chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Oral mucosal eruption
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash mouth in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash mouth. On an unknown date, the outcome of the rash mouth was unknown. It was unknown if the reporter considered the rash mouth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter called GlaxoSmithKline to inquire if there has there been any incidence of getting an oral rash after getting the SHINGRIX vaccine because she had one. The reporter declined to answer any reporting questions. The patient was referred to her health care professional before the call ended. This caller chose to end the call after the package insert was discussed and declined to answer further related questions, so no further information beyond what is documented above was provided during the call.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Syncope
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 57-year-old female patient who received SHINGRIX. On 25th April 2018 12:30, the patient received the 1st dose of SHINGRIX. In April 2018, 13 hrs after receiving SHINGRIX, the patient experienced pain and chills. On 26th April 2018, the patient experienced faint. In April 2018, the outcome of the pain and chills were recovered/resolved. On an unknown date, the outcome of the faint was recovering/resolving. It was unknown if the reporter considered the pain, faint and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. In afternoon, the patient received SHINGRIX. On 26th April 2018, around 1:30 am the patient woke up around with aches and chills. On 26th April 2018, in the afterjnoon 1 day after receiving SHINGRIX, the patient felt faint almost fainted. The patient had denied permission to contact their physician. The reporter refused to answer any additional questions.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Malaise, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a adult female patient who received SHINGRIX. On 3rd April 2018, the patient received the 2nd dose of SHINGRIX. On 3rd April 2018, less than a day after receiving SHINGRIX, the patient experienced pain. In April 2018, the patient experienced dizziness and feeling unwell. On an unknown date, the outcome of pain and feeling unwell were unknown and the outcome of the dizziness was not recovered/not resolved. The reporter considered the pain, dizziness and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that after her vaccination she started to experience dizziness. She stated it did not occur right away after vaccination; it might be a week later. The patient stated to feel uneasy like she might fall. The patient stated that, a day before reporting date, she did almost fall in her house. The dizziness had not gone away and she was looking for answers to stop it. The patient did not take any medication and had not made her physician aware of her experience. The name of the physician and phone number was not captured accidentally.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Injection site erythema, Malaise
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 53-year-old female patient who received SHINGRIX. In April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a month after receiving SHINGRIX, the patient experienced injection site erythema, redness, exhaustion and malaise. In April 2018, the outcome of the injection site erythema, redness, exhaustion and malaise were recovered/resolved. It was unknown if the reporter considered the injection site erythema, redness, exhaustion and malaise to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the week of 16th to 20th April 2018. The patient experienced redness from injection site that included an expanded area into chest area. Extreme exhaustion, malaise that lasted for 2 to 3 days.
Sex: F
Vaccine: VARZOS
Symptoms: Glossitis
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of glossitis in a female patient who received SHINGRIX. Concurrent medical conditions included seasonal allergy. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced glossitis. On an unknown date, the outcome of the glossitis was unknown. It was unknown if the reporter considered the glossitis to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient reported an episode of glossitis 3 to 4 weeks after receiving SHINGRIX. The healthcare professional mentioned that she did not think the event was related vaccine. The reporter told the patient that glossitis might had been due to seasonal allergies.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Skin reaction
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of localized skin reaction in an adult female patient who received SHINGRIX. On 20th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced localized skin reaction, pruritus and pain. On an unknown date, the outcome of the localized skin reaction, pruritus and pain were recovering/resolving. It was unknown if the reporter considered the localized skin reaction, pruritus and pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The age at vaccination was not reported. Over the next four days after receiving SHINGRIX, the patient experienced a large painful and pruritic local reaction which reached a final size of 3 by 5 cm. At the time of this reporting, it was starting to abate. The reporter was asking whether she should receive the 2nd dose and should any precautions be taken.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Local reaction, Pain in extremity, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of local reaction in a female patient who received SHINGRIX. 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 local reaction, pain in arm, swelling and flu like symptoms. On an unknown date, the outcome of the local reaction, pain in arm, swelling and flu like symptoms were unknown. It was unknown if the reporter considered the local reaction, pain in arm, swelling and flu like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. No further information was reported regarding to the event. The healthcare professional preferred not to provide further information.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Injection site pain, Mandibular mass, Myalgia
Clinical narrative: This case was reported by a physician and described the occurrence of injection site pain in a 66-year-old male patient who received SHINGRIX. Concomitant products included FLOMAX, Aspirin and SYNTHROID. On 24th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, fever and tenderness. On 24th April 2018, the patient experienced submandibular mass, headache and muscle pain. On 26th April 2018, the patient experienced loose bowel. On an unknown date, the outcome of the injection site pain and tenderness were unknown and the outcome of the submandibular mass, loose bowel and fever were not recovered/not resolved and the outcome of the headache and muscle pain were recovering/resolving. It was unknown if the reporter considered the injection site pain and tenderness to be related to SHINGRIX. The reporter considered the submandibular mass, headache, muscle pain, loose bowel and fever to be almost certainly related to SHINGRIX. Additional details were provided as follows: On 24th April 2018, in the noon the patient received SHINGRIX in the left deltoid and in the evening (several hours later), the patient experienced submandibular mass, headache and muscle ache. Two days after vaccination, the patient experienced loose bowels.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Tenderness
Clinical narrative: This case was reported by a physician and described the occurrence of injection site pain in a 66-year-old male patient who received SHINGRIX. Concomitant products included FLOMAX, Aspirin and SYNTHROID. On 24th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, fever and tenderness. On 24th April 2018, the patient experienced submandibular mass, headache and muscle pain. On 26th April 2018, the patient experienced loose bowel. On an unknown date, the outcome of the injection site pain and tenderness were unknown and the outcome of the submandibular mass, loose bowel and fever were not recovered/not resolved and the outcome of the headache and muscle pain were recovering/resolving. It was unknown if the reporter considered the injection site pain and tenderness to be related to SHINGRIX. The reporter considered the submandibular mass, headache, muscle pain, loose bowel and fever to be almost certainly related to SHINGRIX. Additional details were provided as follows: On 24th April 2018, in the noon the patient received SHINGRIX in the left deltoid and in the evening (several hours later), the patient experienced submandibular mass, headache and muscle ache. Two days after vaccination, the patient experienced loose bowels.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain, Pollakiuria, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a 53-year-old female patient who received SHINGRIX. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, 6 hrs after receiving SHINGRIX, the patient experienced fever, urinary frequency, nausea, vomiting, chills and general body pain. On an unknown date, the outcome of the fever, urinary frequency, nausea, vomiting, chills and general body pain were recovered/resolved. It was unknown if the reporter considered the fever, urinary frequency, nausea, vomiting, chills and general body pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced body aches. Limited information was provided by the sales representative from the physician.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a 53-year-old female patient who received SHINGRIX. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, 6 hrs after receiving SHINGRIX, the patient experienced fever, urinary frequency, nausea, vomiting, chills and general body pain. On an unknown date, the outcome of the fever, urinary frequency, nausea, vomiting, chills and general body pain were recovered/resolved. It was unknown if the reporter considered the fever, urinary frequency, nausea, vomiting, chills and general body pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced body aches. Limited information was provided by the sales representative from the physician.
Sex: U
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ear noises in a adult patient who received SHINGRIX. On 18th April 2018, the patient received the 1st dose of SHINGRIX. On 23rd April 2018, 5 days after receiving SHINGRIX, the patient experienced ear noises. On an unknown date, the outcome of the ear noises was unknown. It was unknown if the reporter considered the ear noises to be related to SHINGRIX. Additional details were provided as follows; On Monday, the patient had a sudden onset of a high pitched squeaking in ears. It lasted 3 or 4 hours and subsided. On Tuesday, when the patient woke up it was back and did not subside until 4 or 5 PM. On the day of reporting, (Wednesday), the patient felt fine and the patient's blood pressure was unchanged. The patient went for a hearing test on the day of reporting and hearing had little or no changes since last exam 2 years. It was asked if the patient had a change or addition to the medications the patient took and the SHINGRIX was the only medicine. The patient had researched the side effects and did not find any reports of tinnitus and was curious to see if others had reported anything like this. The patient had an appointment with medical doctor on Thursday, 3rd May 2018. That was the first available appointment. The patient was thankful for the opportunity to contact.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in an unspecified number of adult patients who received SHINGRIX. 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 injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The reporter stated that there are some patients that were not willing to return for their second dose of SHINGRIX because of the pain at injection site following the initial dose. The reporter wanted to know efficacy of single dose. The reporter declined to provide any additional information on the adverse event stating that this was a question from his manager. He was not open to follow-up or direct contact with his manager, he suggested that he would provide his business card and would communicate to his manager on request for follow-up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Malaise
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fatigue extreme in a 55-year-old female patient who received SHINGRIX. Previously administered products included SHINGRIX with an associated reaction of chills (For tolerance to 1st dose, refer to case US2018GSK077927). In April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a month after receiving SHINGRIX, the patient experienced fatigue extreme, chills and malaise. In April 2018, the outcome of the fatigue extreme, chills and malaise were recovered/resolved. It was unknown if the reporter considered the fatigue, extreme, chills and malaise to be related to SHINGRIX. Additional details were provided as follows: The patient experienced more extreme fatigue, chills and malaise after 2nd dose compare to 1st dose, the events lasted for 2 to 3 days.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pain
Clinical narrative: Mom noticed next morning arm around injection was red and warm to the touch. Under injection site was hard. Patient complained of pain. Took TYLENOL for pain and applied ice packs. Mom states on 5-4-18 getting better.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Myalgia, Nausea, Skin odour abnormal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of muscle pain in a 55-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020). Previously administered products included SHINGRIX (1st dose received on 29th January 2018 with muscle ache, chills and shakes. (This case is linked with US2018071935)). On 23rd April 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In April 2018, 1 day 4 hrs after receiving SHINGRIX, the patient experienced nausea. On 23rd April 2018, the patient experienced muscle pain, sweating, body odor, chills and tremor. In April 2018, the outcome of the sweating, body odor, chills and tremor were recovered/resolved. On an unknown date, the outcome of the muscle pain and nausea were recovering/resolving. The reporter considered the muscle pain, nausea, sweating, body odor, chills and tremor to be related to SHINGRIX. Additional information was received as follows: Concomitant medication included Vitamins. The patient experienced muscle ache, chills and shakes as she did with the first dose of SHINGRIX. After vaccination with SHINGRIX, the patient experienced tremors after 10 hours, sweating and skin odour after 12 hours. The patient could not explain what the body odor smelt like other than it was a strange odor coming from her entire body. The patient had to take a shower to get rid of the odor. The other side effects from vaccination day seemed to resolve themselves like when a fever breaks. The nausea and muscle ache was getting better at the day of reporting. The physician reported that the patient was in good health and had no health problems.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of muscle pain in a 55-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020). Previously administered products included SHINGRIX (1st dose received on 29th January 2018 with muscle ache, chills and shakes. (This case is linked with US2018071935)). On 23rd April 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In April 2018, 1 day 4 hrs after receiving SHINGRIX, the patient experienced nausea. On 23rd April 2018, the patient experienced muscle pain, sweating, body odor, chills and tremor. In April 2018, the outcome of the sweating, body odor, chills and tremor were recovered/resolved. On an unknown date, the outcome of the muscle pain and nausea were recovering/resolving. The reporter considered the muscle pain, nausea, sweating, body odor, chills and tremor to be related to SHINGRIX. Additional information was received as follows: Concomitant medication included Vitamins. The patient experienced muscle ache, chills and shakes as she did with the first dose of SHINGRIX. After vaccination with SHINGRIX, the patient experienced tremors after 10 hours, sweating and skin odour after 12 hours. The patient could not explain what the body odor smelt like other than it was a strange odor coming from her entire body. The patient had to take a shower to get rid of the odor. The other side effects from vaccination day seemed to resolve themselves like when a fever breaks. The nausea and muscle ache was getting better at the day of reporting. The physician reported that the patient was in good health and had no health problems.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Gait inability, Hypersensitivity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fatigue in a 61-year-old male patient who received SHINGRIX. Co-suspect products included SHINGRIX. On 28th March 2018, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On 28th March 2018, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On 29th March 2018, the patient experienced fatigue, unable to walk, weakness, allergic reaction and joint pain. On an unknown date, the outcome of the fatigue, unable to walk, weakness, allergic reaction, joint pain, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the fatigue, unable to walk, weakness, allergic reaction and joint pain to be related to SHINGRIX. Additional details were provided as follows: On 29th March 2018 the administering health care professional did not understand that the elastic tags on both vials meant they needed to be reconstituted together, but thought since there were 2 vials that this was 2 doses of the vaccine. The health care professional only administered the adjuvant, which led to inappropriate preparation of medication, inappropriate dose of vaccine administered and vaccination error. After discovering that only adjuvant was administered they caught the patient in the parking lot and ask the patient to come back in when they administered appropriately reconstituted vaccine. The patient woke up the next day and went to work. He became so weak that he could not walk so a co-worker had to put him in his car. The patient did not complain of shortness breath. The patient reported severe joint aches and fatigue. The patient was taken to the emergency room where he was diagnosed with an allergic reaction, but the reporter listed above did not agree with this diagnosis as she thought he just experienced severe systemic adverse events as listed in the prescribing information.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fatigue in a 61-year-old male patient who received SHINGRIX. Co-suspect products included SHINGRIX. On 28th March 2018, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On 28th March 2018, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On 29th March 2018, the patient experienced fatigue, unable to walk, weakness, allergic reaction and joint pain. On an unknown date, the outcome of the fatigue, unable to walk, weakness, allergic reaction, joint pain, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the fatigue, unable to walk, weakness, allergic reaction and joint pain to be related to SHINGRIX. Additional details were provided as follows: On 29th March 2018 the administering health care professional did not understand that the elastic tags on both vials meant they needed to be reconstituted together, but thought since there were 2 vials that this was 2 doses of the vaccine. The health care professional only administered the adjuvant, which led to inappropriate preparation of medication, inappropriate dose of vaccine administered and vaccination error. After discovering that only adjuvant was administered they caught the patient in the parking lot and ask the patient to come back in when they administered appropriately reconstituted vaccine. The patient woke up the next day and went to work. He became so weak that he could not walk so a co-worker had to put him in his car. The patient did not complain of shortness breath. The patient reported severe joint aches and fatigue. The patient was taken to the emergency room where he was diagnosed with an allergic reaction, but the reporter listed above did not agree with this diagnosis as she thought he just experienced severe systemic adverse events as listed in the prescribing information.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Feeling cold, Headache, Nasal congestion
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in a 70-year-old female patient who received SHINGRIX. On 20th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st April 2018, 1 days after receiving SHINGRIX, the patient experienced pain, coldness, fever, nasal stuffiness, headache, fatigue and feels poorly. On an unknown date, the outcome of the pain, coldness, fever, nasal stuffiness and headache were not recovered/not resolved and the outcome of the fatigue and feels poorly were unknown. It was unknown if the reporter considered the pain, coldness, fever, nasal stuffiness, headache, fatigue and feels poorly to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in the left deltoid. Only partial information was provided by the physician. The reporting physician stated that he had patient with possible side effects from the SHINGRIX vaccine going on for 5 day. The patient had symptoms of headache, achiness, fatigue, temperature to 99.8 and feels poorly. The physician has contacted the 2 different nurse and they did not call him back.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in a 70-year-old female patient who received SHINGRIX. On 20th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st April 2018, 1 days after receiving SHINGRIX, the patient experienced pain, coldness, fever, nasal stuffiness, headache, fatigue and feels poorly. On an unknown date, the outcome of the pain, coldness, fever, nasal stuffiness and headache were not recovered/not resolved and the outcome of the fatigue and feels poorly were unknown. It was unknown if the reporter considered the pain, coldness, fever, nasal stuffiness, headache, fatigue and feels poorly to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in the left deltoid. Only partial information was provided by the physician. The reporting physician stated that he had patient with possible side effects from the SHINGRIX vaccine going on for 5 day. The patient had symptoms of headache, achiness, fatigue, temperature to 99.8 and feels poorly. The physician has contacted the 2 different nurse and they did not call him back.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypokinesia, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of neck pain in a elderly female patient who received SHINGRIX. Previously administered products included ZOSTAVAX. On 29th March 2018, the patient received the 1st dose of SHINGRIX. On 30th March 2018, 1 days after receiving SHINGRIX, the patient experienced neck pain, stiff neck, headache and movements reduced. On an unknown date, the patient experienced pain in arm. The patient was treated with meloxicam. On an unknown date, the outcome of the neck pain, stiff neck and movements reduced were recovering/resolving and the outcome of the pain in arm was recovered/resolved and the outcome of the headache was unknown. The reporter considered the neck pain, stiff neck, pain in arm, headache and movements reduced to be almost certainly related to SHINGRIX. Additional details were provided as follows: This case was previously reported to physician. The age at vaccination was not reported, but the patient was over age 70. The caller called response center to ask if the side effect she experienced with SHINGRIX were normal. The patient refused to give her address or even zip code. She did give an email address but stated she only wanted to received the SHINGRIX Pl no other emails. The patient refuse to gave date of birth or actual age. She states that she did not received any other vaccines on March 29th or within 4 weeks before. She refused to list names of concomitant medications. She had the SHINGRIX injection at a pharmacy. The next day after vaccination the patient had really severe neck pain, super bad stiff neck, from left to right. It was bad pain traveling from my neck into my head. The patient couldn't move neck, had a stiff neck and headache up toward ear and toward the back of jaw. The patient did not have a fever. The patient went to orthopedic doctor and was given meloxicam. It was not yet resolved. When asking her where the injection was given she said on her left arm near her shoulder (deltoid muscle). She then mentioned that her arm was painful less than a month after injection for a couple of days but that this was resolved. The patient had denied permission to contact their physician.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Headache, Nausea, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tremor in a 71-year-old female patient who received SHINGRIX. Concurrent medical conditions included glaucoma, osteoporosis and heart rate decreased (slow heartbeat). Concomitant products included RESTASIS, carvedilol, KADIAN, LIPITOR, PROLIA, omeprazole, SINGULAIR; LASTACAFT, MOBIC, RANEXA and TRAVATAN Z. On 18th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced feeling bad. On 18th April 2018, the patient experienced tremor, feeling queasy, headache and tiredness. On 19th April 2018, the patient experienced pain in arm, fever and swelling arm. The patient was treated with TYLENOL. In April 2018, the outcome of the tremor, feeling queasy, pain in arm, fever, swelling arm, headache and tiredness were recovered/resolved. On 23rd April 2018, the outcome of the feeling bad was recovered/resolved. The reporter considered the tremor, feeling queasy, pain in arm, fever, swelling arm, headache and tiredness to be related to SHINGRIX. It was unknown if the reporter considered the feeling bad to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient herself. The patient received SHINGRIX on the right arm. An hour after receiving SHINGRIX, the patient experienced shaking, headache, felt queasy and tired. The next day after receiving SHINGRIX, the patient had a fever (body temperature 99.9 degree F), and noted her arm was swollen and sore. She felt bad until 23rd April 2018, Monday and that all events were resolved. The patient considered to call an ambulance, but did not do so. The patient was unable to provide the lot number or expiry date or the name of the pharmacist who administered the SHINGRIX vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tremor in a 71-year-old female patient who received SHINGRIX. Concurrent medical conditions included glaucoma, osteoporosis and heart rate decreased (slow heartbeat). Concomitant products included RESTASIS, carvedilol, KADIAN, LIPITOR, PROLIA, omeprazole, SINGULAIR; LASTACAFT, MOBIC, RANEXA and TRAVATAN Z. On 18th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced feeling bad. On 18th April 2018, the patient experienced tremor, feeling queasy, headache and tiredness. On 19th April 2018, the patient experienced pain in arm, fever and swelling arm. The patient was treated with TYLENOL. In April 2018, the outcome of the tremor, feeling queasy, pain in arm, fever, swelling arm, headache and tiredness were recovered/resolved. On 23rd April 2018, the outcome of the feeling bad was recovered/resolved. The reporter considered the tremor, feeling queasy, pain in arm, fever, swelling arm, headache and tiredness to be related to SHINGRIX. It was unknown if the reporter considered the feeling bad to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient herself. The patient received SHINGRIX on the right arm. An hour after receiving SHINGRIX, the patient experienced shaking, headache, felt queasy and tired. The next day after receiving SHINGRIX, the patient had a fever (body temperature 99.9 degree F), and noted her arm was swollen and sore. She felt bad until 23rd April 2018, Monday and that all events were resolved. The patient considered to call an ambulance, but did not do so. The patient was unable to provide the lot number or expiry date or the name of the pharmacist who administered the SHINGRIX vaccine.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pain, Tremor
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of generalised muscle aches in a 55-year-old female patient who received SHINGRIX (batch number T5242, expiry date 31st March 2020). On 29th January 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 29th January 2018, 4 hrs after receiving SHINGRIX, the patient experienced generalised muscle aches, chills, tremor and general body pain. On 29th January 2018, the outcome of the generalised muscle aches, chills, tremor and general body pain were recovered/resolved. The reporter considered the generalised muscle aches, chills, tremor and general body pain to be related to SHINGRIX. Additional information was received as follows: Concomitant medication included Vitamins. The physician reported that the patient experienced a side effect such as body ache, shakes and chills after a dose of SHINGRIX. Less than a year after receiving SHINGRIX, the patient experienced tremor. The events did resolve but the patient did not provide how long it took for them to subside. This case was linked with case US2018GSK077833, reported by the same reporter.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: 81/2 x 10 cm red, warm swollen, firm, and very tender area on Left thigh around the injection site. Tender to touch and hurts to walk. No fever, but felt "hot" the first day after vaccine. Slightly better today.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site warmth, Pain
Clinical narrative: 81/2 x 10 cm red, warm swollen, firm, and very tender area on Left thigh around the injection site. Tender to touch and hurts to walk. No fever, but felt "hot" the first day after vaccine. Slightly better today.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, 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 erythema in a elderly female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by pharmacist. A female patient over 70 years of age experienced redness at the injection site. The redness was described as about 6 inches across. The patient also experienced pain at the injection site and swelling. The patient denied permission to contact their physician. The pharmacist did not wish to proceed with a safety report.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 73-year-old female patient who received SHINGRIX. Concurrent medical conditions included hypothyroidism (Diagnosed prior to receiving SHINGRIX) and atrial fibrillation (Diagnosed prior to receiving SHINGRIX). Concomitant products included Calcium, Diltiazem, famotidine, iron, Levothyroxine, Vit B Complex and vitamin D. On 23rd April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, several hours after receiving SHINGRIX, the patient experienced sweating. On 23rd April 2018, the patient experienced chills. On 24th April 2018, the patient experienced headache and fever. On an unknown date, the outcome of the chills was recovering/resolving and the outcome of the headache and fever were not recovered/not resolved and the outcome of the sweating was recovered/resolved. The reporter considered the chills, headache, sweating and fever to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At 4 pm, the patient received the vaccine SHINGRIX vaccine. By 8 pm, 4 hours after receiving SHINGRIX, the patient experienced chills. The patient was perspiring throughout the night. 1 day after receiving SHINGRIX, the patient woke up this morning and experienced a low grade fever and headache. The patient asked whether she should receive her 2nd vaccine since she had these symptoms. The reporter referenced the patient information to provide adverse reaction information, and suggested that she follow up with her doctor to make him aware of her symptoms and regarding her inquiry.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: Redness in injection site, severe Headache and side of face, Upset stomach, Severe right eye pain, development of rash in forehead, scabs in scalp, severe swollen eye. Development into shingles. Still ongoing.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal discomfort, Eye pain, Eye swelling, Facial pain, Headache
Clinical narrative: Redness in injection site, severe Headache and side of face, Upset stomach, Severe right eye pain, development of rash in forehead, scabs in scalp, severe swollen eye. Development into shingles. Still ongoing.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Ophthalmic herpes zoster, Rash, Scab
Clinical narrative: Redness in injection site, severe Headache and side of face, Upset stomach, Severe right eye pain, development of rash in forehead, scabs in scalp, severe swollen eye. Development into shingles. Still ongoing.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Decreased appetite, Headache, Herpes zoster, Ophthalmic herpes zoster, Somnolence
Clinical narrative: Redness in injection site, severe Headache and side of face, Upset stomach, Severe right eye pain, development of rash in forehead, scabs in scalp, severe swollen eye. Development into shingles. Still ongoing.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HEP, RV1
Symptoms: Pyrexia
Clinical narrative: Severe fever 103.3 degrees F.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness from injection site, down left arm, warm to touch and slightly swollen. Advised ibuprofen and ice.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Ecchymosis, Erythema, Skin warm, Swelling
Clinical narrative: Moderate ecchymosis with swelling within hours developing into bright redness and warmth within 1-2 days; redness and warmth continued to spread until date of evaluation by this provider 05/05/2018.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: She experienced body aches and a fever of 101. Flu like symptoms.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Local adverse reaction in upper right arm. Reaction happened the same day as injection. Bruising, swelling, hot to the touch, and very sore to the touch. Getting better everyday after initial reaction.
Age: 0.92
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Pt had a fever and a rash resembling measles.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin reaction, Skin warm, Tenderness
Clinical narrative: Patient stopped by pharmacy 3 days later to show localized skin reaction. She said it was slightly painful to the touch and a little warm but it was not bothering her. She has no systemic reaction and did not feel she needed to seek medical attention, but wanted to show the reaction. She does plan to follow up and get 2nd dose in 2 months.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Headache, Malaise
Clinical narrative: This was the #1 dose of the SHINGRIX vaccine for Shingles, administered by the RN at Community Internal Medicine. The shot was given to me at apx 12:30pm. I felt fine and no pain until apx 7pm when my left arm was noticeably sore (no other symptoms.) I woke up in the middle of the night, about 1:00 not feeling well (cold, achy). At apx 4:00am, I began having chills, was sore and had a headache. (My husband got winter PJs for me to wear and I used a blanket, duvet, and the bread spread on top of me to get warm.) I stayed in bed until about 8:00am when the chills had lessened somewhat and took and NSAID-Meloxicam hoping it would help my headache, slight fever, and aching. (When I took my temperature it was just over 99; my normal body temperature is 97.6.).  The following is my complete list of symptoms as of 8:00am this morning: Arm soreness, Chills, Aches, Low grade fever, Headache, Slight nausea, Fatigue.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: This was the #1 dose of the SHINGRIX vaccine for Shingles, administered by the RN at Community Internal Medicine. The shot was given to me at apx 12:30pm. I felt fine and no pain until apx 7pm when my left arm was noticeably sore (no other symptoms.) I woke up in the middle of the night, about 1:00 not feeling well (cold, achy). At apx 4:00am, I began having chills, was sore and had a headache. (My husband got winter PJs for me to wear and I used a blanket, duvet, and the bread spread on top of me to get warm.) I stayed in bed until about 8:00am when the chills had lessened somewhat and took and NSAID-Meloxicam hoping it would help my headache, slight fever, and aching. (When I took my temperature it was just over 99; my normal body temperature is 97.6.).  The following is my complete list of symptoms as of 8:00am this morning: Arm soreness, Chills, Aches, Low grade fever, Headache, Slight nausea, Fatigue.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Feeling abnormal, Hyperhidrosis, Influenza like illness
Clinical narrative: Within an hour my back started hurting, when I got home from work my legs were aching like they needed to be stretched or massaged, the next morning I was sore all over, went to work very tired- no amount of coffee helped, back hurting, legs hurting, bone tired. Left work at 4pm and went right home to bed with 99.8 fever, sweats, pain like the flu. Woke up this morning and my legs don't hurt, no fever-back still hurts and still not feeling quite right- but so much better.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Within an hour my back started hurting, when I got home from work my legs were aching like they needed to be stretched or massaged, the next morning I was sore all over, went to work very tired- no amount of coffee helped, back hurting, legs hurting, bone tired. Left work at 4pm and went right home to bed with 99.8 fever, sweats, pain like the flu. Woke up this morning and my legs don't hurt, no fever-back still hurts and still not feeling quite right- but so much better.
Age: 54.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Patient's left arm experienced redness, swelling, tenderness, and a softball-sized knot near the injection site
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Alanine aminotransferase increased, Arthralgia, Aspartate aminotransferase increased, Chills, Culture urine
Clinical narrative: 33 weeks 3 days pregnant at time of administration and on day of start of adverse event. Developed high fever to 102.8F, chills, arthralgias, nausea. Now admitted with pancytopenia, elevated liver enzymes, ongoing fever requiring supportive care.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Hepatic enzyme increased, Nausea, Pancytopenia, Platelet count decreased, Pregnancy
Clinical narrative: 33 weeks 3 days pregnant at time of administration and on day of start of adverse event. Developed high fever to 102.8F, chills, arthralgias, nausea. Now admitted with pancytopenia, elevated liver enzymes, ongoing fever requiring supportive care.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Urine analysis, White blood cell disorder
Clinical narrative: 33 weeks 3 days pregnant at time of administration and on day of start of adverse event. Developed high fever to 102.8F, chills, arthralgias, nausea. Now admitted with pancytopenia, elevated liver enzymes, ongoing fever requiring supportive care.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed shingles.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: RED BUMPS AND SWELLING AT INJECTION SITE.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: REDNESS, INFLAMMATION, WARMTH AT THE SITE OF INJECTION, NOT ABLE TO LIFT UP THE ARM SYMPTOMS STARTED GETTING BETTER ON DAY 2.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Fatigue, Headache, Induration
Clinical narrative: Horrible headache, body ache and pain (like a bad case of the flu) weakness, fatigue arm swelled with hard lumps, bumps, redness, hot and itching.  The headaches continued until 5/4 with fatigue. Right arm continued to be swollen, hard, lumpy and itching until today 5/5/18. There are still some places on arm still hard. Redness is lighter but still visible.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Limb mass, Pain, Peripheral swelling, Pruritus
Clinical narrative: Horrible headache, body ache and pain (like a bad case of the flu) weakness, fatigue arm swelled with hard lumps, bumps, redness, hot and itching.  The headaches continued until 5/4 with fatigue. Right arm continued to be swollen, hard, lumpy and itching until today 5/5/18. There are still some places on arm still hard. Redness is lighter but still visible.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Horrible headache, body ache and pain (like a bad case of the flu) weakness, fatigue arm swelled with hard lumps, bumps, redness, hot and itching.  The headaches continued until 5/4 with fatigue. Right arm continued to be swollen, hard, lumpy and itching until today 5/5/18. There are still some places on arm still hard. Redness is lighter but still visible.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Influenza like illness, Myalgia, Pain
Clinical narrative: Flu like muscle pain, headaches, soreness, weakness for 2 plus days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles reactivation left face.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: The day after vaccination the patient noticed quarter sized red dots on the right side of back and down the right leg. The spots are somewhat itchy but are not painful.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Injection site urticaria, Urticaria
Clinical narrative: Hives at injection site and down the left torso, joints aching, weakness, fatigue.