chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bradycardia, Electrocardiogram normal, Hyperhidrosis, Hyporesponsive to stimuli, Hypotension
Clinical narrative: Patient was in to get COVID vaccine with her father and mother.  About 10 minutes after getting the vaccine patient became diapharetic, hypotensive, and bradycardic to the 30s.  Code called, EMS arrived.  Patient slightly better by time of EMS transport to hospital for further care.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test normal, Pallor, Seizure like phenomena, Syncope
Clinical narrative: Patient was in to get COVID vaccine with her father and mother.  About 10 minutes after getting the vaccine patient became diapharetic, hypotensive, and bradycardic to the 30s.  Code called, EMS arrived.  Patient slightly better by time of EMS transport to hospital for further care.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram spine, Guillain-Barre syndrome, Intervertebral disc degeneration, Intervertebral disc protrusion, Intervertebral disc space narrowing
Clinical narrative: Pt was hospitalized for GBS with prolonged hospitalization at hospital and rehab hopsital.  Now currently in a wheelchair
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Ligamentum flavum hypertrophy, Magnetic resonance imaging spinal abnormal, Radiculopathy, Scan with contrast abnormal, Scoliosis
Clinical narrative: Pt was hospitalized for GBS with prolonged hospitalization at hospital and rehab hopsital.  Now currently in a wheelchair
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Spinal flattening, Vertebral foraminal stenosis, Vertebral lateral recess stenosis, Wheelchair user
Clinical narrative: Pt was hospitalized for GBS with prolonged hospitalization at hospital and rehab hopsital.  Now currently in a wheelchair
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis, Paraesthesia
Clinical narrative: right hand and facial paresthesias 15 minutes after injection
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: Patient was only given the diluent and it was not mixed with the powder.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given High Dose Flu vaccine and is 61.  There was no adverse effect to the patients wellness.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Peripheral swelling
Clinical narrative: swollen arm, pain in left shoulder
Age: 47.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Mass, Pain, Rash, Sensitive skin, Swelling
Clinical narrative: Patient was seen today for the following reason she received COVID and Influenza vaccine on 11/30/23 the next day she woke up with the following symptoms VERY SENSITIVE SKIN, PAIN, SWOLLEN, BUMP 4Centimeter AND RASH 7 Centimeter in her Left Arm.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event thus far.  Accidental administration of additional 23-24 Covid-19 vaccine
Age: 7.0
Sex: M
Vaccine: PNC20
Symptoms: Cough, Erythema, Fatigue, Peripheral swelling, Urticaria
Clinical narrative: pain that night, followed by significant arm swelling the next day, which continued to increase in size and redness over several days.. more tired overall. 6 days after the vaccine, he had hives. He did develop a cough the night of the vaccine. no fever or runny nose.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: pt felt numbness in L side of face after getting the RSV vaccine earlier today. She says she feels numbness in her lower check, jaw and tongue.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Painful 2x3 inch raised, red, warm welt at injection site for >7 days. Red welt is fainter now but still visible, warm, & intermittent pain.   Fatigue 24/7 despite naps, different locations of muscle & joint pains 24/7, dull headache 24/7, temperature in evenings 100° for 14 days until Prednisone and Azithromycin were started on evening of 14th day.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Injection site swelling, Injection site urticaria, Injection site warmth, Myalgia, SARS-CoV-2 test negative
Clinical narrative: Painful 2x3 inch raised, red, warm welt at injection site for >7 days. Red welt is fainter now but still visible, warm, & intermittent pain.   Fatigue 24/7 despite naps, different locations of muscle & joint pains 24/7, dull headache 24/7, temperature in evenings 100° for 14 days until Prednisone and Azithromycin were started on evening of 14th day.
Sex: F
Vaccine: PNC15
Symptoms: Injury associated with device, Maternal exposure during breast feeding, Occupational exposure to product, Syringe issue
Clinical narrative: she was nursing at the time of the needle stick / and the needle fell towards the Nurse's foot piercing it in the process.; the end of the barrel of the syringe broke off with the needle exposed; she was nursing at the time of the needle stick / and the needle fell towards the Nurse's foot piercing it in the process.; Nurse was preparing a VAXNUEVANCE syringe for administration./ she was nursing at the time of the needle stick / and the needle fell towards the Nurse's foot piercing it in the process.; she was nursing at the time of the needle stick.; This spontaneous report was received from  a female nurse concerning herself. The nurse's concurrent conditions included breast feeding. Her medical history, concomitant medications, drug reactions or allergies were not reported.   On 30-AUG-2023, the nurse was preparing a dose of pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) 0.5 mL (lot #, expiration date, anatomical location not provided), to be administered intramuscular (IM) as part of a 4 dose series for pneumococcal prevention for a patient. When she was screwing the needle onto the end of the syringe, the end of the barrel broke off with the needle exposed (syringe issue). The needle fell towards the patient's foot, piercing it in the process (injury associated with device, occupational exposure to product, accidental exposure to product). She did not seek for any medical attention; however, she was concerned as she was nursing at the time of the needle stick (maternal exposure during breast feeding). It was confirmed that the vaccine was not administered to any patient, and it was disposed as per their facility's protocols after the event occurred. On an unspecified date in 2023, the patient recovered from injury associated with device.
Sex: F
Vaccine: RSV
Symptoms: Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got RSV infection; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 6 weeks after receiving Arexvy, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Got RSV infection). The outcome of the vaccination failure was unknown and the outcome of the respiratory syncytial virus infection was not reported.   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to Arexvy.     It was unknown if the company considered the vaccination failure and respiratory syncytial virus infection to be related to Arexvy.  Additional Information: GSK Receipt Date: 28-NOV-2023 The patient got RSV (respiratory syncytial virus) infection and she received Arexvy 6 weeks before the event. The reporter questioned about lack of efficacy. This case was considered as suspected vaccination failure as details regarding confirmatory laboratory testing for RSV and exclusion of co-infection with other respiratory pathogens were unknown at the time of reporting. Consent to follow-up granted.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pyrexia, Rash
Clinical narrative: Headache; fever; rash on hands; I felt very sick; This non-serious case was reported by a consumer and described the occurrence of headache in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 581600823-11) for prophylaxis.   On 25-OCT-2023, the patient received Shingrix 50 ug. On 26-OCT-2023, 1 days after receiving Shingrix, the patient experienced headache (Verbatim: Headache), fever (Verbatim: fever) and rash (Verbatim: rash on hands). On an unknown date, the patient experienced sickness (Verbatim: I felt very sick). The outcome of the headache, fever and rash were not resolved and the outcome of the sickness was resolved (duration 5 days).   It was unknown if the reporter considered the headache, fever, rash and sickness to be related to Shingrix.  It was unknown if the company considered the headache, fever, rash and sickness to be related to Shingrix.   Additional Information: RA receipt date: 24-NOV-2023 The reporter was a patient. The patient felt very sick for five days and developed the rash on both hands, and symptoms a day after the vaccine (headache, fever, rash on hands). The symptoms were not treated. The reporter requested to consent to follow up.
Sex: F
Vaccine: RVX
Symptoms: Cough, Malaise, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Fever; sneeze; sore throat; runny nose; coughs; sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 79-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included flu symptoms. Concomitant products included dextromethorphan hydrobromide;guaifenesin (Mucinex Dm).   On 15-NOV-2023, the patient received RSV vaccine. In NOV-2023, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: sick). On 19-NOV-2023, the patient experienced fever (Verbatim: Fever), sneezing (Verbatim: sneeze), sore throat (Verbatim: sore throat), runny nose (Verbatim: runny nose) and cough (Verbatim: coughs). The outcome of the fever, sneezing, sore throat, runny nose and cough were resolving and the outcome of the sickness was not reported.   It was unknown if the reporter considered the fever, sneezing, sore throat, runny nose and cough to be related to RSV vaccine. The reporter considered the sickness to be related to RSV vaccine.     It was unknown if the company considered the fever, sneezing, sore throat, runny nose and cough to be related to RSV vaccine. The company considered the sickness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 25-NOV-2023 This case was self-reported by the patient. The patient reported that RSV vaccines were supposed to prevent the RSV virus, but she got sick from taking the RSV Vaccine and asked how that vaccine would help them (fever, sneeze, sore throat, runny nose, coughs). It was reported that fever, sneeze, sore throat, runny nose, coughs were ongoing, and these symptoms were treated. The reporter had denied for the permission to contact.
Sex: F
Vaccine: RVX
Symptoms: Sneezing
Clinical narrative: Fever; sneeze; sore throat; runny nose; coughs; sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 79-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included flu symptoms. Concomitant products included dextromethorphan hydrobromide;guaifenesin (Mucinex Dm).   On 15-NOV-2023, the patient received RSV vaccine. In NOV-2023, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: sick). On 19-NOV-2023, the patient experienced fever (Verbatim: Fever), sneezing (Verbatim: sneeze), sore throat (Verbatim: sore throat), runny nose (Verbatim: runny nose) and cough (Verbatim: coughs). The outcome of the fever, sneezing, sore throat, runny nose and cough were resolving and the outcome of the sickness was not reported.   It was unknown if the reporter considered the fever, sneezing, sore throat, runny nose and cough to be related to RSV vaccine. The reporter considered the sickness to be related to RSV vaccine.     It was unknown if the company considered the fever, sneezing, sore throat, runny nose and cough to be related to RSV vaccine. The company considered the sickness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 25-NOV-2023 This case was self-reported by the patient. The patient reported that RSV vaccines were supposed to prevent the RSV virus, but she got sick from taking the RSV Vaccine and asked how that vaccine would help them (fever, sneeze, sore throat, runny nose, coughs). It was reported that fever, sneeze, sore throat, runny nose, coughs were ongoing, and these symptoms were treated. The reporter had denied for the permission to contact.
Sex: F
Vaccine: RSV
Symptoms: Injection site rash
Clinical narrative: Rash at site of injection; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site rash in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 25-NOV-2023, the patient received Arexvy (left arm). On 26-NOV-2023, 1 days after receiving Arexvy, the patient experienced injection site rash (Verbatim: Rash at site of injection). The outcome of the injection site rash was resolving.   The reporter considered the injection site rash to be related to Arexvy.     The company considered the injection site rash to be related to Arexvy.   Additional Information: GSK receipt date 26th Nov 2023 The reporter experienced rash at site of injection. The reporter did not consent to follow up.
Sex: M
Vaccine: RVX
Symptoms: Nasal congestion
Clinical narrative: Congestion nasal; This non-serious case was reported by a consumer and described the occurrence of nasal congestion in a 69-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) (batch number ndc;58160-0848-11) for prophylaxis.   Concomitant products included Influenza vaccine (Flu vaccine VII) and COVID-19 vaccine.   On 03-NOV-2023, the patient received RSV vaccine. On 04-NOV-2023, 1 days after receiving RSV vaccine, the patient experienced nasal congestion (Verbatim: Congestion nasal). The outcome of the nasal congestion was not resolved.   It was unknown if the reporter considered the nasal congestion to be related to RSV vaccine.     It was unknown if the company considered the nasal congestion to be related to RSV vaccine.   Additional Information: GSK receipt date: 27-NOV-2023 The reporter consented to follow up
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: had a 102 degree fever; very itchy rash covering my entire buttocks and lower back; very red, very itchy rash covering my entire buttocks and lower back; had a welt on my arm for 3 days; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox, shingles, herpes on lip and epstein-barr virus infection.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 10 hrs after receiving Shingrix, the patient experienced fever (Verbatim: had a 102 degree fever), welts (Verbatim: had a welt on my arm for 3 days), itchy rash (Verbatim: very itchy rash covering my entire buttocks and lower back) and red rash (Verbatim: very red, very itchy rash covering my entire buttocks and lower back). The outcome of the fever was not reported and the outcome of the welts was resolved (duration 3 days) and the outcome of the itchy rash and red rash were not resolved.   The reporter considered the fever, welts, itchy rash and red rash to be possibly related to Shingrix.     The company considered the fever, welts, itchy rash and red rash to be possibly related to Shingrix.   Additional Information: Narrative suggestion; RA receipt date: 27-NOV-2023 The patient received 1st dose of Shingrix vaccine and within 10 hours the patient had 102 degree fever and threw up. The patient had a welt on arm for three days and now had a very red, very itchy rash covering entire buttocks and lower back (at the time of reporting). The patient thought that was related because it could not be otherwise explained. The patient asked, have you seen this rash before, how do he/she get it to go away? and should even take the second shot?
Age: 0.33
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate schedule of vaccine administered; Inappropriate schedule of vaccine administered; This spontaneous report has been received from an other health care professional (reported as primary care) via medical records from a case in litigation for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (2310USA002275), concerning a 4-months-old female patient.  The patient's medical history, concomitant medications, and concurrent conditions were not provided.  On 05-JUL-2002, the patient was vaccinated with a first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (dose, units, frequency, route of administration, lot#, and expiration date were not reported) for prophylaxis. On 07-NOV-2002, the patient was vaccinated with a second dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (dose, units, frequency, route of administration, lot#, and expiration date were not reported) for prophylaxis (Inappropriate schedule of product administration). On 24-JAN-2003, the patient was vaccinated with the third dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (dose, units, frequency, route of administration, lot#, and expiration date were not reported) for prophylaxis (Inappropriate schedule of product administration).; Sender's Comments:  US-009507513-2310USA002275: US-009507513-2311USA006377: US-009507513-2311USA006630:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Office manager called to report that an expired dose of PNEUMOVAX 23 was administered to a patient. The dose expired on 10/1/2023 and was administered on 11/14/2023. Caller stated the patient has not had any symptoms. No additional AE/no PQC reported; This spontaneous report was received from an office manager regarding a patient of unspecified age or gender.  The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported.  On 14-NOV-2023, the patient received the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (valid lot # W021636 and expiration date 01-OCT-2023) administered for prophylaxis (strength and route of administration were not provided) (Expired product administered). The patient had no symptoms or there was no adverse event.
Age: 1.0
Sex: F
Vaccine: MMR, UNK
Symptoms: Expired product administered
Clinical narrative: No adverse event; Expired vaccine used; This spontaneous report was received from a health professional referring to a 12-month-old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 05-DEC-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot number N034411 and expiration date of 04-DEC-2019 (expired product administered), at a dose of 0.5 milliliter/once for prophylaxis (route of administration and anatomical location were not reported). The reporter stated she noticed a missing expiration date in the patient's record while reviewing documentation for a immunization chart audit.    The reporter stated the dose administered to the patient on 05-DEC-2019 was given at another provider's office and she was unable to provide the necessary information regarding prior excursion history to perform a stability evaluation. This agent was unable to perform a stability evaluation of unsupported or supported due to insufficient data.  Additionally, the reporter was unable to provide the lot number and expiration date for the diluent used to administer the vaccine due to lack of documentation. There was no report of any issues or side effects from the patient after receiving the expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).  No additional adverse event.
Sex: U
Vaccine: RSV
Symptoms: Headache, Malaise
Clinical narrative: headache; feeling of malease; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced headache (Verbatim: headache) and malaise (Verbatim: feeling of malease). The outcome of the headache and malaise were not reported.   It was unknown if the reporter considered the headache and malaise to be related to Arexvy.     It was unknown if the company considered the headache and malaise to be related to Arexvy.   Additional Information: GSK Receipt Date: 29-NOV-2023 The patient self-reported this case. The patient had terrific headache and feeling of malaise. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Product storage error
Clinical narrative: Administration after exposure 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 specified number of patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patients received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incorrect storage of drug (Verbatim: Administration after exposure to freezing temperatures.). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 20-NOV-2023 A pharmacy technician reported that doses of Arexvy were exposed to the temperature of 24°F.  After being exposed to freezing temperatures, 5 of those doses were administered to 5 different patients which led to incorrect storage of drug.  The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: accidental administration of Twinrix vaccine on 25NOV2023 that expired on 22SEP2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 53-year-old female patient who received HAB (Twinrix adult) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 25-NOV-2023, the patient received Twinrix adult. On 25-NOV-2023, an unknown time after receiving Twinrix adult, the patient experienced expired vaccine used (Verbatim: accidental administration of Twinrix vaccine on 25NOV2023 that expired on 22SEP2023). 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: 27-NOV-2023 Pharmacist requested data on the accidental administration of Twinrix vaccine that expired on 22nd September 2023, which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Product preparation error
Clinical narrative: HCP called to report that an 74 year old adult received Arexvy mixed with steril water; 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 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number G95D4, expiry date 04-MAR-2025) for prophylaxis.   On 20-NOV-2023, the patient received Arexvy. On 20-NOV-2023, an unknown time after receiving Arexvy, the patient experienced wrong solution used in drug reconstitution (Verbatim: HCP called to report that an 74 year old adult received Arexvy mixed with steril water). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 27-NOV-2023 The healthcare professional reported that the patient received Arexvy mixed with sterile water, which led to wrong solution used in drug reconstitution. The reporter consented to follow up via fax to the office.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: He has not yet received a second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 2 years ago from reporting date).   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: He has not yet received a second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: RA Receipt Date: 27-NOV-2023 The patient self-reported this case. The reporter did not consent to follow-up. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Menveo only liquid portion; Menveo only liquid portion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 80-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA976A, expiry date 30-SEP-2024) for prophylaxis.   On 15-NOV-2023, the patient received Menveo. On 15-NOV-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo only liquid portion) and inappropriate dose of vaccine administered (Verbatim: Menveo only liquid portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-NOV-2023 Pharmacist reported that only the liquid portion of Menveo was administered to a patient, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The reporter consented to follow up via email.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: the dose was not reconstituted, so the patient received only the liquid adjuvant portion; was administered a dose of Shingrix on 22Nov2023, and that the dose was not reconstituted, so the patient received only the liquid adjuvant portion; 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 52-year-old male patient who received Herpes zoster (Shingrix) (batch number 2737J, expiry date 23-SEP-2025) for prophylaxis.   On 22-NOV-2023, the patient received the 1st dose of Shingrix. On 22-NOV-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: the dose was not reconstituted, so the patient received only the liquid adjuvant portion) and inappropriate dose of vaccine administered (Verbatim: was administered a dose of Shingrix on 22Nov2023, and that the dose was not reconstituted, so the patient received only the liquid adjuvant portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: RA Receipt Date: 27-NOV-2023  Medical Assistant reported that patient was administered a dose of Shingrix on 22nd November 2023, and that the dose was not reconstituted, so the patient received only the liquid adjuvant portion which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. This was the first dose in the series the patient. At the time of reporting, the dose has not been repeated. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. This case has been linked to the case US2023165562 reported by the same reporter.; Sender's Comments:  US-GSK-US2023165562:patient 2
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: the dose was not reconstituted, so the patient received only the liquid adjuvant portion; patient was administered a dose of Shingrix on 22Nov2023, and that the dose was not reconstituted, so the patient received only the liquid adjuvant portion; 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 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 2737J, expiry date 23-SEP-2025) for prophylaxis.   On 22-NOV-2023, the patient received the 1st dose of Shingrix. On 22-NOV-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: the dose was not reconstituted, so the patient received only the liquid adjuvant portion) and inappropriate dose of vaccine administered (Verbatim: patient was administered a dose of Shingrix on 22Nov2023, and that the dose was not reconstituted, so the patient received only the liquid adjuvant portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-NOV-2023  Medical Assistant reported that patient was administered a dose of Shingrix on 22nd November 2023, and that the dose was not reconstituted, so the patient received only the liquid adjuvant portion which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. This was the first dose in the series the patient.  At the time of reporting, the dose has not been repeated. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. This case has been linked to the case US2023165559 reported by the same reporter.; Sender's Comments:  US-GSK-US2023165559:patient 1 ( MALE PATIENT)
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient had their first dose 17Nov2021 but has not yet received dose 2.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 17th November 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: patient had their first dose 17Nov2021 but has not yet received dose 2.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 27-NOV-2023  Healthcare professional states a patient had their first dose 17November 2021 but has not yet received dose 2 which led to incomplete course of vaccination. No further details provided. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. Reporter grants permission for safety follow up via postal.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Accidental underdose; an adult patient inadvertently received a pediatric dose of Engerix-B.; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 47-year-old male patient who received HBV (Engerix B pediatric) (batch number 77X47) for prophylaxis.   On 27-NOV-2023, the patient received the 1st dose of Engerix B pediatric. On 27-NOV-2023, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: Accidental underdose) and adult use of a child product (Verbatim: an adult patient inadvertently received a pediatric dose of Engerix-B.). The outcome of the accidental underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-NOV-2023  The nurse called to inform that earlier that day, an adult patient inadvertently received a pediatric dose of Engerix-B which led to accidental underdose and adult use of a child product. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date:27-NOV-2023 A GSK field representative stated that a pharmacist reported an adverse event for Shingrix Vaccine. The pharmacist reported that the patient was her mother. The pharmacist reported that the patient received the 1st dose of Shingrix vaccine in April 2023. The patient had shingles after the vaccine was administered. The vaccine was administered at a doctor's office. It was unknown in which arm the vaccine was administered. The lot and expiration date of the vaccine were not provided. No additional information was reported. The reporter consented to follow up. Not all information was available.  The location of the facility and the name of the healthcare professional who administered the vaccine was unknown when it was reported.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: body pain /body aches; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26-MAY-2023, the patient received the 1st dose of Shingrix (left arm). On 26-MAY-2023, less than a day after receiving Shingrix, the patient experienced general body pain (Verbatim: body pain /body aches). On 28-MAY-2023, the outcome of the general body pain was resolved (duration 2 days).   It was unknown if the reporter considered the general body pain to be related to Shingrix.     It was unknown if the company considered the general body pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-NOV-2023 The consumer was the reporter.   The reporter called to state that she had her first Shingrix vaccination administered and stated for two days following the vaccination she experienced body aches and body pain.   No further information was known. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: they got a case of shingles following the first dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included decreased immune responsiveness.   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 shingles (Verbatim: they got a case of shingles following the first dose). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date:28-NOV-2023 The reporter reported this case as an adverse event, so they were not reporting it here, however, this pharmacist had a question regarding whether a patient should have the second dose of Shingrix if they got a case of shingles following the first dose. The patient had a weakened immune system so they were not sure if that had something to do with getting a case of the shingles or if the patient was already about to have a case anyway before the first dose was received. The reporter would like a call regarding whether a patient should get a second dose. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: After the HCP researched further, it appears that the patient received 2 doses in 2018 and received a 3rd dose on May 25, 2023.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a adult female patient who received Herpes zoster (Shingrix) (batch number G3T43, expiry date 07-JUL-2024) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 25th April 2023) and Shingrix (received 2nd dose on 2018).   On 25-MAY-2023, the patient received the 3rd dose of Shingrix. On 25-MAY-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: After the HCP researched further, it appears that the patient received 2 doses in 2018 and received a 3rd dose on May 25, 2023.). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 28-NOV-2023 The pharmacist initially called stating a patient over the age of 50 received the 1st dose of Shingrix on April 25th, 2018 and 2nd dose on May 25, 2023, to ask if the patient needed additional doses. The vaccine administration facility was the same as primary reporter After the HCP researched further, it appears that the patient received 2 doses in 2018 and received a 3rd dose on May 25, 2023, which led to extra dose administered. The reporter consented to follow up via postal.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Pruritus, Urticaria
Clinical narrative: itching around the waist band of her pants.; States the hives spread from her neck to her hip area; This non-serious case was reported by a consumer via call center representative and described the occurrence of pruritus in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 02-NOV-2023 14:00, the patient received Arexvy. On 02-NOV-2023, less than a day after receiving Arexvy, the patient experienced pruritus (Verbatim: itching around the waist band of her pants.) and hives (Verbatim: States the hives spread from her neck to her hip area). The patient was treated with diphenhydramine hydrochloride (Benadryl). The outcome of the pruritus and hives were resolved.   It was unknown if the reporter considered the pruritus and hives to be related to Arexvy.     It was unknown if the company considered the pruritus and hives to be related to Arexvy.   Additional Information: GSK Receipt Date: 28-NOV-2023 The consumer was the reporter reported of receiving Arexvy and at 4:30pm the consumer stated she was itching around the waist band of her pants.   She noticed this area was broken out in hives and stated the hives spread from her neck to her hip area.   She spoke with her pharmacist who advised her to take Benadryl and received 50mg of Benadryl at 6pm and 50mg at 8pm.   By the next morning, the hives and itching had resolved. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate Vaccine schedule; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2022).   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 Vaccine schedule). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-NOV-2023 The patient self-reported this case. The patient forgot to get dose 2. He stated he spoke with his healthcare professional and would get the second dose soon. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: 7 month old patient was inadvertently administered a third dose of Rotarix on 18Nov2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 7-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number FJ442, expiry date 26-APR-2023) for prophylaxis.   Previously administered products included Rotarix (received 1st dose on 20th June 2023). Concomitant products included Rotavirus vaccine live oral 1v (Rotarix).   On 18-NOV-2023, the patient received the 3rd dose of Rotarix lyophilized formulation. On 18-NOV-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: 7 month old patient was inadvertently administered a third dose of Rotarix on 18Nov2023). The outcome of the extra dose 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-NOV-2023 The vaccine administration facility was the same as primary reporter The nurse reported 7 month old patient was inadvertently administered a third dose of Rotarix, which led to extra vaccine used. The reporter consented to follow up.
Age: 53.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient received only the liquid portion of Menveo; patient received only the liquid portion of Menveo; 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 53-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA984A, expiry date 30-SEP-2024) for prophylaxis.   On 30-NOV-2023, the patient received Menveo. On 30-NOV-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient received only the liquid portion of Menveo) and inappropriate dose of vaccine administered (Verbatim: patient received only the liquid portion of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 30-Nov-2023 The certified medical assistant reported the patient received only the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient traveling internationally. All adverse event information reported contained within this report.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave consent for safety team follow up.
Sex: U
Vaccine: COVID19
Symptoms: Affect lability, Suspected COVID-19
Clinical narrative: BECAME EXTREMELY EMOTIONAL CRYING AT EVERY SIMPLE VIDEO; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: xarelto allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: nirmatrelvir/ritonavir (form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from 02-NOV-2023 to 07-NOV-2023 for covid-19 treatment. Concomitant medications included apixaban. On 2023, the patient experienced suspected covid-19 infection. On 04-NOV-2023, the patient experienced became extremely emotional crying at every simple video. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient recovered from became extremely emotional crying at every simple video on 06-NOV-2023, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Took the Moderna vaccine and had a severe reaction; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of IMMUNISATION REACTION (Took the Moderna vaccine and had a severe reaction) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Took the Moderna vaccine and had a severe reaction). At the time of the report, IMMUNISATION REACTION (Took the Moderna vaccine and had a severe reaction) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medications were provided.  The patient went to to get the Pfizer COVID vaccine, and unfortunately, just had Moderna. The patient took the Moderna vaccine and had a severe reaction.   No treatment medications were provided.   Reporter did not allow further contact