chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Redness /at injection site; Swelling at injection site; Fever; Chills; Weakness; Flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, fever, chills, weakness and influenza-like symptoms. On an unknown date, the outcome of the injection site erythema, injection site swelling, fever, chills, weakness and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, fever, chills, weakness and influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that he received first dose of Shingrix. The patient experienced redness and swelling at injection site, fever, chills, weakness and flu like symptoms. The patient stated that the symptoms went away after a few days. The reporter was referred to health care professional. The reporter did not consent to follow-up. Limited information was obtained. All these symptoms also experienced post second dose. For second dose refer linked case US2021168407 (same reporter).; Sender's Comments:  US-GLAXOSMITHKLINE-US2021168407:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Redness /at injection site; Swelling at injection site; Fever; Chills; Weakness; Flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, fever, chills, weakness and influenza-like symptoms. On an unknown date, the outcome of the injection site erythema, injection site swelling, fever, chills, weakness and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, fever, chills, weakness and influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that he received first dose of Shingrix. The patient experienced redness and swelling at injection site, fever, chills, weakness and flu like symptoms. The patient stated that the symptoms went away after a few days. The reporter was referred to health care professional. The reporter did not consent to follow-up. Limited information was obtained. All these symptoms also experienced post second dose. For second dose refer linked case US2021168407 (same reporter).; Sender's Comments:  US-GLAXOSMITHKLINE-US2021168407:Same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccnation failure; shingles /suffering terribly/ nasty; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On 20th April 2019, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, more than 2 years 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 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 and Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient received 1 shot version in 2018. The vaccine only lasted about 5 years and they did not give another vaccination or booster.  The patient had 2nd dose on 20th April 2019. After receiving 2 doses of Shingles vaccine, the patient had shingles at the time of reporting. The patient stated that, it was 97 percent effective and he/she fell into the exception 3 percent. This case was considered as suspected vaccination failure, since the details regarding laboratory test confirmation was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles about a week / shingles; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of shingles in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not applicable. The reporter knew a lot of that got the vaccine came down with shingles. Shingles about a week after the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: it hurt ,for 2, days; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received shingles vaccine. The patient reported that it hurt for 2 days.
Sex: U
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: Had permanent nerve pain; This case was reported by a consumer via other manufacturer and described the occurrence of nerve pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nerve pain. On an unknown date, the outcome of the nerve pain was not recovered/not resolved.   The reporter considered the nerve pain to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient experienced permanent nerve pain from a Shingrix shot. No further information was reported. The reporter did not consented to follow up.
Age: 73.0
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: not receive dose two of Twinrix series/first dose was on 04/28/2021; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female 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.   Concomitant products included HAB (Twinrix) and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device).   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 incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Twinrix on 28th April 2021. The pharmacist reported that, the patient did not receive dose two of Twinrix series.  After first dose the patient had not received 1 month dose, which led to incomplete course of vaccination. The reporter consented to follow up.   The VAERS details reported for 1st dose.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose on 6/23 and second dose on 6/30 but missed the third dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female 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.   Concomitant products included HAB (Twinrix) and HAB (Twinrix).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report.  The pharmacist declined to provide patient details. The patient was on the accelerated dosing schedule of Twinrix. The patient received 1st dose of Twinrix on 23rd June 2021 with batch number 9RT94 and expiry date 24th May 2022. The patient received 2nd dose of Twinrix on 30th June 2021 with batch number 9RT94 and expiry date 24th May 2022. Till the time of reporting, the patient did not receive the 3rd dose of Twinrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody, Inappropriate schedule of product administration, Therapeutic response decreased
Clinical narrative: Prior titter / of 3.1 (as reported) received Engerix-B/ and / had same titer 3.1; Received Engerix-B on 21-Oct-2020, 19-Jan-2021 and 21-Jun-2021; Received Engerix-B on 21-Oct-2020, 19-Jan-2021 and 21-Jun-2021; This case was reported by a other health professional via call center representative and described the occurrence of therapeutic response decreased in a patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On 21st October 2020, the patient received the 1st dose of Engerix B. On 19th January 2021, the patient received the 2nd dose of Engerix B. On 21st June 2021, the patient received the 3rd dose of Engerix B. On 19th January 2021, not applicable after receiving Engerix B and Engerix B, unknown after receiving Engerix B and not applicable after receiving Engerix B and Engerix B, the patient experienced drug dose administration interval too long. On 21st June 2021, the patient experienced drug dose administration interval too long. On 2nd August 2021, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased, drug dose administration interval too long and drug dose administration interval too long were unknown.  Additional details were provided as follows: The age at vaccination was not reported. Health care professional reported that the patient had a prior titer of anti hepatitis B titers of 3.1. The patient received Engerix B longer than the recommended interval, which led to lengthening of vaccine schedule. On 2nd August 2021, a blood sample was drawn and the patient had the same titer 3.1, which led to therapeutic response decreased. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Muscular weakness
Clinical narrative: problem with arm she had the shot in; muscle weakness; This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle weakness and arm discomfort. On an unknown date, the outcome of the muscle weakness and arm discomfort were not recovered/not resolved.   It was unknown if the reporter considered the muscle weakness and arm discomfort to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not provided. The patient received Shingrix and experienced muscle weakness, problem with arm she had the shot in and still having some side effects. No further information reported.
Sex: F
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had her complete vaccination of SHINGRIX got Shingles/suspected vaccination failure; got Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and COVID-19 VACCINE (COVID-19 VACCINE UNKNOWN) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and COVID-19 VACCINE UNKNOWN. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. Pharmacist reported that female patient who had completed her vaccination of Shingrix got Shingles. Patient's physician told her that it might be due to the COVID vaccination.  The pharmacist called to see if Glaxosmithkline had information regarding that topic. The reporter did not have any vaccine information at the time of the call (lot number, expiration date of the doses). This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation were unknown at the time of reporting. No further events were reported at the time of the call. The reporter consented to follow up by email.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Delayed receiving second dose because of COVID-19 pandemic; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 29th October 2019).   On an unknown date, 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. The reporter stated that, the patient was delayed receiving second dose because of COVID-19 pandemic and pharmacy delays in receiving Shingrix vaccines and had not yet been administered. The pharmacist was not able to provide lot number and expiration date of first Shingrix vaccine. The VAERS details were reported for 1st dose of Shingrix. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose /04-Jan-2019 /not received dose two.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th January 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix and did not receive dose two. Till the time of reporting, the patient did not receive the 2nd dose of the vaccine, which led to incomplete course of vaccination. The reporter consented to follow up. This case has been linked to the case US2021168351, US2020079556 and US2019096333 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021168351:Same reporter US-GLAXOSMITHKLINE-US2020079556:Same reporter US-GLAXOSMITHKLINE-US2019096333:Same reporter
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles outbreak / after the complete vaccination/ suspected vaccination failure; shingles outbreak; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number ZG47A, expiry date 12th February 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number B5EK2, expiry date 28th April 2020) for prophylaxis.   On 27th July 2018, the patient received the 2nd dose of Shingrix. On 1st May 2018, the patient received the 1st dose of Shingrix. On 4th August 2021, 1104 days after receiving Shingrix and 1191 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient had a shingles outbreak after the complete vaccination of Shingrix. The shingles outbreak was not confirmed by the pharmacist, the patient stated having shingles. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory test confirmation for shingles were unknown. No further events were reported at the time of the call. The pharmacist called to know if they had to revaccinate the patient or not. The health care professional could not clearly see the last letter of the lot number of the 2nd dose of Shingrix. The reporter consented to follow up by phone.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Gave an expired Boostrix vaccine to one of her patients; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 49-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number HT479, expiry date 8th August 2021) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th August 2021, the patient received Boostrix (intramuscular) and Boostrix Pre-Filled Syringe Device. On 9th August 2021, unknown after receiving Boostrix and Boostrix 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 health care professional reported that she gave an expired Boostrix vaccine to one of her patients in the left deltoid, which was already expired on 8th August 2021. The reporter consented to follow up.
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Inadvertently given a dose of Infanrix instead of Boostrix / 24 yo; Inadvertently given a dose of Infanrix instead of Boostrix / 24 yo; 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 24-year-old male patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 6th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The age at vaccination was not reported. Office administrator reported that patient was inadvertently administered a dose of Infanrix instead of Boostrix which led to wrong vaccine administered and inappropriate age at vaccine administration. No further details provided at time of call. Consent given for safety to follow up via letter in the mail. The reporter Consented to follow up. This case was linked with the case US2021168394 and US2021168395 by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021168394:same reporter US-GLAXOSMITHKLINE-US2021168395:same reporter
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Inadvertently given a dose of Infanrix / 46 years old; inadvertently given a dose of Infanrix instead of Boostrix; 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 46-year-old female patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 6th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported but it could be 45 or 46 years. The health care professional reported that, the patient received Infanrix instead of Boostrix, which led to inappropriate age at vaccine administration and wrong vaccine administered. No further details were provided. The reporter consented to follow up via mail. This is one of three cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021168391:same reporter US-GLAXOSMITHKLINE-US2021168394:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Inappropriate schedule of product administration, Influenza like illness, Injection site erythema
Clinical narrative: redness /at injection site; swelling at injection site; fever; chills; weakness; flu-like symptoms; first dose /December 2020/ second dose August 6, 2021.; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (had swelling, fever, chills, weakness after receiving 1st dose in December 2020, for tolerance refer case US2021AMR169451).   On 6th August 2021, the patient received the 2nd dose of Shingrix. On 6th August 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced injection site erythema, injection site swelling, fever, chills, weakness and influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema, injection site swelling, fever, chills, weakness and influenza-like symptoms were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, fever, chills, weakness and influenza-like symptoms to be related to Shingrix.  Additional details provided were as follows: Age at vaccination was not reported. The patient received the second dose of Shingrix on left deltoid and after 12 hours experienced redness and swelling at injection site, fever, chills, weakness and flu like symptoms. He had not recovered yet from those symptoms and stated his fever comes and went for the last four days. He also mentioned that he had the same symptoms with the first dose but the symptoms went away after a few days. The reporter referred him to health care professional. Limited information was obtained. The reporter did not consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR169451:1st dose, Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: redness /at injection site; swelling at injection site; fever; chills; weakness; flu-like symptoms; first dose /December 2020/ second dose August 6, 2021.; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (had swelling, fever, chills, weakness after receiving 1st dose in December 2020, for tolerance refer case US2021AMR169451).   On 6th August 2021, the patient received the 2nd dose of Shingrix. On 6th August 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced injection site erythema, injection site swelling, fever, chills, weakness and influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema, injection site swelling, fever, chills, weakness and influenza-like symptoms were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, fever, chills, weakness and influenza-like symptoms to be related to Shingrix.  Additional details provided were as follows: Age at vaccination was not reported. The patient received the second dose of Shingrix on left deltoid and after 12 hours experienced redness and swelling at injection site, fever, chills, weakness and flu like symptoms. He had not recovered yet from those symptoms and stated his fever comes and went for the last four days. He also mentioned that he had the same symptoms with the first dose but the symptoms went away after a few days. The reporter referred him to health care professional. Limited information was obtained. The reporter did not consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR169451:1st dose, Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: case of shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 53l2z, expiry date 15th May 2022) for prophylaxis.   On 6th April 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provide are as follows: The age at vaccination was not reported but it could be 65 or 66 years old. The patient received 1st dose of Shingrix and experienced a case of shingles. The Health care professional did not clarify how much time had past after the administration of 1st dose and the begging of the shingles episode. The patient had not yet received the 2nd dose. No further events were reported. The reporter consented to follow-up. The case was linked with case US2021007444 and US2020185477 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021007444:same reporter US-GLAXOSMITHKLINE-US2020185477:same reporter
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Menstrual cycle started 7 days early  Heavy bleeding (more than normal for myself)
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Haemangioma, Swelling face
Clinical narrative: I woke up and the hemangioma on my left cheek had a larger bump - size of pea - and was painful  (Thursday Aug 12). Next day I got up and it was normal.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: DOSE ONE OF THE COVID 19 PFIZER VACCINE ADMINISTERED WAS 6 DAYS EXPIRED
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient falsified immunization paperwork to say she had never received any doses of moderna but had received in early 2021. at the time of administration she was not eligible for 3 rd booster and wasn't caught on cairs until after.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Malaise, Paraesthesia, Thirst
Clinical narrative: Patient received 1st dose pfizer vaccine. About 10 minutes later, patient said she was feeling unwell. Pharmacist went over to check her vitals. Pulse oximeter showed her to be at 151bpm. She complained that she was not feeling well. Looked distressed. She complained that her left arm where she received the injection, was feeling numb/heavy and tingling.  Patient also complained that she was feeling very thirsty and asked for water, which we refused to give her in the fear of her choking if she was to pass out.  Paramedics were called to the scene and she was taken to hospital by ambulance.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin decreased, Ultrasound pelvis, Vaginal haemorrhage
Clinical narrative: Patient was about 3-4 weeks pregnant at the time of second vaccine dose. She subsequently had a miscarriage which started with vaginal bleeding on May 30th in the evening.  Prior to this miscarriage, she had 2 gestations which resulted in 2 full term uncomplicated deliveries.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: DOSE ONE OF THE VACCINE ADMINISTERED WAS 6 DAYS OUT OF DATE, NO ADVERSE EVENT
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Mouth swelling, Nasal congestion, Neuralgia, Swelling face
Clinical narrative: Shingles. Nerve Pain. Swelling of right side of nose, mouth, cheek and lower eyelid.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: Shingles. Nerve Pain. Swelling of right side of nose, mouth, cheek and lower eyelid.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Chest discomfort, Computerised tomogram thorax abnormal, Dyspnoea, Loss of consciousness
Clinical narrative: Onset of symptoms on June 15, 2021, shortness of breath, tightness in lungs, swelling and pain in right calf . Symptoms grew progressively worse over following week. June 24 ? extreme difficulty breathing, loss of consciousness. Ambulance to emergency room. CT Scan at ER revealed dual branch pulmonary embolisms.  Emergency Thrombectomy. Multiple blood clots between 1 and 6 inches long removed from both branches. Anticoagulants prescribed for one year and assisted oxygen.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pulmonary embolism, Pulmonary thrombosis, Thrombectomy
Clinical narrative: Onset of symptoms on June 15, 2021, shortness of breath, tightness in lungs, swelling and pain in right calf . Symptoms grew progressively worse over following week. June 24 ? extreme difficulty breathing, loss of consciousness. Ambulance to emergency room. CT Scan at ER revealed dual branch pulmonary embolisms.  Emergency Thrombectomy. Multiple blood clots between 1 and 6 inches long removed from both branches. Anticoagulants prescribed for one year and assisted oxygen.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling of body temperature change, Nausea, Somnolence
Clinical narrative: come on for a Pfizer Covid 19 IMZ. I gave the IMZ at roughly 9:30 am in her right Deltoid. She was ask along with her husband to stay for 15 minutes to observer and make sure there was no reaction before leaving. In a few minutes waiting she rushed to the restroom feeling hot/cold and nauseated. She returned from the restroom and sat in one of the waiting area chairs. I immediately came out and ask her to come back into the IMZ room and lay down on the floor and I propped up her feet on a ABC plastic container and put a few sacs underneath her head. She complained about feeling hot/cold and woozy. I ask if she had any breathing difficulties and she said no and that she could breath fine. I began taking her blood pressure at around roughly 9:40. It was 123/82 and HR 63. I continued to monitor her BP and HR every few minutes. At roughly 9:50 I ask and then gave her 15ml of diphenhydramine oral solution  12.5mg\5ml to help with any allergic reaction and nausea the might have. She was sleepy but alert and talking. At 10:10 she was talking on the phone to someone while still lying down. She ask at one point if she could sit in the chair but I said for her safety for her to continue to lie on the floor until she felt very stable and she agreed. In roughly another 15 minutes I ask her if she felt like she was improving and she said not really and still felt hot/cold and woozy. I spoke to both of them and suggested calling 911 just to be on the safe side and they agreed. I called 911 and was transferred to the medical center where I gave my name, reason for calling, our address and patient's condition, IMZ received and was requesting EMS to come. While continuing to check BP and HR we waited for EMS to arrive. After 15 to 20 minutes, I believe roughly, they arrived and took over care of patient. They told her that the symptoms she was experiencing were not too unusual with the Pfizer Covid IMZ and that she might have had some anxiety that contributed to her symptoms. The assisted her into a chair at her request and again took her vitals and BS. They ask all routine questions while filling out computer visit questions. After discussing with her the options she had as to go to the hospital for observation or just monitoring herself and calling them back if needed. She decided to not go to the hospital. She signed the computer AMA about going to the hospital. She was still a little woozy and sleepy but as I had told her the EMS techs did also that the generic Benadryl might maker her feel sleepy and sluggish also. She and her husband left on there own power walking out of the clinical service room next to the pharmacy .  BP and HR readings 9:40 - 123/82 HR 63 9:50 - 120/86 HR 63 9:54 - 121-82 HR 59 9:56 - 124-86 HR 62 10:00 - 127/83 HR 60 10:07 - 126/89 HR 68 10:11 - 127/94 HR 64 10:16 - 129/92 HR 67 10:21 - 127/93 HR 67 10:28 - 126/90 HR 65
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hot flush, Nausea, Pyrexia
Clinical narrative: pt reports nausea that occurred for 3 days post 2nd dose. pt also reports fever, chills and hot flashes that have still not gone away 7 days post 2nd dose. told pt this is not normal and that she got go to MD, ER, URGENT CARE ASAP. pt said that she might have possible UTI as she also had blood in her urine prior to 2nd dose that was being treated with abx. TOLD PT NOT NORMAL AND TO SEE MD ASAP.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Eye swelling, Fatigue, Feeling hot
Clinical narrative: Came on gradually.  I felt like it was an additional symptom of Covid 19 about once every hour.  Started with headache, then a neck ache.  Then my eye balls felt swollen and hot in the back .  Next was total body aching and fatigue. The fever started and within about 1.5 hours it was up to 102.6. after about 103 I had chills really bad.  Of course in that time I took Tylenol.I laid under 3 blankets until morning.  By the next morning the fever broke.  And little by little the symptoms started to go away  Today is the third day and I don't feel symptomatic any more.  But I feel like I'm coming down with a terrible head cold and cough.  And the injection sit itches something awful
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pruritus, Nasopharyngitis, Neck pain, Pain
Clinical narrative: Came on gradually.  I felt like it was an additional symptom of Covid 19 about once every hour.  Started with headache, then a neck ache.  Then my eye balls felt swollen and hot in the back .  Next was total body aching and fatigue. The fever started and within about 1.5 hours it was up to 102.6. after about 103 I had chills really bad.  Of course in that time I took Tylenol.I laid under 3 blankets until morning.  By the next morning the fever broke.  And little by little the symptoms started to go away  Today is the third day and I don't feel symptomatic any more.  But I feel like I'm coming down with a terrible head cold and cough.  And the injection sit itches something awful
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Came on gradually.  I felt like it was an additional symptom of Covid 19 about once every hour.  Started with headache, then a neck ache.  Then my eye balls felt swollen and hot in the back .  Next was total body aching and fatigue. The fever started and within about 1.5 hours it was up to 102.6. after about 103 I had chills really bad.  Of course in that time I took Tylenol.I laid under 3 blankets until morning.  By the next morning the fever broke.  And little by little the symptoms started to go away  Today is the third day and I don't feel symptomatic any more.  But I feel like I'm coming down with a terrible head cold and cough.  And the injection sit itches something awful
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Heavy menstral bleeding 5 days before period was due. Heavy clots passed
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Nausea, Vomiting
Clinical narrative: patient received 1st dose of Pfizer vaccine. About 5-10 minutes she became light headed, flushed, dizzy, and nauseous. she ended up throwing up and her bp was 95/81. emt was called but she was not transported as she began to feel better.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: The evening following my vaccination I started heavily menstrating lasting 6 full days. Prior to this vaccine I have not experienced a period for 8 months as I have an IUD. I have experienced a monthly period every month since the vaccination.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was brought to pharmacy by nursing home for second covid shot. The facility did not have COVID card and were going to bring it up after getting the patient returned. Intern confirmed with nurse aid and patient this was 2nd dose of Moderna Vaccine. Intern did not check the system and when nurse aid brought COVID card back to pharmacy to be completed, the patient had received first dose of Pfizer vaccine in March 2021. Went ahead and completed card for second dose and Moderna information, spoke with nursing director and advised to watch for any signs and symptoms of reaction, but felt that there was minimal risk since patient was past due on the Pfizer series.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hypoaesthesia, Myalgia
Clinical narrative: Fatigue (extreme), Headache, chills,  muscle aches (full body) numbness in arms and lower legs
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, SARS-CoV-2 test positive
Clinical narrative: Lost sense of taste and smell . Tested positive via PCR . Healthcare worker and vaccinated
Age: 39.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: patient has redness and pain surrounding the injection site and continuing up to her shoulder. She complained it was hot and painful. I recommended Tylenol for pain, and Benadryl to help with the redness. She was already using ice to help with the warmth. I will contact her in the morning to check her status, and if no improvement will recommend that she seeks further care at ER or urgent care, or contacts her physician.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: FAINTING
Age: 0.33
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Feeling abnormal, Paraesthesia
Clinical narrative: Extreme fatigue, dizzyness, brain fog, tingling feet, joint pain and getting worse 1 week later.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Peripheral swelling
Clinical narrative: Right arm swelling and redness at injection site x5 days
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: shortly after patient got the vaccine , patient felt dizzy and passed out , patient was awake until EMT TAKE OVER
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Disorganised speech, Electroencephalogram abnormal, Magnetic resonance imaging head normal, Seizure like phenomena
Clinical narrative: new onset partial seizure events with garbled speech, negative MRI brain
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Depressed level of consciousness, Dizziness, Heart rate decreased, Hypotension
Clinical narrative: I administered the vaccine and the patient left the booth to sit in the waiting area.  About a minute later, someone called that he had passed out.  I found him in the chair, and his mother was holding him and trying to wake him up.  He woke up briefly but then passed out again.  She again tried to wake him up but he was still only semi-conscious.  We took his blood pressure and it and his pulse were very low.  He kept saying that he felt like he was going to pass out again.  A few minutes later we took his BP again and it was still low.  His mother and I at that point decided to call for an ambulance.  By the time they arrived, the patient was feeling better and his blood pressure had gone up slightly, so he decided not to go to the hospital.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Somnolence
Clinical narrative: I administered the vaccine and the patient left the booth to sit in the waiting area.  About a minute later, someone called that he had passed out.  I found him in the chair, and his mother was holding him and trying to wake him up.  He woke up briefly but then passed out again.  She again tried to wake him up but he was still only semi-conscious.  We took his blood pressure and it and his pulse were very low.  He kept saying that he felt like he was going to pass out again.  A few minutes later we took his BP again and it was still low.  His mother and I at that point decided to call for an ambulance.  By the time they arrived, the patient was feeling better and his blood pressure had gone up slightly, so he decided not to go to the hospital.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: 15 y/o male presents for evaluation of persistent nausea which began 3 days ago. Pt states that he got his COVID vaccine 10 days ago. He went for a short run 06/28/2021 and felt body aches when he came home. On 06/29/2021, pt started "feeling really badly." He vomited 3 times and had two episodes of diarrhea. He also started feeling lightheaded and weak at this time. He states that his sx somewhat resolved on 06/30/2021 but is worse again today, prompting his visit to the ER today. Pt states that movement exacerbates his weakness. Reports associated fever, myalgia, vomiting, diarrhea, weakness, dizziness, SOB, cough, and nausea. Denies associated hematemesis, CP, LOC, or dysuria.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Mononucleosis heterophile test negative, Myalgia, Nausea, Pain
Clinical narrative: 15 y/o male presents for evaluation of persistent nausea which began 3 days ago. Pt states that he got his COVID vaccine 10 days ago. He went for a short run 06/28/2021 and felt body aches when he came home. On 06/29/2021, pt started "feeling really badly." He vomited 3 times and had two episodes of diarrhea. He also started feeling lightheaded and weak at this time. He states that his sx somewhat resolved on 06/30/2021 but is worse again today, prompting his visit to the ER today. Pt states that movement exacerbates his weakness. Reports associated fever, myalgia, vomiting, diarrhea, weakness, dizziness, SOB, cough, and nausea. Denies associated hematemesis, CP, LOC, or dysuria.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative, Vomiting
Clinical narrative: 15 y/o male presents for evaluation of persistent nausea which began 3 days ago. Pt states that he got his COVID vaccine 10 days ago. He went for a short run 06/28/2021 and felt body aches when he came home. On 06/29/2021, pt started "feeling really badly." He vomited 3 times and had two episodes of diarrhea. He also started feeling lightheaded and weak at this time. He states that his sx somewhat resolved on 06/30/2021 but is worse again today, prompting his visit to the ER today. Pt states that movement exacerbates his weakness. Reports associated fever, myalgia, vomiting, diarrhea, weakness, dizziness, SOB, cough, and nausea. Denies associated hematemesis, CP, LOC, or dysuria.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Muscle spasms, Pain
Clinical narrative: Headache dizziness, fever,chills,body ache, muscle spasms
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache dizziness, fever,chills,body ache, muscle spasms
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Syncope
Clinical narrative: syncope for few seconds/vagal episode. Did well in few minutes
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pallor
Clinical narrative: Patient was ok immediately after vaccine, but experienced sweating and paleness about 15- 20 minutes later.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Neuralgia, Pain in extremity
Clinical narrative: Severe arm pain for 6 days; Fatigue that increased from the first day to present (18 days); Severe, progressing neuropathic pain in the RUQ.