chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Received a Shingrix shot 10 days ago and now I have shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2021, the patient received Shingrix. On an unknown date, 10 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient received a Shingrix shot 10 days before the reporting date and now the patient had shingles.
Sex: U
Vaccine: MEN
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: one got very sick from the vaccine; vomiting; fever; chills; This case was reported by a consumer via  interactive digital media and described the occurrence of sickness in a patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced sickness, vomiting, fever and chills. On an unknown date, the outcome of the sickness, vomiting, fever and chills were recovered/resolved.   It was unknown if the reporter considered the sickness, vomiting, fever and chills to be related to Meningococcal B vaccine.  Additional details were provided as follows: The patient was reporter's son/daughter. The age at vaccination was not reported. The patient got very sick from the vaccine and he/she experienced vomiting, fever, chills but it was only lasted about 48 hours. The reporter mentioned that, his/her brother almost died from this, that's why he/she chose to vaccinate his/her kids. The follow-up would not possible, as no contact details were available. This case had been linked with US2021AMR074596, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR074596:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Rash
Clinical narrative: Rash; Lightheadedness; Fatigue; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2021, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced rash, light headedness and fatigue. On an unknown date, the outcome of the rash, light headedness and fatigue were unknown.   It was unknown if the reporter considered the rash, light headedness and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but was selected adult as per vaccine indication. 48 hours before reporting time, the patient had received dose of Shingrix and just before reporting, experienced rash, light headedness and fatigue. No other information was reported.
Sex: M
Vaccine: MEN
Symptoms: Pain in extremity
Clinical narrative: his arm is still hurting a lot; This case was reported by a consumer and described the occurrence of pain in arm in a 16-year-old male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, less than a week after receiving Meningococcal B vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Meningococcal B vaccine.  Additional details were provided as follows: The reporter was patient's parent. The age at vaccination was not reported but could be 15 or 16 years.  The patient received Meningococcal B vaccine a week ago and experienced pain in arm which was still hurting a lot. The reporter asked was that normal and how could he/she help him. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash after taking Shingrix; This case was reported by a consumer and described the occurrence of rash in a adult 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 rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. The patient was vaccinated with Shingrix. The patient developed rash after taking Shingrix vaccine. The follow-up would not be provided as no contact details were available.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: accidentally given a 0.5 ml dose of Menveo that expired; This case was reported by a physician via sales rep and described the occurrence of expired vaccine used in a adolescent male patient who received Men ACWY-CRM NVS (Menveo) (batch number unknown, expiry date 1st March 2021) for prophylaxis.   On an unknown date, the patient received Menveo .5 ml. On an unknown date, 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 age at vaccination was not reported. On 3rd April 2021 reported that a male adolescent patient was accidentally given a 0.5 ml dose of Menveo that expired on 1st March 2021, which led to Expired vaccine used. No Adverse Event was reported after the patient received the expired Menveo dose. Doctor requested follow up by phone to determine whether another dose of Menveo needs to be re-administered to this patient since the dose which was given expired on 1st March 2021.
Sex: M
Vaccine: FLUX, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Recurring rash / where he received / vaccines / rash has appeared 4 times; In the same area where the shots were given / gets red; In the same area where the shots were / It is itchy; This case was reported by a contact via sales rep and described the occurrence of injection site rash in a male patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis, GARDASIL for prophylaxis and INFLUENZA VACCINE for prophylaxis.   On 26th October 2020, the patient received Tdap Vaccine (intramuscular) and Menveo (intramuscular). In October 2020, the patient received GARDASIL (intramuscular). On 16th November 2020, the patient received INFLUENZA VACCINE (intramuscular). On an unknown date, less than 3 months after receiving Tdap Vaccine, Menveo and INFLUENZA VACCINE, the patient experienced injection site rash, injection site erythema and injection site itching. On an unknown date, the outcome of the injection site rash, injection site erythema and injection site itching were unknown.   It was unknown if the reporter considered the injection site rash, injection site erythema and injection site itching to be related to Tdap Vaccine and Menveo.  Additional details provided as follow: This case was reported by patient's mother. The patient received the Tdap and Menveo in left arm and Gardasil in his right arm and about 3 weeks later received the flu vaccine in the same left arm. The patient's mother reported recurring rash every few weeks in patinet's left arm where he received some vaccines. The rash would be itchy but usually with self resolve but always would occur in his left arm. The patient had getting a rash in the same area where the shots were given. It was itchy and gets red. It came and then goes away after a few hours. The first time it happened was somewhere between the vaccines and the second time it happened (January 8th). Therefore, the rash had appeared 4 times since the vaccines were given. The reporter was concerned and was wondering if the vaccines administered to that arm was causing this recurrent rash usually several weeks apart.  The patient did not have any problems or reactions to any vaccines in his life. The reporter stated that patient never had a rash in this location until after the vaccines were given and was wondering if any of these vaccines could have caused this record rash. He has had no other symptoms. The reporter consent to follow up.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: administered one dose / left outside and was very hot for several hours; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: Age at vaccination was not reported. It was reported that the physician administered one dose of Engerix B before without knowing the stability of vaccine. The reporter was unable to confirm if the vaccine was stable when package was retrieved The reporter did not notice the tag alert device had an alarm number. The reporter was concerned about the dose that was administered was it viable.  When the package was retrieved the vaccine left outside and was very hot for several hours, which led to incorrect storage of drug.
Sex: F
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This case was reported by a lawyer and described the occurrence of bell's palsy in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information received on 31 March 2021 (case now medically confirmed).  The patient had Shingrix. On an unknown date patient had bell's palsy.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product
Clinical narrative: Unspecific adverse event; This case was reported by a lawyer and described the occurrence of adverse event in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced adverse event. The action taken with Shingrix was unknown. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  The initial information was received on 31 March 2021 via medical record (case is now medically confirmed). As per pharmacy record, On 20 June 2018, patient ingested shingrix vial kit.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Shingles with ophthalmic complications; retinal detachment OD; dry eye syndrome; This case was reported by a lawyer and described the occurrence of ophthalmic complications in a patient who received  (Shingrix) for an unknown indication.   On an unknown date, the patient started Shingrix at an unknown dose and frequency. On an unknown date, an unknown time after starting Shingrix, the patient experienced Shingles with ophthalmic complications. On an unknown date, the outcome of the Shingles with ophthalmic complications was unknown.  The initial information was received on 31 March 2021 via medical record (case is now medically confirmed). Patient had used shingrix vial kit Intramuscular route on 14 Sept 2020. On 15 Feb 2021 noted that patient had a history of dry eye syndrome. Patient had History of retinal detachment OD. Patient had herpes zoster eye disease.
Age: 74.0
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Unspecified adverse event; This case was reported by a lawyer and described the occurrence of adverse event in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information received on 31 March 2021 via medical records (case now medically confirmed). The patient had Shingrix on 22 August 2019 and 17 December 2019. On an unknown date patient had Unspecified adverse event.
Age: 12.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received by accident Kinrix vaccination instead of T-Dap; 12 years old patient has received by accident Kinrix vaccination instead of T-Dap; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date unknown) 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 wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered 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 received as follows: The reporter was an office manager. The reporter stated that the 12 years old patient had received by accident Kinrix vaccination instead of TDap which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.  Follow up information received from an other health professional on 2nd April 2021: Case classification was updated to FU NO Permission Denied.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles 5 months after receiving 2nd dose of shingrix/ suspected Vaccination failure; got shingles 5 months after receiving 2nd dose of shingrix; This case was reported by a pharmacist and described the occurrence of suspected vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 5KM49, expiry date 26th November 2020) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number XG52X, expiry date 28th November 2020) and (batch number 5km, expiry date 26th November 2020) for prophylaxis.   On 19th October 2020, the patient received the 2nd dose of Shingrix. On 31st July 2020, the patient received the 1st dose of Shingrix. On 19th October 2020, the dose was an unknown dose. On an unknown date, 5 months after receiving Shingrix and between 7 and 8 months 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 and Shingrix.  Additional details were provided as follows: Five months after receiving 2nd dose of Shingrix, the patient experienced shingles. The reporter wanted to know why it happened and if she could be revaccinated. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown. The reporter consented to follow up.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Eyelid disorder, Tic
Clinical narrative: shoulder tic, arm tic, right eyelid tic; movement of the right eyelid; This case was reported by a other health professional via sales rep and described the occurrence of motor tic in a 4-year-old male patient who received HAV (Havrix) (batch number 532H4, expiry date 21st August 2022) for prophylaxis.   On 23rd March 2021, the patient received Havrix. On 26th March 2021, 3 days after receiving Havrix, the patient experienced motor tic and eyelid disorder. On an unknown date, the outcome of the motor tic and eyelid disorder were not recovered/not resolved.   It was unknown if the reporter considered the motor tic and eyelid disorder to be related to Havrix.  Additional details were reported as follows: The patient experienced eyelid tics and movement of the right eyelid, arm and shoulder tic, described as a motor tic.  A pediatric neurologist was consulted and the patient was still being monitored. There was a possibility that this report was reported by the patient's mother, but no record of the patient was found in any database. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / on Nov 2019 and has not received the second dose yet; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November 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 details were provided as follows: The age at vaaccination was not applicable for this report. The patient was past due for dose 2 of Shingrix. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Potentially 9 patients / received adjuvant only and not the active component; Potentially 9 patients / received adjuvant only and not the active component; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at the vaccination was not applicable for this report. The reporter stated that potentially 9 patients over 3 days received adjuvant only and not the active component of Shingrix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The identity of the patients was unknown. The lot number and expiry date of the Shingrix vaccine was unknown. The reporter consented to follow up. facilitywas notified of the event. The reporter had limited information and provided what was available.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Skin discolouration
Clinical narrative: Had a purple color to the surrounding skin; Developed multiple blisters in the inner thighs / pus filled; This case was reported by a consumer via call center representative and described the occurrence of blister in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2020, the patient received the 1st dose of Shingrix (intramuscular). In November 2020, between 1 and 2 weeks after receiving Shingrix, the patient experienced blister and skin discoloration. The patient was treated with dermatologicals nos (Calamine Lotion). In November 2020, the outcome of the blister was recovered/resolved. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the blister and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient received Shingrix in the deltoid of her right arm and about one week to 10 days after receiving Shingrix, the patient developed multiple blisters in the inner thighs of both the legs, which was pus filled and had a purple color to the surrounding skin. The patient applied Calamine lotion and the blisters resolved in about 2 weeks.  The vaccine lot number was not available. The reporter consented to follow up. This case had been linked with case US2021072883, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021072883:Same reporter. Friend's case.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling / at the injection site / kept getting bigger and bigger; Redness at the injection site / kept getting bigger and bigger; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included acetylsalicylic acid (Aspirin (Baby)).   On 3rd December 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovered/resolved.   The reporter considered the injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 1st dose of Shingrix in left deltoid and experienced swelling and redness at injection site, which kept getting bigger and bigger. The events lasted for 6 to 7 days and then resolved. The patient had taken pictures of her left arm. The patient believes that these events were due to the Shingrix shot. The reporter consented to follow up. For the tolerance of 2nd dose, refer case- US2021AMR073347, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073347:Same reporter
Sex: U
Vaccine: HEP, HEP
Symptoms: Product storage error
Clinical narrative: Received Engerix B that suffered a temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) (batch number P4DJ5, expiry date unknown) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number K2L79, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B. On an unknown date, unknown after receiving Engerix B and Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The reporter reported that several patients had received Engerix B that suffered a temperature excursion.  No further information was available. The reporter consented to follow up
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late dose / 1st vaccine on September 19, 2020 and is back today (March 31, 2021) - 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 19-year-old female 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.   Previously administered products included Bexsero (1st dose received on 18th September 2020, lot no: ABXB02AA, expiry date: 28th February 2022).   On 31st March 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 31st March 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional case details were reported as follows: On 31st March 2021, the patient was back to received the 2nd dose of Bexsero, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administrated only with the the adjuvant; Administrated only with the the adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) (batch number 7292M, expiry date 16th April 2022) for prophylaxis.   On 31st March 2021, the patient received Shingrix. On 31st March 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: No patient's identifiers provided. The age at vaccination was not reported. The age group opf the patient was not reported but selected as an adult as per vaccine indication. The reporter stated that, patient was administrated only with the the adjuvant component of the shingrix, which led to  inappropriate preparation of medication and inappropriate dose of vaccine administered. No adverse event was reported. The reporter consented to follow up.
Sex: F
Vaccine: HEP, HEPA
Symptoms: Underdose
Clinical narrative: Adult patient was given pediatric doses of havrix and engerix b; Adult patient was given pediatric doses of havrix and engerix b; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in an adult female patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix pediatric) for prophylaxis and hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric, Engerix B Pre-Filled Syringe Device, Havrix pediatric and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric, Engerix B Pre-Filled Syringe Device, Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. The reporter reported a medication error occurred as an adult patient was given pediatric doses of Havrix and Engerix B which led to adult use of child product and accidental underdose.  The reporter asked how to move forward.  The reporter consented to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: hives on her face; This case was reported by a consumer via call center representative and described the occurrence of hives in a 36-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Flulaval tetra with an associated reaction of urticaria (received Flulaval tetra 2018-2019, for 1st dose refer case US2021AMR073680).   On an unknown date, the patient received the 2nd dose of FluLaval Tetra 2019-2020 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, 3 days after receiving FluLaval Tetra 2019-2020 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced hives. Rechallenge with FluLaval Tetra 2019-2020 season was positive. On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to FluLaval Tetra 2019-2020 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The case was reported by patient herself. The age at vaccination was not reported but patient could be 35 or 36 years old at time of vaccination. The patient reported that she experienced the hives on face, 3 days following the vaccination. The hives came and went for a total of three days and then resolved. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073680:same reporter
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received mistakenly Boostrix vaccination instead of HepB.; newborn infant / 40 week gestation / received mistakenly Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a infant patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The age at vaccination was not reported. A Health Care Provider reported that a newborn patient with 40 weeks of gestational age was administered Boostrix vaccine instead of Hepatitis B which led to wrong vaccine administered. As the patient was a newborn it led to inappropriate age at vaccine administration. The reporter asked were there concerns or was it solely that it would not count towards completion of vaccine schedule. The reporter was concerned and enquired if it would not count towards completion of vaccine schedule. The reporter consented to follow up.
Sex: F
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Havrix on 2016 / never received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 22-year-old female patient who received HAV (Havrix) 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 (received the first dose in 2016).   On an unknown date, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 reported as follows: The age at vaccination was not applicable for this report. The pharmacist reported that a patient received the first dose of Havrix on 2016 and she has never received the second dose. Till the time of reporting patient did not receive 2nd dose of Havrix, which led to incomplete course of vaccination. The reporter consented to follow up. This case has been linked with case US2021065051, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021065051:same reporter
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 10year-old male patient who yesterday (March 31st 2021) received Kinrix by error; 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 10-year-old male patient who received DTPa-IPV (Kinrix) (batch number B75MY, expiry date 15th June 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st March 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 31st March 2021, 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 details were provided as follows: The 10 year patient received Kinrix by error, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Feeling cold
Clinical narrative: cold feeling; shortness of breath; dizziness; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th March 2021, the patient received the 1st dose of Shingrix. On 31st March 2021, 1 days after receiving Shingrix, the patient experienced feeling cold, shortness of breath and dizziness. On an unknown date, the outcome of the feeling cold, shortness of breath and dizziness were unknown.   It was unknown if the reporter considered the feeling cold, shortness of breath and dizziness to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The reporter reported that she received Shingrix on Tuesday and she was feeling fine until 5 pm of Wednesday then after that she experienced cold feeling, dizziness and shortness of breath. The patient also reported that she did not have a fast heartbeat and that her blood pressure was fine at 127. The reporter did not consented to follow up.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Engerix-B; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-month-old male patient who received HBV (Engerix B) (batch number 5Z9S2, expiry date 12th March 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 1st April 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 1st 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 details were provided as follows: The reporter was a medical assistant. The patient received expired dose of Engerix B, was expired on 12th March 2021, which led to expired vaccine used. The healthcare professional consented the follow up via email or mailing address. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site erythema
Clinical narrative: circle around the site of injection; first Shingrix shot on 22 SEP 2020 / has not received the second shot yet; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site erythema and incomplete course of vaccination. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 1st dose of Shingrix in left arm and developed a red circle around the site of injection which was 3 inches around and lasted 4 to 5 days.  Till the time of reporting, the patient had not received the 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site erythema
Clinical narrative: red circle around the site of injection (left arm); received the first shot of Shingrix on 22 SEP  2020; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site erythema and incomplete course of vaccination. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's sister. The age at vaccination was not applicable for 2nd dose of Shingrix. The patient received the first shot of Shingrix in left arm and experienced a red circle around the site of injection (left arm) which lasted for 4 to 5 days.  Till the time of reporting patient did not received the 2nd dose of Shingrix, which led to Incomplete course of vaccination. No further information reported. The reporter did not consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: soreness in her left arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included vitamin d deficiency (recently diagnosed).   On 29th December 2020, the patient received the 1st dose of Shingrix. On 29th December 2020, 4 hrs after receiving Shingrix, the patient experienced pain in arm. On 28th February 2021, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information reported as follows: This case was reported by patient herself. The patient received the 1st dose of Shingrix in the left arm and experienced soreness in her left arm which started 4 hours after vaccine administered. The event resolved on 28th February 2021. The reporter refused offer to email Shingrix PI but did take MI telephone number to give to HCP. The reporter consented to follow up and given permission to contact her healthcare professional. For tolerance of 2nd dose refer case US2021AMR074345; Sender's Comments:  US-GLAXOSMITHKLINE-US2021073782:same reporter (husband´s case) US-GLAXOSMITHKLINE-US2021AMR074345:same reporter
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: muscle pain left arm , site of injection and surrounding; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 30th October 2020, less than a day after receiving Shingrix, the patient experienced injection site muscle pain. The patient was treated with nsaid's (Nsaid). On an unknown date, the outcome of the injection site muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site muscle pain to be related to Shingrix.   Additional details were reported as follows: This case was reported by patient himself. The patient received Shingrix in left deltiod and reported muscle pain in left arm, at the site of injection and surrounding. Till the time of reporting, the event was not resolved. The healthcare professional recommended NSAID cream which provided temporary relief. The reporter given consented to follow up with healthcare professional. The reporter consented to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pyrexia, Rash
Clinical narrative: rash / rash presented on her abdomen, breasts and upper thighs; flu like symptoms; chills; low grade fever; headache; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number X7Z52, expiry date 5th November 2022) for prophylaxis.   On 30th March 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 31st March 2021 06:30, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, chills, fever and headache. On 1st April 2021, the patient experienced rash. On an unknown date, the outcome of the influenza-like symptoms, chills, fever and headache were recovered/resolved and the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, chills, fever, headache and rash to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix in right arm and the next morning she experienced flu like symptoms reported as headache, chills and low-grade fever and those symptoms had resolved. The patient presented a rash on her abdomen, breasts and upper thighs.  The rash was improving but not resolved. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Feeling abnormal
Clinical narrative: and her stomach is off; feels weak; doesn't feel great and feels a little crappy; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2021, the patient received the 1st dose of Shingrix. In April 2021, less than a week after receiving Shingrix, the patient experienced upset stomach, feelings of weakness and feeling bad. On an unknown date, the outcome of the upset stomach, feelings of weakness and feeling bad were not recovered/not resolved.   It was unknown if the reporter considered the upset stomach, feelings of weakness and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The reporter reported that she received dose of Shingrix and experienced bad feeling and feeling crappy. The reporter also experienced stomach off. The consumer decline to give any further details. The consumer declined to give any additional details or answer any further questions before ending the call. The reporter did not consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of Shingrix; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a male patient who received Herpes zoster (Shingrix) (batch number 49R72, expiry date 13th March 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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 age at vaccination was not reported. The nurse reported that the patient received an expired dose of Shingrix, the vaccine expired on 13th March 2021, which led to expired vaccine used. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient is past due for dose two of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 23rd May 2018., batch number-ZY3X4 and expiration date-1st April 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.