chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No AE; received 3 doses of GARDASIL 9. The first dose 4/12/2023, the second dose received 4 weeks later, and received the third dose too early on Friday August 11, 2023.; This spontaneous report was received from a pharmacist and refers to a 12-year-old male patient who was immunosuppressed and had a bone marrow transplant. Concomitant therapies were not reported.  On 12-APR-2023, the patient was given the first dose of human papillomavirus (HPV) rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (dose, frequency, strength, lot #, expiry date, and route of administration were not provided). On 10-MAY-2023 (also reported as 4 weeks later), the second dose of the vaccine was administered. The third dose was given too early on Friday 11-AUG-2023 (Inappropriate schedule of product administration). No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE; HBP called to report inadvertent administration of PROQUAD after a temperature excursion. Limited patient demographics provided. See AE case #02451227 and #02451228. No additional AE/PQC.   ?    Names of vaccines involved (including lot/exp): PROQU; This spontaneous report was received from a healthcare business professional (HBP) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 14-AUG-2023, the patient was vaccinated with an improperly storage measles, mumps, rubella and varicella (OKA-MERCK) virus vaccine live (PROQUAD) subcutaneous injection, therapy type: rHA, valid lot #W016359, expiration date: 16-NOV-2023 (dose, frequency, strength, route of administration, and indication were not provided) (Product storage error). Temperature excursion occurred at 7.3 Fahrenheit (F) for 30 minutes. A previous temperature excursion was reported at 7.9 F for 30 minutes. No additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No symptoms reported.; Caller reported AE for improperly stored administered VARIVAX. TE Filed (Case #02453472). No symptoms reported. Obtained consent contact HCP. No additional AE/PQC. Product: VARIVAX-- Supported Lot: W021743 Exp: 7/10/2024 Temperature: 29F / 14°F up t; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 15-AUG-2023, the patient was vaccinated with an improperly storage varicella virus vaccine live (OKA/MERCK) (VARIVAX) subcutaneous injection, 0.5 milliliter, valid lot #W021743, expiration date: 10-JUL-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). Temperature excursion occurred at 29 Fahrenheit (F) (14 F up to 46 F) for 6 hours and 20 minutes. No previous temperature excursion was reported. No symptoms were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Improperly stored VARIVAX was administered; temperature -12.48 C for 1 hour 30 minutes; This spontaneous report was received from a medical assistant with a physician on the back line and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 22-AUG-2023, the patient was vaccinated with improperly stored first dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # X006983, expiration date: 07-MAR-2025, administered subcutaneously (dose and site of administration were not provided) for prophylaxis (strength was not provided). Vaccine was improperly stored for 1 hour 30 minutes 0 seconds in temperature of - 12.48 degrees Celsius (C). There was no previous temperature excursion reported. There was no additional adverse event (AE).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2308USA008988:
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain, Polyarthritis
Clinical narrative: polyarthritis; joint pain three hours after the vaccine; Diffuse pain; This serious case was reported by a physician via call center representative and described the occurrence of polyarthritis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis (rheumatoid-like arthritis).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced polyarthritis (Verbatim: polyarthritis) (serious criteria GSK medically significant), joint pain (Verbatim: joint pain three hours after the vaccine) and diffuse pain (Verbatim: Diffuse pain).The outcome of the polyarthritis, joint pain and diffuse pain were not reported.   It was unknown if the reporter considered the polyarthritis, joint pain and diffuse pain to be related to Shingrix.   It was unknown if the company considered the polyarthritis, joint pain and diffuse pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-AUG-2023 The patient experienced joint pain three hours after the Shingrix vaccine, 24 hours after administration and she started to experience diffuse pain (she had to be taken to the emergency room by ambulance) and then developed polyarthritis (mainly in the hands).
Sex: U
Vaccine: UNK
Symptoms: Chills, Fatigue, Feeling cold
Clinical narrative: cold chills; I got the shot and was so tired for two day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received RSVPreF3 adjuvanted (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 tiredness (Verbatim: I got the shot and was so tired for two day) and chills (Verbatim: cold chills).  The outcome of the tiredness was resolved (duration 2 days) and the outcome of the chills was not reported.   It was unknown if the reporter considered the tiredness and chills to be related to RSV vaccine.     It was unknown if the company considered the tiredness and chills to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 28-AUG-2023 This case was reported the patient via interactive digital media. The patient received shots of vaccine and was so tired for 2 days and cold chills. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: pain in the arm where the shot was administered/the arm was very sore; feeling very badly; This non-serious case was reported by a physician via sales rep and described the occurrence of feeling bad in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Covid 19 vaccine.   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 feeling bad (Verbatim: feeling very badly) and pain in arm (Verbatim: pain in the arm where the shot was administered/the arm was very sore).  The outcome of the feeling bad was resolved (duration 2 days) and the outcome of the pain in arm was not reported.   It was unknown if the reporter considered the feeling bad and pain in arm to be related to Shingrix.     It was unknown if the company considered the feeling bad and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-AUG-2023 The patient reported that after receiving Shingrix shot he started feeling very badly for at least 2 days after the shot. He reported pain in the arm where the shot was administered and said the arm was very sore. He reported his reaction to dose 1 of Shingrix was worse than his reaction to the COVID shot. He did understand he needed the second shot and he planned to take it in December 2023.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: pain in the arm where the shot was administered; feeling very badly; This non-serious case was reported by a nurse via sales rep and described the occurrence of feeling bad in a adult male 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 very badly) and pain in arm (Verbatim: pain in the arm where the shot was administered).  The outcome of the feeling bad was resolved (duration 2 days) and the outcome of the pain in arm was not reported.   It was unknown if the reporter considered the feeling bad and pain in arm to be related to Shingrix.     It was unknown if the company considered the feeling bad and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-AUG-2023 The patient reported that after receiving Shingrix shot he started feeling very badly for at least 2 days after the shot. He reported pain in the arm where the shot was administered.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: accidentally reconstituted Shingrix with sterile water & administered to patient; accidentally reconstituted Shingrix with sterile water & administered to patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular). On 27-AUG-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: accidentally reconstituted Shingrix with sterile water & administered to patient) and inappropriate dose of vaccine administered (Verbatim: accidentally reconstituted Shingrix with sterile water & administered to patient).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date 27th August 2023: The reporter stated that accidentally reconstituted Shingrix with sterile water and administered to patient.  The reporter need information with how to proceed and guidance with 2nd dose of Shingrix. The reporter consented to follow up. The patient received Shingrix reconstituted with sterile water which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 12.0
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Had a Menveo at 11 then again at 12; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 12-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (unknown dose received at age of 11 years).   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: Had a Menveo at 11 then again at 12).  The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 28-AUG-2023 The reporter reported that the patient received Menveo at 11 years and then again at 12 years, which led to extra dose administered. The reporter wanted to know how we proceed.  The reporter stated that there was no information available regarding patient. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received another 2nd dose by mistake the following day; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   In AUG-2023, the patient received the 3rd dose of Shingrix. In AUG-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received another 2nd dose by mistake the following day).The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 28-AUG-2023 The reporter called to ask about expected problems after receiving two 2nd doses of Shingrix, one day apart. He stated that his family member was in a nursing home and received her Shingrix first dose 2 months ago then received 2nd dose last week and she received another 2nd dose by mistake the following day, which led to extra dose administered. He refused to provide patient initials or exact age, stating that her age range is 75-80 years old. The reporter did not consent to follow-up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Body ache; redness (AE) between the elbow and the arm pit.; tenderness in arm; Patient reports it was administered in the fatty part of the back of her left arm (AE: Vaccine Administered at Inappropriate Site).; Fever; large lump(AE) , between a golf ball and a baseball size on the left arm/swollen (AE) between the elbow and the arm pit; This non-serious case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number Y77XY, expiry date 21-AUG-2024) for prophylaxis.   On 23-AUG-2023, the patient received the 1st dose of Shingrix (left arm). On 23-AUG-2023, an unknown time after receiving Shingrix, the patient experienced vaccine administered at inappropriate site (Verbatim: Patient reports it was administered in the fatty part of the back of her left arm (AE: Vaccine Administered at Inappropriate Site).). On an unknown date, the patient experienced swelling arm (Verbatim: large lump(AE) , between a golf ball and a baseball size on the left arm/swollen (AE) between the elbow and the arm pit), general body pain (Verbatim: Body ache), fever (Verbatim: Fever), erythema of extremities (Verbatim: redness (AE) between the elbow and the arm pit.) and pain in arm (Verbatim: tenderness in arm).  The outcome of the swelling arm was resolved (duration 4 days) and the outcome of the general body pain and vaccine administered at inappropriate site were unknown and the outcome of the fever was resolved (duration 24 hrs) and the outcome of the erythema of extremities was resolving and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the swelling arm, general body pain, fever, erythema of extremities and pain in arm to be related to Shingrix.     It was unknown if the company considered the swelling arm, general body pain, fever, erythema of extremities and pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 28-AUG-2023 The reporter was the patient . The patient reported it was provided at a clinic at a local pharmacy.  The patient reported it was administered in the fatty part of the back of her left arm, which led to vaccine administered at inappropriate site. The patient reported a large lump,  between a golf ball and a baseball size on the left arm.  The patient reported the lump started 12 hours after injection.  It last 4 days but the swelling has decreased .  The patient reported it was still tender.   The patient reported redness and swollen between the elbow and the arm pit.  The patient reported it was mostly gone, now (at the time of reporting). The patient reported body aches and fever.  The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Body ache; redness (AE) between the elbow and the arm pit.; tenderness in arm; Patient reports it was administered in the fatty part of the back of her left arm (AE: Vaccine Administered at Inappropriate Site).; Fever; large lump(AE) , between a golf ball and a baseball size on the left arm/swollen (AE) between the elbow and the arm pit; This non-serious case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number Y77XY, expiry date 21-AUG-2024) for prophylaxis.   On 23-AUG-2023, the patient received the 1st dose of Shingrix (left arm). On 23-AUG-2023, an unknown time after receiving Shingrix, the patient experienced vaccine administered at inappropriate site (Verbatim: Patient reports it was administered in the fatty part of the back of her left arm (AE: Vaccine Administered at Inappropriate Site).). On an unknown date, the patient experienced swelling arm (Verbatim: large lump(AE) , between a golf ball and a baseball size on the left arm/swollen (AE) between the elbow and the arm pit), general body pain (Verbatim: Body ache), fever (Verbatim: Fever), erythema of extremities (Verbatim: redness (AE) between the elbow and the arm pit.) and pain in arm (Verbatim: tenderness in arm).  The outcome of the swelling arm was resolved (duration 4 days) and the outcome of the general body pain and vaccine administered at inappropriate site were unknown and the outcome of the fever was resolved (duration 24 hrs) and the outcome of the erythema of extremities was resolving and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the swelling arm, general body pain, fever, erythema of extremities and pain in arm to be related to Shingrix.     It was unknown if the company considered the swelling arm, general body pain, fever, erythema of extremities and pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 28-AUG-2023 The reporter was the patient . The patient reported it was provided at a clinic at a local pharmacy.  The patient reported it was administered in the fatty part of the back of her left arm, which led to vaccine administered at inappropriate site. The patient reported a large lump,  between a golf ball and a baseball size on the left arm.  The patient reported the lump started 12 hours after injection.  It last 4 days but the swelling has decreased .  The patient reported it was still tender.   The patient reported redness and swollen between the elbow and the arm pit.  The patient reported it was mostly gone, now (at the time of reporting). The patient reported body aches and fever.  The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: accidentally received Kinrix; MD mentioned it was intended for the 16 month old to get the Pentacel vaccine but accidentally received Kinrix; 4th dose of Dtap; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 16-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7DY4, expiry date 22-AUG-2025) for prophylaxis.   On 28-JUL-2023, the patient received Kinrix (right thigh). On 28-JUL-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: accidentally received Kinrix), inappropriate age at vaccine administration (Verbatim: MD mentioned it was intended for the 16 month old to get the Pentacel vaccine but accidentally received Kinrix) and inappropriate schedule of vaccine administered (Verbatim: 4th dose of Dtap).  The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered 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: 28-AUG-2023 Medical physician called to inquire  Did the dose of Dtap and IPV count with these patients and asked how to proceed with series Doctor of medicine reported they inadvertently administered Kinrix  to the patient, get the Pentacel vaccine (this was the patient's 4th dose of Dtap and IPV). The 16th month old patient received Kinrix which led to inappropriate age of vaccine administered. The inadvertently administered Kinrix instead of Pentacel, which lead to wrong vaccinbe administered. The patient received Kinrix as 4th dose, which led to inappropriate schedule of vaccine administered. The health care professional (HCP)did not consent to follow up with the safety. Call Notes:HCP declined follow-up from safety. The case is linked with US2023117325, by same reporter.; Sender's Comments:  US-GSK-US2023117325:Same reporter
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Accidental underdose, Needle issue
Clinical narrative: dose was partially administered; the needle detached from the syringe; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 78-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 93PD7, expiry date 22-OCT-2024) for prophylaxis.   On 28-AUG-2023, the patient received Arexvy. On 28-AUG-2023, an unknown time after receiving Arexvy, the patient experienced accidental underdose (Verbatim: dose was partially administered) and needle issue (Verbatim: the needle detached from the syringe).  The outcome of the accidental underdose and needle issue were unknown.   Additional Information: GSK Receipt Date: 28-AUG-2023 The reporter was a pharmacy Intern who stated that while administering a dose of Arexvy to a patient, the needle detached from the syringe and the dose was partially administered which led to needle issue and accidental underdose. According to the reporter, the issue was not related with the product or the reconstitution process. The reporter consented to follow up.
Age: 4.0
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient was ordered to receive pneumococcal vaccine on 17Aug2023 but she accidentally grabbed meningococcal vaccine Menveo and administered.; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA908A, expiry date 30-APR-2024) for prophylaxis.   On 17-AUG-2023, the patient received the 1st dose of Menveo. On 17-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: patient was ordered to receive pneumococcal vaccine on 17Aug2023 but she accidentally grabbed meningococcal vaccine Menveo and administered.).  The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK receipt date 28 August 2023: The nurse reported 4 year old the patient was ordered to receive pneumococcal vaccine but she accidentally grabbed meningococcal vaccine Menveo and administered.  She was aware the vaccine was approved for children as young as 2 months, but this patient was not at-risk, so normally would not be given Menveo until adolescence. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. The patient accidentally grabbed meningococcal vaccine Menveo instead of pneumococcal vaccine which led to wrong vaccine administered.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Gave lyophilized powder only to a child; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 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 preparation of medication (Verbatim: Gave lyophilized powder only to a child) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29-AUG-2023 The vaccine administration facility was the same as primary reporter. The reporter said that he/ she was not sure if it was reconstituted with normal saline water, but it had to be reconstituted with something other than what was supplied buy Menveo. The patient was gave with lyophilized powder only to a child, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No additional information provided and unknown if follow up is permissible.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: patient received Bexsero, but was supposed to receive Menquadfi; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received Men B NVS (Bexsero) (batch number 5P2P7, expiry date 31-JAN-2026) for prophylaxis.   On 28-AUG-2023, the patient received Bexsero. On 28-AUG-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: patient received Bexsero, but was supposed to receive Menquadfi).  The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 29-AUG-2023 The reporter was a medical assistant. The reporter reported that the patient received Bexsero but was supposed to received Menquadfi, which led to wrong vaccine administered. The reporter reported that Bexsero was given accidentally. The reporter consented to follow up via email.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: 2 female adult patients received Shingrix first dose after being exposed to freezing temperatures; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Herpes zoster (Shingrix) (batch number 5954H, expiry date 15-AUG-2025) for prophylaxis.   On 28-AUG-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: 2 female adult patients received Shingrix first dose after being exposed to freezing temperatures).The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2023 The reporter was a medical assistant. The reporter reported that patient received Shingrix dose after being exposed to freezing temperatures, which led to incorrect storage of drug. The reporter consented to follow up. This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023118050:Same reporter, different patient
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: 2 female adult patients received Shingrix first dose after being exposed to freezing temperatures; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Herpes zoster (Shingrix) (batch number 5954H, expiry date 15-AUG-2025) for prophylaxis.   On 28-AUG-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: 2 female adult patients received Shingrix first dose after being exposed to freezing temperatures).  The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2023 On 28 August 2023 a medical assistant reported that patient received Shingrix dose after being exposed to freezing temperatures, which led to incorrect storage of drug. The reporter consented to follow up. This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023118048:Same reporter, different patient
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient received a 3rd dose of Shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 9277T, expiry date 16-AUG-2025) for prophylaxis.   On 29-AUG-2023, the patient received the 3rd dose of Shingrix. On 29-AUG-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: patient received a 3rd dose of Shingrix).  The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 29-AUG-2023 A nurse reported that a patient received a 3rd dose of Shingrix, which led to extra dose administered. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Bedridden, Dizziness, Feeling abnormal, Headache
Clinical narrative: patient passed out/feeling that she was going to pass out, and in fact she did.; sinus pressure; lack of energy; headache; feeling lousy; had to stay in bed all day; This serious case was reported by a consumer via call center representative and described the occurrence of passed out in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-AUG-2023, the patient received the 2nd dose of Shingrix (left arm). On 12-AUG-2023, 1 days after receiving Shingrix, the patient experienced passed out (Verbatim: patient passed out/feeling that she was going to pass out, and in fact she did.) (serious criteria GSK medically significant) and bedridden (Verbatim: had to stay in bed all day). In AUG-2023, the patient experienced sinus pressure (Verbatim: sinus pressure), loss of energy (Verbatim: lack of energy), headache (Verbatim: headache) and feeling bad (Verbatim: feeling lousy).  In AUG-2023, the outcome of the sinus pressure, loss of energy, headache and feeling bad were resolved (duration 2 weeks). The outcome of the passed out and bedridden were resolved (duration 2 weeks).   It was unknown if the reporter considered the passed out, sinus pressure, loss of energy, headache, feeling bad and bedridden to be related to Shingrix.     It was unknown if the company considered the passed out, sinus pressure, loss of energy, headache, feeling bad and bedridden to be related to Shingrix.   Additional Information: GSK Receipt date: 29-AUG-2023 The reporter reported about herself she received the second dose of Shingrix on 11 August 2023 and the next day the patient woke feeling that she was going to pass out, and in fact she did.  The patient passed out and had to stay in bed all day. The patient also had headache, lack of energy, sinus pressure and feeling lousy.  According to patient the symptoms persisted for about 2 weeks and yesterday 28 August 2023 she started to feeling back to normal.  Reporter states she got a Covid test 4 times with negative results.  Patient contacted her doctor to inform him about the symptoms.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Mobility decreased, Paranasal sinus discomfort, SARS-CoV-2 test negative
Clinical narrative: patient passed out/feeling that she was going to pass out, and in fact she did.; sinus pressure; lack of energy; headache; feeling lousy; had to stay in bed all day; This serious case was reported by a consumer via call center representative and described the occurrence of passed out in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-AUG-2023, the patient received the 2nd dose of Shingrix (left arm). On 12-AUG-2023, 1 days after receiving Shingrix, the patient experienced passed out (Verbatim: patient passed out/feeling that she was going to pass out, and in fact she did.) (serious criteria GSK medically significant) and bedridden (Verbatim: had to stay in bed all day). In AUG-2023, the patient experienced sinus pressure (Verbatim: sinus pressure), loss of energy (Verbatim: lack of energy), headache (Verbatim: headache) and feeling bad (Verbatim: feeling lousy).  In AUG-2023, the outcome of the sinus pressure, loss of energy, headache and feeling bad were resolved (duration 2 weeks). The outcome of the passed out and bedridden were resolved (duration 2 weeks).   It was unknown if the reporter considered the passed out, sinus pressure, loss of energy, headache, feeling bad and bedridden to be related to Shingrix.     It was unknown if the company considered the passed out, sinus pressure, loss of energy, headache, feeling bad and bedridden to be related to Shingrix.   Additional Information: GSK Receipt date: 29-AUG-2023 The reporter reported about herself she received the second dose of Shingrix on 11 August 2023 and the next day the patient woke feeling that she was going to pass out, and in fact she did.  The patient passed out and had to stay in bed all day. The patient also had headache, lack of energy, sinus pressure and feeling lousy.  According to patient the symptoms persisted for about 2 weeks and yesterday 28 August 2023 she started to feeling back to normal.  Reporter states she got a Covid test 4 times with negative results.  Patient contacted her doctor to inform him about the symptoms.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: made the patient fairly sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of sickness 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 sickness (Verbatim: made the patient fairly sick).  The outcome of the sickness was unknown.   The reporter considered the sickness to be related to Shingrix.     The company considered the sickness to be related to Shingrix.   Additional Information: GSK receipt date: 29-AUG-2023 The reporter was the husband of the patient.   The Shingrix vaccine made the patient fairly sick.  It was not clear which dose of Shingrix the patient experienced the event The reporter did not provide further information about the patient.  The reporter denied to follow-up. The case is linked with US2023118061, by same reporter.; Sender's Comments:  US-GSK-US2023118061:1st report
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate Schedule of Vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose last year).   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: Inappropriate Schedule of Vaccine).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 30-Aug-2023 The consumer called in to report that never came back to get the second dose. The reporter asked how to proceed with Shingrix series. Attempt to warm transfer to Agent to further assist.  Phone transfer difficulties, patient/consumer consented to Agent to return call. Consumer unable to provide any vaccine details. Did not consent to follow-up. Till the time of reporting, the patient did not receive second dose, which led to incomplete course of vaccination.
Sex: M
Vaccine: MENB, UNK
Symptoms: Interchange of vaccine products
Clinical narrative: received a booster dose with a different brand; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included MENINGCOCOCCAL AC VACCINE for prophylaxis.   Previously administered products included Bexsero (1st dose received on 28 January 2019, Batch number 177201, Expiry date 31 January 2020, vaccination site was Right deltoid).   On an unknown date, the patient received the 2nd dose of Bexsero and MENINGCOCOCCAL AC VACCINE. On an unknown date, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: received a booster dose with a different brand).  The action taken with MENINGCOCOCCAL AC VACCINE was unknown. The outcome of the interchange of vaccine products 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: 30-AUG-2023 The pharmacist reported that a patient received the two doses of Bexsero then received a booster dose with a different brand which led to interchange of vaccine products. The reporter consented to follow up.
Sex: F
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: his daughter receiving her 2nd dose of BEXSERO only 20 days after the first dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a adolescent female patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO).   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: his daughter receiving her 2nd dose of BEXSERO only 20 days after the first dose).The outcome of the drug dose administration interval too short 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: 30-AUG-2023 and 31-AUG-2023 The patient's father was the caller asking if there would be a negative outcome due to his daughter receiving her 2nd dose of Bexsero only 20 days after the first dose. The reporter referred him to his healthcare professional and provided the telephone number for medical Information department for his doctor.  The patient received 2nd dose of Bexsero earlier than the recommend schedule, which led to shortening of vaccination schedule.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: patient was given a dose of Menveo after it had been reconstituted with sterile water; patient was given a dose of Menveo after it had been reconstituted with sterile water; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   In AUG-2023, the patient received Menveo. In AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: patient was given a dose of Menveo after it had been reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: patient was given a dose of Menveo after it had been reconstituted with sterile water).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 31-Aug-2023 The nurse stated that 1 to 2 weeks ago a patient was given a dose of Menveo after it had been reconstituted with sterile water. The reporter stated that she did not had further details available at time of call, but she granted permission for safety to follow up. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up.  The patient received a dose of Menveo which was reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for covid-19 prophylaxis. No concomitant medications were reported. On AUG-2023, the patient experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shortness of breath was not reported. This report was non-serious. This report was associated with product quality complaint: 90000294162.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient went into a crowd or ER (for something else) got COVID-19 after. It was never super bad. Patient had covid-19 symptoms as a bad cold and fatigue. Patient thought that patient had delta and omicron strains. Patient assumed the effect of the vaccine was waning after 6 months. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-738922 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738922:monovalent case
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Relevant medical history or conditions, allergy, concomitant diseases and risk factor were unknown.     In December 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) outcome was unknown.            It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication not reported.   She got COVID-19 twice, both times 6 months after a booster. She was due for a booster and didn't get it in time. Moderna was protecting her up until 6 months. When she got into a crowd or ER (for something else) she got COVID-19 after. It was never super bad. She had a bad cold and fatigue. She thought she had delta and omicron strains. She assumes the effect of the vaccine was waning after 6 months. She got her Moderna COVID-19 Vaccine, Bivalent booster in Dec 2022.  Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-739236 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739236:monovalent case
Age: 1.67
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Moderna COVID19 vaccine bivalent -dark blue cap instead of a dose of the Moderna COVID19 vaccine bivalent - dark pink cap; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna COVID19 vaccine bivalent -dark blue cap instead of a dose of the Moderna COVID19 vaccine bivalent - dark pink cap) and NO ADVERSE EVENT (No adverse event) in a 20-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (1 st dose, lot AR9236B) on 27-Oct-2022, Moderna COVID-19 vaccine (2nd dose,lot AR9236B) on 01-Dec-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine and Moderna COVID-19 vaccine.    On 31-Aug-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 31-Aug-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Moderna COVID19 vaccine bivalent -dark blue cap instead of a dose of the Moderna COVID19 vaccine bivalent - dark pink cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna COVID19 vaccine bivalent -dark blue cap instead of a dose of the Moderna COVID19 vaccine bivalent - dark pink cap) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna COVID19 vaccine bivalent -dark blue cap instead of a dose of the Moderna COVID19 vaccine bivalent - dark pink cap).    No concomitant medication was reported. No treatment information was provided.