chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspectevaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles at the time of reporting. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: second dose was 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 male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 8th February 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The pharmacist reported that a male patient was late for the 2nd dose of Shingrix and 2nd dose was not administered till the time of reporting which led to incomplete course of vaccination. No adverse event was reported. No lot number and expiration date provided. The reporter consented to follow up.
Age: 0.83
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: administered expired vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 10-month-old male patient who received HBV (Engerix B) (batch number KC57F, expiry date 4th September 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device injection syringe for prophylaxis.   On 8th September 2021, the patient received Engerix B and hepatitis B vaccine pre-filled syringe device. On 8th September 2021, unknown after receiving Engerix B and hepatitis B vaccine 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 nursing assistant. The patient was administered expired Engerix B vaccine inadvertently, the vaccine was expired on 4th September 2021, which led to expired vaccine used. The reporter did not consent to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Axillary pain, Limb discomfort, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: swelling and tightness under his left armpit; swelling and tightness under his left armpit; felt achy all over; arm hurt real bad at first like someone punched him real hard/ arm pain (in the injected arm); This case was reported by a consumer via call center representative and described the occurrence of local swelling in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had mild case of shingles a while back). Previously administered products included Moderna Covid shots with an associated reaction of adverse drug reaction (received 2nd dose on an unknown day and had more side effects with dose 2 than dose 1) and Moderna Covid shots with an associated reaction of adverse drug reaction (received 1st dose on an unknown day and had side effects).   On 8th September 2021, the patient received the 1st dose of Shingrix (intramuscular). In September 2021, less than a week after receiving Shingrix, the patient experienced local swelling, axillary pain, general body pain and pain in arm. On an unknown date, the outcome of the local swelling and axillary pain were not recovered/not resolved and the outcome of the general body pain and pain in arm were recovering/resolving.   The reporter considered the local swelling, axillary pain, general body pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient for himself. The patient stated that his (left) arm hurt bad at first like someone punched him real hard.  The arm pain has improved but it still hurt a little at the time of reporting. He states he felt achy all over. The achiness has improved but he still feels (somewhat) achy.  The patient had swelling and tightness under his left armpit which has not resolved. The swelling and tightness under left armpit had a later onset than the sore arm and achiness. The patient did not have the lot number/expiration date however he did provide his pharmacy contact information (where the shot was given) who should have that data on file.  The reporter did not consent to follow up and did not want to share his physician contact information. He indicated that he would call GlaxoSmithKline later if he has any change in his mind.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021193306:same reporter
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: swelling and tightness under his left armpit; swelling and tightness under his left armpit; felt achy all over; arm hurt real bad at first like someone punched him real hard/ arm pain (in the injected arm); This case was reported by a consumer via call center representative and described the occurrence of local swelling in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had mild case of shingles a while back). Previously administered products included Moderna Covid shots with an associated reaction of adverse drug reaction (received 2nd dose on an unknown day and had more side effects with dose 2 than dose 1) and Moderna Covid shots with an associated reaction of adverse drug reaction (received 1st dose on an unknown day and had side effects).   On 8th September 2021, the patient received the 1st dose of Shingrix (intramuscular). In September 2021, less than a week after receiving Shingrix, the patient experienced local swelling, axillary pain, general body pain and pain in arm. On an unknown date, the outcome of the local swelling and axillary pain were not recovered/not resolved and the outcome of the general body pain and pain in arm were recovering/resolving.   The reporter considered the local swelling, axillary pain, general body pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient for himself. The patient stated that his (left) arm hurt bad at first like someone punched him real hard.  The arm pain has improved but it still hurt a little at the time of reporting. He states he felt achy all over. The achiness has improved but he still feels (somewhat) achy.  The patient had swelling and tightness under his left armpit which has not resolved. The swelling and tightness under left armpit had a later onset than the sore arm and achiness. The patient did not have the lot number/expiration date however he did provide his pharmacy contact information (where the shot was given) who should have that data on file.  The reporter did not consent to follow up and did not want to share his physician contact information. He indicated that he would call GlaxoSmithKline later if he has any change in his mind.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021193306:same reporter
Age: 77.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: Inadvertently administrated an expired dose of Menveo; Patient is 77 years old; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 77-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number unknown, expiry date 31st August 2021) for prophylaxis.   On 10th September 2021, the patient received the 1st dose of Menveo. On 10th September 2021, unknown after receiving Menveo, 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: The reporter stated that they had inadvertently administrated an expired dose of Menveo to the patient on the reporting date, which led to inappropriate age at vaccine administration. The vaccination was meant to be first dose. The lot number of the vaccine was not asked. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Headache, Pyrexia
Clinical narrative: Headache; Chills; Fever; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th June 2021, the patient received the 1st dose of Shingrix. In June 2021, less than a day after receiving Shingrix, the patient experienced headache, chills, fever and fatigue. On an unknown date, the outcome of the headache, chills, fever and fatigue were recovered/resolved.   It was unknown if the reporter considered the headache, chills, fever and fatigue 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 received Shingrix and experienced headache, chills, fever, and fatigue approximately 6-8 hours after she received the dose.  The patient stated that symptoms were at their worst 24-48 hours after onset.  All symptoms were resolved after approximately 3-4 days.  The patient had not yet received second dose. The reporter did not consent to follow-up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered without antigen; Administered without antigen; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 9DM72, expiry date 28th January 2023) and (batch number 3N3GH, expiry date 28th January 2023) for prophylaxis.   On 10th September 2021, the patient received the 2nd dose of Shingrix (intramuscular) 1 ml. On an unknown date, the dose was an unknown dose. On 10th 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 as follows: The patient was administered 1 ml of adjuvant in the left deltoid. The medical assistant reported that, 2 vials of Shingrix adjuvant (batch number 3N3GH) were administered to the patient without active component (antigen), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter gave a consent to follow-up with health care professional office.
Age: 50.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Pain in extremity
Clinical narrative: Head to toe joint pain; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX) for prophylaxis.   On 7th September 2021, the patient received the 1st dose of Shingrix (intramuscular) and PNEUMOVAX. On 9th September 2021, 2 days after receiving Shingrix, the patient experienced joint pain and fatigue. On an unknown date, the outcome of the joint pain and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the joint pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. The patient had fatigue and head to toe joint pain. The reporter gave medical disclaimer and referred to health care professional, spoke per product indication and content and offered product indication.  The reporter provided phone number for health care professional reference. The reporter consented to follow up. This case was linked to case US2021193294 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021193294:Same reporter
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: adult dose of Havrix instead of the pediatric dose; adult dose of Havrix instead of the pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 7-year-old female patient who received HAV (Havrix adult) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device injection syringe for prophylaxis.   On 10th September 2021, the patient received the 2nd dose of Havrix adult and hepatitis A vaccine pre-filled syringe device. On 10th September 2021, unknown after receiving Havrix adult and hepatitis A vaccine pre-filled syringe device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a AMAS (unspecified). Health care professional reported that the patient received adult dose of Havrix instead of pediatric dose, which led to overdose, and adult product administered to child. The reporter consented to follow up. This case had been linked with US2021080764, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021080764:Same reporter
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antigen positive
Clinical narrative: Positive HBsAg; This case was reported by a pharmacist via call center representative and described the occurrence of hepatitis b surface antigen positive in a male patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HBV (Engerix B).   On 31st August 2021, the patient received the 2nd dose of Engerix B. On 7th September 2021, 7 days after receiving Engerix B, the patient experienced hepatitis b surface antigen positive. On an unknown date, the outcome of the hepatitis b surface antigen positive was unknown.  Additional details were provided as follows: The age at vaccination was not reported. 1st vaccination was done in the end of July 2021 (no further data provided) about lot number and expiry date. The patient presented positive hepatitis B surface antigens after 2nd dose of Engerix-B. No further data provided regarding lot number or expiry date of either doses was available. The reporter did not consent to follow-up.
Age: 31.0
Sex: M
Vaccine: UNK
Symptoms: Product administered at inappropriate site
Clinical narrative: Given in tricep not deltoid; This case was reported by a pharmacist via call center representative and described the occurrence of vaccine administered at inappropriate site in a 31-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2021-2022 season) (batch number 339DL, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th September 2021, the patient received FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 13th September 2021, unknown after receiving FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The pharmacist reported he was administered FluLaval Tetra 2021-2022 season and it was given in his tricep area not in the deltoid, which led to vaccine administered at inappropriate site. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2 years later received 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2nd July 2019).   On 1st July 2021, the patient received the 2nd dose of Shingrix. On 1st 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 age at vaccination was reported. The manager reported that, the patient received 2nd dose later than the recommended time interval, which led to lengthening of vaccination schedule. No other details of patient and vaccine available. The reporter consented to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barré, was in the hospital for a long time; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a elderly female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was recovered/resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Flu vaccine.  Age at vaccination was not reported. The reporter is a neighbor of the patient. The patient received a flu shot (year unknown) and later was diagnosed with Guillain-Barre, she was moved from her local hospital to a more specialized hospital and was in the hospital for a long time. The patient was recovered. The reporter has no other information. The reporter did not consented to follow-up. The case was linked with case US2021194306, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021194306:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose a week after the first; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time 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 age at vaccination was reported. The pharmacy intern reported that, the patient received 2nd dose of Shingrix, a week after the first dose, which led to shortening of vaccination schedule. The reporter had no other information about patient at the time of the report. The reporter consented to follow up by phone.
Sex: U
Vaccine: FLU4, FLU4, HEP, TDAP
Symptoms: Product storage error
Clinical narrative: vaccines exposed to high temperature, later administrated; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received HBV (Engerix B) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis, flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis and Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Engerix B, Boostrix, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device and Fluarix Quadrivalent 2019-2020 season. On an unknown date, unknown after receiving Engerix B, Boostrix, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device and Fluarix Quadrivalent 2019-2020 season, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The pharmacist reported that, the administration of Engerix-B, Boostrix, FuLaval, and Fluarix after the vaccines were inappropriately stored.  The health care professional worked in a nursing home were the vaccines were exposed to a high temperature for the course of 2 months and later administrated to the patients of the facility, which led to incorrect storage of drug. There was no information regarding how many patients, age, gender or which vaccine was given to each of them at the time of reporting. There was no information regarding the expiration date or lot number.  The health care professional did not know the date of the administration. It was only known that the vaccines were used after the temperature excursion. The reporter agreed to be contacted for follow-up.
Age: 1.33
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 16 month old patient received KINRIX; received KINRIX by mistake; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (received 2 doses on an unknown date).   On an unknown date, the patient received the 3rd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration 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 provided are as follows: Nurse reported that 16 months old patient received 3rd dose of Kinrix by mistake, which led to inappropriate age at vaccine administration and wrong vaccine administered. The patient's mother did not report any side effects or issues. The reporter reported that Kinrix was the 3rd dose of DTAP and 3rd of IPV.  Medicine of doctor (MD) was trying to catch up his patient who was behind on both.  The information regarding the previous vaccination of the patient was obtained from 2nd line agent after the transfer. No further events were reported at the time of the call. The reporter consented to follow-up by phone.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Feeling hot, Headache, Pain in extremity
Clinical narrative: Chills; Headache; weakness; hot left arm; sore left arm; This case was reported by a consumer via call center representative and described the occurrence of chills in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2021, the patient received the 1st dose of Shingrix (intramuscular). In April 2021, less than an hour after receiving Shingrix, the patient experienced chills, headache, weakness, extremities hot feeling of and pain in arm. On an unknown date, the outcome of the chills, headache, weakness, extremities hot feeling of and pain in arm were recovered/resolved.   It was unknown if the reporter considered the chills, headache, weakness, extremities hot feeling of and pain in arm to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The patient reported that the received Shingrix vaccine and within hour experienced chills, headache, weakness and lasted for a day. The patient also had a hot and sore arm within minutes after getting Shingrix and lasted for week. Referred to health care professional. The reporter did not give consent for follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 26 days after dose 1 received dose 2; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received Herpes zoster (Shingrix) (batch number DP95H, expiry date 15th April 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 28th September 2020, the patient received the 2nd dose of Shingrix. On 28th September 2020, unknown after receiving Shingrix and an unknown time 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 age at vaccination was reported. The patient received 1st dose of Shingrix on 2nd September 2020. The pharmacist reported that, the patient received 2nd dose early than the recommended time interval, which led to shortening of vaccination schedule. The reporter asked, if the patient needed 2nd dose of Shingrix. The health care professional declined to provided further details from patient, only gender reported. No other details of patient and vaccine available. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Injection site pain
Clinical narrative: arm hot at injection site and surrounding deltoid muscle; arm red at injection site and surrounding deltoid muscle; sore at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th September 2021, the patient received the 1st dose of Shingrix (intramuscular). On 8th September 2021, 1 hr after receiving Shingrix, the patient experienced injection site pain. On 13th September 2021, the patient experienced feeling hot and localized erythema. On an unknown date, the outcome of the injection site pain, feeling hot and localized erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, feeling hot and localized erythema to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient herself. The patient received a dose of Shingrix in the left arm and her arm was sore at the injection site when she received the vaccine. On 13th September 2021, the patient experienced that her arm was hot and red at the injection site and surrounding area of the left deltoid muscle. The patient did nit gave permission to contact health care professional and did not want GlaxoSmithKline to contact her. The reporter did not consented to follow-up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose on 08/26/2020, second dose on 08/30/2021; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 7292M, expiry date 16th April 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received 26th August 2020).   On 30th August 2021, the patient received the 2nd dose of Shingrix. On 30th August 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 physician reported that, the patient received 2nd dose later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter asked if needed to do titers because the dosing was not within your guidelines The reporter consented to follow up.
Age: 15.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pediarix administrated to a 15 year old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 7p2y3, expiry date 8th April 2023) 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 September 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 13th September 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient reported that Pediarix was administered on the same day to a 15 year old patient, which led to inappropriate age at vaccine administration. No further events were reported. Health care professional agreed to be contacted for follow-up.
Age: 1.58
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix to a 19 month old patient; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 19-month-old male patient who received DTPa-IPV (Kinrix) (batch number PP9L5, expiry date 16th October 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th August 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 10th August 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The nurse reported that another nurse assistant administered Kinrix to a 19 month old patient, which led to inappropriate age at vaccine administration. This case was linked with US2020AMR130607, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR130607:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: second dose not given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   In 2018, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Rash
Clinical narrative: rash going from her back into her side; Fatigue; Not feeling well; This case was reported by a nurse via call center representative and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced rash, fatigue and feeling unwell. On an unknown date, the outcome of the rash, fatigue and feeling unwell were unknown.   It was unknown if the reporter considered the rash, fatigue and feeling unwell to be related to Shingrix.  Additional details were reported as follows: Information came through a voicemail. This case was reported by the nurse. The nurse reported that a patient experienced a rash going from her back into her side, fatigue and not feeling well one day after a dose of Shingrix. The follow up consent was denied.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Extra dose administered
Clinical narrative: Red arm; 3rd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   In September 2021, the patient received the 3rd dose of Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced erythema of extremities and extra dose administered. On an unknown date, the outcome of the erythema of extremities and extra dose administered were unknown.   The reporter considered the erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was reported. The pharmacist stated that, the patient received a 3rd dose of Shingrix this past week, which led to extra dose administered. The reporter stated that, the patient had a really red arm from the vaccine. The health care professional did not have the exact dates of vaccination for any of the doses administered as they were administered at another pharmacy. The reporter did not have any lot numbers or any additional information to provide at the moment, but stated that she might be able to gather additional information. The reporter consented to follow up.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received 2 doses of adjuvant only; received 2 doses of adjuvant only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number L4H5, expiry date 25th January 2022) for prophylaxis.   On 13th September 2021, the patient received the 1st dose of Shingrix. On 13th 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 as follows: The nurse reported that, the patient received 2 doses of Shingrix adjuvant only, no lyophilized portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Expired product administered
Clinical narrative: received expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 43LY9, expiry date 5th September 2021) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 14th September 2021, the patient received the 2nd dose of Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On 14th September 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator 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 inadvertently received expired dose of Rotarix, which led to expired drug administered.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: second dose was not administer yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 13th October 2020, batch number 9974P, expiry date 9th May 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. The VAERS details reported for 1st dose of Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose: 3 years, second: not receive; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter wanted to know how to proceed. The health care professional provided limited information since she was not at the facility she was calling from her house. The reporter did not consent to follow up.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Accidental underdose
Clinical narrative: received less than half a dose; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 15-month-old female patient who received DTPa (Infanrix) (batch number 5RN39, expiry date 25th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th September 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 14th September 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose 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 less than half a dose of Infanrix vaccine because the patient was moving at the time of the injection, which led to accidental underdose. The reporter consented to follow up.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Shingrix unapproved diluent/ shingrix dose reconstituted with saline solution and not with the correct; shingrix dose reconstituted with saline solution and not with the correct; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number 3R45T, expiry date 17th September 2022) for prophylaxis.   On 13th September 2021, the patient received Shingrix. On 13th September 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The pharmacist reported that a male patient received a shingrix dose reconstituted with saline solution and not with the correct diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Cerebrovascular accident, Condition aggravated
Clinical narrative: Stroke; This case was reported by a consumer via call center representative and described the occurrence of stroke in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included stroke (had stroke 1 time approximately 1 month prior to Shingrix vaccine). Concomitant products included COVID-19 VACCINE MRNA (MRNA 1273) (MODERNA COVID 19 VACCINE (DOSE 1)) and COVID-19 VACCINE MRNA (MRNA 1273) (MODERNA COVID 19 VACCINE (DOSE 1)).   On 26th March 2021, the patient received the 1st dose of Shingrix (intramuscular). On 2nd April 2021, 7 days after receiving Shingrix, the patient experienced stroke (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the stroke was unknown.   It was unknown if the reporter considered the stroke to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient for herself. Teh patient received 2 doses of MODERNA COVID 19 VACCINE on 7th January 2021 and 4th February 2021.  The patient received Shingrix in left arm intramuscularly. The patient had a stroke approximately 1 week after the Shingrix vaccine. The patient inquired about the efficacy of Shingrix after 1 dose. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Illness
Clinical narrative: AUTOIMMUNE DISEASE; GOT SICK; This spontaneous report received via social media from a patient concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown Expiry: unknown) 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, patient got sick. Patient had 10 follow up doctor appointments, weekly physical therapy and injections (unspecified). The patient reported that she was being treated for an autoimmune disorder and had been a trainwreck for months post vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the auto immune disease and got sick was not reported.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210925713-COVID-19 VACCINE AD26.COV2.S-Autoimmune disease. This event(s) is considered unassessable. The event(s) has a unclear/unknown temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).