chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: itchy; Papules; rash patient experienced looked like chickenpox/blistery rash; pain; redness; Felt like could not move arm; hardness; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2019, the patient received the 1st dose of Shingrix. On 23rd July 2019, immediately after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site induration and injected limb mobility decreased. On 29th July 2019, the patient experienced pruritus, papular rash and varicella-like rash. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site induration, injected limb mobility decreased, pruritus, papular rash and varicella-like rash were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site induration, injected limb mobility decreased, pruritus, papular rash and varicella-like rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of Shingrix. Shortly afterward the patient reported local reaction (pain, redness, and hardness) and felt like could not move arm. On 29th July 2019, the patient experienced broke out in a rash-blisters papules itchy on arms, trunk and back,  The reporter consented to follow up. This case has been linked with case US2019139552, reported by the same reporter. The case US2019AMR139399 is identified as duplicate case of US2019139548. The case US2019AMR139399 would be deleted and the US2019139548 will be the case of record for the communications.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Pruritus, Rash, Rash papular, Rash vesicular
Clinical narrative: itchy; Papules; rash patient experienced looked like chickenpox/blistery rash; pain; redness; Felt like could not move arm; hardness; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2019, the patient received the 1st dose of Shingrix. On 23rd July 2019, immediately after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site induration and injected limb mobility decreased. On 29th July 2019, the patient experienced pruritus, papular rash and varicella-like rash. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site induration, injected limb mobility decreased, pruritus, papular rash and varicella-like rash were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site induration, injected limb mobility decreased, pruritus, papular rash and varicella-like rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of Shingrix. Shortly afterward the patient reported local reaction (pain, redness, and hardness) and felt like could not move arm. On 29th July 2019, the patient experienced broke out in a rash-blisters papules itchy on arms, trunk and back,  The reporter consented to follow up. This case has been linked with case US2019139552, reported by the same reporter. The case US2019AMR139399 is identified as duplicate case of US2019139548. The case US2019AMR139399 would be deleted and the US2019139548 will be the case of record for the communications.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a physician via sales rep and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The field representative was notified by a physician that the patient experienced a rash for 2-3 days after receiving Shingrix. The caller was a field representative and did not have additional details.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Immediate post-injection reaction, Pain in extremity, Peripheral swelling
Clinical narrative: significant pain; redness in arm; swelling in arm; felt burning; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccination (had the same symptoms as of Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, erythema of extremities, swelling arm and burning sensation. On an unknown date, the outcome of the pain in arm, erythema of extremities, swelling arm and burning sensation were recovered/resolved.   It was unknown if the reporter considered the pain in arm, erythema of extremities, swelling arm and burning sensation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was in her late 60s or early 70s. The medical assistant reported to a field representative that she received Shingrix and felt burning right after the injection. She experienced significant pain, redness and swelling in her arm that she rated as grade 2. The symptoms resolved after 2 to 3 days. The patient has had the same symptoms with the flu vaccine in the past.
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Product complaint, Product container issue, Skin laceration
Clinical narrative: cuts; accidental exposure; Exposure via skin contact; Product Complaint; This case was reported by a pharmacist via call center representative and described the occurrence of laceration of hand in a male patient who received Herpes zoster (Shingrix) (batch number MP42R, expiry date 19th September 2021) for prophylaxis. This case was associated with a product complaint.   On 13th June 2019, the patient received Shingrix. On 13th June 2019, immediately after receiving Shingrix, the patient experienced laceration of hand, inadvertent exposure to vaccine, exposure via skin contact and pharmaceutical product complaint. On an unknown date, the outcome of the laceration of hand, inadvertent exposure to vaccine, exposure via skin contact and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the laceration of hand to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The pharmacist reported that another one of their pharmacist noticed that the vial of the adjuvant vialof Shingrix was broken, he noticed this as he was trying to reconstitute the vaccine trying to reconstitute the vaccine. The reporter reported that the pharmacist's hands got cuts from the vial, which led to inadvertent exposure to vaccine and exposure via skin contact. The pharmacist threw away the vial. No product available for return. The reporter confirmed that the dose was wasted and not given to a patient. The company was providing credit to wholesaler for one full dose of Shingrix. The company asked was the package or carton or blister tray damaged upon receipt, was there any evidence of leakage or product in package/carton (ex. wet PIL, powder in box), were there any glass pieces still in the vial or carton or evidence of holes or glass pieces missing, was there product still present in the vial and if cracked was it a single hairline crack or is it extended and branched. The pharmacist said no it was thrown away and there was liquid in the vial when the pharmacist was reconstituted. The pharmacist told the vial was shattered from top to bottom.
Sex: M
Vaccine: VARZOS
Symptoms: Blood test normal, Metabolic function test normal, Oral herpes
Clinical narrative: cold sores; This case was reported by a consumer via call center representative and described the occurrence of cold sores 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, less than 3 months after receiving Shingrix, the patient experienced cold sores. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the cold sores was unknown.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The misdirected consumer reported that the patient received Shingrix about 8 weeks ago and 48 hours after receiving the injection he had a terrible reaction. He later states that he has been dealing with ongoing cold sores. The patient was a perfectly healthy person until he received the vaccine. He stated that he was at the time of reporting had plagued with sores and his physician completed blood work including a metabolic and everything was fine. The reporter did not consent to follow up. Related to Patient. The consumer declines to provide any further information stating he already reported all of this to another department at GlaxoSmithKline.  The reporter declined to provide his contact information.      Lab Comments: lab test performed on uknown date
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Product administered at inappropriate site
Clinical narrative: Redness; Soreness; Inappropriate route of vaccination; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number XJ57B, expiry date 18th October 2021) for prophylaxis.   On 27th July 2019, the patient received Shingrix (intramuscular) .5 ml. On 27th July 2019, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On 28th July 2019, the patient experienced erythema and pain. On an unknown date, the outcome of the erythema and pain were recovering/resolving and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the erythema and pain to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix in left arm on Saturday before reporting date. 1 day after vaccination, the patient experienced redness around the elbow and the tricep and soreness. On 30th July 2019, Tuesday, the patient came into the pharmacy asking if the vaccine could have been given too low, which led to vaccine administration at inappropriate site. As of 30th July 2019, the redness and soreness had greatly improved and they were minimal. The reporter consented to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Cold sweat, Fatigue, Feeling abnormal, Headache, Injection site pain
Clinical narrative: soreness at the injection site; feels like someone hit him with a hammer; Fever; Clammy; Fatigue; Headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st July 2019, the patient received the 1st dose of Shingrix (intramuscular). In July 2019, 17 hrs after receiving Shingrix and an unknown time after starting excedrin unknown, the patient experienced headache and fatigue. On 31st July 2019, the patient experienced injection site pain, feeling abnormal, fever and clamminess. The patient was treated with excedrin unknown. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the feeling abnormal, fever and clamminess were unknown and the outcome of the headache and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site pain, feeling abnormal, headache, fever, clamminess and fatigue to be related to Shingrix.  Additional details were provided as follows: On 31st July 2019 at 10:00am, the patient received the 1st dose of the Shingrix vaccine.  A couple of hours after receiving the vaccination, he developed soreness at the injection site. He described that it feels like someone hit him with a hammer. He woke up during the night and noted that he felt clammy 12 hours after receiving the vaccine and knew he was running a slight fever (he did not take his temperature). Approximately 4 to 5 hours after that he started to have a headache 17 hours after receiving the vaccine at 3:00am.  He said that at 5 am this morning he felt fatigued, 19 hours after receiving the vaccine but this is resolving and he is feeling a lot better. He took Excedrin and the headache resolved. The reporter did not consent to follow up and Unable to obtain additional information.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Middle insomnia, Pyrexia
Clinical narrative: soreness at the injection site; feels like someone hit him with a hammer; Fever; Clammy; Fatigue; Headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st July 2019, the patient received the 1st dose of Shingrix (intramuscular). In July 2019, 17 hrs after receiving Shingrix and an unknown time after starting excedrin unknown, the patient experienced headache and fatigue. On 31st July 2019, the patient experienced injection site pain, feeling abnormal, fever and clamminess. The patient was treated with excedrin unknown. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the feeling abnormal, fever and clamminess were unknown and the outcome of the headache and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site pain, feeling abnormal, headache, fever, clamminess and fatigue to be related to Shingrix.  Additional details were provided as follows: On 31st July 2019 at 10:00am, the patient received the 1st dose of the Shingrix vaccine.  A couple of hours after receiving the vaccination, he developed soreness at the injection site. He described that it feels like someone hit him with a hammer. He woke up during the night and noted that he felt clammy 12 hours after receiving the vaccine and knew he was running a slight fever (he did not take his temperature). Approximately 4 to 5 hours after that he started to have a headache 17 hours after receiving the vaccine at 3:00am.  He said that at 5 am this morning he felt fatigued, 19 hours after receiving the vaccine but this is resolving and he is feeling a lot better. He took Excedrin and the headache resolved. The reporter did not consent to follow up and Unable to obtain additional information.
Age: 33.0
Sex: M
Vaccine: HEPA
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Pain right side of neck and shoulder; Pain right side of neck and shoulder; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 33-year-old male patient who received HAV (Havrix) for prophylaxis.   On 23rd July 2019, the patient received Havrix (intramuscular) 1 ml. On 24th July 2019, 1 days after receiving Havrix, the patient experienced shoulder pain and neck pain. The patient was treated with muscle relaxants and analgesic, nos (Pain Medication). On an unknown date, the outcome of the shoulder pain and neck pain were not recovered/not resolved.   The reporter considered the shoulder pain and neck pain to be related to Havrix.  Additional details were provided as follows: The patient received the Havrix in the right deltoid and was continuing to have side effects.  The patient had pain in his right shoulder and neck area which was getting worse. The patient was advised to follow up with his physician. He reported that the doctor gave him muscle relaxers and pain medication but it had not helped.  He stated at first he thought it was a pulled muscle but he now thinks it was related to the vaccine. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information received were as follows: The age at the vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The patient received Shingrix on an unknown arm. The pharmacist stated that the patient had a very sore arm and was inquiring if an alternate sight (thigh) could be used instead. The caller stated that the patient received the vaccine at another pharmacy and therefore did not had additional information regarding the event.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Wheezing
Clinical narrative: fever; shivering; wheezing; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 92M54, expiry date 21st June 2021) for prophylaxis.   Concurrent medical conditions included asthma.   On 10th July 2019, the patient received the 2nd dose of Shingrix. In July 2019, less than 3 weeks after receiving Shingrix, the patient experienced fever, shivering and wheezing. On an unknown date, the outcome of the fever, shivering and wheezing were unknown.   It was unknown if the reporter considered the fever, shivering and wheezing to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix on the left deltoid. The patient experienced fever, shivering and wheezing that resolved and then went back about one week later. This case has been linked with case US2019140579, reported by the same reporter.
Age: 78.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Asthma, Condition aggravated, Cough, Incomplete course of vaccination, Nasopharyngitis
Clinical narrative: Asthma; Condition aggrevated; Inappropriate schedule of vaccine; Cold; Cough lingered; This case was reported by a consumer via call center representative and described the occurrence of cough in a 78-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Concurrent medical conditions included asthma (since 5 years of age, very well controlled).   On 20th February 2019, the patient received the 1st dose of Twinrix. On an unknown date, the patient received the 2nd dose of Twinrix. In March 2019, less than a month after receiving Twinrix and not applicable after receiving Twinrix, the patient experienced cough. In July 2019, the patient experienced cold. On an unknown date, the patient experienced asthma, condition aggravated and incomplete course of vaccination. On an unknown date, the outcome of the cough was recovered/resolved and the outcome of the cold, asthma, condition aggravated and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the cough, cold, asthma and condition aggravated to be related to Twinrix.  Additional details were provided as follows: This case was reported by the patient herself. The lot number/expiry date or any other vaccine details were unknown. In early March 2019, the patient started experiencing cough. At the time of reporting, less than 6 months after the 1st dose of Twinrix, patient just caught a cold and cough lingered. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, missed the 2nd dose due to her asthma and a terrible lingering cough, which led to incomplete course of vaccination. Lingering cough stopped 6 weeks ago of reporting date. The reporter consented to follow up but declined to provide responsible physician's information.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Blistering rash on shoulder; This case was reported by a pharmacist via call center representative and described the occurrence of blistery rash in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 10th January 2019 from batch 9KT7T and expiration date 13th March 2021).   On 28th March 2019, the patient received the 2nd dose of Shingrix. On 22nd July 2019, 116 days after receiving Shingrix, the patient experienced blistery rash. On an unknown date, the outcome of the blistery rash was unknown.   It was unknown if the reporter considered the blistery rash to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix on an unknown arm and experienced a blistering rash on the shoulder. At the time of report, the reporter did not know which arm was injected with the Shingrix.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye irritation, Eye pain, Injection site pain, Injection site rash
Clinical narrative: Rash; Injection site burning and painful; Pain in the eyes; burning sensation in eye; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 7457P, expiry date unknown) for prophylaxis.   On 29th July 2019, the patient received Shingrix. On 31st July 2019, 2 days after receiving Shingrix, the patient experienced injection site rash, injection site burning, eye pain and burning sensation in eye. On an unknown date, the outcome of the injection site rash, injection site burning, eye pain and burning sensation in eye were unknown.   It was unknown if the reporter considered the injection site rash, injection site burning, eye pain and burning sensation in eye to be related to Shingrix.  Additional details were provided as follows: The injection site was burning and painful and it looked like a rash. The patient also had presented with these symptoms in her eye. These symptoms might have started yesterday of reporting date. The reporter did not consent to follow-up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Nausea
Clinical narrative: chills; fever; nausea; Headache; flu-like symptoms; Fatigue; Left arm hurts; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 28th July 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 29th July 2019, the patient experienced chills, fever, nausea, headache, influenza-like symptoms and fatigue. The patient was treated with ondansetron. On 30th July 2019, the outcome of the chills, nausea and headache were resolved with sequelae. On 31st July 2019, the outcome of the fever, influenza-like symptoms and fatigue were resolved with sequelae. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm, chills, fever, nausea, headache, influenza-like symptoms and fatigue to be related to Shingrix.  Additional details were received as follows: The patient experienced multiple adverse events as pain in arm, chills, fever, nausea, headache, influenza-like symptoms and fatigue. Patient stated that had severe nausea and had to take ondansetron on 29th July 2019, just for one day The batch number was not provided. The patient did not consent to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: chills; fever; nausea; Headache; flu-like symptoms; Fatigue; Left arm hurts; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 28th July 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 29th July 2019, the patient experienced chills, fever, nausea, headache, influenza-like symptoms and fatigue. The patient was treated with ondansetron. On 30th July 2019, the outcome of the chills, nausea and headache were resolved with sequelae. On 31st July 2019, the outcome of the fever, influenza-like symptoms and fatigue were resolved with sequelae. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm, chills, fever, nausea, headache, influenza-like symptoms and fatigue to be related to Shingrix.  Additional details were received as follows: The patient experienced multiple adverse events as pain in arm, chills, fever, nausea, headache, influenza-like symptoms and fatigue. Patient stated that had severe nausea and had to take ondansetron on 29th July 2019, just for one day The batch number was not provided. The patient did not consent to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Chills, Eye irritation, Eye pain, Eye ulcer
Clinical narrative: vision loss; herpes simplex in eye; vision problems; eye ulceration; eye pain; eye irritation; vomited; achy; fever; chills; nauseated; This case was reported by a consumer via call center representative and described the occurrence of loss of vision in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (received 1st dose 3 months begore receiving the 2nd dose of Shingrix and experienced flu like symptoms, refer case US2019AMR142096).   On 12th July 2019, the patient received the 2nd dose of Shingrix. On 12th July 2019, less than a day after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced pain. On 13th July 2019, the patient experienced vomiting, fever, chills and nausea. On 16th July 2019, the patient experienced loss of vision (serious criteria GSK medically significant), ophthalmic herpes simplex (serious criteria GSK medically significant), abnormal vision, eye ulcer, eye pain and eye irritation. The patient was treated with acyclovir and antivirals nos. On an unknown date, the outcome of the loss of vision, ophthalmic herpes simplex, abnormal vision, eye ulcer and eye pain were recovering/resolving and the outcome of the eye irritation was not recovered/not resolved and the outcome of the vomiting, pain, fever, chills and nausea were recovered/resolved.   The reporter considered the loss of vision, ophthalmic herpes simplex, abnormal vision, eye ulcer, eye pain and eye irritation to be related to Shingrix. It was unknown if the reporter considered the vomiting, pain, fever, chills and nausea to be related to Shingrix.  Additional details were provided as follows: After receiving the 2nd dose of Shingrix,in the night the patient felt achy. On the next day after receiving Shingrix, at about 5 in the morning the patient experienced fever,chills and felt nauseated. The patient had 101 degree F temperature.  The patient vomited and felt like aching all over that lasted for about two days. On 16th July 2019, the patient started experiencing vision problems. On 18th July 2019 and 22nd July 2019, she called her physician and was diagnosed her with herpes simplex in her left eye.  The physician said that the Shingrix vaccine caused the herpes simplex.  The patient's eye was painful, irritating and she lost vision on that eye.  The day before the date of reporting, the patient could not see how to put on her lipstick. Her ophthalmologist had been having her coming back every other day since two weeks. The patient also experienced some ulceration in her eye.  The patient was treated with Antivirus drops first and it had not helped her so on her fourth day of oral treatment she was treated with Acyclovir. The reporter consented to follow up. It was reported that the company could follow up with her if they really need to speak to her primary care physician as she had not shared any of the information with the physician till the time of reporting.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: vision loss; herpes simplex in eye; vision problems; eye ulceration; eye pain; eye irritation; vomited; achy; fever; chills; nauseated; This case was reported by a consumer via call center representative and described the occurrence of loss of vision in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (received 1st dose 3 months begore receiving the 2nd dose of Shingrix and experienced flu like symptoms, refer case US2019AMR142096).   On 12th July 2019, the patient received the 2nd dose of Shingrix. On 12th July 2019, less than a day after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced pain. On 13th July 2019, the patient experienced vomiting, fever, chills and nausea. On 16th July 2019, the patient experienced loss of vision (serious criteria GSK medically significant), ophthalmic herpes simplex (serious criteria GSK medically significant), abnormal vision, eye ulcer, eye pain and eye irritation. The patient was treated with acyclovir and antivirals nos. On an unknown date, the outcome of the loss of vision, ophthalmic herpes simplex, abnormal vision, eye ulcer and eye pain were recovering/resolving and the outcome of the eye irritation was not recovered/not resolved and the outcome of the vomiting, pain, fever, chills and nausea were recovered/resolved.   The reporter considered the loss of vision, ophthalmic herpes simplex, abnormal vision, eye ulcer, eye pain and eye irritation to be related to Shingrix. It was unknown if the reporter considered the vomiting, pain, fever, chills and nausea to be related to Shingrix.  Additional details were provided as follows: After receiving the 2nd dose of Shingrix,in the night the patient felt achy. On the next day after receiving Shingrix, at about 5 in the morning the patient experienced fever,chills and felt nauseated. The patient had 101 degree F temperature.  The patient vomited and felt like aching all over that lasted for about two days. On 16th July 2019, the patient started experiencing vision problems. On 18th July 2019 and 22nd July 2019, she called her physician and was diagnosed her with herpes simplex in her left eye.  The physician said that the Shingrix vaccine caused the herpes simplex.  The patient's eye was painful, irritating and she lost vision on that eye.  The day before the date of reporting, the patient could not see how to put on her lipstick. Her ophthalmologist had been having her coming back every other day since two weeks. The patient also experienced some ulceration in her eye.  The patient was treated with Antivirus drops first and it had not helped her so on her fourth day of oral treatment she was treated with Acyclovir. The reporter consented to follow up. It was reported that the company could follow up with her if they really need to speak to her primary care physician as she had not shared any of the information with the physician till the time of reporting.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Feeling abnormal, Headache, Pain, Pyrexia
Clinical narrative: Hives on body; Feeling horrible; fever; headache; aches; fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 17th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th July 2019, 1 days after receiving Shingrix, the patient experienced fever (serious criteria clinically significant/intervention required), headache (serious criteria clinically significant/intervention required), pain (serious criteria clinically significant/intervention required), fatigue (serious criteria clinically significant/intervention required) and feels awful. On 19th July 2019, the patient experienced hives (serious criteria clinically significant/intervention required). The patient was treated with ibuprofen (Motrin), benadryl (nos) (Benadryl) and methylprednisolone (Medrol). On 19th July 2019, the outcome of the fever, headache, pain and fatigue were recovered/resolved. On 20th July 2019, the outcome of the hives was recovered/resolved. On an unknown date, the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the fever, headache, pain, fatigue, hives and feels awful to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. On 17th July 2019, in the evening the patient received Shingrix on the left arm. The patient did not have any information about the vaccination. The patient felt horrible and experienced fever,headache, fatigue, and aches. States she The patient was treated at home with Motrin. The patient also experienced hives on her body and went to urgent care and received Benadryl and medrol/steroids to treat the hives. The reporter consented to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: Hives on body; Feeling horrible; fever; headache; aches; fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 17th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th July 2019, 1 days after receiving Shingrix, the patient experienced fever (serious criteria clinically significant/intervention required), headache (serious criteria clinically significant/intervention required), pain (serious criteria clinically significant/intervention required), fatigue (serious criteria clinically significant/intervention required) and feels awful. On 19th July 2019, the patient experienced hives (serious criteria clinically significant/intervention required). The patient was treated with ibuprofen (Motrin), benadryl (nos) (Benadryl) and methylprednisolone (Medrol). On 19th July 2019, the outcome of the fever, headache, pain and fatigue were recovered/resolved. On 20th July 2019, the outcome of the hives was recovered/resolved. On an unknown date, the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the fever, headache, pain, fatigue, hives and feels awful to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. On 17th July 2019, in the evening the patient received Shingrix on the left arm. The patient did not have any information about the vaccination. The patient felt horrible and experienced fever,headache, fatigue, and aches. States she The patient was treated at home with Motrin. The patient also experienced hives on her body and went to urgent care and received Benadryl and medrol/steroids to treat the hives. The reporter consented to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Pain, Pyrexia, Urticaria
Clinical narrative: Hives on body; Feeling horrible; fever; headache; aches; fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 17th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th July 2019, 1 days after receiving Shingrix, the patient experienced fever (serious criteria clinically significant/intervention required), headache (serious criteria clinically significant/intervention required), pain (serious criteria clinically significant/intervention required), fatigue (serious criteria clinically significant/intervention required) and feels awful. On 19th July 2019, the patient experienced hives (serious criteria clinically significant/intervention required). The patient was treated with ibuprofen (Motrin), benadryl (nos) (Benadryl) and methylprednisolone (Medrol). On 19th July 2019, the outcome of the fever, headache, pain and fatigue were recovered/resolved. On 20th July 2019, the outcome of the hives was recovered/resolved. On an unknown date, the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the fever, headache, pain, fatigue, hives and feels awful to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. On 17th July 2019, in the evening the patient received Shingrix on the left arm. The patient did not have any information about the vaccination. The patient felt horrible and experienced fever,headache, fatigue, and aches. States she The patient was treated at home with Motrin. The patient also experienced hives on her body and went to urgent care and received Benadryl and medrol/steroids to treat the hives. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arrhythmia, Atrial fibrillation, Condition aggravated
Clinical narrative: Atrial fibrillation; Abnormal heart rhythm; This case was reported by a nurse via call center representative and described the occurrence of recurrent atrial fibrillation in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cardiac arrhythmia (had abnormal cardiac rhythm), cardioversion and cardiac ablation.   In May 2019, the patient received the 1st dose of Shingrix. In May 2019, 1 day after receiving Shingrix, the patient experienced recurrent atrial fibrillation (serious criteria GSK medically significant) and cardiac arrhythmia (serious criteria GSK medically significant). On an unknown date, the outcome of the recurrent atrial fibrillation and cardiac arrhythmia were unknown.   It was unknown if the reporter considered the recurrent atrial fibrillation and cardiac arrhythmia to be related to Shingrix.  Additional details were received as follows: A nurse reported the adverse events experienced by her husband. After the previous cardio-version with ablation, the patient was stable for 1.5 years.  One day after receiving Shingrix, the patient experienced a re-occurrence of atrial fibrillation and developed abnormal rhythm.  The patient was under the care of a Cardiologist and had another cardio version scheduled. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Rash
Clinical narrative: Redness over upper body; Rash over upper body; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 9KT7T, expiry date 31st March 2021) and (batch number 5S34K, expiry date 31st March 2021) for prophylaxis.   On 15th July 2019, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On 2nd August 2019, 18 days after receiving Shingrix, the patient experienced erythema and rash. On an unknown date, the outcome of the erythema and rash were unknown.   It was unknown if the reporter considered the erythema and rash to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient was administered Shingrix vaccine and on the day of reporting was experiencing a rash and redness over her upper body. The reporter gave consent to follow up.
Sex: M
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: patient developed mumps; Information was received from a pharmacy intern referring to a male patient of unkonw age. The patient's concomitant therapy, pertinent medical history and and concurrent conditions were unknown by the reporter.      On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, dose number, frequency and route, lot number and expiration date were unknown) for prophylaxis.         On an unknown date the patient developed mumps.      No product quality complaint (PQC) was involved. Information about treatment given for the adverse event, lab diagnostics/studies performed, and medical attention was unknown by the reporter. The outcome of mumps was unknown. The causality assessment were not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: rash below injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The patient was reporters father. The age at vaccination was not reported. The patient received a dose of Shingrix a couple of days ago and developed rash inches below the injection site. The reporter did not consent to follow-up. This case had been linked to the case US2019141432, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Influenza like illness
Clinical narrative: feel completely exhausted; mild headache; joint aches; flu like symptoms; This case was reported by a consumer and described the occurrence of exhaustion in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th July 2019, the patient received the 2nd dose of Shingrix. On 27th July 2019, 1 days after receiving Shingrix, the patient experienced exhaustion, headache, joint pain and influenza-like symptoms. On an unknown date, the outcome of the exhaustion, headache, joint pain and influenza-like symptoms were not recovered/not resolved.   It was unknown if the reporter considered the exhaustion, headache, joint pain and influenza-like symptoms to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The reporter reported that unfortunately was a statistic of the side effects from the shot. On Monday, The patient received Shingrix and felt completely exhausted with a mild headache, joint aches and flu like symptoms. The reporter asked should this happen for this long period of time. It would be one week on the Friday, on the reporting date.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injection site discomfort, Nausea, Product administered at inappropriate site
Clinical narrative: feel completely exhausted; mild headache; joint aches; flu like symptoms; This case was reported by a consumer and described the occurrence of exhaustion in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th July 2019, the patient received the 2nd dose of Shingrix. On 27th July 2019, 1 days after receiving Shingrix, the patient experienced exhaustion, headache, joint pain and influenza-like symptoms. On an unknown date, the outcome of the exhaustion, headache, joint pain and influenza-like symptoms were not recovered/not resolved.   It was unknown if the reporter considered the exhaustion, headache, joint pain and influenza-like symptoms to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The reporter reported that unfortunately was a statistic of the side effects from the shot. On Monday, The patient received Shingrix and felt completely exhausted with a mild headache, joint aches and flu like symptoms. The reporter asked should this happen for this long period of time. It would be one week on the Friday, on the reporting date.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles; Spot; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected as an adult as per vaccine indication. The patient came in for 2nd dose of Shingrix, but had spot that the physician said it could be shingles, but it was not confirmed. The reporter did not consent to follow-up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number BB24A, expiry date 26th September 2021) for prophylaxis.   On 3rd July 2019, the patient received Shingrix (intramuscular) .5 ml. On 3rd July 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm on 3rd July 2019, and experienced arm pain till the date of reporting it was not resolved. The patient was seeking information on this adverse event and treatment recommendations. The patient was referred to physician for medical care inquiry.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: rash below injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, several days after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was not recovered/not resolved.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient received a dose of Shingrix a couple of days ago and developed rash inches below the injection site. The reporter did not consent to follow-up. This case had been linked with case US2019141435, reported by the same reporter.