chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Starting 10 days after shot was administered, patient noticed 607 itchy red spots on various parts of his body, followed by very stiff neck, fever, aching joints, headache, tiredness, and general malaise. As of 9/24 (14 days after vaccine given) symptoms have improved, still a few spots but less red and aching joints still present but improved. Patient is under care of PCP and will also be consulting an immunologist to determine if he should receive the second dose or not. PCP is observing and did not suggest any specific treatment.
Age: 27.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Diarrhoea, Exposure during pregnancy, Feeling hot, Nausea, Pain in extremity
Clinical narrative: Patient is 13 weeks 4 days pregnant, EDD 3-28-2019. Patient had 2 vaccines - Hep A and flu vaccine on (9/20) - shortly after pt reported soreness on her right side and arm. That night she developed nausea, diarrhea and a general warm feeling over body although she was afebrile. The patient reports vomiting a couple times in the morning though she was able to drink fluids and keep them down. The patient's symptoms resolved on the morning of (9/22).
Age: 27.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Vomiting
Clinical narrative: Patient is 13 weeks 4 days pregnant, EDD 3-28-2019. Patient had 2 vaccines - Hep A and flu vaccine on (9/20) - shortly after pt reported soreness on her right side and arm. That night she developed nausea, diarrhea and a general warm feeling over body although she was afebrile. The patient reports vomiting a couple times in the morning though she was able to drink fluids and keep them down. The patient's symptoms resolved on the morning of (9/22).
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea
Clinical narrative: Participant states first flu vaccine. Staff, requested her to remain in area for observation following administer of vaccine. Beginning 09:50, participant stated at 09:57 slight dizziness and nausea; no SOB; no itching; no other symptoms. Participant was monitored. B/P readings as follows: 09:57 B/P 124/70, Pulse 78. At 10:05 am BP 126/70; Pulse 80. 10:12 a.m. Blood pressure 118/80, Pulse 70. RN reassessed. Nursing Director, contacted; participant will be escorted by event lead, to Employee Health for further evaluation. Note: Employee went directly to E.R. from Employee Health Department. I do not have access to that record.
Age: 79.0
Sex: M
Vaccine: HEPA
Symptoms: Arthralgia, Loss of personal independence in daily activities, Musculoskeletal discomfort, Musculoskeletal pain, Pain in extremity
Clinical narrative: After a day or so began to feel ache/pain in shoulder, elbow, wrist, finger joints, knee and ankle. Initially, I assumed this was the result of working in the yard, since I had had some left shoulder and knee aches in the past. However, I had not experienced elbow, wrist, ankle and finger joint pain like these previously. The pains in the elbow, wrist, ankle and finger joints were not severe but discomforting and somewhat limiting in some activities. The shoulder pain was more depending on position and what I was attempting to do. However, the shoulder pain may have been the result of specific activity and possibly aggravated by a possible reaction to the immunization. The knee discomfort may be similar. The reason I had not provided this information earlier was that I was not sure if there was an association between the injection and the subsequent joint discomfort experienced. However, after a discussion with others, I prepared the attached. [Note: I use a laptop and could not add the information on this page, thus I send it as a continuation/addition]. The joint discomfort occurred a day or so after the injection but I thought it may be related to working in the yard, the same day of the injection and subsequently thereafter. However, the joint discomfort continued and lasted about three weeks. Then the elbow, wrist, ankle, finger joint discomfort had subsided. However, I was continuing the same type of activity over this entire period. Also, I have continued this activity throughout the summer with no reoccurrence of the joint discomfort/pain indicated. The shoulder discomfort/pain continued but I feel that was related to what I was doing. Same for knee discomfort. I have not had any reoccurrence of the elbow, wrist, ankle and finger joint discomfort/pain after about the third week of July. As indicated, I am not sure the joint issues I had experienced were directly related to the immunization but had not experienced these indicated joint issues previous to the immunization. I am scheduled for the second "dose" of the HAVRIX, and will mention my experience related to the first "dose".
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Localized reaction to (R) deltoid injection site with erythema, edema, pain, induration (Large).
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site reaction of swelling, redness, hot, and painful. Redness persisted 4 days and went 3/4 around upper arm. Tempature of 101 on day 3 with chills and nausea. Day 2 swelling was 4.5 in x 3 in. Day 3 redness increased to 7 in x 5 in.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Nausea
Clinical narrative: Injection site reaction of swelling, redness, hot, and painful. Redness persisted 4 days and went 3/4 around upper arm. Tempature of 101 on day 3 with chills and nausea. Day 2 swelling was 4.5 in x 3 in. Day 3 redness increased to 7 in x 5 in.
Age: 59.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Balance disorder, Dysphagia, Hypoaesthesia, Immunoglobulin therapy, Limb discomfort
Clinical narrative: Pt received her influenza vaccine & TDAP Vaccine 8/28/18 (her first time getting influenza vaccine). No recent illnesses. Developed neck, upper back, bilat arm discomfort on 9/12/18 progressing to both legs with bilateral arm weakness and numbness in hands to the point that she was no longer steady on her feet. Tingling started in her feet and progressed up her legs. Pt with mild swallowing difficulty. IVIG 40g x3 doses started 9/15/18. Patient was discharged to Rehab hospital, but required readmission for plasmapheresis treatments 9/23/18.
Age: 59.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Muscular weakness, Musculoskeletal discomfort, Paraesthesia, Plasmapheresis
Clinical narrative: Pt received her influenza vaccine & TDAP Vaccine 8/28/18 (her first time getting influenza vaccine). No recent illnesses. Developed neck, upper back, bilat arm discomfort on 9/12/18 progressing to both legs with bilateral arm weakness and numbness in hands to the point that she was no longer steady on her feet. Tingling started in her feet and progressed up her legs. Pt with mild swallowing difficulty. IVIG 40g x3 doses started 9/15/18. Patient was discharged to Rehab hospital, but required readmission for plasmapheresis treatments 9/23/18.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Autopsy, Death
Clinical narrative: Received call from patient parent. Patient died on Friday September 21st in the ER. Limited details available. Believe autopsy is pending.
Age: 40.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre syndrome.
Age: 40.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Areflexia, CSF immunoglobulin increased, CSF protein increased, Facial paresis, Guillain-Barre syndrome
Clinical narrative: Guillain Barre syndrome.
Age: 40.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Paraesthesia
Clinical narrative: Guillain Barre syndrome.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Skin reaction
Clinical narrative: Per Dr. -localized skin reaction to flu vaccine, no anaphylaxis, and no presentation of flu vaccine reaction.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Employee received vaccine 9/21/2018, reports hives on 9/22/2018 in the afternoon. States he took BENADRYL with relief of hives. States today 9/24/2018 "I'm totally fine now, last BENADRYL was 9/23/2018 at 11:30 PM".
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: The patient was unable to move for 4 days starting the evening of the dose. He had to call his daughter to help him get dressed. The symptoms resolved without lasting effects or medical intervention.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Discomfort, Dizziness, Headache, Hypotension
Clinical narrative: 9/17 PATIENT RECORDS BREAKING OUT IN RASH AND HEADACHE, HAD A HIP INJECTION (UNKNOWN MEDICATION) ON 9/17, AND RASH RETURNED ON 9/20, ON 9/24 PATIENT REPORTS HAVING RASH (LESSENED) AND LOW BLOOD PRESSURE (STATES approximately 120/approximately 60 MMHG), DIZZINESS, UPSET STOMACH AND GENERAL DISCOMFORT. PATIENT DID NOT TAKE HER BLOOD PRESSURE MEDICATION ON 9/24.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: 9/17 PATIENT RECORDS BREAKING OUT IN RASH AND HEADACHE, HAD A HIP INJECTION (UNKNOWN MEDICATION) ON 9/17, AND RASH RETURNED ON 9/20, ON 9/24 PATIENT REPORTS HAVING RASH (LESSENED) AND LOW BLOOD PRESSURE (STATES approximately 120/approximately 60 MMHG), DIZZINESS, UPSET STOMACH AND GENERAL DISCOMFORT. PATIENT DID NOT TAKE HER BLOOD PRESSURE MEDICATION ON 9/24.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Swelling face, Throat tightness, Urticaria
Clinical narrative: Puffy face, hives, tightness of breath.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: Light headedness, dizziness.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site reaction, Lymphadenopathy, Pain, Rash erythematous
Clinical narrative: Red rash under bicep of left arm and into the armpit area and down side towards left breast. Tenderness to touch. Swollen lymph nodes in the armpit area of left arm. Day after injection patient stated she could not lift/raise her left arm. Patient started taking over the counter ibuprofen to reduce pain and swelling.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Red rash under bicep of left arm and into the armpit area and down side towards left breast. Tenderness to touch. Swollen lymph nodes in the armpit area of left arm. Day after injection patient stated she could not lift/raise her left arm. Patient started taking over the counter ibuprofen to reduce pain and swelling.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Axillary mass, Erythema, Skin warm
Clinical narrative: Patient had lump under armpit, red, and hot.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Blood test, Chest pain, Headache
Clinical narrative: Chest pain, headache, fever, nausea, joint pain, muscle pain and weakness.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Chest pain, headache, fever, nausea, joint pain, muscle pain and weakness.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Skin discolouration
Clinical narrative: Significant bruising of entire deltoid. Patient said bruising develeoped approximately 2 days after receiving vaccine. Was originally very dark black/purple. As of today 9/24/18 it is very purple with a yellow border.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Induration, Mass, Swelling
Clinical narrative: Red, swollen, hard lump. Patient was taken to the MD and MD stated it was cellulitis. Patient is now on steroids and antibiotics.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Fatigue, Headache, Inflammation, Pyrexia
Clinical narrative: Received vaccination the evening of 9/20/18 after waking up on 9/21/18 patient noticed she had a fever at 10:00am. Also was experiencing a headache that morning. Started developing redness and inflammation at the halfway point of the upper arm which eventually extended to just below the elbow. Still having redness and inflammation as of today but less than it was. The fever lasted till the night of 9/23/18 fluctuating between 99-104. Patient took IBU to treat the fever which lasted about 2 hours per dose. By the morning of 9/23/18 the headaches had resolved. Patient was also experiencing fatigue 9/21 thru 9/23/18.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, itching, redness at injection site that increased to a 6 inch diameter and lasted 2 weeks. Very painful.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, itching, redness at injection site that increased to a 6 inch diameter and lasted 2 weeks. Very painful.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 13th September 2018, the patient received SHINGRIX. On 13th September 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, chills, fever and mobility decreased. On an unknown date, the outcome of the pain in arm, chills and fever were unknown and the outcome of the mobility decreased was recovered/resolved. It was unknown if the reporter considered the pain in arm, chills, fever and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. On the evening of vaccination, the patient experienced arm pain, and was unable to move it for a while. The patient also experienced fever and chills.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site rash in a adult female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 2 days after receiving SHINGRIX, the patient experienced injection site rash, injection site erythema and injection site swelling. In August 2018, the outcome of the injection site rash, injection site erythema and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site rash, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm. The healthcare professional was unsure of the date the dose was given, but stated it was in middle August. Beginning 2 days after receiving SHINGRIX, the patient experienced a red, raised, swollen, rash area, below the injection site, which resolved after 4 days. No treatment was required. The vaccine was administered at the patient's pharmacy and not by the reporting doctor.
Age: 81.0
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 81-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date February 2019) for prophylaxis. On 28th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, 30 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The patient developed full blown shingles, 1 month following the injection. The caller stated that the patient's doctor advised her not to get the 2nd dose. The caller stated that the doctor prescribed the patient a few medications to treat the symptoms. No additional information was provided. This case has been linked with US2018167901 and US2018167902, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, 1 day after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site irritation. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site irritation were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site irritation to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The caller was only able to provide gender for the patient, date of birth and initials were not known. The patient experienced a raised area at the injection site following SHINGRIX. The caller did not remember any other details regarding the event. The caller stated that she believed the patient received the injection sometime in September 2018, but could not recall the exact date. This case has been linked with US2018167901 and US2018167898, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of numbness facial in a female patient who received SHINGRIX for prophylaxis. Concomitant products included FLUZONE. On 11th September 2018, the patient received SHINGRIX. On 13th September 2018, 2 days after receiving SHINGRIX, the patient experienced numbness facial. On an unknown date, the outcome of the numbness facial was not recovered/not resolved. It was unknown if the reporter considered the numbness facial to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. On 6th September 2018, the patient was vaccinated with FLUZONE vaccine. The healthcare professional did not want to provide any further information. The reporter did not knew which vaccine caused the reaction so she was contacted all the pharmaceutical companies involved before providing further information.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Accidental underdose, Regurgitation, Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of regurgitation of medication in a 4-month-old female patient who received ROTARIX lyophilized formulation (batch number 23K4J, expiry date 14th October 2019) for prophylaxis. On 14th September 2018, the patient received the 2nd dose of ROTARIX lyophilized formulation (oral). On 14th September 2018, immediately after receiving ROTARIX lyophilized formulation, the patient experienced regurgitation of medication, vomiting and accidental underdose. On an unknown date, the outcome of the regurgitation of medication, vomiting and accidental underdose were unknown. It was unknown if the reporter considered the regurgitation of medication and vomiting to be related to ROTARIX lyophilized formulation. Additional details were provided as follows: The healthcare professional (HCP) reported that while administering the ROTARIX to the patient spit out some of the medication. The reporter stated that, they had to cancel the revaccination as the patient was spitting out the medication and vomiting. No side effects were reported.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Colitis ulcerative, Condition aggravated
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ulcerative colitis in a 72-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included ulcerative colitis (diagnosed back in the 1980's). On 5th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 5th June 2018, 31 days after receiving SHINGRIX, the patient experienced ulcerative colitis (serious criteria GSK medically significant) and condition aggravated. On an unknown date, the outcome of the ulcerative colitis and condition aggravated were not recovered/not resolved. It was unknown if the reporter considered the ulcerative colitis and condition aggravated to be related to SHINGRIX. Additional details were reported as follows: The reporter was the patient, who received SHINGRIX vaccine in an unknown arm. The patient was seen by physician. On 19th September 2018, the patient planned to follow-up with her physician.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a male 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 adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was asking how long side effects would last.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 62-year-old female patient who received SHINGRIX (batch number 957J3, expiry date 15th November 2020) for prophylaxis. On 29th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 29th August 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, injected limb mobility decreased and injection site pain. On 1st September 2018, the outcome of the injected limb mobility decreased and injection site pain were recovered/resolved. On an unknown date, the outcome of the influenza-like symptoms was recovering/resolving. The reporter considered the influenza-like symptoms, injected limb mobility decreased and injection site pain to be unrelated to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in unknown arm. The patient experienced flu like symptoms. Arm unable to be raised or sore to touch at site of injection for day.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Blood pressure decreased, Headache, Heart rate decreased, Syncope, Vomiting
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of syncope in a 6-month-old female patient who received BEXSERO for prophylaxis. Co-suspect products included GARDASIL 9 for prophylaxis. On 22nd July 2018, the patient received the 1st dose of BEXSERO and the 2nd dose of GARDASIL 9. On 22nd July 2018, 1 min after receiving BEXSERO, the patient experienced syncope, headache, vomiting, blood pressure decreased and heart rate decreased. On an unknown date, the outcome of the syncope, headache, vomiting, blood pressure decreased and heart rate decreased were unknown. It was unknown if the reporter considered the syncope, headache, vomiting, blood pressure decreased and heart rate decreased to be related to BEXSERO. Additional details were provided as follows: The patient was given BEXSERO along with GARDASIL 9 and the patient experienced syncope a minute later, along with headache and vomiting. The blood pressure dropped from 112/72 to 90/64 mmHg and heart rate dropped to low 50's. The patient was held at office 2 to 3 hours for observation and released from clinic's care due to improvement. It was unknown if the reporter considered the syncope, headache, vomiting, blood pressure decreased and heart rate decreased to be related to GARDASIL 9 as well.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Insomnia, Pain in extremity, Tenderness, Ultrasound therapy
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a 69-year-old male patient who received SHINGRIX (batch number L7F7E, expiry date 22nd November 2020) for prophylaxis. The patient's past medical history included shingles (1st episode) and shingles (2nd episode in 2012). Previously administered products included ZOSTAVAX (in 2012, vaccinated 3 mos following resolution of 2nd episode). On 23rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, burning sensation, tenderness and insomnia. The patient was treated with gabapentin, TYLENOL, SKELAXIN and narcotics, nos. On an unknown date, the outcome of the pain in arm, burning sensation, tenderness and insomnia were recovered/resolved. The reporter considered the pain in arm, burning sensation, tenderness and insomnia to be related to SHINGRIX. Additional details were reported as follows: The healthcare professional reported localized pain he felt following SHINGRIX in his left arm. The healthcare professional said pain was 8 by 10 and described as burning, tenderness that lasted for 7 days. The healthcare professional stated he couldn't sleep the night he got the vaccine due to the pain. The pain decreased over the 7 days. The healthcare professional took TYLENOL 650 mg Q6 hours for 7 days, gabapentin 300 mg QD for 7 days, and SKELAXIN 300 mg QHS for 5 days. The healthcare professional stated SKELAXIN did not help with the pain but he still took it anyways in attempt to relieve pain. The healthcare professional stated he almost resorted to prescription narcotics for the pain but got some relief after receiving some ultrasound. The healthcare professional denied any other signs or symptoms of adverse events following vaccination, like redness or swelling. The healthcare professional stated the vaccine caused the adverse events but did not seek care at emergency room, did not require hospitalization. He was able to resume work 5 days post vaccination. He works part time and this did not affect his work schedule. The healthcare professional did not have information about vaccine lot number, expiration, date of administration on him. Waiting for his nurse to call back with this information. The healthcare professional stated this adverse event was reported by another GlaxoSmithKline employee but he didn't know the person's name.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of tiredness in a 64-year-old male 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 tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved. It was unknown if the reporter considered the tiredness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported, but it could either be 63 or 64 years of age. The patient said after taking the vaccine he was very tired. He found it very unusual so he had trouble finishing patients in the afternoon normally he was the Energizer bunny, but he felt very tired and it lasted about a week. The patient told the medical representative about the event directly. The duration of the event, he said for almost like a week. He had not decided to take the second dose yet because of the side effects.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of cellulitis in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 27th July 2018, the patient received SHINGRIX. On 30th July 2018, 3 days after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant). The patient was treated with antibiotics nos and steroids nos. On an unknown date, the outcome of the cellulitis was unknown. It was unknown if the reporter considered the cellulitis to be related to SHINGRIX. Additional information received as follows: The case was reported by the registered nurse, clinic manager. On 30th July 2018, the patient noticed reaction. The patient was issued antibiotics and steroid. The reporter agreed to follow up from GlaxoSmithKline.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Product storage error
Clinical narrative: Initial information received on 11-Sep-2018 regarding an unsolicited pregnancy valid non-serious case received from a nurse. This case is linked to case 2018SA258055 (same reporter). This case involves a 20 years old female patient who received 0.5 ml booster dose of ADACEL (expiry date 22 June 2020 and lot details U5980DA) on 10 Sep 2018 while she was pregnant. It was a case of vaccine exposure during pregnancy. The patient was at 32 weeks gestational age at the time of event. The date of last menstrual period was reported as unknown. The estimated due date is 06-Nov-2018 (based on ultrasound). The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient had no concomitant. It was a case actual medication error due to incorrect product storage as adacel too long in shipping (greater than 2 days) after dose given to pregnant female outside of stability recommendations. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Facial pain, Fatigue, Headache, Neck pain, Sluggishness
Clinical narrative: Initial information received on 11-Sep-2018 regarding an unsolicited valid non-serious case received from a non-health professional. This case involves a 63 years old female patient who experienced neck pain, facial pressure, sluggish movement, she feels like something is in her throat, headache and fatigue, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Oct-2017, patient received a 0.5 mL dose of suspect FLUZONE QUADRIVALENT lot 00844621A via unknown route in the left deltoid (Frequency- once). On an unknown date, the patient developed a non-serious neck pain, facial pressure (facial pain), sluggish movement (hypokinesia), she feels like something is in her throat (throat irritation), headache and fatigue, following the administration of FLUZONE QUADRIVALENT. The patient had visited the office on 31-Oct-2017, 24-Jan-2018 and 08-Aug-2018. Relevant tests were not reported. Final diagnosis was fatigue, headache, she feels like something is in her throat, sluggish movement, facial pressure and neck pain. It was not reported if the patient received a corrective treatment. The patient was not recovered from the events. Documents held by sender: none.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Throat irritation
Clinical narrative: Initial information received on 11-Sep-2018 regarding an unsolicited valid non-serious case received from a non-health professional. This case involves a 63 years old female patient who experienced neck pain, facial pressure, sluggish movement, she feels like something is in her throat, headache and fatigue, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Oct-2017, patient received a 0.5 mL dose of suspect FLUZONE QUADRIVALENT lot 00844621A via unknown route in the left deltoid (Frequency- once). On an unknown date, the patient developed a non-serious neck pain, facial pressure (facial pain), sluggish movement (hypokinesia), she feels like something is in her throat (throat irritation), headache and fatigue, following the administration of FLUZONE QUADRIVALENT. The patient had visited the office on 31-Oct-2017, 24-Jan-2018 and 08-Aug-2018. Relevant tests were not reported. Final diagnosis was fatigue, headache, she feels like something is in her throat, sluggish movement, facial pressure and neck pain. It was not reported if the patient received a corrective treatment. The patient was not recovered from the events. Documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pruritus, Injection site swelling
Clinical narrative: Initial information received on 11-Sep-2018 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves a 58 years old female patient who experienced hot, red and swollen, injection site hard knot and severe itching, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included Food allergy and anaphylactic reaction. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in the left deltoid. On an unknown date, the patient developed a non-serious the injection site in the left deltoid, became hot, red and swollen (vaccination site inflammation) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious injection site hard knot (vaccination site nodule) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious severe itching (vaccination site pruritus) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. (Other relevant tests included no lab data.) Final diagnosis was severe itching, injection site hard knot and the injection site in the left deltoid, became hot, red and swollen. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for the injection site in the left deltoid, became hot, red and swollen, as Unknown for injection site hard knot and as Unknown for severe itching. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth
Clinical narrative: Initial information received on 11-Sep-2018 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves a 58 years old female patient who experienced hot, red and swollen, injection site hard knot and severe itching, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included Food allergy and anaphylactic reaction. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in the left deltoid. On an unknown date, the patient developed a non-serious the injection site in the left deltoid, became hot, red and swollen (vaccination site inflammation) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious injection site hard knot (vaccination site nodule) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious severe itching (vaccination site pruritus) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. (Other relevant tests included no lab data.) Final diagnosis was severe itching, injection site hard knot and the injection site in the left deltoid, became hot, red and swollen. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for the injection site in the left deltoid, became hot, red and swollen, as Unknown for injection site hard knot and as Unknown for severe itching. List of documents held by sender: none.
Age: 0.75
Sex: M
Vaccine: HEP, HIBV, IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 07-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 9 months old male patient who received unstable vaccine IPOL which was in temperature excursion (open) and temperature maximum was 11.5 degree C for 1 hour 46 min. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication received Hep B and HIB. On 24-Aug-2018, the patient received a dose of suspect IPV (VERO) lot N1J45 expiry date: 05-Oct-2019 via intramuscular route in the left thigh. It was a case of actual medication error due to incorrect product storage and deteriorated drug administered. It was not reported that if any adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 25 years old male patient who received vaccine  FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.25ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6259JA. It was a case of actual medication error due to vaccine underdose. It was unknown any adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLUR4, HPV4, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non HCP (office staff). This case is linked to case 2018SA260284 (same reporter). This case involves a 17 years old male patient received vaccine FLUBLOK QIV. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ADACEL for Immunization; and GARDASIL for Immunization. On 04-Sep-2018, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot 2FAA1802 via unknown route and site of administration. It was a case of actual medication error due to inappropriate age at vaccination. It was not reported that any adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site swelling, Local reaction
Clinical narrative: Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves female patient (between the ages of 50 and 64) who experienced local reaction two years in a row/ swelling on the upper part of her arm so bad that she couldnt put her arm all the way down, while she received vaccine FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number, expiry date not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious couldnt put her arm all the way down (injected limb mobility decreased) with unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious local reaction/swelling on the upper part of her arm (vaccination site swelling) with unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This would last two weeks. Relevant tests were not reported. Final diagnosis was local reaction/swelling on the upper part of her arm and couldnt put her arm all the  way down. It was not reported if the patient received a corrective treatment. The outcome of the event reported as unknown. List of documents held by sender- none.
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Dizziness, Palpitations
Clinical narrative: Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves female patient of an unknown age who experienced heart racing, diarrhea and felt dizzy (light-headed), while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included Celiac disease and Autoimmune thyroiditis. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On 12-Sep-2018, the patient received a dose of suspect FLUZONE QUADRIVALENT lot UI975AC via unknown route in the left deltoid (dose not reported). On an unknown date, the patient developed a non-serious heart racing (palpitations) and felt dizzy (light-headed) (dizziness), one hour following the administration of  FLUZONE QUADRIVALENT. On 13-Sep-2018, the patient developed a non-serious diarrhea (diarrhoea), one-day (next morning) following the administration of FLUZONE QUADRIVALENT.  Relevant tests were not reported. Final diagnosis was felt dizzy (light-headed), diarrhea and heart racing. It was not reported if the patient received a corrective treatment. The patient was recovering from the events. Documents held  by sender: none.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Extensive swelling of vaccinated limb, Feeling hot, Infection, Inflammation
Clinical narrative: Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 75 years old female patient who experienced swelling in her left forearm up to her clavicle and heat, redness and pain in this arm, entire muscle was infected all the way up to her neck, It's like the entire muscle is infected, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOVAX 23 for Immunisation. On 12-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI994AA, expiry date: 09-Apr-2019 in the left deltoid. On 12-Sep-2018, the patient developed a non-serious swelling in her left forearm up to her clavicle on that same night, following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, the patient developed a non-serious heat, redness and pain in this arm and entire muscle was infected all the way up to her neck, It's like the entire muscle is infected, following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The Caller called to report this incidence in case this lot was contaminated. Relevant tests were not reported. Final diagnosis was heat, redness and pain in this arm and swelling in her left forearm up to her clavicle and entire muscle was infected all the way up to her neck, It's like the entire muscle is infected. The patient received an unspecified antibiotics as corrective treatment. The outcome of the events was not reported. List of documents held by the sender: none.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 75 years old female patient who experienced swelling in her left forearm up to her clavicle and heat, redness and pain in this arm, entire muscle was infected all the way up to her neck, It's like the entire muscle is infected, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOVAX 23 for Immunisation. On 12-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI994AA, expiry date: 09-Apr-2019 in the left deltoid. On 12-Sep-2018, the patient developed a non-serious swelling in her left forearm up to her clavicle on that same night, following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, the patient developed a non-serious heat, redness and pain in this arm and entire muscle was infected all the way up to her neck, It's like the entire muscle is infected, following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The Caller called to report this incidence in case this lot was contaminated. Relevant tests were not reported. Final diagnosis was heat, redness and pain in this arm and swelling in her left forearm up to her clavicle and entire muscle was infected all the way up to her neck, It's like the entire muscle is infected. The patient received an unspecified antibiotics as corrective treatment. The outcome of the events was not reported. List of documents held by the sender: none.