chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 4 month old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On 09-OCT-2018, the patient received inadvertently a dose of VARIVAX 0.5 ml once, intramuscular, lot # R007695, expiration date 14-MAR-2020, for prophylaxis. The reporter stated that the patient received this dose of VARIVAX several months earlier than indication of 12 months (drug administered to patient of inappropriate age). The vaccine was reconstituted with sterile diluent lot # N030721, expiration date 20-JUL-2020. No adverse effects were reported.
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a 7 week old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 04-OCT-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ per oral route (dose, dose number, frequency, and anatomical location were unknown) with lot # N030364, and expiration date 06-MAR-2018 for prophylaxis. The administered dose of vaccine experienced the temperature excursion of 13.3 °C degrees Celsius for 1 hour and 17 minutes. There was a digital data logger involved, but there was no previous temperature excursion reported. No adverse effects were reported. Sender's Comments: US-009507513-1810USA004453: US-009507513-1810USA004452.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a 6 months old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 04-OCT-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ per oral route (dose, dose number, frequency, and anatomical location were unknown) with lot # N030364, and expiration date 06-MAR-2018 for prophylaxis. The administered dose of vaccine experienced the temperature excursion of 13.3 °C degrees Celsius for 1 hour and 17 minutes. There was a digital data logger involved, but there was no previous temperature excursion reported. No adverse effects were reported. Sender's Comments: US-009507513-1810USA004400.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to an 8 week old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 05-OCT-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ per oral route (dose, dose number, frequency, and anatomical location were unknown) with lot # N030364, and expiration date 06-MAR-2018 for prophylaxis. The administered dose of vaccine experienced the temperature excursion of 13.3 °C degrees Celsius for 1 hour and 17 minutes. There was a digital data logger involved, but there was no previous temperature excursion reported. No adverse effects were reported. Sender's Comments: US-009507513-1810USA004400.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Prostatic specific antigen increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of psa increased in a 71-year-old male patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020) for prophylaxis. On 5th June 2018, the patient received SHINGRIX. On 5th June 2018, less than a day after receiving SHINGRIX, the patient experienced PSA increased. On an unknown date, the outcome of the PSA increased was unknown. It was unknown if the reporter considered the PSA increased to be related to SHINGRIX. Additional information was reported as follows: This case was previously not reported to anyone. The patient stated that he was on other medications at the time of vaccination with SHINGRIX, but the patient did not listed them. The patient showed his normal Prostatic specific antigen reading as 4.3 and 4.7. The patient received vaccination with SHINGRIX, and had his prostatic specific antigen was tested routinely the same day. After vaccination with SHINGRIX, when the patient's blood was withdrawn, the prostatic specific antigen lab test showed a level of 7.5. On 19th June 2018, the test was repeated for the patient and the prostatic specific antigen lab results showed as 8.0. The patient provided contact details of the physician. Follow-up information was received from physician on 3rd October 2018:  The batch number and expiry date for SHINGRIX was updated. The patient was vaccinated with the 1st dose of SHINGRIX intramuscularly. The VAERS details were updated. Lab Comments: On an unknown date the patient showed his normal Prostatic specific antigen reading as 4.3 and 4.7.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 53-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. On an unknown date, the patient received SHINGRIX (subcutaneous) .5 ml. On an unknown date, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional information was received as follows: This case was reported by pharmacy intern. The health care professional stated that the patient inadvertently received the dose of SHINGRIX subcutaneously instead of the indicated intramuscular route, which led to the intramuscular formulation administered by other route. Additional information was received as follows: This case was reported by pharmacy intern. The health care professional stated that the patient inadvertently received the dose of SHINGRIX subcutaneously instead of the indicated intramuscular route, which led to the intramuscular formulation administered by other route. Follow up information was received from other healthcare professional on 3rd October 2018: The patient's demographic details were updated. On 3rd July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a month after vaccination, the injection site was red for several days, but no other adverse events were occurred. SHINGRIX was processed through insurance, covered and the patient received the vaccine subcutaneously unintentionally instead of intramuscularly. The patient was immediately informed once the medication error was discovered. The VAERS details were updated. This case was associated with medication error with adverse event. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Feeling abnormal, Headache, Hypoaesthesia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of pain in a 56-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included ankylosing spondylitis (all her life). On 24th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, several hours after receiving SHINGRIX, the patient experienced pain, neck pain, sickness, numbness of upper extremities, headache, shoulder pain and knee pain. On 24th September 2018, the patient experienced burning sensation, tingling, feeling bad and injection site pain. On an unknown date, the outcome of the pain, neck pain, burning sensation, tingling, sickness, numbness of upper extremities and injection site pain were not recovered/not resolved and the outcome of the headache, feeling bad, shoulder pain and knee pain were unknown. It was unknown if the reporter considered the pain, neck pain, burning sensation, tingling, sickness, numbness of upper extremities, headache, feeling bad, shoulder pain, knee pain and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. The patient reported that she had the SHINGRIX vaccine on Monday afternoon and she had been so sick with aches. The patient claimed that she had Ankylosing spondylitis so she was not sure if it was making it worse. She also reported pain in her neck, shoulder and knees and her arm goes numb. She claimed that her side effects were just horrible. She felt a stinging when the vaccine was administered in her arm and later there was a numbness down her arm with burning and tingling. She awoke in the middle of the night and felt so bad. She claimed that her knees were killing her and her head hurt so bad. The patient claimed that she was not getting the 2nd shot because of her experience with the 1st shot.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Middle insomnia, Musculoskeletal pain, Neck pain
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of pain in a 56-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included ankylosing spondylitis (all her life). On 24th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, several hours after receiving SHINGRIX, the patient experienced pain, neck pain, sickness, numbness of upper extremities, headache, shoulder pain and knee pain. On 24th September 2018, the patient experienced burning sensation, tingling, feeling bad and injection site pain. On an unknown date, the outcome of the pain, neck pain, burning sensation, tingling, sickness, numbness of upper extremities and injection site pain were not recovered/not resolved and the outcome of the headache, feeling bad, shoulder pain and knee pain were unknown. It was unknown if the reporter considered the pain, neck pain, burning sensation, tingling, sickness, numbness of upper extremities, headache, feeling bad, shoulder pain, knee pain and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. The patient reported that she had the SHINGRIX vaccine on Monday afternoon and she had been so sick with aches. The patient claimed that she had Ankylosing spondylitis so she was not sure if it was making it worse. She also reported pain in her neck, shoulder and knees and her arm goes numb. She claimed that her side effects were just horrible. She felt a stinging when the vaccine was administered in her arm and later there was a numbness down her arm with burning and tingling. She awoke in the middle of the night and felt so bad. She claimed that her knees were killing her and her head hurt so bad. The patient claimed that she was not getting the 2nd shot because of her experience with the 1st shot.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of pain in a 56-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included ankylosing spondylitis (all her life). On 24th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, several hours after receiving SHINGRIX, the patient experienced pain, neck pain, sickness, numbness of upper extremities, headache, shoulder pain and knee pain. On 24th September 2018, the patient experienced burning sensation, tingling, feeling bad and injection site pain. On an unknown date, the outcome of the pain, neck pain, burning sensation, tingling, sickness, numbness of upper extremities and injection site pain were not recovered/not resolved and the outcome of the headache, feeling bad, shoulder pain and knee pain were unknown. It was unknown if the reporter considered the pain, neck pain, burning sensation, tingling, sickness, numbness of upper extremities, headache, feeling bad, shoulder pain, knee pain and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. The patient reported that she had the SHINGRIX vaccine on Monday afternoon and she had been so sick with aches. The patient claimed that she had Ankylosing spondylitis so she was not sure if it was making it worse. She also reported pain in her neck, shoulder and knees and her arm goes numb. She claimed that her side effects were just horrible. She felt a stinging when the vaccine was administered in her arm and later there was a numbness down her arm with burning and tingling. She awoke in the middle of the night and felt so bad. She claimed that her knees were killing her and her head hurt so bad. The patient claimed that she was not getting the 2nd shot because of her experience with the 1st shot.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin mass
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin nodule in a 72-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (had a severe case of shingles previously in her left eye). In August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 1 day after receiving SHINGRIX, the patient experienced skin nodule. On an unknown date, the outcome of the skin nodule was recovered/resolved. It was unknown if the reporter considered the skin nodule to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient developed a lump between her neck and shoulder that lasted about a week and resolved. The physician recommended that she get her 2nd dose in her right buttock or her right hand. The patient had denied permission to contact their physician.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cervical radiculopathy, Condition aggravated, Myalgia, Neuralgia, Nuclear magnetic resonance imaging
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 63-year-old female patient who received SHINGRIX (batch number J4D5J, expiry date February 2019) for prophylaxis. The patient's past medical history included cervical radiculopathy. On 13th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th September 2018, less than a day after receiving SHINGRIX, the patient experienced muscle pain and cervical radiculopathy. On an unknown date, the outcome of the muscle pain was not recovered/not resolved and the outcome of the cervical radiculopathy was unknown. It was unknown if the reporter considered the muscle pain and cervical radiculopathy to be related to SHINGRIX. Additional details were provided as follows: The patient had a history of cervical radiculopathy, but was not having any symptoms prior to getting SHINGRIX. At 10:00, the patient received SHINGRIX in the left arm. Within 2 hours, she had pain in the muscle of her left arm that was enough to distract her from the meeting she was attending. A little later, the pain seemed to be running down her nerve from her neck down her left arm. The pain was a recurrence of her cervical radiculopathy and had continued since she got the vaccine.  She had an magnetic resonance imaging (MRI) and had been to the emergency room for pain relief. She had an appointment scheduled with an orthopedist. The reported batch number J4D5F for SHINGRIX did not exist and was updated as J4D5J as per sales database.
Age: 75.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Headache, Nasopharyngitis, Rhinorrhoea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cold symptoms in a 75-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On 24th September 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On 25th September 2018, 1 days after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced cold symptoms, chills, runny nose and headache. On an unknown date, the outcome of the cold symptoms, chills and headache were unchanged and the outcome of the runny nose was recovering/resolving. It was unknown if the reporter considered the cold symptoms, chills, runny nose and headache to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: This case was reported by the patient's wife. The patient received an unspecified influenza vaccine on Monday. The patient experienced cold like symptoms which consisted of chills, headache, and runny nose. The patient stated that, the physician did not specify which manufacturer was used, but referred the reporter to GlaxoSmithKline (GSK). The patient did not know if the vaccine was FLUARIX or FLULAVAL. This case was one of the 2 cases, reported by the same reporter.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a month after receiving SHINGRIX the patient experienced hives and itchy rash. On an unknown date, the outcome of the hives and itchy rash were not recovered/not resolved. It was unknown if the reporter considered the hives and itchy rash to be related to SHINGRIX. Additional details were reported as follows: The patient developed rash across upper chest which looked like bed bug bites and was very itchy. The patient had hives which was very amorphous in shape, also itchy on arms, legs and buttocks. The patient was not sure if the events related to SHINGRIX or not and they would see a dermatologist later this week. The patient requested to remain anonymous. The patient had denied permission to contact their physician. This case has been linked with US2018178311, reported by same reporter.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a 86-year-old male patient who received SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced hives and itchy rash. On an unknown date, the outcome of the hives and itchy rash were not recovered/not resolved. It was unknown if the reporter considered the hives and itchy rash to be related to SHINGRIX. Additional details were reported as follows: The patient developed rash across upper chest which looked like bed bug bites and was very itchy. The patient had hives which was very amorphous in shape, also itchy on arms, legs and buttocks. The patient was not sure if the events related to SHINGRIX or not and they would see a dermatologist later this week. The patient requested to remain anonymous. The patient had denied permission to contact their physician. This case has been linked with US2018178311, reported by same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 4th September 2018, the patient received the 1st dose of SHINGRIX. On 17th September 2018, 13 days after receiving SHINGRIX, the patient experienced shingles and pruritus. On an unknown date, the outcome of the shingles and pruritus were not recovered/not resolved. The reporter considered the shingles and pruritus to be related to SHINGRIX. Additional details were reported as follows: On 17th or 18th September 2018, she developed what she thought was a mosquito bite that was very itchy. The mosquito bite multiplied and she went to her doctor the day of reporting and was diagnosed with shingles.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 65-year-old male patient who received SHINGRIX (batch number EH9Z7, expiry date 8th March 2021) for prophylaxis. On 26th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, less than a week after receiving SHINGRIX, the patient experienced contusion. On 27th September 2018, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were recovering/resolving and the outcome of the contusion was not recovered/not resolved. It was unknown if the reporter considered the injection site pain, contusion and injection site swelling to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX in the left deltoid. Within 48 hours after receiving SHINGRIX, the patient experienced a pretty bad looking bruise under the shoulder muscle.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a 65-year-old female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 1 day after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left arm. The patient got sick the next day but her symptoms were resolved by the end of the 3rd day (unspecified). For tolerance to next dose, refer case US2018GSK182018.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Dizziness, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received refer linked case US2018GSK182167). On 28th September 2018, the patient received the 2nd dose of SHINGRIX. On 28th September 2018, several hours after receiving SHINGRIX, the patient experienced shivering. On 29th September 2018, the patient experienced injection site pain and injection site erythema. On 1st October 2018, the patient experienced dizziness and stomach pain. On an unknown date, the outcome of the injection site pain, dizziness, shivering, injection site erythema and stomach pain were unknown. It was unknown if the reporter considered the injection site pain, dizziness, shivering, injection site erythema and stomach pain to be related to SHINGRIX. Additional details were provided as follows: At 12:00, the patient received 2nd dose of SHINGRIX on left arm. On the same night, the patient started shivering and that lasted throughout the next day. On Saturday, 1 day after receiving SHINGRIX, the patient experienced redness and pain at the injection site and the area was approximately the size of an orange. The symptoms were resolving. The patient reported that on the day of reporting, 3 days after receiving SHINGRIX, she started feeling dizzy and had stomach pain. The patient did not know if it was related to the vaccination.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 27th July 2018, the patient received the 1st dose of SHINGRIX. On 27th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site itching were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were reported as follows: The patient developed puffiness at the injection site after receiving SHINGRIX. The symptoms lasted for three days in July 2018. The reporter did not have lot number of the vaccine.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenitis, Lymphadenopathy, Oral herpes, Pain in extremity
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of pain in arm in a 63-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included lymphoma. On 24th September 2018, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm, enlargement of lymph nodes and cold sores. The patient was treated with ABREVA. On an unknown date, the outcome of the pain in arm and cold sores were recovered/resolved and the outcome of the enlargement of lymph nodes was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, enlargement of lymph nodes and cold sores to be related to SHINGRIX. Additional details were provided as follows: The patient reported that he received the SHINGRIX vaccine on Monday and his arm was extremely sore. In addition, his lymph nodes were greatly inflamed and he had a cold sore break out after the vaccination. The patient stated that his original symptom was a sore arm, which resolved after about 4 days, and 2 to 3 days after he received the vaccine his lymph nodes started swelling up. He had lymphoma and the nodes that have swollen are the ones affected by his lymphoma. They are hard and swollen. About 2 days after the vaccination he developed a cold sore as well. He treated the cold sore with ABREVA and it had resolved. The patient called back to deny permission to contact doctor. He changed his mind and did not want his doctor to be contacted.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: 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 SHINGRIX for prophylaxis. On 14th May 2018, the patient received the 1st dose of SHINGRIX. On 15th May 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The reporter reported that she had a sore arm after getting a dose of SHINGRIX. By the 4th day it had mostly resolved and only hurt if she laid on it. The patient had denied permission to contact their physician.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 24th July 2018, the patient received SHINGRIX. On 24th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient had pain at the injection site which lasted for about 2 days. The patient had denied permission to contact their physician.
Sex: M
Vaccine: FLU4
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Flu Seasonal QIV Dresden for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that she knows a man that told her that he no longer gets the flu vaccine, because when he received the flu vaccine (unknown manufacturer), he got flu-like symptoms. The patient called to report that she was certain SHINGRIX was not causing her symptoms. She was relating it to the flu shot. She did not want any follow up at all. She specifically asked that she not received any mailing of any kind. The reporter did not have any additional information regarding this event.
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 85-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included unspecified Flu vaccine. On 28th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 2nd October 2018, 4 days 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 age at vaccination was not reported but the patient could be 84 or 85 years old. The patient received the dose of the SHINGRIX in the left deltoid at 3 pm. The patient reported that the injected arm was sore when he raised his arm. This symptom did not start until, the date of reporting. The patient was aware that this was a possible side effect but stated that he was surprised that it was starting 4 days after he received the SHINGRIX. The patient was referred to his healthcare professional. The patient had denied permission to contact their physician. This case was linked with US2018179229, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shortness of breath in a adult male patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) and (batch number 75GJ5, expiry date 2nd February 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shortness of breath. On an unknown date, the outcome of the shortness of breath was unknown. It was unknown if the reporter considered the shortness of breath to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported.  The health care professional reported that she had a patient that developed shortness of breath after his initial dose of SHINGRIX and would not be completing the series. The patient received SHINGRIX in Left deltoid. Complications was none The VIS for the recombinant zoster vaccine (RZV) dated 1st August 2018, was given to the patient.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Joint swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of swelling of wrists in a 65-year-old female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling of wrists and wrist pain. On an unknown date, the outcome of the swelling of wrists and wrist pain were recovered/resolved. It was unknown if the reporter considered the swelling of wrists and wrist pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however; it could be 64 or 65 years. In 2018, the patient developed swelling down to her wrist, and it was super painful. The symptoms lasted about a week. The reporter stated that, this was getting old when being asked adverse event questions. The reporter declined to provide more information other than what was in the report.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details reported as follows: This case was reported by the pharmacist on behalf of the another health care provider. The age at vaccination was not reported. In 2018, the patient received a dose of SHINGRIX. At the time of reporting, the patient came back for 2nd dose of SHINGRIX, but the patient had case of shingles. The reporter did not have any additional information.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 64-year-old male patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. On 12th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The health care professional (HCP) reported that after receiving a dose of SHINGRIX, the patient developed a mild case of shingles prior to receipt of the second dose of SHINGRIX.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: CSF culture negative, Encephalopathy
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of encephalopathy in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 25th September 2018, the patient received the 2nd dose of SHINGRIX. On 28th September 2018, 3 days after receiving SHINGRIX, the patient experienced encephalopathy (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the encephalopathy was recovered/resolved. It was unknown if the reporter considered the encephalopathy to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient was admitted to the hospital on 28th September 2018 and diagnosed with encephalopathy. The patient's cerebrospinal fluid cultures were all negative and everything from a micro standpoint was negative as well. The reporter had provided contact details of the physician. Lab Comments: The patient's CFS cultures were all negative and everything from a micro standpoint was negative as well.
Sex: M
Vaccine: VARZOS
Symptoms: Haematemesis, Haemoglobin decreased, Transfusion
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vomiting blood in a adult male patient who received SHINGRIX for prophylaxis. On 19th September 2018, the patient received SHINGRIX. On 19th September 2018, 4 hrs after receiving SHINGRIX, the patient experienced vomiting blood (serious criteria hospitalization, GSK medically significant, life threatening and other: as per reporter) and hemoglobin decreased (serious criteria hospitalization, life threatening and other: as per reporter). The patient was treated with blood transfusion, auxiliary products (Blood Transfusion). On an unknown date, the outcome of the vomiting blood and hemoglobin decreased were unknown. It was unknown if the reporter considered the vomiting blood and hemoglobin decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient was vomiting blood. The pharmacist reported that the patient's hemoglobin decreased and went as low as 7.2. On 19th September 2018, less than a day after vaccination, the patient's hemoglobin went from 14.2 to 12.5, then on 2nd October 2018 his hemoglobin went down to 7.5, and then on the same day at the hospital his hemoglobin went down to 7.2. The patient went to the emergency room on 2nd October 2018 and was hospitalized and received a blood transfusion. Limited information was provided by the pharmacist from the physician.
Sex: F
Vaccine: TDAP
Symptoms: Cough, Musculoskeletal chest pain, Nasopharyngitis, Rib fracture
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of rib pain in a female patient who received BOOSTRIX for prophylaxis. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, less than a year after receiving BOOSTRIX, the patient experienced rib pain, painful cough and cold. On an unknown date, the outcome of the rib pain, painful cough and cold were unknown. It was unknown if the reporter considered the rib pain, painful cough and cold to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient commented on here before about her experience that she and her daughter just survived this over the summer. The patient caught it and went undiagnosed after seeing 3 doctors who said it was a cold. The doctors did not recognize it anymore, and unfortunately the patient's 4 week old baby caught it from her. The patient's child was in pediatric intensive care unit for 14 days. The patient even received TDAP vaccine at the hospital the day her child received it. The patient experienced cough which was very painful, and was in the worst pain of her life, and she cracked her ribs coughing. The patient told to be vigilant.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Tenderness
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in arm in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year 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 details were provided as follows: The age at vaccination was not reported. The caller was a dermatologist reporting that he has seen a patient who had had both doses of SHINGRIX. The patient experienced tender arm for a few days. The reporter was driving in his car and was not able to provide further details but was fine with follow-up from safety team. For tolerance to 2nd dose refer linked case US2018172571, reported for same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: 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 SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and injection site erythema. On an unknown date, the outcome of the pain in arm and injection site erythema were recovered/resolved. It was unknown if the reporter considered the pain in arm and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient herself who is a medical assistant (MA). The age at vaccination was not reported. The patient' right arm was very sore and had round red circle around injection which lasted one week. The reported agreed to be contacted to follow up from GlaxoSmithKline.
Sex: F
Vaccine: MNQ
Symptoms: Pain in extremity, Syncope
Clinical narrative: This case was reported by a other health professional via patient support programs and described the occurrence of fainting in a female patient who received MENVEO (batch number M17076, expiry date 31st July 2019) for prophylaxis. On 17th September 2018, the patient received the 2nd dose of MENVEO .5 ml. On 17th September 2018, less than a day after receiving MENVEO, the patient experienced pain in arm. On 18th September 2018, the patient experienced fainting. On an unknown date, the outcome of the fainting and pain in arm were unknown. It was unknown if the reporter considered the fainting and pain in arm to be related to MENVEO. Additional information received as follows: The caller had been informed that they had reported an experience with a GlaxoSmithKline product that needs to be shared with GlaxoSmithKline. This case was received from the healthcare provider via the vaccine patient assistant program. The case was reported by the medical assistant. The age at vaccination was not reported. The patient received MENVEO on the right arm. After the patient left the clinic, she felt pain in her left arm. Next morning of the vaccination day, the patient went to the bus stop and she fainted. The patient went to the hospital. This event did not include a product complaint.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity, Sleep disorder
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 1st June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st June 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and injection site erythema. On an unknown date, the outcome of the pain in arm and injection site erythema were recovered/resolved. It was unknown if the reporter considered the pain in arm and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The reporter reported that, her arm was extremely painful after the injection. It was painful enough to wake her up if she rolled on it when sleeping. The patient also had some redness at the injection site. The pain finally resolved after about 1 week. Caller stated that, her pharmacist called and spoke with GlaxoSmithKline about her reaction, however, no duplicate case could be found.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of arthralgia in a elderly female patient who received SHINGRIX (batch number 4LP5Y, expiry date 27th February 2021) for prophylaxis. On 24th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced arthralgia, fever, myalgia and injection site swelling. On an unknown date, the outcome of the arthralgia, fever, myalgia and injection site swelling were unknown. It was unknown if the reporter considered the arthralgia, fever, myalgia and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. The patient had a severe fever, arthralgia, myalgia and severe swelling at the injection site. The reporter agreed to be contacted for follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hypersomnia, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a 65-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of malaise (1st dose received in April 2018, refer case US2018178351). On 28th September 2018, the patient received the 2nd dose of SHINGRIX. On 29th September 2018, 1 days after receiving SHINGRIX, the patient experienced sickness, chills, headache, fever, tremor and hypersomnia. On 1st October 2018, the patient experienced skin peeling. Rechallenge with SHINGRIX was positive. On 30th September 2018, the outcome of the fever was recovered/resolved. On 1st October 2018, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the sickness and hypersomnia were unknown and the outcome of the skin peeling was not recovered/not resolved and the outcome of the chills and tremor were recovering/resolving. It was unknown if the reporter considered the sickness, skin peeling, chills, headache, fever, tremor and hypersomnia to be related to SHINGRIX. Additional information was received as follows: At 3:00 pm in the afternoon, the patient received SHINGRIX on the left arm. The patient got sick again but the symptoms were more intense than sickness after the 1st dose of SHINGRIX. On Saturday, she woke up with fever, chills, shaking and a headache. She slept most of the day. It felt as if her fever was gone by Sunday and her headache was gone in morning of the reporting day. However, she noticed at work in morning of the reporting day, that her skin was peeling on the palm and inside of her fingers of her left hand. The contact details of the physician was provided.