chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient has had no reported side effects; expired dose of PROQUAD was accidently administered to a patient; This spontaneous report was received from a physician and refers to a 4-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, concomitant medications and medical history was provided.  On 23-MAR-2022, the patient was vaccinated with an expired Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rHa (recombinant Human albumin) (PROQUAD) lot number T030481, expiration date 07-MAR-2022 0.5mL, one dose subcutaneously (SQ) (strength and anatomical location were not reported) for prophylaxis (expired product administered). The vaccine was used with sterile diluent, lot U015345 established to be valid, expiration date 04-OCT-2023. No temperature excursions was reported for the vaccine and sterile diluent. The patient had no reported side effects (no adverse event).
Age: 5.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs were reported; A physician called to report that a 5 year old patient received a dose of GARDASL 9 today.; This spontaneous report was received from a physician, concerning a 5-years-old female patient. The patient's medical history, concurrent conditions, concomitant medications, and drug allergies or reactions were not reported.   On 28-MAR-2022 (reported as "today"), the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (vaccination scheme, route of administration, anatomical location, strength, lot number, and expiration date were not reported) (product administered to patient of inappropriate age). No additional AEs were reported.   The outcome of the event was unknown.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; A medical assistant reported an expired ROTATEQ was administered to a patient. The vaccine had no temperature excursions. No additional AE reported. No PQC.; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender. Information regarding the patient's concurrent conditions or concomitant medications was not provided.  On 28-MAR-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliters, for prophylaxis (route of administration, vaccination scheme frequency were not provided; valid lot #1741375 with an expiration date: 05-MAR-2022) (expired product administered). No adverse event was reported. The vaccine did not have previous temperature excursions and no additional product quality complaint (PQC) was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury
Clinical narrative: shingles; nerve damage; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 31-MAR-2022. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around May 2014, the patient was administered with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered shingles and nerve damage. As a direct and proximate result of using Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior using Zoster Vaccine Live (ZOSTAVAX). Also, experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions. As a result of the manufacture, marketing, advertising, promotion, distribution and or sale of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of the events was considered as not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No further AE' reported; Nurse reporting administration of an expired dose of ROTATEQ. Dose was administered today (01Apr2022) and expired on 29Mar2022.; HCP reports this lot # of ROTATEQ has undergone a temperature excursion.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 01-APR-2022, the patient was administered an expired and improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml one time, lot #1707496, expiration date: 29-MAR-2022 (dose number and route of administration were not provided) administered for prophylaxis  (expired product administered, product storage error). Administered dose of vaccine experienced the temperature excursion of 57.0 degrees Fahrenheit for 3 hours. No further adverse events (AE's) were reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE details; a 35 year old was 2 months late on their 3rd dose of GARDASIL 9; This spontaneous report was received from a physician referring to a 35-year-old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, and drug reactions/allergies were not reported.  On unknown dates, the patient was vaccinated with first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, schedule, route of administration, lot/batch # and expiration date were not provided) as prophylaxis.  On 04-FEB-2022, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter (route of administration, lot/batch # and expiration date were not provided). The reporter stated that patient was 2 months late for this dose. No adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additonal AE reported; administration of an expired GARDASIL 9 [Lot: S023476, Exp: 3/26/2022] to a patient on 04APRIL2022; This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, and drug reactions/allergies were not reported.  On 04-APR-2022, the patient was administered an expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose and anatomical location were not reported; lot # S023476 has been validated to be a valid lot # for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), expiration date 26-MAR-2022) as prophylaxis.   The reporter confirmed that vaccine was not involved in any temperature excursions and was stored within the recommended storage range until administration. The reporter was provided with supported disclaimer from post expiry memo. No adverse events were reported
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; Patient received improperly stored vaccines; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-MAR-2022, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (lot #U026217, expiration date: 02-NOV-2023) administered for prophylaxis (strength, and route of administration were not provided).  The administered doses experienced a temperature excursion of 34.3 Fahrenheit (°F) during a time frame of 55 minutes. No previous temperature excursions were reported.   No additional adverse events were reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: No additional AEs were reported; Patient received improperly stored vaccines; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported.  On 03-MAR-2022, the patient was vaccinated with an improperly  stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, (lot # U026664, expiration date: 24-FEB-2023 and/or lot# 1741817 with expiration date: 30-JUL-2022) administered for prophylaxis by oral route (strength, and route of administration were not provided) as well as the patient received another improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (lot #U026217, expiration date: 02-NOV-2023) administered for prophylaxis (strength, and route of administration were not provided).  The administered doses experienced a temperature excursion of 34.3 Fahrenheit (°F) during a time frame of 55 minutes. No previous temperature excursions were reported.   No additional adverse events were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No other adverse events reported; an expired dose of VAQTA was administered to a patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 31-MAR-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA)1 dosage form, lot #T040581, expiration date: 28-MAR-2022, administered intramuscularly for prophylaxis (strength was not provided). No additional events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Swelling; redness; This case was reported by a nurse via sales rep and described the occurrence of swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling and erythema. On an unknown date, the outcome of the swelling and erythema were recovered/resolved.   It was unknown if the reporter considered the swelling and erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-MAR-2022 Reporter's Comments: The nurse mentioned that when she received the vaccine she had swelling and redness for almost 3 weeks. The reporter did not consent to follow-up. Additional Supportive Information: This case was linked with case US2021AMR070799, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR070799:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache
Clinical narrative: chills; headache; very tired and worn out; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, headache and tiredness. On an unknown date, the outcome of the chills, headache and tiredness were unknown.   It was unknown if the reporter considered the chills, headache and tiredness to be related to Shingrix.     Additional Information: GSK receipt date: 03-Apr-2022 Reporter's comment: The case was received from consumer via interactive digital media. The patient asked that how long after getting a dose of Shingrix could felt chills, headaches and very tired and worn out. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Body aches, worse than the first; Fatigue; Headache; Very sore arm; This case was reported by a nurse via sales rep and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date, refer case US2022AMR060171).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced general body pain, fatigue, headache and pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the general body pain, fatigue, headache and pain in arm were unknown.   It was unknown if the reporter considered the general body pain, fatigue, headache and pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR060171   Additional Information: GSK Receipt Date: 4-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received dose Shingrix vaccine and experienced body aches, fatigue, headache, and a very sore arm. The patient thought this was the normal reaction though. The pharmacist warned her it would be worse than the first. The patient also stated that the second shot was wicked. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR060171:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Body aches, worse than the first; Fatigue; Headache; Very sore arm; This case was reported by a nurse via sales rep and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced general body pain, fatigue, headache and pain in arm. On an unknown date, the outcome of the general body pain, fatigue, headache and pain in arm were unknown.   It was unknown if the reporter considered the general body pain, fatigue, headache and pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR060165   Additional Information: GSK Receipt Date: 4-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received dose Shingrix vaccine and experienced body aches, fatigue, headache, and a very sore arm. The patient thought this was the normal reaction though. The pharmacist warned her that the second shot would be worse than the first. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR060165:Same reporter.
Age: 37.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: expiration date 02/28/2022, administered 04/04/2022; This case was reported by a pharmacist via sales rep and described the occurrence of expired vaccine used in a 37-year-old male patient who received HAB (Twinrix) (batch number GG3S5, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th April 2022 17:00, the patient received the 1st dose of Twinrix (intramuscular) 1 ml. On 4th April 2022, the patient started Twinrix Pre-Filled Syringe Device. On 4th April 2022 17:00, unknown after receiving Twinrix and Twinrix 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: 04-APR-2022 Reporter's comment: The pharmacist reported that, Twinrix was given to a patient after the expiry date of 28th February 2022.  The reporter consented to follow up. Additional Supportive Information: The use of Twinrix dose which was already expired on 28th February 2022, led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: sore arm; flu like symptoms; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 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 pain in arm and influenza-like symptoms. On an unknown date, the outcome of the pain in arm and influenza-like symptoms were unknown.   It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to Shingrix.     Additional Information: GSK Receipt Date: 5-APR-2022 Reporter's Comment: The reporter did not consent to follow-up.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Menveo was given to patient on 4/5/22 , expired 3/31/22; This case was reported by a nurse and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA468A, expiry date 31st March 2022) for prophylaxis.   On 5th April 2022, the patient received Menveo. On 5th April 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: 04-APR-2022 Reporter's comment: The NDC number was provided 58160-955-09. The nurse reported that, Menveo was given to a patient after the expiry date of 31st March 2022. The reporter wanted to have recommendation of the expired dose of Menveo given to the patient. Additional Supportive Information: The nurse reported use of Menveo dose to a patient and the vaccine was already expired on 31st March 2022, which led to expired vaccine used.
Age: 62.0
Sex: M
Vaccine: HEPAB
Symptoms: Blood bilirubin increased, Chills, Chromaturia, Diarrhoea, Liver function test normal
Clinical narrative: bilirubin was increased; Chills; Fever; Diarrhea; Dark Urine; itchiness all over; feeling "unwell" or malaise; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 62-year-old male patient who received HAB (Twinrix adult) (batch number X-239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th March 2022, the patient received the 3rd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 25th March 2022, 1 days after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced malaise. On 27th March 2022, the patient experienced chills, fever, diarrhea, dark urine and generalized pruritus. On 31st March 2022, the patient experienced bilirubin increased. On 27th March 2022, the outcome of the malaise was recovered/resolved. On an unknown date, the outcome of the chills, fever, diarrhea and generalized pruritus were recovered/resolved and the outcome of the dark urine and bilirubin increased were not recovered/not resolved.   It was unknown if the reporter considered the malaise, chills, fever, diarrhea, dark urine, generalized pruritus and bilirubin increased to be related to Twinrix adult and Twinrix 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: Additional Information: GSK Receipt Date: 01-APR-2022 Reporter's Comments:  The patient reported case for himself. On Friday 25th March 2022 patient began feeling unwell or malaise which was lasted until Sunday 27th March 2022. On 27th March 2022 , 3 days after receiving Twinrix adult patient experienced chills, fever, diarrhea and generalized pruritus, dark urine. On 31st March 2022, 7 days after receiving Twinrix adult patient experienced bilirubin increased.    The patient began feeling other symptoms that same day including chills, fever, diarrhea, dark urine and itchiness all over. On 31st March 2022 the reporter was sent to the emergency room by his HCP (health care professional) to check his liver function and he states all his labs were normal except his bilirubin was increased compared to his last bloodwork. The patient was sent home without admission. The only symptom persisting was the dark urine which was not gone away. The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: HEPAB
Symptoms: Malaise, Pruritus, Pyrexia
Clinical narrative: bilirubin was increased; Chills; Fever; Diarrhea; Dark Urine; itchiness all over; feeling "unwell" or malaise; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 62-year-old male patient who received HAB (Twinrix adult) (batch number X-239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th March 2022, the patient received the 3rd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 25th March 2022, 1 days after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced malaise. On 27th March 2022, the patient experienced chills, fever, diarrhea, dark urine and generalized pruritus. On 31st March 2022, the patient experienced bilirubin increased. On 27th March 2022, the outcome of the malaise was recovered/resolved. On an unknown date, the outcome of the chills, fever, diarrhea and generalized pruritus were recovered/resolved and the outcome of the dark urine and bilirubin increased were not recovered/not resolved.   It was unknown if the reporter considered the malaise, chills, fever, diarrhea, dark urine, generalized pruritus and bilirubin increased to be related to Twinrix adult and Twinrix 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: Additional Information: GSK Receipt Date: 01-APR-2022 Reporter's Comments:  The patient reported case for himself. On Friday 25th March 2022 patient began feeling unwell or malaise which was lasted until Sunday 27th March 2022. On 27th March 2022 , 3 days after receiving Twinrix adult patient experienced chills, fever, diarrhea and generalized pruritus, dark urine. On 31st March 2022, 7 days after receiving Twinrix adult patient experienced bilirubin increased.    The patient began feeling other symptoms that same day including chills, fever, diarrhea, dark urine and itchiness all over. On 31st March 2022 the reporter was sent to the emergency room by his HCP (health care professional) to check his liver function and he states all his labs were normal except his bilirubin was increased compared to his last bloodwork. The patient was sent home without admission. The only symptom persisting was the dark urine which was not gone away. The reporter consented to follow up.
Age: 1.33
Sex: U
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Kinrix was administered to a 16 month old; Kinrix was administered as first dose of DTaP and IPV.; 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 16-month-old patient who received DTPa-IPV (Kinrix) (batch number PX27D, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th March 2022, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 9th March 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-Apr-2022 Reporter's comment: The medical assistant reported that a patient received first dose of Kinrix. It was the patient's first dose of DTaP and IPV. The reporter did not consent to follow up and declined providing additional information. The expiration date was from agency. Additional Supportive Information: The 16 month old patient received Kinrix and that was patient's first dose of DTaP and IPV, which led to Inappropriate age at vaccine administration and Inappropriate schedule of vaccine administered.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Insomnia, Pain in extremity, Paraesthesia
Clinical narrative: Redness at injection site; Swelling at injection site; Prevented sleeping at night; Tingling in left hand; Excruciating pain throughout left arm; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th March 2022, the patient received the 1st dose of Shingrix. In March 2022, less than a week after receiving Shingrix, the patient experienced pain in arm, difficulty sleeping and tingling of extremity. On an unknown date, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site swelling and pain in arm were recovered/resolved and the outcome of the difficulty sleeping was unknown and the outcome of the tingling of extremity was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, pain in arm, difficulty sleeping and tingling of extremity to be related to Shingrix.     Additional Information: GSK receipt date: 01-Apr-2022 Reporter's comment: The case was reported by physician for herself. The patient received a dose of Shingrix in left arm and experienced redness and swelling at the injection site, that had since resolved. The patient not keeping track of the redness and swelling, as they were expected side effects.  The patient experiencing excruciating pain throughout the entire left arm within a couple of days of receiving the dose and the pain in the left arm prevented them sleeping at night. This pain in left arm lasted approximately 1 week.  The patient reported experiencing tingling in the left hand approximately 6 or 7 days after the resolution of the excruciating pain in the left arm and approximately 2 weeks after receiving the dose.  The patient reported tingling in left hand was ongoing.  The patient reported wearing a brace at night in an attempt to resolve the tingling, to no avail. Did not consent to follow-up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Lethargy, Pain, Poor quality sleep, Somnolence
Clinical narrative: Insomnia, not sleeping well; Lethargy; Soreness; Feels groggy; This case was reported by a consumer via call center representative and described the occurrence of insomnia in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2022, the patient received the 1st dose of Shingrix (intramuscular). On 1st April 2022, less than a day after receiving Shingrix, the patient experienced insomnia, lethargy and pain. In April 2022, the patient experienced groggy. On 2nd April 2022, the outcome of the pain was recovered/resolved. On an unknown date, the outcome of the insomnia, lethargy and groggy were not recovered/not resolved.   It was unknown if the reporter considered the insomnia, lethargy, pain and groggy to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-APR-2022 Reporter's comment: The case was self-reported by the patient. The patient received first dose of Shingrix and experienced insomnia, lethargy and soreness. Till the time of reporting, the patient still felt groggy and was not sleeping well. The soreness resolved the next day. The reporter gave consent to contact HCP (health care professional) but could only provide name. Reporter did not have the lot or expiration date of the vaccine. The reporter consented to follow up.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: LOW GRADE FEVER; FATIGUE; HEADACHE; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st April 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 1st April 2022, less than a day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced fatigue and headache. On 2nd April 2022, the patient experienced low grade fever. On an unknown date, the outcome of the low grade fever, fatigue and headache were unknown.   It was unknown if the reporter considered the low grade fever, fatigue and headache to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 04-Apr-2022 Reporter's comment: The case was reported by patient's parent. The patient received a dose of Bexsero and on same day experienced headache and fatigue and 1 day after vaccination on Saturday night (2nd April 2022) had a low grade fever and was unsure if the adverse events were still ongoing.  The reporter inquired if her son could receive the 2nd dose of the vaccine 7 weeks after 1st dose. Consent obtained to contact consumer and health care professional for follow-up but consumer did not want to prove health care professional contact information.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental underdose, Needle issue
Clinical narrative: some of the liquid spilled from the needle,  did not receive the full dose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th April 2022, the patient received the 1st dose of Shingrix. On 4th April 2022, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 04-Apr-2022 Reporter's Comments: The reporter stated that they were administering a first dose of Shingrix to a patient and when he went to administer the reconstituted vaccine, some of the liquid spilled from the needle and was not administered. The reporter was not sure if the syringe was screwed on correctly but he stated this one came ready from the packaging and did not have to change the needle. The reporter believed the patient did not receive the full dose although he does not know how much was administered or left over. Reporter stated there was no accidental exposure as the medication sprayed onto the floor not the patient or himself. The reporter did not consent to follow-up. Additional Supportive Information: The reporter believed the patient did not receive the full dose, which led to accidental underdose.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the 2nd dose with one month respect the 1st dose.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 04-Apr-2022 Reporter's comment: The patient received the 2nd dose of Shingrix with one month of different respect the 1st dose. The reporter did not provide Shingrix lot number or expiration date as it was not legible. The reporter consented to follow-up. Additional Supportive Information: the patient received 2nd dose earlier than recommended interval, which led to shortening of vaccination schedule
Age: 36.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult received the pediatric formulation; adult received the pediatric formulation; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 36-year-old female patient who received HAV (Havrix 720 Junior) for prophylaxis.   On 4th April 2022, the patient received Havrix 720 Junior. On 4th April 2022, unknown after receiving Havrix 720 Junior, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 04-Apr-2022 Reporter's comment: An adult patient received the pediatric formulation of Havrix, which led to underdose and adult use of a child product. The reporter consented to follow-up.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: administered with a third dose; 1st dose of shingrix on Feb 2019, and 2nd dose on August 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 4NX5J, expiry date 9th June 2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in February 2019).   On 4th April 2022, the patient received the 3rd dose of Shingrix. In August 2021, the patient received the 2nd dose of Shingrix. In August 2021, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 4th April 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 04-APR-2022 Reporter's comments: The patient was administered with a third dose of Shingrix on the day of reporting. The reporter explained that, after getting medical history of patient's vaccination, they got that the patient received only one dose. Then, he administered what he believed was the 2nd dose of Shingrix on the day of reporting. During the day, the pharmacist received new information and was that the patient was administered with 1st dose of shingrix on February 2019 and 2nd dose on August 2021. The reporter consented to follow up. Additional Supportive Information: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. On the day of reporting, patient received 3rd dose of Shingrix, which led to extra dose administered.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received an extra dose; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 4th September 2019) and Shingrix (received 2nd dose on 14th November 2019).   On 3rd March 2022, the patient received the 3rd dose of Shingrix. On 3rd March 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 04-APR-2022 Reporter's comments: Nurse reported that the patient received an extra dose of Shingrix. The reporter consented to follow-up. Additional Supportive Information:  The patient received 3rd dose of Shingrix, which led to extra dose administered. This case was linked with case US2022059685, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022059685:same reporter - 2nd patient
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: receiving an extra dose; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12th September 2019) and Shingrix (received 2nd dose on 14th November 2019).   On 3rd March 2022, the patient received the 3rd dose of Shingrix. On 3rd March 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 04-APR-2022 Reporter's comments: Nurse reported that the patient received an extra dose of Shingrix. The reporter consented to follow-up. Additional Supportive Information:  The patient received 3rd dose of Shingrix, which led to extra dose administered. This case was linked with case US2022059684, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022059684:same reporter - 1st patient
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pruritus
Clinical narrative: red itching blisters in body; red itching blisters in body; red itching blisters in body; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number A725Y, expiry date 20th May 2023) for prophylaxis.   On 28th March 2022, the patient received the 2nd dose of Shingrix. On 29th March 2022, 1 days after receiving Shingrix, the patient experienced blister, erythema and pruritus. On an unknown date, the outcome of the blister, erythema and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the blister, erythema and pruritus to be related to Shingrix.     Additional Information: GSK Receipt Date: 4-APR-2022 Reporter's Comment: Registered pharmacist reported that the patient received dose of Shingrix vaccine and one day after the patient noticed red itching blisters in different parts of the body not only near the injection site but in different places. The reporter stated that one day appeared one blister and the other day another 2 blisters and so on.  The patient still had presents some of those red blisters. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022028969:Same reporter
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: This dose makes the 5th dose the patient has received; This dose makes the 5th dose the patient has received, 2 year old; 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 2-year-old male patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10th June 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Infanrix (completed booster dose of series on an unspecified date).   On 31st March 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 31st March 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and drug dose administration interval too short. On an unknown date, the outcome of the inappropriate age at vaccine administration and drug dose administration interval too short 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: 5-APR-2022 Reporter's Comment: Office manager reported that the patient came in to clinic for wellness visit and the medical assistant thought the patient was missing DTaP (Infanrix) booster dose, so it was administered.  Afterward it was discovered that the patient had already received the booster dose. This dose made the 5th dose the patient had received. The HCP (Health Care Professional) gave permission for follow-up. Additional supportive information:  The 2 years old patient received another booster dose i.e. 5th dose of Infanrix but too early, which led to inappropriate age at vaccine administration and drug dose administration interval too short.
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: 3 patients received a dose that was exposed to low temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 4NX5J, expiry date 9th June 2023) for prophylaxis.   On 4th April 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.       Additional Information: GSK Receipt Date: 5th April 2022 Reporter's Comments: The pharmacist reported the patient received a dose of Shingrix that was exposed to low temperature excursion of 31.5 degree F. The reporter did not consent to follow-up. Additional Supportive Information: As the Shingrix was exposed to low temperature excursion, which led to incorrect storage of drug. The case has been linked with the case US2022060314 and US2022060315 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022060314:same reporter US-GLAXOSMITHKLINE-US2022060315:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: 3 patients received a dose that was exposed to low temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number AE2J4, expiry date 30th March 2023) for prophylaxis.   On 1st April 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.       Additional Information: GSK Receipt Date: 5th April 2022 Reporter's Comments: The pharmacist reported the patient received a dose of Shingrix that was exposed to low temperature excursion of 31.5 degree F. The reporter did not consent to followup. Additional Supportive Information: As the Shingrix was exposed to low temperature excursion, which led to incorrect storage of drug. The case has been linked with the case US2022060313 and US2022060315 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022060313:same reporter US-GLAXOSMITHKLINE-US2022060315:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: 3 patients received a dose that was exposed to low temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number AE2J4, expiry date 30th March 2023) for prophylaxis.   On 1st April 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.       Additional Information: GSK Receipt Date: 5th April 2022 Reporter's Comments: The pharmacist reported the patient received a dose of Shingrix that was exposed to low temperature excursion of 31.5 degree F. The reporter did not consent to follow-up. Additional Supportive Information: As the Shingrix was exposed to low temperature excursion, which led to incorrect storage of drug. The case has been linked with the case US2022060314 and US2022060313 reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2022060313:same reporter US-GLAXOSMITHKLINE-US2022060314:same reporter
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Adult failure to thrive, Underdose
Clinical narrative: Pediatric dose instead of the adult dose; Pediatric dose instead of the adult dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 37-year-old female patient who received HBV (Engerix B pediatric) (batch number 77X47, expiry date 22nd December 2023) for prophylaxis.   On 7th March 2022, the patient received the 1st dose of Engerix B pediatric (intramuscular). On 7th March 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 5-APR-2022 Reporter's Comment: HCP (Health care professional) was calling on behalf of an employee who received the pediatric dose of Engerix B instead of the adult dose. This occurred on 7th March 2022 but was just discovered today (on the day of reporting). The health care professional reporting the event does not have the patient's HCP information so no contact information was able to be provided. The reporter did not consent to follow-up. Additional supportive information:  The patient received the pediatric dose of Engerix B instead of the adult dose, which led to underdose and adult use of a child product.