chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: Caller is the patient inquiring about a third dose of GARDASIL 9.  In 2021, patient said she was told that she only needed 2 doses of the GARDASIL 9.  She had the first shot in May 2021 and the second in August 2021, both at Pharmacy.  Patient was reading; No other AE; This spontaneous report was received from a consumer and refers to a female patient of unknown age. No information on patient's medical history, current conditions and concomitant medications was provided.  In MAY-2021 the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided). In AUG-2021 the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided). In 2021, patient said she was told that she only needed 2 doses of the GARDASIL 9. Patient was reading up on it and saw that the recommendation is for three shots. Patient was asking if she should go back and get the third shot. Caller indicated she will discuss further with her health care professional (HCP) on whether having only the two doses was sufficient, or if she should get the third dose (inappropriate schedule of product administration). No other adverse event and no product quality complaint reported (no adverse event)
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Influenza like illness, Nausea, Pyrexia, Vertigo
Clinical narrative: Vertigo; flu-like symptoms; fever; nausea; blurry vision; vomiting; chills; This non-serious case was reported by a consumer via sales rep and described the occurrence of vertigo in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number 2Y393) for prophylaxis.   Concomitant products included fluoxetine.   On 26-JUL-2024, the patient received Bexsero (left deltoid). In JUL-2024, less than a week after receiving Bexsero, the patient experienced influenza-like symptoms (Verbatim: flu-like symptoms), fever (Verbatim: fever), nausea (Verbatim: nausea), blurred vision (Verbatim: blurry vision), vomiting (Verbatim: vomiting) and chills (Verbatim: chills). On 27-JUL-2024, the patient experienced vertigo (Verbatim: Vertigo). The outcome of the vertigo, influenza-like symptoms, fever, nausea, blurred vision, vomiting and chills were not resolved.   The reporter considered the vertigo, influenza-like symptoms, fever, nausea, blurred vision, vomiting and chills to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the vertigo, influenza-like symptoms, fever, nausea, blurred vision, vomiting and chills 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: 29-JUL-2024 It was reported that patient was experiencing vertigo, flu-like symptoms, fever, nausea, blurry vision, vomiting, chills. The patient was taken to an emergency room at his Healthcare professional advice and was told that he will need to be rechecked in 2 to 3 days if not improving or if he develops new or worsening symptoms.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Vision blurred, Vomiting
Clinical narrative: Vertigo; flu-like symptoms; fever; nausea; blurry vision; vomiting; chills; This non-serious case was reported by a consumer via sales rep and described the occurrence of vertigo in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number 2Y393) for prophylaxis.   Concomitant products included fluoxetine.   On 26-JUL-2024, the patient received Bexsero (left deltoid). In JUL-2024, less than a week after receiving Bexsero, the patient experienced influenza-like symptoms (Verbatim: flu-like symptoms), fever (Verbatim: fever), nausea (Verbatim: nausea), blurred vision (Verbatim: blurry vision), vomiting (Verbatim: vomiting) and chills (Verbatim: chills). On 27-JUL-2024, the patient experienced vertigo (Verbatim: Vertigo). The outcome of the vertigo, influenza-like symptoms, fever, nausea, blurred vision, vomiting and chills were not resolved.   The reporter considered the vertigo, influenza-like symptoms, fever, nausea, blurred vision, vomiting and chills to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the vertigo, influenza-like symptoms, fever, nausea, blurred vision, vomiting and chills 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: 29-JUL-2024 It was reported that patient was experiencing vertigo, flu-like symptoms, fever, nausea, blurry vision, vomiting, chills. The patient was taken to an emergency room at his Healthcare professional advice and was told that he will need to be rechecked in 2 to 3 days if not improving or if he develops new or worsening symptoms.
Sex: F
Vaccine: RVX
Symptoms: Hypoaesthesia, Neuralgia, Skin discolouration
Clinical narrative: numbness on my left side; my left toe turned purple and the the back of my right leg; wrist nerve is hurting,; This non-serious case was reported by a consumer and described the occurrence of numbness in a elderly female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Previously administered products included pneumonia vaccine with an associated reaction of hypersensitivity.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced numbness (Verbatim: numbness on my left side), skin discoloration (Verbatim: my left toe turned purple and the the back of my right leg) and nerve pain (Verbatim: wrist nerve is hurting,). The outcome of the numbness was resolved and the outcome of the skin discoloration was not reported and the outcome of the nerve pain was not resolved.   It was unknown if the reporter considered the numbness, skin discoloration and nerve pain to be related to RSV vaccine.     It was unknown if the company considered the numbness, skin discoloration and nerve pain to be related to RSV vaccine.   Additional Information: GSK receipt date: 01-AUG-2024 The reporter contacted right after the shot because of numbness on the left side that last weeks, when they talked the pharmacy they said they must of hit a never.  But started having problems with the feet, the left toe turned purple and the the back of right leg, though it was nothing.  Now the right wrist nerve was hurting, was trying to find a hematologist in , left, to find help.  Should the reporter be worried.  The patient also had an allergic reaction to the first pneumonia shot, never took the second one.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had a Shingrix shot 10-4-2021 and I just received another today; 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 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 4th October 2021).   On 30-JUL-2024, the patient received the 2nd dose of Shingrix. On 30-JUL-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: had a Shingrix shot 10-4-2021 and I just received another today). The outcome of the drug dose administration interval too long was not reported.   Additional Information: GSK Receipt Date: 30-JUL-2024 The patient self-reported this case for herself. The patient had a Shingrix 2 shot, the patient asked were they the same vaccine. The reporter reported that, the pharmacist said Shingrix had not been out that long, online it says it had been around since 2017. The reporter was just wondered if a new version came out, she thaught she was just wrong. The reporter reported that, they had an insurance battle with the first dose and forgot to follow up with the second.  The reporter's physician said to get the second shot so the patient did. The patient received the second dose of Shingrix longer than the recommended interval which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Malaise
Clinical narrative: Feeling really bad/Feeling super crappy; Chills; Sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling bad in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling bad (Verbatim: Feeling really bad/Feeling super crappy), chills (Verbatim: Chills) and sickness (Verbatim: Sick). The outcome of the feeling bad was resolved and the outcome of the chills and sickness were unknown.   It was unknown if the reporter considered the feeling bad, chills and sickness to be related to Shingrix.     It was unknown if the company considered the feeling bad, chills and sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-JUL-2024 The reporter was a friend of the patient. The age of the patient was between 55 years and 75 years old. The patient got sick after receiving the Shingrix vaccine.  The patient reported chills and feeling super crappy.  The patient felt really bad after receiving the Shingrix vaccine, but it was short lived. This was 1 of 4 linked cases by the same reporter for different patients.; Sender's Comments:  US-GSK-US2024095868:Same reporter/Male patient US-GSK-US2024AMR096059:Same reporter/Female patient US-GSK-US2024AMR096057:Same reporter/Female patient US-GSK-US2024095870:Same reporter/Female patient
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Malaise
Clinical narrative: Feeling really bad/Feeling super crappy; Chills; Sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling bad in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling bad (Verbatim: Feeling really bad/Feeling super crappy), chills (Verbatim: Chills) and sickness (Verbatim: Sick). The outcome of the feeling bad was resolved and the outcome of the chills and sickness were unknown.   It was unknown if the reporter considered the feeling bad, chills and sickness to be related to Shingrix.     It was unknown if the company considered the feeling bad, chills and sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-JUL-2024 The reporter was a friend of the patient. The age of the patient was between 55 years and 75 years old. The patient got sick after receiving the Shingrix vaccine.  The patient reported chills and feeling super crappy.  The patient felt really bad after receiving the Shingrix vaccine, but it was short lived. This was 1 of 4 linked cases by the same reporter for different patients.; Sender's Comments:  US-GSK-US2024095868:Same reporter/Male patient US-GSK-US2024AMR096057:Same reporter/Female patient US-GSK-US2024AMR096058:Same reporter/Female patient US-GSK-US2024095870:Same reporter/Female patient
Sex: U
Vaccine: RVX
Symptoms: Diarrhoea, Fatigue, Headache, Pyrexia, Somnolence
Clinical narrative: Headache; Vomiting; Fever; Diarrhoea; Very sleepy; Tired; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced headache (Verbatim: Headache), vomiting (Verbatim: Vomiting), fever (Verbatim: Fever), diarrhea (Verbatim: Diarrhoea), sleepiness (Verbatim: Very sleepy) and tiredness (Verbatim: Tired). The outcome of the headache, vomiting, fever, diarrhea and sleepiness were not reported and the outcome of the tiredness was not resolved.   It was unknown if the reporter considered the headache, vomiting, fever, diarrhea, sleepiness and tiredness to be related to RSV vaccine.     It was unknown if the company considered the headache, vomiting, fever, diarrhea, sleepiness and tiredness to be related to RSV vaccine.   Additional Information: GSK receipt date: 01-AUG-2024 This case was reported the patient via interactive digital media The patient have been left with after-effects and now (on the time of reporting) trusted what got from the second horrible vaccine was headache, vomiting, fever, diarrhoea and very sleepy and was tired now. The patient was afraid of all the vaccines.
Sex: U
Vaccine: RVX
Symptoms: Vomiting
Clinical narrative: Headache; Vomiting; Fever; Diarrhoea; Very sleepy; Tired; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced headache (Verbatim: Headache), vomiting (Verbatim: Vomiting), fever (Verbatim: Fever), diarrhea (Verbatim: Diarrhoea), sleepiness (Verbatim: Very sleepy) and tiredness (Verbatim: Tired). The outcome of the headache, vomiting, fever, diarrhea and sleepiness were not reported and the outcome of the tiredness was not resolved.   It was unknown if the reporter considered the headache, vomiting, fever, diarrhea, sleepiness and tiredness to be related to RSV vaccine.     It was unknown if the company considered the headache, vomiting, fever, diarrhea, sleepiness and tiredness to be related to RSV vaccine.   Additional Information: GSK receipt date: 01-AUG-2024 This case was reported the patient via interactive digital media The patient have been left with after-effects and now (on the time of reporting) trusted what got from the second horrible vaccine was headache, vomiting, fever, diarrhoea and very sleepy and was tired now. The patient was afraid of all the vaccines.
Sex: F
Vaccine: FLU4
Symptoms: COVID-19, Fatigue, Rhinorrhoea
Clinical narrative: COVID-19; fatigue; coughing; sniffling; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of covid-19 in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) for prophylaxis.   Concurrent medical conditions included drug allergy.   On 30-SEP-2023, the patient received Fluarix Quadrivalent 2023-2024 season. On 28-JUL-2024, 302 days after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced fatigue (Verbatim: fatigue), cough (Verbatim: coughing) and sniffles (Verbatim: sniffling). On 29-JUL-2024, the patient experienced covid-19 (Verbatim: COVID-19). The outcome of the covid-19, fatigue, cough and sniffles were resolving.   It was unknown if the reporter considered the covid-19, fatigue, cough and sniffles to be related to Fluarix Quadrivalent 2023-2024 season and Fluarix Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the covid-19, fatigue, cough and sniffles to be related to Fluarix Quadrivalent 2023-2024 season and Fluarix Tetra 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: 02-AUG-2024 The patient received Arexvy and contracted Covid and tested positive on 29 July 2024. Her symptoms included coughing, sniffling, and fatigue.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1 was given 06-May-2024 and dose 2 was given 25-June-2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes. Additional patient notes included Patient was not immunocompromised. Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix) and insulin porcine protamine zinc (Insuline).   On 25-JUN-2024, the patient received the 2nd dose of Shingrix (intercostal) .5 ml. On 25-JUN-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Dose 1 was given 06-May-2024 and dose 2 was given 25-June-2024). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 30-JUL-2024 The pharmacist who works at the pharmacy gave the suspect vaccine on an incorrect dosing schedule. The patient received 2nd dose in shorter time not as per recommended, which led to shortening of vaccination schedule. The reporter was unwilling to give any other information at the time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Malaise
Clinical narrative: Feeling really bad/Feeling super crappy; Chills; Sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling bad in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling bad (Verbatim: Feeling really bad/Feeling super crappy), chills (Verbatim: Chills) and sickness (Verbatim: Sick). The outcome of the feeling bad was resolved and the outcome of the chills and sickness were unknown.   It was unknown if the reporter considered the feeling bad, chills and sickness to be related to Shingrix.     It was unknown if the company considered the feeling bad, chills and sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-JUL-2024 The reporter was a friend of the patient. The age of the patient was between 55 years and 75 years old. The patient got sick after receiving the Shingrix vaccine.  The patient reported chills and feeling super crappy. The patient felt really bad after receiving the Shingrix vaccine, but it was short lived. This was 1 of 4 linked cases by the same reporter for different patients.; Sender's Comments:  US-GSK-US2024095868:Same reporter/Male patient US-GSK-US2024AMR096057:Same reporter/Female patient US-GSK-US2024AMR096058:Same reporter/Female patient US-GSK-US2024AMR096059:Same reporter/Female patient US-GSK-US2024AMR096059:Same reporter/Female patient
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: A pediatric dose of Engerix-B was administered to an adult patient of 21 years old.; Adult use of a child product; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 21-year-old male patient who received HBV (Engerix B pediatric) (batch number A9349, expiry date 19-APR-2024) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: A pediatric dose of Engerix-B was administered to an adult patient of 21 years old.) and adult use of a child product (Verbatim: Adult use of a child product). The outcome of the underdose was not reported and the outcome of the adult use of a child product 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: 31-JUL-2024 A pediatric dose of Engerix-B was administered to an adult patient of 21 years old, which led to underdose and adult use of a child product.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received second dose of Shingrix vaccine 3 years after the first 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 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 9RC7A, expiry date 21-NOV-2025) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 years ago).   On 01-APR-2024, the patient received the 2nd dose of Shingrix. On 01-APR-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient received second dose of Shingrix vaccine 3 years after the first dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 01-AUG-2024 Pharmacist reported that 63 year old female patient received second dose of Shingrix vaccine 3 years after the first dose. Pharmacist unsure of exact date of first dose, but the second dose was given on 01 April 2024  The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. This case is linked with US2024096365, same reporter.; Sender's Comments:  US-GSK-US2024096365:Same reporter/Different patient
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient had first dose of Shingrix vaccine 12Dec2022 (lot number 943GS) and did not receive second dose until 17Apr2024; 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 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 29Z52, expiry date 18-APR-2026) for prophylaxis.   Previously administered products included Shingrix (On 12-DEC-2022 received 1st dose with batch number 943GS and expiry date-09-FEB-2024).   On 17-APR-2024, the patient received the 2nd dose of Shingrix. On 17-APR-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient had first dose of Shingrix vaccine 12Dec2022 (lot number 943GS) and did not receive second dose until 17Apr2024). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 01-AUG-2024 The patient received 1st dose and did not receive second dose until 17-APR-2024. The patient received 2nd dose at longer time not as per recommended, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: patient had received an expired dose of Menveo on 07/31/2024; 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 male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA946A, expiry date 31-JUL-2024) for prophylaxis.   On 01-AUG-2024, the patient received the 2nd dose of Menveo. On 01-AUG-2024, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: patient had received an expired dose of Menveo on 07/31/2024). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 01-AUG-2024 A pharmacist called and reported that the patient had received an expired dose of Menveo, which led to expired vaccine used. The reporter wanted to know how to proceed.  The lyophilized component had been the one that expired. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Longer than recommended interval; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date received 1st dose).   On 01-AUG-2024, the patient received the 2nd dose of Shingrix. On 01-AUG-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Longer than recommended interval). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 01-AUG-2024 The patient received 2nd dose of Shingrix after couple of years pass by 1st dose, which led to lengthening of vaccination schedule. The reporter asking for the guidance around the late 2nd Shingrix dose.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late 2nd 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 39-year-old female patient who received HBV (Engerix B) (batch number 982NK2, expiry date 29-SEP-2026) for prophylaxis.   On 01-AUG-2024, the patient received the 2nd dose of Engerix B. On 01-AUG-2024, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd 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: 02-AUG-2024 Pharmacist reported that female patient received a dose of Engerix B on January 18th 2024, the second dose administered on August 1st 2024. When should the 3rd dose be administered. The patient received 2nd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccinations schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: pharmacy called him and told him that he never had the second dose of SHINGRIX administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: pharmacy called him and told him that he never had the second dose of SHINGRIX administered). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-AUG-2024 The patient self-reported this case.   The patient stated he had his first and second dose of Shingrix administered in 2021.   However, his pharmacy called him and told him that he never had the second dose of Shingrix administered (possible missed dose) Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case has been linked with US2024097042, by same reporter for different patient; Sender's Comments:  US-GSK-US2024097042:Saame reporter/Different patient
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: has now received 3 doses of Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date in 2021, received 1st dose) and Shingrix (on an unknown date in 2021, received 2nd dose).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: has now received 3 doses of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 02-AUG-2024 Husband was reporting on behalf of wife.   The reporter stated that she had both doses of Shingrix administered in 2021, however, the pharmacy called and told her that she only had one dose of Shingrix administered in 2021.   The patient did go to the pharmacy and received another dose of Shingrix.   Consumer was just informed by the pharmacy that she had now (at the time of reporting) received 3 doses of Shingrix(overdose.), which led to extra dose administration. No further information is known including dates of administration or injection site. Consented to follow up. The case was linked with US2024097039, by same reporter.; Sender's Comments:  US-GSK-US2024097039:Saame reporter/Different patient
Sex: U
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: thinks that a patient could have received only the diluent portion of the vaccine; thinks that a patient could have received only the diluent portion of the vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3G55B, expiry date 30-JUN-2025) 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: thinks that a patient could have received only the diluent portion of the vaccine) and inappropriate dose of vaccine administered (Verbatim: thinks that a patient could have received only the diluent portion of the vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-AUG-2024 The clinical operations manager or registered nurse was seeking a recommendation for Arexvy as they found a vial of powder that was not attached to a diluent and thought that a patient could have received only the diluent portion of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. They had narrowed it down to only 6 patients that could had received the vaccine, but did not had a specific patient yet. The Vaccine Administration Facility was the same as Primary Reporter The reporter consent to follow up via email.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose administered to adult; Pediatric dose administered to adult; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 23-year-old female patient who received HBV (Engerix B pediatric) (batch number 9452S, expiry date 14-SEP-2025) for prophylaxis.   On 26-JUL-2024, the patient received Engerix B pediatric. On 26-JUL-2024, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Pediatric dose administered to adult) and underdose (Verbatim: Pediatric dose administered to adult). 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: 02-AUG-2024 A medical assistant called in to report that a patient received a less than recommended dose of Engerix B on July 26th by getting a pediatric presentation which led to adult use of a child product and underdose. Data about vaccines, event and patient given.
Age: 7.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: administer a Engerix-B that was expire; 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 7-year-old female patient who received HBV (Engerix B) (batch number N73FA, expiry date 31-MAY-2024) for prophylaxis.   On 29-JUL-2024, the patient received Engerix B. On 29-JUL-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: administer a Engerix-B that was expire). 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: 02-AUG-2024 The nurse administered a Engerix-B that was expired, which led expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of a Menveo-1 vial vaccine to a pediatric patient less than 10 year old; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a child patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: administration of a Menveo-1 vial vaccine to a pediatric patient less than 10 year old). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 02-AUG-2024 The pharmacist asked about safety/further information about the administration of a Menveo 1 vial vaccine to a pediatric patient less than 10 year old, to see if there was any difference about this situation which led to inappropriate age at vaccine administration.  The pharmacist did not consent to provide any further detail about the vaccine or patient detail (demographics).
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: A pediatric dose of Engerix-B was administered to an adult patient of 42 years old; underdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 42-year-old female patient who received HBV (Engerix B) (batch number 9452S, expiry date 14-SEP-2025) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced adult use of a child product (Verbatim: A pediatric dose of Engerix-B was administered to an adult patient of 42 years old) and underdose (Verbatim: underdose). 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: 02-AUG-2024 The pediatric dose of Engerix-B was administered to an adult patient, which led adult use of a child product and underdose. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Dizziness, Heart rate increased, Hypotension, Loss of consciousness
Clinical narrative: fainting; Black out; low blood pressure/extremely low blood pressure; light headiness; Tachycardia; heart racing; elevated heart rate; This serious case was reported by a pharmacist via call center representative and described the occurrence of fainting in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included Patient was not immunocompromised.   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 fainting (Verbatim: fainting) (serious criteria GSK medically significant), blackout (Verbatim: Black out) (serious criteria GSK medically significant), low blood pressure (Verbatim: low blood pressure/extremely low blood pressure), light headedness (Verbatim: light headiness), tachycardia (Verbatim: Tachycardia), heart racing (Verbatim: heart racing) and heart rate increased (Verbatim: elevated heart rate). The outcome of the fainting, low blood pressure, light headedness and heart rate increased were unknown and the outcome of the blackout, tachycardia and heart racing were not reported.   It was unknown if the reporter considered the fainting, blackout, low blood pressure, light headedness, tachycardia, heart racing and heart rate increased to be related to Shingrix.     The company considered the fainting and blackout to be unrelated to Shingrix. It was unknown if the company considered the low blood pressure, light headedness, tachycardia, heart racing and heart rate increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-AUG-2024 The patient was over 50 years. The pharmacist reported that, the patient developed light headiness, fainting, low blood pressure, and elevated heart rate after receiving the first dose of Shingrix. The patient also presented heart racing, tachycardia, black out and extremely low blood pressure.; Sender's Comments: Syncope and Loss of consciousness are unlisted events which are considered unrelated to GSK vaccine Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations, Syncope, Tachycardia
Clinical narrative: fainting; Black out; low blood pressure/extremely low blood pressure; light headiness; Tachycardia; heart racing; elevated heart rate; This serious case was reported by a pharmacist via call center representative and described the occurrence of fainting in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included Patient was not immunocompromised.   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 fainting (Verbatim: fainting) (serious criteria GSK medically significant), blackout (Verbatim: Black out) (serious criteria GSK medically significant), low blood pressure (Verbatim: low blood pressure/extremely low blood pressure), light headedness (Verbatim: light headiness), tachycardia (Verbatim: Tachycardia), heart racing (Verbatim: heart racing) and heart rate increased (Verbatim: elevated heart rate). The outcome of the fainting, low blood pressure, light headedness and heart rate increased were unknown and the outcome of the blackout, tachycardia and heart racing were not reported.   It was unknown if the reporter considered the fainting, blackout, low blood pressure, light headedness, tachycardia, heart racing and heart rate increased to be related to Shingrix.     The company considered the fainting and blackout to be unrelated to Shingrix. It was unknown if the company considered the low blood pressure, light headedness, tachycardia, heart racing and heart rate increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-AUG-2024 The patient was over 50 years. The pharmacist reported that, the patient developed light headiness, fainting, low blood pressure, and elevated heart rate after receiving the first dose of Shingrix. The patient also presented heart racing, tachycardia, black out and extremely low blood pressure.; Sender's Comments: Syncope and Loss of consciousness are unlisted events which are considered unrelated to GSK vaccine Shingrix.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Faeces discoloured, SARS-CoV-2 test, Weight decreased
Clinical narrative: stool become about the consistency of tan color; lost 5 lbs that week; I tested positive for Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I tested positive for Covid), FAECES DISCOLOURED (stool become about the consistency of tan color) and WEIGHT DECREASED (lost 5 lbs that week) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    The patient's past medical history included Stent placement (stent placed LLD) in 2011. Concurrent medical conditions included Gluten free diet (gluten free for about 7 years).   In 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 03-Jun-2023, the patient experienced COVID-19 (I tested positive for Covid). On an unknown date, the patient experienced FAECES DISCOLOURED (stool become about the consistency of tan color) and WEIGHT DECREASED (lost 5 lbs that week). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at a dose of Paxlovid 150 (XI) 100 mg and BENZONATATE for Cough, at a dose of 200 milligram three times a day. In June 2023, COVID-19 (I tested positive for Covid) had resolved. In May 2024, FAECES DISCOLOURED (stool become about the consistency of tan color) had resolved. At the time of the report, WEIGHT DECREASED (lost 5 lbs that week) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2023, SARS-CoV-2 test: Positive. In June 2023, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.  The patient drank about 3 oz of liquor with 7-up in the evening. On 03-Jun-2023, the patient tested positive for COVID at clinic (received COVID vaccine 2 shots in early 2020, thought it was Moderna and then all the boosters which might have been M Or P). The prescribed Paxlovid 150 (XI) 100 mg, PK and benzonatate 200 mg capsule 3x/day for the slight cough and stopped cholesterol meds for 10 days.  10 days later, tested negative and had been clear since then, lost 5 lbs. that week, not drinking. The patient believed that as a side effect his stool became about the consistency of tan color toothpaste and was less than half inch in diameter longer strings but no change in frequency. His diet did not change before, during or after covid until about early April 2024, when the patient started a premier protein 30 gm drink, did 8 oz/day for 2-3 weeks then cut back to 4 oz daily. By mid-May his stool was back to precovid dark brown quite solid and 1 inch or more in diameter and shorter pieces. The patient was still on the protein drink and feel good.  The patient received Prevnar 20 vaccine on 26-Apr-2024.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Shoulder injury related to vaccine administration
Clinical narrative: small pain didn't go away it's kept getting worse; I have SIRVA (a shoulder injury related to vaccine administration); This spontaneous case was reported by a patient and describes the occurrence of PAIN (small pain didn't go away it's kept getting worse) and SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (I have SIRVA (a shoulder injury related to vaccine administration)) in an 8-decade-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2024, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 02-Jul-2024, the patient experienced PAIN (small pain didn't go away it's kept getting worse) (seriousness criteria disability and medically significant) and SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (I have SIRVA (a shoulder injury related to vaccine administration)) (seriousness criteria disability and medically significant). At the time of the report, PAIN (small pain didn't go away it's kept getting worse) had not resolved and SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (I have SIRVA (a shoulder injury related to vaccine administration)) was resolving.          Patient was in her 70A s. No concomitant medication was reported.  Patient will be doing physical therapy and maybe getting a cortisone injection, and patient was sure she will gradually feel better. Company Comments: This spontaneous case concerns an 8-decade-old female patient, with no medical history reported who experienced unexpected serious (due to medically significant and disability) events of pain and shoulder injury related to vaccination administration that occurred the same month as SPIKEVAX NOS (SPIKEVAX NOS). No more information was provided. At the time of the report the events were resolving. Considering biological plausibility of the events they are assessed as related to vaccination. Benefit risk relationship of SPIKEVAX NOS (SPIKEVAX NOS).is not affected by this report.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: 0.25ml was chosen and administered as dispensed dose instead of a full dose of 0.5ml. Patient later received a full booster dose o f0.5ml in September and was protected
Age: 23.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given a dose of Varivax that expired 2024AUG10 on 2024AUG12. NO NEGATIVE OUTCOMES WERE EXPERIENCED. MERCK Case # 02653934- manufacturer recommends that vaccine should not be re-administered. PATIENT WAS NOTIFIED>
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Muscle spasms
Clinical narrative: complaints of leg cramps
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Child woke up on Saturday with a red swollen area on R thigh were vaccine was administered. Sunday the redness area became worse and more painful, mother took child to ED and was diagnosed with cellulitis. Was placed on an antibiotics and tylenol/ibuprofen as needed. Recommended to follow up with PCP if no improvement
Age: 77.0
Sex: F
Vaccine: PNC20
Symptoms: Anxiety, Headache, Rash, Urticaria
Clinical narrative: Patient reported having hives and rash on her body a few days after getting the vaccine. She also stated that she got an uneasy feeling and had a headache. She called her doctor, and she is taking Benadryl right now, and has gotten better but is still having symptoms of hives.