chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.75
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Shipment/Delivery Issue; No side effects reported.; HCP calling to report VAQTA was administered after it experienced a temperature excursion.; This spontaneous report was received from a medical assistant referring to unknown number of patients with unknown age and gender. The medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, hepatitis A vaccine, inactivated (VAQTA) experienced temperature excursion at temperature 8.7 C, time frame: 11 minutes. No previous temperature excursion.   On 12-SEP-2024, the patients were vaccinated with hepatitis A vaccine, inactivated (VAQTA) intramuscular injection, lot #Y007585, expiration date: 31-OCT-2025, administered for prophylaxis (strength, dose, and route of administration were not provided) (Product storage error). HCP calling to report hepatitis A vaccine, inactivated (VAQTA) was administered after it experienced a temperature excursion. No side effects reported (No adverse event).  Follow up information was received on 30-OCT-2024 from the medical assistant, referring to a 21-month-old female patient. The case became valid as patient information was added.  On 12-SEP-2024, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) intramuscular injection 0.5 milliliter via right thigh (reported as right vastus lateralis) (lot #Y007585, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 31-OCT-2025), administered for prophylaxis.  It was reported that Shipment/Delivery Issue (Manufacturing product shipping issue) caused the temperature excursion. Room was left for too long during vaccine shipment.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No side effects reported; HCP calling to report an adult patient received a pediatric dose of RECOMBIVAX HB. No side effects reported. No additional information/clarification provided. No additional AE/no PQC.; This spontaneous report was received from a physician assistant referring to a 21-year-old male patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 18-OCT-2024, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # Y004552, expiration date 14-OCT-2026, 5 microgram (route of administration not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms reported; HCP reported administration of expired ROTATEQ to patient.  Product expired 9/18/2024 and was administered 10/23/2024.  No symptoms reported.  Consent to correspond was granted.  No additional AE/No PQC.; This spontaneous report has been received from a physician, regarding a 2-month-old patient of unknown gender. The patient's previous allergies, medical history, concurrent conditions, and concomitant medications were not provided.  On 24-OCT-2024 (also reported on 23-OCT-2024), the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, dose of 2 mL, orally administrated (strength, frequency, and vaccination scheme were not provided; lot # 1965569 which has been verified to be a valid number, expiration date reported and validated as 18-SEP-2024) as a prophylaxis. Moreover, the vaccine was administrated beyond expiration date (expired product administered). No symptoms were reported. No additional adverse event was provided. The product did not experienced any temperature excursion.
Sex: F
Vaccine: BCG
Symptoms: Vaccination site scar
Clinical narrative: : BCG vaccine left a scar that was normally pale, depressed and non-tender.; This spontaneous report was received from patient and refers herself, a female of unknown age. The patient's medical history and concomitant therapies were not reported.  On an unknown date (reported as over 30 years ago), the patient was vaccinated with bcg live (BCG VACCINE USP) powder for injection, administered for prophylaxis on left deltoid (strength, lot #, expiry date, and route of administration were not provided).    On an unknown date, the vaccination left a scar that was normally, pale, depressed and non-tender (Vaccination site scar).  The outcome of the event and causal relationship between the event and suspect vaccine was not provided, but the causality assessment was handled as related as per guidelines.  Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Dose #2 was given at the incorrect interval.  It was given 18 days after dose number one, which was given on 9/23/2024.  There were no adverse outcomes reported by the patient.
Age: 17.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: Erythema, Induration, Injection site pain, Pruritus, Skin warm
Clinical narrative: Painful to sight, warm, red,  hard, and itchy.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received adult dose of Moderna vaccine instead of the pediatric dose.  There were no adverse effects reported at this time.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Sever muscle pain and discomfort. Unable to lift arm up 90 degrees.  Mild relief with OTC NSAID.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Pt was given only the Hib mixed with Sterile Water instead of DTAP-IPV.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Hypoaesthesia, Paraesthesia
Clinical narrative: Chest tightness that lasted for 1 day. Numbness and tingling in left arm (elbow to hands) and left leg (knee to foot)
Age: 15.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Headache, Loss of consciousness, Posture abnormal, Skin discolouration
Clinical narrative: Roughly 2 minutes after receiving both the flu and COVID vaccines, patient stated she was feeling dizzy. Her mom was in the room and had her sit down in the chair. Immediately after sitting, patient slumped over and was passed out for ~10 seconds. She was pale and her color turned greenish. Her mom was there to hold onto her head, so she did not hit her head on anything. I took her blood pressure, which was around 100/50 initially. I gave her some candy and her brother got her a Gatorade. I had her continue sitting in the counseling room for over 20 minutes until she felt okay to get up and walk again. I took her blood pressure again before she left, which had gone up to 109/73. Patient also reported a headache, which her mom gave her Advil for. I informed patient to make sure to eat plenty of food and drink plenty of fluids (Gatorade and water).
Age: 17.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Blood pressure decreased, Fall
Clinical narrative: Patient fell to ground approximately 10-15 minutes after receiving the vaccines. He was able to quickly get back up with help from his mom. His mother helped him to the chair in our waiting area. We checked his blood pressure and it was 96/67. He also reported that he had not eaten much all day and had little appetite due to his adhd medication.  He also reported that low blood pressure runs in his family. His mom got a bottle of orange juice and he drank it. We waited another 10-15 minutes and check his blood pressure. It had risen to 115-68 and patient reported he was feeling fine. He waited a little while longer and left with his mom under his own power.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Chills, Dizziness, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Nausea, dizziness, swollen, red and painful injection site, slight tingling/numbness, vision loss after standing up quickly. Pale ness, sweating, chills/shivers.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea, Pallor
Clinical narrative: Nausea, dizziness, swollen, red and painful injection site, slight tingling/numbness, vision loss after standing up quickly. Pale ness, sweating, chills/shivers.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Nausea, dizziness, swollen, red and painful injection site, slight tingling/numbness, vision loss after standing up quickly. Pale ness, sweating, chills/shivers.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 10 years old and was given a 12 year and older COVID vaccine.
Age: 8.0
Sex: F
Vaccine: FLU3, HEP, HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient received her first Hep A Vaqta vaccine on 7/16/24. She received the second dose on 11/8/24, which was 2 months too soon. Patient did not seem to have any adverse reactions by the time she left the office. Mother of patient called about an hour after the appointment, stating that the patient was not due for the second Hep A dose, and that patient has had a history of having adverse reactions to vaccines in the past.
Age: 52.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; Received from the AE Self-Service Portal: Report submitted by Merck Employee. At FFM today, medical assistant reported that just this morning, a 52 year old female patient "insisted" on receiving Gardasil-9 at her checkup despite being told that; This spontaneous report was received from company representative and refers to a 52-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 29-OCT-2024 (reported as 'today'), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (1 dose, exact dose, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis, because at 'FFM', patient insisted on receiving that vaccine at her checkup despite being told that she was outside of the vaccine's age indication. The office administered the vaccine as requested by the patient (Off label use in unapproved age group). No additional AE/ No PQC (No adverse event).  Additional information is not expected.
Age: 0.92
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; dose of MMR II had a labeled expiration date of 10/21/2024 and the dose was administered to the patient on 10/22/2024; dose of MMR II had a labeled expiration date of 10/21/2024 and the dose was administered to the patient on 10/22/2024; This spontaneous report was received from a physician and refers to an 11-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-OCT-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 ml / two dose series, lot #X020654, expiration date reported as and upon internal review confirmed to be: 21-OCT-2024, administered for prophylaxis (route of administration and vaccination site were not provided) (inappropriate age at vaccine administration). The reporter stated that the dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) had a labeled expiration date of 21-OCT-2024 and the dose was administered to the patient on 22-OCT-2024 (expired product administered). The reporter confirmed that there have been no reports of the patient having any medical concerns or symptoms after being administered the expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The reporter was informed on validity of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administration using post-expiry memo and information provided in article. No additional information was provided. No additional adverse event (AE) and no product quality compliant (PQC) was reported (no adverse event).
Sex: M
Vaccine: PNC15, PNC21, PPV
Symptoms: Vaccination failure
Clinical narrative: An "inadequate" response to pneumococcal vaccination; Literature Report:  This literature-marketed information has been received from the authors of a published article, titled as above, regarding a currently 70-year-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions included chronic cough (dating back to the 1990s), cough variant asthma,  gastrooesophageal reflux disease (GERD), and chronic rhinosinusitis without nasal polyps (over the ensuing 30 years). Concomitant therapies were not reported.  On an unknown date, the patient started therapy with a pneumococcal vaccine (manufacturer unknown) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date (over the ensuing 30 years), the patient experienced an "inadequate" response to pneumococcal vaccination (manufacturer unknown). The patient's outcome was unknown.   The reporter considered an "inadequate" response to pneumococcal vaccination to be related to pneumococcal vaccine (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  Lot # is being requested and will be submitted if received.
Age: 8.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Type III immune complex mediated reaction
Clinical narrative: Arthus reaction is a type III hypersensitivity reaction, triggered by interaction between vaccine antigens and pre-existing IgG antibodies; Literature Report.       This literature marketed report has been received from the authors of the published article and refers an 8-year-old female patient.    The patient's medical history, concurrent conditions, and concomitant medications were not provided. The patient's historical vaccines included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (Tdap vaccine).   On unspecified date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (reported as polysaccharide vaccine) (manufacturer unknown) injection (strength, dose, frequency, route of administration, vaccination scheme, site of administration, lot #, and expiration date were not provided) as a prophylaxis.    On unspecified date reported as following vaccination, the patient experienced swelling, redness, and pain at vaccine injection site within several hours, resolving after one week. Therefore the patient was diagnosed with arthus reaction which was a type III hypersensitivity reaction, triggered by interaction between vaccine antigens and pre-existing IgG antibodies. At the reporting time, the outcome of the event was not provided.   The causal relationship between suspect vaccine with the event of type III immune complex mediated reaction was considered as related.    Upon internal review, the event of type III immune complex mediated reaction was considered as medically significant.   A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional adverse event; a 50 year old patient who was given the second dose of RECOMBIVAX after the recommended dosing interval. The patient received the first dose on 6/21/2024 and the second dose on 11/05/2024; This spontaneous report has been received from a nurse regarding a 50-year-old patient of unknown gender.   The patient's medical history, concurrent conditions, Concomitant therapies, past drug reactions and allergies were not reported.  On 21-JUN-2024, the patient was vaccinated with the first dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection. On 05-NOV-2024, the patient was vaccinated with the second dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB); both administered as prophylaxis (dose, lot number, expiration date, route of administration and anatomical site of injection were not provided for any of the administered doses) (Inappropriate schedule of product administration). The reporter denied having any additional information.   No additional adverse event was reported for the patient.
Age: 19.0
Sex: F
Vaccine: COVID19, HPV4, HPV9
Symptoms: Chest discomfort, Dyspnoea, Product origin unknown
Clinical narrative: chest tightness and shortness of breath; chest tightness and shortness of breath; hpv; This spontaneous report has been received from a consumer via Other Company regarding a 19-year-old female patient. The patient's concurrent conditions included food allergy. Her medical history, concomitant therapies, and previous drug reactions were not reported.  On 04-NOV-2024, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (strength, dose, vaccination scheme, route of administration, anatomical site of injection, lot number, and expiration date were not provided) (Product origin unknown). On that same date at 10:00:00, the patient was vaccinated with covid-19 vaccine (COVID-19 VACCINE), (strength, dose, vaccination scheme, indication, route of administration, anatomical site of injection, lot number, and expiration date were not provided).  On 04-NOV-2024 at 22:00, the patient experienced chest tightness and shortness of breath (Chest discomfort and Dyspnoea). On an unknown date in November 2024, the patient was admitted to the hospital due to the events. On an unknown date in November 2024, the patient started treatment with prednisone and albuterol for the events. The outcome of the events was not reported.   The causal relationship between chest discomfort and dyspnoea and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), and covid-19 vaccine (COVID-19 VACCINE) was not reported.
Sex: U
Vaccine: PNC15, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; Patient inadvertently received their fourth dose of VAXNEUVANCE on 06NOV2024 at the age of 9-months-old and also received a dose of ROTATEQ; This spontaneous report was received from other health care professional concerning a 9-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 06-NOV-2024, the patient was inadvertently vaccinated with the fourth dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, administered for prophylaxis (strength, dose, lot #, expiry date, route of administration, and anatomical location were not provided); and with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered for prophylaxis (strength, dose, lot #, and expiry date were not provided) (product administered to patient of inappropriate age). Past administration dates of the suspect vaccines were unknown by the reporter at the time of call. No additional adverse events (AE).  Lot # is being requested and will be submitted if received
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Vaccination failure
Clinical narrative: 4 Doses and Still Showing Low Titer Levels; 4 Doses and Still Showing Low Titer Levels; Initial report received on 26-Sep-2024.  A nurse reported that a 55-year-old male (race and ethnicity not provided) received four doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and was still showing low titer levels.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 27-Oct-2022, the patient received the first dose of a hepatitis B vaccine [HEPLISAV-B (lot #939672, expiration date 14-May-2024, and NDC # 43528-003-01)] intramuscularly in the right deltoid.   On 19-Dec-2022, the patient received the second dose of HEPLISAV-B (lot # 941054, expiration date 23-Nov-2024, and NDC # 43528-003-01) intramuscularly in the right deltoid.   On 13-Feb-2023, the patient received the third dose of HEPLISAV-B (lot # 941055, expiration date 29-Nov-2024, and NDC # 43528-003-01) intramuscularly in the right deltoid.   On 13-Mar-2023, the patient received the fourth dose of HEPLISAV-B (lot # 941581, expiration date 18-Jan-2025, and NDC # 43528-003-01) intramuscularly in the left deltoid.   On an unspecified date, in Jan-2024, after having been vaccinated with HEPLISAV-B the patient's titers levels was reported as "good" and then decreased to under the immunity threshold level.  No adverse events were reported.  No additional information was reported.   Company Comment: The company assessed the event as non-serious and not immunologically confirmed for vaccination failure. The serological marker and the time  of testing  was  not specified.; Sender's Comments: The company assessed the event as non-serious and not immunologically confirmed for vaccination failure. The serological marker and the time  of testing  was  not specified.
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Injection site pain
Clinical narrative: First dose in Feb-2024, Second dose in Sep-2024; Very Bad Arm Pain at the Injection Site; Initial report received on 26-Sep-2024.  A consumer reported that he, a male (age, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and received the second dose 7 months later and experienced very bad arm pain at the injection site.  Medical history and concomitant medications were not reported.  In Feb-2024, the patient received the first dose of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, and NDC #, route, and site not reported)] from a pharmacist.    On 24-Sep-2024, 226 days after receiving the initial dose, the patient received the second dose of HEPLISAV-B (lot #, expiration date, and NDC # not reported) in the upper right arm.  Concomitant vaccines administered included an unspecified influenza vaccine (lot#, expiration date, route not reported) in the upper left arm.  The same day that he received the second dose of HEPLISAV-B, the patient experienced very bad arm pain at the injection site.  It was described as pain in the right shoulder area for the first 24 hours.  The pain in the right shoulder area got better after doing some exercises.   The patient stated that he did not remember receiving the first dose of HEPLISAV-B.  No additional information was reported.    Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: F
Vaccine: RSV
Symptoms: Injection site discomfort
Clinical narrative: Injection site discomfort; This non-serious case was reported by a other health professional and described the occurrence of injection site discomfort in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 52z52, expiry date 16-OCT-2025) for prophylaxis.   Concomitant products included INFLUENZA VACCINE (INFLUENZA VACCIN).   On 11-OCT-2024, the patient received Arexvy (unknown arm). On 11-OCT-2024, less than a day after receiving Arexvy, the patient experienced injection site discomfort (Verbatim: Injection site discomfort). The outcome of the injection site discomfort was not reported.   It was unknown if the reporter considered the injection site discomfort to be related to Arexvy.     It was unknown if the company considered the injection site discomfort to be related to Arexvy.   Additional Information: GSK receipt date: 11-OCT-2024 Nurse Practionar reported that she was changing the needle that had been used to puncture both vials when the mixture suddenly flowed out of the syringe without any pressure on the plunger. She thought it was user error and drew up replacement dose new syringe & needle. She was not changed the needle which caused some discomfort to the patient which she stated was minor. On the day or reporting 10th October 2024 she drewed up a dose of Arexvy being careful to make sure the vaccine was well away from the end of the syringe while changing the needle. She placed the syringe on a clean paper towel that was covered a refrigerator temperature ice pack while reviewed the consent form and cleaned the patient's injection area.  When she picked up the syringe 1/4 cc was noted to be in the cap. She was unable to drawn all of the fluid back into the syringe 1/8 cc remained in the cap.  She started over and carefully changed the needle and injected the vaccine immediately. The needle seemed to not glided easily into the patient's arm, and she said she felt the difference from the flu shot that she had given in the opposite arm just a few minutes earlier. Both patients had a flu shot and an Arexvy in opposite arms. Both stated the Arexvy vaccine needle was uncomfortable, and the flu vaccine needle wasn't felt at all. This case has been linked to the US2024AMR126748 case reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR126748:same reporter
Sex: F
Vaccine: RSV
Symptoms: Discomfort, Syringe issue
Clinical narrative: Discomfort; This non-serious case was reported by a other health professional and described the occurrence of injection site discomfort in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 52z52, expiry date 16-OCT-2025) for prophylaxis.   Concomitant products included INFLUENZA VACCINE (INFLUENZA VACCIN).   On 11-OCT-2024, the patient received Arexvy (unknown arm). On 11-OCT-2024, less than a day after receiving Arexvy and an unknown time after receiving INFLUENZA VACCIN, the patient experienced injection site discomfort (Verbatim: Discomfort). The outcome of the injection site discomfort was not reported.   It was unknown if the reporter considered the injection site discomfort to be related to Arexvy.     It was unknown if the company considered the injection site discomfort to be related to Arexvy.   Additional Information: GSK receipt date: 11-OCT-2024 Nurse Practionar reported that she was changing the needle that had been used to puncture both vials when the mixture suddenly flowed out of the syringe without any pressure on the plunger. She thought it was user error and drew up replacement dose new syringe & needle. She was not changed the needle which caused some discomfort to the patient which she stated was minor. On the day or reporting 10th October 2024 she drewed up a dose of Arexvy being careful to make sure the vaccine was well away from the end of the syringe while changing the needle. She placed the syringe on a clean paper towel that was covered a refrigerator temperature ice pack while reviewed the consent form and cleaned the patient's injection area.  When she picked up the syringe 1/4 cc was noted to be in the cap. She was unable to drawn all of the fluid back into the syringe 1/8 cc remained in the cap.  She started over and carefully changed the needle and injected the vaccine immediately. The needle seemed to not glided easily into the patient's arm, and she said she felt the difference from the flu shot that she had given in the opposite arm just a few minutes earlier. Both patients had a flu shot and an Arexvy in opposite arms. Both stated the Arexvy vaccine needle was uncomfortable, and the flu vaccine needle wasn't felt at all. It was unknown if the reporter considered the discomfort to be related to Flu vaccine.; Sender's Comments:  US-GSK-US2024125531:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Product was not reconstituted, and two patients received the adjuvant only; Product was not reconstituted, and two patients received the adjuvant only; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of inappropriate preparation of medication in a specified number of patients who received Herpes zoster (Shingrix) (batch number FJ9A7, expiry date 16-JUL-2026) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Product was not reconstituted, and two patients received the adjuvant only) and inappropriate dose of vaccine administered (Verbatim: Product was not reconstituted, and two patients received the adjuvant only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date:  Other HCP reported that product was not reconstituted, and two patients received the adjuvant only. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Bexsero was exposed to 48.8 F for 78 hrs, 35 min; 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 female patient who received Men B NVS (Bexsero) (batch number TH9NR, expiry date 31-JAN-2027) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Bexsero was exposed to 48.8 F for 78 hrs, 35 min). 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: 08-OCT-2024 CMA stated that Bexsero was exposed to 48.8 Fahrenheit for 78 hours, 35 minutes. It was administered to a patient which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024123924:Same reporter/Different patient US-GSK-US2024123936:Same reporter/Different patient US-GSK-US2024123928:Same reporter/Different patient US-GSK-US2024123934:Same reporter/Different patient US-GSK-US2024123926:Same reporter/Different patient US-GSK-US2024123922:Same reporter/Different patient US-GSK-US2024123912:Same reporter/Different patient US-GSK-US2024123919:Same reporter/Different patient US-GSK-US2024123909:Same reporter/Different patient US-GSK-US2024123911:Same reporter/Different patient US-GSK-US2024123905:Same reporter/Different patient US-GSK-US2024123915:Same reporter/Different patient US-GSK-US2024123920:Same reporter/Different patient US-GSK-US2024123897:Same reporter/Different patient US-GSK-US2024123899: US-GSK-US2024123920:Same reporter/Different patient US-GSK-US2024123915:Same reporter/Different patient US-GSK-US2024123903:Same reporter/Different patient
Age: 79.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: receiving Arexvy on October of 2023, and then receiving Arexvy again on October 2024.; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 79-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (received 1st dose in October 2023).   In OCT-2024, the patient received the 2nd dose of Arexvy. In OCT-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: receiving Arexvy on October of 2023, and then receiving Arexvy again on October 2024.). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 09-OCT-2024 The patient self-reported this case. The patient received Arexvy 2 times which was in October of 2023 and then receiving Arexvy again in October 2024, which led to extra dose administered.
Sex: U
Vaccine: FLU3, MNQ, TDAP
Symptoms: Expired product administered
Clinical narrative: Vaccines were out of range for 9 days; 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 an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis and Flu Seasonal TIV Dresden (Fluarix) for prophylaxis.   On an unknown date, the patient received Menveo, Boostrix and Fluarix. On an unknown date, an unknown time after receiving Menveo, Boostrix and Fluarix, the patient experienced incorrect storage of drug (Verbatim: Vaccines were out of range for 9 days). 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: 10-OCT-2024  The other health professional (clinic manager) that the Fluarix, Menveo (1 vial), Boostrix vaccines exposed to 53 degree Fahrenheit.  The vaccines were out of range for 9 days. The other health professional confirmed that these vaccines were adminsitered but could not provide information about the number of patients involved in this situation.
Age: 0.08
Sex: F
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: patient received the diluent portion only of Hiberix; patient received the diluent portion only of Hiberix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 2-month-old female patient who received Hib (Hiberix) (batch number 4777F, expiry date 17-MAR-2026) for prophylaxis.   On 14-SEP-2024, the patient received Hiberix. On 14-SEP-2024, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: patient received the diluent portion only of Hiberix) and inappropriate dose of vaccine administered (Verbatim: patient received the diluent portion only of Hiberix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 10-OCT-2024 The nurse reported that a patient received the diluent portion only of Hiberix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. They did not knew which patient was the one receiving the non-reconstituted vaccine and asked how to proceed. The Vaccine Administration Facility was the same as Primary Reporter The case is 1 of the 5 linked case, by same reporter; Sender's Comments:  US-GSK-US2024125018:Same reporter/Diffrent patient US-GSK-US2024125020:Same reporter/Diffrent patient US-GSK-US2024125012:Same reporter/Diffrent patient US-GSK-US2024125010:Same reporter/Diffrent patient
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: a 16-year-old was given an adult hepA (Havrix); a 16-year-old was given an adult hepA (Havrix); This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 16-year-old female patient who received HAV (Havrix adult) for prophylaxis.   Previously administered products included Havrix (received first dose of Havrix on an unknown date).   On 03-OCT-2024, the patient received the 2nd dose of Havrix adult. On 03-OCT-2024, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: a 16-year-old was given an adult hepA (Havrix)) and adult product administered to child (Verbatim: a 16-year-old was given an adult hepA (Havrix)). The outcome of the overdose and adult product administered to child 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-OCT-2024. The other health professional (a medical assistant) reported that the 16 year old patient was given an adult hepatitis A (Havrix) which led to overdose and adult product administered to child. The Vaccine Administration Facility was the same as Primary Reporter
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: patient got an extra dose of Hepatitis A vaccine; This non-serious case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced extra dose administered (Verbatim: patient got an extra dose of Hepatitis A vaccine). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 10-OCT-2024 and 11-OCT-2024 The other health professional reported that the patient got an extra dose of Hepatitis A vaccine which led to extra dose administered and they requested to be contacted by GlaxoSmithKline medical Information to clarify a question in regards to that scenario.  The other health professional did not had any additional details on the adverse event.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Fear, Pain in extremity, Pruritus, Scab, Sensitive skin
Clinical narrative: her arms are still sensitive sometimes; arm still itches sometimes; she had a black scab; the patient reports that she still has a divot and a scar in her arm; afraid; pain in arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Smallpox vaccine (received her smallpox vaccine when she was 5 years old).   On 20-DEC-2023, the patient received Arexvy (left arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: pain in arm), sensitive skin (Verbatim: her arms are still sensitive sometimes), itchy upper limbs (Verbatim: arm still itches sometimes), scab (Verbatim: she had a black scab), scar (Verbatim: the patient reports that she still has a divot and a scar in her arm) and fear (Verbatim: afraid). The outcome of the pain in arm was resolved (duration 2 weeks) and the outcome of the sensitive skin, itchy upper limbs and scar were not resolved and the outcome of the scab was resolved and the outcome of the fear was unknown.   It was unknown if the reporter considered the pain in arm, sensitive skin, itchy upper limbs, scab, scar and fear to be related to Arexvy.     It was unknown if the company considered the pain in arm, sensitive skin, itchy upper limbs, scab, scar and fear to be related to Arexvy.   Additional Information: GSK receipt date: 10-OCT-2024 The patient received Arexvy vaccine and reported that she had pains in her arms for two weeks these pains in her arms started later, not the day the vaccine was administered (no specific date provided). The patient also reports that her arms was still sensitive sometimes, and still itches sometimes. She had a black scab, about the size of a sliver dollar, that formed where she received the vaccine. She still had a divot and a scar in her arm where she received the vaccine. She was afraid to receive another vaccine due to the adverse reactions she had from Arexvy. The patient reported that the administrator of the Arexvy vaccine, administered the vaccine where she received her Smallpox Vaccine when she was 5 years old. The patient did not provide lot number, expiry date and route of administration.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: an extra dose for one of my patients; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 4-year-old female patient who received HAV (Havrix) (batch number 7PK53, expiry date 04-MAR-2026) for prophylaxis.   Previously administered products included Havrix (received first dose of Havrix on an unknown date) and Havrix (received second dose of Havrix on an unknown date).   On 07-OCT-2024, the patient received the 3rd dose of Havrix. On 07-OCT-2024, an unknown time after receiving Havrix, the patient experienced extra dose administered (Verbatim: an extra dose for one of my patients). 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: 10-OCT-2024  The other health professional reported that he/she gave a Hepatitis a dose, an extra dose for one of his/her patient which led to extra dose administered. The other health professional reported that this was related to Havrix vaccine. The patient already had their dose scheme, and this inadvertently vaccine was the third Havrix dose. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: RVX
Symptoms: Intercepted product prescribing error
Clinical narrative: Medication Error- Intercepted/Potential; This non-serious case was reported by a consumer via call center representative and described the occurrence of intercepted product prescribing error in a 77-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Previously administered products included RSV vaccine (received first dose of RSV vaccine in 2023).   On an unknown date, the patient did not receive the 2nd dose of RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced intercepted product prescribing error (Verbatim: Medication Error- Intercepted/Potential). The outcome of the intercepted product prescribing error was unknown.   Additional Information: The patient self-reported this case for herself. The reporter reported that about this time last year she got an RSV shot.  The reporter does not know if it was GlaxoSmithKline's  Respiratory Syncytial Virus Vaccine Arexvy or another company's product.  The reporter got the shot at her physician's office.  The reporter went to the physician and was told that she should get another RSV shot (and should get one every year).  The reporter went to the pharmacy and they said that she does not need another shot because it was once per lifetime which led to intercepted product prescribing error.  Then the reporter went online and read that it was given once every 2 years.  The reporter GlaxoSmithKline to find out what the correct answer was because she had three different answers.
Sex: U
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: accidently given 2 vials of the adjuvant component of AREXVY instead of the reconstituted vaccine; accidently given 2 vials of the adjuvant component of AREXVY instead of the reconstituted vaccine; 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 RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 10-OCT-2024, the patient received Arexvy. On 10-OCT-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: accidently given 2 vials of the adjuvant component of AREXVY instead of the reconstituted vaccine) and inappropriate dose of vaccine administered (Verbatim: accidently given 2 vials of the adjuvant component of AREXVY instead of the reconstituted vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-OCT-2024 The pharmacist reported that a patient was accidently given 2 vials of the adjuvant component of Arexvy instead of the reconstituted vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not wished to provide patient demographics at this time.
Age: 11.0
Sex: U
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: received Bexsero at 11 years of age when the intention was to administered MenA; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Meningococcal vaccine A for prophylaxis.   On 11-OCT-2024, the patient received Bexsero. On an unknown date, the patient did not receive Meningococcal vaccine A. On 11-OCT-2024, immediately after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: received Bexsero at 11 years of age when the intention was to administered MenA). The outcome of the wrong vaccine 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: 11-OCT-2024 The license practical nurse reported that a patient received Bexsero vaccine when the intention was to administer MenA, which led to wrong vaccine administered.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: an extra dose of Shingrix was administered to a patient today; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number J327J, expiry date 19-JUN-2026) for prophylaxis.   Previously administered products included Shingrix (First dose administered on 22Mar2024) and Shingrix (Second dose administered on 06Jun2024).   On 18-OCT-2024, the patient received the 3rd dose of Shingrix. On 18-OCT-2024, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: an extra dose of Shingrix was administered to a patient today). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 18-OCT-2024 Certified medical assistant stated an extra dose of Shingrix was administered to a patient, which led to extra dose administered.
Age: 0.67
Sex: M
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose of Flulaval was given 24 days after the first dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 8-month-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number J245K, expiry date 05-JUN-2025) for prophylaxis.   Concomitant products included Influenza vaccine inact split 4v (Flulaval quadrivalent).   On 26-OCT-2024, the patient received the 2nd dose of FluLaval Quadrivalent 2023-2024 season. On 26-OCT-2024, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced drug dose administration interval too short (Verbatim: second dose of Flulaval was given 24 days after the first dose). The outcome of the drug dose administration interval too short 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: 28-OCT-2024 The patient received 2nd dose of Flulaval quadrivalent vaccine earlier than the recommended interval, which led to shortening of the vaccination scheduled.