chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RSV
Symptoms: Pain, Pain in extremity
Clinical narrative: Injection site is swollen; joints painful; Hurts to move, pain with movement; headache; sore arm; running grade tempreture; too hard; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of extensive swelling of vaccinated limb in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 06-APR-2024, the patient received Arexvy. In APR-2024, an unknown time after receiving Arexvy, the patient experienced extensive swelling of vaccinated limb (Verbatim: Injection site is swollen), joint pain (Verbatim: joints painful), pain (Verbatim: Hurts to move, pain with movement), headache (Verbatim: headache), pain in arm (Verbatim: sore arm), body temperature increased (Verbatim: running grade tempreture) and injection site induration (Verbatim: too hard). The outcome of the extensive swelling of vaccinated limb, joint pain, pain, headache, pain in arm, body temperature increased and injection site induration were not reported.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, joint pain, pain, headache, pain in arm, body temperature increased and injection site induration to be related to Arexvy.     It was unknown if the company considered the extensive swelling of vaccinated limb, joint pain, pain, headache, pain in arm, body temperature increased and injection site induration to be related to Arexvy.   Additional Information: GSK Receipt Date: 08-APR-2024 The case was received from the patient via interactive digital media. The patient was reporter. The reported that patient had received the Arexvy vaccine. The reported that after the vaccination patient had hurt all over, joint painful, hurt to move, injection site swollen and patient had almost elbow and very hard running grade temperature and headache. Till the time of reporting reported that patient vaccination was 2 days ago. The patient had usually had a reaction to vaccine except a sore arm. The reported that this one causing paint with movement.
Sex: U
Vaccine: RSV
Symptoms: Influenza
Clinical narrative: flu; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, less than a day after receiving Arexvy, the patient experienced influenza (Verbatim: flu). The outcome of the influenza was not resolved.   It was unknown if the reporter considered the influenza to be related to Arexvy.   It was unknown if the company considered the influenza to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-APR-2024 This case was reported the patient via interactive digital media. The patient developed a flu condition the same night after receiving the Arexvy vaccine shot and have been this way for days now. The patient was looking at the side effects.
Sex: U
Vaccine: RSV
Symptoms: Positive airway pressure therapy, Sleep apnoea syndrome
Clinical narrative: Sleep apnea; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sleep apnea 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 sleep apnea (Verbatim: Sleep apnea). The outcome of the sleep apnea was not reported.   It was unknown if the reporter considered the sleep apnea to be related to Arexvy.     It was unknown if the company considered the sleep apnea to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-APR-2024 This case was reported via interactive digital media. The patient stated that s/he had sleep apnea and use a C-PAP.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles outbreak; 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.   The patient's past medical history included shingles. Previously administered products included varicella zoster vaccine (received first dose of varicella zoster vaccine on unknown date, first shot was awful).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles outbreak). 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: 12-APR-2024 The case was received from the patient via interactive digital media.   The patient got the shingles so he/she got the vaccine. The patient also stated his/her first shot was awful and second was worse.  The patient actually had a shingles outbreak directly after the second shot. This case is liked with US2024AMR047657 for same reporter different patient.; Sender's Comments:  US-GSK-US2024AMR047657:Same reporter differnet patient
Sex: U
Vaccine: RSV
Symptoms: Auditory disorder
Clinical narrative: This vaccine seems to have caused my hearing to become sounding; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of auditory disorder 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 auditory disorder (Verbatim: This vaccine seems to have caused my hearing to become sounding). The outcome of the auditory disorder was not reported.   It was unknown if the reporter considered the auditory disorder to be related to Arexvy.     It was unknown if the company considered the auditory disorder to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-APR-2024 This case was reported via interactive digital media. The patient stated that vaccine caused his/her hearing to become sounding.
Sex: U
Vaccine: RSV
Symptoms: Back pain, Dizziness
Clinical narrative: Dizziness; Back pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of dizziness in a 66-year-old 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 dizziness (Verbatim: Dizziness) and back pain (Verbatim: Back pain). The outcome of the dizziness and back pain were not reported.   It was unknown if the reporter considered the dizziness and back pain to be related to Arexvy.     It was unknown if the company considered the dizziness and back pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 9-Apr-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient reported that he or she was received RSV vaccine and experienced some side effects including dizziness and back pain. The reporter stated that it was helpful to read this web site. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Fatigue, Headache, Injection site pain
Clinical narrative: Feel injection site pain; fatigue; headache next day; 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, 1 day after receiving Arexvy, the patient experienced injection site pain (Verbatim: Feel injection site pain), fatigue (Verbatim: fatigue) and headache (Verbatim: headache next day). The outcome of the injection site pain, fatigue and headache were not reported.   It was unknown if the reporter considered the injection site pain, fatigue and headache to be related to Arexvy.     It was unknown if the company considered the injection site pain, fatigue and headache to be related to Arexvy.   Additional Information: GSK receipt date: 09-APR-2024 This case was reported the patient via (Open field AE monitoring) interactive digital media. The patient felt injection site pain, fatigue, headache next day. Yuch.
Sex: U
Vaccine: RSV
Symptoms: Cough
Clinical narrative: persistent cough; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of persistent cough 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 persistent cough (Verbatim: persistent cough). The outcome of the persistent cough was not resolved.   It was unknown if the reporter considered the persistent cough to be related to Arexvy.     It was unknown if the company considered the persistent cough to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-APR-2024 This case was received via (Open field AE monitoring) interactive digital media. The reporter was very concerned about persistent cough.
Sex: U
Vaccine: RSV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: swelling around vaccination site; heat around vaccination site; 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.   On an unknown date, the patient received Arexvy. On an unknown date, 3 days after receiving Arexvy, the patient experienced injection site swelling (Verbatim: swelling around vaccination site) and injection site warmth (Verbatim: heat around vaccination site). The outcome of the injection site swelling and injection site warmth were not reported.   It was unknown if the reporter considered the injection site swelling and injection site warmth to be related to Arexvy.     It was unknown if the company considered the injection site swelling and injection site warmth to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-APR-2024 The case was received from the consumer via (Open field AE monitoring) interactive digital media.   The reporter stated three days after the vaccination he/she had swelling, heat and a large (illegible text) area around the vaccination site.  The patient asked was this concerning and would call the pharmacy where he/she got the vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate Vaccine Schedule; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix vaccine in 2021 Intramuscularlly).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate Vaccine Schedule). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 09-APR-2024 The patient was the reporter. The patient was received 1st dose of Shingrix vaccine in 2021 and 2nd dose received in 2024, which led to lengthening of vaccination schedule. The 1st dose at 0 month followed by 2nd dose administered 2 to 6th month later.  The lot number and exact date of vaccine administration not available. The reporter consent to follow up.
Age: 0.17
Sex: F
Vaccine: RV1, RV1
Symptoms: Infantile spitting up, Oral administration complication
Clinical narrative: They repeated the dose again (at the same visit) as recommended and the baby spit it up again; they gave a 2 month old baby Rotarix but the baby spit it up; This non-serious case was reported by a nurse via call center representative and described the occurrence of regurgitation of medication in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number GG2YS, expiry date 18-OCT-2025) for prophylaxis.   Co-suspect products included Rota (Rotarix lyophilized formulation) (batch number GG2YS, expiry date 18-OCT-2025) for prophylaxis.   On 08-APR-2024, the patient received the 2nd dose of Rotarix lyophilized formulation (oral) and the 1st dose of Rotarix lyophilized formulation (oral). On 08-APR-2024, immediately after receiving Rotarix lyophilized formulation and Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: They repeated the dose again (at the same visit) as recommended and the baby spit it up again) and accidental underdose (Verbatim: they gave a 2 month old baby Rotarix but the baby spit it up). Rechallenge with Rotarix lyophilized formulation was positive. The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose was unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Rotarix lyophilized formulation and Rotarix Oral Applicator Device.     It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Rotarix lyophilized formulation and Rotarix Oral Applicator 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: 08-APR-2024 The nurse reported 2-month-old patient was administered a dose of Rotarix and the baby (patient) spit the dose out and then they had repeated the dose again (at the same visit) as recommended and the baby spit it up again, which led to accidental underdose and regurgitation of medication. The reporter reported that the dose valid and can they proceed to the 2nd dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: administered an adult dose of Engerix-B to 18 year old male patient; patient should have received 10 mcg dose based on their age but instead received a 20 mcg d; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 18-year-old male patient who received HBV (Engerix B adult) (batch number CF424, expiry date 24-AUG-2024) for prophylaxis.   On 05-APR-2024, the patient received the 1st dose of Engerix B adult 20 µg. On 05-APR-2024, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: administered an adult dose of Engerix-B to 18 year old male patient) and adult product administered to child (Verbatim: patient should have received 10 mcg dose based on their age but instead received a 20 mcg d). The outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 09-APR-2024 The pharmacist administered an adult dose of Engerix-B to a patient. The patient should have received 10 mcg dose based on their age but instead received a 20 mcg dose, which led to overdose and adult product administered to child. The vaccine administration facility was the same as primary reporter.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: 48 year old male ended up administering a pediatric dose of Hep B; 48 year old male ended up administering a pediatric dose of Hep B; Co-suspect products included  .     In NOV-2023, an unknown time after receiving Engerix B, the patient experienced adult use of a child product (Verbatim: 48 year old male ended up administering a pediatric dose of Hep B) and underdose (Verbatim: 48 year old male ended up administering a pediatric dose of Hep B). The outcome of the adult use of a child product and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-APR-2024 The reporter was following up on an incident that occurred with one of patients who ended up administering a pediatric dose of Hepatitis B which led to adult use of a child product and underdose. Reporter confirmed Engerix-B was administered, and that such dose had been administered in November 2023 (exact date was not specified).
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: gave a Menveo vaccine without the proper diluent; gave a Menveo vaccine without the proper diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 20-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA950A, expiry date 31-JUL-2024) for prophylaxis.   On 01-APR-2024, the patient received Menveo. On 01-APR-2024, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: gave a Menveo vaccine without the proper diluent) and inappropriate dose of vaccine administered (Verbatim: gave a Menveo vaccine without the proper diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-APR-2024 The reporter stated that she gave a Menveo vaccine without the proper diluent, it was mixed with sterile water which led to which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Conjunctivitis, Foreign body sensation in eyes, Headache, Ocular hyperaemia
Clinical narrative: Conjunctivitis right eye; Chills; Fever 100.6F; headache; right eye has redness; felt like sand in her eye; This non-serious case was reported by a consumer via call center representative and described the occurrence of conjunctivitis in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included breast cancer.   On 01-APR-2024, the patient received the 1st dose of Shingrix (left deltoid) .5 ml. On 02-APR-2024, 1 days after receiving Shingrix, the patient experienced chills (Verbatim: Chills), fever (Verbatim: Fever 100.6F) and headache (Verbatim: headache). On 07-APR-2024, the patient experienced conjunctivitis (Verbatim: Conjunctivitis right eye). In APR-2024, the patient experienced eye red (Verbatim: right eye has redness) and abnormal sensation in eye (Verbatim: felt like sand in her eye). The patient was treated with ibuprofen and ofloxacin. On 03-APR-2024, the outcome of the chills, fever and headache were resolved (duration 1 day). The outcome of the conjunctivitis was not resolved and the outcome of the eye red and abnormal sensation in eye were not reported.   It was unknown if the reporter considered the conjunctivitis, chills, fever, headache, eye red and abnormal sensation in eye to be related to Shingrix.     It was unknown if the company considered the conjunctivitis, chills, fever, headache, eye red and abnormal sensation in eye to be related to Shingrix.   Additional Information: GSK Receipt date: 09-APR-2024 The patient self-reported this case. The patient had chills, fever and headache one day after receiving first dose of vaccine. The symptoms resolved in one day and also, she had conjunctivitis in her right eye 7 days after receiving first dose of vaccine that had not resolved. The patient reported conjunctivitis felt like sand in her eye and her right eye had redness. The patient tried to get an appointment with her physician with negative results, since she could not get an appointment with her physician she used her daughter's medication, Ofloxacin to treat conjunctivitis (medication error). The patient stated she also used Ibuprofen for relief of all symptoms reported.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Conjunctivitis right eye; Chills; Fever 100.6F; headache; right eye has redness; felt like sand in her eye; This non-serious case was reported by a consumer via call center representative and described the occurrence of conjunctivitis in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included breast cancer.   On 01-APR-2024, the patient received the 1st dose of Shingrix (left deltoid) .5 ml. On 02-APR-2024, 1 days after receiving Shingrix, the patient experienced chills (Verbatim: Chills), fever (Verbatim: Fever 100.6F) and headache (Verbatim: headache). On 07-APR-2024, the patient experienced conjunctivitis (Verbatim: Conjunctivitis right eye). In APR-2024, the patient experienced eye red (Verbatim: right eye has redness) and abnormal sensation in eye (Verbatim: felt like sand in her eye). The patient was treated with ibuprofen and ofloxacin. On 03-APR-2024, the outcome of the chills, fever and headache were resolved (duration 1 day). The outcome of the conjunctivitis was not resolved and the outcome of the eye red and abnormal sensation in eye were not reported.   It was unknown if the reporter considered the conjunctivitis, chills, fever, headache, eye red and abnormal sensation in eye to be related to Shingrix.     It was unknown if the company considered the conjunctivitis, chills, fever, headache, eye red and abnormal sensation in eye to be related to Shingrix.   Additional Information: GSK Receipt date: 09-APR-2024 The patient self-reported this case. The patient had chills, fever and headache one day after receiving first dose of vaccine. The symptoms resolved in one day and also, she had conjunctivitis in her right eye 7 days after receiving first dose of vaccine that had not resolved. The patient reported conjunctivitis felt like sand in her eye and her right eye had redness. The patient tried to get an appointment with her physician with negative results, since she could not get an appointment with her physician she used her daughter's medication, Ofloxacin to treat conjunctivitis (medication error). The patient stated she also used Ibuprofen for relief of all symptoms reported.
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: gave a 47 year-old female immunocompetent patient a Shingrix first dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 47-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-APR-2024, the patient received the 1st dose of Shingrix. On 09-APR-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: gave a 47 year-old female immunocompetent patient a Shingrix first dose). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 09-APR-2024 The immunization coordinator reported that, one of their nurses gave a under age immunocompetent patient a Shingrix dose, which led to inappropriate age at vaccine administration.; Sender's Comments: On 4/9/2024, an Immunization Coordinator reported that on 4/9/2024 one of their nurses gave a 47 year-old female immunocompetent patient a Shingrix first dose.  ~~~~~~~Consented to follow up.Call Notes:No data about lot number or expiration date injected. HCP has an hybrid position so she was calling from home. Her phone number corresponds to her personal phone. Full name was not provided during the call. Follow up to the office accepted.
Age: 67.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine/ 1st dose of Twinrix received on 19-Aug-2023 and did not receive the second dose until 02-Apr-2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 19-AUG-2023).   On 02-APR-2024, the patient received the 2nd dose of Twinrix. On 02-APR-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine/ 1st dose of Twinrix received on 19-Aug-2023 and did not receive the second dose until 02-Apr-2024). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-APR-2024 The pharmacist reported a patient received first dose of Twinrix series and did not receive the second dose until 2nd April 2024. The pharmacist did not have the lot number information of the two doses. The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of Twinrix later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: gave the vaccine to a 16 year old girl and it expired; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA9125, expiry date 20-MAR-2024) for prophylaxis.   On 08-APR-2024, the patient received Menveo. On 08-APR-2024, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: gave the vaccine to a 16 year old girl and it expired). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 09-APR-2024 The reporter stated that s/he gave the vaccine to a girl which expired on March 31st 2024 which led to expired vaccine used. The reporter was wondering what to do and question to revaccinate.
Age: 36.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: 36 year old male patient was administered a pediatric dose of Havrix; 36 year old male patient was administered a pediatric dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 36-year-old male patient who received HAV (Havrix 720) (batch number 2YS34, expiry date 02-MAR-2025) for prophylaxis.   On 04-MAR-2024, the patient received the 1st dose of Havrix 720. On 04-MAR-2024, an unknown time after receiving Havrix 720, the patient experienced underdose (Verbatim: 36 year old male patient was administered a pediatric dose of Havrix) and adult use of a child product (Verbatim: 36 year old male patient was administered a pediatric dose of Havrix). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-Apr-2024 The reporter was a medical assistant. The reporter reported that the 36 year old male patient received a pediatric dose of Havrix, which led to underdose and adult use of a child product.   The reporter stated that at the time of reporting no further doses had been administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Syringe issue, Underdose
Clinical narrative: patient probably got only half of the 0.5 dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 2F9C5, expiry date 18-APR-2026) for prophylaxis.   On 09-APR-2024, the patient received the 1st dose of Shingrix. On 09-APR-2024, an unknown time after receiving Shingrix, the patient experienced accidental underdose (Verbatim: patient probably got only half of the 0.5 dose). The outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 09-APR-2024 The registered nurse reported that, while they gave the Shingrix vaccine at the office, he/she gave the patient the vaccine and he/she did not know if the hub of the needle was not tied right or what, but some of the vaccine liquid came out around the hub of the needle. The reporter stated, probably, he/she would guess might be half of the amount of the vaccine so, the patient probably got only half of the 0.5 dose, which led to accidental underdose. The vaccine administration facility was the same as primary reporter.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Gave them the adult hepatis A instead of the peds Hepatits A.; 12 month old baby give a hepatitis A vaccine(adult Havrix); This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 12-month-old male patient who received HAV (Havrix adult) (batch number T9TL9, expiry date 05-DEC-2025) for prophylaxis.   On 08-APR-2024, the patient received the 1st dose of Havrix adult. On 08-APR-2024, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: Gave them the adult hepatis A instead of the peds Hepatits A.) and adult product administered to child (Verbatim: 12 month old baby give a hepatitis A vaccine(adult Havrix)). The outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 10-APR-2024 The reporter had given a 12 month old patient a hepatitis A vaccine (Havrix) and they gave them the adult hepatitis A instead of the pediatric hepatitis A which led to overdose and adult product administered to child. The reporter called to see if there was anything they needed to do or to watched out for in regard to that patient. They got Havrix instead of VAQTA. The reporter consented to follow up.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient that got his first dose of Engerix-B on October 2023 then was late for second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old male patient who received HBV (Engerix B) (batch number PE9G5, expiry date 19-MAY-2025) for prophylaxis.   Previously administered products included Engerix b (1st dose received in October 2023).   On 25-JAN-2024, the patient received the 2nd dose of Engerix B. On 25-JAN-2024, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: patient that got his first dose of Engerix-B on October 2023 then was late for second dose). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-APR-2024 The pharmacist wanted to know the time frame for a third shot for a patient that got his first dose of Engerix-B in October 2023 then was late for the second dose, which was 25th January 2024, which led to lengthening vaccination schedule. The vaccine administration facility was the same as primary reporter. The reporter did not consent for follow up.
Sex: U
Vaccine: COVID19-2
Symptoms: Endometrial cancer
Clinical narrative: Endometrial Cancer; This report concerns an unknown subject who was involved in phase IV study. The subject received ELASOMERAN, DAVESOMERAN (Spikevax Bivalent .222 (Original/Omicron BA.4/5)) for COVID-19 prophylaxis. The report describes a case of ENDOMETRIAL CANCER (Endometrial Cancer).     No Medical History information was reported.    On an unknown date, the subject received dose of ELASOMERAN, DAVESOMERAN (Spikevax Bivalent .222 (Original/Omicron BA.4/5)) (unknown route) 1 dosage form at an unspecified frequency. On 24-Apr-2023, the subject experienced ENDOMETRIAL CANCER (Endometrial Cancer) (seriousness criterion medically significant). At the time of the report, ENDOMETRIAL CANCER (Endometrial Cancer) had not resolved.        The action taken with ELASOMERAN, DAVESOMERAN (Spikevax Bivalent .222 (Original/Omicron BA.4/5)) (Unknown) was unknown.   For ELASOMERAN, DAVESOMERAN (Spikevax Bivalent .222 (Original/Omicron BA.4/5)) (Unknown), the reporter considered ENDOMETRIAL CANCER (Endometrial Cancer) to be not related.    This is a Sponsored (Post-Marketing Surveilance, Use-Result Surveilance with Spikevax Bivalent .222 (Original/Omicron BA.4/5)) case with study name: Spikevax Bivalent and protocol number.  The subject had presence of concomitant medications.  Reporter causality for the event of endometrial cancer with respect to the suspect vaccine was reported as not related.  No treatment information was reported.  Company Comment: This case concerns an unknown age and gender subject with no medical history reported, who experienced the unexpected seriousness criteria medically significant unexpected event of endometrial cancer. The event began unknown days after a dose of Spikevax Bivalent .222 (Original/Omicron BA.4/5 . Very limited information is available for medical assessment. As per data available to date, there is no evidence that mRNA-1273 vaccine can cause cancer or relapses and vaccine does not modify DNA. On the other hand, COVID-19 mRNA vaccines are recommended in cancer patients as protection from a possible SARS-COV-2 infection. The event was considered as "not related to the study drug. The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5 is not affected by this report.
Sex: U
Vaccine: COVID19-2
Symptoms: Myasthenia gravis
Clinical narrative: myastenia, LT ,Myasthenia Crisis; This   The subject (patient ID) received ELASOMERAN, DAVESOMERAN (Spikevax Bivalent .222 (Original/Omicron BA.4/5)) for COVID-19 prophylaxis.   The report describes a case of MYASTHENIA GRAVIS (myastenia, LT ,Myasthenia Crisis).     No Medical History information was reported.    On an unknown date, the subject received dose of ELASOMERAN, DAVESOMERAN (Spikevax Bivalent .222 (Original/Omicron BA.4/5)) (unknown route) 1 dosage form at an unspecified frequency. On 04-Aug-2023, the subject experienced MYASTHENIA GRAVIS (myastenia, LT ,Myasthenia Crisis) (seriousness criteria hospitalization, medically significant and life threatening). On 18-Aug-2023, MYASTHENIA GRAVIS (myastenia, LT ,Myasthenia Crisis) had resolved.        The action taken with ELASOMERAN, DAVESOMERAN (Spikevax Bivalent .222 (Original/Omicron BA.4/5)) (Unknown) was unknown.   For ELASOMERAN, DAVESOMERAN (Spikevax Bivalent .222 (Original/Omicron BA.4/5)) (Unknown), the reporter considered MYASTHENIA GRAVIS (myastenia, LT ,Myasthenia Crisis) to be not related.    This was a Sponsored case with study name.  No concomitant medications were provided.  No treatment information was reported.  Company Comment: This case concerns an unknown age and gender subject with no medical history reported, who experienced the unexpected seriousness criteria hospitalization, medically significant and life threatening AESI of myasthenia gravis. The event began unknown days after a dose of Spikevax Bivalent .222 (Original/Omicron BA.4/5 . Very limited information is available for medical assessment. No medical history, no latency nor risk factors for the event were reported, as no alternative explanation was provided thus conservatively kept as related to the study drug. The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 68 people died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (68 people died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medication was not reported by reporter. It was reported that, a 52-year-old female reported 68 people die with that lot number (012L20A). "So, she dodged a bullet. No other details were provided. The treatment medication was not reported by reporter. This case contains information about 18th patient out of 68 patients  Company Comment: This is a Spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the serious unexpected event of Death which occurred on an unknown date and onset latency with an unspecified dose number of mRNA-1273 vaccine. Very limited information regarding this event has been provided at this time, the cause of death was not reported, and it is unknown if an autopsy was performed. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 18 out of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.  This case contains information for patient 29 out of 68.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Reporter's Comments: Company comment: This spontaneous case concerns a patient of unknown age and gender, with no medical history information reported, who experienced the unexpected serious (death and medically significant) event of death. The event occurred on an unknown date after a dose of mRNA-1273. No further information about the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 29 out of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Suspect product dosage text was reported as unknown.  No treatment medication was reported.  This case is reported for patient 31 out of 68 patients.  Company Comment This spontaneous case concerns an unknown age and gender patient, with no medical history reported, who experienced the unexpected, medically significant and death seriousness criteria event of death unknown days after a dose of mRNA-1273 vaccine.  Concomitant medication nor Treatment details were reported. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.    The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 31 out of 68; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 68 people died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (68 people died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medication was not reported by reporter. It was reported that, a 52-year-old female reported 68 people die with that lot number (012L20A). "So, she dodged a bullet. No other details were provided. The treatment medication was not reported by reporter. This case contains information about 32th patient out of 68 patients.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Reporter's Comments: Company comment: This spontaneous case concerns a patient of unknown age and gender, with no medical history information reported, who experienced the unexpected serious (death and medically significant) event of death. The event occurred on an unknown date after a dose of mRNA-1273. No further information about the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 32 out of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 68 people died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (68 people died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medication was not reported by reporter.  Dosage text for suspect product was reported as unknown. As date of death was reported as 01-Jan-1990 which was a discrepancy, and no dates were reported in the narrative, so date of death was captured as unknown. The treatment medication was not reported by reporter. This case contains information for patient 33 out of 68 described by the reporter.  Company comment: This spontaneous case was reported by a consumer and describes the occurrence of DEATH in a patient of an unknown age and gender who received mRNA-1273 vaccine for COVID-19 prophylaxis. Neither vaccination date nor the date of death has been reported, hence latency could not be assessed. No further information is available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 33 out of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient had died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient had died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Suspect vaccine dosage text was reported as unknown. Treatment information was not provided.  This case contains information about patient 34th out of 68 patients.  Company Comment: This is a Spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the serious unexpected event of Death which occurred on an unknown date and onset latency with an unspecified dose number of mRNA-1273 vaccine. Very limited information regarding this event has been provided at this time, the cause of death was not reported, and it is unknown if an autopsy was performed. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 34 out of 68; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient had died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient had died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 35th out of 68 patients.   Company Comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the serious (due to medically significant and Fatal) unexpected event of Death. The event occurred on an unknown date after a dose of mRNA-1273 vaccine. Reason, date for death, whether an autopsy was performed or not, dates for vaccination and dose numbers, circumstances leading to death, supportive diagnostic procedures, treatment, medical history and concomitant medications, that would contribute the assessment of the case, were not provided. The outcome of the event was reported as fatal. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 35 out of 68; Reported Cause(s) of Death: Unknown cause of death