chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the vaccine got shingles/Suspected vaccination failure; Got shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient had the Shingles vaccine and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: always administered Fluarix to their pregnant patients; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in an unspecified number of female patients who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Quadrivalent 2020-2021 season at an unknown time during the pregnancy. On an unknown date, unknown after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The reporter mentioned that, they had always administered Fluarix to their pregnant patients, which led to vaccine exposure during pregnancy. No other information was provided. The reporter consented to follow up.   Follow up information received on 2nd March 2021: The reporter stated that none of the patients had experience adverse reaction. The reporter asked if GlaxoSmithKline need records of all patients given Fluarix Quadrivalent 2020-2021 even if no reaction.  Follow up information received from other healthcare professional on 9th September 2021: The reporter reported that he/she did receive this form earlier this year but there was no patient information on it. He/she do not show in their records that any patient called them with an adverse reaction, so without patient information from GlaxoSmithKline, he/she was not sure who this was for. The pregnancy outcome was considered lost to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid pain, Headache, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Swollen right eyelid; Painful right eyelid at times; Fever of 101.7; Grape-size swollen lymph node under left armpit; Headache; Body aches; This case was reported by a consumer via call center representative and described the occurrence of axillary lymph nodes enlarged in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 30th August 2021, less than a day after receiving Shingrix, the patient experienced axillary lymph nodes enlarged, headache and general body pain. On 31st August 2021, the patient experienced fever. On 1st September 2021, the patient experienced swelling of eyelid and eyelid pain. On 1st September 2021, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the axillary lymph nodes enlarged, headache and general body pain were recovered/resolved and the outcome of the swelling of eyelid and eyelid pain were not recovered/not resolved.   It was unknown if the reporter considered the axillary lymph nodes enlarged, headache, general body pain, fever, swelling of eyelid and eyelid pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient.  The patient received Shingrix on the left arm and she felt a grape-size swollen lymph node under left armpit, a headache and body aches on the evening of the vaccination day which had recovered. On the next day after vaccination, the patient stated that she had a fever of 101.7 that went away the next morning.  Two days after the vaccination, the patient stated that she woke up with a swollen and at times painful right eyelid which had not recovered till the time of reporting.  The reporter consented to follow-up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling of eyelid
Clinical narrative: Swollen right eyelid; Painful right eyelid at times; Fever of 101.7; Grape-size swollen lymph node under left armpit; Headache; Body aches; This case was reported by a consumer via call center representative and described the occurrence of axillary lymph nodes enlarged in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 30th August 2021, less than a day after receiving Shingrix, the patient experienced axillary lymph nodes enlarged, headache and general body pain. On 31st August 2021, the patient experienced fever. On 1st September 2021, the patient experienced swelling of eyelid and eyelid pain. On 1st September 2021, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the axillary lymph nodes enlarged, headache and general body pain were recovered/resolved and the outcome of the swelling of eyelid and eyelid pain were not recovered/not resolved.   It was unknown if the reporter considered the axillary lymph nodes enlarged, headache, general body pain, fever, swelling of eyelid and eyelid pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient.  The patient received Shingrix on the left arm and she felt a grape-size swollen lymph node under left armpit, a headache and body aches on the evening of the vaccination day which had recovered. On the next day after vaccination, the patient stated that she had a fever of 101.7 that went away the next morning.  Two days after the vaccination, the patient stated that she woke up with a swollen and at times painful right eyelid which had not recovered till the time of reporting.  The reporter consented to follow-up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Axillary pain, Chest pain, Chills, Injection site pain
Clinical narrative: Swelling in chest spreading from armpit area; Chills; Body aches; Weakness; Pain in the armpit from swelling areas; Pain in the chest from swelling areas; Feeling warm; Pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chickenpox.   On 3rd September 2021 18:00, the patient received the 1st dose of Shingrix (intramuscular). On 3rd September 2021, less than a day after receiving Shingrix, the patient experienced injection site pain. On 4th September 2021, the patient experienced axillary pain, chest pain, feeling of warmth, chills, general body pain and weakness. On 5th September 2021, the patient experienced swelling. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain, chest pain, feeling of warmth, chills, general body pain and weakness were recovered/resolved and the outcome of the axillary pain and swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, axillary pain, chest pain, feeling of warmth, swelling, chills, general body pain and weakness to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The patient stated that she received shingrix vaccine and experienced injection site pain on the day of vaccination. The next date, the patient developed chills, body aches, weakness, pain and swelling in her armpit of the same arm of the injection site. The patient also stated that the next to next day of vaccination her armpit swelling was more painful and spreading to her chest. The patient had a call in to her health care professional. The patient stated that she took ibuprofen. Also gave medical disclaimer and rferred to health care professional. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: Swelling in chest spreading from armpit area; Chills; Body aches; Weakness; Pain in the armpit from swelling areas; Pain in the chest from swelling areas; Feeling warm; Pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chickenpox.   On 3rd September 2021 18:00, the patient received the 1st dose of Shingrix (intramuscular). On 3rd September 2021, less than a day after receiving Shingrix, the patient experienced injection site pain. On 4th September 2021, the patient experienced axillary pain, chest pain, feeling of warmth, chills, general body pain and weakness. On 5th September 2021, the patient experienced swelling. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain, chest pain, feeling of warmth, chills, general body pain and weakness were recovered/resolved and the outcome of the axillary pain and swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, axillary pain, chest pain, feeling of warmth, swelling, chills, general body pain and weakness to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The patient stated that she received shingrix vaccine and experienced injection site pain on the day of vaccination. The next date, the patient developed chills, body aches, weakness, pain and swelling in her armpit of the same arm of the injection site. The patient also stated that the next to next day of vaccination her armpit swelling was more painful and spreading to her chest. The patient had a call in to her health care professional. The patient stated that she took ibuprofen. Also gave medical disclaimer and rferred to health care professional. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Underdose
Clinical narrative: vaccine running down on patient's arm; did not receive a full dose; vaccine running down on patient's arm; This case was reported by a pharmacist via call center representative and described the occurrence of exposure via skin contact in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th September 2021, the patient received the 1st dose of Shingrix .5 ml. On 5th September 2021, unknown after receiving Shingrix, the patient experienced exposure via skin contact, accidental underdose and inadvertent exposure to vaccine. On an unknown date, the outcome of the exposure via skin contact, accidental underdose and inadvertent exposure to vaccine were unknown.  Additional details were reported as follows: This case was reported by the pharmacist. The age at vaccination was not reported. The reporter stated that while administering the Shingrix vaccine to the patient, some of vaccine was running down on patient's arm, which led to exposure via skin contact, inadvertent exposure to vaccine and accidental underdose. The reporter's concern was that the patient did not receive a full dose of Shingrix. The reporter consented to follow up.
Age: 41.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: administered an expired dose; 41 years old patient received Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 41-year-old male patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 1st July 2021) for prophylaxis.   On 7th September 2021, the patient received the 1st dose of Shingrix. On 7th September 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: On 7th September 2021, the nurse administered an expired dose of Shingrix in right arm to 41 year old patient which got expired on 7th July 2021, which led to expired vaccine used and inappropriate age at vaccine administration. No other detail was available. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: was given an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA380A, expiry date 31st August 2021) for prophylaxis.   On 7th September 2021, the patient received Menveo. On 7th September 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: This case was reported by the pharmacist. The reporter stated that, the patient was given an expired dose of Menveo on 7th September 2021. The Menveo expired on 31st August 2021,Which led to expired vaccine used. The reporter consented to follow up. The initial and followup processed together.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 12-year-old received Infanrix; received Infanrix instead of Boostrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old male patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th September 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 7th September 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, 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: Nurse reported that a 12-year-old patient received Infanrix instead of Boostrix which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis
Clinical narrative: cellulitis below injection site; This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 29-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular). On an unknown date, less than 2 years after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was recovered/resolved.   It was unknown if the reporter considered the cellulitis to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided are as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient received Fluarix in 2019 in left arm and had cellulitis right below injection site on left arm after getting Fluarix. The patient stated that she had a reaction to Fluarix. The reporter consented to follow-up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Third dose due not administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 28-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 (received 1st dose on an unknown date) and Twinrix with an associated reaction of no adverse event (received 2nd dose on 10th November 2020, batch number dk23d expiry date 8th February 2022).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix 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 provided as follows: The age at vaccination was not applicable. The patient received 1st and 2nd dose of Twinrix at primary reporter's facility. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination. No date of birth was provided. The reporter consented to follow up.
Age: 11.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV, DTAPIPV
Symptoms: Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: kinrix was dose 3; kinrix was dose 2; Kinrix given instead of Tdap; 11 YO pt was given Kinrix; kinrix was dose 4; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa-IPV (Kinrix) (batch number HN9Y52, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included kinrix (1st dose received on an unknown date).   On 2nd September 2021, the patient received the 4th dose of Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Kinrix, Kinrix Pre-Filled Syringe Device, the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 2nd September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device and not applicable after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered, inappropriate age at vaccine administration and extra dose administered. On an unknown date, the patient experienced extra dose administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered, inappropriate age at vaccine administration, extra dose administered, extra dose administered and extra dose 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 provided were as follows: The nurse called to report that an 11 years old patient was administered 4th dose of Kinrix in left arm instead of Tdap which led to wrong vaccine used, inappropriate age at vaccine administration and extra dose administered.  The 3 doses of Kinrix was already received by the patient, which led to extra dose administered for the 2nd dose and 3rd dose. The vaccine administration facility is the same as primary reporter. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021190992:deleted duplicate case
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Rash
Clinical narrative: shingles on breast, neck, back, hairline; miserable; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's son got shingles but he was not vaccinated against shingles).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced shingles and feeling miserable. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the feeling miserable was unknown.   It was unknown if the reporter considered the shingles and feeling miserable 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 stated that, she got a shingles shot about a year ago from the date of reporting. She had 1 shot (not 2) and also did not know the name of the product (if it was Shingrix or Zostavax). The patient reported a couple days after getting the shot had got a shingles outbreak on her breast and back and up around her neck and hairline which made her miserable. Because she did not know which shingles immunization she received, she provided the phone number to the pharmacy where she got the shot.
Age: 18.0
Sex: F
Vaccine: MNQ
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 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA377A, expiry date 31st August 2021) for prophylaxis.   On 1st September 2021, the patient received Menveo. On 1st September 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details provided were as follows: The health care professional reported that a female patient received an expired dose of Menveo and the dose expired on 31st August 2021 which led to expired vaccine used. Reporter consented to follow up. The vaccine administration facility is the same as primary reporter. Reporter consent to follow up.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: administered with a Boostrix dose Subcutaneously.; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 10-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number E55XZ, expiry date 24th June 2022) for prophylaxis.   On 7th September 2021, the patient received Boostrix. On 7th September 2021, unknown after receiving Boostrix, 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 reported as follows: This case was reported by nurse. The nurse reported that patient was administered with a Boostrix dose subcutaneously, instead of intramuscular route, which led to Intramuscular formulation administered by other route. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Asthenia, Back pain, Pain, Photosensitivity reaction
Clinical narrative: Abdominal cramps; Fever; Sun sensitivity; Weight loss; generalized weakness; body aches; back pain; This case was reported by a consumer via call center representative and described the occurrence of abdominal cramp in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced abdominal cramp, fever, sun sensitivity, weight loss, weakness generalized, general body pain and back pain. On an unknown date, the outcome of the abdominal cramp and fever were recovered/resolved and the outcome of the sun sensitivity, weight loss, weakness generalized and general body pain were not recovered/not resolved and the outcome of the back pain was unknown.   It was unknown if the reporter considered the abdominal cramp, fever, sun sensitivity, weight loss, weakness generalized, general body pain and back pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. Patient had received the second dose of shingrix vaccine over a month ago.  She stated that since then, she had abdominal cramps, fever, body aches, generalized weakness, experienced weight loss, back pain and sun sensitivity.  The fever had resolved, but the other symptoms interchanged daily and would go away after 5 to 6 hours. The patient was advised to see health care professional.  Patient declined to provide health care professional information.  No further information was provided. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Weight decreased
Clinical narrative: Abdominal cramps; Fever; Sun sensitivity; Weight loss; generalized weakness; body aches; back pain; This case was reported by a consumer via call center representative and described the occurrence of abdominal cramp in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced abdominal cramp, fever, sun sensitivity, weight loss, weakness generalized, general body pain and back pain. On an unknown date, the outcome of the abdominal cramp and fever were recovered/resolved and the outcome of the sun sensitivity, weight loss, weakness generalized and general body pain were not recovered/not resolved and the outcome of the back pain was unknown.   It was unknown if the reporter considered the abdominal cramp, fever, sun sensitivity, weight loss, weakness generalized, general body pain and back pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. Patient had received the second dose of shingrix vaccine over a month ago.  She stated that since then, she had abdominal cramps, fever, body aches, generalized weakness, experienced weight loss, back pain and sun sensitivity.  The fever had resolved, but the other symptoms interchanged daily and would go away after 5 to 6 hours. The patient was advised to see health care professional.  Patient declined to provide health care professional information.  No further information was provided. The reporter did not consent to follow-up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administered the Shingrix second dose at 4 weeks and 2 days; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 77427, expiry date 25th March 2023) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 3rd September 2021, the patient received the 2nd dose of Shingrix. On 3rd September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The Pharmacist stated that they administered the Shingrix second dose at 4 weeks and 2 days to a patient, instead of at 2 months, which led to drug dose administration interval too short. The reporter did not consent to follow-up.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Abdominal pain, Gingival swelling, Lip swelling, Penile swelling, Rash
Clinical narrative: swelling of penis; swelling of gums; swelling of lips; abdominal pain; skin rash; This case was reported by a nurse via call center representative and described the occurrence of penile swelling in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABxB29BA, expiry date 30th June 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 25th August 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 26th August 2021, 1 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced penile swelling, gum swelling, lip swelling, abdominal pain and rash. On an unknown date, the outcome of the penile swelling, gum swelling, lip swelling, abdominal pain and rash were unknown.   It was unknown if the reporter considered the penile swelling, gum swelling, lip swelling, abdominal pain and rash to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The nurse at the patient's health care professional office was the reporter.  The following day of the vaccination patient had symptoms such as skin rash, abdominal pain, swelling of the lips, gums, and penis.  The reporter consented to follow up.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 14-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number BB74J, expiry date 30th June 2021) for prophylaxis.   On 8th September 2021, the patient received FluLaval Quadrivalent. On 8th September 2021, unknown after receiving FluLaval Quadrivalent, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: The nurse reported that patient received an expired dose of Flulaval Quadrivalent, the vaccine expired on 30th June 2021, which led to expired vaccine used. The reporter consented to follow-up. This case had been linked with US2021191998, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021191998:same reporter
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: receiving expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number BB74J, expiry date 30th June 2021) for prophylaxis.   On 8th September 2021, the patient received FluLaval Quadrivalent. On 8th September 2021, unknown after receiving FluLaval Quadrivalent, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: The nurse reported that patient received an expired dose of Flulaval Quadrivalent, the vaccine expired on 30th June 2021, which led to expired vaccine used. The reporter consented to follow-up. This case had been linked with US2021191992, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021191992:same reporter
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Musculoskeletal stiffness, Neck pain
Clinical narrative: stiff neck; painful neck; This case was reported by a consumer via call center representative and described the occurrence of stiff neck in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had outbreak 35 years ago), neck pain (during outbreak) and stiff neck (during outbreak).   On 10th June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 21st June 2021, 11 days after receiving Shingrix, the patient experienced stiff neck and neck pain. On 21st June 2021, the outcome of the stiff neck and neck pain were recovered/resolved.   It was unknown if the reporter considered the stiff neck and neck pain to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The patient received dose of Shingrix and approximately 11 days after receiving the Shingrix dose he had the same stiff and painful neck, which resolved on the same day. The patient consented to follow up with his physician.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Neuropathy peripheral
Clinical narrative: neuropathy amplified; uncomfortable; This case was reported by a consumer via call center representative and described the occurrence of neuropathy in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2021, the patient received the 1st dose of Shingrix. In August 2021, 24 hrs after receiving Shingrix, the patient experienced neuropathy (serious criteria GSK medically significant) and discomfort. On an unknown date, the outcome of the neuropathy and discomfort were recovered/resolved.   It was unknown if the reporter considered the neuropathy and discomfort to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient had received her first dose of Shingrix and after about 24 hours the patient experienced being uncomfortable and neuropathy which might had been amplified.  This had lasted for about 2 weeks. The reporter did not consent to follow-up. This case was linked with US2021192008, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021192008:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Muscle disorder
Clinical narrative: muscular reaction; This case was reported by a consumer via call center representative and described the occurrence of muscle disorder in a male 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 muscle disorder. On an unknown date, the outcome of the muscle disorder was unknown.   It was unknown if the reporter considered the muscle disorder to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient's spouse. The age at vaccination was not reported. The patient received the dose of Shingrix and experienced a muscular reaction. The reported did not consent to follow up. This case has been linked with the case US2021192003, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021192003:same reporter, different  patient.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: doesn't know how much of the medication patient received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number TP2N2, expiry date 10th February 2023) for prophylaxis.   On 8th September 2021, the patient received Shingrix. On 8th September 2021, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details were provided as follows: The pharmacist reported that, he administered Shingrix and the needle was defective and either the medication started coming back out or was not going in.  The pharmacist did not know how much of the medication, if any, the patient received, which led to incomplete dose administered. The reporter consented to follow up via email.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: late 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 patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination is not applicable for this report. Pharmacy intern reported a patient was late for dose 2nd of Shingrix and the patient was not received 2nd dose till the time of reporting which led to incomplete course of vaccination. The reporter consented to follow up. No further information was reported.
Sex: U
Vaccine: HEP, HEPAB
Symptoms: Incomplete course of vaccination, Wrong product administered
Clinical narrative: first dose twinrix second dose engerix; first and third dose twinrix second dose engerix; This case was reported by a pharmacist via and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B, the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and incomplete course of vaccination. On an unknown date, the outcome of the wrong vaccine administered and incomplete course of vaccination 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 for Engerix B and not applicable for Twinrix. The reporter stated that the patient administrated with a first dose of Twinrix, second dose as Engerix-b, which led to wrong vaccine administered and third dose as Twinrix. Till the time of reporting, the patients did not received 3rd dose of Twinrix, which led to incomplete course of vaccination. The healthcare professional thought could be multiple patients involved. No adverse event was reported. No batch number and expiry date reported. No patient details were reported. The reporter consented to follow-up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Headache, Neck pain, Neuralgia, Pain in extremity
Clinical narrative: Blisters on toes; Residual nerve pain; Pain in arm; pain in neck; Headache; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number P2J7E, expiry date 10th October 2022) for prophylaxis.   On 8th May 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 8th May 2021, immediately after receiving Shingrix, the patient experienced pain in arm, neck pain, headache and nerve pain. On an unknown date, the patient experienced blister. On an unknown date, the outcome of the pain in arm, headache and blister were recovered/resolved and the outcome of the neck pain was unknown and the outcome of the nerve pain was not recovered/not resolved.   The reporter considered the pain in arm, neck pain, headache, blister and nerve pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by health care professional from pharmacy on behalf of patient.  The patient reported that within minutes of receiving her first dose of Shingrix, she began to experience pain in her arm and neck, headache and nerve pain. She also developed blisters on her toes (unknown date) which had since resolved. She stated she still experienced the residual nerve pain on and off. The pain in arm, neck and headache had resolved.  The reporter did not consent to follow-up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Only administered the diluent portion; Only administered the diluent portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 4C493, expiry date 20th March 2023) for prophylaxis.   On 2nd September 2021, the patient received Shingrix. On 2nd September 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 reported as follows: Medical Assistant reported that female patient was vaccinated with the Shingrix vaccine but they only administered the diluent portion which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Health care professional (HCP) declined Medical Information when offered, as HCP reported they had already revaccinated the patient and they just want to get a replacement for the vial. The reporter consented to follow up.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: This would be dose #3; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (2 dose received in 2019).   On 8th September 2021, the patient received the 3rd dose of Shingrix (intramuscular). On 8th September 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 reported as follows: A pharmacist stated she gave the patient Shingrix on the day of reporting and patient states this was dose number 2nd, dose number 1st given in 2019.  The patient's daughter reported that the patient had already received his 2 doses of Shingrix in 2019, and this would be dose number 3 which led to extra dose administered.  They could not find information or paperwork on vaccines to verify dates.  The pharmacist asked for more information on patient who receive three doses of shingrix.  Consent to follow up was granted.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 26-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 525NP, expiry date 4th September 2021) for prophylaxis.   On 6th September 2021, the patient received Boostrix. On 6th September 2021, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided are as follows: Nurse reported that, the patient received expired boostrix vaccine, which led to expired vaccine used. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only adjuvant portion administered; only adjuvant portion administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 7F234, expiry date 13th October 2022) for prophylaxis.   In September 2021, the patient received the 2nd dose of Shingrix. In September 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 are as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix a week ago (date not specified) and only the adjuvant portion was administered, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow-up.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: administered Menveo instead of Bexsero by mistake; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA467A, expiry date 31st March 2022) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.  Additional details were provided are as follows: The case was reported by Medical assistant. The reporter reported that a 16 years old and 10 months old patient received 3rd dose Menveo instead of the 2nd dose of Bexsero by mistake, which led to wrong vaccine administered. The reporter consented to follow-up. The case was linked with case US2020180923 and US2021173183 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020180923:same reporter US-GLAXOSMITHKLINE-US2021173183:same reporter