chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: The shot hurts like all get out; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: The shot hurts like all get out). The outcome of the pain was not reported.   The reporter considered the pain to be related to Shingles vaccine.     The company considered the pain to be related to Shingles vaccine.   Additional Information: GSK received date: 01-Mar-2024 This case was reported by a patient via interactive digital media. Patient stated that, shot hurts like all get out, but it was worth it. Mine was on my face. Patient went to pharmacy and had received two shots. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: I got really sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: I got really sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-MAR-2024 This case was reported by the patient via interactive digital media. The reporter understands that, because he/she got really sick after last one (dose) of the series, but further stated that it was better to be protected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Shot is painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Shot is painful). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-Mar-2024 This case was reported by patient via interactive digital media. The patient stated that the shot was painful he/she received and the other one in this month The reporter further stated that the no one would want to go through the pain ove this. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: sick from taking it; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick from taking it). The outcome of the sickness was not resolved.   The reporter considered the sickness to be related to Shingles vaccine.     The company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2024 This case was reported by a patient via interactive digital media. Patient reported that he/she took the Shingles shot and he/she so regret it, it had been 3 months now and patient was still sick from taking it.
Sex: U
Vaccine: RSV
Symptoms: Nasopharyngitis
Clinical narrative: Cold; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cold 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 cold (Verbatim: Cold). The outcome of the cold was unknown.   It was unknown if the reporter considered the cold to be related to Arexvy.     It was unknown if the company considered the cold to be related to Arexvy.   Additional Information: GSK Receipt Date: 04-MAR-2024 The reporter stated that hopefully it was a cold and no shortness of breath. Follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: njection is kind of painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in an unspecified number of patients 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 injection site pain (Verbatim: njection is kind of painful). The outcome of the injection site pain was not reported.   It was unknown if the reporter considered the injection site pain to be related to Arexvy.     It was unknown if the company considered the injection site pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 04-MAR-2024 This case was reported by a consumer via (Open field AE monitoring) interactive digital media. The reporter stated that some people were not know how to do this also this injection was kind of painful when administered but he/she push the component into the muscle slowly so it did not hurt as much he/she thought this should be added to your video. So people were not afraid of getting vaccinated.  This was the only way he/she had been able to get more of his/her patients to get vaccinated.
Sex: M
Vaccine: RSV
Symptoms: Headache, Heart rate increased
Clinical narrative: rapid heartbeat; headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of heartbeats increased in a 79-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 03-FEB-2024, the patient received Arexvy. In FEB-2024, less than a day after receiving Arexvy, the patient experienced heartbeats increased (Verbatim: rapid heartbeat) and headache (Verbatim: headache). The outcome of the heartbeats increased was not reported and the outcome of the headache was not resolved.   It was unknown if the reporter considered the heartbeats increased and headache to be related to Arexvy.     It was unknown if the company considered the heartbeats increased and headache to be related to Arexvy.   Additional Information: GSK Receipt Date: 04-MAR-2024 The reported stated they both received the Arexvy vaccine, and her husband (patient) experienced rapid heartbeat and headache. The patient awakened about 1am due to headache and now at 6.30 am his headache was still present.; Sender's Comments:  US-GSK-US2024AMR029303:Original Case : US2024AMR029268
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Headache, Injection site induration, Injection site swelling, Pain
Clinical narrative: Injection site is swollen and (illegeble) almost to my elbow; Injection site is swollen and (illegeble) almost to my elbow and very hard; Injection site is swollen and (illegeble) almost to my elbow; hurt all over/Hurts to move; joints painful; grade headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included pain in arm ((illegible) 't usually have a reaction to vaccines except a sore arm).   On 02-MAR-2024, the patient received Arexvy. In MAR-2024, an unknown time after receiving Arexvy, the patient experienced injection site swelling (Verbatim: Injection site is swollen and (illegeble) almost to my elbow), injection site induration (Verbatim: Injection site is swollen and (illegeble) almost to my elbow and very hard), swelling arm (Verbatim: Injection site is swollen and (illegeble) almost to my elbow), pain upon movement (Verbatim: hurt all over/Hurts to move), joint pain (Verbatim: joints painful) and headache (Verbatim: grade headache). The outcome of the injection site swelling, injection site induration, swelling arm, pain upon movement, joint pain and headache were not reported.   It was unknown if the reporter considered the injection site swelling, injection site induration, swelling arm, pain upon movement, joint pain and headache to be related to Arexvy.     It was unknown if the company considered the injection site swelling, injection site induration, swelling arm, pain upon movement, joint pain and headache to be related to Arexvy.   Additional Information: GSK Receipt date: 04-MAR-2024 This case was reported by patient via (Open field AE monitoring) interactive digital media. The patient stated that hurt all over, joints painful, hurts to move, injection site was swollen and (illegible) almost to his/her elbow and very hard. Running (illegible) grade temp (illegible) grade headache, vaccination was 2 days prior to the reporting date. He/she (illegible) 't usually had a reaction to vaccines except a sore arm, this one was causing pain with movement.
Sex: M
Vaccine: RSV
Symptoms: Chills, Hyperhidrosis, Myalgia
Clinical narrative: chills; sweats; severe muscle pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chills in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 03-MAR-2024, the patient received Arexvy. In MAR-2024, less than a day after receiving Arexvy, the patient experienced chills (Verbatim: chills), sweating (Verbatim: sweats) and muscle pain (Verbatim: severe muscle pain). The outcome of the chills, sweating and muscle pain were not reported.   It was unknown if the reporter considered the chills, sweating and muscle pain to be related to Arexvy.     It was unknown if the company considered the chills, sweating and muscle pain to be related to Arexvy.   Additional Information: GSK Receipt date: 04-MAR-2024 This case was reported by consumer via interactive digital media. A reporter reported that her husband had the RSV vaccine yesterday, and woke in the middle of the night with chills, sweats and severe muscle pain.
Sex: F
Vaccine: RSV
Symptoms: Chills, Myalgia, Skin warm, Swelling
Clinical narrative: muscle aches; chills; warm to the touch; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle pain 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 muscle pain (Verbatim: muscle aches), chills (Verbatim: chills) and skin warm (Verbatim: warm to the touch). The outcome of the muscle pain, chills and skin warm were not reported.   It was unknown if the reporter considered the muscle pain, chills and skin warm to be related to Arexvy.     It was unknown if the company considered the muscle pain, chills and skin warm to be related to Arexvy.   Additional Information: GSK Receipt date: 04-MAR-2024 This case was reported by patient's child via interactive digital media. A reporter reported that his/her mother (patient) was very ill with muscle aches, chills and a large (illegible). Local reaction hitch was (illegible) in color, raised and warm to the touch.
Sex: U
Vaccine: RSV
Symptoms: Fatigue, Headache, Pain, Pyrexia, Swelling
Clinical narrative: fever; fatique; pain; swelling; headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever 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 fever (Verbatim: fever), fatigue (Verbatim: fatique), pain (Verbatim: pain), swelling (Verbatim: swelling) and headache (Verbatim: headache). The outcome of the fever, fatigue, pain, swelling and headache were not reported.   It was unknown if the reporter considered the fever, fatigue, pain, swelling and headache to be related to Arexvy.     It was unknown if the company considered the fever, fatigue, pain, swelling and headache to be related to Arexvy.   Additional Information: GSK Receipt Date: 04-MAR-2024 The case was received from the patient via (Open field AE monitoring) interactive digital media. The patient received Arexvy vaccine and had fever, fatigue, pain, swelling and headache badly.
Sex: U
Vaccine: RSV
Symptoms: Fatigue
Clinical narrative: Feel tired; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included COVID-19 vaccine (did well with Covid vaccine 4 times and mild disease 2 times). Concurrent medical conditions included ocular sarcoidosis (on Azathioprine for sarcoid eye disease in remission). Concomitant products included azathioprine.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced tiredness (Verbatim: Feel tired). The outcome of the tiredness was not reported.   It was unknown if the reporter considered the tiredness to be related to Arexvy.     It was unknown if the company considered the tiredness to be related to Arexvy.   Additional Information: GSK Receipt Date: 04-MAR-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient felt tired. The patient had sarcoid eye disease in remission and it could reduce his/her immune response some.
Sex: U
Vaccine: RSV
Symptoms: Bronchitis, Respiratory symptom
Clinical narrative: respiratory symptoms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of respiratory symptom 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 respiratory symptom (Verbatim: respiratory symptoms). The outcome of the respiratory symptom was not reported.   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: 03-MAR-2024 This case was reported by patient via (Open field AE monitoring) interactive digital media. The patient was getting respiratory symptoms similar to bronchitis after his/her vaccine. The patient wanted to know was this (illegible text).
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Injection site pain, Myalgia
Clinical narrative: Injection site pain; neck muscle soreness; shoulder soreness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain 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 injection site pain (Verbatim: Injection site pain), muscle soreness (Verbatim: neck muscle soreness) and shoulder soreness (Verbatim: shoulder soreness). The outcome of the injection site pain, muscle soreness and shoulder soreness were not reported.   It was unknown if the reporter considered the injection site pain, muscle soreness and shoulder soreness to be related to Arexvy.     It was unknown if the company considered the injection site pain, muscle soreness and shoulder soreness to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-MAR-2024 The case was received from the patient via interactive digital media. The patient experienced Injection site pain, neck muscle soreness, shoulder soreness.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: got shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2024 This case was reported by a consumer via interactive digital media. The reporter's sister in law got shingles right after she got the shot.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Urticaria
Clinical narrative: shingles; Rash; had hives all over; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles), rash (Verbatim: Rash) and hives (Verbatim: had hives all over). The outcome of the shingles was not reported and the outcome of the rash was resolved (duration 3 weeks) and the outcome of the hives was resolved (duration 5 months).   It was unknown if the reporter considered the shingles, rash and hives to be related to Shingles vaccine.     It was unknown if the company considered the shingles, rash and hives to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-MAR-2024 This case was reported by the patient via interactive digital media. The patient got his/her first shingles vax and a few days later the patient got the shingles. The patient also had rash lasted about 3 weeks and after the rash cleared, the patient had hives all over for 5 months.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Product administered to patient of inappropriate age
Clinical narrative: pretty painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: pretty painful). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-MAR-2024 This case was reported by the reporter for self and for daughter via interactive digital media. The reporter's daughter had chicken pox as a baby. The College finals she wound up with shingles. That actually means that she probably should get the shingles vaccine which is a double shot even if she not So, they did get our shingles shot as the reporter had chicken pox twice. They were pretty painful yuky shots but better than shingles. The follow-up could not be possible as no contact details were available; Sender's Comments:  US-GSK-US2024GSK033065:Same Article Different Patient
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Injections hurt like hell tho. 2nd shot not as much as the first; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Injections hurt like hell tho. 2nd shot not as much as the first). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2024AMR030826   Additional Information: GSK Receipt date: 07-MAR-2024 This case was reported by consumer via interactive digital media. The reporter was a patient. The patient reported that the Shingles injections hurt like hell. Patient said that 2nd shot of Shingles not as much as hurt as the first shot, but patient was wishing the he or she had not gotten it. The only reason patient did was because patient's brother had shingles and patient was not risking it. Patient said that it was miserable. This case had been linked with the case US2024AMR030826, reported by same reporter for second dose.; Sender's Comments:  US-GSK-US2024AMR030826:same patient, different dose
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Injections hurt like hell tho; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Injections hurt like hell tho). Rechallenge with Shingles vaccine was positive. The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2024AMR030823   Additional Information: GSK Receipt date: 07-MAR-2024 This case was reported by consumer via interactive digital media. The patient reported that the Shingles injections hurt like hell and mentioned that 2nd shot of Shingles not as much as hurt as the 1st shot, but was wished that if had not got the vaccine. The only reason patient did was because patient's brother had shingles and patient was not risking it. Patient said that it was miserable. This case had been linked with the case US2024AMR030823, reporter by same reporter for first dose.; Sender's Comments:  US-GSK-US2024AMR030823:same patient, different dose
Sex: U
Vaccine: HEPA, RV1
Symptoms: Incomplete course of vaccination
Clinical narrative: Incomplete course of vaccination; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of incomplete course of vaccination in a 5-year-old patient who received Rota (Rotarix liquid formulation) for prophylaxis.   Co-suspect products included Hepatitis A vaccine for prophylaxis.   Previously administered products included Infanrix Hexa (1st dose received on an unknown date), Rotarix (1st dose received at age of 4 months 23 days), Hepatitis A (received 2 doses on an unknown date), Hexaxim, BCG, MMR, chickenpox vaccine and Meningococcal vaccine.   On an unknown date, the patient did not receive the 2nd dose of Rotarix liquid formulation and the 3rd dose of Hepatitis A vaccine. On an unknown date, an unknown time after receiving Rotarix liquid formulation and Hepatitis A vaccine, the patient experienced incomplete course of vaccination (Verbatim: Incomplete course of vaccination). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-FEB-2024 Till the time of reporting the patient did not receive 2nd dose of Rotarix and 3rd dose of Hepatitis A. This case is linked with US2024AMR032030, same reporter.; Sender's Comments:  US-GSK-US2024AMR032030:same reporter
Age: 17.0
Sex: M
Vaccine: MEN, MENB
Symptoms: Dizziness, Fatigue
Clinical narrative: dizziness; severe fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizziness in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis.   On 01-MAR-2024, the patient received Bexsero (unknown arm) and the 1st dose of Menquadfi (unknown arm). On 01-MAR-2024, 1 hr after receiving Bexsero, the patient experienced dizziness (Verbatim: dizziness) and fatigue (Verbatim: severe fatigue). The outcome of the dizziness and fatigue were not resolved.   It was unknown if the reporter considered the dizziness and fatigue to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the dizziness and fatigue to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-MAR-2024 The reporter was the mother of the patient. The reporter stated her son (patient) received Bexsero and Menquadfi one in each arm (reporter was not sure which side) this morning (on the day of reporting).  The reporter stated that within an hour patient was experiencing dizziness and severe fatigue. The patient was referred to healthcare professional (HCP). It was unknown if the reporter considered the dizziness and fatigue to be related to Menquadfi.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: stability data for Boostrix stored at -2.8C x 50 minutes. Boostrix administered to 5 different patients.; 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 25-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number P5SR5, expiry date 26-APR-2026) for prophylaxis.   On 22-FEB-2024, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: stability data for Boostrix stored at -2.8C x 50 minutes. Boostrix administered to 5 different patients.). 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: 01-MAR-2024  A medical assistant reported to request stability data for Boostrix stored at minus 2.8 degree Celsius for 50 minutes and administered to 5 different patient which led to incorrect storage of drug.  The reporter consented to follow up. This is 1 of 5 linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2024027787:Different patient US-GSK-US2024027791:Different patient US-GSK-US2024027789:Different patient US-GSK-US2024027788:Different patient
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: extremely tired; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-SEP-2023, the patient received the 1st dose of Shingrix. In SEP-2023, 1 day after receiving Shingrix, the patient experienced tiredness (Verbatim: extremely tired). The outcome of the tiredness was resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.     It was unknown if the company considered the tiredness to be related to Shingrix.   Additional Information: GSK receipt date: 04-MAR-2024 The patient self-reported this case. The reporter reported that she had received first dose of Shingrix vaccine at a local pharmacy. The reporter stated that one or two days later she experienced tiredness. No additional events were reported. The reporter did not consent to the follow up.
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age, Product prescribing issue
Clinical narrative: 52 years old was prescribed Arexvy intentionally by doctor; This non-serious case was reported by a consumer via call center representative and described the occurrence of off label use in a 52-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concomitant products included oxygen.   On an unknown date, the patient did not receive Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced off label use (Verbatim: 52 years old was prescribed Arexvy intentionally by doctor). The outcome of the off label use was unknown.   Additional Information: GSK receipt date: 04-MAR-2024 The reporter was the patient who stated that she was 52 years old and was prescribed Arexvy. Arexvy is only FDA approved for ages 60 and older. The vaccine had not yet been administered as the pharmacy was unwilling. Her insurance had approved it. She had provided her pharmacy with a prescription from her doctor. Prescription was intentional which led to off label use.
Age: 70.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Half dose administered; accidentally administered 1 pediatric vial of Havrix to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 70-year-old male patient who received HAV (Havrix pediatric) (batch number X2233, expiry date 14-NOV-2025) for prophylaxis.   On 29-FEB-2024, the patient received Havrix pediatric. On 29-FEB-2024, an unknown time after receiving Havrix pediatric, the patient experienced accidental underdose (Verbatim: Half dose administered) and adult use of a child product (Verbatim: accidentally administered 1 pediatric vial of Havrix to a patient). The outcome of the accidental underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 04-MAR-2024 The pharmacist reported that she accidentally administered 1 pediatric vial of Havrix to a patient (1 pediatric vial per patient), which led to an accidental underdose and adult use of child product. This case was linked with US2024028529, reported by same reporter for different patient. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2024028529:different patient
Age: 1.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Pediarix administered instead of DTap/ Pediarix was the patient's 4th dose of DTaP and IPV and 6th dose of HepB; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 16-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 4N2PM, expiry date 28-MAR-2025) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Pediarix administered instead of DTap/ Pediarix was the patient's 4th dose of DTaP and IPV and 6th dose of HepB). The outcome of the inappropriate schedule of 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: 04-MAR-2024 The medical assistant called to inform that a 16-month-old patient had received a dose of Pediarix instead of a DTap dose.  According to reporter, Pediarix was the patient's 4th dose of DTaP and IPV and 6th dose of HepB, which led to inappropriate schedule for vaccine administration.  The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Half dose administered; accidentally administered 1 pediatric vial of Havrix to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 70-year-old female patient who received HAV (Havrix pediatric) (batch number X2233, expiry date 14-NOV-2025) for prophylaxis.   On 29-FEB-2024, the patient received Havrix pediatric. On 29-FEB-2024, an unknown time after receiving Havrix pediatric, the patient experienced accidental underdose (Verbatim: Half dose administered) and adult use of a child product (Verbatim: accidentally administered 1 pediatric vial of Havrix to a patient). The outcome of the accidental underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 04-MAR-2024 The pharmacist reported that she accidentally administered 1 pediatric vial of Havrix to a patient (1 pediatric vial per patient), which led to an accidental underdose and adult use of child product. This case was linked with US2024028527, reported by same reporter for different patient. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2024028527:different patient
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pyrexia, Rash
Clinical narrative: chills; nausea; fever; rash left arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-SEP-2023, the patient received the 1st dose of Shingrix (left deltoid). In SEP-2023, 10 hrs after receiving Shingrix, the patient experienced fever (Verbatim: fever) and rash (Verbatim: rash left arm). On 26-SEP-2023, the patient experienced chills (Verbatim: chills) and nausea (Verbatim: nausea). The outcome of the chills, nausea, fever and rash were resolved.   It was unknown if the reporter considered the chills, nausea, fever and rash to be related to Shingrix.     It was unknown if the company considered the chills, nausea, fever and rash to be related to Shingrix.   Additional Information: GSK receipt date: 04-MAR-2024 The patient experienced chills and nausea 1 day after her first dose that had resolved. The patient stated that she had a fever 10 hours after administration and a rash on her left arm 2 days after administration of her first dose of Shingrix that resolved. The patient stated that she was going to get her 2nd dose of the series on day of reporting and already been in contact with her pharmacy and physician concerning the symptoms that occurred after her first dose of Shingrix.
Sex: U
Vaccine: MENB
Symptoms: Syringe issue, Underdose
Clinical narrative: syringe of Bexsero leaked out/majority of the liquid leaked out; syringe of Bexsero leaked out; Product Complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a patient who received Men B NVS (Bexsero) (batch number PX7E2, expiry date 30-SEP-2026) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced accidental underdose (Verbatim: syringe of Bexsero leaked out/majority of the liquid leaked out), syringe leak (Verbatim: syringe of Bexsero leaked out) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the accidental underdose, syringe leak and pharmaceutical product complaint 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: 04-MAR-2024 The reporter was the office manager.  The reporter stated that a syringe of Bexsero leaked out of the hub of the needle where it attaches to the syringe (between the leur lock and needle). The reporter confirmed a leur-lok needle was used. During administration, after partial use of the multipack the defect was discovered. It was unknown, how was the mixing or shaking performed after reconstitution and/or re-suspension. The Bexsero was partially administered, the majority of the liquid leaked out, which led to accidental underdose. It was unknown how much, if any, of the product was injected into the patient. The healthcare professional (HCP) preparing/administering the vaccine was a experienced user. The syringe was pre-assembled with needle some time before administration. No more than 10 minutes. The size gauge of needle was used 1 inch and 25g. No blister and/or carton were damaged and no luer lok damaged. The needle which was used, available. There was no any damage or breakage on the syringe barrel.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: Patient received one dose of the Twinrix, and instead of finishing the series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Patient received one dose of the Twinrix, and instead of finishing the series). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-Mar-2024 The reporter reported that the patient received one dose of the Twinrix vaccine and instead of finishing the series, she received 2 doses of the Heplisav.  The reporter wanted to know how will she get protection for the Hepatitis A or do we restart the series or can she get Havrix. The reporter stated that the patient had not received any of the additional doses inquired about yet.  Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up via email.
Age: 1.58
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: mistakenly gave an expired dose of Infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received DTPa (Infanrix) (batch number Y4259, expiry date 03-MAR-2024) for prophylaxis.   On 04-MAR-2024, the patient received the 4th dose of Infanrix. On 04-MAR-2024, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: mistakenly gave an expired dose of Infanrix). 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: 04-MAR-2024 Medical assistant reported that they mistakenly gave an expired dose of Infanrix to a patient, which led to expired vaccine used. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: sore arm; chills; Generalized body aches; Headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included headache.   On 28-FEB-2024 05:30, the patient received Shingrix (unknown arm). On 29-FEB-2024, 1 days after receiving Shingrix, the patient experienced chills (Verbatim: chills), general body pain (Verbatim: Generalized body aches) and headache (Verbatim: Headache). On an unknown date, the patient experienced pain in arm (Verbatim: sore arm). The patient was treated with paracetamol (Tylenol). The outcome of the pain in arm, chills and general body pain were resolved and the outcome of the headache was not resolved.   It was unknown if the reporter considered the pain in arm, chills, general body pain and headache to be related to Shingrix.     It was unknown if the company considered the pain in arm, chills, general body pain and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-MAR-2024 The reporter called on behalf of the patient who was her daughter. The reporter made an estimate of administration occurring on 28-FEB-2024 at 5:30pm.  The reporter did not know the lot number of the vaccine or in which arm her daughter (patient) received injection. The patient had a sore arm. The patient had chills, general body aches, and headache 24 hours after receiving vaccine. The reporter was concerned about how long the patient's headache would last.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Lethargy, Pain in extremity
Clinical narrative: feeling wiped out and tired; feeling lethargic; Sore arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of tiredness in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced tiredness (Verbatim: feeling wiped out and tired), lethargy (Verbatim: feeling lethargic) and pain in arm (Verbatim: Sore arm). Shingrix was discontinued. The outcome of the tiredness, lethargy and pain in arm were unknown.   It was unknown if the reporter considered the tiredness, lethargy and pain in arm to be related to Shingrix.     It was unknown if the company considered the tiredness, lethargy and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-MAR-2024 The registered pharmacist reported that since covid a lot of people were reporting feeling wiped out and tired following administration of Shingrix and state they did not want to get second dose. Before covid, she only heard patients complained of sore arms but now everyone was reporting feeling lethargic and tired.  The reporter did not had specific patient details nor could she quantify how many.
Sex: U
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: received only the adjuvant portion of Arexvy; received only the adjuvant portion of Arexvy; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 72Y25, expiry date 19-OCT-2024) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: received only the adjuvant portion of Arexvy) and inappropriate dose of vaccine administered (Verbatim: received only the adjuvant portion of Arexvy). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 04-MAR-2024 The reporter called to inform that the unspecified patient received only the adjuvant portion of Arexvy, which led to inappropriate preparation of medication and Inappropriate dose of vaccine administered. The reporter wants to know if there was any information about this scenario and they did not know who the patient. Partial information was given.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: patient was administered an expired vaccine of Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-day-old male patient who received HBV (Engerix B) (batch number 39A3L, expiry date 23-FEB-2024) for prophylaxis.   On 05-MAR-2024, the patient received Engerix B. On 05-MAR-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: patient was administered an expired vaccine of Engerix-B). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 05-MAR-2024 The reporter reported that a patient was administered an expired vaccine of Engerix-B, which led to expired vaccine used. The reporter consented to follow-up.
Age: 0.33
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Infanrix was administered to a patient 2 days past the expiration date; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-month-old female patient who received DTPa (Infanrix) (batch number Y4259, expiry date 03-MAR-2024) for prophylaxis.   On 05-MAR-2024, the patient received Infanrix. On 05-MAR-2024, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Infanrix was administered to a patient 2 days past the expiration date). 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: 05-MAR-2024 Certified medical assistant sated that Infanrix was administered to a patient 2 days past the expiration date, which led to expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Monoplegia, Pyrexia
Clinical narrative: the leg paralysis; Unable to move leg; that he had fever; This serious case was reported by a pharmacist via call center representative and described the occurrence of leg paralysis in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number NM22D, expiry date 11-DEC-2025) for prophylaxis.   Concurrent medical conditions included restless legs syndrome. Concomitant products included mirtazapine.   On 05-MAR-2024, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 06-MAR-2024, 1 days after receiving Shingrix, the patient experienced leg paralysis (Verbatim: the leg paralysis) (serious criteria GSK medically significant) and mobility decreased (Verbatim: Unable to move leg). In MAR-2024, the patient experienced fever (Verbatim: that he had fever). The outcome of the leg paralysis was resolving and the outcome of the mobility decreased was not resolved and the outcome of the fever was not reported.   It was unknown if the reporter considered the leg paralysis, mobility decreased and fever to be related to Shingrix.     It was unknown if the company considered the leg paralysis, mobility decreased and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-MAR-2024 The pharmacist stated that the patient was administered a dose of Shingrix and that night he took a dose of mirtazapine for Restless Leg Syndrome and then this morning when he woke up, he stated he was unable to move his legs. The patient reported that he had fever. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter.