chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had the vaccine and still got them 4 times so far; 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. The patient was treated with benadryl (nos) (Benadryl Spray). 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 Information: GSK Receipt Date: 15-AUG-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient had vaccine and still got them 4 times so far. The patient used Benadryl spray. Additional Supportive Information:  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the vaccine, Shingles came back/Suspected vaccination failure; 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 Information: GSK Receipt Date: 15-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient received Shingles vaccine. The patient experienced Shingles. The reporter stated that it did not work for everyone. Follow-up would not possible as no contact details were available. Additional supportive information: 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
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Got vaccine, ended up with shingles in her eyes/ Suspected vaccination failure; Shingles in her eyes; 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.   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 ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   The reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.     Additional Information: GSK receipt date: 15-Aug-2022 Reporter's Comments: The patient's friend reported the case via interactive digital media. The reporter stated not to get this vaccine. The patient got Shingles vaccine and ended up with shingles in her eyes. She was almost because of this vaccine. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary immunization, 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: Anxiety, Herpes zoster, Vaccination failure
Clinical narrative: had the vaccine, Suffered with breakouts / suspected vaccination failure; Breakouts mostly on legs feet and arms, in hot months; Feel doomed; 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.   The patient's past medical history included shingles (suffered over 20 years with breakouts, mostly happened in hot months).   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 impending doom. On an unknown date, the outcome of the vaccination failure and impending doom were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and impending doom to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient stated that, he/she had vaccine and it did not work on him/her. The patient felt doomed and he/she had shingles mostly on legs feet and arms, which drive him/her crazy. Additional Supportive Information: 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. Note: From narrative it seems that, patient had shingles breakouts over 20 years, hence it was captured as historical condition and outcome of shingles captured as not recovered, because it seems that, patient was suffered from the shingles breakouts at the time of reporting as well.
Age: 51.0
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Dizziness after first dose; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2022, the patient received the 1st dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was not recovered/not resolved.   It was unknown if the reporter considered the dizziness to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comments:  This case was received from consumer via interactive digital media. The patient want to know that at what point should seek medical attention when had dizziness after first dose. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Blood test abnormal, White blood cell count increased
Clinical narrative: white blood count is quite high; This case was reported by a consumer via call center representative and described the occurrence of white blood cell increased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In August 2022, the patient received Shingles vaccine. In August 2022, 2 days after receiving Shingles vaccine, the patient experienced white blood cell increased. On an unknown date, the outcome of the white blood cell increased was not recovered/not resolved.   It was unknown if the reporter considered the white blood cell increased to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-Aug-2022 Reporter's Comment: The reporter reported this case. The patient received dose of Shingles vaccine and two days later he/she had bloodwork done and he/she just got the lab results and his/her white blood count was quite high.  The patient asked was there a correlation between the shot and increase in his/her white blood cells. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever; Chill; Body Aches; This case was reported by a consumer via sales rep and described the occurrence of fever in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 8 hrs after receiving Shingrix, the patient experienced fever, chills and general body pain. On an unknown date, the outcome of the fever, chills and general body pain were unknown.   It was unknown if the reporter considered the fever, chills and general body pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comments: The reporter reported that the patient experienced fever, chill, body aches starting approximately 8 hours post administration. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever; Chill; Body aches; This case was reported by a consumer via sales rep and described the occurrence of fever in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 8 hrs after receiving Shingrix, the patient experienced fever, chills and general body pain. On an unknown date, the outcome of the fever, chills and general body pain were unknown.   It was unknown if the reporter considered the fever, chills and general body pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comments: The patient reported that the she experienced fever, chill, body aches starting approximately 8 hours post administration. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: White blood cell count increased
Clinical narrative: Very high white blood cell count; This case was reported by a consumer via interactive digital media and described the occurrence of increased white cell count in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced increased white cell count. On an unknown date, the outcome of the increased white cell count was unknown.   It was unknown if the reporter considered the increased white cell count to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comments:  This case was received from consumer via interactive digital media. The patient reported that had vaccine and 2 days later had bloodwork done.  The reporter want to know if there was a correlation with the vaccine and very high white cell count. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: having little fever; having body pain; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th August 2022, the patient received Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced fever and general body pain. On an unknown date, the outcome of the fever and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the fever and general body pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-Aug-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had received the vaccine the day before reporting and had a little fever and body pain. The patient asked was it okay to take ibuprofen or something for side effects. Follow-up would not possible as no contact details were available.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Inflammation, Influenza like illness, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: first dose 13-JAN-2022, second 5-AUG-2022; flu-like symptoms; pain in the arm; inflammation of the arm; pain of the right shoulder; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX with an associated reaction of influenza like illness (for tolerance to the 1st dose refer case US2022118618).   On 5th August 2022, the patient received the 2nd dose of Shingrix. On 5th August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In August 2022, the patient experienced influenza-like symptoms, pain in arm, inflammation localized and shoulder pain. The patient was treated with ibuprofen. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms, pain in arm, inflammation localized, shoulder pain and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain in arm, inflammation localized and shoulder pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022118618   Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comments: The patient self reported this case for herself.  The patient's doctor recommended that she wait 3 months before she get her second Shingrix dose. The patient received her second dose of Shingrix. After her second dose, she experienced pain in the arm, inflammation of the arm, pain of the right shoulder and flu-like symptoms. The patient stated that she took ibuprofen to help with the pain. The reporter consented to follow up. Additional supportive information: The patient received 2nd dose delayed than the recommended vaccination schedule, which led to lengthening of the vaccination schedule.; Sender's Comments:  US-GSK-US2022118618:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Dizziness; This case was reported by a consumer via interactive digital media and described the occurrence of dizziness 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 dizziness. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's comment: This case was reported by a patient via interactive digital media. This case was self reported by the patient. The patient experienced the side effect of dizziness. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Culture positive, Herpes zoster, Rash pruritic, Varicella
Clinical narrative: shingles; Chickenpox; i am in th ER with a rash that is itching and burning; i am in th ER with a rash that is itching and burning; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In July 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, 10 days after receiving Shingles vaccine, the patient experienced shingles, chickenpox, itchy rash and burning sensation. On an unknown date, the outcome of the shingles, chickenpox, itchy rash and burning sensation were not recovered/not resolved.   The reporter considered the shingles, chickenpox, itchy rash and burning sensation to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comments: The patient received vaccine at the end of July from the reporting date and 10 days later he/she was in emergency room with a rash that was itching and burning. The reporter mentioned that, they took at least 4 cultures (some of which were not back ye), they were told him/her that he/she had shingles/chickenpox. The reporter mentioned, it looked like he/she got shingles/chickenpox from the 1st shot. The reporter asked if this would going to happen again if he/she would get the second shot and he/she scared to get it and he/she did not wanted to go through this again. The consent to follow-up was requested. Note: It was not clear whether patient had shingles or chickenpox, hence both events were captured conservatively.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain after shot; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's comments; This case was reported by a patient via interactive digital media. The reporter stated that he/she had pain after shot. Additional supportive information: Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Pain
Clinical narrative: Pain that has moved up to left shoulder; Radiating pain; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain 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 shoulder pain and radiating pain. On an unknown date, the outcome of the shoulder pain and radiating pain were unknown.   It was unknown if the reporter considered the shoulder pain and radiating pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient experienced the pain after receiving Shingrix that had moved up to left shoulder. Follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Culture positive, Herpes zoster, Rash pruritic, Skin burning sensation, Varicella
Clinical narrative: Shingles; rash that is itching; rash that is burning; chickenpox; 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.   In July 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced shingles, itchy rash, burning skin and chickenpox. On an unknown date, the outcome of the shingles, itchy rash, burning skin and chickenpox were unknown.   It was unknown if the reporter considered the shingles, itchy rash, burning skin and chickenpox to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient received first dose of Shingles vaccine in the end of July 2022 and 10 days later patient was in the emergency room with a rash that was itching and burning. The patient reported that they took at least four cultures (Till the time of reporting, some of which were not back) and they were telling patient had shingles or chickenpox. The patient did not saw that anywhere. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Had one dose of Shingrix but not 2nd.; 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 dose received on an unknown date).   On an unknown date, the patient did not 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 Information: GSK Receipt Date: 15-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient did not receive second dose it's been over six months. The reporter asked what patient should do. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Vaccine positive rechallenge
Clinical narrative: I got so sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (1st dose received on an unknown date, for tolerance of previous dose refer case US2022AMR120495).   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 sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR120495   Additional Information: GSK receipt date: 15-AUG-2022 Reporter's comments: This case was reported by patient via interactive digital media. The patient got so sick on the vaccines, but patient would do it again. The patient did not want shingles. The follow up would not be possible as contact details were not provided.; Sender's Comments:  US-GSK-US2022AMR120495:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm would never stop hurting; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK receipt date: 15-AUG-2022 Reporter's comments: This case was reported by patient via interactive digital media. It was reported that patient's arm hurt too. The patient thought that his/her arm would never stop hurting. The follow up would not be possible as contact details were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: was painful for a week; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comments:  This case was received from patient cousin via interactive digital media. The patient received 1st vaccine which was painful for a week. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Pain in extremity
Clinical narrative: My arm is sore; was a bit uncomfortable; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm and discomfort. On an unknown date, the outcome of the pain in arm and discomfort were unknown.   It was unknown if the reporter considered the pain in arm and discomfort to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient arm was sore. The patient wished to had got in other arm because this was the side he/she sleep and it was bit uncomfortable. The follow-up could not be possible as no contact details were available.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Muscle spasticity
Clinical narrative: balance was significantly worse; spascisity in muscles; spascisity in muscles had increase; This case was reported by a consumer via call center representative and described the occurrence of balance disorder in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cerebral palsy.   On 17th June 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In July 2022, 3 weeks after receiving Shingrix, the patient experienced balance disorder, spasticity and condition aggravated. On an unknown date, the outcome of the balance disorder, spasticity and condition aggravated were recovered/resolved.   It was unknown if the reporter considered the balance disorder, spasticity and condition aggravated to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-Aug-2022 Reporter's comment: The patient self reported the case. The patient stated that he had cerebral palsy and got his first shingrix vaccine on 17th June 2022 on right arm.  He stated that about 3 weeks after the vaccine, he noticed his balance was significantly worse and the spasticity in his muscles had increased.  He stated that this lasted for about 3 weeks and had cleared up.  The reporter denied to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise
Clinical narrative: flu-like symptoms; did not feel well; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced influenza-like symptoms and feeling unwell. On an unknown date, the outcome of the influenza-like symptoms and feeling unwell were unknown.   It was unknown if the reporter considered the influenza-like symptoms and feeling unwell to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR118966   Additional Information: GSK Receipt Date: 12-Aug-2022 Reporter's comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and experienced flu-like symptoms and did not feel well. In May 2022, she received a cortisone shot in her shoulder. Her doctor recommended that she wait 3 months before she got her second SHINGRIX dose. The reporter consented to follow-up. Additional supportive information: As per narrative it seems that the patient experienced adverse event before cortisone administration, hence it was not considered as suspect in the case.  For tolerance of 2nd dose refer case US2022AMR118966.; Sender's Comments:  US-GSK-US2022AMR118966:Same reporter
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult female patient received an Enerix-b peds; Adult received Engerix B pediatic (0.5ml); This case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 22-year-old female patient who received HBV (Engerix B pediatric) (batch number 333m4, expiry date 7th April 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th August 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 12th August 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose 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 Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comments: The nurse reported that an adult female patient received an Engerix B paediatrics. The patient had no adverse event was reported.  The reporter consented to follow up. Additional supportive information: The adult patient received a child dose of Engerix B pediatric, which led to adult use of a child product and underdose.
Age: 81.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Injection site erythema, Lip swelling, Swelling face
Clinical narrative: Jaw little swollen; top lip swelling/ lower lip  really swollen; a pink mark on her arm at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site redness in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included botulinum toxin type a (Botox) solution for injection for prophylaxis.   On 27th July 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient started Botox at an unknown dose and frequency. On 28th July 2022, 1 days after receiving Shingrix, the patient experienced injection site redness. In August 2022, the patient experienced jaw swelling and lip swelling. The patient was treated with methylprednisolone sodium succinate (Solu-Medrol) and benadryl (nos) (Benadryl). The action taken with Botox was unknown. In August 2022, the outcome of the jaw swelling and lip swelling were recovered/resolved. On an unknown date, the outcome of the injection site redness was recovered/resolved.   It was unknown if the reporter considered the injection site redness, jaw swelling and lip swelling to be related to Shingrix.     Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comments: The caller was the reporter and the patient.  The patient stated that the following day after vaccination she had a pink mark on her arm at the injection site that had resolved. In August 2022, 1 week after receiving Shingrix and unknown after starting Botox, the patient experienced jaw swelling and swollen lips.  The patient also reported that one week after receiving the Shingrix shot, she woke up in the morning with her jaw little swollen but it got worse at noon time with her top lip swelling and reaching the bottom of her nose and her lower lip was getting really swollen.  The patient further described it as a Botox injection gone really bad.  The patient went to urgent care around 1:30 PM same day, she was given Solu-Medrol injection in the hip and Benadryl tablets after which the swelling went away.  The consented to follow up was granted. The patient gave permission for safety follow-up with her health care professional (HCP). Patient states her HCP is not aware of this incidence. Additional supportive information: It was unknown if the reporter considered the jaw swelling and swollen lips to be related to Botox.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Myalgia
Clinical narrative: itching at injection site; muscle soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th August 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 9th August 2022, less than a day after receiving Shingrix, the patient experienced injection site itching and muscle soreness. On an unknown date, the outcome of the injection site itching was not recovered/not resolved and the outcome of the muscle soreness was recovered/resolved.   It was unknown if the reporter considered the injection site itching and muscle soreness to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-Aug-2022 Reporter's comment: The patient did not want to give any demographics or further information.  The patient disconnected abruptly prior to being able to ask any further questions.  The patient received Shingrix vaccine in Right arm. The patient stated that after second dose of Shingrix vaccine, started with muscle soreness and itching at the injection site.  The patient stated that the muscle soreness was gone, but the itching was still present.  The patient did not consent to follow-up.  The patient did not consent for follow up with healthcare professional.
Age: 1.25
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 15 month old baby was administered boostrix; 15 month old baby was administered boostrix; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 15-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number MY515, expiry date 31st January 2023) for prophylaxis.   On 11th August 2022, the patient received Boostrix. On 11th August 2022, unknown after receiving Boostrix, the patient experienced underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the underdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comment: The reporter reported that, a 15 months old baby was administered Boostrix. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, a 15 months old baby was administered Boostrix, which led to underdose and inappropriate age at vaccine administration.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Supposed to have meningococcal B vaccine administered/ Menveo was administered; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA714A, expiry date 30th June 2023) for prophylaxis.   Previously administered products included Menactra (received on 17th September 2021).   On 12th August 2022, the patient received Menveo. On 12th August 2022, unknown after receiving Menveo, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.       Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comments: The medical assistant reported patient came in to clinic on the day of the reporting and was supposed to had meningococcal B vaccine administered, however she inadvertently administered Menveo.  The vaccine administration facility was the same as primary reporter. The consent to follow up was granted.  Additional Supportive Information: As patient received Menveo vaccine instead of meningococcal B vaccine, which led to Wrong vaccine administered.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: dose was reconstituted with a different sterile diluent, not the supplied CYW-135; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA732Z, expiry date 30th August 2023) for prophylaxis.   On 11th August 2022, the patient received Menveo. On 11th August 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comments: The medical assistant reported that, the patient was administered a dose of Menveo, however the dose was reconstituted with a different sterile diluent, not the supplied CYW-135.  At the time of reporting, the dose had not been repeated. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The patient received vaccine, which was reconstituted with a different sterile diluent, which led to wrong solution used in drug reconstitution.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, Incorrect dose administered, Product preparation error
Clinical narrative: lyophilized powder vial component reconstituted with sterile diluent; inappropriate dose of vaccine administration; Expired vaccine used; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA643A, expiry date 30th January 2022) for prophylaxis.   On 5th August 2022, the patient received Menveo. On 5th August 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and expired vaccine used. On an unknown date, the outcome of the wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and expired vaccine used were unknown.   Additional Information: GSK receipt date: 12-Aug-2022 Reporter comment: The nurse reported that a patient received the contents of the Mena lyophilized powder vial component reconstituted with sterile diluent. The reporter consented to follow up. Additional supportive information: The patient was administered with Menveo reconstituted with sterile diluent instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administration. The patient was administered an expired dose of Menveo, which led to expired vaccine used.
Age: 66.0
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received MENVEO instead of the prescribed SHINGRIX; received Menveo; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 66-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA713A, expiry date 30th June 2023) for prophylaxis.   On 12th August 2022, the patient received Menveo (intramuscular). On 12th August 2022, unknown after receiving Menveo, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's comments: The office manager from a medical office reported that the patient had received Menveo instead of the prescribed Shingrix. The reporter consented to follow-up. Additional supportive information: The patient was given Menveo instead of Shingrix, which led to wrong vaccine administered. Since, Menveo was only allowed until from 2 months to 55 years of age and the patient's age was 66 years at the time of reporting, which led to inappropriate age at vaccine administration.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Received a second dose of menveo by mistake; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA7222V, expiry date 31st August 2023) for prophylaxis.   On 5th August 2022, the patient received Menveo. On 5th August 2022, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 12-Aug-2022 Reporter comment: A nurse reported that the patient received a second dose of Menveo by mistake. The reporter consented to follow up. Additional supportive information: The patient received second dose of Menveo, which led to extra dose administrated.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Induration, Injection site pruritus, Joint swelling, Muscle swelling
Clinical narrative: itchiness at the injection site; swelling in bicep and shoulder area; swelling in bicep and shoulder area; a rock-hard ball swelling; Dizziness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd August 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd August 2022, immediately after receiving Shingrix, the patient experienced dizziness. On 4th August 2022, the patient experienced muscle swelling, swollen joints and induration. On 12th August 2022, the patient experienced injection site itching. On 3rd August 2022, the outcome of the dizziness was recovered/resolved. On an unknown date, the outcome of the injection site itching, muscle swelling, swollen joints and induration were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching, muscle swelling, swollen joints, induration and dizziness to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comments: The reporter was the pharmacist. The reported stated that a patient received Shingrix and experienced dizziness immediately and it resolved while in the pharmacy waiting room. The reported stated that the next day patient had swelling in her bicep and shoulder area. The swelling was described as a rock-hard ball. The reported stated that on the day of reporting, the patient experienced itchiness at the injection site. The reported stated that he felt the injection site may be low and had nothing else to report. The reporter consented to follow up with Healthcare professional (pharmacist). The patient received Shingrix on an unknown arm. Additional supportive information: 1 day after receiving Shingrix, the patient experienced muscle swelling, swollen joints and induration 9 days after receiving Shingrix, the patient experienced injection site itching.
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Shingrix given to patient outside the age guidelines; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     Additional Information: GSK receipt date: 15-AUG-2022 Reporter's comments: The reporter was the pharmacist called to report a dose of Shingrix was given to a patient outside the age guidelines by accident. (Inappropriate Age).  The caller reported the patient was not immunocompromised. The reporter reported she did not have the injection date or arm used.  The reporter asked should she wait until age 50 to give the second dose or stay with the 2 -6 month schedule. Transferred to medical information (MI) for assistance.  The consent to follow up was granted. Additional Supportive Information:  As patient received Shingrix not as per the recommended age, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: vaccinated with an expired Havrix dose; 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 KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   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 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 Information: GSK Receipt Date: 15-Aug-2022 Reporter's comment: The patient was vaccinated with an expired Havrix dose. Vaccination date not specified. The consent to follow up was granted. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 12 months ago, never received second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose about 12 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.    Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's Comments: The Pharmacist reported that the patient never received his second dose.  The Vaccine Administration Facility was the same as Primary Reporter. Asked about follow up but HCP didn't really say yes or no. Additional Supportive Information: Till the time of reporting patient did not received second dose of Shingrix which led to incomplete course of vaccination.