-2024, the patient received Bexsero. On an unknown date, less than a day after receiving Bexsero, the patient experienced injection site bruising (Verbatim: Bruise around the injection site was normal, as any vaccine) and red hands (Verbatim: pink red lines that looks like the lymph ducts/ 4 straight lines). The outcome of the injection site bruising and red hands were not resolved.   It was unknown if the reporter considered the injection site bruising and red hands to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site bruising and red hands to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-JUL-2024 The patient received Bexsero and still have a bruise and pink red lines that looked like the lymph ducts. Patient sent a picture to the pharmacist and stated that there were 4 straight lines that showed up yesterday (day before reporting).  HCP believed that this occurred because patient had a cat and looked like scratch marks.  Bruise around the injection site was normal, as any vaccine.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: I have a 24 year old male that was given the hepatitis B vaccine but the pediatric dose; I have a 24 year old male that was given the hepatitis B vaccine but the pediatric dose"; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 24-year-old male patient who received HBV (Engerix B pediatric) for prophylaxis.   On 12-JUL-2024, the patient received Engerix B pediatric. On 12-JUL-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: I have a 24 year old male that was given the hepatitis B vaccine but the pediatric dose) and adult use of a child product (Verbatim: I have a 24 year old male that was given the hepatitis B vaccine but the pediatric dose"). The outcome of the underdose and adult use of a child product 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: 12-JUL-2024 The reporter had a patient who was given the hepatitis B vaccine but the pediatric dose which led to underdose and adult use of a child product. The reporter said that she did not have the lot number at hand but she can have it later.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18 July 2019  batch number HB2B2).   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: 2nd dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-JUL-2024 Pharmacist who had a patient that only received one dose of Shingrix, back in 2019 enquired what was the recommendation if she never received the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: staff commonly take it out of the fridge and leave it on the counter, sometimes for 12 hours and generally administer the vaccines after they have been left out of the refrigerator; 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 a patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: staff commonly take it out of the fridge and leave it on the counter, sometimes for 12 hours and generally administer the vaccines after they have been left out of the refrigerator). The outcome of the incorrect storage of drug 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: 12-JUL-2024 The pharmacy intern stated that their staff commonly took Engerix B vaccine out of the fridge and leave it on the counter, sometimes for 12 hours and reporter asked if they generally administer the vaccines after they have been left out of the refrigerator for the time stated, and she (staff) stated that they do, which led to incorrect storage of drug. The reporter was requesting above stability data for Engerix-B. The reporter did not ask for patient information or lot numbers as the HCP stated that this was a common occurrence at their facility. The reporter consent to follow up via postal.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix-B was administered after the expiry date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 30-year-old female patient who received HBV (Engerix B) (expiry date 12-JUL-2024) for prophylaxis.   On 15-JUL-2024, the patient received Engerix B. On 15-JUL-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B was administered after the expiry date). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 15-JUL-2024 Occupational Health nurse reported Engerix-B was administered after the expiry date to a patient which led to expired vaccine used. Expiry date was 12 July 2024 and it was administered today, 15 July 2024. The reporter did not have a lot information at time of call or exact date of birth for patient and stated patient was in her mid 30's.