chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 66-years-old male patient. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 09-JUL-2009, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the prophylaxis.  In October 2019, subsequent to the patient vaccination, he was caused to suffer shingles, including any and all of its sequelae. As a result of his receipt of the zoster vaccine live (ZOSTAVAX) vaccine, Plaintiff had severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages, other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. At the reporting time, the outcome of the event was unknown.  The reporter considered the events of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event information; Vaccine administered two days after labeled expiration date; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported      On 22-MAR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD), (0.5 unit not reported), lot # t032147, expiration date 20-MAR-2022 (route not reported) for prophylaxis (expired product administered). No additional adverse event information and no product quality complain reported.
Age: 31.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: costumer calling to ask about what to do if a patient is late to get seconded dose of gardasil 9; This Spontaneous report has been received from a pharmacist regarding a 31-yeard-old female patient. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) as prophylaxis (dose, frequency, route, lot # and expiration date were not reported). The reporter wanted to know what to do if the patient is late to get the second dose of the vaccine and also wanted to know if the patient needed a different series due to the patient's age.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Expired vaccine used; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant medications were not reported.  On 23-MAR-2022, the patient was vaccinated with and expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T030761 (rHA), expiration date 08-MAR-2022, 0.5 milliliter (route and anatomical location were not reported) for prophylaxis. No adverse event reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse events reported; an expired dose of ROTATEQ was administered to a patient today; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On 23-MAR-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 1 dose, lot number 1707470, expiration date 21-MAR-2022 (route of administration not reported) for prophylaxis (expired product administered). No adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details or PQC; A patient was inadvertently administered a dose of ROTATEQ past it's expiration date; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.      On 21-MAR-2022, the patient was vaccinated inadvertently with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (expiration date: 10-MAR-2022) for prophylaxis (strength, dose, anatomical location, route of administration, and lot # were not reported) (expired product administered).         No additional adverse events were reported.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: tested positive for hpv on a pap smear; This spontaneous report was received from a consumer, concerning herself as an approximately 22 years old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  Starting in 2009, the patient received 3 vaccinations with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) administered intramuscularly for prophylaxis (strength, dose, anatomical location, lot #, and expiration date were not provided).   In 2016 (also reported as 6 years ago and as in 1996; conflicting information), the patient tested positive for human papillomavirus (HPV) on a pap smear. The patient sought medical attention but no treatment was given for the event. At the time of reporting, the outcome of the event was unknown.   No causality was provided.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Gave an Expired Dose of Heplisav-B to a Patient; Initial Report Received on 16-Feb-2022  A registered nurse reported that a 22-year-old female patient (race and ethnicity unknown) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.   No concomitant medications were reported.  On 15-Feb-2022, the patient received an expired dose of HEPLISAV-B (Lot # 933623, expiration date 22-Aug-2021, NDC # 4352800305) intramuscularly in the right deltoid. A clinician at the facility did not follow the 2-check validation process and gave an expired dose of HEPLISAV-B to the patient. The patient did not experience any side effects.   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Received First Dose with Heplisav-b and Second Dose with Engerix; Initial Report Received on 22-Feb-2022  A registered pharmacist reported that a 33-year-old female patient (race and ethnicity unknown) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and Engerix-B as the second dose.  No medical history was reported. Allergies reported included codeine.   No concomitant medications were reported.  On 15-Aug-2021, the patient received dose 1 of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site unknown).  On 15-Sep-2021, 32 days after having received the HEPLISAV-B vaccine, the patient received Engerix-B (Lot #, expiration date, NDC #, route, and injection site unknown) as the second dose.  On 22-Feb-2022, 191 days after having received the HEPLISAV-B vaccine and 160 days after having received the Engerix-B vaccine, the patient came to a different pharmacy for the third dose. The patient reported to the pharmacist that she received HEPLISAV-B vaccine as the first dose and Engerix-B vaccine as the second dose. The patient did not report any adverse reactions.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Received 3 Doses of Heplisav-b; Initial Report Received on 28-Feb-2022  A pharmacist in the reported that a 30-year-old female patient (race and ethnicity unknown) received 3 doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization instead of 2 doses.  No medical history was reported.   No concomitant medications were reported.  On 02-Feb-2021, the patient received dose 1 of HEPLISAV-B (Lot #, expiration date, and NDC # unknown) in the left deltoid.  On 26-Mar-2021, 52 days after having received dose 1 of HEPLISAV-B, the patient received dose 2 of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site unknown) in the left deltoid.  On 03-Sep-2021, 213 days after having received dose 1 of HEPLISAV-B and 161 days after having received dose 2 of HEPLISAV-B, the patient received the dose 3 of HEPLISAV-B in the left deltoid.   Lot # provided was 934975, expiration date 13-Aug-2022, NDC # 43528-003-05, and serial # 208660319850.   On 28-Feb-2022, during a review of notes, an error was discovered that the patient received 3 doses of HEPLISAV-B instead of 2. The additional dose was accidently given due to following the Engerix-B dosing schedule. Per the report, the patient did not experience adverse reactions from the injections.   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2 Month Old Received Dose of Heplisav-B; Initial Report Received on 01-Mar-2022  A medical assistant reported that a 2-month-old female patient (race and ethnicity unknown) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.   No concomitant medications were reported.  On 01-Mar-2022, the 2-month-old patient received a dose of HEPLISAV-B (Lot # 934974, expiration date 29-Apr-2022, and NDC # 43528-003-05) in the left upper thigh by the medical assistant (reporter). No adverse reactions have been reported.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Given an Expired Dose of Heplisav-B; Initial Report Received on 02-Mar-2022   A registered nurse reported that a 21-year-old female patient (race and ethnicity unknown) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.   No concomitant medications were reported.  On 02-Mar-2022, the patient received an expired dose of HEPLISAV-B (Lot # 934599, expiration date 22 Feb-2022, and NDC # 4352800301) in the left deltoid. It was unknown if the patient had any adverse side effects.   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Given an Expired Dose of Heplisav-B; Initial Report Received on 08-Mar-2022  A nurse practitioner reported that a 72-year-old female patient (race and ethnicity unknown) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.   No concomitant medications were reported.  On 08-Mar-2022, the patient received an expired dose of HEPLISAV-B (Lot # 934599, expiration date 22 Feb-2022, and NDC # 4352800301) in the left deltoid. No adverse side effects were reported by the patient.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: TDAP
Symptoms: Circumstance or information capable of leading to medication error, Documented hypersensitivity to administered product
Clinical narrative: may or may not have latex allergy; Patient may or may not have latex allergy; This case was reported by a pharmacist via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included latex allergy (possibly).   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced circumstance or information capable of leading to medication error and documented hypersensitivity to administered product. On an unknown date, the outcome of the circumstance or information capable of leading to medication error and documented hypersensitivity to administered product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details reported were as follows: The age at vaccination was not reported. The patient may or may not had latex allergy and patient received Boostrix in 2015 or 2016, which led to circumstance or information capable of leading to medication error and documented hypersensitivity to administered product. The healthcare professional gave permission for follow up. This case was linked with US2022050444, US2022AMR051880 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022050444:Same reporter. US-GLAXOSMITHKLINE-US2022AMR051880:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Had the shot but didnt cure them, they r bad; They r bad, small cluster went inside bad/had an outbreak and got pills; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pain (had severe pain years ago) and shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that shingles were bad, really bad he/she knew from the experience, the patient  did not had but a small cluster but they went inside bad on him/her causing severe pain years ago. Thankful the patient have not had them for a long while he/she had the shot but it did not cure them, the next time had an outbreak the patient got the pills and a cream and they healed quickly. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirmation for shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on mar2020, no 2nd dose yet; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date in March 2020).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingle vaccine, which led to incomplete course of vaccination. The patient enquired if he/she should get 2nd dose now or start over again with the 1st dose. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received the shot then the patient got shingles was fine until then. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the vaccine. I have had them twice/ Suspected vaccination failure; I have had them twice; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient did not have shingles till he/she got the vacine and had shingles twice after vaccination. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. Follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shots and still got shingles/Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The patient self-reported this case. The age at vaccination was not reported. The patient had the Shingle shots and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles on my left leg; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included decreased immune responsiveness (immune system might have been in a weakened state).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the shingles vaccine shot and one week later, he/she developed shingles on his/her left leg.  The patient's physician said that no vaccine was 100 percent effect and stated that, his/her immune system might have been in a weakened state when he/she got the shot. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site induration, Injection site nodule, Peripheral swelling, Product administered at inappropriate site
Clinical narrative: developed a knot that was getting larger and harder in the shot area; started turning red and started swelling and developed a knot that was getting larger and harder in the shot area; started turning red and started swelling and developed a knot that was getting larger and harder in the shot area; Took the shot in the back of my arm; This case was reported by a consumer via interactive digital media and described the occurrence of injection site induration in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had 3 outbreaks of shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site induration, erythema, swelling arm and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site induration, erythema, swelling arm and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site induration, erythema and swelling arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had 3 outbreaks of shingles. The patient thought that taking the vaccine would help and took the shot in the back of his/her arm which led to vaccine administered at inappropriate site. On an unknown date after receiving the shot, the patient started turning red and started swelling and developed a knot that was getting larger and harder in the shot area. The patient stated that he/she had to take a shot to count- react the vaccine and was told never to take another one. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose #1 Dec 11, 2020, got dose #2 until 8/26/2021; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 11th December 2020).   On 26th August 2021, the patient received the 2nd dose of Shingrix. On 26th August 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 was the reporter.  The age at vaccination was not reported. The patient received 2nd dose of Shingrix, 8 months 2 weeks after the 1st dose, which led to lengthening of vaccination schedule. The patient reported that due to circumstances his/her 2nd dose was late and enquired would this be effective given that was longer window between doses than was recommended. The patient asked to forward the email with package insert and asked for transcript.
Sex: U
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Vitamin B12 deficiency
Clinical narrative: autoimmune vitamin deficiency; vitamin B12 deficiency; This case was reported by a consumer via interactive digital media and described the occurrence of autoimmune disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles a lot).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced autoimmune disorder (serious criteria GSK medically significant) and vitamin b12 deficiency. The patient was treated with cyanocobalamin (Vitamin B12). On an unknown date, the outcome of the autoimmune disorder and vitamin b12 deficiency were unknown.   It was unknown if the reporter considered the autoimmune disorder and vitamin b12 deficiency to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient get shingles a lot and received shingles vaccine which helped for a while. After vaccination the patient had autoimmune B12 deficiency and ran across B12 shots as treatment for shingles. The patient stated that, B12 repaired myelin. Note: from the narrative it was not clear if the patient had autoimmune B12 deficiency as current condition or experienced after shingles vaccination, hence coded as event conservatively.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: fatigue; arm was sore for a few days; This case was reported by a consumer and described the occurrence of fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced fatigue and pain in arm. On an unknown date, the outcome of the fatigue and pain in arm were recovered/resolved.   It was unknown if the reporter considered the fatigue and pain in arm to be related to Shingrix.     Additional details reported were as follows: This case was reported by the patient. The age at vaccination was not reported. After receiving Shingrix, the patient had very little reaction, some fatigue and arm was sore for a few days. For tolerance of 2nd dose refer case US2022AMR053806.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR053806:Same patient, different dose
Sex: U
Vaccine: HEPA
Symptoms: Circumstance or information capable of leading to medication error, Documented hypersensitivity to administered product
Clinical narrative: Circumstance or information capable of leading to medication error; Patient may or may not have latex allergy and possibly received Havrix, Boostrix, FluLaval or Fluarix in 2015 and 2016; This case was reported by a pharmacist via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included latex allergy (had possible latex allergy).   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced circumstance or information capable of leading to medication error and documented hypersensitivity to administered product. On an unknown date, the outcome of the circumstance or information capable of leading to medication error and documented hypersensitivity to administered product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR051879, US2022AMR051880  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that, the patient may or may not have had latex allergy and received Havrix in 2015 and 2016, which led to documented hypersensitivity to administered product and circumstance or information capable of leading to medication error. The reporter declined to provide any adverse event details. The reporter gave permission for follow up. The case was linked with case US2022AMR051879 and US2022AMR051880 reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR051879:Same reporter. US-GLAXOSMITHKLINE-US2022AMR051880:Same reporter.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 15Oct2021, has not received another; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male 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 (1st dose received on 15th October 2021).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. The vaccine administration facility was the same as primary reporter. The reporter did not want to give out patients details beside gender. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on December-2020 have not received 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 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 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 case was reported by patient herself. The age at vaccination was not applicable for this report. The patient received the first dose of Shingrix and they had not received the second dose, which led to incomplete course of vaccination.  The reporter stated that they will be getting the second dose as soon as possible. Gave medical disclaimer. Referred to health care professional.  The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient has not received 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 9th September 2020, from batch number EG3A3 and expiry date 10th December 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 pharmacist reporting 2nd dose was greater than 6 months.  Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Inadvertently administered an expired dose to a patient; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (batch number FE272, expiry date 18th February 2022) for prophylaxis.   On 22nd March 2022, the patient received Shingrix. On 22nd March 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported they inadvertently administered an expired Shingrix dose to a patient which led to expired vaccine used. The pharmacist asked if the patient need to be revaccinated. The pharmacist unable to provide patient details. The reporter did not consent to follow-up.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a nurse via call center representative and described the occurrence of rash in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th February 2022 15:30, the patient received the 1st dose of Bexsero (intramuscular) .5 ml. On 16th February 2022, the patient started Bexsero Pre-Filled Syringe Device. In February 2022, less than a day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Bexsero and Bexsero 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 patient received dose of Bexsero into the left deltoid. At 12:30 pm next day, the patient called the office to report she was experiencing a rash. The rash resolved the following day.  The reporter reported that the doctor had already made a report to VAERS of this adverse event to Bexsero. The Agency representative did not asked for their permission but reporter details were provided.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th February 2022, the patient received the 2nd dose of Shingrix (intramuscular) 50 ug. On 15th February 2022, immediately after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   The reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received doe of Shingrix vaccine into his left arm and immediately after the vaccination he experienced arm pain which was still unresolved after 5 weeks. No further information reported. The reporter gave consent to contact HCP (health care professional). The reporter consented to follow-up.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th February 2022, the patient received the 2nd dose of Shingrix (intramuscular) 50 ug. On 15th February 2022, immediately after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   The reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received doe of Shingrix vaccine into his left arm and immediately after the vaccination he experienced arm pain which was still unresolved after 5 weeks. No further information reported. The reporter gave consent to contact HCP (health care professional). The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received the 1st dose in 2020; 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 on an unknown date in 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. The reporter stated that the patient received the first dose of the Shingrix vaccine in 2020 and wanted to know how to proceed. The patient had not received the 2nd dose of the Shingrix vaccine till the time of reporting, which led to incomplete course of vaccination. The reporter stated she did not have additional information about the patient. The reporter did not consent to follow-up.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Injection site nodule, Pain in extremity
Clinical narrative: Developed a nodule at the injection site; Experienced soreness; This case was reported by a consumer and described the occurrence of injection site nodule in a 19-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th November 2021, the patient received the 1st dose of Bexsero (intramuscular) .5 ml and Bexsero Pre-Filled Syringe Device. On 20th November 2021, immediately after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site nodule and pain in arm. On an unknown date, the outcome of the injection site nodule and pain in arm were recovered/resolved.   It was unknown if the reporter considered the injection site nodule and pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was the mother of the patient The reporter stated that the patient received his first dose of Bexsero intramuscularly into his left arm and immediately following the injection, he experienced soreness in the arm and developed a nodule at the injection site. The nodule and soreness took 30 days to resolve. The reporter did not have the lot or expiration date of the administered vaccine. The reporter did not consent to follow-up.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: headache; nausea; vomiting; tiredness; chills; fever that went up tp 106.9 F; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number h2pe2, expiry date 19th May 2023) for prophylaxis.   On 18th March 2022 16:00, the patient received the 1st dose of Shingrix. In March 2022, less than a day after receiving Shingrix, the patient experienced nausea (serious criteria hospitalization), vomiting (serious criteria hospitalization), tiredness (serious criteria hospitalization), chills (serious criteria hospitalization) and fever (serious criteria hospitalization). On 20th March 2022, the patient experienced headache (serious criteria hospitalization). The patient was treated with antiemetics and antinauseants (Anti-Nausea (Nos)), hydrocortisone and intravenous fluid (nos) (Intravenous Fluids). On 20th March 2022, the outcome of the fever and headache were recovered/resolved. On an unknown date, the outcome of the nausea, vomiting, tiredness and chills were recovered/resolved.   It was unknown if the reporter considered the nausea, vomiting, tiredness, chills, fever and headache to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient' wife. The patient received a dose of Shingrix last Friday around 4 pm and on Saturday morning the patient was feeling nauseous and started vomiting. The patient also felt tired, had chills, and experienced a fever that went up to 106.9 F.  The reporter stated that fever went up and down during the day and the patient called primary care doctor who recommended went to the emergency room. The reporter stated that they went to the emergency room on Saturday where the patient received IV fluids, a dose of hydrocortisone and anti-nausea medication. The patient went back from the emergency room on Sunday morning and was still experiencing a fever and headache which subsided that afternoon.  In March 2022, all symptoms were resolved. The reporter did not consent to follow-up.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: headache; nausea; vomiting; tiredness; chills; fever that went up tp 106.9 F; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number h2pe2, expiry date 19th May 2023) for prophylaxis.   On 18th March 2022 16:00, the patient received the 1st dose of Shingrix. In March 2022, less than a day after receiving Shingrix, the patient experienced nausea (serious criteria hospitalization), vomiting (serious criteria hospitalization), tiredness (serious criteria hospitalization), chills (serious criteria hospitalization) and fever (serious criteria hospitalization). On 20th March 2022, the patient experienced headache (serious criteria hospitalization). The patient was treated with antiemetics and antinauseants (Anti-Nausea (Nos)), hydrocortisone and intravenous fluid (nos) (Intravenous Fluids). On 20th March 2022, the outcome of the fever and headache were recovered/resolved. On an unknown date, the outcome of the nausea, vomiting, tiredness and chills were recovered/resolved.   It was unknown if the reporter considered the nausea, vomiting, tiredness, chills, fever and headache to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient' wife. The patient received a dose of Shingrix last Friday around 4 pm and on Saturday morning the patient was feeling nauseous and started vomiting. The patient also felt tired, had chills, and experienced a fever that went up to 106.9 F.  The reporter stated that fever went up and down during the day and the patient called primary care doctor who recommended went to the emergency room. The reporter stated that they went to the emergency room on Saturday where the patient received IV fluids, a dose of hydrocortisone and anti-nausea medication. The patient went back from the emergency room on Sunday morning and was still experiencing a fever and headache which subsided that afternoon.  In March 2022, all symptoms were resolved. The reporter did not consent to follow-up.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, Product administration error
Clinical narrative: maladministration of havrix (exp date 24-JAN-2022); This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix) (batch number 299X2, expiry date 24th January 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd March 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 22nd March 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that, a maladministration of expired havrix into a patient, which led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: expired dose was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Infanrix) (batch number KG4m7, expiry date 6th February 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient was administered with an expired dose of Infanrix, which led to expired vaccine used. No other information was available. The reporter consented to follow up.