chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue discomfort
Clinical narrative: Pt c/o tongue feeling funny, like it does when I drink orange juice. I have a mild allergy to orange juice.  BP was 124/76, pulse 94. 75mg of benadryl administer and observed for another 30 minutes. Stated her tongue felt better.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product administration error
Clinical narrative: no known adverse events, patient was given 2 pediatric doses rather than 1 adult dose.
Age: 10.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Fatigue, Pain, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Pt received an adult dose of Covid vaccine. Billing is being completed for an offsite clinic 10/18/23.  It was discovered that pt received an adult dose of Comirnaty instead of Pfizer age 5-11 year old.  Contacted the mother, and discussed if any adverse reactions were noted.  She reports that the pt felt "tired and sore all weekend after the vaccines.  Fever was noted, but seemed similar to other Covid doses she had before."  Mother states overall, no adverse reactions were noticed.  She will contact the clinic with any other questions or concerns.
Age: 9.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Fatigue, Pain, Product administered to patient of inappropriate age
Clinical narrative: Pt received an adult dose of Covid vaccine. Billing is being completed for an offsite clinic 10/18/23.  It was discovered that pt received an adult dose of Comirnaty instead of Pfizer age 5-11 year old.  Contacted the mother and discussed if any adverse reactions were noted.  She reports that the pt felt "tired and sore all weekend after the vaccines.  Fever was noted, but seemed similar to other Covid doses she had before."  Mother states overall, no adverse reactions were noticed.  She will contact the clinic with any other questions or concerns.
Age: 21.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Musculoskeletal stiffness, Presyncope
Clinical narrative: I vaccinated the patient with a COVID vaccine followed by a Flucelvax  vaccine in their right and then left arm, respectively.  Shortly after I put a band-aid on her arm, she told me she was feeling dizzy.  I told her to sit back in her chair and take a deep breath.  She very shortly lost consciousness so I just supported her body and called for help.  Another customer in the store was a nurse and heard my call for help and came to my aid followed by my pharmacy co-workers.  The patient was very sweaty and because of the way her arms were cinching and stiffing up I was concerned she was having a seizure.   The nurse called 911.  The patient eventually came to and told us she hadn't eaten that day nor had she had much to drink.  We gave her some water and a small sucker.  She said she didn't want the paramedics to come so we gave her the phone to talk with the dispatcher in order to cancel the call.  We then called her parents to come and pick her up.  She is a college kid home for the holidays.  I waited with her until her dad arrived.  When he arrived he said it was probably a vasovagal response as he is prone to that kind of a reaction.   I released the patient/customer into the care of her dad.  You have my permission to contact patient directly about how she is doing now.  I was not involved or have any knowledge of any follow-up care she may have recieved.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: patient did not want to stay he left immediately but no signs or symptoms after receiving the vaccines
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain, Hypersomnia, Injection site pain, Lymphadenopathy
Clinical narrative: After he got the vaccine his arm was very sore. It stung at the time of the injection and then he napped for a long time which is not normal, he never naps. His arm is still sore today 12/27/23  and now he has swollen lymph nodes in his neck.
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Confirmed no symptoms or side effects reported.; Nurse called to report a patient received GARDASIL 9 while pregnant on 12/14/2023. Confirmed it was the first dose of the series and patient is 30 weeks and 5 days pregnant. Confirmed no symptoms or side effects reported. Operator of device is an HCP; This spontaneous prospective pregnancy report was received from a nurse refers to a 27-year-old female patient. The patient's concurrent conditions included drug hypersensitivity (allergic to BACTRIM). The patient's medical history included seizure (seizure disorder). The patient's concomitant therapies included KEPPRA [LEVETIRACETAM].    On 14-DEC-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), formulation: injection, lot# 1965045, expiration date: 19-JAN-2026, 0.5 milliliter (route of administration and anatomical location were not provided) for prophylaxis.   On unknown day, the patient became pregnant. The LMP and EDD was not provided. The pregnancy outcome and the fetal outcome was unknown.   It was reported that, on 14-DEC-2023, the patient received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in 30 weeks and 5 days pregnant (maternal exposure during pregnancy). No additional adverse event reported (no adverse event).
Sex: M
Vaccine: VARCEL, VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse Event; Inappropriate schedule of vaccine administered; Overdose; This spontaneous report was received from a nurse refers to a 55-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-OCT-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), formulation: injection, lot# x002100, expiration date: 19-JAN-2025 (exact dose, route of administration and anatomical location were not provided) (one time) for prophylaxis. On the same day, the patient was vaccinated with varicella zoster vaccine rge (cho)(SHINGRIX) (batch# reported as: 2Z9N3, expiration date reported as: 26-SEP-2025) (one time) for prophylaxis (inappropriate schedule of product administration, overdose). No additional adverse event reported (no adverse event).
Sex: U
Vaccine: RSV
Symptoms: Bronchitis, Pneumonia
Clinical narrative: pnemonia; brochitis; This serious case was reported by a consumer via interactive digital media and described the occurrence of pneumonia in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pneumonia (Verbatim: pnemonia) (serious criteria GSK medically significant) and bronchitis (Verbatim: brochitis). The outcome of the pneumonia and bronchitis were not reported.   It was unknown if the reporter considered the pneumonia and bronchitis to be related to Arexvy.   It was unknown if the company considered the pneumonia and bronchitis to be related to Arexvy.   Additional Information: GSK Receipt Date: 20-DEC-2023 This case was reported by a consumer via (AE monitoring) interactive digital media. The patient experienced pneumonia and bronchitis.
Sex: F
Vaccine: RSV
Symptoms: Cough, Headache, Nasal congestion, Nausea, Pain
Clinical narrative: Headache; Nausea; Body pain; Coughing; Congestion; This non-serious case was reported by a consumer and described the occurrence of headache in a 77-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number MZ735) for prophylaxis.   The patient's past medical history included hypothyroidism. Concomitant products included levothyroxine sodium (Levoxyl).   On 13-DEC-2023, the patient received Arexvy 1 ml. On 14-DEC-2023, 1 days after receiving Arexvy, the patient experienced headache (Verbatim: Headache), nausea (Verbatim: Nausea), general body pain (Verbatim: Body pain), cough (Verbatim: Coughing) and nasal congestion (Verbatim: Congestion). The outcome of the headache, nausea, general body pain, cough and nasal congestion were not resolved.   It was unknown if the reporter considered the headache, nausea, general body pain, cough and nasal congestion to be related to Arexvy.     It was unknown if the company considered the headache, nausea, general body pain, cough and nasal congestion to be related to Arexvy.   Additional Information: GSK Receipt Date: 14-DEC-2023 On 14-DEC-2023, the patient experienced headache, nausea, body pains, coughing, congestion which was ongoing. Headache, nausea, body pains, coughing and congestion were not treated. The reporter consented to follow up. The case US2023175233 was found as duplicate of this case US2023175226. All the information from the case US2023175233 was merged into this case US2023175226. The case US2023175233 was deleted, and all the future information would be added in this case US2023175226 which stands as case of record for this patient.
Sex: F
Vaccine: RVX
Symptoms: Nausea, Vomiting
Clinical narrative: Vomiting; Nausea; This non-serious case was reported by a consumer and described the occurrence of vomiting in a 71-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 19-DEC-2023, the patient received RSV vaccine. In DEC-2023, an unknown time after receiving RSV vaccine, the patient experienced vomiting (Verbatim: Vomiting) and nausea (Verbatim: Nausea). The patient was treated with ondansetron. The outcome of the vomiting and nausea were not resolved.   It was unknown if the reporter considered the vomiting and nausea to be related to RSV vaccine.     It was unknown if the company considered the vomiting and nausea to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 23-DEC-2023 The patient reported she received the RSV vaccine and experienced vomiting and nausea which had continued till the date of reporting. The patient was treated with Ondansetron.  The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Myalgia, Nasal congestion
Clinical narrative: congestion in my nose; burning aches muscle in shoulder blades and middle back that burn; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nasal congestion in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced nasal congestion (Verbatim: congestion in my nose) and muscle burning sensation (Verbatim: burning aches muscle in shoulder blades and middle back that burn). The outcome of the nasal congestion and muscle burning sensation were not resolved.   It was unknown if the reporter considered the nasal congestion and muscle burning sensation to be related to Arexvy.     It was unknown if the company considered the nasal congestion and muscle burning sensation to be related to Arexvy.   Additional Information: GSK Receipt Date: 17-DEC-2023 This case was reported by a patient via interactive digital media. The reporter reported that patient was exposed last week from her boyfriend as he did not cover his mouth when coughing and do so 2 to 3 fee in front of her. The patient reported that she was on bacterium for a nose condition when her septum had a whole in one nostril. She used it mixed in a nose with bacterium. The patient enquired could this lesson the congestion in her nose because she did not have that symptom. The patient had burning aches muscle in shoulder blades and middle back that burn. The follow-up could not be possible as no contact details were available.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Pain in extremity
Clinical narrative: Shingrix was accidentally administered Sub-Q instead of IM; sore arm; This non-serious case was reported by a physician via sales rep and described the occurrence of pain in arm in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-DEC-2023, the patient received the 2nd dose of Shingrix (subcutaneous). On 07-DEC-2023, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Shingrix was accidentally administered Sub-Q instead of IM). In DEC-2023, the patient experienced pain in arm (Verbatim: sore arm). The outcome of the pain in arm was not reported and the outcome of the intramuscular formulation administered by other route was unknown.   The reporter considered the pain in arm to be related to Shingrix.     The company considered the pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 13-DEC-2023 Patient visited office on 7th December for 2nd dose of Shingrix.  Patient returned to office on 13th December, complaining of a sore arm and agreed that the arm soreness was more pronounced due to the Sub-Q injection.  Patient also wanted re-assurance as well. Shingrix was accidentally administered Sub-Q instead of intramuscular, which led to intramuscular formulation administered by other route. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Had a customer's wife to get 2 Shingrix doses, 2 weeks apart from each; 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 female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   In SEP-2023, the patient received the 2nd dose of Shingrix. In SEP-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Had a customer's wife to get 2 Shingrix doses, 2 weeks apart from each). The outcome of the drug dose administration interval too short was unknown.    GSK Receipt Date: 11-DEC-2023 The reporter had a customer's wife to get 2 Shingrix doses, 2 weeks apart from each other at another location, which led to shortening of vaccine schedule. That was in September 2023.  They were just asking for a recommendation on what they should do next or if another dose was needed.
Sex: M
Vaccine: RVX
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This non-serious case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a adult male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced influenza-like symptoms (Verbatim: Flu like symptoms). The outcome of the influenza-like symptoms was resolved (duration 3 days).   It was unknown if the reporter considered the influenza-like symptoms to be related to RSV vaccine.     It was unknown if the company considered the influenza-like symptoms to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 11-DEC-2023 The reporter reported that the patient took RSV vaccine and had flu like symptoms for 3 days. It was unknown if it was GSK vaccine or Pfizer. The reporter did not consent to follow-up.
Sex: F
Vaccine: RSV
Symptoms: Intercepted product prescribing error, Product administered to patient of inappropriate age
Clinical narrative: Doctor wrote her a prescription to get Arexvy since she is immunocompromised; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intercepted drug prescribing error in a 58-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient did not receive Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted drug prescribing error (Verbatim: Doctor wrote her a prescription to get Arexvy since she is immunocompromised). The outcome of the intercepted drug prescribing error was unknown.   Additional Information: GSK Receipt Date: 14-DEC-2023 The pharmacy intern was checking to see if there was any on Arexvy administration to a patient who was 58 years old and immunocompromised.  The patient's doctor wrote her a prescription to get Arexvy since she was immunocompromised, which led to intercepted drug prescribing error. Reporter stated that it did not appear that the vaccine had been administered yet but the patient had an active prescription.  The reporter consented to follow up via postal.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: female patient received a dose of Boostrix on December 13th 2023 and the dose had expired on December 9th 2023..; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 32-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 72D7L, expiry date 09-DEC-2023) for prophylaxis.   On 13-DEC-2023, the patient received Boostrix. On 13-DEC-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: female patient received a dose of Boostrix on December 13th 2023 and the dose had expired on December 9th 2023..). 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: 18-DEC-2023 The Vaccine Administration Facility was the same as Primary Reporter Nurse reported that female patient received a dose of Boostrix on December 13th 2023 and the dose had expired on December 9th 2023, which led to expired vaccine used. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia
Clinical narrative: fFel fatigued; Weakness; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In NOV-2023, the patient received the 1st dose of Shingrix (left arm). In NOV-2023, 1 day after receiving Shingrix, the patient experienced fatigue (Verbatim: fFel fatigued) and weakness (Verbatim: Weakness). The outcome of the fatigue and weakness were resolved.   It was unknown if the reporter considered the fatigue and weakness to be related to Shingrix.     It was unknown if the company considered the fatigue and weakness to be related to Shingrix.   Additional Information: GSK receipt date: 18-DEC-2023 The reporter was the patient. The patient was received the 1st dose of Shingrix in left arm about a month ago from reporting date. The patient stated that the next day she started to feel fatigued and weakness.  The patient stated that the she starting to feel better now. The patient  was afraid to get 2nd dose. The reporter consent to follow up.
Age: 26.0
Sex: F
Vaccine: RSV
Symptoms: Delivery, Exposure during pregnancy, Product administered to patient of inappropriate age, Product confusion, Product use issue
Clinical narrative: Pregnant patient received Arexvy; Live birth; Underage; This non-serious retrospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 26-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number gx45d, expiry date 19-OCT-2024) for prophylaxis.   On 17-OCT-2023, the patient received Arexvy. On 17-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Pregnant patient received Arexvy) and live birth (Verbatim: Live birth). The outcome of the inappropriate age at vaccine administration, vaccine exposure during pregnancy and live birth were unknown.    Pregnancy Outcome: Live neonate with no apparent congenital anomaly   Additional Information: GSK receipt date: 18-DEC-2023 This patient already gave birth and it was a normal birth.  Med Tech stated there was confusion work wise.  They went off standing orders but have no standing order for RSV vaccines and that the script comes in from the provider.   There was lots of back and forth with who can give which vaccines.  At the time when Pfizer vaccine was approved for pregnant patients, they thought the 2 vaccines were interchangeable.  She stated the FDA website stated there were 2 separate RSV vaccines approved and ACIP recommendations sounded like you can use either one. The 26 year old pregnant patient received Arexvy, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up. The case is linked with US2023176722 and US2023176724, by same reporter.; Sender's Comments:  US-GSK-US2023176722:Different patient US-GSK-US2023176724:Different patient
Age: 26.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age, Product confusion, Product use issue
Clinical narrative: administered Arexvy to pregnant patient; patient received Arexvy vaccine at underage; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 26-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number gx45d, expiry date 19-OCT-2024) for prophylaxis.   On 27-NOV-2023, the patient received Arexvy. On 27-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: patient received Arexvy vaccine at underage). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: administered Arexvy to pregnant patient). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing  Additional Information: GSK Receipt Date: 18-DEC-2023 The medical technician reported that she administered Arexvy to a pregnant patient. This patient was at 35 weeks pregnant and was due next week (from the reporting date). The medical technician stated there was confusion.  They go off standing orders but had no standing order for RSV vaccines and that the script comes in from the provider.  There was lots of back and forth with who could give which vaccines. At the time when Pfizer vaccine was approved for pregnant patients, they thought the 2 vaccines were interchangeable.  The reporter stated the Food and Drug Administration (FDA) website states there are 2 separate RSV vaccines approved and Committee recommendations sounded like you could use either one.  The patient below 60 years of age received Arexvy, which led to inappropriate age at vaccine administration. The reporter consented to follow up. This was 1 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023176718:Different patient US-GSK-US2023176722:Different patient
Age: 1.0
Sex: M
Vaccine: FLU4
Symptoms: Wrong technique in product usage process
Clinical narrative: the needle was put again in the patient's muscle to administer the other half of the dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong injection technique in a 1-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number C2PH4) for prophylaxis.   On 13-DEC-2023, the patient received Fluarix Quadrivalent 2023-2024 season .5 ml. On 13-DEC-2023, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced wrong injection technique (Verbatim: the needle was put again in the patient's muscle to administer the other half of the dose). The outcome of the wrong injection technique 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: 18-DEC-2023 Medical assistant called to informed that, during the administration of Fluarix QIV a patient moved after receiving half of the dose, so the needle was taken out of the patient's muscle. After this the needle was put again in the patient's muscle, to administered the other half of the dose, which led to wrong injection technique. The reporter consented to follow-up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Muscular weakness, Pain, Paraesthesia
Clinical narrative: Soreness at the injection site; left leg totally gave out; she experienced tingling; pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-OCT-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Soreness at the injection site), leg pain (Verbatim: left leg totally gave out), tingling (Verbatim: she experienced tingling) and pain (Verbatim: pain). The outcome of the injection site pain was resolved and the outcome of the leg pain, tingling and pain were resolved (duration 3 days).   It was unknown if the reporter considered the injection site pain, leg pain, tingling and pain to be related to Shingrix.     It was unknown if the company considered the injection site pain, leg pain, tingling and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-DEC-2023 The patient was the reporter. The patient received the first dose of shingrix and experienced soreness at the injection site.  The patient reported that next morning, while she was getting out of bed and stepped on the floor, her left leg totally gave out.  The patient reported that she was able to get her left leg functioning again, but during the day, her left leg would give out again. The patient also experienced tingling and pain.  The reporter consent to follow up.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: 36 week pregnant patient received Arexvy instead of the intended Abrysvo; 36 week pregnant patient received Arexvy; This non-serious prospective pregnancy case was reported by a physician via sales rep and described the occurrence of wrong vaccine administered in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: 36 week pregnant patient received Arexvy instead of the intended Abrysvo) and vaccine exposure during pregnancy (Verbatim: 36 week pregnant patient received Arexvy). The outcome of the wrong vaccine administered and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 18-DEC-2023 The physician reported that the 36-week pregnant patient received Arexvy instead of the intended Abrysvo at a pharmacy, which led to wrong vaccine administered and vaccine exposure during pregnancy. Unknown date of birth (DOB), initials, age, lot number, specific location of pharmacy.  Nothing else was reported. Minimal information reported to GlaxoSmithKline Field Representative.  GSK Field Representative did not know full address of physician. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age, Product use issue
Clinical narrative: The administration of Arexvy to a pregnant patient.; Inappropriate age at vaccine administration; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 34-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 18-DEC-2023, the patient received Arexvy. On 18-DEC-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: The administration of Arexvy to a pregnant patient.). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 18-DEC-2023 The health care professional contacted via phone on inquring about Arexvy. The reporter asked what information was available regarding administered of Arexvy to a pregnant patient.  34 year old pregnant patient received arexvy which led to exposure during pregnancy and inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. Did not consent to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: the patient received two doses of Shingrix from her pharmacy and two doses of Shingrix elsewhere; the patient received two doses of Shingrix from her pharmacy and two doses of Shingrix elsewhere; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number g3t43, expiry date 07-JUL-2024) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix) and Varicella zoster vaccine rgE (CHO) (Shingrix).   On 18-DEC-2023, the patient received Shingrix. On 22-MAY-2023, the patient received Shingrix. On 22-MAY-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: the patient received two doses of Shingrix from her pharmacy and two doses of Shingrix elsewhere). On 18-DEC-2023, the patient experienced extra dose administered (Verbatim: the patient received two doses of Shingrix from her pharmacy and two doses of Shingrix elsewhere). The outcome of the extra dose administered and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 19-DEC-2023 The pharmacist reported the patient received two doses of Shingrix from her pharmacy and two doses of Shingrix elsewhere. The reporter notes the dose received on 16th May 2023 was received at the health department and the dose received on 22nd May 2023 was received at his physician's office.  Full lot number and expiration date details were not available for the May doses.  No additional information provided. The reporter consented to follow up. The patient received two extra doses of Shingrix vaccine, which led to extra dose administered. VAERS details pertains to 3rd  dose of Shingrix (received on 22-MAY-2023) in product tab.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: fourth dose on 5-DEC-2023; received a third dose on 28-SEP-2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose about 4 years ago) and Shingrix (received 2nd dose about 4 years ago).   On 05-DEC-2023, the patient received the 4th dose of Shingrix. On 28-SEP-2023, the patient received the 3rd dose of Shingrix. On 28-SEP-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received a third dose on 28-SEP-2023). On 05-DEC-2023, the patient experienced extra dose administered (Verbatim: fourth dose on 5-DEC-2023). The outcome of the extra dose administered and extra dose administered were unknown.   Additional Information: GSK receipt date:19-DEC-2023 The pharmacist reported that a patient was completed the full dose series about four year ago from the date of reporting. The patient was forgot she already received Shingrix. The patient was received 2 extra dose which led to extra dose administered. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: asked for information about the safety of an extra dose; 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 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2020).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: asked for information about the safety of an extra dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 19-DEC-2023 The healthcare professional called to report the administration of a third dose of Shingrix to a patient which led to extra dose administered. The healthcare professional asked for information about the safety of an extra dose. The reporter mentioned that the first dose was given in 2020 but did not provide further information about the three Shingrix doses. The reporter consented to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Fluarix QIV Vaccine given to a patient younger than 6 months; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-day-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra) for prophylaxis.   On an unknown date, the patient received Fluarix Tetra. On an unknown date, an unknown time after receiving Fluarix Tetra, the patient experienced inappropriate age at vaccine administration (Verbatim: Fluarix QIV Vaccine given to a patient younger than 6 months). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-DEC-2023 A pharmacist reported that a 1-day old baby received the Fluarix QIV vaccine, which led to inappropriate age at vaccine administration. The reporter asked for safety information regarding that issue.  The vaccine was administered 2 hours after the patient was born. The reporter did not provide information about the dose given (lot number, expiration date). The reporter consented to follow up.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: which had an expiration date of 30Sep2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA728A, expiry date 30-SEP-2023) for prophylaxis.   On 14-DEC-2023, the patient received Menveo. On 14-DEC-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: which had an expiration date of 30Sep2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 19-DEC-2023 Nurse Practitioner stated a nurse administered a dose of Menveo (2 vial formulation) on 14-Dec-2023 to a patient which had an expiration date of 30-Sep-2023. At the time of reporting, a repeat dose had not been administered. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. The patient received Menveo beyond the expiration date, which led to expired vaccine used.
Sex: U
Vaccine: RSV
Symptoms: Respiratory symptom
Clinical narrative: with respiratory symptoms; This non-serious case was reported by a physician via call center representative and described the occurrence of respiratory symptom in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 16-DEC-2023, the patient received Arexvy. On 19-DEC-2023, 3 days after receiving Arexvy, the patient experienced respiratory symptom (Verbatim: with respiratory symptoms). The outcome of the respiratory symptom was unknown.   It was unknown if the reporter considered the respiratory symptom to be related to Arexvy.     It was unknown if the company considered the respiratory symptom to be related to Arexvy.   Additional Information: GSK Receipt date: 19-DEC-2023 A physician reported that a patient that had the Arexvy vaccine administered on 16 December 2023 and presented today 19 December 2023 with respiratory symptoms.  The reporter consented to follow up.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: patient was administered a dose of Engerix-B on 19FDec2023 which had an expiration date of 03Dec2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 49-year-old female patient who received HBV (Engerix B) (batch number TB3KN, expiry date 03-DEC-2023) for prophylaxis.   On 19-DEC-2023, the patient received the 2nd dose of Engerix B. On 19-DEC-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: patient was administered a dose of Engerix-B on 19FDec2023 which had an expiration date of 03Dec2023). 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: 19-DEC-2023 The nurse reported that a patient was administered a dose of Engerix-B which was already expired. At the time of reporting, the dose had not been repeated.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. This case had been link with US2023177289, reported by the same reporter.; Sender's Comments:  US-GSK-US2023177289:Same reporter
Sex: M
Vaccine: HEP
Symptoms: Product supply issue
Clinical narrative: pharmacy does not have Engerix-B in stock currently; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of product supply issue in a male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included ENGERIX B (received 1st dose in May 2023) and Engerix B (received 2nd dose in June 2023).   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced product supply issue (Verbatim: pharmacy does not have Engerix-B in stock currently). The outcome of the product supply issue was unknown.   Additional Information: GSK Receipt Date: 20-DEC-2023 The pharmacist may complete a patient's series of Engerix-B with Twinrix as the pharmacy did not had Engerix-B in stock currently.  The patient received the first two doses of Engerix-B. The patient did not received 3rd dose of Engerix-B, which led to product supply issue. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain, Monoplegia, Myalgia, Pain in extremity
Clinical narrative: The patient received the first dose in 2022; pain in the left arm became paralyzing; experienced a sore arm/pain in the injected arm; This serious case was reported by a consumer via call center representative and described the occurrence of monoplegia in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Influenza vaccine (Flu) for prophylaxis.   The patient's past medical history included hip surgery. Previously administered products included shingrix (received 1st dose in 2022).   On 19-DEC-2023, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, the patient received Flu (right arm). In DEC-2023, an unknown time after receiving Shingrix, the patient experienced monoplegia (Verbatim: pain in the left arm became paralyzing) (serious criteria GSK medically significant) and pain in arm (Verbatim: experienced a sore arm/pain in the injected arm). On 19-DEC-2023, the patient experienced drug dose administration interval too long (Verbatim: The patient received the first dose in 2022). The outcome of the monoplegia and pain in arm were not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the monoplegia and pain in arm to be related to Shingrix.     It was unknown if the company considered the monoplegia and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date- 20-DEC-2023 The reporter was the patient. The patient received 1st dose in 2022 and 2nd dose received on 19 December 2023, which led to drug dose administration interval too long. The patient experienced a sore arm (Left) after receiving the second dose of shingrix. As the day progressed, the pain in the injected arm (Left) became worse and worse. The pain in the left arm became paralyzing, the patient feels like he was hit with a base ball bat in his left bicep. The patient states that he received 3 shots that day the flu vaccine (unspecified manufacturer) another vaccine (not specified), and shingrix. The flu vaccine was administered in the right arm, it was believed the unnamed vaccine was administer in the right arm. The reporter consented to follow up.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: inadvertently administered only the adjuvant to patient; administered only the adjuvant to patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 76-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 45MG37, expiry date 10-JUL-2025) for prophylaxis.   On 19-DEC-2023, the patient received Arexvy. On 19-DEC-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: inadvertently administered only the adjuvant to patient) and inappropriate dose of vaccine administered (Verbatim: administered only the adjuvant to patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-DEC-2023 The reporter reported that she inadvertently administered only the adjuvant to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow-up.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Back pain, Chills, Discomfort, Feeling cold, Injection site pain
Clinical narrative: Nausea; Injection site soreness; Uncomfortable; Back Pain/body, neck and back aches; Neck Pain/body, neck and back aches; Body aches/body, neck and back aches; Chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 929PN, expiry date 29-MAR-2025) for prophylaxis.   On 20-DEC-2023 10:40, the patient received Arexvy (left arm). In DEC-2023, an unknown time after receiving Arexvy, the patient experienced discomfort (Verbatim: Uncomfortable), back pain (Verbatim: Back Pain/body, neck and back aches), neck pain (Verbatim: Neck Pain/body, neck and back aches), general body pain (Verbatim: Body aches/body, neck and back aches) and chills (Verbatim: Chills). On 20-DEC-2023, the patient experienced injection site pain (Verbatim: Injection site soreness). On 21-DEC-2023 02:00, the patient experienced nausea (Verbatim: Nausea). The patient was treated with paracetamol (Tylenol). The outcome of the injection site pain, discomfort, back pain, neck pain, general body pain and chills were not resolved and the outcome of the nausea was resolved.   It was unknown if the reporter considered the injection site pain, nausea, discomfort, back pain, neck pain, general body pain and chills to be related to Arexvy.     It was unknown if the company considered the injection site pain, nausea, discomfort, back pain, neck pain, general body pain and chills to be related to Arexvy.   Additional Information: GSK Receipt Date: 21-DEC-2023 The patient self-reported this case. The patient reported that the injection site got sore as the evening progressed and was still sore today (on reporting day). The patient also reported that she had chills last night from reporting starting around midnight, where she was so cold, she had to drink a warm drink to warm up, and was still cold on reporting day. The patient also reported she had body, neck and back aches that started around midnight last night from reporting, and she still had these aches on reporting day. The patient was very uncomfortable and having to use heat on her back. The patient also reported that she had nausea that started around 2:30 to 2 AM (15 hours 20 minutes after vaccination) on reporting day morning, but it was now gone. The patient reported that she took 1-Tylenol Rapid Release 500 mg tablet around 1 to 2 AM reporting day morning; and the patient took 2 more Tylenol Rapid Release 500 mg tablets reporting day morning (no specific time provided). The reporter consented to follow up.