chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on February 28, 2020; This case was reported by a consumer via media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 28th February 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient had reported for him/herself. 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 vaccination schedule. The patient asked, if it was okay to get 2nd dose if the 1st dose was on 28th February 2020.
Sex: U
Vaccine: VARZOS
Symptoms: Eye infection viral
Clinical narrative: virus in my left eye; This case was reported by a consumer and described the occurrence of eye infection viral in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine, the patient experienced eye infection viral. On an unknown date, the outcome of the eye infection viral was unknown.   It was unknown if the reporter considered the eye infection viral to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingles vaccine and got a virus in his/her left eye just a month after. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had the shingles\ suspected vaccination failure; shingles; pain; 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had shingles, got the Shingles shot and had a lot less pain from the shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; had the worst case of 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, 1 year 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient had this Shingles shot many years before the date of reporting when they first came out and one and a half years later the patient had the worst case of shingles that the patient has ever heard of. The patient stated forget the shot as far as he/she concerned. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule and laboratory confirmation for shingles were unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling
Clinical narrative: possible cellulitis on injection arm.; swelling and redness with possible cellulitis on injection arm./ Shoulder to elbow; swelling and redness with possible cellulitis on injection arm.; This case was reported by a physician via sales rep and described the occurrence of cellulitis of arm in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, 1 day after receiving Shingrix, the patient experienced cellulitis of arm (serious criteria GSK medically significant), extensive swelling of vaccinated limb and erythema of extremities. The patient was treated with medication unknown (Patch) and antibiotics nos (Antibiotics Therapy (Unknown)). On an unknown date, the outcome of the cellulitis of arm, extensive swelling of vaccinated limb and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the cellulitis of arm, extensive swelling of vaccinated limb and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A day after administration of Shingrix, the patient had swelling, redness with possible cellulitis on injection arm from shoulder to elbow. The patient sought treatment at local emergency department. The patient was given patch and antibiotics. The symptoms resolved. No additional information known at the time of reporting. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Itching at vaccine site an allergic reaction?; This case was reported by a consumer via interactive digital media and described the occurrence of injection site itching in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2021, the patient received Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was unknown.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for himself/herself. The age at vaccination was not reported. The patient reported that, he/she got the Shingrix vaccine 3 days ago and had the normal reactions, but there was some itching at the vaccine site.  The patient asked, was this considered an allergic reaction.
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had the TWINRIX vaccine at schedule 0 and 6; This case was reported by a consumer via (Twinrix GSK Chatbot) interactive digital media and described the occurrence of drug dose administration interval too long in a 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).   On an unknown date, the patient received the 2nd 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 drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received Twinrix vaccine at schedule 0 and 6 months instead of the intended 0, 1 and 6 months schedule, which led to lengthening of vaccination schedule. The reporter would like to know what was the coverage and if next dose required.
Sex: U
Vaccine: VARZOS
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: received doses that were impacted by the voluntary recall; received doses that were impacted by the voluntary recall; This case was reported by a pharmacist via call center representative and described the occurrence of recalled drug administered in a patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date unknown) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2 doses of Shingrix from recalled batch, which led to recalled drug administered and drug dispensing error. No further details provided on the call. The specialist neglected to note potential event during call, and thus limited details were obtained and specialist neglected to ask whether safety had permission to follow up. This case was linked with case US2021AMR213387 and US2021212537 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR213387:same reporter US-GLAXOSMITHKLINE-US2021212537:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Injection site pain
Clinical narrative: arm is sore where the shot was given; shivering; slight burning sensation in my arm; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In September 2021, unknown after receiving Shingrix, the patient experienced injection site pain, shivering and burning sensation. On an unknown date, the outcome of the injection site pain, shivering and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, shivering and burning sensation to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received the Shingrix shot and was shivering at the time of reporting.  The patient's left upper arm was sore where the shot was given, and the patient had a slight burning sensation in the arm. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose September 2020; This case was reported by a other health professional and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on September 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: shot in May 2018 when am I due for the next shot; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose in May 2018).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaaccination 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.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling cold, Lymph node pain, Lymphadenopathy, Pain in extremity
Clinical narrative: less fever; chills; shoulder pain; arm pain; swollen lymph node; painful lymph node; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 11th October 2021, the patient received Shingles vaccine. In October 2021, less than a week after receiving Shingles vaccine, the patient experienced fever, chills, shoulder pain, pain in arm, enlargement of lymph nodes and lymph node pain. On an unknown date, the outcome of the fever, chills, shoulder pain, pain in arm, enlargement of lymph nodes and lymph node pain were unknown.   It was unknown if the reporter considered the fever, chills, shoulder pain, pain in arm, enlargement of lymph nodes and lymph node pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingrix vaccine on Monday before reporting date. The patient had all the symptoms above less fever (but chills). Moreover, the patient had developed a swollen, painful lymph node above clavicle certainly arm and shoulder pain. The patient enquired if he or she was ok. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: less fever; chills; shoulder pain; arm pain; swollen lymph node; painful lymph node; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 11th October 2021, the patient received Shingles vaccine. In October 2021, less than a week after receiving Shingles vaccine, the patient experienced fever, chills, shoulder pain, pain in arm, enlargement of lymph nodes and lymph node pain. On an unknown date, the outcome of the fever, chills, shoulder pain, pain in arm, enlargement of lymph nodes and lymph node pain were unknown.   It was unknown if the reporter considered the fever, chills, shoulder pain, pain in arm, enlargement of lymph nodes and lymph node pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingrix vaccine on Monday before reporting date. The patient had all the symptoms above less fever (but chills). Moreover, the patient had developed a swollen, painful lymph node above clavicle certainly arm and shoulder pain. The patient enquired if he or she was ok. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: headache; body aches; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13th October 2021, the patient received Shingles vaccine. On 13th October 2021, less than a day after receiving Shingles vaccine, the patient experienced headache and general body pain. On an unknown date, the outcome of the headache and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the headache and general body pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient took the shingles vaccine and experienced body aches and headache. The patient enquired if he/she could take acetaminophen. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on 24Aug2020; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 24th August 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Paraesthesia
Clinical narrative: Tingling, left arm, hand, leg and foot; first on 8-March 2021, second on 24-September 2021; This case was reported by a consumer via call center representative and described the occurrence of tingling in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis and flu seasonal qiv dresden pre-filled syringe device (Influenza Vaccine Quadrivalent Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Covid 19 vaccine (received 1st dose of COVID in April 2021), Covid 19 vaccine (received 2nd dose of COVID in May 2021) and Shingrix (received 1st dose on 8th March 2021 in right arm, refer case US2021212569).   On 24th September 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 10th September 2021, the patient received Influenza vaccine Quadrivalent unspecified season and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device. On 24th September 2021, unknown after receiving Shingrix and not applicable after receiving Influenza vaccine Quadrivalent unspecified season and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced tingling. On an unknown date, the outcome of the tingling and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the tingling to be related to Shingrix, Influenza vaccine Quadrivalent unspecified season and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was the patient. The patient received 2nd dose in right deltoid at physician's office. The patient received flu vaccine 2 weeks prior to the 2nd dose of Shingrix. The reporter stated that after 2nd dose of Shingrix, developed tingling down her left arm and hand, as well as down her left leg and foot. The tingling in leg and foot has resolved. The tingling in arm and hand is unresolved. The patient received 2nd dose later than the 1st dose of Shingrix, which led to lengthening of vaccination schedule. The patient had an appointment scheduled for tomorrow with her health care professional regarding the unresolved tingling.The reporter could not provide the lot or expiration of the vaccine but stated that the physician's office administered the vaccines and would have that information.  The reporter consented to follow up with her physician. The case was linked with case US2021212569, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021212569:Same patient
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not receive their second dose; This case was reported by a other health professional via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over 2 years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided asa 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 asked if the patient need to repeat the series.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash 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, 3 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.   Additional details were provided as follows: The case was reported by the patient. Age at vaccination was not reported. The patient asked was a rash starting 3 days after your 2nd shot was common. No contact details were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: Missed the window for 2nd shot; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose in January 2021) and Covid 19 vaccine (received 1st dose in April 2021).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter suggested to wait on the second shingles dose until, the patient's second COVID dose, which led to social problem.
Sex: U
Vaccine: VARZOS
Symptoms: Product administration error, Syringe issue
Clinical narrative: user attempted to administer, adjuvant leaked from the sides of the vial.; Pharmaceutical product complaint; This case was reported by a consumer and described the occurrence of intercepted drug administration error in a patient who received Herpes zoster (Shingrix) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted drug administration error and pharmaceutical product complaint. On an unknown date, the outcome of the intercepted drug administration error and pharmaceutical product complaint were unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient attempted to administer a dose of shingrix, adjuvant leaked from the sides of the vial, which led to intercepted drug administration error and pharmaceutical product complaint.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Feeling abnormal, Herpes zoster, Injection site pain, Injection site paraesthesia
Clinical narrative: right hand swelling; blisters or vesicles on right forearm down from injection site; Pain right arm; 2 patches of Rash right forearm & antecubital / abrasion; feeling bad; tingling right arm; Suspects Shingles; This case was reported by a physician via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2021, the patient received Shingrix. On 5th October 2021, less than a day after receiving Shingrix, the patient experienced shingles, feeling bad and tingling of extremity. On 6th October 2021, the patient experienced patchy rash. On 7th October 2021, the patient experienced hand swelling, blister and pain in arm. On 8th October 2021, the outcome of the shingles, patchy rash, feeling bad, tingling of extremity, hand swelling, blister and pain in arm were recovered/resolved.   It was unknown if the reporter considered the shingles, patchy rash, feeling bad, tingling of extremity, hand swelling, blister and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a very unusual rash following Shingrix vaccination on the right deltoid.  Patient experienced general feeling bad and tingling right arm on evening. The patient experienced 2 patches of rash on right forearm and antecubital similar to an abrasion.  Patient had seen in office with right hand swelling, blisters or vesicles on right forearm down from injection site and pain. Reporter suspected Shingles. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: right hand swelling; blisters or vesicles on right forearm down from injection site; Pain right arm; 2 patches of Rash right forearm & antecubital / abrasion; feeling bad; tingling right arm; Suspects Shingles; This case was reported by a physician via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2021, the patient received Shingrix. On 5th October 2021, less than a day after receiving Shingrix, the patient experienced shingles, feeling bad and tingling of extremity. On 6th October 2021, the patient experienced patchy rash. On 7th October 2021, the patient experienced hand swelling, blister and pain in arm. On 8th October 2021, the outcome of the shingles, patchy rash, feeling bad, tingling of extremity, hand swelling, blister and pain in arm were recovered/resolved.   It was unknown if the reporter considered the shingles, patchy rash, feeling bad, tingling of extremity, hand swelling, blister and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a very unusual rash following Shingrix vaccination on the right deltoid.  Patient experienced general feeling bad and tingling right arm on evening. The patient experienced 2 patches of rash on right forearm and antecubital similar to an abrasion.  Patient had seen in office with right hand swelling, blisters or vesicles on right forearm down from injection site and pain. Reporter suspected Shingles. The reporter consented to follow up.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: received vaccine 19 hours after the vaccine was reconstituted /  was placed back into the refrigerator after it was reconstituted; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA636A, expiry date 31st May 2023) for prophylaxis.   On 8th October 2021, the patient received Menveo (intramuscular). On an unknown date, unknown after receiving Menveo, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The health care professional called that a pediatric age patient inadvertently received the Menveo 19 hours after the vaccine was reconstituted received in the left arm which led to incorrect storage of drug.  The office manager stated that Menveo was reconstituted and drawn up into a syringe yesterday around 4:45 pm from the day of reporting and was not administered until this morning at 10:40.  It was placed back into the refrigerator after it was reconstituted. The reporter consented to follow up viz email. The case US2021209451 identified as duplicate of US2021209460, so the case US2021209451 will be delete and all the information from the case will be merged into the case US2021209460, the case US2021209460 will be the case of record.
Sex: F
Vaccine: VARZOS
Symptoms: Intercepted product prescribing error
Clinical narrative: Shingrix to patients under 50; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (the patient had shingles before).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.  Additional details were reported as follows: This case was reported by the pharmacist. The age at vaccination was not applicable for this report. The pharmacist reported that that Doctors have been prescribed  Shingrix to patients under the age of 50, which led to  intercepted drug prescribing error. The pharmacist reported that they did not have patients information, she was looking for general information about Shingrix in patients under 50. The health care professional mentioned that Shingrix was administered to a female patient but she was not sure if the patient was immunocompromised, the patient had shingles before. The reporter consented to follow-up. The has been linked with US2021AMR210277, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR210277:Same reporter US-GLAXOSMITHKLINE-US2021209480:Same reporter
Age: 1.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 4 months of age (administered on 29Jul2019 / 16 months of age (administered on 14Aug2020 / 19 months of age (administered on 13Nov2020; 4 months of age (administered on 29Jul2019 / 16 months of age (administered on 14Aug2020 / 19 months of age (administered on 13Nov2020; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 1-year-old female patient who received DTPa (Infanrix) (batch number D2KX9, expiry date 26th November 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) (batch number 5CK5K, expiry date 17th January 2022) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Infanrix (received 1st dose on 29th May 2019 at 8 weeks of age, batch number and expiration date were unknown) and Infanrix (received 2nd dose on 29th July 2019 at 4 month of age, batch number and expiration date were unknown).   On 13th November 2020, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 14th August 2020, the patient received the 3rd dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 14th August 2020, not applicable after receiving Infanrix and Infanrix Pre-Filled Syringe Device and unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On 13th November 2020, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long and drug dose administration interval too long 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 nurse reported that patient received 3rd dose of Infanrix at 16 months of age and booster dose at 19 months of age longer than recommended schedule, which led to lengthening of vaccine schedule. The first two doses were administered at a different doctor's office, the second two doses were administered at the reporter's facility. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Product supply issue, Social problem
Clinical narrative: unable to receive second dose, lack of availability; unable to receive second dose due to Covid pandemic; This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date, 0.5 ml,  intramuscularly about 2 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 product supply issue and social problem. On an unknown date, the outcome of the product supply issue and social problem were unknown.  Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not applicable for this report. The patient received the first dose of Shingrix 2 years ago. he was unable to receive the second dose due to lack of availability , which led to product supply issue. And then later was not able to get the second dose due to the Covid pandemic, which led to social problem. The reporter did not consent to follow-up. This case was linked with US2021210625, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021210625:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Syringe issue, Underdose
Clinical narrative: did not get full vaccine.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2021, the patient received Shingrix. On 11th October 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 age at vaccination was not reported. The registered pharmacist reported that, during administration of Shingrix, the needle leaked and the patient did not get full vaccine which led to incomplete dose administered. No product quality complaint was reported by healthcare professional.  No other detail of vaccine or patient was available.  The vaccine administration facility was the same as primary reporter.  The reporter consented to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: first dose on 2019, due to the pandemic, received dose 2 today; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number Z4427, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 03rd September 2019, batch number 249DB).   On 12th October 2021, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Due to the pandemic, the patient did not return for 2nd dose of Shingrix and received vaccine on the date of reporting The reporter consented to follow up via email. No further details were provided via call.
Sex: U
Vaccine: UNK
Symptoms: Accidental underdose, Product complaint
Clinical narrative: full dose then administered on second attempt; Vials had missing component that keeps vials secure; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2021-2022 season) (batch number A2AK3, expiry date 30th June 2022) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2021-2022 season (intramuscular) and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced accidental underdose and pharmaceutical product complaint. On an unknown date, the outcome of the accidental underdose and pharmaceutical product complaint 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 age at vaccination was not report Health care professional reported Flulaval administered as a partial dose after the needle separated from the syringe, which led to accidental underdose. Health care professional reported full dose then administered on second attempt. Health care professional was unable to provide adverse event. The reporter was asked at what step was the defect discovered and when putting needle on and heared the click. The reporter was asked whether or not the product was administered or partially administered included statement to provide this information even if did not seem applicable and received a reply as 1 patient. The reporter was asked if health care professional preparing/administering vaccine was a new or experienced user, so got answer as experienced user. The reporter enquired to clearly describe which component was impacted and got answer as vials had missing component that keeps vials secure. The reporter was asked what type of needle was used and if any defect or damage on the syringe was noticed and got answer as no. The reporter was asked while removing the cap, was it pulled off or screwed off (as it should be), the health care professional was unsure. The reporter was asked about the needle connected and was it screwed on the device or pushed on, the health care professional was unsure. The reporter was asked if a problem was detected when screwing the needle on, did the customer continued to attempt to screw it on (perhaps stripping the locking mechanism), the health care professional stopped when they heard a click. The reporter was asked if the device began to spin around the syringe cone, did you hold the device in place when attaching the needle, the health care professional was unsure.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: given a dose stored out of range; This case was reported by a other health professional via call center representative and described the occurrence of incorrect product storage in a 26-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number GC5NG, expiry date 1st April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th October 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage 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 stated that, the patient was given a dose of Boostrix that might have been stored out of range, which led to incorrect product storage. The reporter stated that, the tag alert was red but the fridge log did not have any out of range temperatures. Med info was unable to determine viability as the vaccine was ordered from some other facility. The reporter consented to follow up.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 3rd dose administered; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number J7J4x, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (received 2 doses on an unknown date).   On 4th October 2021, the patient received the 3rd dose of Shingrix. On 4th October 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The reporter was a medical assistant. She stated that, the pharmacy gave one of their patient's a 3rd dose of Shingrix vaccine, which led to extra dose administered. The reporter was not able to provide additional details regarding the administration of the Shingrix (Expiration date, site or route of administration). The call center representative did not collect consent to contact doctor because the reporter was not the patient.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose at less recommended interval; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 30th October 2022) for prophylaxis.   Concomitant products included ZOSTER VACCINE RECOMBINANT, ADJUVANTED (NON-LIVE) (SHINGRIX).   On 13th July 2021, the patient received the 2nd dose of Shingrix. On 13th July 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 age at vaccination was not reported but it could be 58 or 59 years. The first dose was administrated to the patient on 22nd June 2021. The patient had received a second dose of the vaccine at a less recommended interval from the first dose, which led to shortening of vaccination schedule. No further events were reported. The reporter agreed to be contacted for follow-up.  Consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Inadvertently received a 3rd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 9th November 2018) and Shingrix (received 2nd dose on 6th February 2019).   On 6th November 2020, the patient received the 3rd dose of Shingrix. On 6th November 2020, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported but it could be 56 or 57 years. The patient inadvertently received a third dose of Shingrix, which led to extra dose administered. The lot number unavailable as the vaccines were not administered at the pharmacy. No email address available.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 24Sep2020 and did not receive 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th September 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this case. The patient received her 1st dose of Shingrix and did not receive 2nd dose till the time of reporting, which led to incomplete course of vaccination. No lot or Expiry Date provided when asked as 1st dose was administered at different facility. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021212544:Same patient - FU1 deleted case
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose July 2020, 2nd dose 10/13/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in July 2020).   On 13th October 2021, the patient received the 2nd dose of Shingrix. On 13th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received first dose of shingrix a year ago and 2nd dose on the day of reporting, which led to lengthening of vaccination schedule. The reporter consented to follow up. No details of patient or vaccine available.
Sex: F
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: administered engerix-b instead of twinrix; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a female patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.  Additional details were provided as follows: The age at vaccination was not provided. The patient was administered inadvertently the engerix-b vaccine instead of the twinrix vaccine, which led to wrong vaccine administered. At the time of the report, the reporter did not want to give patient's information. The reporter consented to follow up.