chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: HBP Immunization coordinator called to report PROQUAD TE, case: 02507410. HBP informed it had been inadvertently administered to one patient after the excursion. Date of administration is unknown. No further information provided. Call was disconnecte; No additional AE/PQC; This spontaneous report has been received from other unspecified reporter, concerning a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated inadvertently with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, (lot #W039839, has been verified to be valid, expiration date: 12-JUN-2024, albumin status recombinan human albumin (rHa)) administered for prophylaxis (strength, and route of administration were not provided).No additional AE/PQC.   It was reported that temperature and Time frame- 47 farenheit (F) to 77F for 1 hours 30 minutes 21 seconds; 14F to 46F for 20 hours 30 minutes 0 seconds; 6F to 14F for 38 hours 0 minutes 0 seconds, witj no previous temperature excursion.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PROQUAD was accidentally administered to a 13-year-old patient. No signs/symptoms of adverse reactions were reported. Limited information was provided. Permission to contact HCP was given. No additional AE/no PQC; No additional AE/no PQC; This spontaneous report was received from a medical assisstant concerning to a 13-year-old patient. The patient's concurrent conditions, medical history, concomitant therapes and previous drugs reactions were not provided.     On 14-NOV-2023, the patient was accidentally vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # x018581 is a valid lot number with an expiration date of 05-JAN-2025, for prophylaxis (strength, dose, route of administration was not provided) (product administered to patient of inappropriate age). No additional adverse event was reported.
Age: 50.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: received the first dose on 04/12/2019 (age 50) and the second dose on 05/29/2019 (age 50); No additional AE.; received the first dose on 04/12/2019 (age 50) and the second dose on 05/29/2019 (age 50); received the first dose on 04/12/2019 (age 50) and the second dose on 05/29/2019 (age 50); This spontaneous report was received from a Registered Nurse (RN) referring to a 50 years old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  The patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection on 12-APR-2019 (age 50 years old), and the second dose of on 29-MAY-2019 (age 50 years old) with different healthcare providers, both used for prophylaxis (strength, dose, route, lot# and expiration date were not reported) (product administered to patient of inappropriate age).   The patient was now requesting to finish the series and obtain the third dose (inappropriate schedule of product administration) and the reporter called to ask if it was okay. No additional adverse event (AE) was provided (no adverse event).
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Transcription medication error
Clinical narrative: The dose of VARIVAX was documented by another HCP as "MMR AND VARICELLA" instead of VARIVAX; No additional AE/no PQC reported.; This spontaneous report was received from nurse, concerning a 60-year-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant medication were not reported.  On unknown date, it was reported that the patient came back as not immune to chicken pox. Therefore, the patient/employee received their first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection lot #U025204 has been verified to be valid, , expiration date: 13-AUG-2023) (route and anatomical location were not reported) as prophylaxis because of the titer outcomes.   The dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection was documented by another HCP as "measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) AND VARICELLA" instead of varicella virus vaccine live (oka/merck) (VARIVAX)  (Transcription medication error). The caller confirmed the employee/patient did receive the dose of varicella virus vaccine live (oka/merck) (VARIVAX)  , as ordered and no med error occurred because of this confusion. The caller said the issue was only about the documentation at this time. The call ended and the caller did not provide dates as to when this incident occurred or when the patient/employee received dose 1 of varicella virus vaccine live (oka/merck) (VARIVAX) . It is unknown if the patient missed any doses or when the employee/patient received the product. The caller said no adverse effects occurred. No additional information was provided to further clarify these details
Sex: M
Vaccine: HPV9
Symptoms: HIV test positive, Inappropriate schedule of product administration, Smear cervix abnormal
Clinical narrative: HCP reports that this patient is also HIV positive. Unspecified if the patient became HIV positive before or after beginning therapy with GARDASIL 9; CP reports that this patient was tested for HPV using a pap smear method. HCP reports the patient tested positive for HPV specifically the MRNA E6 and E7 on an unspecified date; First Gardasil 9 on 11/4/2020, the 2nd on 11/3/2021, and the third on 08/03/2022; This spontaneous report has been received from a nurse and refers to a 36-year-old male patient.  The patient's pertinent medical history was not reported. The patient's concurrent conditions included human immunodeficiency virus (HIV). Concomitant medications included bictegravir sodium (+) emtricitabine (+) tenofovir alafenamide fumarate (BIKTARVY).   On 04-NOV-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliter (ml). The second dose was administered on 04-NOV-2021 and the third dose on 03-AUG-2022 (inappropriate schedule of product administration), all doses were administered intramuscularly for prophylaxis (strength, lot #, and expiry date were not provided).  On an unspecified date, the patient tested positive for human immunodeficiency virus (HIV) (HIV test positive) and also tested positive for human papillomavirus (HPV) after having a pap smear method performed (human papillomavirus test positive), specifically the messenger ribonucleic acid (MRNA) E6 and E7.   At the time of the reporting, the patient had not recovered from the events.   Causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not established.
Sex: M
Vaccine: HPV9
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Employee calling to report an adverse event for her son. She states he received his second GARDASIL 9 injection in left arm on 11/14/2023 at his pediatrics office. On 11/15/2023 swelling at and below the injection site was noticed as well as redness; On 11/15/2023 swelling at and below the injection site was noticed as well as redness and slight tenderness.; On 11/15/2023 swelling at and below the injection site was noticed as well as redness and slight tenderness.; In the evening of 11/15/2023 her son began complaining of itching at the injection site and she gave him BENADRYL; This spontaneous report was received from a Nurse Practitioner and refers to a 9-year-old male patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 14-NOV-2023 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 reported).  On 15-NOV-2023, the patient experienced vaccination site erythema, vaccination site pruritus, vaccination site pain and vaccination site swelling. The patient was given Benadryl as a treatment of vaccination site pruritus. The outcome of vaccination site swelling, vaccination site pruritus, vaccination site pain and vaccination site erythema was reported as not recovered. Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding the events was not applicable.   The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was not provided.
Age: 64.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; HBP reporting a 64 year old patient has received 2 doses of the GARDASIL 9 Vaccine.  First dose was administered on 09/29/2023 and the second dose was on 11/15/2023.  No symptoms or additional details provided.  No other AE and no PQC; Information has been received from an unspecified reporter, referring to a 64 years-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 29-SEP-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 15-NOV-2023, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (inappropriate age at vaccine administration). No adverse events were reported.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Caller reported expired 1st dose of GARDASIL 9 was administered.  Caller asked what side effects would be expected.  No other information provided.  No additional AEs or PQC reported.  See related AE cases 02510121 and 02510150.; Information has been received from a pharmacist, referring to a 11 years-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 17-NOV-2023, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #U019413, expiration date: 01-NOV-2023, administered intramuscularly for prophylaxis (strength was not provided). No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Device data issue, No adverse event
Clinical narrative: No other AE; HBP calling to report the administration of 1 PROQUAD vaccine to a patient following a possible temperature excursion with Insufficient Data.; This spontaneous report was received from an medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not provided.  On 10-NOV-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rha) (PROQUAD) injection (lot number X009883, which had been verified to be a valid lot #, expiration date 06-SEP-2024; dose, frequency, route of administration, and anatomical location were not provided), administered for prophylaxis following a possible temperature excursion with insufficient data (product storage error). Facility's data logger was not monitoring during the time of administration.  No symptoms or additional details provided. No other adverse event (AE) reported (no adverse event).
Age: 0.17
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects noted; 2 month old received dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a 2 month-old patient of unknown gender.  Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 20-NOV-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, single dose, lot #X019555, expiration date: 19-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided) (Product administered to patient of inappropriate age). No adverse effects noted.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HBP calling to report AE for improperly stored PROQUAD that was administered to a patient. No side effects reported. Vaccine was administered on 17NOV2023. Operator of device was a Healthcare Professional. No other medical information was known. HCP; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not provided.  On 17-NOV-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rha) (PROQUAD) injection (valid lot number W024553, expiration date 31-JAN-2024), administered for prophylaxis (dose, dose number, frequency, and route of administration were not provided), after a temperature excursion of 31.98 degrees Fahrenheit (F) with a time frame of 45 minutes (min). Additionally, the vaccine had a previous temperature excursion of 25.07 degrees F for 2 hours and 30 min (product storage error).   No additional adverse event (AE) reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Caller reported expired dose of PNEUMOVAX 23 was administered; This spontaneous report has been received from other health care professional referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 20-NOV-2023, the patient was vaccinated with an expired dose of pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) 0.5 mL intramuscularly on right deltoid (lot number W004863 which was verified to be a valid lot number with an expiry date of 21-AUG-2023) administered for prophylaxis (strength was not reported) (expired product administered). No additional AEs (no adverse event) or PQC were reported.
Age: 21.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: FBE calling on behalf of HCP to report a pediatric dose of VAQTA accidentally administered to a 21-year-old patient. Permission to contact HCP was unspecified. Caller stated adverse event has already been reported. No additional infor; No AE; This spontaneous report was received from  a nurse and refers to a 21-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pediatric dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). No additional adverse event was reported.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FBE reporting AE for HBP.  HBP reported pediatric dose of VAQTA was administered to a 19 year old.  No other information provided.  No additional AEs or PQC reported.; No additional AEs; This spontaneous report was received from a physician and refers to a 19-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient started therapy with pediatric dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). No additional adverse event was reported.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: FBE calling to report AE for GARDASIL reported to her by a HCP. HCP states his patient was vaccinated with GARDASIL and tested positive for HPV 18 last year, and is still positive this year. No side effects reported. No date of vaccination is known,; This spontaneous report was received from Physician and refers to a 43-year-old female.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection,  (strength, dose description, lot #, expiry date, route of administration, and indication were not provided) and tested positive for HPV 18 last year, and was still positive this year (Human papilloma virus test positive).  The causal relationship between the event and was quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) unknown.
Sex: U
Vaccine: RSV
Symptoms: Chest pain, Cough, Pneumonia
Clinical narrative: Pneumonia; Chest pains; Coughing; This serious case was reported by a consumer via interactive digital media and described the occurrence of pneumonia in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pneumonia (Verbatim: Pneumonia) (serious criteria GSK medically significant), chest pain (Verbatim: Chest pains) and cough (Verbatim: Coughing). The outcome of the pneumonia, chest pain and cough were not reported.   It was unknown if the reporter considered the pneumonia, chest pain and cough to be related to Arexvy.     It was unknown if the company considered the pneumonia, chest pain and cough to be related to Arexvy.   Additional Information: GSK Receipt Date: 18-Nov-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Arexvy vaccine and experienced pneumonia, chest pains and coughing. The patient stated that he or she will ask his or her pulmonologist about this drug. The follow up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Dysgeusia, Flatulence, Headache, Therapeutic product ineffective
Clinical narrative: Dibilatating headache /Raging headache unresponsibe to meds; metallic taste; Diarrhea; Gastro issue, gas; This non-serious case was reported by a consumer and described the occurrence of headache in a 55-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 10-NOV-2023, the patient received the 1st dose of Shingles vaccine. On 11-NOV-2023, 1 days after receiving Shingles vaccine, the patient experienced headache (Verbatim: Dibilatating headache /Raging headache unresponsibe to meds), taste metallic (Verbatim: metallic taste), diarrhea (Verbatim: Diarrhea) and gas (Verbatim: Gastro issue, gas). The outcome of the headache, taste metallic, diarrhea and gas were not resolved.   It was unknown if the reporter considered the headache, taste metallic, diarrhea and gas to be related to Shingles vaccine.     It was unknown if the company considered the headache, taste metallic, diarrhea and gas to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-NOV-2023 The patient received only received 1st dose and the side effects suck. The reporter did not consent to follow up.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Peripheral swelling
Clinical narrative: right leg from the knee down to the foot wasextremely swollen; This non-serious case was reported by a consumer and described the occurrence of swelling of legs in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3Y7P4) and (batch number 555Z2) for prophylaxis.   On 02-NOV-2023, the patient received Arexvy .5 ml. In NOV-2023, an unknown time after receiving Arexvy, the patient experienced swelling of legs (Verbatim: right leg from the knee down to the foot wasextremely swollen). The outcome of the swelling of legs was not resolved.   It was unknown if the reporter considered the swelling of legs to be related to Arexvy.     It was unknown if the company considered the swelling of legs to be related to Arexvy.   Additional Information: GSK Receipt date: 13-NOV-2023 The reporter was a patient. The patient reported that the morning after the vaccine was given her right leg from the knee down to the foot was extremely swollen. Patient reported that this condition had existed for more than 10 days. Patient asked question that was this an adverse side effect. Patient reported that she had no injury, sprain por insect bite to account for the massive swelling. Patient's physician had ruled out DVT. The reporter requested to consent the follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Immunisation reaction, Pyrexia
Clinical narrative: fever; This non-serious case was reported by a physician via sales rep and described the occurrence of fever in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received first dose on an unknown date and felt fine).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: fever). The outcome of the fever was resolved.   The reporter considered the fever to be possibly related to Shingrix.     The company considered the fever to be possibly related to Shingrix.   Additional Information: GSK Receipt Date-13-NOV-2023 The patient age was less than 50 years. The physician reported that the patient upon receipt of his second dose of Shingrix experienced fever which lasted for several hours.  The reporter reported that the event only resulted had taken an OTC antipyretic. The reporter believed the event due to patient received his Shingrix shot the day prior. The reported did not consent to follow up.
Sex: F
Vaccine: RVX
Symptoms: Illness
Clinical narrative: got real sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female 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 sickness (Verbatim: got real sick). The outcome of the sickness was not reported.   The reporter considered the sickness to be possibly related to RSV vaccine.     The company considered the sickness to be possibly related to RSV vaccine.   Additional Information: GSK Receipt date: 13-NOV-2023 This case was reported by a consumer via interactive digital media. The patient reported that he/she got the shot still got real sick. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: made me feel bad after 1st dose; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling bad (Verbatim: made me feel bad after 1st dose). The outcome of the feeling bad was not reported.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the feeling bad to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-NOV-2023 The reporter was patient. The reporter had not a flu shot in 30 years and do not plan to get anymore. The reporter reported that patient received 1st dose of shingles vaccine and felt bad. The follow up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: The first dose of Shingrix in sept 2021, do they have to start the series over or administer the 2nd dose now; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on September 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: The first dose of Shingrix in sept 2021, do they have to start the series over or administer the 2nd dose now). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 13-Nov-2023 The reporter wanted to know that if the patient received his or her first dose of Shingrix vaccine in September 2021, do they need to restart the series over or administer the second dose now. The reporter asked please send information that addresses the second dose was outside the second dose 2 to 6 month window. The patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Intercepted product storage error
Clinical narrative: The mother did not know that she had to put it in the refrigerator; This non-serious case was reported by a consumer via call center representative and described the occurrence of intercepted product storage error in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced intercepted product storage error (Verbatim: The mother did not know that she had to put it in the refrigerator). The outcome of the intercepted product storage error was unknown.   Additional Information: GSK receipt date: 13-NOV-2023 The patient's daughter wanted to report that the patient received Shingrix in the mail (from the mail order pharmacy).  The patient did not know that she had to put it in the refrigerator.  The reporter thought that it was an error that the patient was sent a vaccine and wanted to report it so that it did not happen to someone else.  The product had not been injected.  The reporter provided limited information. Did not consent to follow-up. The patient did not receive a dose of Shingrix which was incorrectly store, which led to intercepted product storage error.
Sex: M
Vaccine: RSV
Symptoms: Circumstance or information capable of leading to medication error, Exposure via eye contact, Occupational exposure to product
Clinical narrative: Pharmacist reports he was administering a dose of Arexvy, the patient jumped during administration and some of the vaccine squirted into his right eye; Splash of Arexvy in right Eye; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while administering product in a male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 59K92, expiry date 26-MAR-2025) for prophylaxis.   On an unknown date, the patient did not receive Arexvy. On 13-NOV-2023, an unknown time after receiving Arexvy, the patient experienced occupational exposure while administering product (Verbatim: Pharmacist reports he was administering a dose of Arexvy, the patient jumped during administration and some of the vaccine squirted into his right eye) and exposure via eye contact (Verbatim: Splash of Arexvy in right Eye). The outcome of the occupational exposure while administering product and exposure via eye contact were unknown.  Additional Information: GSK Receipt Date: 13-NOV-2023 The pharmacist reported he was administering a dose of Arexvy, the patient jumped during administration and some of the vaccine squirted into his right eye, which led to occupational exposure while administering product and exposure via eye contact.  The pharmacist would be open to any safety follow up.  The reporter did not provide date of birth. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023157051:
Sex: F
Vaccine: RSV
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: the patient jumped, the needle came out of her arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 59K92, expiry date 26-MAR-2025) for prophylaxis.   On 13-NOV-2023, the patient received Arexvy. On 13-NOV-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: the patient jumped, the needle came out of her arm). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date:13-NOV-2023 The pharmacist reported Arexvy vaccine was given and during administration, the patient jumped and the needle came out of her arm. Some of the vaccine squirted out of the needle and into the pharmacist's right eye, which led to incomplete dose administered. The reporter consented to follow up. The pharmacist could not provide the patients initials or date of birth. Adverse event filed separately for the pharmacist. This case had been linked with US2023157050, reported by the same reporter.; Sender's Comments:  US-GSK-US2023157050:Pharmacist case, same reporter
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity, Vomiting
Clinical narrative: Unable to lift left arm; vomiting; headache; Severe left arm soreness; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injected limb mobility decreased in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number 4M24Z, expiry date 31-JUL-2026) for prophylaxis.   Concomitant products included Meningococcal vaccine B rfHbp/NadA/NHBA OMV (Bexsero) and ibuprofen sodium (Ibuprofen).   On 30-OCT-2023, the patient received the 2nd dose of Bexsero (intramuscular, left deltoid). On 30-OCT-2023, immediately after receiving Bexsero, the patient experienced pain in arm (Verbatim: Severe left arm soreness). On an unknown date, the patient experienced injected limb mobility decreased (Verbatim: Unable to lift left arm), vomiting (Verbatim: vomiting) and headache (Verbatim: headache). The outcome of the injected limb mobility decreased, pain in arm and headache were not resolved and the outcome of the vomiting was unknown.   It was unknown if the reporter considered the injected limb mobility decreased, pain in arm, vomiting and headache to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injected limb mobility decreased, pain in arm, vomiting and headache 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:13-NOV-2023 The medical assistant reported that patient received Bexsero vaccine and experienced severe left arm soreness and her arm was still so sore she could not lift it. The patient was also having headaches post dosing, which had not resolved.   The patient also experienced vomiting, but the reporter did not know if this had resolved or was ongoing.   The patient was seen in office for these symptoms on 10th November 2023, and also had a phone follow-up today 13th November 2023 and the symptoms had not improved.   This was the patients second dose in series, no known issues from first dose.   The patient was taking ibuprofen for the pain.  The Vaccine Administration Facility was the same as Primary Reporter. This case was linked with US2023157076 and US2023157077, reported by same reporter for different patients. The reporter consent to follow up.; Sender's Comments:  US-GSK-US2023157076:Diff. patient US-GSK-US2023157077:Diff. patient
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site mass, Injection site swelling, Muscle spasms
Clinical narrative: complaints of hard bump on left arm at injection site; complaints of hard bump on left arm at injection site; unable to move left arm; arm cramping; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number 4M24Z, expiry date 31-JUL-2026) for prophylaxis.   Previously administered products included Bexsero (1st dose received on 04-APR-2023 with batch number EN939 and expiry date 31-OCT-2024).   On 06-NOV-2023, the patient received the 2nd dose of Bexsero (intramuscular, left deltoid). On 08-NOV-2023, 2 days after receiving Bexsero, the patient experienced injection site swelling (Verbatim: complaints of hard bump on left arm at injection site), injection site induration (Verbatim: complaints of hard bump on left arm at injection site), injected limb mobility decreased (Verbatim: unable to move left arm) and cramp of limb (Verbatim: arm cramping). The outcome of the injection site swelling, injection site induration, injected limb mobility decreased and cramp of limb were not resolved.   It was unknown if the reporter considered the injection site swelling, injection site induration, injected limb mobility decreased and cramp of limb to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site swelling, injection site induration, injected limb mobility decreased and cramp of limb 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: 13-NOV-2023 The medical assistant reported that a patient received Bexsero dose and she came back in 2 days later with complaints of hard bump on left arm at injection site and arm cramping, and unable to move arm.  This remains ongoing. This was the patient's second dose in the series. This patient was instructed to use ibuprofen and ice the injection site. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter. This case had been link with US2023157074 and US2023157076, reported by the same reporter.; Sender's Comments:  US-GSK-US2023157074:same reporter US-GSK-US2023157076:same reporter
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Live birth, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: pregnant patient was administered arexvy; patient was administered arexvy by mistake instead of abryvo; patient was administered arexvy by mistake instead of abryvo; No complications during birth; This non-serious retrospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 45-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant patient was administered arexvy), wrong vaccine administered (Verbatim: patient was administered arexvy by mistake instead of abryvo), inappropriate age at vaccine administration (Verbatim: patient was administered arexvy by mistake instead of abryvo) and live birth (Verbatim: No complications during birth). The outcome of the vaccine exposure during pregnancy, wrong vaccine administered, inappropriate age at vaccine administration and live birth were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Live neonate with no apparent congenital anomaly   Additional Information: GSK Receipt Date: 13-NOV-2023 The pharmacist reported a pregnant 45 year old patient was administered Arexvy by mistake instead of abryvo before the approved 60 years of age ,which led to wrong vaccine administered and inappropriate age at vaccine administration The patient was between 32 and 36 weeks received vaccine which led to vaccine exposure during pregnancy. No complications was reported during birth. No lot number or specific vaccination date reported, only stated event happened about a month ago. The reported consented to follow via email.; Sender's Comments:  US-GSK-US2023157093:Same patient, same product
Sex: F
Vaccine: RSV
Symptoms: Extremity necrosis
Clinical narrative: three days after the administration of Arexvy, their arm had gotten necrotic; This non-serious case was reported by a consumer via call center representative and described the occurrence of extremity necrosis in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In OCT-2023, the patient received Arexvy. In OCT-2023, 3 days after receiving Arexvy, the patient experienced extremity necrosis (Verbatim: three days after the administration of Arexvy, their arm had gotten necrotic). The outcome of the extremity necrosis was unknown.   It was unknown if the reporter considered the extremity necrosis to be related to Arexvy.     It was unknown if the company considered the extremity necrosis to be related to Arexvy.   Additional Information: GSK receipt date: 13-NOV-2023 The patient called to inform that three days after the administration of Arexvy, their arm had gotten necrotic. According to the patient, the vaccine was received around the 3rd and 5th of October 2023, and the symptoms began 3 days after the administration of the vaccine. The patient also reported that the necrotic condition worsened after going to a cruise. Follow-up not possible as no contact details provided.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: a patient received an expired dose of Boostrix.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2ZS9N, expiry date 24-SEP-2023) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: a patient received an expired dose of Boostrix.). 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: 14-NOV-2023 The reporter was a Pharmacy Student. The reporter reported that the patient received an expired dose of Boostrix, which led to expired vaccine used. No additional details were provided by the reporter. The reporter had consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash macular
Clinical narrative: Rash was on both arms and lower leg; red spots on her arms and lower legs; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced rash (Verbatim: Rash was on both arms and lower leg) and red spotty rash (Verbatim: red spots on her arms and lower legs). The patient was treated with prednisone. The outcome of the rash was resolving and the outcome of the red spotty rash was not resolved.   It was unknown if the reporter considered the rash and red spotty rash to be related to Shingrix.     It was unknown if the company considered the rash and red spotty rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-NOV-2023 The pharmacist reported after the receipt of the 1st dose of Shingrix a patient developed a rash a few days later, rash was on both arms and lower legs. The patient was prescribed a prednisone taper and the rash had not resolved but was better.  The patient still (at the time of reporting) reported seeing red spots on her arms and lower legs. The reporter consented to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: administration of expired Flulaval to 4 employees; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number J7C77, expiry date 26-JUN-2023) for prophylaxis.   On 18-OCT-2023, the patient received FluLaval Quadrivalent 2022-2023 season. On 18-OCT-2023, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: administration of expired Flulaval to 4 employees). 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: 14-NOV-2023 The reporter reported that the administration of expired Flulaval vaccine to patient, which led to expired vaccine used. The reporter consented to follow up. This case is 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR162074:4 st employee, same reporter US-GSK-US2023AMR162065:3 rd  employee, same reporter US-GSK-US2023AMR162052:2 ND employee, same reporter
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: a patient received and expired dose of Kinrix.; 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 patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 09-NOV-2023) for prophylaxis.   On 13-NOV-2023, the patient received Kinrix. On 13-NOV-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: a patient received and expired dose of Kinrix.). 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: 14-NOV-2023 The reporter was a vaccine coordinator. The patient received an expired dose of Kinrix, which led to expired vaccine used. No patient details available. The reporter consented to follow up. This case was linked with US2023157862, reported by same reporter.; Sender's Comments:  US-GSK-US2023157862:same reporter, patient 2
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: expired dose administered; 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 patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 09-NOV-2023) for prophylaxis.   On 13-NOV-2023, the patient received Kinrix. On 13-NOV-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: expired dose administered). 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: 14-NOV-2023 The reporter was a vaccine coordinator. The patient received an expired dose of Kinrix, which led to expired vaccine used. No patient details available. The reporter consented to follow up. This case was linked with US2023157860, reported by same reporter.; Sender's Comments:  US-GSK-US2023157860:same reporter, patient 1
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Reporter stated a expired medication was given yesterday; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired drug used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 2kl4k, expiry date 09-NOV-2023) for prophylaxis.   On 13-NOV-2023, the patient received Kinrix (right deltoid). On 13-NOV-2023, an unknown time after receiving Kinrix, the patient experienced expired drug used (Verbatim: Reporter stated a expired medication was given yesterday). The outcome of the expired drug 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: 14-NOV-2023 The report was the health care professional (HCP) reporting on behalf of the patient.  Patient had not reported any symptoms at that time.  Reporter stated a expired medication was given yesterday (day before reporting) which expired on 09th November 2023, which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation error, Underdose
Clinical narrative: patient received Shingrix shot and was only given the liquid part; patient received Shingrix shot and was only given the liquid part; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication 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 inappropriate preparation of medication (Verbatim: patient received Shingrix shot and was only given the liquid part) and inappropriate dose of vaccine administered (Verbatim: patient received Shingrix shot and was only given the liquid part). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 14-NOV-2023 A HCP reported that a patient today told him that around 2 years she got a Shingrix shot and was only given the liquid part (adjuvant) which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.  This may have been reported with GSK 2 years ago.  The reporter consented to follow up.