chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: first booster on 2/14/2020 / gave him another booster on 8/03/2021; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (patient received the vaccine on 16th October 2014) and Menveo (1st booster dose received on 14th February 2020).   On 3rd August 2021, the patient received Menveo. On 3rd August 2021, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The case was reported by patient mother. The patient received an extra booster of Menveo, which led to extra dose administered. The reporter asked if patient mother had the lot numbers for the 3 doses and she did not however she stated that per the documentation she has they all are listed as MCV40 Menveo. The reporter did not consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: was administered her 2nd dose of the Hepatitis B vaccine in 1997; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 27-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis B vaccine (received 2nd dose in 1997).   On an unknown date, the patient received the 3rd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received 3rd dose of Hepatitis B vaccine, which led to incomplete course of vaccination. The pharmacist had minimal information about the patient and was unaware of which Hepatitis B vaccine the patient received. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.
Age: 1.33
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received Havrix expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-year-old female patient who received HAV (Havrix) (batch number BE554, expiry date 1st August 2021) for prophylaxis.   On 4th August 2021, the patient received the 1st dose of Havrix. On 4th August 2021, unknown after receiving Havrix, 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: On 4th August 2021, the patient was administered Havrix, which was expired on 1st August 2021. The reporter consented to follow up via mail.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult/ received a pediatric dose; adult/ received a pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 29-year-old male patient who received HBV (Engerix B pediatric) (batch number MY3RA, expiry date 21st September 2022) for prophylaxis.   On 5th August 2021, the patient received Engerix B pediatric. On 5th August 2021, unknown after receiving Engerix B pediatric, 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.  Additional details were provided as follows: Nurse reported that the adult patient was administered with Engerix B pediatric, which led to underdose and adult use of a child product. The vaccine administration facility was same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Off label use, Pruritus, Scar
Clinical narrative: 3rd dose / Her doctor has approved the prescription; Suspected vaccination failure; Mild case of shingles in July; Had itching; Had / scars; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   In February 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In November 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 3rd dose of Shingrix. In July 2021, between 4 and 6 months after receiving Shingrix, between 7 and 9 months after receiving Shingrix, not applicable after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus and scar. On an unknown date, the patient experienced off label use. The patient was treated with valaciclovir hydrochloride (Valtrex) and ascorbic acid (Vitamin C). On an unknown date, the outcome of the vaccination failure, shingles, pruritus, scar and off label use were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and scar to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got the first dose of Shingrix vaccine November 2020 and second dose February 2021 . The patient got a mild case of shingles in July 2021, that affected her from her shoulders to base of her neck. The patient went to urgent care, got Valtrex, vitamin C for itching and scars.  The patient was currently at receiving a 3rd dose of Shingrix because the first two did not work. Advised Shingrix was only indicated for two doses and a third dose was not approved. The patient was  going to get the 3rd dose anyway as her doctor has approved the prescription and was preparing the dose for her which led to off label use. extra dose administered and off label use in unapproved indication. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: 3rd dose / Her doctor has approved the prescription; Suspected vaccination failure; Mild case of shingles in July; Had itching; Had / scars; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   In February 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In November 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 3rd dose of Shingrix. In July 2021, between 4 and 6 months after receiving Shingrix, between 7 and 9 months after receiving Shingrix, not applicable after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus and scar. On an unknown date, the patient experienced off label use. The patient was treated with valaciclovir hydrochloride (Valtrex) and ascorbic acid (Vitamin C). On an unknown date, the outcome of the vaccination failure, shingles, pruritus, scar and off label use were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and scar to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got the first dose of Shingrix vaccine November 2020 and second dose February 2021 . The patient got a mild case of shingles in July 2021, that affected her from her shoulders to base of her neck. The patient went to urgent care, got Valtrex, vitamin C for itching and scars.  The patient was currently at receiving a 3rd dose of Shingrix because the first two did not work. Advised Shingrix was only indicated for two doses and a third dose was not approved. The patient was  going to get the 3rd dose anyway as her doctor has approved the prescription and was preparing the dose for her which led to off label use. extra dose administered and off label use in unapproved indication. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. The reporter consented to follow up.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: COVID-19
Clinical narrative: COVID in February 2021 / hospitalize for maybe 2 months; This case was reported by a pharmacist via call center representative and described the occurrence of covid-19 in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number AG7M9, expiry date 19th October 2021) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix. In February 2021, between 3 and 5 months after receiving Shingrix, the patient experienced covid-19 (serious criteria hospitalization). On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix and had COVID and being hospitalize for 2 months. The reporter was unsure of dates of hospitalization and site of Shingrix administration. The reporter consented to follow up. For tolerance of 2nd dose refer case US2021AMR167468.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR167468:Same reporter.
Sex: U
Vaccine: MNQ
Symptoms: Product complaint, Syncope
Clinical narrative: new lot / was administered / asking to know if they could continue using that lot of vaccines; 3 out of 18 patients fainted; This case was reported by a nurse via call center representative and described the occurrence of fainting in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. This case was associated with a product complaint.   In August 2021, the patient received Menveo. In August 2021, less than a week after receiving Menveo, the patient experienced fainting (serious criteria GSK medically significant). On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the fainting and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the fainting to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not reported. The reporter called to report, a new lot of Menveo was administered to 18 patients since 2nd August 2021. The patient fainted after receiving the Menveo vaccine.  The health care professional called on behalf of a nurse manager who was asking to know if they could continue using that lot of vaccines.  The health care professional who made the call did not have any patient's demographics information nor vaccine information. Follow-up was not asked because the health care professional who reported the event did not have any information. On 5th August 2021, call back to nurse manager, but she was not available.  As per the judgment there has to be a PQC associated, for that the health care professional was transferred to the Agency, but not sure if they collected it, because the agent said it was not, and afterwards she took the call. The data in health care professional detail was from the nurse manager who has all the information on the event. This case was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR167724:Same reporter US-GLAXOSMITHKLINE-US2021AMR167723:Same reporter
Sex: U
Vaccine: TDAP
Symptoms: Product preparation issue
Clinical narrative: administering a dose of BOOSTRIX via prefilled syringe using a BD safety glide (25 gauge) needle/Product quality complaint ruled out because Luer Lok needle was not used; This case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in device usage process in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number GC5NG, expiry date 1st April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th August 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 4th August 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong technique in device usage process. The action taken with Boostrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the wrong technique in device usage process 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 reported. The reporter was administering to the patient a dose of Boostrix via prefilled syringe using a BD safety glide (25 gauge) needle.  She attempted to inject into an unspecified arm, but the plunger would not push which led to wrong technique in device usage process.  She did not think the patient received any medication during the attempted administration, so she prepared another dose using a new syringe from the same box and a new needle and was able to successfully administer a complete dose in the opposite arm. Product quality complaint was ruled out because Luer Lok needle was not used. The reporter failed to obtain patient's gender and date of birth. The vaccine administration facility was the same as primary reporter. This case had been linked with case US2021167026, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021167026:Same reporter
Sex: U
Vaccine: TDAP
Symptoms: Product preparation issue
Clinical narrative: administering a dose of BOOSTRIX via prefilled syringe using a BD safety glide (25 gauge) needle/ Product quality complaint ruled out because Luer Lok needle was not used; This case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in device usage process in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number GC5NG, expiry date 1st April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th August 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 5th August 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong technique in device usage process. The action taken with Boostrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the wrong technique in device usage process 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 reported. The reporter was administering to the patient a dose of Boostrix via prefilled syringe using a BD safety glide (25 gauge) needle which led to wrong technique in device usage process.  She attempted to inject into an unspecified arm, but the plunger would not push.  She did not think the patient received any medication during the attempted administration, so she prepared another dose using a new syringe from the same box and a new needle and was able to successfully administer a complete dose in the opposite arm.   Product quality complaint was ruled out because Luer Lok needle was not used. The reporter failed to obtain patient's gender and date of birth. The vaccine administration facility was the same as primary reporter. This case had been linked with case US2021167025, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021167025:Same reporter
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Fatigue, Loss of personal independence in daily activities, Musculoskeletal pain, Myalgia
Clinical narrative: Cough 8 days after the vaccine / Covid19 test / was negative; Soreness in / left leg / getting worse daily; Fatigue / Even going up the stairs exhausts him; "Pain in thigh and buttocks muscles"; decrease all of his daily activity; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Pfizer Covid19 Vaccine (received both doses of Pfizer Covid 19 vaccine on an unknown date), Pneumonia vaccine (received Pneumonia vaccine on an unknown date) and Zostavax (received Zostavax on an unknown date).   On 20th July 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 22nd July 2021, 2 days after receiving Shingrix, the patient experienced fatigue, muscle pain and activities of daily living impaired. On 28th July 2021, the patient experienced cough and leg pain. On an unknown date, the outcome of the fatigue, muscle pain, activities of daily living impaired, cough and leg pain were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, muscle pain, activities of daily living impaired, cough and leg pain to be related to Shingrix.  Additional details were provide are as follows: The case was reported by patient himself. The patient stressed that he was very fit for his age and had an intense exercise routine he follows everyday. The patient had no adverse reactions from Zostavax, Pneumonia or Pfizer Covid 19 vaccines. The patient received 0.5 ml of 1st dose of Shingrix and 2 days after vaccination, patient began to had fatigue and pain in thigh and buttocks muscles and had to decrease all of his daily activity and even going up the stairs exhausted him and 8 days after vaccination, patient developed cough which was audible throughout the call and began to had soreness in his left leg was getting worse daily. The patient went to nurse about the cough, she said his lungs are clear and there was no fever and she would like him to see the doctor about the cough because she thought the cough was unrelated to the Shingrix vaccine. The patient had performed Covid 19 test which was negative. The reporter consented to follow-up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: Cough 8 days after the vaccine / Covid19 test / was negative; Soreness in / left leg / getting worse daily; Fatigue / Even going up the stairs exhausts him; "Pain in thigh and buttocks muscles"; decrease all of his daily activity; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Pfizer Covid19 Vaccine (received both doses of Pfizer Covid 19 vaccine on an unknown date), Pneumonia vaccine (received Pneumonia vaccine on an unknown date) and Zostavax (received Zostavax on an unknown date).   On 20th July 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 22nd July 2021, 2 days after receiving Shingrix, the patient experienced fatigue, muscle pain and activities of daily living impaired. On 28th July 2021, the patient experienced cough and leg pain. On an unknown date, the outcome of the fatigue, muscle pain, activities of daily living impaired, cough and leg pain were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, muscle pain, activities of daily living impaired, cough and leg pain to be related to Shingrix.  Additional details were provide are as follows: The case was reported by patient himself. The patient stressed that he was very fit for his age and had an intense exercise routine he follows everyday. The patient had no adverse reactions from Zostavax, Pneumonia or Pfizer Covid 19 vaccines. The patient received 0.5 ml of 1st dose of Shingrix and 2 days after vaccination, patient began to had fatigue and pain in thigh and buttocks muscles and had to decrease all of his daily activity and even going up the stairs exhausted him and 8 days after vaccination, patient developed cough which was audible throughout the call and began to had soreness in his left leg was getting worse daily. The patient went to nurse about the cough, she said his lungs are clear and there was no fever and she would like him to see the doctor about the cough because she thought the cough was unrelated to the Shingrix vaccine. The patient had performed Covid 19 test which was negative. The reporter consented to follow-up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Glossitis, Stomatitis
Clinical narrative: raw/ tongue/ feeling like when you burn your mouth; raw /palette/ feeling like when you burn your mouth; This case was reported by a consumer via call center representative and described the occurrence of raw tongue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2021 12:00, the patient received the 1st dose of Shingrix (intramuscular). In August 2021, less than a week after receiving Shingrix, the patient experienced raw tongue and raw mouth. On an unknown date, the outcome of the raw tongue and raw mouth were not recovered/not resolved.   It was unknown if the reporter considered the raw tongue and raw mouth to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient herself. The patient received 1st dose of Shingrix in right arm and on 3rd or 4th August 2021 felt a raw sensation on her tongue and palette. The caller described the feeling like when we burn our mouth after eating something too hot. The caller reported her dentist said that it might be related to the Shingrix vaccine. The reporter did not gave permission to contact health care professional. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose of Shingrix given at less than 2 months.; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 6th August 2021, the patient received the 2nd dose of Shingrix. On 6th August 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided are as follows: The case was reported by Practitioner. The age at vaccination was not reported. The patient received 2nd dose of Shingrix at less than 2 months after receiving 1st dose, which led to shortening of vaccination schedule. The reporter did not consent to follow-up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Hypokinesia, Injection site erythema
Clinical narrative: Redness / at injection site; Swelling at injection site; Joint pain; Muscle pain; Fatigue; Shivering; Has been in bed the last 3 days; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 4th August 2021, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, joint pain, muscle pain, fatigue, shivering and movements reduced. On an unknown date, the outcome of the injection site erythema, injection site swelling, joint pain, muscle pain, fatigue, shivering and movements reduced were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, joint pain, muscle pain, fatigue, shivering and movements reduced to be related to Shingrix.  Additional details were provide are as follows: The case was reported by patient for herself. The patient received 1st dose of Shingrix in right arm and experienced redness and swelling at injection site. The patient stated that she had been in bed the last 3 days with joint pain, muscle pain, fatigue, and shivering. The patient was referred to health care professional. The reporter did not consented to follow-up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia
Clinical narrative: Redness / at injection site; Swelling at injection site; Joint pain; Muscle pain; Fatigue; Shivering; Has been in bed the last 3 days; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 4th August 2021, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, joint pain, muscle pain, fatigue, shivering and movements reduced. On an unknown date, the outcome of the injection site erythema, injection site swelling, joint pain, muscle pain, fatigue, shivering and movements reduced were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, joint pain, muscle pain, fatigue, shivering and movements reduced to be related to Shingrix.  Additional details were provide are as follows: The case was reported by patient for herself. The patient received 1st dose of Shingrix in right arm and experienced redness and swelling at injection site. The patient stated that she had been in bed the last 3 days with joint pain, muscle pain, fatigue, and shivering. The patient was referred to health care professional. The reporter did not consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1St dose of Shingrix was administered in 2019 and never receied 2nd dose; 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 an unknown date in 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 case details were provided as follows: The age at vaccination was not applicable for this report. The patient never received the 2nd dose of Shingrix, which led to incomplete course of vaccination. No reactions were reported. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Do I get the second shot or do I have to start the series again.?; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 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 patient reported the case for himself. The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient wanted to know that do he/she get the second shot or do have to start the series again. The reporter did not want to provide his address or any further information. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received only the adjuvant; Received only the adjuvant; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication 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 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 physician reported that a patient received Shingrix and was administered only the adjuvant (ASO1B) portion of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not have any other information about the patient. The physician could not confirm the date of incident nor details about the patient. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: had been given only the liquid portion; had been given only the liquid portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 6th August 2021, the patient received Menveo. On 6th August 2021, unknown after receiving Menveo, 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. Nurse reported that a patient was given only the liquid portion of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No patient data was provided by reporter aside from age, which was mentioned casually.  The reporter did not consent to follow-up.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: Wrong Route of Administration / was given subcutaneously instead of IM; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 56-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 59TH3, expiry date 30th September 2022) for prophylaxis.   On 6th August 2021, the patient received Boostrix (subcutaneous). On 6th August 2021, unknown after receiving Boostrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional case details were provided as follows: Boostrix vaccine was given subcutaneously instead of intramuscular route which led to intramuscular formulation administered by other route. No other details were given. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received first dose of Shingrix vaccine 05Jun2018 / has not yet received second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 5th June 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.   The reporter was not able to provide lot number or expiration date of 1st Shingrix dose. VAERS details were reported for the 1st dose of Shingrix. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: diluent was administered alone; diluent was administered alone; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 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 reporter asked for days/time that the patient should wait to receive Shingrix in case the diluent was administered alone, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The health care professional reported that the patient already had got 1st dose but they were not sure if it actually had happened, so they want to had data just in case. The reporter consented to follow up by email. No further information was available.
Age: 18.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: eighteen year old patient received a 1 mL dose of Engerix-B; eighteen year old patient received a 1 mL dose of Engerix-B; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 18-year-old patient who received HBV (Engerix B adult) (batch number Xa4dd, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th June 2021, the patient received the 1st dose of Engerix B adult 1 ml and Engerix B Pre-Filled Syringe Device. On 15th June 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration 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 reporter reported that an eighteen year old patient received a 1 ml dose of Engerix-B adult, which led to inappropriate age at vaccine administration and overdose. The reporter did not consent to follow-up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Pt was given 0.5 ml instead of 0.3 ml. pt states soreness in arm & headache the night of imz but said she thought it was normal. wasnt too concerned, I told her info I recieved from Pfizer, recommendations & that patients were given higher doses in trials with main adverse events being more pain at injection site than with 0.3 ml dose.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Bacteraemia, Blood culture, Central venous catheterisation, Computerised tomogram
Clinical narrative: Extremely painful recurrence of bulbous phemphigoid  covered most of body.  3.5 weeks after initial vaccine. Required hospitalization 3 times and admission to rehab twice. Unable to walk, difficulty breathing, swollen legs,  2nd hospital. Unable to speak or walk 3rd hosp, ended in death/ bacteremia.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Culture urine, Death, Disease recurrence, Dyspnoea, Gait inability
Clinical narrative: Extremely painful recurrence of bulbous phemphigoid  covered most of body.  3.5 weeks after initial vaccine. Required hospitalization 3 times and admission to rehab twice. Unable to walk, difficulty breathing, swollen legs,  2nd hospital. Unable to speak or walk 3rd hosp, ended in death/ bacteremia.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pemphigoid, Peripheral swelling, Ultrasound scan
Clinical narrative: Extremely painful recurrence of bulbous phemphigoid  covered most of body.  3.5 weeks after initial vaccine. Required hospitalization 3 times and admission to rehab twice. Unable to walk, difficulty breathing, swollen legs,  2nd hospital. Unable to speak or walk 3rd hosp, ended in death/ bacteremia.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Hypoaesthesia, Injection site swelling
Clinical narrative: PATIENT felt numbness in her face and swelling of the side where she got her shot.patient stated even her ears feels numb
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Infection, Respiratory disorder, SARS-CoV-2 test positive
Clinical narrative: Breakthrough infection - developed respiratory symptoms and tested positive for COVID on 8/5/21
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, Infection
Clinical narrative: Breakthrough infection - developed respiratory symptoms and tested positive for COVID on 8/5/21
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Beginning approximately one week after receiving the first dose of the COVID-19 vaccine by Pfizer I began to develop a rash on my legs and arms. This was treated with cortisone cream and aloe. After receiving the 2nd dose, the rash that has been receding and healing has come back to cover my arms, hands, and stomach and sides of my breasts starting about 4 days after receiving the 2nd dose. This is being treated again with cortisone, aloe, and now sensitive skin lotion by lubriderm.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: SORE BODY; WOKE UP WITH CHILLS; FEVER KICKED AGAIN; PRETTY TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sore body, woke up with chills, fever kicked again, and pretty tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever kicked again, woke up with chills, sore body, and pretty tired. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial spasm, Fatigue, Heavy menstrual bleeding, Intermenstrual bleeding
Clinical narrative: After the first dose I  had facial spasms on the right side of my face. Those facial spasms were continuous up until my second dose of Pfizer. I am menstruating for an average of three weeks or longs. I am spotting in between. I started to take Iron supplements due to feeling fatigue attributed that to loss of blood while menstruating.  It is now august and I have been bleeding non stop since July. I am tired and to be honest am regretting getting the vaccine. This is depressing and starting to take a toll on me mentally and physically.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Breast tenderness, Dysmenorrhoea, Heavy menstrual bleeding, Postmenopausal haemorrhage
Clinical narrative: 4 years post-menopausal, started heavy menstrual bleeding for a10 days.   Hormone responses like pms/acne/tender breasts and cramps still occurring monthly but no more menstrual bleeding.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Premenstrual syndrome
Clinical narrative: 4 years post-menopausal, started heavy menstrual bleeding for a10 days.   Hormone responses like pms/acne/tender breasts and cramps still occurring monthly but no more menstrual bleeding.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Exposure during pregnancy, Full blood count, Loss of consciousness
Clinical narrative: Patient is 20 weeks pregnant with a due date of 12/27/2021. Has factor V leiden mutation for which takes aspirin.  7-8 minutes after first dose, patient started getting dizzy and passed out. Did not suffer injury as was sitting in chair. Went to emergency room and was given CT to rule out blood clots and pulmonary embolism. Patient discharged feeling better.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Injection site haemorrhage, Pain in extremity
Clinical narrative: Patient had bleeding at the site of inyection that lasted a few hours with severe arm pain from the inyection. She has small arms and maybe the 3mL of vaccine could have been too much. Patient also had severe chest pain and shortness of breath after 1-2 hours after taking the vaccine, I almost took her to the emergency room at the hospital that evening but we don't have insurance and going to the hospital would put us at higher risk of contracting COVID-19. So I waited for her symptoms to wear down.  Patient felt moderate chest pain for 3-4 days after the vaccine and still experiences some shortness of breath  as of today, 08/10/2021, therefore we have been discouraged from taking the second dose.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest X-ray, Chest pain, Dizziness, Dyspnoea
Clinical narrative: Pericarditis: agonizing chest and back pains, frequent dizziness, shortness of breath
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Laboratory test, Pericarditis
Clinical narrative: Pericarditis: agonizing chest and back pains, frequent dizziness, shortness of breath
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site red, swollen, itchy, tender
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Blood test abnormal, Inflammation, Rash, Urticaria
Clinical narrative: No immediate reaction, but Pt woke up with hives the morning after getting the vaccine. The hives spread all over his body and progressed to angioedema on his eyes/mouth. Urgent Care proscribed prednisone, which brought the inflammation down. Dr. (allergist) put Pt on a  Pregimen of Allegra, Zyrtec and Benadryl to bring his hives under control. It took more than 10 weeks for Pt hives to subside, and we are beginning to wean him off his antihistamines.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient returned to pharmacy ~30 minutes after the immunization. Patient states he had an outbreak on his forehead (could see bumps on head) starting ~25 minutes after immunization; patient noticed the outbreak while waiting in car and while talking to his mother on the phone (patient left pharmacy waiting area after sitting there for 10 - 15 minutes. Patient stated the outbreak was slightly itchy. When asked if patient had difficulty breathing or experienced swelling, he denied it. Advised patient to take Benadryl for the rash and go to the ER if necessary. Called patient ~30 minutes after he left pharmacy to see how he was doing, patient stated he was doing okay and did take a Benadryl, still had the outbreak (still slightly itchy and bumpy, but also occurred partially around the chin/mouth area). However, patient also denied having difficulty breathing or experiencing swelling. Then advised patient to go to ER for further evaluation to be extra safe.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: My period came two weeks early for the last two cycles. Once my period came it was extremely heavy and long for 9 days . I have never taken nor am I on Birth Control so this is strange. Further, this has never happen to me until  I took this vaccine.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pyrexia
Clinical narrative: This morning after his second shot yesterday he had a fever of 99.  This afternoon about 24 hours after his vaccination it was 100.8.  Normal for him is 97.5.  He's complained of chills also and dizziness.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Injected COVID Pfizer vaccine LOT FC3181 IM left deltoid.  Patient 5 minutes later reported trouble breathing and closing of airways.  EMS was notified immediately and patient was given 50 mg of diphenhydramine and monitored. Patient was transported to hospital for further evaluation and monitoring.
Age: 42.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Injection site mass, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: I developed a lump/nodule at the injection site immediately after the shot and it has persisted for almost a month. While on vacation I did a telehealth urgent care visit because the lump seemed more swollen and tender and the doctor prescribed two antibiotics which I have been taking for a week (out of a 10-day course). The swelling and tenderness has lessened but the lump/nodule is still there.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Cough, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Diagnosed with bilateral pneumonia on 7/26/21, coughing, back pain, wheezing, headache, nausea, vomiting, diarrhea, runny nose, nasal passages swollen almost shut, fluid in both ears, fatigue, dizziness, fever
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Middle ear effusion, Nausea, Pneumonia, Pyrexia
Clinical narrative: Diagnosed with bilateral pneumonia on 7/26/21, coughing, back pain, wheezing, headache, nausea, vomiting, diarrhea, runny nose, nasal passages swollen almost shut, fluid in both ears, fatigue, dizziness, fever
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rhinorrhoea, Sinusitis, Vomiting, Wheezing
Clinical narrative: Diagnosed with bilateral pneumonia on 7/26/21, coughing, back pain, wheezing, headache, nausea, vomiting, diarrhea, runny nose, nasal passages swollen almost shut, fluid in both ears, fatigue, dizziness, fever
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstrual disorder
Clinical narrative: Mid cycle menstrual spotting followed by heavier than normal period. Have not experienced mid cycle spotting at all in perhaps the last decade outside of irregular periods while breastfeeding. So far have only had one cycle since symptoms began.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Laboratory test, Menstrual disorder, Menstruation irregular, Ultrasound scan
Clinical narrative: Menstrual changes- started bleeding