chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot few days later took the shingle again/ Suspected vaccination failure; Got the shot few days later took the shingle again; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (four times).   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days 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: The patient self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. The patient got the shot and few days later had the shingles again. Physician said that the patient broke the record. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, exact time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: F
Vaccine: COVID19, COVID19, VARZOS
Symptoms: Chills, Erythema, Feeling abnormal, Herpes simplex, Induration
Clinical narrative: Fever; Chills; Massive induration; Erythemia; Arm swelled up, it was huge / took over a week to resolve; Felt beaten down; Like with flu; Very severe oral outbreak of Herpes Simplex; This case was reported by a physician via sales rep and described the occurrence of fever in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis and covid-19 vaccine for prophylaxis.   Previously administered products included Shingrix (Received 1st dose on an unknown date).   In April 2021, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of COVID-19 VACCINE. In January 2021, the patient started covid-19 vaccine at an unknown dose and frequency. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced fever, chills, induration, erythema, swelling arm, feels awful, influenza-like symptoms and herpes simplex. On an unknown date, the outcome of the fever, chills, induration, erythema, feels awful, influenza-like symptoms and herpes simplex were unknown and the outcome of the swelling arm was recovered/resolved.   It was unknown if the reporter considered the fever, chills, induration, erythema, swelling arm, feels awful, influenza-like symptoms and herpes simplex to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had first dose og Shingrix without issue prior to receipt of COVID vaccines. As then had both doses of covid vaccines second dose in JAN 2021. The patient also received recived second dose of Shingrix in April and experiencing Fever , Chills , Massive induration and erythemia, arm  swelled up. and overall felt beaten down like flu for a few days ,severe oral outbreak of herpes simplex and required Valtrex for treatment for a week. No issue with Shingrix first dose prior to covid vaccines. Consented to follow up was unknown.
Sex: F
Vaccine: COVID19, COVID19, VARZOS
Symptoms: Influenza like illness, Peripheral swelling, Pyrexia
Clinical narrative: Fever; Chills; Massive induration; Erythemia; Arm swelled up, it was huge / took over a week to resolve; Felt beaten down; Like with flu; Very severe oral outbreak of Herpes Simplex; This case was reported by a physician via sales rep and described the occurrence of fever in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis and covid-19 vaccine for prophylaxis.   Previously administered products included Shingrix (Received 1st dose on an unknown date).   In April 2021, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of COVID-19 VACCINE. In January 2021, the patient started covid-19 vaccine at an unknown dose and frequency. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced fever, chills, induration, erythema, swelling arm, feels awful, influenza-like symptoms and herpes simplex. On an unknown date, the outcome of the fever, chills, induration, erythema, feels awful, influenza-like symptoms and herpes simplex were unknown and the outcome of the swelling arm was recovered/resolved.   It was unknown if the reporter considered the fever, chills, induration, erythema, swelling arm, feels awful, influenza-like symptoms and herpes simplex to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had first dose og Shingrix without issue prior to receipt of COVID vaccines. As then had both doses of covid vaccines second dose in JAN 2021. The patient also received recived second dose of Shingrix in April and experiencing Fever , Chills , Massive induration and erythemia, arm  swelled up. and overall felt beaten down like flu for a few days ,severe oral outbreak of herpes simplex and required Valtrex for treatment for a week. No issue with Shingrix first dose prior to covid vaccines. Consented to follow up was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pruritus
Clinical narrative: Painful / stabbing; itching; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles Shot with an associated reaction of herpes zoster (had older shot and got shingles after this).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain and pruritus. On an unknown date, the outcome of the pain and pruritus were recovered/resolved.   It was unknown if the reporter considered the pain and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient get the newer shingles vaccine shot dose and was painfull, Stabbing and Itching. This case has been linked with the case US2021AMR102061, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR102061:Same patient
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Musculoskeletal pain, Vaccination failure
Clinical narrative: getting the two part shingle shot / I still break out in shingles / get the two dosage shot and they keep coming back/Suspected vaccination failure; getting the two part shingle shot / I still break out in shingles; just a pain in the butt. That's where mine break out; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had before the 1st shot of vaccination).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), 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 and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was captured as an adult as per vaccine indication. The patient had shingles and then ended up getting the 2 shot of Shingles vaccine. The patient still breakout in shingles after receiving shingles vaccine. The patient said luckily it did not hurt, but just the pain in the butt, that was where his/her breakout was. The physician told the patient that this happens as the shot are not 100 percent, but the patient was glad that working out for others. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation were unknown at the time of reporting.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered
Clinical narrative: received a birth dose of hepatitis B vaccine  /  hepatitis B on 03/JUN/2020; Extra 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 1-year-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis B vaccine (received 1st dose), Pediarix (received 1st dose on 3rd February 2020) and Pediarix (received 2nd dose on 3rd April 2020).   On 28th August 2020, the patient received the 4th dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 3rd June 2020, the patient received the 5th dose of Hepatitis B vaccine. On 3rd June 2020, not applicable after receiving Pediarix and Pediarix Pre-Filled Syringe Device and unknown after receiving Hepatitis B vaccine, the patient experienced extra dose administered. On 28th August 2020, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received extra dose of Hepatitis B vaccine and Pediarix., which led to extra dose used.. The reporter consented to follow up.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Herpes zoster
Clinical narrative: administrated / Menveo on April 7 2021 / developed Shingles on April 10 2021; This case was reported by a physician via call center representative and described the occurrence of shingles in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA417A, expiry date 30th September 2021) for prophylaxis.   On 7th April 2021, the patient received Menveo. On 10th April 2021, 3 days after receiving Menveo, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Menveo.  Additional details were provided as follows: Physician reported that patient was administrated with Menveo on April 7 2021 and developed Shingles. The reporter consent to follow up. The reported batch number amza417a for Menveo did not exist and was updated to AMVA417A as per the sales datasheet.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Received 3 doses of shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The pharmacist reported that a patient received 3 doses of Shingrix, which led to extra dose administration. The reporter consented to follow up. The patient did not receive the 3rd dose at the reporters pharmacy so no lot number or expiry date.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Bexsero/given on 05May2021 and Covid vaccine (unknown) on 01May2021; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB28AA, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and COVID 19 VACCINE for prophylaxis.   On 5th May 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st May 2021, the patient received COVID 19 VACCINE. On 5th May 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follow: The patient received a dose of Bexsero vaccine, 4 days after having Covid Vaccine (unknown) on 1st May 2021, which led to inappropriate schedule of vaccine administration. As per CDC (Center for Disease Control and Prevention ) recommendations, Bexsero was given in less than 14 days in  between with a Covid vaccine. The reporter consented to follow up by email. No address provided by reporter.
Age: 70.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Atrial fibrillation, Chills, Condition aggravated
Clinical narrative: it hurt (at site of injection) but it's worse today and it's spreading to shoulder; has upset stomach; has not eaten since yesterday afternoon; it hurt (at site of injection) but it's worse today/ her arm is  so sore; heart is racing even worse than usual; has 4 bumps around site of administration.; can't move arm away from body; had chills for 2 days; This case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation aggravated in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   Previously administered products included COVID-19 vaccine (completed COVID-19 vaccine series before receiving 1st dose of Shingrix). Concurrent medical conditions included atrial fibrillation.   On 5th May 2021, the patient received the 1st dose of Shingrix (intramuscular) and PNEUMONIA VACCINE (intramuscular). On 5th May 2021, less than a day after receiving Shingrix, the patient experienced chills. On 6th May 2021, the patient experienced upset stomach, appetite absent and pain in arm. On 7th May 2021, the patient experienced shoulder pain. In May 2021, the patient experienced atrial fibrillation aggravated (serious criteria GSK medically significant), injection site swelling and injected limb mobility decreased. On an unknown date, the outcome of the atrial fibrillation aggravated, injection site swelling, upset stomach, appetite absent, pain in arm and shoulder pain were not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown and the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the atrial fibrillation aggravated, injection site swelling, injected limb mobility decreased, chills, upset stomach, appetite absent, pain in arm and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself. The patient received pneumonia shot at same time as the dose of Shingrix in right arm. The patient reported that her heart was racing even worse than usual. The patient has had chills for 2 days. The patient had upset stomach and had not eaten since afternoon of day before reporting. The patient reported that day before reporting it hurt (at site of injection) but it was worse on the day of reporting and it was spreading to shoulder. The patient could not move arm away from body, her arm was so sore. The patient had 4 bumps around site of administration. The reporter did not have batch number or expiry date of vaccine. The reporter did not consent to follow up. It was unknown if the reporter considered the atrial fibrillation aggravated, injection site swelling, injected limb mobility decreased, chills, upset stomach, appetite absent, pain in arm and shoulder pain to be related to pneumonia vaccine.
Age: 70.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Decreased appetite, Injected limb mobility decreased, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: it hurt (at site of injection) but it's worse today and it's spreading to shoulder; has upset stomach; has not eaten since yesterday afternoon; it hurt (at site of injection) but it's worse today/ her arm is  so sore; heart is racing even worse than usual; has 4 bumps around site of administration.; can't move arm away from body; had chills for 2 days; This case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation aggravated in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   Previously administered products included COVID-19 vaccine (completed COVID-19 vaccine series before receiving 1st dose of Shingrix). Concurrent medical conditions included atrial fibrillation.   On 5th May 2021, the patient received the 1st dose of Shingrix (intramuscular) and PNEUMONIA VACCINE (intramuscular). On 5th May 2021, less than a day after receiving Shingrix, the patient experienced chills. On 6th May 2021, the patient experienced upset stomach, appetite absent and pain in arm. On 7th May 2021, the patient experienced shoulder pain. In May 2021, the patient experienced atrial fibrillation aggravated (serious criteria GSK medically significant), injection site swelling and injected limb mobility decreased. On an unknown date, the outcome of the atrial fibrillation aggravated, injection site swelling, upset stomach, appetite absent, pain in arm and shoulder pain were not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown and the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the atrial fibrillation aggravated, injection site swelling, injected limb mobility decreased, chills, upset stomach, appetite absent, pain in arm and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself. The patient received pneumonia shot at same time as the dose of Shingrix in right arm. The patient reported that her heart was racing even worse than usual. The patient has had chills for 2 days. The patient had upset stomach and had not eaten since afternoon of day before reporting. The patient reported that day before reporting it hurt (at site of injection) but it was worse on the day of reporting and it was spreading to shoulder. The patient could not move arm away from body, her arm was so sore. The patient had 4 bumps around site of administration. The reporter did not have batch number or expiry date of vaccine. The reporter did not consent to follow up. It was unknown if the reporter considered the atrial fibrillation aggravated, injection site swelling, injected limb mobility decreased, chills, upset stomach, appetite absent, pain in arm and shoulder pain to be related to pneumonia vaccine.
Age: 70.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pain in extremity, Palpitations
Clinical narrative: it hurt (at site of injection) but it's worse today and it's spreading to shoulder; has upset stomach; has not eaten since yesterday afternoon; it hurt (at site of injection) but it's worse today/ her arm is  so sore; heart is racing even worse than usual; has 4 bumps around site of administration.; can't move arm away from body; had chills for 2 days; This case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation aggravated in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   Previously administered products included COVID-19 vaccine (completed COVID-19 vaccine series before receiving 1st dose of Shingrix). Concurrent medical conditions included atrial fibrillation.   On 5th May 2021, the patient received the 1st dose of Shingrix (intramuscular) and PNEUMONIA VACCINE (intramuscular). On 5th May 2021, less than a day after receiving Shingrix, the patient experienced chills. On 6th May 2021, the patient experienced upset stomach, appetite absent and pain in arm. On 7th May 2021, the patient experienced shoulder pain. In May 2021, the patient experienced atrial fibrillation aggravated (serious criteria GSK medically significant), injection site swelling and injected limb mobility decreased. On an unknown date, the outcome of the atrial fibrillation aggravated, injection site swelling, upset stomach, appetite absent, pain in arm and shoulder pain were not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown and the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the atrial fibrillation aggravated, injection site swelling, injected limb mobility decreased, chills, upset stomach, appetite absent, pain in arm and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself. The patient received pneumonia shot at same time as the dose of Shingrix in right arm. The patient reported that her heart was racing even worse than usual. The patient has had chills for 2 days. The patient had upset stomach and had not eaten since afternoon of day before reporting. The patient reported that day before reporting it hurt (at site of injection) but it was worse on the day of reporting and it was spreading to shoulder. The patient could not move arm away from body, her arm was so sore. The patient had 4 bumps around site of administration. The reporter did not have batch number or expiry date of vaccine. The reporter did not consent to follow up. It was unknown if the reporter considered the atrial fibrillation aggravated, injection site swelling, injected limb mobility decreased, chills, upset stomach, appetite absent, pain in arm and shoulder pain to be related to pneumonia vaccine.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Neoplasm malignant
Clinical narrative: cancer treatment / cancer diagnose was after the first dose of Shingrix but could not be sure; First dose was given on 03Jun2019 / not get the second dose; This case was reported by a pharmacist and described the occurrence of cancer in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 99D9F, expiry date 14th April 2020) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 3rd June 2019, the patient received the 1st dose of Shingrix (unknown). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the cancer and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix and some point after vaccination diagnosed with cancer. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up via email. This case was linked with case US2020202323 and US2021009401, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021009401:same reporter
Age: 5.0
Sex: U
Vaccine: DTAPIPV, FLU4
Symptoms: Product storage error
Clinical narrative: inadvertently administered frozen vaccine / frozen temp ranging -8.2 to -13.4 C for 7 hrs; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 5-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis and flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th May 2021, the patient received Kinrix, Kinrix Pre-Filled Syringe Device, FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On 6th May 2021, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. The action taken with Flulaval Tetra Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details was reported as follows: The patient was administered with frozen vaccine Kinrix and FluLaval Quadrivalent  which was kept on temperature ranging from-8.2 to -13.4 C for 7 hours, which led to incorrect storage of drug. The mobile cooler went too cold. The reporter wanted to know, if the patients can be revaccinated. The vaccine details were available. The reporter consented to follow up. This case is one of the several cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021100521:same reporter US-GLAXOSMITHKLINE-US2021100518:same reporter US-GLAXOSMITHKLINE-US2021100514:same reporter US-GLAXOSMITHKLINE-US2021100519:same reporter US-GLAXOSMITHKLINE-US2021100517:same reporter US-GLAXOSMITHKLINE-US2021100510:same reporter
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Bacterial test positive, Blood test abnormal, Creatinine urine increased, Cystoscopy, Haematuria
Clinical narrative: High Creatinine; high nitrates; After her first Shingrix dose in January she developed urinary bleeding (hematuria); This case was reported by a consumer via call center representative and described the occurrence of hematuria in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 16th January 2021, less than a day after receiving Shingrix, the patient experienced hematuria. On an unknown date, the patient experienced creatinine increased and nitrite urine. On an unknown date, the outcome of the hematuria was not recovered/not resolved and the outcome of the creatinine increased and nitrite urine were unknown.   It was unknown if the reporter considered the hematuria, creatinine increased and nitrite urine to be related to Shingrix.  Additional details were provided as follows: It was reported as after her first Shingrix dose in January the patient developed urinary bleeding (hematuria) that had not resolved. It became less when the patient drank more water but it never went away. The patient seen a urologist and had a cystoscopy performed and no cause of the bleeding was found. The patient's urinalysis showed a normal levels of bacteria, not enough to cause bleeding. The patient underwent blood test and back with high creatine and nitrates. The patient had first Pfizer COVID-19 dose on 27th  February  2021 and second Pfizer COVID-19 dose on 20th  March 2021.  The patient received second of Shingrix on 3rd April 2021. All vaccine injections were in her right arm.  The patient will follow up with a new urologist next Friday on 14th May 2021.  The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR101259:
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Nitrite urine present, Urine analysis abnormal
Clinical narrative: High Creatinine; high nitrates; After her first Shingrix dose in January she developed urinary bleeding (hematuria); This case was reported by a consumer via call center representative and described the occurrence of hematuria in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 16th January 2021, less than a day after receiving Shingrix, the patient experienced hematuria. On an unknown date, the patient experienced creatinine increased and nitrite urine. On an unknown date, the outcome of the hematuria was not recovered/not resolved and the outcome of the creatinine increased and nitrite urine were unknown.   It was unknown if the reporter considered the hematuria, creatinine increased and nitrite urine to be related to Shingrix.  Additional details were provided as follows: It was reported as after her first Shingrix dose in January the patient developed urinary bleeding (hematuria) that had not resolved. It became less when the patient drank more water but it never went away. The patient seen a urologist and had a cystoscopy performed and no cause of the bleeding was found. The patient's urinalysis showed a normal levels of bacteria, not enough to cause bleeding. The patient underwent blood test and back with high creatine and nitrates. The patient had first Pfizer COVID-19 dose on 27th  February  2021 and second Pfizer COVID-19 dose on 20th  March 2021.  The patient received second of Shingrix on 3rd April 2021. All vaccine injections were in her right arm.  The patient will follow up with a new urologist next Friday on 14th May 2021.  The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR101259:
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Condition aggravated, Fatigue, Pain in extremity, Rheumatoid arthritis
Clinical narrative: RA flair up; sore arm; sore knees; tiredness; This case was reported by a consumer and described the occurrence of rheumatoid arthritis flare up in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis, fibromyalgia and diverticulitis.   On 6th May 2021, the patient received the 1st dose of Shingrix. On 6th May 2021, less than a day after receiving Shingrix, the patient experienced rheumatoid arthritis flare up (serious criteria GSK medically significant), pain in arm, knee pain and tiredness. On an unknown date, the outcome of the rheumatoid arthritis flare up was unknown and the outcome of the pain in arm, knee pain and tiredness were recovering/resolving.   It was unknown if the reporter considered the rheumatoid arthritis flare up, pain in arm, knee pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. After receiving Shngrix, the patient experienced arm soreness, tiredness and knees soreness. The patient believed that the sore knees were a result of rheumatoid arthritis flare up not the vaccine. The reporter consented to follow up.
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: recieved a pediatric dose of Engerix B; recieved a pediatric dose of Engerix B; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 25-year-old male patient who received HBV (Engerix B pediatric) (batch number D423N, expiry date 1st June 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th May 2021, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 7th May 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   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: Medical assistant reported that male adult patient received on May 7th 2021 a pediatric dose of Engerix B, which led to underdose and adult use of a child product. The Vaccine Administration Facility is the same as Primary Reporter. The reporter did not consent to follow up.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: has not received the third dose yet (more than six months / since the first dose); This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 35-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received 1st dose on unknown ate) and Engerix B (received nd dose on unknown date).   On an unknown date, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B 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 reporter stated that, it was more than 6 months after the 1st dose but the patient did not receive the 3rd dose of Engerix B, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: expired dose of shingrix had been administered on 5/7/2021 / expired on 5/5/2021; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a adult patient who received Herpes zoster (Shingrix) (batch number 5MG5E, expiry date 5th May 2021) for prophylaxis.   On 7th May 2021, the patient received Shingrix. On 7th May 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. On 7th May 2021 patient received Shingrix, which was expired on 5th may 2021. The reporter asked if patient needs to be revaccinated. No other patient or  vaccination details were available. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: his arm felt sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2021, the patient received the 1st dose of Shingrix. In February 2021, an unknown time after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details was reported as follows: The age at vaccination was not reported but it could be 61 or 62 years. The patient received Shingrix 1st dose 3 months ago of the reporting date and his arm felt sore and it lasted for a couple of days. The patient had not received his 2nd dose yet. The reporter consented to follow up. The case is linked with US2021101408, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021101408:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first shot /January 2020 /not received their second shot yet.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 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 case details were reported as follows: The patient reported case for herself. The age at vaccination was not applicable for this report. The reporter declined to provide any demographic information. Till the time of report the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow up. This case has been linked with US2021101406 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021101406:Husband´s case
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Influenza like illness
Clinical narrative: Experienced flu like symptoms / after getting the shingrix vaccine; Experienced / sweats after getting the shingrix vaccine; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms 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 influenza-like symptoms and sweating. On an unknown date, the outcome of the influenza-like symptoms and sweating were unknown.   It was unknown if the reporter considered the influenza-like symptoms and sweating to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter was not the patient. The patient was a nurse that the reporter was talking with. After the Shingrix vaccination, the patient experienced flu like symptoms and sweats. No additional details provided. The reporter did not consented to follow up. this case has been linked to US2021101407, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021101407:Same reporter.
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received an expired dose of Engerix-B on 10May2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 50-year-old male patient who received HBV (Engerix B) (batch number 2NK52, expiry date 20th February 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th May 2021, the patient received the 1st dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 10th May 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: it was reported that a male patient received an expired dose of Engerix-B on 10th May2021. The vaccine expired on 20th February 2021. No symptoms reported. The reporter consented to follow up.
Age: 27.0
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, Underdose
Clinical narrative: Administration of a pediatric dose of Engerix-B to an adult patient; Administration of a pediatric dose of Engerix-B to an adult patient; The dose had expired on 05Feb2021; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 27-year-old patient who received HBV (Engerix B pediatric) (batch number 97Y27, expiry date 5th February 2021) for prophylaxis.   On 10th May 2021, the patient received Engerix B pediatric. On 10th May 2021, unknown after receiving Engerix B pediatric, the patient experienced underdose, adult use of a child product and expired vaccine used. On an unknown date, the outcome of the underdose, adult use of a child product and expired vaccine used were unknown.  Additional details were provided as follows: The pediatric dose of Engerix-B was given to the adult patient, which led to underdose and  adult use of child product. During reconciliation of adverse event data, it was found that the dose of administered vaccine was expired, which led to expired vaccine used. The HCP (Health Care Professional) shared limited information of patient. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Migraine
Clinical narrative: Scheduled for the first infusion of Vyepti for the treatment of migraines; This case was reported by a pharmacist via call center representative and described the occurrence of migraine in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced migraine. On an unknown date, the outcome of the migraine was unknown.   It was unknown if the reporter considered the migraine to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The pharmacist contacted medical information reporting that a patient needed to receive the second dose of Shingrix but was also scheduled for the first infusion of Vyepti for the treatment of migraines. No further information was available. The reporter did not consent to follow-up.
Sex: M
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: received first dose of Havrix in 2019 / never received the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (1st dose received in 2019).   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix 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. Till the time of reporting patient did not receive the booster dose of Havrix, which led to incomplete course of vaccination. Patient requesting for 2nd dose is was it advisable to give. No other details of vaccine available. The reporter did not consented to follow up
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered the diluent portion of vaccine and not the powder portion; administered the diluent portion of vaccine and not the powder portion; This case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient had received only diluent portion of Shingrix vaccine and not the powder portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No other detail of vaccine available. The reporter consented to follow up.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: got her first dose in Aug 2019 and due to Covid 19, patient received 2nd dose on Dec 2020; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received in August 2019).   In December 2020, the patient received the 2nd dose of Shingrix. In December 2020, 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 patient received her 1st dose in August 2019 and due to Covid 19, patient received 2nd dose on December 2020. All patient identifiers reported.  No Batch Number or Expiration Date when asked, as HCP reported it was administered on a different facility.  No further clarifications
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness postural, Fatigue, Feeling abnormal, Vision blurred
Clinical narrative: CLOUDY HEAD; TIREDNESS; ABDOMINAL CRAMPS; CLOUDY VISION/HAZINESS/ BLURRED VISION; DIZZINESS WHEN STANDING AND WALKING; .This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included double pneumonia.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 13:24 for prophylactic vaccination. No concomitant medications were reported.  On 30-APR-2021, the subject experienced cloudy vision /haziness/ blurred vision. On 30-APR-2021, the subject experienced dizziness when standing and walking. On 01-MAY-2021, the subject experienced cloudy head. On 01-MAY-2021, the subject experienced tiredness. On 01-MAY-2021, the subject experienced abdominal cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal cramps on 01-MAY-2021, had not recovered from cloudy vision /haziness/ blurred vision, and dizziness when standing and walking, and the outcome of tiredness and cloudy head was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.