chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Hypersensitivity, Pruritus, Rash, Swelling face
Clinical narrative: swollen face; swollen tongue; rare allergic reaction; itchy; rashes on her entire torso / legs, back, neck and hands / stomach and forearms; throat closed; could not swallow; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included prednisone unknown for product used for unknown indication.   On 17th November 2021 11:00, the patient received the 1st dose of Shingrix. On 18th November 2021, the patient started prednisone 40 mg at an unknown frequency. On an unknown date, the dose was changed to 20 mg at an unknown frequency. On 9th October 2021, the dose was changed to 10 mg at an unknown frequency. On 17th November 2021, less than an hour after receiving Shingrix, the patient experienced allergic reaction, pruritus, generalized rash, throat constriction and unable to swallow. On 21st November 2021, the patient experienced facial swelling and swollen tongue. The patient was treated with benadryl (nos) (Benadryl) and steroids nos (Steroid (Not Specified)). The action taken with prednisone was unknown. On an unknown date, the outcome of the allergic reaction, throat constriction, unable to swallow, facial swelling and swollen tongue were unknown and the outcome of the pruritus was recovered/resolved and the outcome of the generalized rash was not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, pruritus, generalized rash, throat constriction, unable to swallow, facial swelling and swollen tongue to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient received the first dose of Shingrix and within an hour, she started feeling itchy.  Four hours after she received the vaccine she was covered in rashes on her entire torso. Rash was also seen on her legs, back, neck and hands.  Later that night, her throat closed and she could not swallow.  She stated that she went to the emergency room in the morning of 18th November 2021 where she was given 40 mg prednisone.  3 days later, she experienced a swollen face and swollen tongue.  Her doctor gave her a large dose of steroid (name unknown).  She had been taking 20 mg prednisone for the last week and she took 10mg prednisone yesterday.  She had also been using Benadryl on her rashes to help treat it.  She was still experiencing rash which was seen on her stomach and forearms.  The patient also had a rare allergic reaction. Emergency room visit was required. It was unknown if the reporter considered the allergic reaction, pruritus, generalized rash, throat constriction, unable to swallow, facial swelling and swollen tongue to be related to Prednisone. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Swollen tongue, Throat tightness
Clinical narrative: swollen face; swollen tongue; rare allergic reaction; itchy; rashes on her entire torso / legs, back, neck and hands / stomach and forearms; throat closed; could not swallow; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included prednisone unknown for product used for unknown indication.   On 17th November 2021 11:00, the patient received the 1st dose of Shingrix. On 18th November 2021, the patient started prednisone 40 mg at an unknown frequency. On an unknown date, the dose was changed to 20 mg at an unknown frequency. On 9th October 2021, the dose was changed to 10 mg at an unknown frequency. On 17th November 2021, less than an hour after receiving Shingrix, the patient experienced allergic reaction, pruritus, generalized rash, throat constriction and unable to swallow. On 21st November 2021, the patient experienced facial swelling and swollen tongue. The patient was treated with benadryl (nos) (Benadryl) and steroids nos (Steroid (Not Specified)). The action taken with prednisone was unknown. On an unknown date, the outcome of the allergic reaction, throat constriction, unable to swallow, facial swelling and swollen tongue were unknown and the outcome of the pruritus was recovered/resolved and the outcome of the generalized rash was not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, pruritus, generalized rash, throat constriction, unable to swallow, facial swelling and swollen tongue to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient received the first dose of Shingrix and within an hour, she started feeling itchy.  Four hours after she received the vaccine she was covered in rashes on her entire torso. Rash was also seen on her legs, back, neck and hands.  Later that night, her throat closed and she could not swallow.  She stated that she went to the emergency room in the morning of 18th November 2021 where she was given 40 mg prednisone.  3 days later, she experienced a swollen face and swollen tongue.  Her doctor gave her a large dose of steroid (name unknown).  She had been taking 20 mg prednisone for the last week and she took 10mg prednisone yesterday.  She had also been using Benadryl on her rashes to help treat it.  She was still experiencing rash which was seen on her stomach and forearms.  The patient also had a rare allergic reaction. Emergency room visit was required. It was unknown if the reporter considered the allergic reaction, pruritus, generalized rash, throat constriction, unable to swallow, facial swelling and swollen tongue to be related to Prednisone. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Immediate post-injection reaction, Incorrect route of product administration, Mobility decreased, Shoulder injury related to vaccine administration
Clinical narrative: SIRVA (shoulder injury related to vaccine administration); During injection shoulder pain / after injection it hurt worse; limited mobility of shoulder; BEXSERO via intrarticular injection; This case was reported by a nurse via call center representative and described the occurrence of shoulder injury related to vaccine administration in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB36AA, expiry date 31st July 2022) 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 10th December 2021, the patient received Bexsero (intraarticular) and Bexsero Pre-Filled Syringe Device. On 10th December 2021, immediately after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced shoulder injury related to vaccine administration, shoulder pain, mobility decreased and intramuscular formulation administered by other route. On an unknown date, the outcome of the shoulder injury related to vaccine administration and intramuscular formulation administered by other route were unknown and the outcome of the shoulder pain and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the shoulder injury related to vaccine administration, shoulder pain and mobility decreased 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: This case was reported by the nurse practitioner. The patient received dose of Bexsero vaccine in an unknown arm via intrarticular injection, which led to intramuscular formulation administered by other route. The patient experienced shoulder pain during injection and after injection it hurt worse. In middle of night following administration, the patient experienced significant pain. She also experienced limited mobility of shoulder.  She woke up because it was hurting so bad. She went to emergency room where on 11th December 2021 they said it was SIRVA (shoulder injury related to vaccine administration).  The reporter stated that they saw the patient in the morning of 13th December 2021 (day of reporting) and she was still in pain with limited mobility of shoulder. It's gotten a little better but still present. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Muscle spasms, Product preparation issue
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of cramps of lower extremities in a adult female patient who received Herpes zoster (Shingrix) (batch number 5454X, expiry date 25th October 2022) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced cramps of lower extremities, inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the cramps of lower extremities, inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown. It was unknown if the reporter considered the cramps of lower extremities to be related to Shingrix. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. Health Care Provider who was also the patient reported being given the Shingrix diluent without reconstitution with the powder which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The patient reported waiting for a while to take first dose and then received the second dose during the 2 to 6 month window. The patient also reported having leg and feet cramps after receiving the diluent only. The reporter consented to follow up.
Age: 0.08
Sex: M
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: Rotarix given IM in right thigh; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate route of vaccination in a 6-week-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 53T9Z, expiry date 27th April 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 13th December 2021, the patient received Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 13th December 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route 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 provided as follows: The medical assistant (MA) stated that the patient received dose of Rotarix intramuscularly into the right thigh, which led to inappropriate route of vaccination. No further information was reported. The reporter consented to follow-up.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received Kinrix at 4 months; Kinrix given instead of Pediarix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DTPa-HBV-IPV (Pediarix).   On 28th October 2020, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th October 2020, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device and not applicable after receiving Pediarix, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received 1st dose of pediarix on an unknown date. The reporter stated that, the nurse documented administering a dose of Pediarix to the patient, however search of lot number YZ97N revealed that the dose was actually Kinrix.   The patient was 4 months old and received Kinrix instead of Pediarix, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up. This is one of 4 cases, reported by the same reporter.; Reporter's Comments: Pharmacist reports a nurse documented administering a dose of Pediarix to a patient , however search of lot number YZ97N revealed that the dose was actually Kinrix.  The dose was administered on 28Oct2020 (child was 16 months of age).  This was supposed to have been the second dose of the Pediarix series.  The expiration date of the Kinrix dose administered was 26Aug2022.  ~~~~~~~Consented to follow up.Call Notes:HCP gave permission for follow-up; Sender's Comments:  US-GLAXOSMITHKLINE-US2021254893:Same reporter US-GLAXOSMITHKLINE-US2021254961:Same reporter US-GLAXOSMITHKLINE-US2021159295:Same reporter US-GLAXOSMITHKLINE-US2021159292:Same reporter
Age: 48.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Product administered to patient of inappropriate age, Vaccination failure
Clinical narrative: suspected vaccination failure/1st and 2nd doses in 2019 / had Shingles in 2020; Shingles; received Shingrix when she was 48 / prior to approval of Shingrixfor patients under 50; This case was reported by a consumer via and described the occurrence of suspected vaccination failure in a 48-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and inappropriate age at vaccine administration. On an unknown date, the outcome of the vaccination failure and inappropriate age at vaccine administration were 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 Shingrix and Shingrix.  Additional details were provided are as follows: The case was reported by patient's husband. The patient received 2 doses of Shingrix in an unknown arm in summer of 2019 (exact dates were unknown) and had first outbreak of shingles in 2020. The patient received both doses when she was 48 years old prior to the FDA approval Shingrix for immunocompromised patients under 50 years of age, which led inappropriate age at vaccine administration. The reporter was not asked for lot, expiration date and arm administered. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting. The case has been linked with case US2021AMR255952, reported by same reporter for same patient for shingles experienced in 2021.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR255952:Same reporter, same product, same patient, case created for event that happened in another point in time
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 934NJ, expiry date 10th December 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 13th December 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 13th December 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 details were provided as follows: The reporter was a certified medical assistant. The age at vaccination was not reported. The patient received an expired dose of Pediarix today (day of reporting), which led to expired vaccine used. The reporter consented to follow-up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received a  late 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number x3p72, expiry date 7th November 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 01st November 2019).   On 29th July 2021, the patient received the 2nd dose of Shingrix. On 29th July 2021, 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 provided as follows: The patient received a late 2nd dose, which led to drug dose administration interval too long.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, 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 details were provided are as follows: The age at vaccination was not reported.  No patient demographics were provided. The reporter did not had time to look into that.  Nurse reported that a patient received a dose of Shingrix and had sore arm for 6 weeks. The patient was wondering how effective one dose of shingrix was because he was not sure about getting a second. The reporter  did not probe any further and did not ask permission for follow up due to this. The reporter did not consent to follow-up.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Patient got BEXSERO instead of MENACTRA; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB57AA, expiry date 31st August 2022) 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 14th December 2021, the patient received Bexsero (intramuscular) .5 ml and Bexsero Pre-Filled Syringe Device. On 14th December 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: Health care professional reported that, the patient was accidentally given Bexsero instead of Menactra, which led to wrong vaccine administered. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Chest pain, Nerve injury
Clinical narrative: Like I have a bad sun burn; Nerve damage; This case was reported by a consumer via interactive digital media and described the occurrence of burning sensation in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2020, the patient received Shingles vaccine. In October 2021, less than 2 years after receiving Shingles vaccine, the patient experienced burning sensation and nerve damage. On an unknown date, the outcome of the burning sensation and nerve damage were unknown.   It was unknown if the reporter considered the burning sensation and nerve damage to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received the Shingles shots felt like have a bad sun burn on the front right of chest.  No marks just nerve damage.  The patient was just wondering if anyone had noticed this when having had the vaccine. No contact details were available.
Age: 4.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect route of product administration, Injection site erythema
Clinical narrative: given Kinrix subcutaneously; redness at the injection site; This case was reported by a nurse and described the occurrence of injection site erythema in a 4-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 13th December 2021, the patient received Kinrix (subcutaneous) and Kinrix Pre-Filled Syringe Device. On 13th December 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. In December 2021, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site erythema to be related to Kinrix and Kinrix 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 are as follows: The nurse stated that the patient was accidentally given a dose of Kinrix subcutaneously, which led to intramuscular formulation administered by other route The patient's mother reported that the patient had local reaction of redness at the injection site and sent a picture of the redness to the office. No further details were provided on the call. The reporter consented to follow-up from safety.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021258903:FU1 - deleted
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Third dose given; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number L5A35, expiry date 4th September 2023) and (batch number 2N7NP4, expiry date 4th September 2023) for prophylaxis.   Previously administered products included Shingrix (2nd dose received on 23rd August 2018).   On 14th December 2021, the patient received the 3rd dose of Shingrix. On 14th December 2021, the dose was an unknown dose. On 14th December 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided are as follows: The health care professional reported that, recently the patient was administered with 3rd dose of Shingrix, which led to extra dose administered. The reporter could not clarify which lot number was for powder and liquid (vial 1- L5A35 and vital 2- 2N7NP4). The reporter consented to follow-up.
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Finished the series 2 months early; This case was reported by a pharmacist and described the occurrence of drug dose administration interval too short in a 64-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 13th July 2021) and Twinrix (2nd dose received on an unknown date).   On 17th November 2021, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 17th November 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   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 age at vaccination was not reported. The pharmacist reported that the patient finished the series of Twinrix 2 months too early, which led to drug dose administration interval too short. No further information reported. The reporter did not consent to follow-up.
Age: 0.5
Sex: M
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Administered Engerix-B instead of Pediarix; This case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 6-month-old male patient who received HBV (Engerix B) (batch number CP23D, expiry date 7th December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th December 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 10th December 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The physician reported that, the nurse inadvertently administered Engerix-B to a patient instead of Pediarix instead of wrong vaccine administered. Lot number was from. The reporter did not consent to follow-up. The health care professional (HCP) said follow-up phone call from safety was okay (not postal or email).
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: adult patient was given a pediatric dose; adult patient was given a pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 46-year-old female patient who received HBV (Engerix B pediatric) (batch number 722KC, expiry date 6th April 2022) for prophylaxis.   On 13th December 2021, the patient received Engerix B pediatric 10 mcg. On 13th December 2021, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: The clinic supervisor reported that, an adult patient was given a pediatric dose of Engerix-B during a visit, which led to underdose and adult use of a child product. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in 2019 and has not received his second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 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 to this report. The reporter was a (Health Care Professional) HCP calling on behalf of the patient.  Till the time of reporting the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter reported with very limited information. No additional information was provided. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles after completing the schedule/ Suspected vaccination failure; Shingles; This case was reported by a pharmacist and described the occurrence of suspected vaccination failure in a 81-year-old female patient who received Herpes zoster (Shingrix) (batch number 3454n, expiry date 23rd August 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On 26th December 2020, between 1 and 3 months after receiving Shingrix and unknown 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 are as follows: The age at vaccination was not reported. The patient had received immunosuppressive therapy in November 2020. The health care professional reported that the patient suffered a case of shingles after completing the schedule of Shingrix vaccine. No further events were reported. The reporter agreed to be contacted for follow-up. This case was considered as suspected vaccination failure since the detail regarding the laboratory confirmation for shingles was not reported.
Age: 59.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Diplopia, Eye patch application, Headache
Clinical narrative: Slight headache; Double vision; This case was reported by a consumer via call center representative and described the occurrence of headache in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   On 7th December 2021, the patient received the 2nd dose of Shingrix and Influenza vaccine Quadrivalent 2021-2022 season. On 11th December 2021, 4 days after receiving Shingrix and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced headache and double vision. On an unknown date, the outcome of the headache and double vision were not recovered/not resolved.   It was unknown if the reporter considered the headache and double vision to be related to Shingrix and Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were reported as follows: This case was reported by the patient himself. The patient received second dose of Shingrix and Flu shot (Unknown type/brand) together. In the early morning of 11th December 2021, the patient experienced a slight headache and double vision The patient reported that headache and double vision had remained constant since onset. The symptoms had not gotten better nor worse. The patient reported only being able to alleviate the double vision by wearing an eyepatch over one eye. The patient reported double vision returned as soon as patch was removed.  The reporter did not consent to follow-up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th December 2021, the patient received the 1st dose of Shingrix. On 14th December 2021, unknown after receiving Shingrix, the patient experienced incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.  Additional details were provided as follows: The medical assiatant at the office went to administer a first dose of Shingrix to a patient and when the patient received it, she moved causing some of the vaccine to leak out onto the patient's arm and also reported that, some of the vaccine was left in the syringe as well but the medical assistant threw the syringe away immediately so they are unable to know how much of it was administered and how much was leftover, which led to incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose on 2019, second dose on 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 8th November 2019).   In September 2021, the patient received the 2nd dose of Shingrix. In September 2021, 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 provided as follows: The age at vaccination was not reported. The patient did not return for 2nd dose in recommended time interval after 1st dose of Shingrix. The patient then went to a different pharmacy in September 2021 and was given another dose, which led to lengthening of vaccination schedule. No further details provided. The reporter did not consent to follow up. This case was linked with case US2021AMR258228, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR258228:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a consumer 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) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 5th November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix (injection). 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 reporter was the patient. 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.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: was administered with an engerix-B expired dose; This case was reported by a nurse and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 5397F, expiry date 6th December 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 14th December 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 14th December 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 patient received an expired dose of Engerix B, which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Shingrix subcutaneously instead of IM; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th December 2021, the patient received the 1st dose of Shingrix (subcutaneous). On 14th December 2021, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix subcutaneously instead of Intramuscularly, which led to intramuscular formulation administered by other route. The reporter consented to follow up.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Received third dose; This case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On 18th September 2019, the patient received the 3rd dose of Shingrix. On 18th September 2019, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter consented to follow up. This case was linked with case US2021257813, reported by same reporter for different patient,; Sender's Comments:  US-GLAXOSMITHKLINE-US2021257813:same reporter
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; POSITIVE PCR CONFIRMED COVID-19 VACCINE AFTER BOOSTER DOSE OF JANSSEN COVID-19 VACCINE; This spontaneous report received from a patient concerned a 47 year old male. The patient's height and weight were not reported. The patient had no significant medical history. The patient was previously vaccinated with covid-19 vaccine ad26. cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: 23-AUG-2021) dose was not reported, 01 total was administered on 23-MAR-2021 on left arm for prophylactic vaccination (dose number in series 1). The reporter had not reported any adverse events following vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 expiry: 09-APR-2022) dose was not reported, 01 total was administered on 17-NOV-2021 on left arm for prophylactic vaccination (dose number in series 2). No concomitant medications were reported. On 29-NOV-2021 or 30 NOV-2021 (exact date not mentioned) the patient tested self (rapid test) found negative as his wife started to show symptoms to Covid. On 02-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2), the patient had cold like symptoms, little/light cough, feeling cold. On the same day, the patient reported a positive coronavirus disease (COVID)-19 test for himself on self (rapid) test when he retested after he began experiencing loss of smell. On 04-DEC-2021, laboratory test was performed and he had positive polymerase chain reaction (PCR) confirmed covid-19 vaccine after booster dose of Janssen covid-19 vaccine (confirmed clinical vaccination failure). He reported that, the lab result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was detected abnormal (Ab). He was treated with zinc, vitamin C, multivitamin and reported that he always wore a mask, prior to and after vaccination whenever leaving the house. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from positive PCR confirmed covid-19 vaccine after booster dose of Janssen covid-19 vaccine and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). The case was associated with product quality complaint (PQC): 90000205848. This case, involving the same patient is linked to 20211220582 and 20211217118, 20211217766 (wife's case).; Sender's Comments: V0:20211217227-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Feeling drunk, Hunger, Injection site pain
Clinical narrative: HEAVY IRREGULAR MENSTRUAL PERIODS; HORRIBLE HUNGER (COULD EAT AN ENTIRE BIG MEAL); FELT DRUNK; BODY ACHES; MUSCLE PAIN; HORRIBLE ARM PAIN (PAIN AT INJECTION SITE); FEVER OF 103 TO 105 DEGREE; DIZZINESS; DROWSINESS; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was 137 pounds, and height was 63 inches. The patient's concurrent conditions included: gluten intolerance, exercising, perimenopausal, non-smoker, non-alcoholic,  drug allergy  (esomeprazole), acetomycin (penicillin) allergy, and allergy to oral steroids. Patient was not on any medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: Unknown) dose was not reported, 1 in total, administered on 06-APR-2021 for prophylactic vaccination on her right arm (dose number in series 1). No concomitant medications were reported.  On 06-APR-2021, the patient experienced dizziness, drowsiness, body aches, muscle pain, horrible hunger (could eat an entire big meal), felt drunk which lasted for 3 days, fever of 103 to 105 degree which lasted for few days and horrible arm pain (pain at injection site) relived by putting ice and lasted for 1 week. Laboratory data included: Body temperature (NR: not provided) fever of 103 to105 degree. On an unspecified date, the patient experienced heavy irregular menstrual periods (got period twice a month for 3 months after receiving the vaccine then it went back to normal) (dose number in series 1). The patient did not take any medication for all her symptoms, the only measure she took was having chamomile drinks and getting a lot of sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, drowsiness, horrible hunger (could eat an entire big meal), felt drunk, body aches, and muscle pain on 09-APR-2021, heavy irregular menstrual periods, horrible arm pain (pain at injection site) on 13-APR-2021, and fever of 103 to 105 degree on APR-2021. This report was non-serious. This case, involving the same patient is linked to 20211219942.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Menometrorrhagia, Myalgia, Pain, Pyrexia, Somnolence
Clinical narrative: HEAVY IRREGULAR MENSTRUAL PERIODS; HORRIBLE HUNGER (COULD EAT AN ENTIRE BIG MEAL); FELT DRUNK; BODY ACHES; MUSCLE PAIN; HORRIBLE ARM PAIN (PAIN AT INJECTION SITE); FEVER OF 103 TO 105 DEGREE; DIZZINESS; DROWSINESS; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was 137 pounds, and height was 63 inches. The patient's concurrent conditions included: gluten intolerance, exercising, perimenopausal, non-smoker, non-alcoholic,  drug allergy  (esomeprazole), acetomycin (penicillin) allergy, and allergy to oral steroids. Patient was not on any medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: Unknown) dose was not reported, 1 in total, administered on 06-APR-2021 for prophylactic vaccination on her right arm (dose number in series 1). No concomitant medications were reported.  On 06-APR-2021, the patient experienced dizziness, drowsiness, body aches, muscle pain, horrible hunger (could eat an entire big meal), felt drunk which lasted for 3 days, fever of 103 to 105 degree which lasted for few days and horrible arm pain (pain at injection site) relived by putting ice and lasted for 1 week. Laboratory data included: Body temperature (NR: not provided) fever of 103 to105 degree. On an unspecified date, the patient experienced heavy irregular menstrual periods (got period twice a month for 3 months after receiving the vaccine then it went back to normal) (dose number in series 1). The patient did not take any medication for all her symptoms, the only measure she took was having chamomile drinks and getting a lot of sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, drowsiness, horrible hunger (could eat an entire big meal), felt drunk, body aches, and muscle pain on 09-APR-2021, heavy irregular menstrual periods, horrible arm pain (pain at injection site) on 13-APR-2021, and fever of 103 to 105 degree on APR-2021. This report was non-serious. This case, involving the same patient is linked to 20211219942.