chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Transient ischaemic attack, Ultrasound scan
Clinical narrative: Amnesia; Cardiac disorder; Thrombosis; Transient ischaemic attack; This case was received via another Manufacturer (Reference number: vsafe) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of AMNESIA (Amnesia), CARDIAC DISORDER (Cardiac disorder), THROMBOSIS (Thrombosis) and TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included Glaucoma and Hypothyroidism. Concurrent medical conditions included Stroke. Concomitant products included LEVOTHYROXINE, BRIMONIDINE, LATANOPROST and TIMOLOL for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced AMNESIA (Amnesia) (seriousness criterion hospitalization), CARDIAC DISORDER (Cardiac disorder) (seriousness criterion hospitalization), THROMBOSIS (Thrombosis) (seriousness criteria hospitalization and medically significant) and TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) (seriousness criteria hospitalization and medically significant). At the time of the report, AMNESIA (Amnesia), CARDIAC DISORDER (Cardiac disorder), THROMBOSIS (Thrombosis) and TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Catheterisation cardiac: inconclusive. On 14-Jan-2021, Echocardiogram: inconclusive. On 14-Jan-2021, Magnetic resonance imaging: inconclusive. On 14-Jan-2021, Ultrasound scan: inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The next day, the patient had short term memory loss, patient went to the hospital, and they said patient had some type of heart episode. The patient was taken by ambulance to the hospital and was told  had a blood clot in brain and had suffered a mini stroke. The patient was hospitalized for 4 nights. The patient was given blood thinner and got improved.  Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine, the onset of the reported events, a causal relationship cannot be excluded.  However patient had an underlying risk in the past history of stroke.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine, the onset of the reported events, a causal relationship cannot be excluded.  However patient had an underlying risk in the past history of stroke.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had a bad case that lasted about six months( had the shot) / Have taken the new shot/Suspected vaccination failure; Had a bad case that lasted about six months; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient received the shot and had a bad case that lasted about six months. The reporter stated that vaccine did not prevent shingles. The patient had taken new shot and hoping to never get it again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation and time to onset of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles twice even after I got the vaccine/suspected vaccination failure; got shingles twice even after I got the vaccine; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got shingles twice even after vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; shinghles on left side and back; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient got Shingles shot first and following year patient had gotten the shingles on left side and back. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, exact time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: I had the flu shot and got the flu / Suspected vaccination failure; flu; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included whooping cough vaccine with an associated reaction of pertussis (received on an unknown date).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The patient had the flu shot and got the flu so he/she did not have it any more. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming Influenza were unknown at the time of reporting. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise, Pain, Post herpetic neuralgia
Clinical narrative: First dose of shringrix 4 months ago and now have shingles; Suffer from the PHN; So painful; Made me I'll for a day/ didn't work; This case was reported by a consumer via  source and described the occurrence of shingles in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   In January 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced shingles, post herpetic neuralgia, pain and unwell. On an unknown date, the outcome of the shingles was unknown and the outcome of the post herpetic neuralgia, pain and unwell were recovered/resolved.   It was unknown if the reporter considered the shingles, post herpetic neuralgia, pain and unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 61 or 62 years. After receiving 1st dose of Shingrix 4 months ago of the reporting date, the patient had experienced shingles and also suffered from PHN (Post Herpetic neuralgia). The patient reported that it was so painful. The patient experienced shingles for 2nd time and the patient was on no medication and exercises at least 5 days a week. The patient was not sure about receiving the 2nd dose because 1st dose made patient ill and did not work.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle pain; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was captured as an adult as per vaccine indication. The patient received dose of Shingrix and experienced muscle pain. The reporter inquired that how long would the muscle pain last after the 2nd dose and was there anything could take to ease the pain. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dyspnoea, Tremor
Clinical narrative: trouble breathing; shaking; This case was reported by a other health professional via sales rep and described the occurrence of difficulty breathing in a 16-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 and MENACTRA for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero, Bexsero Pre-Filled Syringe Device and MENACTRA. On an unknown date, less than a day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced difficulty breathing and tremor. On an unknown date, the outcome of the difficulty breathing and tremor were unknown.   It was unknown if the reporter considered the difficulty breathing and tremor 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 details were reported as follows: The age at vaccination was not reported. The patient received dose of Bexsero and Menactra at the same time and experienced shaking and trouble breathing about 2 to 3 hours. It was the urgent care who told that event was from the vaccine. It was unknown if the reporter considered the difficulty breathing and tremor to be related to Menactra. It was the urgent care who told that event was from the vaccine. No further information was reported. The reporter consented to follow up.
Age: 55.0
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: first vaccine was 2/26/20 / couldn't get the 2nd one in 6 months due to Covid shut down / get the 2nd one yesterday, 15 months later; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 55-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 26th February 2020).   On 5th May 2021, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The patient did not get the 2nd dose in 6 months due to Covid shut down. The day before the reporting date, the patient received the 2nd dose, about 15 months later.  The patient asked he/she should consider that to be starting over with the first vaccine and plan a 2nd one in 2-6 months. No further information was reported.
Sex: U
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 6 month old accidently was given meningitis b; This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old 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 an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero 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 details were provided as follows: The patient who was 6 month old at the time of vaccination, accidently received Meningococcal B (Bexsero), which led to inappropriate age at vaccine administered. The reporter asked what could the risk of this mistake. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: fever; she had chills; headache for 24 hours; This case was reported by a consumer via call center representative and described the occurrence of chills 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 chills, headache and fever. On an unknown date, the outcome of the chills and headache were recovered/resolved and the outcome of the fever was unknown.   It was unknown if the reporter considered the chills, headache and fever to be related to Shingrix.  Additional details were provided as follows: The case was reported by the friend of the patient. The age at vaccination was not reported. Patient received Shingrix vaccine and experienced chills, fever and headache for 24 hours. The reporter refused to provide any other details other than what was reported in this report. The reporter did not consent to follow up. This case is one of the 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021097925:Same reporter US-GLAXOSMITHKLINE-US2021AMR099471:Same reporter US-GLAXOSMITHKLINE-US2021097926:Same reporter US-GLAXOSMITHKLINE-US2021AMR099469:Same reporter US-GLAXOSMITHKLINE-US2021AMR099470:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: she had flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided a sfollows: The Age at vaccination was not reported. The reporter reported about her friend. The patient received Shingrix vaccine and experienced Influenza like symptoms. The reporter refused to provide any other details other than what was reported in this report. The reporter did not consented to follow up. This is one of 5 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021097925:Same reporter US-GLAXOSMITHKLINE-US2021AMR099468:Same reporter US-GLAXOSMITHKLINE-US2021AMR099471:Same reporter US-GLAXOSMITHKLINE-US2021097926:Same reporter US-GLAXOSMITHKLINE-US2021AMR099470:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: She just felt bad all day; This case was reported by a consumer via call center representative and described the occurrence of feeling bad 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 feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional details were provided as follows: The case was reported by the friend of the patient. The age at vaccination was not reported. Patient received Shingrix vaccine and felt bad all day. The reporter refused to provide any other details other than what was reported in this report. The reporter did not consent to follow up. This case is one of the 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021097925:Same reporter US-GLAXOSMITHKLINE-US2021AMR099468:Same reporter US-GLAXOSMITHKLINE-US2021AMR099469:Same reporter US-GLAXOSMITHKLINE-US2021AMR099471:Same reporter US-GLAXOSMITHKLINE-US2021097926:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2-3 friends who have received their 2nd vaccine a month of so past the 6 month mark; This case was reported by a consumer and described the occurrence of drug dose administration interval too long in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis  Previously administered products included Shingrix (1st dose received on an unknown date).   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 long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: This case was reported by reporter who reported for friends. Age at vaccination was not applicable. The reporter had 2 to 3 friends who had received their 2nd vaccine a month or so past the 6-month mark, which led to lengthening of vaccination schedule. The reporter refused to provide any other details other than what was reported in this report. The reporter did not consent to follow up. This case is one of the 5 cases reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021097925:Same reporter US-GLAXOSMITHKLINE-US2021AMR099468:Same reporter US-GLAXOSMITHKLINE-US2021AMR099469:Same reporter US-GLAXOSMITHKLINE-US2021AMR099470:Same reporter US-GLAXOSMITHKLINE-US2021097926:
Age: 62.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Blister, Contusion, Urticaria
Clinical narrative: Bruising on sides of legs and stomach.; Blisters on chest and arms / travelling down her legs; Reactions of hives on her chest / spread to her back, butt, and arms / spread to her face; This case was reported by a consumer and described the occurrence of hives in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included celecoxib (Celebrex) for product used for unknown indication.   On 23rd March 2021, the patient received the 1st dose of Shingrix (intramuscular) and Celebrex at an unknown dose and frequency. On 6th April 2021, 14 days after receiving Shingrix, the patient experienced hives (serious criteria clinically significant/intervention required). On 10th April 2021, the patient experienced blister (serious criteria clinically significant/intervention required). On 13th April 2021, the patient experienced bruising of leg (serious criteria clinically significant/intervention required). The patient was treated with cortisone (non-proprietary) (Cortisone Shot), prednisone and dermatologicals nos (Anti-Itch Cream (Medication Unknown)). The action taken with Celebrex was unknown. On an unknown date, the outcome of the hives, blister and bruising of leg were not recovered/not resolved.   It was unknown if the reporter considered the hives, blister and bruising of leg to be related to Shingrix.  Additional details were provided as follows:  The patient received Shingrix vaccine and experienced reactions of hives on her chest. On 10th April 2021, the patient had hives spread to her back, butt, arms, blisters on chest and arms, started traveling down her legs. Consumer went to an urgent care in (contact information unknown) and received a Cortisone shot and also visited local Urgent care. On 13th April 2021, the consumer returned to PCP with little improvement of adverse reactions, and now with bruising on sides of the legs and stomach.  PCP administered second Cortisone shot and as of today, has continues with little improvement of adverse reactions.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Expired product administered
Clinical narrative: Patient was administered with Bexsero / the vaccine had expired / March 2021; patient felt lightheaded for two minutes soon after the administration; This case was reported by a nurse via sales rep and described the occurrence of light headedness in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA15AA, expiry date 31st March 2021) 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.   The patient's past medical history included anxiety (had preexisting anxiety problems and used to experience lightheadedness during dentist visits and prior vaccinations).   On 30th April 2021, the patient received Bexsero. On an unknown date, the patient started Bexsero Pre-Filled Syringe Device. On an unknown date, less than a week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced light headedness and expired vaccine used. On an unknown date, the outcome of the light headedness and expired vaccine used were unknown.   It was unknown if the reporter considered the light headedness 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 details were provided as follows: The patient received Bexsero and the nurse then noticed that the vaccine had expired.  The patient received Bexsero dose that had expired in March 2021, which led to expired vaccine used. The patient felt lightheaded for two minutes soon after the administration of the dose. The reporter consented to follow up. This case US2021096005 is a duplicate of US2021095993. All future correspondence will be submitted to US2021095993.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021096005:FU 1 (deleted)
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Hypoaesthesia, Muscular weakness, Musculoskeletal chest pain, Neuralgia
Clinical narrative: experienced nerve pain in her arms, chest, and ribs; weakness in her arms; arms numb; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number X2XJ7, expiry date 8th August 2021) for prophylaxis.   On 4th November 2020, the patient received Boostrix. On an unknown date, less than 6 months after receiving Boostrix, the patient experienced nerve pain, weakness of arms and numbness of upper extremities. On an unknown date, the outcome of the nerve pain, weakness of arms and numbness of upper extremities were not recovered/not resolved.   It was unknown if the reporter considered the nerve pain, weakness of arms and numbness of upper extremities to be related to Boostrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient stated, ever since she received vaccine, she experienced nerve pain in her arms, chest and ribs. She also had weakness in her arms. All above events were unresolved. The patient had been to multiple doctors who could not diagnose what was wrong and due to this she was a bit uncooperative, was very upset that no one did give her answers on why she felt this way. She did ask for legal, so this case might be legally significant The patient reported that, her pharmacist called GlaxoSmithKline to report this event, but could not locate in any data base. It was also reported on VAERS. The patient did not consent to follow-up. Note:The events were reported as Nerve pain in arms, ribs and chest but in event section these are provided separately. These are coded as nerve pain according to narrative.
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Administration of pediatric 2nd dose of Havrix to an adult patient; Administration of pediatric 2nd dose of Havrix to an adult patient; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 55-year-old female patient who received HAV (Havrix pediatric) (batch number 3JK57, expiry date 20th December 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix adult (1st dose received on an unknown date).   On 27th April 2021, the patient received the 2nd dose of Havrix pediatric and Havrix Pre-Filled Syringe Device. On 27th April 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Nurse reported that, the administration of pediatric 2nd dose of Havrix to an adult patient, which led to underdose and adult use of a child product. No further information available. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose Oct 2019, can the series be continued or should it be restarted?; 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 in October 2019).   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 was provided as follows:  The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental underdose, Exposure via skin contact, Injection site extravasation, Syringe issue
Clinical narrative: Pharmacist told him he received about 80% of the vaccine; The customer reports the liquid vaccine ran down his arm; Vaccine squirted out the side / ran down his arm and dripped down on to his pants; This case was reported by a consumer via call center representative and described the occurrence of accidental underdose in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th May 2021, the patient received the 1st dose of Shingrix (intramuscular). On 4th May 2021, unknown after receiving Shingrix, the patient experienced accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.  Additional details were provided as follows: The patient received first dose of Shingrix in the left deltoid. The pharmacist administered the  vaccine to the patient. At the time of vaccination, the reporter mentioned something happened to the needle and the vaccine squirted out the side. The liquid vaccine ran down his arm and dripped down on to his pants, which led to inadvertent exposure to vaccine and exposure via skin contact. The pharmacist told him, he received about 80 percent of the vaccine, which led to accidental underdose. The patient did not think the pharmacist contacted GSK (GlaxoSmithKline). The reporter consented to follow up.
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: experienced a shingles outbreak/ Suspected vaccination failure/ Lack of drug effect; shingles outbreak; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE PFIZER for prophylaxis.   The patient's past medical history included shingles (several shingles outbreaks). Concomitant products included TOZINAMERAN (COVID-19 VACCINE PFIZER).   On an unknown date, the patient received Shingrix and the 2nd dose of COVID-19 VACCINE PFIZER. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by the daughter of the patient The age at vaccination was not reported. The patient's daughter reported the patient had several shingles outbreaks prior to receiving the Shingrix vaccine. The patient has had previous shingles outbreaks in the setting of stress. The patient received Shingrix approximately one and a half years ago from the time of reporting. The patient received the COVID-19 vaccine (dates were not available). One week following the patient's second COVID-19 vaccine, the patient experienced a shingles outbreak. The reporter did not want to share any additional information. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had the first dose / has not had the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2018).   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 was provided as follows:  The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: received an expired dose; a 65 year old / received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 65-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA14AB, expiry date 31st March 2021) 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 5th May 2021, the patient received the 2nd dose of Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. On 5th May 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration 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 was provided as follows:  The certified nurse aid (CNA) reported that on 5th May 2021, the patient received Bexsero which was already expired on 31st March 2021.  The patient was 65 year at the time of vaccination which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: dose of Pediarix already expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number MG92G, expiry date 3rd May 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th May 2021, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 4th May 2021, 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 was provided as follows:  On 4th May 2021, patient received Pediarix vaccine which was already expired on 3rd May 2021. The reporter consented to follow up.
Age: 2.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: reports a two year old patient received a dose of Kinrix; 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 patient who received DTPa-IPV (Kinrix) 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 detail details were provided as follows: The reporter reported that, two year old patient received a dose of Kinrix, which led to inappropriate age at vaccine administration. The reporter did not provide full address, patient demographics, lot number, or expiration date of the product administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient didn´t receive 2nd dose/ 9 months before of 1st dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date; 9 m onths ago prior to reporting.).   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 was provided as follows:  The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient received 1st dose 9 months prior to reporting. The healthcare professional (HCP) asked how to proceed if patient did not received 2nd dose. The reporter consented to follow up.
Age: 0.83
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: a patient received on 30/APR/2021 a dose/expired on 13/APR/2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 10-month-old female patient who received HBV (Engerix B) (batch number CP275, expiry date 13th April 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th April 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 30th April 2021, unknown after receiving Engerix B and Engerix B 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 was provided as follows:  The nurse reported that  on 30th April 2021, the patient received Engerix B vaccine which was  already expired on 13th April 2021. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on October 23. 2020 and has not received the 2nd dose yet; This case was reported by a consumer 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 on 23rd October 2020).   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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. Thee reporter refused to answer any additional questions. The reporter did not consent to follow up. This case was linked with case US2021097926, reported by same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021097926:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: experienced uncontrollably shivering for 2 hours after receiving Shingrix; This case was reported by a consumer via call center representative and described the occurrence of shivering 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 shivering. On an unknown date, the outcome of the shivering was recovered/resolved.   It was unknown if the reporter considered the shivering to be related to Shingrix.  Additional details was reported as follows: The age at vaccination was not reported. The patient received shingrix and experienced uncontrollably shivering for 2 hours. The reporter refused to provide any other details. The reporter did not consent to follow up. This is 1 of the 6 linked cases, reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021097925:Same reporter US-GLAXOSMITHKLINE-US2021AMR099468:Same reporter US-GLAXOSMITHKLINE-US2021AMR099469:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got the first dose of shingrix, 2.5 yrs ago , never went back for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix).   Previously administered products included Shingrix (received 1st dose two and half years before reporting day).   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 details were provided as follows: The age at vaccination was not applicable to this report. The pharmacist reported that patient never went back for the 2nd dose. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient received first dose in another state.  The patient wanted to know if he need to start over the vaccination series. No other information of vaccine available . The reporter consent to follow up. This case is linked with case US2021097929, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021097929:SAME REPORTER
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the first dose /on 11/11/2019 and wasn't able to get in to get second dose; This case was reported by a pharmacist via and described the occurrence of incomplete course of vaccination in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 11th November 2019, batch number 95R52,expiry date 10th November 2020).   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 details were provided as follows: The age at vaccination was not reported. Till the time of reporting patient did not receive the 2nd dose of Shingrix vaccination, which led to incomplete course of vaccination. The pharmacist reported that patient was not able to got in to get the 2nd dose.  The pharmacist had concerns of how to proceed with second dose since it was over a year. The reporter did not consent to follow up. The healthcare professional (HCP) stated after call would provide patient with medical information received and would see how patient would like to proceed.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Menveo, it expired on 31Mar2021 / administered on 14Apr2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA419A, expiry date 31st March 2021) for prophylaxis.   On 14th April 2021, the patient received Menveo. On 14th April 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The healthcare provider reported that on 14th April 2021 the patient received Menveo which was alredy expired on 31st March 2021. The reporter consent to follow up. The reported batch number AMXA419A for Menveo did not exist and was updated to AMVA419A as per the sales datasheet.
Age: 0.33
Sex: U
Vaccine: DTAPHEPBIP, DTAPIPV
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: received both Pediarix and Kinrix/ over dose of DTP, Filamentous Haemagglutinin, Pertactin and IPV; A 4 month old received / Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 4-month-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix and Kinrix Pre-Filled Syringe Device, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The 4 month old patient received Kinrix, which led to inappropriate age at vaccine administration. The patient received both Pediarix and Kinrix, which led to overdose of DTP, Filamentous Haemagglutinin, Pertactin and IPV. The reporter did not consent to follow up. No more information was provided by the reporter.