chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 71-year-old male patient who received SHINGRIX. On 18th April 2018, the patient received SHINGRIX (intramuscular). In April 2018, 7 days after receiving SHINGRIX, the patient experienced fever, dizziness and bedridden. On an unknown date, the outcome of the fever, dizziness and bedridden were unknown. It was unknown if the reporter considered the fever, dizziness and bedridden to be related to SHINGRIX. Additional information was reported as follows: In April 2018, 1 week after vaccination with SHINGRIX the patient experienced reaction like fever, could not get out of bed, dizzy. The healthcare professional had not provided any further information.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Bedridden, Dizziness, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 71-year-old male patient who received SHINGRIX. On 18th April 2018, the patient received SHINGRIX (intramuscular). In April 2018, 7 days after receiving SHINGRIX, the patient experienced fever, dizziness and bedridden. On an unknown date, the outcome of the fever, dizziness and bedridden were unknown. It was unknown if the reporter considered the fever, dizziness and bedridden to be related to SHINGRIX. Additional information was reported as follows: In April 2018, 1 week after vaccination with SHINGRIX the patient experienced reaction like fever, could not get out of bed, dizzy. The healthcare professional had not provided any further information.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site discomfort, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX. Concomitant products included WELLBUTRIN and Atorvastatin. On 26th April 2018 10:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced muscle soreness. On 26th April 2018, the patient experienced injection site erythema, injection site discomfort, injection site itching and pain in arm. On 27th April 2018, the patient experienced fever, chills, fatigue and injection site burning. In April 2018, the outcome of the fever, chills and fatigue were recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site discomfort, injection site itching, pain in arm and muscle soreness were recovering/resolving and the outcome of the injection site burning was unknown. The reporter considered the injection site erythema, injection site discomfort, injection site itching, fever, chills, fatigue, injection site burning, pain in arm and muscle soreness to be related to SHINGRIX. Additional details were provided as follows: The nurse reported that she received SHINGRIX and she started getting redness, discomfort and itching at the injection site that day. The next day the patient had a low grade fever, shivering, chills and fatigue and the injection site had a big red reaction, about 4 inches by 2 inches, that was very tender to the touch. Her arm was also sore, but she could do what she needed to do. The fever and fatigue would have kept her from work on Friday (27th April 2018), if she was working. At the time of reporting, she had burning, itching and redness at the injection site and her muscles were sore. The patient stated she was only 98 pounds.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX. Concomitant products included WELLBUTRIN and Atorvastatin. On 26th April 2018 10:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced muscle soreness. On 26th April 2018, the patient experienced injection site erythema, injection site discomfort, injection site itching and pain in arm. On 27th April 2018, the patient experienced fever, chills, fatigue and injection site burning. In April 2018, the outcome of the fever, chills and fatigue were recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site discomfort, injection site itching, pain in arm and muscle soreness were recovering/resolving and the outcome of the injection site burning was unknown. The reporter considered the injection site erythema, injection site discomfort, injection site itching, fever, chills, fatigue, injection site burning, pain in arm and muscle soreness to be related to SHINGRIX. Additional details were provided as follows: The nurse reported that she received SHINGRIX and she started getting redness, discomfort and itching at the injection site that day. The next day the patient had a low grade fever, shivering, chills and fatigue and the injection site had a big red reaction, about 4 inches by 2 inches, that was very tender to the touch. Her arm was also sore, but she could do what she needed to do. The fever and fatigue would have kept her from work on Friday (27th April 2018), if she was working. At the time of reporting, she had burning, itching and redness at the injection site and her muscles were sore. The patient stated she was only 98 pounds.
Sex: U
Vaccine: VARZOS
Symptoms: Dysaesthesia, Pain, Purpura
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of dysesthesia in a adult 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 dysesthesia, purpura and pain. On an unknown date, the outcome of the dysesthesia, purpura and pain were unknown. It was unknown if the reporter considered the dysesthesia, purpura and pain to be related to SHINGRIX. Additional information was received as follows: The physician reported that the patient was seen today another physician and he diagnosed with purpuric, painful and dysesthesia. The reporter would like to know if the patient's physician needs to fill out a form documenting reaction regarding SHINGRIX. The reporter didn't received any information when he reached to reporter additional information.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a71-year-old female patient who received SHINGRIX. Concomitant products included LIPITOR. On 1st may 2018, the patient received SHINGRIX. On 1st May 2018, several hours after receiving SHINGRIX, the patient experienced headache, muscle pain and chills. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the muscle pain and chills were unknown. The reporter considered the headache, muscle pain and chills to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the morning. On the same day, the patient started to experience adverse events in the evening. The patient denied permission to contact their physician. Some questions were not asked because someone came at the door during the call, and the patient ended the call.
Sex: M
Vaccine: VARZOS
Symptoms: Joint swelling, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a elderly male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 24th April 2018, the patient received SHINGRIX (intramuscular). On 27th April 2018, 3 days after receiving SHINGRIX, the patient experienced rash and swelling of knees. On an unknown date, the outcome of the rash and swelling of knees were unknown. The reporter considered the rash and swelling of knees to be almost certainly related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received the vaccine on the left arm. The patient experienced rash on both arms and on the scalp along with swollen knee.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Limb injury, Neck pain, Pain
Clinical narrative: 5/2/2018 Visit with FNP-Pt. states that she didn't notice any initial symptoms outside of the customary soreness that she normally has with vaccination to her arms. Three to four days after the injection she began to have an increase in her left shoulder pain that has led to inability to move the arm related to pain. Denies radiation down her arm but states that when attempting lift her left arm she will get a 'sting' that travels up her left neck. She has taken 800 mg ibuprofen every 6-8 hours for the past 3-4 days without good relief. She is also using moist heat packs to her shoulder. Pt. with TTP over lateral aspect of left deltoid with mild swelling. No noted erythema or drainage. Pain to left shoulder with active and passive abduction and with extension of the left shoulder posteriorly. No spinal or trapezius TTP. Pt. will continue resting shoulder and applying moist heat. Can alternate TYLENOL and Ibuprofen. Should use TYLENOL as main stay while taking Prednisone 50 mg tabs - take one tablet x7 days. RTC 1 week to see Dr. 5/9/2018-Visit with MD-Pt states "no change". Left Shoulder Exam: Visual Inspection: No swelling, no ecchymosis, no erythema, no deformity. Palpation: No warmth, no acromioclavicular tenderness or step-off, no sternoclavicular joint tenderness, no subacromial space tenderness. Small pinpoint of pain over old injection side below the ACJ laterally directly. Range of Motion: Does not have flexion and abduction past 90 without severe pain either passively or actively. Negative scarf sign and empty can test. No pain under axilla and no lymph nodes palpated. Pain is severe if passively goes above 90. Seems to favor the shoulder as well. Strength: Difficult for assessment due to pain. Special Tests: No pain with Hawkins test (impingement), no pain with Cross-Body Adduction test and negative Apprehension/Relocation test (shoulder instability). Shoulder injury related to vaccine administration SIRVA-PPT from Oct 2017 on CDC website found. Reviewed injury and history on site and fits with the description of about 1000 reported VAERS from 2010-16. Ice packs to shoulder for 20-30 minutes every 3-4 hours for 2-3 days or as needed. Anti-inflammatory medications, taken with food, as directed. PT appointment for other modalities. Will continue to ice and do ROM exercises as well. Will report to VAERS.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Vaccination complication
Clinical narrative: 5/2/2018 Visit with FNP-Pt. states that she didn't notice any initial symptoms outside of the customary soreness that she normally has with vaccination to her arms. Three to four days after the injection she began to have an increase in her left shoulder pain that has led to inability to move the arm related to pain. Denies radiation down her arm but states that when attempting lift her left arm she will get a 'sting' that travels up her left neck. She has taken 800 mg ibuprofen every 6-8 hours for the past 3-4 days without good relief. She is also using moist heat packs to her shoulder. Pt. with TTP over lateral aspect of left deltoid with mild swelling. No noted erythema or drainage. Pain to left shoulder with active and passive abduction and with extension of the left shoulder posteriorly. No spinal or trapezius TTP. Pt. will continue resting shoulder and applying moist heat. Can alternate TYLENOL and Ibuprofen. Should use TYLENOL as main stay while taking Prednisone 50 mg tabs - take one tablet x7 days. RTC 1 week to see Dr. 5/9/2018-Visit with MD-Pt states "no change". Left Shoulder Exam: Visual Inspection: No swelling, no ecchymosis, no erythema, no deformity. Palpation: No warmth, no acromioclavicular tenderness or step-off, no sternoclavicular joint tenderness, no subacromial space tenderness. Small pinpoint of pain over old injection side below the ACJ laterally directly. Range of Motion: Does not have flexion and abduction past 90 without severe pain either passively or actively. Negative scarf sign and empty can test. No pain under axilla and no lymph nodes palpated. Pain is severe if passively goes above 90. Seems to favor the shoulder as well. Strength: Difficult for assessment due to pain. Special Tests: No pain with Hawkins test (impingement), no pain with Cross-Body Adduction test and negative Apprehension/Relocation test (shoulder instability). Shoulder injury related to vaccine administration SIRVA-PPT from Oct 2017 on CDC website found. Reviewed injury and history on site and fits with the description of about 1000 reported VAERS from 2010-16. Ice packs to shoulder for 20-30 minutes every 3-4 hours for 2-3 days or as needed. Anti-inflammatory medications, taken with food, as directed. PT appointment for other modalities. Will continue to ice and do ROM exercises as well. Will report to VAERS.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site bruising
Clinical narrative: Left thigh bruise after vaccines. Rx: supportive care.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Tenderness
Clinical narrative: Tender arm with large pinkish area (31cm x 22cm) around injection site and warm for 2 days.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: (R) dorsal thigh w/baseball sized area of erythema, warmth, mild tenderness and bruising; mild itching at times, developed 24 hours after vaccine, advised Ibuprofen, cool compress and BENADRYL.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 74-year-old male patient who received SHINGRIX. Concomitant products included TENORETIC and ZOCOR. On 19th April 11:30, the patient received the 1st dose of SHINGRIX. On 19th April 2018, several hours after receiving SHINGRIX, the patient experienced headache, muscle cramp, generalized muscle aches, weakness, tiredness, occipital neuralgia, lightheadedness, fever, chills, insomnia and nausea. On 24th April 2018, the outcome of the insomnia was recovered/resolved. On 25th April 2018, the outcome of the weakness, tiredness, occipital neuralgia, lightheadedness, fever, chills and nausea were recovered/resolved. On 26th April 2018, the outcome of the headache, muscle cramp and generalized muscle aches were recovered/resolved. The reporter considered the headache, muscle cramp, generalized muscle aches, weakness, tiredness, occipital neuralgia, lightheadedness, fever, chills, insomnia and nausea to be almost certainly related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The patient reported that after receiving SHINGRIX, the patient could not sleep, and the reason he could not sleep was because of the symptoms he was experiencing such as the leg cramps. The patient experienced muscle aches or muscle cramps, whole body especially in legs and lower back stated that legs were killing him and neuralgia of eyes- little bit. The patient stated that the doctor was aware that he got the SHINGRIX shot but was not aware that he experienced side effects. The pharmacy was aware that this patient experienced side effects.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Muscle spasms, Myalgia, Nausea, Occipital neuralgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 74-year-old male patient who received SHINGRIX. Concomitant products included TENORETIC and ZOCOR. On 19th April 11:30, the patient received the 1st dose of SHINGRIX. On 19th April 2018, several hours after receiving SHINGRIX, the patient experienced headache, muscle cramp, generalized muscle aches, weakness, tiredness, occipital neuralgia, lightheadedness, fever, chills, insomnia and nausea. On 24th April 2018, the outcome of the insomnia was recovered/resolved. On 25th April 2018, the outcome of the weakness, tiredness, occipital neuralgia, lightheadedness, fever, chills and nausea were recovered/resolved. On 26th April 2018, the outcome of the headache, muscle cramp and generalized muscle aches were recovered/resolved. The reporter considered the headache, muscle cramp, generalized muscle aches, weakness, tiredness, occipital neuralgia, lightheadedness, fever, chills, insomnia and nausea to be almost certainly related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The patient reported that after receiving SHINGRIX, the patient could not sleep, and the reason he could not sleep was because of the symptoms he was experiencing such as the leg cramps. The patient experienced muscle aches or muscle cramps, whole body especially in legs and lower back stated that legs were killing him and neuralgia of eyes- little bit. The patient stated that the doctor was aware that he got the SHINGRIX shot but was not aware that he experienced side effects. The pharmacy was aware that this patient experienced side effects.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 74-year-old male patient who received SHINGRIX. Concomitant products included TENORETIC and ZOCOR. On 19th April 11:30, the patient received the 1st dose of SHINGRIX. On 19th April 2018, several hours after receiving SHINGRIX, the patient experienced headache, muscle cramp, generalized muscle aches, weakness, tiredness, occipital neuralgia, lightheadedness, fever, chills, insomnia and nausea. On 24th April 2018, the outcome of the insomnia was recovered/resolved. On 25th April 2018, the outcome of the weakness, tiredness, occipital neuralgia, lightheadedness, fever, chills and nausea were recovered/resolved. On 26th April 2018, the outcome of the headache, muscle cramp and generalized muscle aches were recovered/resolved. The reporter considered the headache, muscle cramp, generalized muscle aches, weakness, tiredness, occipital neuralgia, lightheadedness, fever, chills, insomnia and nausea to be almost certainly related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The patient reported that after receiving SHINGRIX, the patient could not sleep, and the reason he could not sleep was because of the symptoms he was experiencing such as the leg cramps. The patient experienced muscle aches or muscle cramps, whole body especially in legs and lower back stated that legs were killing him and neuralgia of eyes- little bit. The patient stated that the doctor was aware that he got the SHINGRIX shot but was not aware that he experienced side effects. The pharmacy was aware that this patient experienced side effects.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Dry skin, Injection site bruising, 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 65-year-old male patient who received SHINGRIX. Previously administered products included ZOSTAVAX (received in 2016). On 14th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. In April 2018, the patient experienced injection site erythema, pimples, skin scaly, pruritus, skin irritation and injection site bruising. The patient was treated with dermatologicals nos (Lotion (Nos)). On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site erythema,pimples, skin scaly, pruritus, skin irritation and injection site bruising were unknown. The reporter considered the injection site pain, injection site erythema, pimples, skin scaly, pruritus, skin irritation and injection site bruising to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient reported soreness at site the on the day of the injection and then 48 hours later redness, bruising at the site, tiny pimple like bumps, rough over his arm and forearm. The patient was using lotion and ice and the issue resolved toward the end of the week, but this past Wednesday the same issue returned to the left upper arm and forearm of the tiny, raised bumps and itching. In April 2018, less than a month after receiving SHINGRIX, the patient experienced pruritus. The patient stated that it was not that bad and was not as initially or worse, but was encouraged to report it to GlaxoSmithKline by the pharmacist. He preferred to receive the authorization form. This case has been linked with case US2018075823, reported by same reporter.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Skin irritation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old male patient who received SHINGRIX. Previously administered products included ZOSTAVAX (received in 2016). On 14th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. In April 2018, the patient experienced injection site erythema, pimples, skin scaly, pruritus, skin irritation and injection site bruising. The patient was treated with dermatologicals nos (Lotion (Nos)). On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site erythema,pimples, skin scaly, pruritus, skin irritation and injection site bruising were unknown. The reporter considered the injection site pain, injection site erythema, pimples, skin scaly, pruritus, skin irritation and injection site bruising to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient reported soreness at site the on the day of the injection and then 48 hours later redness, bruising at the site, tiny pimple like bumps, rough over his arm and forearm. The patient was using lotion and ice and the issue resolved toward the end of the week, but this past Wednesday the same issue returned to the left upper arm and forearm of the tiny, raised bumps and itching. In April 2018, less than a month after receiving SHINGRIX, the patient experienced pruritus. The patient stated that it was not that bad and was not as initially or worse, but was encouraged to report it to GlaxoSmithKline by the pharmacist. He preferred to receive the authorization form. This case has been linked with case US2018075823, reported by same reporter.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Influenza like illness, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 74-year-old female patient who received SHINGRIX (batch number 4492P, expiry date April 2019). Concurrent medical conditions included anxiety and herpes virus infection. Concomitant products included acyclovir, amlodipine besylate, Bupropion XL and SYNTHROID. On 23rd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd April 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site swelling, injection site pain and influenza-like symptoms. On an unknown date, the outcome of the injection site swelling, injection site pain and influenza-like symptoms were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site swelling, injection site pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: At 13:30 hours, the patient received a dose of SHINGRIX vaccine subcutaneously instead of intramuscularly, which led to inappropriate route of vaccine administration. The patient experienced strong reaction to SHINGRIX and developed aching and swelling at the injection site. The patient gave permission to contact her healthcare professional (HCP). All questions were asked. The reporter would follow up with their healthcare provider and have them reach out to GlaxoSmithKline (GSK) medication information line for further data on effectiveness of SHINGRIX given subcutaneously.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 65-year-old male patient who received SHINGRIX (batch number B4C42, expiry date 25th April 2020). Concomitant products included simvastatin. On 30th April 2018, the patient received SHINGRIX. On 30th April 2018, 1 hr after receiving SHINGRIX, the patient experienced shivering, muscle soreness, headache and influenza-like symptoms. On an unknown date, the outcome of the shivering, muscle soreness and headache were not recovered/not resolved and the outcome of the influenza-like symptoms was unknown. The reporter considered the shivering, muscle soreness and headache to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional information was reported as follows: The patient describes the events experienced by him after vaccination with SHINGRIX as almost flu-like events. Only the physician name was known at the time of reporting.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 72-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date unknown). On 30th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 30th April 2018, less than a day after receiving SHINGRIX, the patient experienced appetite lost. On 1st May 2018, the patient experienced fever and general body pain. On an unknown date, the outcome of the fever and general body pain were recovering/resolving and the outcome of the appetite lost was recovered/resolved. The reporter considered the fever, appetite lost and general body pain to be related to SHINGRIX. Additional details were provided as follows: On 30th April 2018 at 12:00, the patient received SHINGRIX vaccine in left deltoid and had loss of appetite in evening. The fever was 100.3 degree F and presented the next day accompanied by body aches.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Head discomfort, 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 75-year-old female patient who received SHINGRIX. Concomitant products included Losartan, vitamin D, AMBIEN, PLAQUENIL and SYNTHROID. On 28th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm, head pressure, foggy feeling in head and tiredness. The patient was treated with ADVIL. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the head pressure, foggy feeling in head and tiredness were not recovered/not resolved. The reporter considered the pain in arm, head pressure, foggy feeling in head and tiredness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient herself. The patient received SHINGRIX in the left arm. The patient developed arm soreness after the shot and that it had improved some but was not totally resolved till the time of reporting. The patient had treated this with ADVIL. The patient also experienced pressure in her head and fogginess in her head. The patient had not notified her physician and had not treated these events. The patient declined to provide her address and requested to not be contacted for follow up. The patient had denied permission to contact their physician. The patient was unable to provide full demographics for the pharmacy and only provided the first name of the pharmacist that administered the dose.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Insomnia, Pain in extremity, Restlessness
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a 50-year-old female patient who received SHINGRIX. On 30th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 30th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, restlessness and sleep loss. On an unknown date, the patient experienced fatigue. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the restlessness, sleep loss and fatigue were unknown. It was unknown if the reporter considered the pain in arm, restlessness, sleep loss and fatigue to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the physician who herself was the patient. The patient received the vaccine in the right deltoid. The patient came to work complaining of restless night and lack of sleep due to sore arm and complained arm was still sore and was experiencing fatigue. The patient did not seek medical attention. The patient agreed to be contacted for follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Immunodeficiency
Clinical narrative: She developed a case of shingles. Administered SHINGRIX on 5/1/18 and received medication for antiviral on 5/10/18. She was immunosuppressed and under supervision of oncology doctor.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult 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 fever and injection site pain. On an unknown date, the outcome of the fever and injection site pain were unknown. The reporter considered the fever and injection site pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist called to check the incidence rates of adverse events and commented that 3 patients who received SHINGRIX did report injection site pain or low grade fever. At the time of call, the health care professional did not have patient or vaccine information. The reporter was unsure if anything was done to treat the symptoms and if the symptoms were resolved, etc. This case has been linked with US2018GSK082721 and US2018GSK082722, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Local reaction
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, erythema of extremities and blister. On an unknown date, the outcome of the local reaction, erythema of extremities and blister were unknown. It was unknown if the reporter considered the local reaction, erythema of extremities and blister to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that, the patient developed red spot and a blister on arm. No further information was available at the time of report.
Age: 67.0
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 67-year-old female patient who received SHINGRIX. On 2nd May 2018, the patient received the 1st dose of SHINGRIX. On 2nd May 2018, several hours 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. The reporter considered the pain in arm to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX in right arm and experienced soreness of right arm. They still planned to get the 2nd dose of SHINGRIX. This case has been linked to case US2018078807, reported by same reporter, husband's case.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult 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 fever and injection site pain. On an unknown date, the outcome of the fever and injection site pain were unknown. The reporter considered the fever and injection site pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist called to check the incidence rates of adverse events and commented that 3 patients who received SHINGRIX did report injection site pain or low grade fever. At the time of call, the health care professional did not have patient or vaccine information. The reporter was unsure if anything was done to treat the symptoms and if the symptoms were resolved, etc. This case has been linked with US2018077568 and US2018GSK082722, reported by the same reporter.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, TYP
Symptoms: Angiogram, Blood creatine phosphokinase MB, Chest X-ray normal, Chest discomfort, Chest pain
Clinical narrative: Patient received SPV (1) and AVA (1) on 26 Mar 2018. 4 Apr, Onset of chest pain: about 4 hours after completing work out. Thought maybe it was a pulled muscle, so "toughed it out". (Intensity at onset (5/10). That night, he had difficulty sleeping due to pain. 5 Apr, Substernal chest pain "like a sumo wrestler on chest" continued and became progressively worse (10/10) during the day. Pain worse with deep breaths. No change with position changes. No radiation. No shortness of breath, palpitations, and pedal edema. By late afternoon, in addition to chest pain, patient was nauseous and had one emesis; his coworkers said he was pale. He went to the local ER where he was admitted. In the ER, patient had abnormal ECG and elevated troponins. He received TORADOL with some decrease in chest pain, but pain not resolution. He was admitted and taken for cardiac angiography in cath lab. (Report not visible at time of submission.) During procedure, IV NTG was administered under sedation. Patient remained in the hospital through Sunday, 8 Apr. He was diagnosed with Printzmetal Angina and discharged on Isosorbide 60 mg daily, ASA 81 mg daily, and L-arginine 1000 mg 3x/day. Patient has been asymptomatic since 6 Apr. He is on limited duty with no traveling x 6 months. Plans are for patient to have follow up with cardiologist.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, TYP
Symptoms: Drug screen negative, Echocardiogram, Ejection fraction normal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal
Clinical narrative: Patient received SPV (1) and AVA (1) on 26 Mar 2018. 4 Apr, Onset of chest pain: about 4 hours after completing work out. Thought maybe it was a pulled muscle, so "toughed it out". (Intensity at onset (5/10). That night, he had difficulty sleeping due to pain. 5 Apr, Substernal chest pain "like a sumo wrestler on chest" continued and became progressively worse (10/10) during the day. Pain worse with deep breaths. No change with position changes. No radiation. No shortness of breath, palpitations, and pedal edema. By late afternoon, in addition to chest pain, patient was nauseous and had one emesis; his coworkers said he was pale. He went to the local ER where he was admitted. In the ER, patient had abnormal ECG and elevated troponins. He received TORADOL with some decrease in chest pain, but pain not resolution. He was admitted and taken for cardiac angiography in cath lab. (Report not visible at time of submission.) During procedure, IV NTG was administered under sedation. Patient remained in the hospital through Sunday, 8 Apr. He was diagnosed with Printzmetal Angina and discharged on Isosorbide 60 mg daily, ASA 81 mg daily, and L-arginine 1000 mg 3x/day. Patient has been asymptomatic since 6 Apr. He is on limited duty with no traveling x 6 months. Plans are for patient to have follow up with cardiologist.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, TYP
Symptoms: Fibrin D dimer normal, Impaired work ability, Insomnia, Nausea, Painful respiration
Clinical narrative: Patient received SPV (1) and AVA (1) on 26 Mar 2018. 4 Apr, Onset of chest pain: about 4 hours after completing work out. Thought maybe it was a pulled muscle, so "toughed it out". (Intensity at onset (5/10). That night, he had difficulty sleeping due to pain. 5 Apr, Substernal chest pain "like a sumo wrestler on chest" continued and became progressively worse (10/10) during the day. Pain worse with deep breaths. No change with position changes. No radiation. No shortness of breath, palpitations, and pedal edema. By late afternoon, in addition to chest pain, patient was nauseous and had one emesis; his coworkers said he was pale. He went to the local ER where he was admitted. In the ER, patient had abnormal ECG and elevated troponins. He received TORADOL with some decrease in chest pain, but pain not resolution. He was admitted and taken for cardiac angiography in cath lab. (Report not visible at time of submission.) During procedure, IV NTG was administered under sedation. Patient remained in the hospital through Sunday, 8 Apr. He was diagnosed with Printzmetal Angina and discharged on Isosorbide 60 mg daily, ASA 81 mg daily, and L-arginine 1000 mg 3x/day. Patient has been asymptomatic since 6 Apr. He is on limited duty with no traveling x 6 months. Plans are for patient to have follow up with cardiologist.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, TYP
Symptoms: Pallor, Prinzmetal angina, Red blood cell sedimentation rate normal, Troponin I increased, Ventricular extrasystoles
Clinical narrative: Patient received SPV (1) and AVA (1) on 26 Mar 2018. 4 Apr, Onset of chest pain: about 4 hours after completing work out. Thought maybe it was a pulled muscle, so "toughed it out". (Intensity at onset (5/10). That night, he had difficulty sleeping due to pain. 5 Apr, Substernal chest pain "like a sumo wrestler on chest" continued and became progressively worse (10/10) during the day. Pain worse with deep breaths. No change with position changes. No radiation. No shortness of breath, palpitations, and pedal edema. By late afternoon, in addition to chest pain, patient was nauseous and had one emesis; his coworkers said he was pale. He went to the local ER where he was admitted. In the ER, patient had abnormal ECG and elevated troponins. He received TORADOL with some decrease in chest pain, but pain not resolution. He was admitted and taken for cardiac angiography in cath lab. (Report not visible at time of submission.) During procedure, IV NTG was administered under sedation. Patient remained in the hospital through Sunday, 8 Apr. He was diagnosed with Printzmetal Angina and discharged on Isosorbide 60 mg daily, ASA 81 mg daily, and L-arginine 1000 mg 3x/day. Patient has been asymptomatic since 6 Apr. He is on limited duty with no traveling x 6 months. Plans are for patient to have follow up with cardiologist.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, TYP
Symptoms: Vomiting
Clinical narrative: Patient received SPV (1) and AVA (1) on 26 Mar 2018. 4 Apr, Onset of chest pain: about 4 hours after completing work out. Thought maybe it was a pulled muscle, so "toughed it out". (Intensity at onset (5/10). That night, he had difficulty sleeping due to pain. 5 Apr, Substernal chest pain "like a sumo wrestler on chest" continued and became progressively worse (10/10) during the day. Pain worse with deep breaths. No change with position changes. No radiation. No shortness of breath, palpitations, and pedal edema. By late afternoon, in addition to chest pain, patient was nauseous and had one emesis; his coworkers said he was pale. He went to the local ER where he was admitted. In the ER, patient had abnormal ECG and elevated troponins. He received TORADOL with some decrease in chest pain, but pain not resolution. He was admitted and taken for cardiac angiography in cath lab. (Report not visible at time of submission.) During procedure, IV NTG was administered under sedation. Patient remained in the hospital through Sunday, 8 Apr. He was diagnosed with Printzmetal Angina and discharged on Isosorbide 60 mg daily, ASA 81 mg daily, and L-arginine 1000 mg 3x/day. Patient has been asymptomatic since 6 Apr. He is on limited duty with no traveling x 6 months. Plans are for patient to have follow up with cardiologist.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, TYP
Symptoms: Acute myocardial infarction, Angiogram, Blood creatine phosphokinase MB increased, Chest X-ray normal, Chest discomfort
Clinical narrative: Patient received SPV (1) and AVA (1) on 26 Mar 2018. 4 Apr, Onset of chest pain: about 4 hours after completing work out. Thought maybe it was a pulled muscle, so "toughed it out". (Intensity at onset (5/10). That night, he had difficulty sleeping due to pain. 5 Apr, Substernal chest pain "like a sumo wrestler on chest" continued and became progressively worse (10/10) during the day. Pain worse with deep breaths. No change with position changes. No radiation. No shortness of breath, palpitations, and pedal edema. By late afternoon, in addition to chest pain, patient was nauseous and had one emesis; his coworkers said he was pale. He went to the local ER where he was admitted. In the ER, patient had abnormal ECG and elevated troponins. He received TORADOL with some decrease in chest pain, but pain not resolution. He was admitted and taken for cardiac angiography in cath lab. (Report not visible at time of submission.) During procedure, IV NTG was administered under sedation. Patient remained in the hospital through Sunday, 8 Apr. He was diagnosed with Printzmetal Angina and discharged on Isosorbide 60 mg daily, ASA 81 mg daily, and L-arginine 1000 mg 3x/day. Patient has been asymptomatic since 6 Apr. He is on limited duty with no traveling x 6 months. Plans are for patient to have follow up with cardiologist.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, TYP
Symptoms: Chest pain, Drug screen negative, Ejection fraction normal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal
Clinical narrative: Patient received SPV (1) and AVA (1) on 26 Mar 2018. 4 Apr, Onset of chest pain: about 4 hours after completing work out. Thought maybe it was a pulled muscle, so "toughed it out". (Intensity at onset (5/10). That night, he had difficulty sleeping due to pain. 5 Apr, Substernal chest pain "like a sumo wrestler on chest" continued and became progressively worse (10/10) during the day. Pain worse with deep breaths. No change with position changes. No radiation. No shortness of breath, palpitations, and pedal edema. By late afternoon, in addition to chest pain, patient was nauseous and had one emesis; his coworkers said he was pale. He went to the local ER where he was admitted. In the ER, patient had abnormal ECG and elevated troponins. He received TORADOL with some decrease in chest pain, but pain not resolution. He was admitted and taken for cardiac angiography in cath lab. (Report not visible at time of submission.) During procedure, IV NTG was administered under sedation. Patient remained in the hospital through Sunday, 8 Apr. He was diagnosed with Printzmetal Angina and discharged on Isosorbide 60 mg daily, ASA 81 mg daily, and L-arginine 1000 mg 3x/day. Patient has been asymptomatic since 6 Apr. He is on limited duty with no traveling x 6 months. Plans are for patient to have follow up with cardiologist.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, TYP
Symptoms: Fibrin D dimer normal, Insomnia, Loss of personal independence in daily activities, Nausea, Painful respiration
Clinical narrative: Patient received SPV (1) and AVA (1) on 26 Mar 2018. 4 Apr, Onset of chest pain: about 4 hours after completing work out. Thought maybe it was a pulled muscle, so "toughed it out". (Intensity at onset (5/10). That night, he had difficulty sleeping due to pain. 5 Apr, Substernal chest pain "like a sumo wrestler on chest" continued and became progressively worse (10/10) during the day. Pain worse with deep breaths. No change with position changes. No radiation. No shortness of breath, palpitations, and pedal edema. By late afternoon, in addition to chest pain, patient was nauseous and had one emesis; his coworkers said he was pale. He went to the local ER where he was admitted. In the ER, patient had abnormal ECG and elevated troponins. He received TORADOL with some decrease in chest pain, but pain not resolution. He was admitted and taken for cardiac angiography in cath lab. (Report not visible at time of submission.) During procedure, IV NTG was administered under sedation. Patient remained in the hospital through Sunday, 8 Apr. He was diagnosed with Printzmetal Angina and discharged on Isosorbide 60 mg daily, ASA 81 mg daily, and L-arginine 1000 mg 3x/day. Patient has been asymptomatic since 6 Apr. He is on limited duty with no traveling x 6 months. Plans are for patient to have follow up with cardiologist.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Decreased appetite, Diarrhoea, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of feeling bad 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 week after receiving SHINGRIX, the patient experienced feeling bad, general body pain, swelling arm and skin warm. On an unknown date, the outcome of the feeling bad, general pain, swelling arm and skin warm were unknown. It was unknown if the reporter considered the feeling bad, general body pain, swelling arm and skin warm to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient got the shot on Tuesday and felt bad until Saturday that included general achy blah feeling and swollen and warm arm.