chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Eye pain, Pyrexia, Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a male patient who received KINRIX for prophylaxis. Concomitant products included PROQUAD. On an unknown date, the patient received KINRIX at an unknown dose. On an unknown date, several hours after receiving KINRIX, the patient experienced fever. The patient was treated with ADVIL and TYLENOL. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to KINRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed high fever within hours after receiving the KINRIX vaccine. The health care professional recommended TYLENOL or ADVIL for the fever. This case has been linked with US2018112030 and US2018112032 reported by same reporter.
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a male patient who received KINRIX for prophylaxis. Concomitant products included PROQUAD. On an unknown date, the patient received KINRIX at an unknown dose. On an unknown date, several hours after receiving KINRIX, the patient experienced fever. The patient was treated with ADVIL and TYLENOL. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to KINRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed high fever within hours after receiving the KINRIX vaccine. The health care professional recommended TYLENOL or ADVIL for the fever. This case has been linked with US2018112030 and US2018112032 reported by same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 72-year-old female patient who received SHINGRIX (batch number L7F7E, expiry date 22nd November 2020) for prophylaxis. On 13th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th June 2018, 3 days after receiving SHINGRIX, the patient experienced shingles and weird feeling. The patient was treated with Valacyclovir and TYLENOL. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the weird feeling was unknown. The reporter considered the shingles to be possibly related to SHINGRIX. It was unknown if the reporter considered the weird feeling to be related to SHINGRIX. Additional details were reported as follows: The patient received the SHINGRIX on the right arm. On 16th June 2018, the patient felt weird, and went to the emergency room (ER) and was diagnosed with shingles. The patient was treated with valacyclovir 1 gram TID and TYLENOL since 18th June 2018. A MEDROL dose pack was also ordered, but was not administered. The healthcare professional stated of not being aware of a previous diagnosis of shingles and unsure of previous ZOSTAVAX vaccination.
Age: 32.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a 32-year-old female patient who received HAVRIX for prophylaxis. On 18th June 2018, the patient received the 1st dose of HAVRIX. On 21st June 2018, 3 days after receiving HAVRIX, the patient experienced hives, pruritus and erythema. The patient was treated with SINGULAIR, ATARAX and Topical Steroid. On an unknown date, the outcome of the hives, pruritus and erythema were unchanged. It was unknown if the reporter considered the hives, pruritus and erythema to be related to HAVRIX. Additional details were provided as follows: The patient developed reddish itchy hives all over torso, neck, breast, stomach and lower back after receiving GlaxoSmithKline (GSK) hepatitis A vaccine. The patient also reported she went to the physician on the day of reporting to report the reactions after which she received prescriptions for a topical steroid, SINGULAIR and ATARAX. The patient initially called in wanting to speak to a representative on how to proceed with 2nd dose in series after the adverse reaction from initial dose. The request for call back was being forwarded to Global Response Center (GRC) for consumer call-back per the follow-up patient request. The patient was okay with GSK safety further contacting the pharmacy for further information regarding product details and adverse reaction. No further information was reported regarding the event.
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram, Induration, Leukocytosis, Lymphadenopathy, Lymphangitis
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of lymphangitis in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced lymphangitis (serious criteria GSK medically significant), leukocytosis, lymphadenopathy, neck pain and induration. The patient was treated with clindamycin. On an unknown date, the outcome of the lymphangitis, leukocytosis, lymphadenopathy, neck pain and induration were not recovered/not resolved. It was unknown if the reporter considered the lymphangitis, leukocytosis, lymphadenopathy, neck pain and induration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in the left deltoid. Within 2 to 3 days after vaccination, the patient was experiencing pain radiating in the left side of the neck. Within 7 days after vaccination, the patient had a large painful induration. The patient seen in the hospital and was given a computerized axial tomography (CAT) scan and started on Clindamycin. The patient was diagnosed with lymphangitis, adenopathy and leukocytosis. The symptoms had not resolved. The call center representative was unable to get patient information because the physician was frustrated and unfortunately, hung up before this information could be obtained. Lab Comments: on an unknown date, the lab test was performed.
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of lymphangitis in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced lymphangitis (serious criteria GSK medically significant), leukocytosis, lymphadenopathy, neck pain and induration. The patient was treated with clindamycin. On an unknown date, the outcome of the lymphangitis, leukocytosis, lymphadenopathy, neck pain and induration were not recovered/not resolved. It was unknown if the reporter considered the lymphangitis, leukocytosis, lymphadenopathy, neck pain and induration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in the left deltoid. Within 2 to 3 days after vaccination, the patient was experiencing pain radiating in the left side of the neck. Within 7 days after vaccination, the patient had a large painful induration. The patient seen in the hospital and was given a computerized axial tomography (CAT) scan and started on Clindamycin. The patient was diagnosed with lymphangitis, adenopathy and leukocytosis. The symptoms had not resolved. The call center representative was unable to get patient information because the physician was frustrated and unfortunately, hung up before this information could be obtained. Lab Comments: on an unknown date, the lab test was performed.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Headache
Clinical narrative: Became very tired and started to have chills, muscles aches, headache and joint aches. Site became swollen and painful. Went to bed. By the morning, chills were gone, but had a slight headache all day and was tired. Arm remained slightly swollen, red, hot and sore for about 4 days, then got itchy. This was the second injection. First one was 4/23/18.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Became very tired and started to have chills, muscles aches, headache and joint aches. Site became swollen and painful. Went to bed. By the morning, chills were gone, but had a slight headache all day and was tired. Arm remained slightly swollen, red, hot and sore for about 4 days, then got itchy. This was the second injection. First one was 4/23/18.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin warm
Clinical narrative: Became very tired and started to have chills, muscles aches, headache and joint aches. Site became swollen and painful. Went to bed. By the morning, chills were gone, but had a slight headache all day and was tired. Arm remained slightly swollen, red, hot and sore for about 4 days, then got itchy. This was the second injection. First one was 4/23/18.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Skin warm
Clinical narrative: Called mom on 7/2/18 to check on sister and mom reports that Patient has 1 "bug-bite" like spot on left thigh. She has also felt a little warm over the weekend. She did not have any signs of spot on Friday when I talked to mom and is acting normal and feels normal temperature today.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Feeling abnormal, Full blood count, Herpes zoster, Malaise
Clinical narrative: Patient states she started to feel poorly within 1/2 hour. Presented to clinic on 7/2/18 with fever 101.5 after Tylenol. nerve pain and blister on left hand. General Malaise and muscle soreness. She was diagnosed with Shingles on this date.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Neuralgia, Pyrexia
Clinical narrative: Patient states she started to feel poorly within 1/2 hour. Presented to clinic on 7/2/18 with fever 101.5 after Tylenol. nerve pain and blister on left hand. General Malaise and muscle soreness. She was diagnosed with Shingles on this date.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia, Biopsy artery normal, Burning sensation, C-reactive protein increased
Clinical narrative: Patient states she started to feel poorly within 1/2 hour. Presented to clinic on 7/2/18 with fever 101.5 after Tylenol. nerve pain and blister on left hand. General Malaise and muscle soreness. She was diagnosed with Shingles on this date.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Gait disturbance, Headache, Injection site pain
Clinical narrative: Patient states she started to feel poorly within 1/2 hour. Presented to clinic on 7/2/18 with fever 101.5 after Tylenol. nerve pain and blister on left hand. General Malaise and muscle soreness. She was diagnosed with Shingles on this date.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Joint stiffness, Joint swelling, Laboratory test normal, Musculoskeletal stiffness, Neck pain
Clinical narrative: Patient states she started to feel poorly within 1/2 hour. Presented to clinic on 7/2/18 with fever 101.5 after Tylenol. nerve pain and blister on left hand. General Malaise and muscle soreness. She was diagnosed with Shingles on this date.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Patient states she started to feel poorly within 1/2 hour. Presented to clinic on 7/2/18 with fever 101.5 after Tylenol. nerve pain and blister on left hand. General Malaise and muscle soreness. She was diagnosed with Shingles on this date.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Red blood cell sedimentation rate increased, Streptococcus test negative
Clinical narrative: Patient states she started to feel poorly within 1/2 hour. Presented to clinic on 7/2/18 with fever 101.5 after Tylenol. nerve pain and blister on left hand. General Malaise and muscle soreness. She was diagnosed with Shingles on this date.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Complication associated with device
Clinical narrative: In arm that had the vaccine: Have limited range of motion. Pain. Dr prescribed physical therapy. Arm was normal before vaccine. Now doing physical therapy daily at home.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Hyperaesthesia, Immediate post-injection reaction, Myalgia, Pain
Clinical narrative: Achy right after the shot, then extreme skin sensitivity in his torso. Pt has had shingles twice before and this felt like having shingles. No rash. Felt feverish, but pt did not take his temperature. Muscle and joint aches. Symptoms lasted 5 days and then resolved. Pt did not use any treatment and did not visit the doctor's office fore this. Pt also felt sensitive to temperature, expecially heat.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Temperature intolerance
Clinical narrative: Achy right after the shot, then extreme skin sensitivity in his torso. Pt has had shingles twice before and this felt like having shingles. No rash. Felt feverish, but pt did not take his temperature. Muscle and joint aches. Symptoms lasted 5 days and then resolved. Pt did not use any treatment and did not visit the doctor's office fore this. Pt also felt sensitive to temperature, expecially heat.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Dermatitis bullous, Eczema, Pruritus, Rash vesicular
Clinical narrative: Vesiculobullous dermatitis-generalized within a couple of days after vaccine (does not indicate on form the date that the adverse event started; assumed 'a couple of days' to be two days after vaccination). Pruritic varicella form is character.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Cellulitis, Decreased appetite, Injection site pain, Pyrexia
Clinical narrative: CELLULITIS , FEBRILE,NOT EATING OR DRINKING, LEFT ARM PAIN.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Influenza like illness
Clinical narrative: Intense shakes, teeth chattering, stiff neck, locked jaw, then body would stiffen rigidly, then back to curled up and shaking uncontrollably...lasted several hours...next day, flu-like symptoms, sore joints, sore muscles, lack of appetite, exhausted (but it was a rough night.) It took four days for the malaise to lift.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Muscle rigidity, Musculoskeletal stiffness, Myalgia, Tremor
Clinical narrative: Intense shakes, teeth chattering, stiff neck, locked jaw, then body would stiffen rigidly, then back to curled up and shaking uncontrollably...lasted several hours...next day, flu-like symptoms, sore joints, sore muscles, lack of appetite, exhausted (but it was a rough night.) It took four days for the malaise to lift.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Trismus
Clinical narrative: Intense shakes, teeth chattering, stiff neck, locked jaw, then body would stiffen rigidly, then back to curled up and shaking uncontrollably...lasted several hours...next day, flu-like symptoms, sore joints, sore muscles, lack of appetite, exhausted (but it was a rough night.) It took four days for the malaise to lift.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injection site erythema, Injection site inflammation, Injection site pruritus, Malaise
Clinical narrative: Patient states that on 6/30/2018 she developed redness, inflammation and itching at injection site. She also complains of tiredness and not feeling well. As of today 7/2/2018 there is still redness with a defined border and inflammation and she still is feeling "unwell". I consulted patient to treat with ibuprofen for swelling and diphenhydramine for itching and ice pack as well.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: Patient states that on 6/30/2018 she developed redness, inflammation and itching at injection site. She also complains of tiredness and not feeling well. As of today 7/2/2018 there is still redness with a defined border and inflammation and she still is feeling "unwell". I consulted patient to treat with ibuprofen for swelling and diphenhydramine for itching and ice pack as well.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Post herpetic neuralgia
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 16-APR-2012, the patient was inoculated with ZOSTAVAX from her primary care physician at that time for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent and severe strain of herpes zoster. In approximately 2012 (reported as "shortly after" receiving ZOSTAVAX), the patient began to experience burning sensations near her hip and stomach. In response to these complaints, the patient presented to the same physician and was diagnosed as suffering from internal shingles and "posthepatic" (considered to mean post herpetic) neuralgia. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events were not recovered/not resolved (lawyer reported that currently, the patient continued to suffer from the effects of internal shingles and "posthepatic" neuralgia). Causality assessment was considered related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The reporting pharmacy intern stated that the patient experienced rash 2 to 3 days after vaccination with SHINGRIX. The reporter stated that she had no other information and that she spoke to the patient very briefly over the phone.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Gastrointestinal disorder, Headache, Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site redness, myalgia, gastrointestinal disturbance, headache, shivering, fever, fatigue and pain in arm. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site redness, myalgia, gastrointestinal disturbance, headache, shivering, fever, fatigue and pain in arm were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site redness, myalgia, gastrointestinal disturbance, headache, shivering, fever, fatigue and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age group of the patient was not reported, however it could be adult as per package insert of SHINGRIX. The age at vaccination was not reported. A healthcare provider who had administered 202 total doses of SHINGRIX reports that approximately 10 patients had reported having all adverse events that were listed in the prescribing information. Some reported a sore arm lasting 4 to 5 days, but all other reactions resolved within 1 to 3 days. There were no reports of any serious adverse events or any symptoms not noted in the prescribing information. The healthcare provider did not want to report a particular patient's experience. The incidence of adverse events came up casually while discussing an unrelated question. She feels that because what the patients experienced were common side effects and not alarming, she did not want to report them individually.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site redness, myalgia, gastrointestinal disturbance, headache, shivering, fever, fatigue and pain in arm. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site redness, myalgia, gastrointestinal disturbance, headache, shivering, fever, fatigue and pain in arm were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site redness, myalgia, gastrointestinal disturbance, headache, shivering, fever, fatigue and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age group of the patient was not reported, however it could be adult as per package insert of SHINGRIX. The age at vaccination was not reported. A healthcare provider who had administered 202 total doses of SHINGRIX reports that approximately 10 patients had reported having all adverse events that were listed in the prescribing information. Some reported a sore arm lasting 4 to 5 days, but all other reactions resolved within 1 to 3 days. There were no reports of any serious adverse events or any symptoms not noted in the prescribing information. The healthcare provider did not want to report a particular patient's experience. The incidence of adverse events came up casually while discussing an unrelated question. She feels that because what the patients experienced were common side effects and not alarming, she did not want to report them individually.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of adverse event in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that there were multiple doctors within the practice that had patients that are reporting adverse events with SHINGRIX. Most of the adverse events are from the VIS list. The health care professional did not have patient information or specific adverse event and said that she would gather all of the information and call GlaxoSmithKline medical information.
Age: 69.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 69-year-old female patient who received SHINGRIX (batch number 54KZ4, expiry date 25th August 2020) for prophylaxis. Concomitant products included Measles mumps rubella vaccine. On 2nd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, 2 days after receiving SHINGRIX, the patient experienced injection site rash and 3 days after the vaccination, the patient experienced injection site itching. On an unknown date, the outcome of the injection site rash was recovered/resolved and the outcome of the injection site itching was unknown. It was unknown if the reporter considered the injection site rash and injection site itching to be related to SHINGRIX. Additional information was reported as follows: The healthcare professional reported that the patient experienced rash & itchiness in an area of approximately 3 to 5 inches in diameter around vaccination site. The patient did not consult any health care professional or carried out the self administration of any medication. No further information was provided. This case was linked with case US2018GSK116968 (2nd dose), reported by the same reporter for the same patient.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo positional
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of benign paroxysmal positional vertigo in a 67-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included gastroesophageal reflux disease and blood pressure high. Concomitant products included Losartan and hydrochlorothiazide. On 24th April 2018, the patient received the 1st dose of SHINGRIX. In May 2018, 30 days after receiving SHINGRIX, the patient experienced benign paroxysmal positional vertigo. The patient was treated with Physical Therapy. On an unknown date, the outcome of the benign paroxysmal positional vertigo was not recovered/not resolved. It was unknown if the reporter considered the benign paroxysmal positional vertigo to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the physician. The patient's concomitant medication included gastroesophageal reflux disease (GERD) medication, and cholesterol medication. The patient received SHINGRIX in the left arm. One month later, the patient was diagnosed with benign paroxysmal positional vertigo (BPPV). The patient stated that, she was about 75 percent better and was doing physical therapy to deal with the condition. The patient stated that, it was unknown if the vaccine caused that condition, but it probably did not. The patient went to her doctor and they sent her to the emergency room when this first occurred.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 76-year-old female patient who received SHINGRIX (batch number B334Y, expiry date 17th October 2020) for prophylaxis. On 15th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 17th June 2018, 2 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: It was unknown if the consumer had previous cases of shingles or had received the ZOSTAVAX vaccine. Concomitant medications included unknown medication. At 14:30 hours, the patient received SHINGRIX in the left deltoid. On Monday, 18th June 2018, the patient went to her physician and was diagnosed with a mild case of Shingles. It was reported that the pharmacist was made aware of the event by a phone call from the consumer on Monday also. The pharmacist noted the physician was baffled that SHINGRIX would cause the case, but noted it was a milder case probably because of the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. On 6th June 2018, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The batch number for SHINGRIX was not reported. The healthcare professional stated that the patient developed rash above her lips after a dose of SHINGRIX. The patient went to her doctor and was treated in an outpatient clinic. The healthcare professional did not have any vaccine information at the time of reporting and did not want to provide the patient's date of birth.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 21st June 2018, the patient received the 2nd dose of SHINGRIX. On 22nd June 2018, 1 days after receiving SHINGRIX, the patient experienced shivering, upset stomach and fever. The patient was treated with TYLENOL and PEPCID. On an unknown date, the outcome of the shivering, upset stomach and fever were unknown. The reporter considered the shivering, upset stomach and fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. This case was not reported to anyone previously. The patient received SHINGRIX in the left arm a day before the reporting date. On 22nd June 2018, in the morning, the patient awoke with shivering, fever and upset stomach. The reporter had contacted the pharmacist, who advised TYLENOL and PEPCID. The reporter was referred to his wife's physician, as he was seeking treatment recommendations from GSK. The side effects of this kind reported in clinical trials were reviewed but noted not able to provide medical advice. The patient's husband had declined additional questions, and was requesting medical advice.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: 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 66-year-old female patient who received SHINGRIX (batch number 490558 ?, expiry date unknown GSK note: the reported lot number did not match with any GSK lot number) for prophylaxis. On 12th June 2018, the patient received SHINGRIX (intramuscular). In June 2018, less than a month after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovering/resolving. The reporter considered the injection site pain to be probably related to SHINGRIX. Additional details were provided as follows: The health care professional stated that the patient experience soreness at injection site after vaccination which was still on going as during the date of reporting. The health care professional stated that the soreness was improving and no swelling or bruising was present. The health care professional stated that the patient said soreness occurred after vaccination but unsure of time. The health care professional provided lot number but unsure if this was correct. The health care professional unsure of outcome but stated it was improving.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 69-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020) for prophylaxis. Previously administered products included ZOSTAVAX (received years before the date of reporting at her physician office). On 18th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 19th June 2018, 1 days after receiving SHINGRIX, the patient experienced fever. On 20th June 2018, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the injection site erythema and injection site swelling were recovering/resolving. It was unknown if the reporter considered the fever, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The patient did not receive any concomitant medication. The patient received SHINGRIX on left arm. The patient came back to the pharmacy 2 days later with a large swollen red area of 8cm by 5cm on her injection arm at the site. The swelling and redness were improving the patient reported when the reporter spoke with the patient on the day of reporting. The batch number reported 3NY3B for SHINGRIX did not exist and was changed to 5NY3B as per sales database.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Cardiac disorder, Headache, Mobility decreased, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included breast cancer. Concomitant products included LYRICA. On 11th June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, several hours after receiving SHINGRIX, the patient experienced fever, upset stomach, heart disorder and headache. On an unknown date, the outcome of the fever, upset stomach, heart disorder and headache were recovered/resolved. The reporter considered the fever, upset stomach, heart disorder and headache to be related to SHINGRIX. Additional details were provided as follows: The patient reported having the SHINGRIX vaccination at noon. The patient started having side effects at midnight that night. The patient was experienced high fever. The patient was unable to get out of bed for 3 days. The patient also felt that her heart didn't give her a full beat like her heart was weak and couldn't complete a full beat. The patient felt that she had these side effects because she only weighs 80 pounds.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Skin discolouration, Skin reaction, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin reaction in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 19th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced tiredness and sleepiness. On 19th June 2018, the patient experienced skin reaction and skin discoloration. The patient was treated with Cortisone Cream. On an unknown date, the outcome of the skin reaction and skin discoloration were recovering/resolving and the outcome of the tiredness and sleepiness were unknown. The reporter considered the skin reaction, tiredness and skin discoloration to be related to SHINGRIX. It was unknown if the reporter considered the sleepiness to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, (later that day) less than a day, the patient experienced skin reaction to her watch band, noted it was under the watch band that was colored red and less so to the watch band side colored blue. The patient had the watch over a month and had not had any reactions to it previously. The patient contacted the watch manufacturer and reported incident to them as well. The patient was using cortisone cream on the skin reaction and it was improving but not resolved yet. The patient experienced tiredness since getting the SHINGRIX. The patient had periods when riding the bus when she can barely stay awake and also she had slept about an hour later the past three days. The patient did not contact the physician. The patient had denied permission to contact their physician.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 21st June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In June 2018, less than a week after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved. The reporter considered the fever to be probably related to SHINGRIX. Additional details were provided as follows: The day before reporting (yesterday), the patient received SHINGRIX. After receiving SHINGRIX, the patient had a fever with body temperature of 100.3 degree F. On the day of reporting at morning, the patient called to the physician to report the fever.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema was unknown and the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The reporter asked whether pain and redness at the injection site were common side effects. The patient's arm was sore till the time of reporting. The reporter asked how long should this last.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza virus test negative, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of chills in a 62-year-old female patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020) for prophylaxis. On 5th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 6th March 2018, 1 days after receiving SHINGRIX, the patient experienced chills, general body pain and fever. On 7th March 2018, the outcome of the chills, general body pain and fever were recovered/resolved. The reporter considered the chills, general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient experienced chills, achy body and low grade fever. The patient was tested for the flu but was negative.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of adverse event in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, immediately after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was reported from emergency room for the patient that had just received SHINGRIX. The patient had multiple tests done to rule out other issues before emergency room provider ultimately agreed it must be from the vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Injection site reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pimples in a 69-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site rash (1st dose administered on 2nd April 2018 (refer case US2018111999)) and MMR vaccine. On 22nd June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 22nd June 2018, 10 min after receiving SHINGRIX, the patient experienced pimples and injection site reaction. On an unknown date, the outcome of the pimples and injection site reaction were unknown. The reporter considered the pimples and injection site reaction to be probably related to SHINGRIX. Additional information was reported as follows: The patient came to the pharmacy to receive her 2nd dose of SHINGRIX vaccine, at that time the pharmacist monitored that after her injection the patient had a small pimple appeared at the injection site.
Sex: U
Vaccine: MENB
Symptoms: Pallor, Pyrexia, Tremor
Clinical narrative: This is a spontaneous report from a contactable physician. An 18-year-old patient of an unspecified gender received TRUMENBA, via an unspecified route of administration on 26Jun2017 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient was pale, shaky, and had fever of 101.7 on 26Jun2017, an hour later after vaccination. There was no rash, no hives , and no shortness of breath. Outcome of the events was unknown. Follow-up activities are possible and information on the batch number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain lower, Dizziness, Dyspnoea, Headache, Heart rate increased
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program TRUMENBA Pharmacy Locator.  A contactable Nurse reported for a 20-Year-old female patient that received the 2nd injection of TRUMENBA at single dose on unknown date for immunization. Relevant medical history included abdominal pain, ongoing. Later that evening she went to the ER for nausea, feverish, light headed, headache, shortness of breath, right lower abdominal pain and elevated heart rate. Abdominal pain prior to injected. Similar reacted to 1st injection not as severe. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: MENB
Symptoms: Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program TRUMENBA Pharmacy Locator.  A contactable Nurse reported for a 20-Year-old female patient that received the 2nd injection of TRUMENBA at single dose on unknown date for immunization. Relevant medical history included abdominal pain, ongoing. Later that evening she went to the ER for nausea, feverish, light headed, headache, shortness of breath, right lower abdominal pain and elevated heart rate. Abdominal pain prior to injected. Similar reacted to 1st injection not as severe. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Confusional state, Electromyogram, Grip strength decreased
Clinical narrative: Pain in arm, injection site muscle, loss of strength in forearm. Inability to use that hand for grasping, severe pain down entire arm. Confusion. Had tetanus shot from getting punctured by rusty old nail. Person giving vaccine said she wasn't very good giving shot in left arm because she's left handed very painful at right injection site that day then muscle loss and coordination in that arm and hand set in. Became severe so went to PCP who didn't think the shot could cause this but ordered EMG. Those results said it's outcome was abnormal and warranted further testing. So had the abnormal and warranted further testing. So had the MRI and ultrasound test. Have seen a orthopedic surgeon and appointment to see him again. As of today no one had an answer, muscle still wasting and cannot grip with that hand. This all started after (soon) this injection was given. Through this all there has been joint pain in my wrist and stiffness as well as my elbow.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site reaction, Joint stiffness, Muscle atrophy, Musculoskeletal disorder
Clinical narrative: Pain in arm, injection site muscle, loss of strength in forearm. Inability to use that hand for grasping, severe pain down entire arm. Confusion. Had tetanus shot from getting punctured by rusty old nail. Person giving vaccine said she wasn't very good giving shot in left arm because she's left handed very painful at right injection site that day then muscle loss and coordination in that arm and hand set in. Became severe so went to PCP who didn't think the shot could cause this but ordered EMG. Those results said it's outcome was abnormal and warranted further testing. So had the abnormal and warranted further testing. So had the MRI and ultrasound test. Have seen a orthopedic surgeon and appointment to see him again. As of today no one had an answer, muscle still wasting and cannot grip with that hand. This all started after (soon) this injection was given. Through this all there has been joint pain in my wrist and stiffness as well as my elbow.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Ultrasound scan, Wound
Clinical narrative: Pain in arm, injection site muscle, loss of strength in forearm. Inability to use that hand for grasping, severe pain down entire arm. Confusion. Had tetanus shot from getting punctured by rusty old nail. Person giving vaccine said she wasn't very good giving shot in left arm because she's left handed very painful at right injection site that day then muscle loss and coordination in that arm and hand set in. Became severe so went to PCP who didn't think the shot could cause this but ordered EMG. Those results said it's outcome was abnormal and warranted further testing. So had the abnormal and warranted further testing. So had the MRI and ultrasound test. Have seen a orthopedic surgeon and appointment to see him again. As of today no one had an answer, muscle still wasting and cannot grip with that hand. This all started after (soon) this injection was given. Through this all there has been joint pain in my wrist and stiffness as well as my elbow.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Blood test, Chills, Computerised tomogram, Decreased appetite
Clinical narrative: Pain, redness, swelling at injection site Muscle pain, tiredness, headache, shivering, fever, upset stomach, no appetite for 2 weeks.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness, swelling at injection site Muscle pain, tiredness, headache, shivering, fever, upset stomach, no appetite for 2 weeks.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Urine analysis
Clinical narrative: Pain, redness, swelling at injection site Muscle pain, tiredness, headache, shivering, fever, upset stomach, no appetite for 2 weeks.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: The day following vaccination, pt. experience fever and flu like symptoms for 24 - 36 hours. Injection arm was red, warm, and swollen x 1 wk.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Febrile convulsion, Vomiting
Clinical narrative: VOMITING AND FEBRILE SEIZURE.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Patient is unable to lift or move left arm due to pain from to vaccine. Patient stated that she had a fever the day of the vaccine and has been running a low grade fever off and on since then.
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cough, Influenza like illness, Oropharyngeal pain, Pyrexia
Clinical narrative: Patient had flu-like symptoms including sore throat, fever, and cough. Symptoms lasted two days and were self resolving.