chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine administered; No additional AEs; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 01-SEP-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # S025157 with an expiration date on 13-AUG-2021) at a dose of 0.5 milliliters subcutaneously  (strength and anatomical location were not reported) for prophylaxis (expired product administered).         No additional adverse events were reported.
Sex: U
Vaccine: ANTH
Symptoms: Injection site pain, Injection site swelling, Insomnia, Loss of personal independence in daily activities
Clinical narrative: Fever; Swelling at injection side; Pain and tenderness at injection side; Extremely difficult to sleep or rest in any manner; Side effects impacted daily activity; On 27AUG2021, a spontaneous report was received from a patient.  On an unknown date, an adult male (age unknown) experienced "swelling at injection side" (PT: Injection site swelling), "pain and tenderness at injection side" (PT: Injection site pain), and "fever" (PT: Pyrexia) after receiving a second dose (date unknown) of BioThrax (anthrax vaccine adsorbed). The patient, who was also a company representative, reported that "all of these side effects lasted for a couple days and impacted daily activity and made it extremely difficult to sleep or rest in any manner" (PT: Loss of personal independence in daily activities, PT: Insomnia). The reporter stated that he was under the impression that the events he experienced were "standard side effects" of the product, but was advised to report these events. The outcome of the events swelling at injection site, pain and tenderness at injection site and fever were reported as recovered/resolved. The outcome of the events impacted daily activity and difficult to sleep or rest was unknown.  The patient's medical history and concomitant medication use was unknown.  No additional information was provided regarding these event.  Company Comment:  The injection site reaction and fever are known phenomenon caused by BioThrax and considered "probable" related. Difficulty sleeping and impaired daily activities were a consequence of the injection site reaction but not due to the vaccine. The Company considers that these events are not related.
Sex: U
Vaccine: VARZOS
Symptoms: Limb discomfort, Nerve injury, Rotator cuff syndrome, Shoulder injury related to vaccine administration
Clinical narrative: Sirva; Shut my arm DOWN; HIT A NERVE; It is like I have got a rotator cuff injury; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder injury related to vaccine administration in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 shoulder injury related to vaccine administration, arm discomfort, nerve injury and rotator cuff injury. On an unknown date, the outcome of the shoulder injury related to vaccine administration, arm discomfort, nerve injury and rotator cuff injury were unknown.   It was unknown if the reporter considered the shoulder injury related to vaccine administration, arm discomfort, nerve injury and rotator cuff injury 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 stated that the vaccine shut their arm down and hit a nerve. The patient had SIRVA (shoulder injury related to vaccine administration) and also felt like they had got a rotator cuff injury. The patient was supposed to get the second dose in a few months and they were dreading it because they just don't know if they could handle it.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: was fully vaccinated against shingles 2 years ago and came down with shingles five days ago; came down with 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.  Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included covid-19 (came down with covid 3 weeks before the day of reporting in August 2021). Previously administered products included COVID 19 VACCINE MODERNA (was fully vaccinated with COVID 19 VACCINE MODERNA in March 2021).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On 5th September 2021, between 1 and 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient was fully vaccinated against shingles 2 years ago and came down with shingles five days before the day of reporting. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: feel two days not so good; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles and pain burning (6 months terrible).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. Age at vaccination was not reported. The patient received dose of Shingles vaccine and felt not so good for 2 days. The reporter reported but better than getting shingles again. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Hives; Allergic reaction; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 hives and allergic reaction. On an unknown date, the outcome of the hives and allergic reaction were not recovered/not resolved.   It was unknown if the reporter considered the hives and allergic reaction to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient got shingles shot and got allergic reaction to it broken out in hives. The patient asked what to do anyone besides call doctor because it was weekend. The contact details were not reported hence follow-up not possible
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had them after the shot/ suspected vaccination failure; had them; This case was reported by a consumer via interactive digital media and described the occurrence of 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 age at vaccination was not reported. The reporter stated that, after the shot, had shingles. 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. This case was linked with cases US2021AMR195007 and US2021AMR194989, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR194989:same reporter US-GLAXOSMITHKLINE-US2021AMR195007:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Polymyalgia rheumatica
Clinical narrative: Polymyalgia Rhuemetica; This case was reported by a consumer via interactive digital media and described the occurrence of polymyalgia rheumatica 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 polymyalgia rheumatica (serious criteria GSK medically significant). The patient was treated with steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the polymyalgia rheumatica was recovered/resolved.   The reporter considered the polymyalgia rheumatica to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient reported that the shingles vaccine gave polymyalgia rhuematica a listed side effect. The patient took 30 months of steroids to get it in remission. The patient could not take vaccine because they could trigger it out of remission, not good during a pandemic . The patient wish that had never taken the shingles vaccine. The contact details of patient was not reported hence follow-up not possible.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Mother had the shots and still got shingles/ suspected vaccination failure; shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's son or daughter. The age at vaccination was not reported. The reporter stated that, his or her mother got shot and still had shingles and pain. The reporter stated that, the physician could not seam to have her any thing to help. 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.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the 2 vaccines/ Suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) 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 and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. The reporter stated that, her husband got the 2 vaccines and then got shingles. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got vaccine/ Suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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 reporter stated that, got vaccinated then got shingles. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Hyperhidrosis, Influenza like illness, Myalgia, No reaction on previous exposure to drug
Clinical narrative: severe flulike symptoms; fever; joint aches; muscle aches; sweating; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of adverse reaction (1st shot had very little to no adverse side effects).   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 influenza-like symptoms, fever, joint pain, muscle pain and sweating. On an unknown date, the outcome of the influenza-like symptoms, fever, joint pain, muscle pain and sweating were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever, joint pain, muscle pain and sweating to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received 2 shot series of Shingles vaccine. The patient received the 2nd dose of Shingles vaccine and experienced severe flu like symptoms for about 24-36 hours, fever, joint, muscle aches and sweating, but then it was gone. The patient reported that the vaccine was absolutely worth getting. Follow-up would not be possible as no contact details available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR195197:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: severe flulike symptoms; fever; joint aches; muscle aches; sweating; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of adverse reaction (1st shot had very little to no adverse side effects).   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 influenza-like symptoms, fever, joint pain, muscle pain and sweating. On an unknown date, the outcome of the influenza-like symptoms, fever, joint pain, muscle pain and sweating were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever, joint pain, muscle pain and sweating to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received 2 shot series of Shingles vaccine. The patient received the 2nd dose of Shingles vaccine and experienced severe flu like symptoms for about 24-36 hours, fever, joint, muscle aches and sweating, but then it was gone. The patient reported that the vaccine was absolutely worth getting. Follow-up would not be possible as no contact details available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR195197:Same reporter
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Depressed mood
Clinical narrative: was down for two days; This case was reported by a consumer via interactive digital media and described the occurrence of feeling down in a 65-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (shingles on back and chest when patient was about 45 years and was out of work for two weeks).   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 feeling down. On an unknown date, the outcome of the feeling down was recovered/resolved.   It was unknown if the reporter considered the feeling down to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported the case. The patient was given the shingles vaccine and had a bad reaction to shingles shots where the patient was down for two days. The follow up would not be possible as no contact details were available. For tolerance of 2nd dose refer case US2021AMR195343, reported with same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR195343:Same reporter
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Depressed mood
Clinical narrative: was down for two days; This case was reported by a consumer via interactive digital media and described the occurrence of feeling down in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (shingles on back and chest when patient was about 45 years and was out of work for two weeks). Previously administered products included shingles vaccine with an associated reaction of depressed mood (1st dose received on an unknown date refer case US2021AMR195300).   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 feeling down. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feeling down was recovered/resolved.   It was unknown if the reporter considered the feeling down to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported the case. The patient was given the shingles vaccine and had a bad reaction to shingles shots where the patient was down for two days. The follow up would not be possible as no contact details were available; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR195300:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: shingrix shot expires expires on 4-30-21; This case was reported by a consumer via (Shingrix interactive digital media and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 30th April 2021) for prophylaxis.   On 10th September 2021, the patient received the 1st dose of Shingrix. On 10th September 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received a expired shot of Shingrix expired on 30th April 2021 which led to expired vaccine used. The patient enquired if the expiry date was written wrong in the sheet which they give him/her. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had Shingrix vaccine about two years ago,I did not get the second injection; This case was reported by a consumer via (Shingrix) interactive digital media 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 2 years ago on an unknown date).   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 the consumer for herself/himself. The age at vaccination was not reported. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient asked, should he/she start the two injection vaccine again.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first shot for Shingrix one year ago and not received 2nd dose; 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 (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st shot received one 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 reported as follows: The age at vaccination was not applicable for this report. The reporter asked what was the recommendation when a customer received the 1st shot for Shingrix one year ago from the date of reporting, the patient did not received 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Near death experience
Clinical narrative: first one like to have killed me; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   It was unknown if the reporter considered the near death experience to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient reported that, first dose liked to had killed him/her.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) 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 and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. In spring at the time of reporting after receiving both the doses of Shingles vaccine, the patient broke out in shingles across right chest under arm and a tiny bit on the back.  Nothing was foolproof, they definitely made him/her notice them, but sure they were not as severe as if he/she had never gotten the shots. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by an other health professional via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. 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: The age at vaccination was not applicable for this report. The reporter said if a patient missed his 2nd dose of Shingrix by 1 year, do they have to restart the 2 dose vaccination. The patient did not received 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only the reconstitute agent was given; only the reconstitute agent was given; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate dose of vaccine administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate 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 reported as follows: The age at vaccination was not reported. Nurse only administered one part of the product.  She explained that only the reconstitute agent was given which led to inappropriate dose of vaccine administered and inappropriate preparation of medication.  The reporter did not know any more information. The reporter agree to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received their second dose a week after their first dose; This case was reported by a other health professional via interactive digital media (Shingrix  and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 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 information was provided as follows: The age at vaccination was not reported. The reporter stated that the patient received the second dose a week after their first dose which led to shortening of vaccination schedule. The reporter asked if the patient would require a third dose in 2 to 6 months.
Sex: M
Vaccine: MENB
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: low grade temperature; headache; chills; fatigue; nausea; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a 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 13th September 2021 04:30, the patient received Bexsero. On 13th September 2021, the patient started Bexsero Pre-Filled Syringe Device. On 13th September 2021, less than a day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced fever, headache, chills, fatigue and nausea. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, headache, chills, fatigue and nausea were unknown.   It was unknown if the reporter considered the fever, headache, chills, fatigue and nausea 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 was reporter's son. The age at vaccination was not reported. The patient received Bexsero shot and he started having a low grade temperature of 100.5 degree F with Tylenol onboard for an hour. The patient also experienced headache, chills, fatigue and nausea.  The reporter asked if these were common side effects. The reporter further stated according to information some was common side effects.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling hot
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extremities hot feeling of in a patient who received Herpes Zoster (Shingrix) for prophylaxis. On 13th September 2021, the patient received Shingrix. On 13th September 2021, less than a day after receiving Shingrix, the patient experienced extremities hot feeling of. On an unknown date, the outcome of the extremities hot feeling of was unknown. It was unknown if the reporter considered the extremities hot feeling of to be related to Shingrix. Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient stated that he/she  had the shot a couple of hours ago and feeling hot already. The patient wanted to know at what point might the patient start to feel side effects, within a couple of hours or 24 hours. The patient did not think that feeling hot on legs was an adverse event.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received both the doses of Shingrix 2 years ago from the date of reporting. After receiving Shingles vaccine, the patient contracted shingles 2 week ago from the date of reporting. the reporter was not 100 percent sure if the patient got Shingrix but thought so. The reporter did not consent to follow up. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Food allergy
Clinical narrative: alergic to eggs; This case was reported by a consumer via media and described the occurrence of egg allergy 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 egg allergy. On an unknown date, the outcome of the egg allergy was unknown.   The reporter considered the egg allergy 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 the shingles vaccine left the patient completely allergic to eggs. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Injection site is very red; injection site sore; injection site hot to the touch; i am dizzy; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2021, the patient received the 1st dose of Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site pain, injection site warmth and dizziness. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site warmth and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site warmth and dizziness to be related to Shingrix.  Additional details were provided as follows: The patient self reported this case. Age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced Injection site was very red and sore, hot to the touch, and dizziness. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; I still  get 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingrix, the patient still got shingles. The patient stated that, Shingrix did not work for him/her. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's wife. The age at vaccination was not reported. 2 years after receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation of shingles were not provided.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the diluent of Menveo; received only the diluent of Menveo; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA431A, expiry date 30th October 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Menveo .5 ml. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only the diluent of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The diluent was not used to reconstitute the lyophylized powder to administer a complete dose of vaccine. The patient did not experience any adverse effects following administration of the diluent alone. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; have had them 3 times; very painful; 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles three times and it was very painful. The patient would get vaccinated again. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; had shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a female 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 case was reported for the reporter's sister in law. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. Reporter also had shingles and asked doctor if he could guarantee that he/she would not get them again and he said no. Reporter stated that, there was not been any studies on it to make a guarantee. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 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 age at vaccination was not reported. Reporter knew few people who after receiving Shingles vaccine, still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Had both types of vx. Had shingles twice; Had shingles 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.   The patient's past medical history included shingles (had shingles twice on an unknown day before vaccination).   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 age at vaccination was not reported. The patient had both types of vaccines and still had Shingles twice. The reporter stated that neither type of shot will keep oneself from getting shingles again and will just keep them from being so severe. 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.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Underdose
Clinical narrative: patient of 23 years received pediatric dose; patient of 23 years received pediatric dose; Date of vaccination 2nd dose of Engerix- B: 8/03/2021 (adult dose) and Date of vaccination 3rd dose of Engerix-B:  09/07/2021 (pediatric dose); first dose of EngerixB was administered in 11/13/1998.; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 23-year-old female patient who received HBV (Engerix B pediatric) (batch number 5295P, expiry date 27th 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, HBV (Engerix B adult) (batch number 5295P, expiry date 27th December 2022) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B pediatric (received first dose on 13th November 1998).   On 7th September 2021, the patient received the 3rd dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 3rd August 2021, the patient received the 2nd dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 3rd August 2021, not applicable after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device and unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On 7th September 2021, the patient experienced underdose, adult use of a child product and drug dose administration interval too short. On an unknown date, the outcome of the underdose, adult use of a child product, drug dose administration interval too long and drug dose administration interval too short were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Medical Assistant reported that the patient was vaccinated with second dose of Engerix B adult, later than the recommended interval, which led to lengthening of vaccination schedule. The patient was tested for Hepatitis antibodies 28th July 2021 and it showed that they did not have immunity to Hepatitis B so they restarted the series. The patient then received the third dose with Engerix B pediatric earlier than the recommended interval as per Engerix B schedule, which led to underdose, adult use of a child product and shortening of vaccination schedule. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021190995:duplicate deleted case
Sex: M
Vaccine: VARZOS
Symptoms: Intercepted product prescribing error
Clinical narrative: Patient with prescription for Shingrix first dose at 40 years; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product prescribing error in a 40-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient had recurrent cases of shingles in the past).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product prescribing error. On an unknown date, the outcome of the intercepted product prescribing error was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report.   The patient was not immunocompromised but had recurrent cases of shingles. The patient was prescribed Shingrix vaccine at 40 years of age, which led to intercepted product prescribing error. The vaccine was not administered till the time of reporting.  The patient did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021193314:Same reporter.