chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Incorrect route of product administration
Clinical narrative: received Engerix intravenously during a dialysis; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B (intravenous inf). On an unknown date, unknown after receiving Engerix B, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.    Additional Information: GSK receipt date: 02-Sep-2022 Reporter's comment: A pharmacist reported on behalf of the physician that a patient received Engerix intravenously during a dialysis infusion. No symptoms reported. The reporter did not have any patient or vaccination details. Reporter did not consent but neither declined consent; only replied by saying she did not have any further information. Additional supportive information: Patient received Engerix B intravenously rather than intramuscularly as per vaccine schedule, which led to intramuscular formulation administered by other route.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Muscular weakness, Nausea, Ocular hyperaemia, Pain in extremity
Clinical narrative: fever of 101 F; blood vessels in her eyes were expanded and red; sore arm; muscle weakness of whole body; headache, stabbing head pain; nausea; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th May 2022).   On 30th August 2022, the patient received the 2nd dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced pain in arm, generalized muscle weakness, headache and nausea. In September 2022, the patient experienced fever and eye red. On an unknown date, the outcome of the pain in arm, generalized muscle weakness, headache, nausea, fever and eye red were unknown.   It was unknown if the reporter considered the pain in arm, generalized muscle weakness, headache, nausea, fever and eye red to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-SEP-2022  Reporter's Comment: The case was self reported by the patient. The patient received second dose of Shingrix and experienced sore arm, muscle weakness of whole body, a headache and nausea. Additionally patient had a fever of 101 Fahrenheit last night (the day before reporting), stabbing head pain, and noticed that the blood vessels in her eyes were expanded and red. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever of 101 F; blood vessels in her eyes were expanded and red; sore arm; muscle weakness of whole body; headache, stabbing head pain; nausea; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th May 2022).   On 30th August 2022, the patient received the 2nd dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced pain in arm, generalized muscle weakness, headache and nausea. In September 2022, the patient experienced fever and eye red. On an unknown date, the outcome of the pain in arm, generalized muscle weakness, headache, nausea, fever and eye red were unknown.   It was unknown if the reporter considered the pain in arm, generalized muscle weakness, headache, nausea, fever and eye red to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-SEP-2022  Reporter's Comment: The case was self reported by the patient. The patient received second dose of Shingrix and experienced sore arm, muscle weakness of whole body, a headache and nausea. Additionally patient had a fever of 101 Fahrenheit last night (the day before reporting), stabbing head pain, and noticed that the blood vessels in her eyes were expanded and red. The reporter consented to follow up.
Age: 0.33
Sex: U
Vaccine: RV1
Symptoms: Incorrect dose administered, Incorrect route of product administration, Product preparation error
Clinical narrative: Rotarix administered iM; reconstituted Rotarixwith normal saline; Rotarix administered iM; This case was reported by a physician via call center representative and described the occurrence of inappropriate route of vaccination in a 4-month-old patient who received Rota (Rotarix lyophilized formulation) (batch number 322CM, expiry date 15th February 2024) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 2nd September 2022, the patient received Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 2nd September 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate route of vaccination, wrong solution used in drug reconstitution and inappropriate dose 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: 02-SEP-2022 Reporter's comment: Medical Doctor reported they inadvertently reconstituted Rotarix lyophilized component with normal saline then administered intramuscularly to a patient. The reporter did not provide any additional details. Medical Doctor called to inquire what to do. The reporter did not consent to follow-up. Additional Supportive Information: The patient received dose of Rotarix lyophilized intramuscularly which was inadvertently reconstituted with normal saline, which led to inappropriate route of vaccination, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: F
Vaccine: FLU4
Symptoms: Visual impairment
Clinical narrative: Vision problems; This case was reported by a consumer via call center representative and described the occurrence of abnormal vision in a female patient who received Flu Seasonal QIV  (FluLaval Quadrivalent 2017-2018 season) (batch number GM2TF, expiry date unknown) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent 2017-2018 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2017-2018 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced abnormal vision. On an unknown date, the outcome of the abnormal vision was unknown.   It was unknown if the reporter considered the abnormal vision to be related to FluLaval Quadrivalent 2017-2018 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 2-Sep-2022 Reporter's Comment: Reporter stated that patient after receiving Flulaval QIV in 2017, had experienced vision problems, after receiving the vaccine. The caller declined to provide any information, aside from their first name and phone number.  All information provided had been reported. There was no further information or demographics available. The reporter did not consent to follow up.; Sender's Comments: Caller is the patient. Caller reported receiving Flulaval QIV in 2017. Caller reported they have experienced vision problems, after receiving the vaccine. Did not consent to follow-up. Call Notes:Caller declined to provide any information, aside from their first name and phone number. ALL INFORMATION PROVIDED HAS BEEN REPORTED. THERE IS NO FURTHER INFORMATION/DEMOGRAPHICS AVAILABLE.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 11/2021. Second dose not yet administered.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on November 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-SEP-2022 Reporter's Comment:  The reporter stated that the patient did not received second dose of Shingrix vaccine yet. The reporter consented to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Expired kinrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th August 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 30th August 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 2-Sept-2022 Reporter's comment: The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up. Additional supportive information: The patient receive an expired dose of Kinrix, which led to expired vaccine used.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear haemorrhage, Ear infection, Hypoacusis, Noninfective gingivitis, Pain in jaw
Clinical narrative: possible ear infection; 50% hearing loss; Ruptured left eardrum; bleeding from ear; sores near left side of mouth; Left jaw pain; inflamed gums; Slight fever; This case was reported by a consumer via call center representative and described the occurrence of ear infection in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd August 2022, the patient received the 1st dose of Shingrix. On 24th August 2022, 2 days after receiving Shingrix, the patient experienced fever. On 27th August 2022, the patient experienced ear infection, partial hearing loss, perforated eardrum, ear hemorrhage, skin ulcer, jaw pain and gingival inflammation. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)) and antiinfectives, otological (nos) (Antibiotic Ear Drops (Nos)). On an unknown date, the outcome of the ear infection, partial hearing loss, perforated eardrum, skin ulcer, jaw pain and gingival inflammation were not recovered/not resolved and the outcome of the ear hemorrhage was unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the ear infection, partial hearing loss, perforated eardrum, ear hemorrhage, fever, skin ulcer, jaw pain and gingival inflammation to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's Comment: The reporter was the patient. The reporter stated that after received Shingrix vaccine the patient experienced a slight fever, 5 days after received Shingrix vaccine the patient had sores near the left side of mouth, left jaw pain, inflamed gums, ruptured left eardrum with bleeding from ear and 50 present hearing loss. The patient visited primary care physician and was given an unknown antiviral pill for 10 days.  Patient visited an ear, nose and throat (ENT) healthcare professional (HCP) and was told patient had a possible ear infection and was given an antibiotic ear drop.  Patient had a follow up appointment with the ear, nose and throat (ENT) today (on the reporting day).  Reporter had nothing else to report. The reporter declined consent to follow up with healthcare professional. The reporter consented to follow up only with her.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin lesion, Skin ulcer, Tympanic membrane perforation
Clinical narrative: possible ear infection; 50% hearing loss; Ruptured left eardrum; bleeding from ear; sores near left side of mouth; Left jaw pain; inflamed gums; Slight fever; This case was reported by a consumer via call center representative and described the occurrence of ear infection in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd August 2022, the patient received the 1st dose of Shingrix. On 24th August 2022, 2 days after receiving Shingrix, the patient experienced fever. On 27th August 2022, the patient experienced ear infection, partial hearing loss, perforated eardrum, ear hemorrhage, skin ulcer, jaw pain and gingival inflammation. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)) and antiinfectives, otological (nos) (Antibiotic Ear Drops (Nos)). On an unknown date, the outcome of the ear infection, partial hearing loss, perforated eardrum, skin ulcer, jaw pain and gingival inflammation were not recovered/not resolved and the outcome of the ear hemorrhage was unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the ear infection, partial hearing loss, perforated eardrum, ear hemorrhage, fever, skin ulcer, jaw pain and gingival inflammation to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's Comment: The reporter was the patient. The reporter stated that after received Shingrix vaccine the patient experienced a slight fever, 5 days after received Shingrix vaccine the patient had sores near the left side of mouth, left jaw pain, inflamed gums, ruptured left eardrum with bleeding from ear and 50 present hearing loss. The patient visited primary care physician and was given an unknown antiviral pill for 10 days.  Patient visited an ear, nose and throat (ENT) healthcare professional (HCP) and was told patient had a possible ear infection and was given an antibiotic ear drop.  Patient had a follow up appointment with the ear, nose and throat (ENT) today (on the reporting day).  Reporter had nothing else to report. The reporter declined consent to follow up with healthcare professional. The reporter consented to follow up only with her.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: product was stored outside extended stability data and then administered.; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   The reporter considered the incorrect storage of drug to be related to Havrix.     Additional Information: GSK receipt date: 06-September-2022: Reporters comment:  The reporter reported that patient was inadvertently administered Havrix following a temperature excursion. Nurse stated this was already reported by another HCP and does not have any details regarding this. The reporter reported would send other HCP contact information in follow up email. Nurse only wanted information on when to revaccinate. Confirmed with registered nurse that product was stored outside extended stability data and then administered. The reporter also mentioned Havrix was outside of recommended range for 3 months and administered to patient. No further details provided. Additional Supportive information: The product was stored outside extended stability data and then administered to patient, which led to incorrect storage of drug.
Age: 0.75
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: expired Menveo administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 9-month-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA585A, expiry date 30th August 2022) for prophylaxis.   On 2nd September 2022, the patient received Menveo. On 2nd September 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's comment: The nurse administered to the patient an expired dose of Menveo by error. The reporter consented to follow-up via postal. Additional Supportive Information:  The patient received a dose of Menveo which was already expired, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Neck pain
Clinical narrative: neck pain; some sleeplessness; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced neck pain and sleeplessness. On an unknown date, the outcome of the neck pain and sleeplessness were unknown.   It was unknown if the reporter considered the neck pain and sleeplessness to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's Comment: The case was reported by the patient. The patient stated that, he received his first dose of Shingrix in March or possibly April of 2022.  The reporter stated that, he experienced neck pain later that day and also some sleeplessness.  Less than 6 months, after receiving Shingrix, the patient experienced sleeplessness. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Chicken pox; This case was reported by a pharmacist via call center representative and described the occurrence of chickenpox in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chickenpox. On an unknown date, the outcome of the chickenpox was unknown.   It was unknown if the reporter considered the chickenpox to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's comment: Pharmacist reported that the patient developed chicken pox after receiving the Shingrix vaccination. The reporter consented to follow-up.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Mild shingles outbreak; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2022, the patient received the 1st dose of Shingrix. In June 2022, 1 week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's Comment: One week later of vaccination, the patient developed a mild shingles outbreak. She had nothing else to report.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 18 year old was given a full dose ( 1 mL); the 18 year old  patient was given a full dose ( 1 mL) of ENGERIX; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 18-year-old female patient who received HBV (Engerix B) (batch number 337TC, expiry date 29th March 2024) for prophylaxis.   On 31st August 2022, the patient received Engerix B (intramuscular) 1 ml. On 31st August 2022, unknown after receiving Engerix B, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 6-SEP-2022 Reporter's Comments: The pharmacist reporting an adverse event .  The reporter stated that states the 18 year old  patient was given a full dose ( 1 mL) of ENGERIX in Left deltoid on 31-August 2022. The patient was not sure what number dose it was.  The reporter did not give consent to follow-up. Additional Supportive Information: The patient received full dose 1ml which lead to overdose.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: sore arm; chills; fever; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included motion sickness. Concomitant products included paracetamol (Tylenol).   In January 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced pain in arm, chills and fever. On an unknown date, the outcome of the pain in arm, chills and fever were recovered/resolved.   It was unknown if the reporter considered the pain in arm, chills and fever to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR130000   Additional Information: GSK Receipt Date: 6-SEP-2022 Reporter's Comments: The patient self-reported this case.  The reporter stated taking Tylenol and an unspecified OTC (over the counter) motion sickness medication. The patient received her 1st dose of Shingrix and experienced a sore arm, chills, and fever which resolved in a few days.  The reporter did not give consent to follow-up. Additional Supportive Information: For tolerance of 2nd dose refer case US2022AMR130000, reported by same reporter; Sender's Comments:  US-GSK-US2022AMR130000:Same patient
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administrated with an expired dose of Kinirx on September 26 2022. The vaccine expired on August 26 2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-IPV (Kinrix) (batch number yz97n, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th September 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 6th September 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 06-SEP-2022 Reporters comment:  The medical assistant reported that the patient was administrated with an expired dose of Kinirx on 26th September 2022. The vaccine expired on 26th August 2022. No adverse event was reported  The reporter consent to follow-up. No patient's identifiers were provided Additional Supportive information: The patient was administrated with an expired dose of Kinirx on 26th September 2022 which was already expired in 26th August 2022.  which led to Expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Chills, Gait disturbance, Impaired work ability, Malaise
Clinical narrative: not able to go to work; I can't feel better; bones hurt everyday, Doesn't go away; Fever; Chills; Feet pain; Muscle pain; Difficulty walking; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In August 2022, the patient received Shingles vaccine. In August 2022, less than a day after receiving Shingles vaccine, the patient experienced feeling unwell, bone pain, fever, chills, foot pain, muscle pain and walking difficulty. On an unknown date, the patient experienced inability to work. On an unknown date, the outcome of the feeling unwell, fever, chills, foot pain, muscle pain, walking difficulty and inability to work were unknown and the outcome of the bone pain was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, bone pain, fever, chills, foot pain, muscle pain, walking difficulty and inability to work to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 06-SEP-2022 and 12-SEP-2022 Reporter's Comment: The patient self-reported this case. The patient got Shingles vaccine one week ago from reporting date and could not felt better. Patient bone hurts every day. The patient stated she was doing just fine after being given the vaccine, but later at night the events started. Patient reported experiencing fever, chills, feet pain, muscle pain. Also, patient stated that got very sick and the bone pain did not go away. Patient reported experienced with Shingles vaccine because patient was healthy person and bones had never hurt before. The patient's doctor was not there at that time, so patient was treated by a nurse. Patient stated less than 2 weeks after vaccination, she had been not able to go to work. Patient had difficulty walking due to the feet pain. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: not able to go to work; I can't feel better; bones hurt everyday, Doesn't go away; Fever; Chills; Feet pain; Muscle pain; Difficulty walking; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In August 2022, the patient received Shingles vaccine. In August 2022, less than a day after receiving Shingles vaccine, the patient experienced feeling unwell, bone pain, fever, chills, foot pain, muscle pain and walking difficulty. On an unknown date, the patient experienced inability to work. On an unknown date, the outcome of the feeling unwell, fever, chills, foot pain, muscle pain, walking difficulty and inability to work were unknown and the outcome of the bone pain was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, bone pain, fever, chills, foot pain, muscle pain, walking difficulty and inability to work to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 06-SEP-2022 and 12-SEP-2022 Reporter's Comment: The patient self-reported this case. The patient got Shingles vaccine one week ago from reporting date and could not felt better. Patient bone hurts every day. The patient stated she was doing just fine after being given the vaccine, but later at night the events started. Patient reported experiencing fever, chills, feet pain, muscle pain. Also, patient stated that got very sick and the bone pain did not go away. Patient reported experienced with Shingles vaccine because patient was healthy person and bones had never hurt before. The patient's doctor was not there at that time, so patient was treated by a nurse. Patient stated less than 2 weeks after vaccination, she had been not able to go to work. Patient had difficulty walking due to the feet pain. The reporter consented to follow up.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Expired Pediarix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 4977T, expiry date 5th September 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th September 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 6th September 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 6-SEP-2022 Reporter's Comments: The reporter stated that that an expired dose of Pediarix was administered to a patient on the reporting day. The reporter consented to follow up. Additional Supportive Information:  The patient received expired dose of Pediarix which leads to expire vaccine used. This case has been linked to the US2022128919 case reported by the same reporter.; Sender's Comments:  US-GSK-US2022128919:Same reporter
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Engerix B adult administered to 11y/o patient; Engerix B adult instead of pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 11-year-old male patient who received HBV (Engerix B adult) (batch number F73DG, expiry date 3rd July 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th August 2022, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 18th August 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child 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: 6-Sept-2022 Reporter's comment: The medical assistant reported that the patient received a dose of Engerix-B adult instead of pediatric dose. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: The patient received  a dose of Engerix-B adult instead of pediatric dose, which led to overdose and adult product administered to child.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2 years ago, never got 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patient states that he received his first dose of Shingrix 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's Comment:  The patient stated that he received his first dose of SHINGRIX 2 years ago, and never got his second dose. The reporter give consent to follow up. Additional Supportive Information: The patient never got his second dose which lead to incomplete course of vaccination
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered only the liquid portion; Administered only the liquid portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA712A, expiry date 31st May 2023) for prophylaxis.   On 6th September 2022, the patient received Menveo. On 6th September 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date:06-Sep-2022 Reporters comment:  The Medical assistant administered only the liquid portion of Menveo. The reporter (HCP)gives permission for safety team follow up Additional Supportive information:The Medical assistant administered only the liquid portion of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose on Aug/2021, 2nd dose not administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose in August 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's Comment: The reporter request information if the series should be restarted in case the 2nd dose was not administered yet. The reporter asked if the patient repeat both dose or only get 2nd dose. Since there was not contact with healthcare professional directly, request of follow up was not gathered. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on May-2019, 2nd dose not administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in May 2019 with expiration date 31st May 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's comment: The reporter asked if patient could receive second dose or needs to start over vaccination. Pharmacist did not provide lot number of vaccine as well as exact date of administration of the first dose of Shingrix. Details were reported for 1st dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 8 months ago, 2nd dose not administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 8 months ago from reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's comment: The pharmacist reported that the patient had not received the second dose of Shingrix yet. The reporter did not answer if follow up was okay, she only knew the patient gender, no other details at time of reporting. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to a 3 years and 3 months patient; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number H9FN5, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 07-SEP-2022 Reporter's Comments: The nurse reported that a 3 years and 3 months old patient received a Kinrix dose. The reporter consent to follow up. Additional Supportive Information: The 3 years and 3 months old patient received a Kinrix dose, which led to inappropriate age at vaccine administration
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to a 1 year and 8 months old patient; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 19th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 07-SEP-2022 Reporter's Comments: The health care professional reported that a 1 years and 8 months old patient received a Kinrix dose. The reporter consent to follow up. Additional Supportive Information: The 1 years and 8 months old patient received a Kinrix dose, which led to inappropriate age at vaccine administration.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling at the injection site, in the arm; Redness at the injection site, in the arm; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 31st August 2022, 1 days after receiving Shingrix, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's comment: The patient self-reported this case. The patient received dose of Shingrix vaccine in the left arm and next day after the vaccination she had swelling and redness at the injection site. The patient also reported that the redness and swelling lasted for about 4 days and then started to went away. The patient reported that today(on the day of reporting), the redness and swelling had returned in the arm where she got her Shingrix vaccine. No HCP(Health Care Professional) for follow up. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Did not receive 2nd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 2nd September 2020, batch number zx27e, expiry date 16th September 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's Comments:  The pharmacist reported that the patient was late for the second dose of Shingrix.  No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of vaccine after 1st dose, which led to incomplete course of vaccination.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 20 mcg administered to 19 YO; Engerix-B adult administered to 19 YO; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B adult) (batch number f73dg, expiry date 3rd July 2023) for prophylaxis.   On 6th August 2022, the patient received the 1st dose of Engerix B adult 20 µg. On 6th August 2022, unknown after receiving Engerix B adult, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's Comment: The reporter reported a 19 year old was administered 20 mcg of Engerix-B.  The reporter consented to follow up via phone. Additional Supportive Information: The reporter reported a 19 year old was administered 20 mcg of Engerix-B, which led to overdose and inappropriate age at vaccine administration.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Engerix-B adult administered to a 13 YO; Engerix-B adult administered to a 13 YO; This case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 13-year-old female patient who received HBV (Engerix B adult) (batch number M4KE9, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd August 2022, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 2nd August 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose 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: 07-SEP-2022 Reporter's Comment: The reporter reported that an adult dose of Engerix-B was administered to a 13 years old patient. The reporter stated that the patient received pediatric dose as a 2nd dose on 2nd September 2022 The reporter did consent to follow up via mail. Additional supportive information: The adolescent received adult dose of Engerix-B, which led to adult product administered to child and overdose.
Sex: F
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose on 15-Jun-2022 and a third dose on 25-Aug-2022.; first dose on 23-Mar-2022, second dose on 15-Jun-2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received HBV (Engerix B) (batch number 98X5P, expiry date unknown) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number 98X5P, expiry date unknown) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 25th August 2022, the patient received the 3rd dose of Engerix B. On 15th June 2022, the patient received the 2nd dose of Engerix B. On 15th June 2022, not applicable after receiving Engerix B and unknown after receiving Engerix B, the patient experienced drug dose administration interval too long. On 25th August 2022, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too long and drug dose administration interval too short were unknown.       Additional Information: GSK receipt date: 07-SEP--2022 Reporters comment:  The reporter reported that the adult patients received the Engerix-B vaccination series, first dose on 23rd March 2022. As per the reporter, all doses were from lot 98X5P. The reporter consent to follow-up. As no other patient identifiers were reported, as per the reporter, patients received the same product on the same dates, same lot number Additional Supportive information: On 25th August 2022, the patient received the 3rd dose of Engerix B, which led to shortening of vaccinations schedule. 15th June 2022, the patient received the 2nd dose of Engerix B which led to lengthening of vaccination schedule.  This case has been linked to the US2022129657 case reported by the same reporter.; Sender's Comments:  US-GSK-US2022129657:Same reporter