chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Impaired work ability, Injection site erythema, Somnolence
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a adult 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 injection site erythema, sleepiness and upset stomach. On an unknown date, the outcome of the injection site erythema and upset stomach were unknown and the outcome of the sleepiness was recovered/resolved. The reporter considered the injection site erythema, sleepiness and upset stomach to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced sleepiness, redness at the injection site, and upset stomach after receiving the SHINGRIX vaccine. He had to miss a day of work.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Incorrect route of drug administration, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of joint pain in a 61-year-old male patient who received SHINGRIX (batch number XC534, expiry date May 2019). Concomitant products included Atorvastatin, diclofenac sodium, esomeprazole, Hydroxyzine, Levothyroxine, Loperamide, FOLBIC Tablet, LYRICA and metaxalone. On 4th May 2018, the patient received SHINGRIX (subcutaneous) .5 ml. On 4th May 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. In May 2018, the patient experienced joint pain and pain in arm. In May 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the joint pain and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the joint pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The pharmacist stated that the SHINGRIX vaccine was administered to the patient at their pharmacy and he did not give the vaccine to the patient. The patient received the SHINGRIX via subcutaneously instead of intramuscularly, which led to inappropriate route of vaccination. Less than a month after vaccination, the patient complained about pain from the side administrations from the triceps all the way down to his forearm for 8 to 9 days. The patient also complained about elbow joint pain. The reporter provided batch number as 5/2019 however, said that this was probably incorrectly put in by the computer.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 60-year-old 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 injection site erythema and injection site irritation. On an unknown date, the outcome of the injection site erythema and injection site irritation were recovered/resolved. It was unknown if the reporter considered the injection site erythema and injection site irritation to be related to SHINGRIX. Additional details were provided as follows: The medical student who was working at a primary care office said after vaccination the patient had a local reaction from SHINGRIX. The health care professional stated these reactions had resolved within a few days. No further information was provided.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 76-year-old male patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 2020). On 15th May 2018 15:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, myalgia and injection site tenderness. On an unknown date, the outcome of the injection site erythema, myalgia and injection site tenderness were unknown. The reporter considered the injection site erythema to be related to SHINGRIX. It was unknown if the reporter considered the myalgia and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The pharmacist stated the reactions started on 16th May, the day after he was given SHINGRIX. The patient developed some redness around the site that was 3 to 4 inches wide, it became tender and he also suffered some pain and myalgia. All outcomes are unknown at the time of reporting.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: 5/2/18 note: Pt c/o severe ached and pain all over his body muscles and joints, HA, subjective fever, fatigue, sweating. Headache, Myalgia, Arthralgia, Fever and fatigue, sweating, chills. Acetaminophen/hydrocodone 5/325 mg tablet tab TID.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: 5/2/18 note: Pt c/o severe ached and pain all over his body muscles and joints, HA, subjective fever, fatigue, sweating. Headache, Myalgia, Arthralgia, Fever and fatigue, sweating, chills. Acetaminophen/hydrocodone 5/325 mg tablet tab TID.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity, Rash, Swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a male patient who received SHINGRIX. On 20th April 2018, the patient received SHINGRIX. On 20th April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, swelling and rash. The patient was treated with Probiotics. On an unknown date, the outcome of the injection site pain, swelling and rash were unknown. It was unknown if the reporter considered the injection site pain, swelling and rash to be related to SHINGRIX. Additional information were provided as follows: The patient was provided with information about possible rash but no photo of how the rash would looked like. As anticipated, the patient had pain in arm and swelling along with a developing rash. The course of antibiotics started along with a course of probiotic. This case was linked with US2018GSK076229, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Dizziness, Headache, Impaired work ability, Malaise
Clinical narrative: This patient received 1st dose of SHINGRIX vaccine and reported severe side effects continuing 6 days post-injection. Side effects, as reported by the patient, include, fever of up to 103, significant swelling of the arm, significant general malaise, severe headaches, lack of appetite, dizziness, blurry vision, patient was unable to work the day after injection and had to take a sick day. She also spent over 2 days following injection in bed, too unwell to be able to do much more than use the restroom.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Vision blurred
Clinical narrative: This patient received 1st dose of SHINGRIX vaccine and reported severe side effects continuing 6 days post-injection. Side effects, as reported by the patient, include, fever of up to 103, significant swelling of the arm, significant general malaise, severe headaches, lack of appetite, dizziness, blurry vision, patient was unable to work the day after injection and had to take a sick day. She also spent over 2 days following injection in bed, too unwell to be able to do much more than use the restroom.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Skin rash and Urticarial Pruritus.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Continual arm pain with difficulty with range of motion.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received SHINGRIX (batch number ML532, expiry date 13th July 2020). On 21st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd May 2018, 2 days after receiving SHINGRIX, the patient experienced injection site erythema, macular rash, injection site warmth and injection site bruising. On an unknown date, the outcome of the injection site erythema, macular rash, injection site warmth and injection site bruising were unknown. The reporter considered the injection site erythema, macular rash, injection site warmth and injection site bruising to be related to SHINGRIX. Additional details were provided as follows: On 21st May 2018, at 12:45 hours, the patient received SHINGRIX in the left deltoid. The patient came into the pharmacy on the date of reporting to show her arm to the reporter. The patient experienced redness and blotchiness that extended from the injection site out, taking up most of the left deltoid area. It was warm to the touch. There was bruising right at the site where the product was injected. The patient indicated that she did not know exactly when these symptoms started but she first noticed them on the day before reporting. The patient thought that the area was redder on the reporting date than it was a day before.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of chills in a adult 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 chills, tiredness, fever and headache. On an unknown date, the outcome of the chills, tiredness, fever and headache were recovering/resolving. The reporter considered the chills, tiredness, fever and headache to be almost certainly related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. This case was not previously reported to any one. The healthcare provider provided information as reported by patient after receiving vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (subcutaneous) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. The age at vaccination was not reported. The healthcare professional was a retail pharmacist. The healthcare professional suspected that the patient received a dose of SHINGRIX subcutaneously instead of the indicated intramuscular route, which led to possible inappropriate route of vaccination. He thought the patient received a dose of SHINGRIX subcutaneously instead of intramuscular because the patient complained of site pain and described a subcutaneous route of administration. The vaccine was not administered at the notifying healthcare professional's site. The patient was not a customer, and no vaccine or patient information was available.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Muscle twitching, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Left arm started hurting, very sore really bad around 2:00 pm the same day as injection. Around 10 pm got fever and had chills with uncontrollable shaking. Temperature was 102.2. Took 2 TYLENOL for fever. Would help fever then after about 5 or 6 hours would have fever again. Took 2 TYLENOL about every 6 hours to help fever. Next day still had fever, but the uncontrollable shaking stopped. The following next day April 27th the fever went away. Since then, I now have tremors and twitching about 10 times a day that last about a second. I have never had this problem before.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Headache, Injection site pain, Injection site swelling
Clinical narrative: Reaction to first dose of SHINGRIX; local site pain and swelling. Reaction to second dose of SHINGRIX included: local site pain and swelling, shivering whole night after vaccination, splitting headache, nausea, back pains and some body aches.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Reaction to first dose of SHINGRIX; local site pain and swelling. Reaction to second dose of SHINGRIX included: local site pain and swelling, shivering whole night after vaccination, splitting headache, nausea, back pains and some body aches.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Nodule, Rash, Rash macular
Clinical narrative: Patient stopped by pharmacy to receive/inquire about 2nd vaccine (SHINGRIX). I ask him how 1st vaccine went. He explained that a couple days later, noticed a penny size nodule on armpit. He also reported a splotch on chest and pimple like rash on torso. This resolved in a week.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Hypoaesthesia, Influenza like illness, Injection site pain
Clinical narrative: Pain in injection site for few days. The second day I felt awful! Terrible headache. Flu-like for 2 days. Had no energy could barely function and spent most of the day on the sofa. I'd say that I felt "off" for about 5-7 days. But the worst sensation was a "numbness" on the L side of my face and my head hurt!! My skull (top of head mostly) hurt! It was scary. These more scary sensations lasted about 5 days. I'm afraid to get the second shot!
Age: 69.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Musculoskeletal pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Severe pain in my right arm from my neck to my fingers. Could not sit or lay in any position any thing touching any part of my arm was painful. About 24 hours after the injection pain subsided to upper arm and shoulder. Pain and discomfort spread to left arm. 3 months later I have pain on lifting with either arm, pain from elbows to shoulder on both arms, pain on raising either arm above chest level, also a popping kind of arm upon lifting my arms, even drying off with a towel after a shower is painful, just about any kind of movement can be painful. Is this permanent?? Get back to me.
Age: 69.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site pain, Joint noise, Limb discomfort, Musculoskeletal pain, Neck pain
Clinical narrative: Severe pain in my right arm from my neck to my fingers. Could not sit or lay in any position any thing touching any part of my arm was painful. About 24 hours after the injection pain subsided to upper arm and shoulder. Pain and discomfort spread to left arm. 3 months later I have pain on lifting with either arm, pain from elbows to shoulder on both arms, pain on raising either arm above chest level, also a popping kind of arm upon lifting my arms, even drying off with a towel after a shower is painful, just about any kind of movement can be painful. Is this permanent?? Get back to me.
Age: 69.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Severe pain in my right arm from my neck to my fingers. Could not sit or lay in any position any thing touching any part of my arm was painful. About 24 hours after the injection pain subsided to upper arm and shoulder. Pain and discomfort spread to left arm. 3 months later I have pain on lifting with either arm, pain from elbows to shoulder on both arms, pain on raising either arm above chest level, also a popping kind of arm upon lifting my arms, even drying off with a towel after a shower is painful, just about any kind of movement can be painful. Is this permanent?? Get back to me.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Back pain, Erythema, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 69-year-old female patient who received SHINGRIX. Concomitant products included vitamin E. On 5th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 5th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain, erythema, shingles, fever, weakness, difficulty sleeping, rash and swelling. The patient was treated with Antiviral and ADVIL. On an unknown date, the outcome of the pain, erythema, shingles, fever, weakness, difficulty sleeping, rash and swelling were not recovered/not resolved. It was unknown if the reporter considered the pain, erythema, shingles, fever, weakness, difficulty sleeping, rash and swelling to be related to SHINGRIX. Additional details were provided as follows: Five days after receiving SHINGRIX, the patient reported that she went to see her physician, was diagnosed as having shingles, and was prescribed antiviral and ADVIL. The patient planned to follow up with her physician on an unknown date. This case has been linked with US2018GSK097013, reported by the same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Erythema, Herpes zoster, Insomnia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 69-year-old female patient who received SHINGRIX. Concomitant products included vitamin E. On 5th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 5th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain, erythema, shingles, fever, weakness, difficulty sleeping, rash and swelling. The patient was treated with Antiviral and ADVIL. On an unknown date, the outcome of the pain, erythema, shingles, fever, weakness, difficulty sleeping, rash and swelling were not recovered/not resolved. It was unknown if the reporter considered the pain, erythema, shingles, fever, weakness, difficulty sleeping, rash and swelling to be related to SHINGRIX. Additional details were provided as follows: Five days after receiving SHINGRIX, the patient reported that she went to see her physician, was diagnosed as having shingles, and was prescribed antiviral and ADVIL. The patient planned to follow up with her physician on an unknown date. This case has been linked with US2018GSK097013, reported by the same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Rash, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 69-year-old female patient who received SHINGRIX. Concomitant products included vitamin E. On 5th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 5th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain, erythema, shingles, fever, weakness, difficulty sleeping, rash and swelling. The patient was treated with Antiviral and ADVIL. On an unknown date, the outcome of the pain, erythema, shingles, fever, weakness, difficulty sleeping, rash and swelling were not recovered/not resolved. It was unknown if the reporter considered the pain, erythema, shingles, fever, weakness, difficulty sleeping, rash and swelling to be related to SHINGRIX. Additional details were provided as follows: Five days after receiving SHINGRIX, the patient reported that she went to see her physician, was diagnosed as having shingles, and was prescribed antiviral and ADVIL. The patient planned to follow up with her physician on an unknown date. This case has been linked with US2018GSK097013, reported by the same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 69-year-old female patient who received SHINGRIX. Concomitant products included vitamin E. On 5th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 5th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain, erythema, shingles, fever, weakness, difficulty sleeping, rash and swelling. The patient was treated with Antiviral and ADVIL. On an unknown date, the outcome of the pain, erythema, shingles, fever, weakness, difficulty sleeping, rash and swelling were not recovered/not resolved. It was unknown if the reporter considered the pain, erythema, shingles, fever, weakness, difficulty sleeping, rash and swelling to be related to SHINGRIX. Additional details were provided as follows: Five days after receiving SHINGRIX, the patient reported that she went to see her physician, was diagnosed as having shingles, and was prescribed antiviral and ADVIL. The patient planned to follow up with her physician on an unknown date. This case has been linked with US2018GSK097013, reported by the same reporter.
Age: 57.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Contusion, Pain, Varicose vein
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of DVT in a 58-year-old male patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). Concomitant products included allopurinol, Aspirin, CARDIZEM, NEURONTIN, PNEUMOVAX, DIOVAN HCT, NORCO, XARELTO and PRILOSEC. On 3rd May 2018, the patient received the 1st dose of SHINGRIX .5 ml. In May 2018 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On 23rd May 2018, the patient experienced DVT (serious criteria disability, GSK medically significant and other: as per reporter) and subclavian vein thrombosis (serious criteria disability, GSK medically significant and other: as per reporter). On an unknown date, the patient experienced bruising of arm. On an unknown date, the outcome of the DVT and subclavian vein thrombosis were not recovered/not resolved and the outcome of the bruising of arm and pain in arm were unknown. The reporter considered the DVT and subclavian vein thrombosis to be possibly related to SHINGRIX. It was unknown if the reporter considered the bruising of arm and pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to a doctor. The patient received SHINGRIX vaccine on right deltoid. The patient was vaccinated on the same day with PNEUMOVAX. Immunization program manager reported that three to four days after vaccination the patient experienced bruising in the arm at the injection site. He was seen in the office on 17th May 2018 with a lot of pain and bruising around his entire right arm. No treatment was recommended other than to watch the symptoms. The reporter called back to the office on Monday that the condition was worsening and they did an ultrasound on 23rd May 2018 and he was diagnosed with occlusive DVT in the right subclavian vein. They referred the patient to vascular surgery. The reporter asked in email if there was anything she needed to do for GlaxoSmithKline concerning the adverse event.
Age: 57.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Contusion, Deep vein thrombosis, Injection site bruising, Pain in extremity, Subclavian vein thrombosis
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of DVT in a 58-year-old male patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). Concomitant products included allopurinol, Aspirin, CARDIZEM, NEURONTIN, PNEUMOVAX, DIOVAN HCT, NORCO, XARELTO and PRILOSEC. On 3rd May 2018, the patient received the 1st dose of SHINGRIX .5 ml. In May 2018 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On 23rd May 2018, the patient experienced DVT (serious criteria disability, GSK medically significant and other: as per reporter) and subclavian vein thrombosis (serious criteria disability, GSK medically significant and other: as per reporter). On an unknown date, the patient experienced bruising of arm. On an unknown date, the outcome of the DVT and subclavian vein thrombosis were not recovered/not resolved and the outcome of the bruising of arm and pain in arm were unknown. The reporter considered the DVT and subclavian vein thrombosis to be possibly related to SHINGRIX. It was unknown if the reporter considered the bruising of arm and pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to a doctor. The patient received SHINGRIX vaccine on right deltoid. The patient was vaccinated on the same day with PNEUMOVAX. Immunization program manager reported that three to four days after vaccination the patient experienced bruising in the arm at the injection site. He was seen in the office on 17th May 2018 with a lot of pain and bruising around his entire right arm. No treatment was recommended other than to watch the symptoms. The reporter called back to the office on Monday that the condition was worsening and they did an ultrasound on 23rd May 2018 and he was diagnosed with occlusive DVT in the right subclavian vein. They referred the patient to vascular surgery. The reporter asked in email if there was anything she needed to do for GlaxoSmithKline concerning the adverse event.
Age: 57.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Ultrasound scan abnormal
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of DVT in a 58-year-old male patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). Concomitant products included allopurinol, Aspirin, CARDIZEM, NEURONTIN, PNEUMOVAX, DIOVAN HCT, NORCO, XARELTO and PRILOSEC. On 3rd May 2018, the patient received the 1st dose of SHINGRIX .5 ml. In May 2018 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On 23rd May 2018, the patient experienced DVT (serious criteria disability, GSK medically significant and other: as per reporter) and subclavian vein thrombosis (serious criteria disability, GSK medically significant and other: as per reporter). On an unknown date, the patient experienced bruising of arm. On an unknown date, the outcome of the DVT and subclavian vein thrombosis were not recovered/not resolved and the outcome of the bruising of arm and pain in arm were unknown. The reporter considered the DVT and subclavian vein thrombosis to be possibly related to SHINGRIX. It was unknown if the reporter considered the bruising of arm and pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to a doctor. The patient received SHINGRIX vaccine on right deltoid. The patient was vaccinated on the same day with PNEUMOVAX. Immunization program manager reported that three to four days after vaccination the patient experienced bruising in the arm at the injection site. He was seen in the office on 17th May 2018 with a lot of pain and bruising around his entire right arm. No treatment was recommended other than to watch the symptoms. The reporter called back to the office on Monday that the condition was worsening and they did an ultrasound on 23rd May 2018 and he was diagnosed with occlusive DVT in the right subclavian vein. They referred the patient to vascular surgery. The reporter asked in email if there was anything she needed to do for GlaxoSmithKline concerning the adverse event.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Immediate post-injection reaction, Seizure, Syncope
Clinical narrative: I gave the patient the shot, and immediately after he passed out and started to shake. I lied him back and made sure his legs were in an upright position. About 1 second after, he woke back up and then he was okay.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Immediate post-injection reaction, Loss of consciousness, Tremor
Clinical narrative: I gave the patient the shot, and immediately after he passed out and started to shake. I lied him back and made sure his legs were in an upright position. About 1 second after, he woke back up and then he was okay.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient claims 12 hours after he noticed a large rash on his buttocks near the anus area. He said it itches and is painful. He believes he contracted shingles from the vaccine. However, Dr. does not believe he could have contracted shingles since SHINGRIX is not live.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site pain, Pruritus, Throat tightness
Clinical narrative: Started to have redness on her body about 10 different places and got bigger and more itching on those spots every day. Pt complained her throat was kind of tight. The painful sensation on injection site got better with time though. Pt did not do anything and did not call the pharmacy and doctor at all. Pt finally called me on Wednesday night. She is contacting Dr. for treatment for further discussion.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Malaise, Pruritus, Rash, Urticaria
Clinical narrative: Started to have redness on her body about 10 different places and got bigger and more itching on those spots every day. Pt complained her throat was kind of tight. The painful sensation on injection site got better with time though. Pt did not do anything and did not call the pharmacy and doctor at all. Pt finally called me on Wednesday night. She is contacting Dr. for treatment for further discussion.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site pain, Pruritus, Throat tightness
Clinical narrative: Injection on Friday late afternoon, next day (Saturday) I didn't feel well and had chills. On Sunday had itching and hive type bumps behind right ear, around bellybutton area and around left shoulder. On Monday the bumps and itching had expanded to left side under breast and right shoulder. Tuesday I still had the bumps/itching behind right ear, bellybutton, left shoulder and under left breast, but now bumps appeared on right shoulder, under right breast and lower back. Wednesday the bumps and itching continues, so I contacted the pharmacy who were going to contact CDC. Today is Thursday and I have been given a medication to fight the virus.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Malaise, Pruritus, Rash, Urticaria
Clinical narrative: Injection on Friday late afternoon, next day (Saturday) I didn't feel well and had chills. On Sunday had itching and hive type bumps behind right ear, around bellybutton area and around left shoulder. On Monday the bumps and itching had expanded to left side under breast and right shoulder. Tuesday I still had the bumps/itching behind right ear, bellybutton, left shoulder and under left breast, but now bumps appeared on right shoulder, under right breast and lower back. Wednesday the bumps and itching continues, so I contacted the pharmacy who were going to contact CDC. Today is Thursday and I have been given a medication to fight the virus.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Heart rate increased, Pain, Pyrexia
Clinical narrative: Soreness, fever, very tired, elevated pulse.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema
Clinical narrative: REDNESS TO SITE.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a licensed practical nurse reporting on two patients of unknown ages and genders. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unspecified date in May 2018 (reported as since 03-MAY-2018), the patients received an improperly stored dose of GARDASIL 9 for prophylaxis (N020353 lot number and expiration date 28-APR-2020) (anatomical location, route of administration, strength and dose were not reported). No adverse effects reported. It was reported that on an unspecified date, the vaccine was exposed to a temperature bellow 0 degrees Celsius (C) (-2.10 degrees C) for 20 minutes. The licensed practical nurse reported that there was no previous temperature excursion. The call was placed because of a Digital Data logger report.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Pain, Pyrexia, Tremor, Vomiting
Clinical narrative: This spontaneous report has been received from the patient's mother (reported as an "office manager"), via a company representative, referring to her daughter, whose age was not specified. The patient's pertinent medical history, concomitant medications taken by her and information about her drug reactions or allergies were not provided. On 08-JAN-2013, the patient was vaccinated with the first dose of GARDASIL for prophylaxis (concentration, dose, frequency, route and anatomical location of administration, lot number and expiration date were not provided). It was reported that the patient did not experience any adverse event then. Later, on 07-AUG-2013, the patient was vaccinated with the second dose of GARDASIL for prophylaxis (concentration, dose, frequency, route and anatomical location of administration, lot number and expiration date were not provided) (inappropriate schedule of drug administration). It was reported that, on an unspecified date after receiving the second dose of GARDASIL, the patient experienced "severe body aches (pain), vomiting, high fever (pyrexia) and body shakes (tremor)". The company representative stated not being sure about pain, vomiting, pyrexia and tremor being previously reported. In addition, the company representative mentioned that, at vaccination time, the patient's physician was "Dr."; however, "he no longer practiced at the clinic and there was no contact information for him". Further information was not provided. At reporting time, the outcome of pain, vomiting, pyrexia and tremor was unknown. The office manager did not provide any causality assessment for pain, vomiting, pyrexia and tremor in regards with GARDASIL vaccination.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an intramuscular dose of GARDASIL 9 (strength, dose, and anatomical location were not reported) for prophylaxis. The valid lot number was N025428, with an expiry date of 19-JUN-2020. The dose of GARDASIL 9 vaccine was dispensed to the patient after it was exposed to a temperature excursion of 0.4 Celsius degrees, for 1 hour and 44 minutes. It was also reported that there was a data logger. This was the first temperature excursion for this product. No adverse effects were reported. No other information was available. No product quality complaint was filed.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a nurse regarding an unknown gender patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with an improperly stored GARDASIL 9 (lot# N017697 and expiration date 21-JAN-2020 for prophylaxis) (dose, strength, frequency, route of administration were not reported). The temperature excursion and time frame was between 9 degrees C to 25 degrees C for 17 hours. The data logger was reported. No adverse effects was reported. Product quality complain was not present.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Fatigue, Headache, Heart rate increased
Clinical narrative: This spontaneous report was received from a female patient of unknown age, via company representative. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient went to a pharmacy to receive her initial injection of ZOSTAVAX, lot # reported as 26815 and expiration date on 25-DEC-2018, for prophylaxis (route of administration and anatomical location were not reported). The patient was asked by the pharmacist to remain for a short time frame for post-dose observation, and within an approximately ten minute time period, the patient began to exhibit dizziness, fatigue, acceleration of heart rate and pallor. Within 20 minutes of dose administration, the patient experienced wheezing and shortness of breath. It was also reported that the patient experienced headache. Within an hour of injection, all symptoms appeared to resolve. The reporter did not assess the causal relationship between ZOSTAVAX and the events.
Sex: F
Vaccine: VARZOS
Symptoms: Pallor, Wheezing
Clinical narrative: This spontaneous report was received from a female patient of unknown age, via company representative. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient went to a pharmacy to receive her initial injection of ZOSTAVAX, lot # reported as 26815 and expiration date on 25-DEC-2018, for prophylaxis (route of administration and anatomical location were not reported). The patient was asked by the pharmacist to remain for a short time frame for post-dose observation, and within an approximately ten minute time period, the patient began to exhibit dizziness, fatigue, acceleration of heart rate and pallor. Within 20 minutes of dose administration, the patient experienced wheezing and shortness of breath. It was also reported that the patient experienced headache. Within an hour of injection, all symptoms appeared to resolve. The reporter did not assess the causal relationship between ZOSTAVAX and the events.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a medical assistant referring to a 4 year old female patient. There was no pertinent medical history. The patient's concurrent conditions included seasonal allergies. On 21-MAY-2018, the patient was vaccinated with a dose of VARIVAX, (lot # N029628, expiry date 23-OCT-2019), subcutaneous in the left anterolateral thigh, for routine vaccination. The vaccine was reconstituted with sterile diluent (MERCK), (lot # N030572, expiry date 20-APR-2020). Concomitant therapies included VERAMYST and SINGULAIR. On an unknown date in May 2018, 12 hours after the vaccine administration, the patient developed "cellulitis" at the injection site. The patient was seen in the physician's office on 23-MAY-2018 and was prescribed an unspecified dose of clindamycin palmitate HCL and an epinephrine pen. At the time of reporting the patient's outcome for the cellulitis was not recovered. No causality assessment between the event and the vaccine was provided by the reporter. Upon internal review, the cellulitis was considered medically significant as the patient received treatment with epinephrine pen. This is one of two reports from the same reporter source, linked to case # 1805USA012539. Sender's Comments: US-009507513-1805USA012539.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included MERCK STERILE DILUENT. On 21-MAY-2018, the patient was inadvertently vaccinated with an expired dose of Oka/Merck VARIVAX) lot # M009769, expiration date on 25-FEB-2018, subcutaneously (anatomical location was not reported) for prophylaxis. No adverse effects were reported.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Right arm pain.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient given 2nd dose of PCV 13 within 6 months of last vaccine of same PCV 13.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The patient experienced heat, redness, and swelling on the middle bicep to elbow of the left arm in which she received the vaccine. Currently the reaction measures about 5" by 3". She denied any reaction right at the injection site (left deltoid). The reaction began a few hours after receiving the vaccine, was worse the day following administration, and patient reports it has begun improving (2 days after administration). When the reaction was at its worst (5/30), the patient took acetaminophen. The patient was advised to take acetaminophen or BENADRYL as needed, and report worsening or persistence of the reaction.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented almost 24 hours post vaccination with erythema, swelling and warmth in right thigh, temperature 100 degrees F, no other symptoms.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium decreased
Clinical narrative: Rash, sensation of throat tightness/difficulty breathing, fever. Rec'd BENADRYL, hydroxyzine, prednisone, IV fluids, topical steroids.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood chloride normal, Blood creatinine normal, Blood culture negative, Blood glucose normal, Blood potassium normal
Clinical narrative: Rash, sensation of throat tightness/difficulty breathing, fever. Rec'd BENADRYL, hydroxyzine, prednisone, IV fluids, topical steroids.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood sodium normal, Blood urea normal, C-reactive protein increased, Carbon dioxide normal, Culture throat negative
Clinical narrative: Rash, sensation of throat tightness/difficulty breathing, fever. Rec'd BENADRYL, hydroxyzine, prednisone, IV fluids, topical steroids.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dyspnoea, Glycosylated haemoglobin decreased, Haematocrit normal, Haemoglobin normal, Lymphocyte percentage decreased
Clinical narrative: Rash, sensation of throat tightness/difficulty breathing, fever. Rec'd BENADRYL, hydroxyzine, prednisone, IV fluids, topical steroids.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Monocyte percentage decreased, Mononucleosis heterophile test negative, Mycoplasma test negative, Neutrophil percentage increased, Platelet count normal
Clinical narrative: Rash, sensation of throat tightness/difficulty breathing, fever. Rec'd BENADRYL, hydroxyzine, prednisone, IV fluids, topical steroids.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pyrexia, Rash, Red blood cell sedimentation rate normal, Respiratory viral panel, Streptococcus test negative
Clinical narrative: Rash, sensation of throat tightness/difficulty breathing, fever. Rec'd BENADRYL, hydroxyzine, prednisone, IV fluids, topical steroids.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Throat tightness, Viral test negative, White blood cell count increased
Clinical narrative: Rash, sensation of throat tightness/difficulty breathing, fever. Rec'd BENADRYL, hydroxyzine, prednisone, IV fluids, topical steroids.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: After 3 days patient experienced shoulder pain and has had ever since. Doctor's office recommended icing shoulder and TYLENOL or MOTRIN, which patient just started today. Couldn't get in to be seen at Doctor's office.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site discomfort, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 82-year-old male patient who received SHINGRIX. Concurrent medical conditions included osteoarthritis and fusion lumbar spine. Concomitant products included AVODART, Aspirin, Pravastatin, CELEXA and NEXIUM. In February 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). In February 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site discomfort and injection site swelling. On an unknown date, the outcome of the injection site discomfort and injection site swelling were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site discomfort and injection site swelling to be related to SHINGRIX. Additional information was received as follows: This case was reported by the patient's wife. The patient received SHINGRIX on the left arm subcutaneously instead of intramuscularly, which led to incorrect route of vaccine administration. Less than a year, after receiving SHINGRIX, the patient experienced injection site discomfort and injection site swelling. The symptoms lasted about 24 hours before resolving. On 25th April 2018, the patient received the 2nd dose of SHINGRIX. The reporter did not know if it was administered subcutaneously or intramuscularly and did not report any adverse events following the 2nd dose of SHINGIRX. This case has been linked to the case US2018092508, reported by same reporter (husband's case).
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Back pain, Blood test, Confusional state, Dizziness
Clinical narrative: Severe high fever 104 and shaking uncontrollably. Major headache lower back pain, weakness, lethargic, nausea, blurred vision, neck pain, skin hurt, very sleepy, confused. Dizziness. Still getting bad headaches.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Lethargy, Nausea, Neck pain, Pain of skin
Clinical narrative: Severe high fever 104 and shaking uncontrollably. Major headache lower back pain, weakness, lethargic, nausea, blurred vision, neck pain, skin hurt, very sleepy, confused. Dizziness. Still getting bad headaches.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia, Somnolence, Tremor, Vision blurred, X-ray
Clinical narrative: Severe high fever 104 and shaking uncontrollably. Major headache lower back pain, weakness, lethargic, nausea, blurred vision, neck pain, skin hurt, very sleepy, confused. Dizziness. Still getting bad headaches.
Age: 22.0
Sex: F
Vaccine: YF
Symptoms: Headache, Malaise, Myalgia, Oropharyngeal pain
Clinical narrative: Approximately one hour post injection the patient started felling ill and had headache and muscle aches. The patient also had a sore throat.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling cold, Headache, Nausea
Clinical narrative: On the day following administration of the vaccine (5/23), the patient reported experiencing headache, dizziness, nausea, and "feeling cold". These symptoms were significant enough for her to go home at lunchtime and go to bed. The next day (5/24), the patient woke with a headache but all symptoms had resolved by that evening. The patient did not report any reappearance of symptoms after the evening of 5/24.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: His left arm at the injection site swelled up and was rock hard by the next day. He had pain about a 3 at the injection site. By May 31st most of the swelling is down and it is not so hard now. I was told by his doctor to give him BENADRYL.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: High fever and rash.