chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: pregnant patient received two doses; received two doses; This prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 34-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Influenza Vaccine Quadrivalent Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis and flu seasonal qiv dresden pre-filled syringe device (Influenza Vaccine Quadrivalent Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 2nd dose of Influenza vaccine Quadrivalent 2021-2022 season, Influenza Vaccine Quadrivalent Pre-Filled Syringe Device, the 1st dose of Influenza vaccine Quadrivalent 2021-2022 season and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was 7th November 2021. The patient received Influenza vaccine Quadrivalent 2021-2022 season at an unknown time during the pregnancy. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent 2021-2022 season, Influenza Vaccine Quadrivalent Pre-Filled Syringe Device, Influenza vaccine Quadrivalent 2021-2022 season and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy and extra dose administered. On an unknown date, the outcome of the vaccine exposure during pregnancy and extra dose administered were unknown. The pregnancy was ongoing.   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 pregnant patient received two doses of either Fluarix or Flulaval approximately one week apart, which led to vaccine exposure during pregnancy and extra dose administered. The reporter consented to follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Dyspnoea
Clinical narrative: Shortness of breath, loss of exercise, chest discomfort.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: Tiredness, difficulty breathing, soreness at injection site, diarrhea, muscle soreness, back pain, joint pain, fatigue, fever.    This vaccine was worse/harder on my body then actually being tested positive for COVID-19.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Pyrexia
Clinical narrative: Tiredness, difficulty breathing, soreness at injection site, diarrhea, muscle soreness, back pain, joint pain, fatigue, fever.    This vaccine was worse/harder on my body then actually being tested positive for COVID-19.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations
Clinical narrative: Immune response began within 2 hours (Covid survivor.)  Resting heart rate increased to 96bpm and stayed there for a month. Increase in palpitations noticed  during workouts and continues to present while working out.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult patient received a pediatric dose; adult patient received a pediatric dose; second dose longer than 1 month; This case was reported by a pharmacist and described the occurrence of underdose in a 27-year-old male patient who received HBV (Engerix B pediatric) (batch number LM992, expiry date 13th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 6th October 2021, the patient received the 2nd dose of Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On 6th October 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose, adult use of a child product and drug dose administration interval too long. On an unknown date, the outcome of the underdose, adult use of a child product and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received 1st dose of Engerix B on 29th July 2021. The patient received a pediatric dose (half dose) of Engerix B later than the recommended interval, which led to underdose, adult use of a child product and drug dose administration interval too long. The reporter stated that it had been longer than 1 months since patient got first dose of Engerix B. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: accidentally received an extra dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 14-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number XK524, expiry date 8th October 2022) for prophylaxis.   Previously administered products included Boostrix (patient was vaccinated with a full course of BOOSTRIX on an unknown date).   On 6th October 2021, the patient received Boostrix (intramuscular) .5 ml. On 6th October 2021, unknown after receiving Boostrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The reporter was the office manager of the health care professional office. The patient received Boostrix on right arm. The patient was vaccinated with a full course of Boostrix and then accidentally received an extra dose on a different date, which led to extra dose administered. The reporter gave a consent to follow-up with health care professional.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: (8 months later) to get her second shot; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2021).   On 7th October 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 7th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient reported for herself's. The patient received 2nd dose of Shingrix later (8 months after 1st dose) than the recommended time interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA392A, expiry date 30th September 2021) for prophylaxis.   On 4th October 2021, the patient received Menveo. On 4th October 2021, unknown after receiving Menveo, 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 Medical assistant reported that, the patient received expired dose of Menveo, which led to expired vaccine used. The reporter consented to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose 10/2/2020, has not received third dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) (batch number unknown, expiry date 24th May 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 4th September 2020) and Twinrix (received 2nd dose on 2nd October 2020, batch number 3Y7NL, expiry date 24 May 2022).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, 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, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination. The reporter declined to provide patient details. The reporter did not consent to follow up. This case was linked with case US2021AMR209359, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR209359:same reporter
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administrated only the adjuvant portion; administrated only the adjuvant portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number ga5s2, expiry date 25th March 2023) for prophylaxis.   On 7th October 2021, the patient received Shingrix. On 7th October 2021, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional details were provided as follows: The patient administered with only the adjuvant portion of Shingrix by error, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. No further events were reported. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: late second dose and a late third dose; late second dose and a late third dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 30-year-old female patient who received HBV (Engerix B) (batch number N4GA4, expiry date unknown) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on September 2020).   In October 2021, the patient received the 3rd dose of Engerix B. In May 2021, the patient received the 2nd dose of Engerix B. In May 2021, not applicable after receiving Engerix B and unknown after receiving Engerix B, the patient experienced drug dose administration interval too long. In October 2021, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long and drug dose administration interval too long were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient had been given a late second dose and a late third dose of the Engerix-B vaccine, which led to lengthening of vaccination schedule.  The reporter consented to follow.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: 1st dose 27Aug2019, is late for the 2nd; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 27th August 2019, batch number T2472, expiry date 23rd 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 details were provided as follows: The reporter was the pharmacy intern. 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. No symptoms reported. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix reconstituted with a Merck diluent; Shingrix reconstituted with a Merck diluent; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th October 2021, the patient received Shingrix. On 4th October 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient was administrated Shingrix which was inadvertently reconstituted with a Merck diluent as supposed to the AS01B adjuvant, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Booster should have been on 06Sep2021; 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 HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 3 doses of twinrix on an unknown date).   On an unknown date, the patient received the 4th dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at the vaccination was not applicable for this report. The patient asked information administration of a late booster dose.  The booster dose should have been given on 6th September 2021 but was differed by their physician until patient had the Covid19 vaccine.  Till the time of reporting, the patient did not receive booster dose which led to incomplete course of vaccination. Due to the nature of the call no more information was requested from patient aside from phone and zip code. The reporter did not consent to follow-up.
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Hive from head to toes; This case was reported by a consumer via call center representative and described the occurrence of hives in a 17-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Flu vaccine (had been receiving flu vaccines for over 10 years).   On an unknown date, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, several hours after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by the mother of the patient. The age at vaccination was not reported. The patient's mother reported that, in 2021 when the patient got Flulaval vaccine, a few hours after the administration of the vaccine, she was covered in hive from head to toes.  No further details were provided at the time of the reporting.  The reporter consented to follow up by phone. The patient's mother mentioned that she would call the physician to know the lot number and expiration date of the vaccine given to the patient.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First on 10/2/2020, had not received the second; 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 (received 1st dose on 2nd October 2020, batch number:454st, expiry date: 5th November 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had received the first dose and had not yet received the second dose of Shingrix till the time of reporting, which led to incomplete course of vacation.  No further events were reported. The health care professional agreed to be contacted for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 11/10/2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter asked, how to proceed with schedule from now on. Lot number and expiration date were asked but healthcare professional did not have that information. Healthcare professional did not mention about administering any 2nd dose of Shingrix. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: not yet gotten the 2nd dose; 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 (received 1st dose, 8 months ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided 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 vaccination schedule. The patient reported no symptoms. She would get the second dose as soon as possible.  No other information to report. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Rash, Vaccination failure
Clinical narrative: Shingles; pain in left heel and thumb; rash on left waist; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, less than 4 months after receiving Shingrix, the patient experienced shingles and pain. On an unknown date, the patient experienced rash. On 1st January 2020, the outcome of the pain was recovered/resolved. On an unknown date, the outcome of the shingles was unknown and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the shingles, pain and rash to be related to Shingrix.  Additional details were provided as follows: The patient reported the case for herself. The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccine in July or August of 2019 in an unknown arm. In October 2019, the patient experienced pain in her left heel and left thumb. The patient's health care practitioner thought it might be related to shingles. The patient experienced possible mild case of shingles. The pain in her left thumb and heel resolved in January 2020.  In January or February 2020, patient had a rash on the left side of her waist that was not itchy. The patient's health care practitioner gave her shingles medication and it cleared up in approximately 3 weeks. The patient did not remember name of medication. The reporter did not consent to follow up
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: declined to administer second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose an year ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Pharmacist reported that, someone she knew was late for their second dose after forgetting about the second dose. The patient waited a year since the first dose.  The pharmacy reportedly declined to administer the second dose late. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter did not consent to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix one month too early; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included ZOSTER VACCINE RECOMBINANT, ADJUVANTED (NON-LIVE) (SHINGRIX).   On 7th October 2021, the patient received the 2nd dose of Shingrix. On 7th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The reporter was the part of a team in a health care clinic. The patient received 1st dose of Shingrix in September 2021. The patient received 2nd dose of Shingrix 1 month after 1st Shingrix dose, which led to shortening of vaccination schedule. The reporter was calling to get data available for early dosing of the vaccine. Pharmacist was transferred to Medical Information for dosing recommendation and additional data. The reporter was not probed for additional information regarding the adverse event or the patient involved. The reporter did not have more data, stated the nurse who vaccinated the patient would call with further information. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021208835:Same reporter
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose on 10/7/2021, first on 06/28/2021; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 55-year-old male patient who received HBV (Engerix B) (batch number bg92z, expiry date 4th July 2022) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 28th June 2021).   On 7th October 2021, the patient received the 2nd dose of Engerix B. On 7th October 2021, unknown after receiving Engerix B, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received 2nd dose of Engerix B later than the recommended schedule which led to lengthening of vaccination schedule. Healthcare professional did not provide address or email. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not receive second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2021 but the reporter was not sure).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional details were reported as follows: Age at vaccination was not applicable for this report. The pharmacist reported that a patient did not received the 2nd dose of Shingrix at appropriate time also not received till the time of reporting which led incomplete course of vaccination. The reporter did not consent to follow-up. VAERS details were reported for 1st dose of Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose more than six months ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 17th October 2019, batch number 5k99).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter consented to follow up. This case had been linked with case US2021AMR210168, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 3 years ago / didn't complete the series; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 23rd September 2018, batch number M77B4, expiry date 08th February 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The pharmacist did not know, whether to restart the series or give the second dose.  The pharmacist declined to provide patient details. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first shot over a year ago; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st shingrix shot received over a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional details were reported as follows: This case was reported by the patient for himself. The age at vaccination was not reported. The patient asked about the timing of the second shingrix shot and what to do if outside the 6 month window. The patient stated that he got his shingrix shot 1 year ago, which led to incomplete course of vaccination. The patient did not consented to follow-up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Swelling
Clinical narrative: swelling in the right armpit; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in June 2021).   On 4th October 2021, the patient received the 2nd dose of Shingrix. In October 2021, less than a week after receiving Shingrix, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was recovering/resolving.   It was unknown if the reporter considered the local swelling to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient herself. The patient received a dose of Shingrix and after a day or two experienced swelling in the right arm pit. The patient reported that the swelling had subsided slightly, but was ongoing at the time of reporting. The health care professional consented to follow-up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Gastrointestinal disorder, Headache, Injection site erythema, Injection site pain
Clinical narrative: rash under breast; myalgia; fever; shivering; headache; gastrointestinal symptoms; pain; redness; swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th October 2021, the patient received the 1st dose of Shingrix. On 6th October 2021, less than a day after receiving Shingrix, the patient experienced myalgia, fever, shivering, headache and gastrointestinal disorder. On 8th October 2021, the patient experienced rash. In October 2021, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, myalgia, fever, shivering, headache, gastrointestinal disorder and rash were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, myalgia, fever, shivering, headache, gastrointestinal disorder and rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The patient received her first Shingrix vaccine and within 12 hours of her vaccine she was experiencing pain, redness, and swelling at the injection site as well as myalgia, fever, shivering, headache, and gastrointestinal symptoms. The patient also stated that she woke up on the day of reporting, with a rash under her breast. The patient stated that she was feeling much better. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Pyrexia, Rash
Clinical narrative: rash under breast; myalgia; fever; shivering; headache; gastrointestinal symptoms; pain; redness; swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th October 2021, the patient received the 1st dose of Shingrix. On 6th October 2021, less than a day after receiving Shingrix, the patient experienced myalgia, fever, shivering, headache and gastrointestinal disorder. On 8th October 2021, the patient experienced rash. In October 2021, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, myalgia, fever, shivering, headache, gastrointestinal disorder and rash were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, myalgia, fever, shivering, headache, gastrointestinal disorder and rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The patient received her first Shingrix vaccine and within 12 hours of her vaccine she was experiencing pain, redness, and swelling at the injection site as well as myalgia, fever, shivering, headache, and gastrointestinal symptoms. The patient also stated that she woke up on the day of reporting, with a rash under her breast. The patient stated that she was feeling much better. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: had been given an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 8th October 2021, the patient received the 2nd dose of Shingrix. On 8th October 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On 8th October 2021, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient received an expired dose of the Shingrix vaccine, which led to expired vaccine used. According to the nurse only the powder portion had expired. There was no specific information for the vaccine nor patient information aside from gender. Nurse did confirm that patient had not experienced any reaction or side effect at time of the call. The reporter agreed to follow-up by email.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose on 9/25/2019 / second dose on 6/4/2021; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 25th September 2019).   On 4th June 2021, the patient received the 2nd dose of Shingrix. On 4th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose late, which led lengthening of vaccination schedule. The reporter did not consent to follow-up. No additional demographics provided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: gave just the adjuvant solution; gave just the adjuvant solution; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number FZ7Z4, expiry date 27th January 2023) for prophylaxis.   On 28th September 2021, the patient received Shingrix. On 28th September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: Other health professional called and said they had given 2 appropriate doses of Shingrix to 2 patient out of the box of 10 and the 8 remaining doses they gave just the adjuvant solution so they do not remember which of the 10 patient got the full dose, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No reactions was reported for any patient (as reported). The reporter did not consent to follow-up. Sales representative stated that the health care professional declined follow up the case. This case was one of 9 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021209483:same reporter US-GLAXOSMITHKLINE-US2021209482:same reporter US-GLAXOSMITHKLINE-US2021209478:same reporter US-GLAXOSMITHKLINE-US2021209470:same reporter US-GLAXOSMITHKLINE-US2021209468:same reporter US-GLAXOSMITHKLINE-US2021209467:same reporter US-GLAXOSMITHKLINE-US2021209463:same reporter US-GLAXOSMITHKLINE-US2021209462:Same reporter.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: 8 patients received the adjuvant solution; 8 patients received the adjuvant solution; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number FZ7Z4, expiry date 27th January 2023) for prophylaxis.   On 29th September 2021, the patient received Shingrix. On 29th September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: Other health professional reported that they had given 2 appropriate doses of Shingrix to 2 patient out of the box of 10 and the 8 remaining doses they gave just the adjuvant solution so they do not remember which of the 10 patient got the full dose, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No reactions was reported for any patient (as reported). The reporter did not consent to follow-up. Sales representative stated that the health care professional declined follow up the case. This case was one of the 9 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021209483:Same reporter. US-GLAXOSMITHKLINE-US2021209458:Same reporter. US-GLAXOSMITHKLINE-US2021209463:Same reporter. US-GLAXOSMITHKLINE-US2021209467:Same reporter. US-GLAXOSMITHKLINE-US2021209468:Same reporter. US-GLAXOSMITHKLINE-US2021209470:Same reporter. US-GLAXOSMITHKLINE-US2021209482:Same reporter. US-GLAXOSMITHKLINE-US2021209478:Same reporter.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: Sudden death on 9/3/2021
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Eye pain, Fatigue, Feeling abnormal, Heavy menstrual bleeding
Clinical narrative: Burning itch all over. Vaginal itching. heavy ministration. Eyes hurt, extreme tiredness and weak muscles. Cloudy/ foggy thinking and memory.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Muscular weakness, Pruritus, Vulvovaginal pruritus
Clinical narrative: Burning itch all over. Vaginal itching. heavy ministration. Eyes hurt, extreme tiredness and weak muscles. Cloudy/ foggy thinking and memory.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Axonal neuropathy, Electromyogram abnormal, Hypoaesthesia, Muscular weakness
Clinical narrative: Left arm became numb, improved in about two weeks. Right leg became numb and weak- last months.
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, Cardiac failure, Condition aggravated, Cough
Clinical narrative: Hospitalized 10/10/2021; COVID-19 positive 10/09/2021; fully vaccinated  ED visit on 10/9/2021 discharged home:  Patient seen in conjunction with the physician assistant.  I agree with his assessment plan.  Patient is vaccinated against COVID-19 but now has symptoms that started 24 hours ago that are concerning for infection.  She is COVID positive here.  Vitals are within normal limits, no indication for hospitalization.  She does have a history of atrial fibrillation and heart disease with cardiomyopathy.  Does qualify for monoclonal antibody infusion.  I did review the treatment with her and cleaning risks and benefits.  Verbal consent was obtained.  Antibody infusion ordered.  Will be monitored post infusion for the appropriate amount of time HISTORY OF PRESENT ILLNESS: 87-year-old female who is currently vaccinated for COVID-19 presents emergency department with cough nasal congestion and rhinorrhea which started yesterday afternoon.  Patient states she otherwise feels fine and has not had any fevers chills sweats chest pain chest pressure shortness of breath and is not coughing anything up.  Patient states she took Tylenol yesterday states she currently has no pain is 0/10 on the pain scale.  Patient states she also received her flu shot yesterday.  Patient denies any muscle aches and nausea vomiting diarrhea.  Patient states that on Wednesday she saw her grandson who had some mild upper respiratory symptoms and they just got him tested and he is currently positive for COVID-19. Assessment/Plan    DIAGNOSIS at time of disposition: 1. COVID-19 virus infection  2. Encounter for laboratory testing for COVID-19 virus     Discharge summary  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure with hypoxia COVID-19    HOSPITAL COURSE: 87 y/o female with history of atrial fib on xarelto, chronic HFpEF, hyperthyroid, Crohn's.  Positive COVID and received monoclonal antibody infusion on 10/09.  Returns with worsening shortness of breath, orthopnea.  She is fully vaccinated since March 2021.  Initially on 6L NC, and then requiring high flow and weaned back down to NC after lasix. She was diagnosed with a combination of heart failure and COVID-19 and admitted to the hospitalist service. She was started on decadron and remdesivir for COVID-19. Her oxygen was weaned to room air. Ambulatory pulse ox was stable and did not drop below 92%. Her stay was uncomplicated. She got her dose of remdesivir prior to discharge. She will finish her course of decadron outpatient. She was discharged home in stable and improved condition.      Active Issues Requiring Follow-up Issue: covid PNA Recommended follow-up provider/specialty: PCP What is needed: close outpatient follow up, continue follow up with GI   DISCHARGE DISPOSITION: Home without services