chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray abnormal, Influenza virus test negative, Pneumonia
Clinical narrative: This spontaneous report was received from a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. In approximately 2016 (reported as "about 2 years ago"), the patient was vaccinated with an unspecified pneumococcal vaccine, polyvalent (23-valent)(route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis (reported as " to avoid pneumonia"). On approximately 02-MAR-2017(reported as "3 weeks ago"), the patient reported that she thought she had the flu and visited an unspecified hospital which said she tested negative for flu, and an X-Ray was performed to the patient that showed pneumonia in her right lung. At the time of the report, the patient stated she was fine. She did not provide the name of her physician or the hospital that diagnosed her with pneumonia. The patient did not mention the causality assessment between the event of pneumonia, and the unspecified pneumococcal vaccine, polyvalent (23-valent). Upon internal review, pneumonia was determined to be medically significant.
Sex: F
Vaccine: HPV4
Symptoms: Neurological symptom
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date in 2015, the patient was vaccinated with GARDASIL (dose, units and frequency not reported) (lot# and expiration date not reported), intramuscularly as middle school vaccine. On an unknown date in 2015, the patient experienced unspecified neurological reaction and was referred to an unspecified neurologist and told that the unspecified neurological reaction (neurological symptom) might have been caused by GARDASIL. The outcome of the event neurological symptom was not reported. The reporter did not provide the causal relationship for the event neurological symptom. No product quality complaint was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a patient who received SHINGRIX. On 23rd March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced localized erythema (serious criteria other: as per reporter). On an unknown date, the outcome of the localized erythema was unknown. The reporter considered the localized erythema to be probably related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The healthcare professional reported that the patient reported to the emergency room on 26th March 2018 complaining of redness on chest and redness on both arms. Reporting healthcare professional was not able to provide patient details and vaccine lot number and expiration date. The healthcare professional only reported that the patient had chest and arm redness but did not know when it started. The healthcare professional was calling on behalf of the emergency room physician and was not able to give any other details at that moment because they were only asking for a recommendation on how to treat the patient. The patient was currently in the emergency room when the healthcare professional contacted them. The emergency room physician who contacted the healthcare professional believed the reaction was caused by the SHINGRIX and would like a recommendation on whether or not it was an anaphylactic reaction or a less severe reaction.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Biopsy muscle abnormal, Blood creatine phosphokinase increased, C-reactive protein increased, Muscular weakness
Clinical narrative: 10/23/17 Patient seen in office for profound aching in muscles and weakness. Pt found to have 11/6/17 elevated CRP and CK on ER visit. 11/9/17 Muscle biopsy inflammatory myopathy.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Myalgia, Myopathy
Clinical narrative: 10/23/17 Patient seen in office for profound aching in muscles and weakness. Pt found to have 11/6/17 elevated CRP and CK on ER visit. 11/9/17 Muscle biopsy inflammatory myopathy.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Breast tenderness, Herpes zoster, Hyperaesthesia, Scab
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of shingles in a 76-year-old female patient who received SHINGRIX (batch number 5Z5LX, expiry date 30th January 2020). The patient's past medical history included shingles. On 16th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a year after receiving SHINGRIX, the patient experienced breast tenderness, blister, crust and scratch. On 24th March 2018, the patient experienced shingles (serious criteria other: as per reporter). The patient was treated with FAMVIR. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the breast tenderness, blister, crust and scratch were unknown. The reporter considered the shingles to be unlikely related to SHINGRIX. It was unknown if the reporter considered the breast tenderness, blister, crust and scratch to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in right deltoid. The healthcare professional (HCP) stated that, the patient was diagnosed with shingles about 1 month after receiving the SHINGRIX vaccine. The patient reported with sensitivity and small, sparse, blisters started on her right breast and gone towards the back, about 3 to 4 cm in width. The patient had a few blisters that did crust over and were scratched off prior to the week of reporting, so the HCP was unsure of the exact start date of the shingles. The HCP did not think this was due to the vaccine. The HCP stated yes for the question that, the event required an intervention to prevent an outcome because they had to start the patient on FAMVIR 500 mg three times daily. The reported lot number (575LX) for SHINGRIX did not exist and was updated to 5Z5LX, according to sales database.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Scratch
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of shingles in a 76-year-old female patient who received SHINGRIX (batch number 5Z5LX, expiry date 30th January 2020). The patient's past medical history included shingles. On 16th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a year after receiving SHINGRIX, the patient experienced breast tenderness, blister, crust and scratch. On 24th March 2018, the patient experienced shingles (serious criteria other: as per reporter). The patient was treated with FAMVIR. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the breast tenderness, blister, crust and scratch were unknown. The reporter considered the shingles to be unlikely related to SHINGRIX. It was unknown if the reporter considered the breast tenderness, blister, crust and scratch to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in right deltoid. The healthcare professional (HCP) stated that, the patient was diagnosed with shingles about 1 month after receiving the SHINGRIX vaccine. The patient reported with sensitivity and small, sparse, blisters started on her right breast and gone towards the back, about 3 to 4 cm in width. The patient had a few blisters that did crust over and were scratched off prior to the week of reporting, so the HCP was unsure of the exact start date of the shingles. The HCP did not think this was due to the vaccine. The HCP stated yes for the question that, the event required an intervention to prevent an outcome because they had to start the patient on FAMVIR 500 mg three times daily. The reported lot number (575LX) for SHINGRIX did not exist and was updated to 5Z5LX, according to sales database.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Vaccination site irritation, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Vaccine given subcutaneously rather than intramuscularly. Patient reported 6 inch raised, red, warm, irritated area around vaccine site.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Aphthous ulcer, Dysphagia, Fatigue, Headache, Irritability
Clinical narrative: The next evening, I started feeling like my glands on the right side of my jaw/neck were swelling. Also was feeling like my throat needed clearing and experiencing headaches. Then Thursday the symptoms became worse, that evening my right jaw neck was swollen like a golf ball and it was hard to swallow, it felt like my throat was full of marbles. Also noticed a canker sore on the bottom of my mouth under my tongue. This lasted for a few hours, the swelling started going down but didn't return to normal. Friday, the swelling and canker sore were bothersome, plus had a horrible headache, was irritated and felt fatigued plus had a lot of post nasal drip.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy, Streptococcus test negative, Swelling, Throat irritation, Upper-airway cough syndrome
Clinical narrative: The next evening, I started feeling like my glands on the right side of my jaw/neck were swelling. Also was feeling like my throat needed clearing and experiencing headaches. Then Thursday the symptoms became worse, that evening my right jaw neck was swollen like a golf ball and it was hard to swallow, it felt like my throat was full of marbles. Also noticed a canker sore on the bottom of my mouth under my tongue. This lasted for a few hours, the swelling started going down but didn't return to normal. Friday, the swelling and canker sore were bothersome, plus had a horrible headache, was irritated and felt fatigued plus had a lot of post nasal drip.
Age: 57.0
Sex: F
Vaccine: YF
Symptoms: Abdominal pain, Back pain, Blood test normal, Facial paralysis, Nuclear magnetic resonance imaging brain normal
Clinical narrative: 3/10/201- Abdominal and back aches start, followed by the development of bilateral Bell's palsy. Seen by Dr., neurologist, on 3/19/2018 and started on prednisone and VALTREX. After her courses of these medications her abdominal and back aches recurred and restarted on prednisone, which she was told to taper on 04/02/2018.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspepsia, Fatigue, Pain, Peripheral swelling, Rash
Clinical narrative: R arm swelling, rash, pain, fatigue, dyspepsia. Sx started 1 day after vaccine administered.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Influenza like illness, Malaise, Nausea
Clinical narrative: About  24 hours later, I suddenly felt ill and feverish. It came out of nowhere. For the next 2 days, I had a 100 degree temperature, extremely painful body aches everywhere, nauseous, no appetite. I called the pharmacist and she told me I was having a reaction to one of the ingredients of the vaccine and it would last 2-3 days. She was right because on day 3, I felt much better. Although, felt tired & still a little sick but I was able to get out and drive. I took lots of Tylenol, phenagrin, used cool packs for my head/forehead and behind neck. In conclusion, it felt like having the flu for 2 days. It was awful!!!
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: About  24 hours later, I suddenly felt ill and feverish. It came out of nowhere. For the next 2 days, I had a 100 degree temperature, extremely painful body aches everywhere, nauseous, no appetite. I called the pharmacist and she told me I was having a reaction to one of the ingredients of the vaccine and it would last 2-3 days. She was right because on day 3, I felt much better. Although, felt tired & still a little sick but I was able to get out and drive. I took lots of Tylenol, phenagrin, used cool packs for my head/forehead and behind neck. In conclusion, it felt like having the flu for 2 days. It was awful!!!
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: The second day after immunization the patient stated that the area started itching, Visual verification of area showed an area of approximately 3 inches by 6 inches of redness. I advised patient to use hydrocortisone cream and if needed a diphenhydramine 25mg up to 4 times daily if needed. Patient stated that the redness and itching started to subside after another 24 hours.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Injection site pain, Joint injury, Joint range of motion decreased
Clinical narrative: Ever since I received the flu shot my shoulder muscle has experienced pain right where the needle entered. Also, most troubling, my elbow has been damaged. My elbow has been in chronic pain and stiff and movement is limited. I have lost most of the strength in my left arm.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Joint stiffness
Clinical narrative: Ever since I received the flu shot my shoulder muscle has experienced pain right where the needle entered. Also, most troubling, my elbow has been damaged. My elbow has been in chronic pain and stiff and movement is limited. I have lost most of the strength in my left arm.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Exposure during pregnancy, Foetal disorder, Heart rate increased, Induced labour
Clinical narrative: I received this vaccine when I was 40 weeks and 2 days pregnant (my due date was on the 24th of February. I received the vaccine on the 26th). The symptoms I had included mild fever, body aches and chills, and increased heart rate. My unborn baby also experienced an increased heart rate and this caused me to be induced. My pregnancy up until this point was normal and my baby's heart rate was always in the normal range. Baby was born and weighed 6 lbs. 1 oz.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: I received this vaccine when I was 40 weeks and 2 days pregnant (my due date was on the 24th of February. I received the vaccine on the 26th). The symptoms I had included mild fever, body aches and chills, and increased heart rate. My unborn baby also experienced an increased heart rate and this caused me to be induced. My pregnancy up until this point was normal and my baby's heart rate was always in the normal range. Baby was born and weighed 6 lbs. 1 oz.
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Pain
Clinical narrative: This spontaneous report was received from a non-pregnant female patient of unknown age who is also a nurse (via company representative) regarding herself. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On an unknown date, the patient was vaccinated with first dose of GARDASIL (dose, unit, route and frequency, expiration date and lot number not specified) for the prevention of human papillomavirus and on an unknown date in 2008 (reported as 10 years ago), the patient was vaccinated with second dose of GARDASIL (dosing details were not reported) for prevention of human papillomavirus. The patient experienced a severe adverse experience after receiving the second dose of GARDASIL 10 years ago. The patient experienced pain and an [unspecified] allergic reaction and had to be hospitalized at an unspecified hospital for an unspecified period of time. It was unknown, if the patient received any treatment for the event. The patient sought medical attention. The outcome of the events was reported as recovered. The reporter did not assess the causality of the events with suspect therapy. No product quality complaint involved.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood culture, Body temperature increased, C-reactive protein, Differential white blood cell count, Full blood count
Clinical narrative: Elevated temp of 104.2. Pain, Red spots to face.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pain, Platelet count, Rash, Rash erythematous
Clinical narrative: Elevated temp of 104.2. Pain, Red spots to face.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Patient called to report a sharp stabbing pain in right arm where flu shot was given. It happens only when laying on it or after using the deltoid muscle for awhile.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Soon after vaccination arm began to feel hot. Within 24 hours arm swelled up along with intense pain that was felt from upper arm to fingertips. Swelling resolved after 4 days. Pain continues periodically in upper arm. Has history of reaction to preservatives.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Concussion, Dizziness, Seizure, Syncope
Clinical narrative: Later that night patient had several episodes of dizziness, syncope resulting in a concussion, and a seizure.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Impaired work ability, Influenza like illness, Malaise
Clinical narrative: Patient became very ill with flu-like symptoms while at work. Called off the next day.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: Client returned to clinic with Mother 1 day after vaccination L Deltoid site red, inflamed, indurated evaluated by ARNP on staff instructed to use cold compress and oral Benadryl per package directions. if not improved in 24-48 hours rtc. t/c to client's mom next day mom had taken client to Hospital ER dx w/ cellulitis and given rx antibiotic. F/u t/c to 03/12/18 inflammation/induration and redness resolved was completing antibiotic course of tx.
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Swelling, pain and redness at site, fever 102, body aches.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: From 3/16/18 telephone triage encounter. Pt seen on 3/14/18, received DTap/IPV and MMRV. Mom states pt's right arm, just above the elbow and below injection site is red, swollen, and warm to the touch. Just noticed this morning. Was not there last night. Area of redness is the size of mother's palm. Pt states it is painful. Reaction is in the arm that received DTap/IPV. He was treated for localized reaction as well as cellulitis. 5 days of oral steroid and Augmentin. Also TYLENOL, ibuprofen and BENADRYL PRN.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Local reaction
Clinical narrative: From 3/16/18 telephone triage encounter. Pt seen on 3/14/18, received DTap/IPV and MMRV. Mom states pt's right arm, just above the elbow and below injection site is red, swollen, and warm to the touch. Just noticed this morning. Was not there last night. Area of redness is the size of mother's palm. Pt states it is painful. Reaction is in the arm that received DTap/IPV. He was treated for localized reaction as well as cellulitis. 5 days of oral steroid and Augmentin. Also TYLENOL, ibuprofen and BENADRYL PRN.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Eczema, Rash
Clinical narrative: Rash/Eczema developed within 48 hours.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: PATIENT PRESENTED TO PHARMACY DUE TO PHYSICIAN REFERAL TO PHARMACY FOR VARES COMPLETION. PRESENTED WITH RED SWOLLEN, TENDER, FLATTENED IN APPEARENCE, SOFT BALL SIZE.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Disorientation, Dizziness, Nausea
Clinical narrative: No Fever, but she experienced chills, nausea, lightheadedness, was disoriented (on Saturday), and had throbbing joint pain (hip, elbows).
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: No Fever, but she experienced chills, nausea, lightheadedness, was disoriented (on Saturday), and had throbbing joint pain (hip, elbows).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Patients right arm appears to have a hard, red circular area where the ZOSTAVAX was injected. Patient was instructed to use hydro-cortisone cream to the area and diphenhydramine 25mg up to 4 times daily if needed. Patient was instructed to contact her physician also.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Per patient, pt received SHINGRIX vaccination on 3/10/18 and 2 days letter, her arm was swollen, red and hot to touch. Pt called clinic and was advised to go to Urgent care. Pt went to Urgent care and MD said to apply Ice for 2 days and then heat. Patient states the reaction went away after 8 days. Pt is doing fine as of now.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 57 y/o Female patient received SHINGRIX vaccine in her L arm on Thursday 29 March 2018/, the next day patient noticed swelling and soreness in the area. Pt also experienced chills and a fever for 2 days. Pt presented to clinic today 02 April 2018, with bruising and redness in the deltoid area and travelling along the inner bicep muscle.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 57 y/o Female patient received SHINGRIX vaccine in her L arm on Thursday 29 March 2018/, the next day patient noticed swelling and soreness in the area. Pt also experienced chills and a fever for 2 days. Pt presented to clinic today 02 April 2018, with bruising and redness in the deltoid area and travelling along the inner bicep muscle.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: PT HAS SORENESS IN HIS ADMINISTRATION ARM, AROUND INJECTION SITE. IT HAS BEEN A MONTH NOW, SO PT CAME TO DISCUSS THE LIKELIHOOD OF THIS. HE SAYS HE NOTICES EVERYDAY. HE DOES HAVE NEPHROPATHY AND HAS INJURED HIS ARM YEARS AGO. FEELS IT IS DUE TO THIS VACCINE.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: GOLF BALL SIZE INFLAMMED AREA /RED SWOLLEN / AT INJECTION SITE.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: Chills, swelling, redness and pain at the site, weakness, headache, myalgia, lymphadenopathy.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Lymphadenopathy, Myalgia
Clinical narrative: Chills, swelling, redness and pain at the site, weakness, headache, myalgia, lymphadenopathy.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Insomnia
Clinical narrative: Redness, swelling, pain and itching of moderate intensity involving an area at injection site which was approximately 6x2 inches in size. The symptoms were severe enough to cause difficulty sleeping. They appeared in approximately 24 hrs after the injection, became more severe over days and resolved after approximately 10 days.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Blood pressure decreased, Nausea, Pyrexia, Vomiting
Clinical narrative: Initial symptoms 3/30/18 in the evening: Nausea, vomiting, mild fever. Next morning 3/31/2018: Worsening symptoms, blood pressure drop to 70/30, anaphylaxis.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous
Clinical narrative: Small, red, raised bumps occurred 2 days after vaccination given.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature increased, Fatigue, Lethargy, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a arm in a 73-year-old female patient who received SHINGRIX. Previously administered products included Flu shot with an associated reaction of pain in extremity. On 6th March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, feeling unwell, weakness, lethargy, tiredness and body temperature increased. In March 2018, the outcome of the pain in arm, feeling unwell, weakness, lethargy, tiredness and body temperature increased were recovered/resolved. The reporter considered the pain in arm, feeling unwell, weakness, lethargy, tiredness and body temperature increased to be related to SHINGRIX. Additional details were provided as follows: The reporter was husband of the patient. The patient experienced events that occurred within 12 to 24 hours after receiving SHINGRIX. Arm soreness that occurred in left arm was greater than anything experienced with flu shots in the past. Specific name of flu shot was not provided. The events resolved within 36 hours after SHINGRIX dose. This case was linked with US2018049831 and US2018049818, reported by same reporter and with US2018GSK055557 for the same patient.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a arm in a 73-year-old female patient who received SHINGRIX. Previously administered products included Flu shot with an associated reaction of pain in extremity. On 6th March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, feeling unwell, weakness, lethargy, tiredness and body temperature increased. In March 2018, the outcome of the pain in arm, feeling unwell, weakness, lethargy, tiredness and body temperature increased were recovered/resolved. The reporter considered the pain in arm, feeling unwell, weakness, lethargy, tiredness and body temperature increased to be related to SHINGRIX. Additional details were provided as follows: The reporter was husband of the patient. The patient experienced events that occurred within 12 to 24 hours after receiving SHINGRIX. Arm soreness that occurred in left arm was greater than anything experienced with flu shots in the past. Specific name of flu shot was not provided. The events resolved within 36 hours after SHINGRIX dose. This case was linked with US2018049831 and US2018049818, reported by same reporter and with US2018GSK055557 for the same patient.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received BEXSERO (batch number 157101, expiry date unknown). On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional information was reported as follows: The age at vaccination was not reported. The patient called back to the reporter's office about the pain with the vaccine. The reporter agreed to follow up. This case is 1 of the 8 cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: This case was reported by a physician and described the occurrence of fatigue in a 65-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue, pain in arm and foggy feeling in head. On an unknown date, the outcome of the fatigue, pain in arm and foggy feeling in head were recovered/resolved. It was unknown if the reporter considered the fatigue, pain in arm and foggy feeling in head to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The reporter reported that his close relative had the SHINGRIX vaccine and did not like the adverse effects fatigue, arm pain and foggy head that had after SHINGRIX vaccine. The events lasted for 3 days.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at (L) thigh where IZ administered- 7cm x 7cm in size No fever, walking is normal, active, no acute distress BENADRYL susp-1 tsp given at office - con't Q4hrs- F/U w/OV in 24 hrs.
Age: 59.0
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 59-year-old female patient who received SHINGRIX (batch number T5242, expiry date 31st March 2020). Concomitant products included BACTRIM DS, gabapentin, phentermine, TOPAMAX, XANAX, ZOCOR, bisoprolol + hydrochlorothiazide and oxybutynin. On 17th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th March 2018, 1 days after receiving SHINGRIX, the patient experienced numbness facial. On an unknown date, the outcome of the numbness facial was not recovered/not resolved. The reporter considered the numbness facial to be related to SHINGRIX. Additional information was reported as follows: Concomitant products included PROTONIX. The patient received SHINGRIX in right deltoid. At 5 am, the patient awoke with a numbing sensation on the forehead.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a female patient who received ENGERIX B. On an unknown date, the patient received ENGERIX B at an unknown dose. On an unknown date, unknown after receiving ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B. Additional details were provided as follows: This case was reported by a medical assistant (MA). The age at vaccination was not reported. The nursing student received ENGERIX B and showed no protective titers for hepatitis B which led the patient to be a therapy non-responder. A complete 2nd series was subsequently initiated. The patient had received the first doses of the series, with the most recent dose given 5 months before the reporting date. The health care professional did not have any lot number and expiry date of the doses given. Also of note, the patient was pregnant at the reporting time, but was not pregnant at the time of vaccination.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 67-year-old female patient who received SHINGRIX. Concurrent medical conditions included osteoporosis. Concomitant products included EFFEXOR, Levothyroxine, Probiotics, PROLIA and Vitamin D3. On 19th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 20th March 2018, 1 days after receiving SHINGRIX, the patient experienced tiredness, pain in arm, swelling arm and general body pain. On an unknown date, the outcome of the tiredness, pain in arm, swelling arm and general body pain were not recovered/not resolved. It was unknown if the reporter considered the tiredness, pain in arm and general body pain to be related to SHINGRIX. Additional information was received as follows: On an unknown date, the patient planned to follow-up with her physician.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received BEXSERO (batch number 157101, expiry date unknown). In August 2016, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional information was reported as follows: The age at vaccination was not reported. The reporter's clinic had a patient who was vaccinated around 11th August 2016 that had severe pain at the injection site. The patient ended up going to the Emergency Room. The reporter agreed to follow up. This case is 1 of the 8 cases reported by the same reporter.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received BEXSERO (batch number 157101, expiry date unknown). On 11th August 2016, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional information was reported as follows: The age at vaccination was not reported. The reporter's clinic had a patient who was vaccinated around 11th August 2016 that had severe pain at the injection site. The reporter agreed to follow up. This case is 1 of the 8 cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Impaired work ability, Myalgia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of myalgia in a female patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020). Previously administered products included allergy medication (receiving allergy shot compounded with extract and glycerin, once monthly for over 20 years without issue). On 19th March 2018, the patient received SHINGRIX .5 ml. In March 2018, less than a day after receiving SHINGRIX, the patient experienced myalgia, headache, shivering, fatigue and inability to work. On an unknown date, the outcome of the myalgia, headache, shivering, fatigue and inability to work were unknown. It was unknown if the reporter considered the myalgia, headache, shivering, fatigue and inability to work to be related to SHINGRIX. Additional details were provided as follows: The case was transferred by the GSK Vaccine Service Center. The reporter did not have an exact date of birth to provide during the call but said that this patient was past 60 years old. The reporter could not recall during the call which arm she had administered the SHINGRIX vaccine, but said it was the upper arm deltoid muscle. The symptoms started not immediately but at some unknown time before the next morning on Tuesday. The patient called the doctor the next morning after the day the vaccine was administered to report the symptoms. The patient did not report any pain or redness at the site of injection. The doctor did not know if the reported shivering indicated any fever. The patient had not been able to go into work since receiving the vaccine. The symptoms were not resolved by yesterday when the doctor last spoke with the consumer. The status of symptoms was unknown at this time. The patient received an allergy shot subcutaneously in each of the patient's lower arms the same day as the SHINGRIX. The patient had been receiving allergy shot compounded with extract and glycerin by the reporter once monthly for over 20 years without issue. The patient granted permission to be contacted by Regulatory Authority. A nonrelated QA follow up for an entirely different case UV20180076 in which no product was administered to any consumer was submitted during the call. The lot number was the same for that case as for this one. The reporter said the patient had no quality concern with the product which was administered to this consumer. The lot number and expiration date was provided from the product box, as the product was already discarded. The call was transferred to the GSK MI team regarding the inquiry of whether or not the patient should have a second dose of SHINGRIX in the series.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received BEXSERO (batch number 157101, expiry date unknown). in August 2016, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional information was reported as follows: The age at vaccination was not reported. The reporter's clinic had a patient who was vaccinated around 11th August 2016 that had severe pain at the injection site. The patient ended up going to the emergency room. The reporter agreed to follow up. This case is 1 of the 8 cases reported by the same reporter.
Age: 64.0
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 64-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020. On 9th March 2018 14:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th March 2018, 7 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: Concomitant medication were unknown. The patient was administered SHINGRIX in the left deltoid. Pharmacist reported that the patient developed shingles a few days after receiving SHINGRIX. The patient was seen by the physician and got a prescription for VALTREX on 19th March 2018.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature increased, Fatigue, Lethargy, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old male patient who received SHINGRIX. Previously administered products included Flu vaccine with an associated reaction of pain in extremity. On 6th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain in arm, feeling unwell, weakness, lethargy, body temperature increased and tiredness. On an unknown date, the outcome of the pain in arm, feeling unwell, weakness, lethargy, body temperature increased and tiredness were recovered/resolved. The reporter considered the pain in arm, feeling unwell, weakness, lethargy, body temperature increased and tiredness to be related to SHINGRIX. Additional information was received as follows: The patient experienced arm soreness occurred in the left arm greater than anything experienced with flu shots in the past. The patient experienced events which occurred within 12-24 hours after receiving SHINGRIX. The elevated temperature reported as 99 degrees F. Events resolved within 36 hours after SHINGRIX dose. The contact details of the physician was also provided. This case was linked with cases US2018049831 and US2018049830, reported by the same reporter.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old male patient who received SHINGRIX. Previously administered products included Flu vaccine with an associated reaction of pain in extremity. On 6th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain in arm, feeling unwell, weakness, lethargy, body temperature increased and tiredness. On an unknown date, the outcome of the pain in arm, feeling unwell, weakness, lethargy, body temperature increased and tiredness were recovered/resolved. The reporter considered the pain in arm, feeling unwell, weakness, lethargy, body temperature increased and tiredness to be related to SHINGRIX. Additional information was received as follows: The patient experienced arm soreness occurred in the left arm greater than anything experienced with flu shots in the past. The patient experienced events which occurred within 12-24 hours after receiving SHINGRIX. The elevated temperature reported as 99 degrees F. Events resolved within 36 hours after SHINGRIX dose. The contact details of the physician was also provided. This case was linked with cases US2018049831 and US2018049830, reported by the same reporter.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Impaired work ability, Influenza like illness
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020). Concomitant products included Multivitamin. On 20th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st March 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, fatigue, general body pain, fever, shivering, influenza-like symptoms and inability to work. On an unknown date, the outcome of the injection site pain, fatigue, general body pain, fever, shivering, influenza-like symptoms and inability to work were recovering/resolving. The reporter considered the injection site pain, fatigue, general body pain, fever and shivering to be related to SHINGRIX. It was unknown if the reporter considered the influenza-like symptoms and inability to work to be related to SHINGRIX. Additional information was reported as follows: Concomitant products included OTC multivitamin. The patient received SHINGRIX in left deltoid. The lot number and expiration date were provided from box as the actual product vial was already discarded. The symptoms described as flu-like symptoms began the next morning of the day after the vaccination was administered. The patient felt she could not do her job for two days, so she missed 21st March 2018 and 22nd March 2018 work days. She had not had to take any medicine for any of the symptoms. At the time of reporting the patient was back at work and told the nurse she was feeling better but not completely herself. The arm soreness was at the left deltoid muscle area at the injection site. The nurse indicated she needed to check the patient, so no further information was provided due to time constraints. She granted permission to be contacted with further related questions.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020). Concomitant products included Multivitamin. On 20th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st March 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, fatigue, general body pain, fever, shivering, influenza-like symptoms and inability to work. On an unknown date, the outcome of the injection site pain, fatigue, general body pain, fever, shivering, influenza-like symptoms and inability to work were recovering/resolving. The reporter considered the injection site pain, fatigue, general body pain, fever and shivering to be related to SHINGRIX. It was unknown if the reporter considered the influenza-like symptoms and inability to work to be related to SHINGRIX. Additional information was reported as follows: Concomitant products included OTC multivitamin. The patient received SHINGRIX in left deltoid. The lot number and expiration date were provided from box as the actual product vial was already discarded. The symptoms described as flu-like symptoms began the next morning of the day after the vaccination was administered. The patient felt she could not do her job for two days, so she missed 21st March 2018 and 22nd March 2018 work days. She had not had to take any medicine for any of the symptoms. At the time of reporting the patient was back at work and told the nurse she was feeling better but not completely herself. The arm soreness was at the left deltoid muscle area at the injection site. The nurse indicated she needed to check the patient, so no further information was provided due to time constraints. She granted permission to be contacted with further related questions.
Sex: U
Vaccine: MENB
Symptoms: Erythema, Extensive swelling of vaccinated limb, Incomplete course of vaccination, Limb discomfort
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a patient who received BEXSERO. Co-suspect products included BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO and the 2nd dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO and not applicable after receiving BEXSERO, the patient experienced extensive swelling of vaccinated limb, arm discomfort, erythema of extremities and incomplete course of vaccination. On an unknown date, the outcome of the extensive swelling of vaccinated limb, arm discomfort, erythema of extremities and incomplete course of vaccination were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, arm discomfort and erythema of extremities to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not applicable. The reporting nurse practitioner did not have any patient data or vaccine data to share. The patients received BEXSERO on the unknown arm. The patients experienced local reactions such as redness, extensive swelling of vaccinated limb, and discomfort on the whole arm above and around the injection site. The nurse reported that the patients were not returning for the 2nd dose in the BEXSERO series because of adverse reactions, which led to incomplete course of vaccination.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 18-year-old female patient who received BEXSERO (batch number 15C801, expiry date unknown). On 20th March 2018, the patient received the 2nd dose of BEXSERO. On 20th March 2018, less than a day after receiving BEXSERO, the patient experienced injection site erythema. The patient was treated with BENADRYL and Cold Compresses. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved. The reporter considered the injection site erythema to be almost certainly related to BEXSERO. Additional details were provided as follows: The health care professional reported that patient was experiencing erythema on the right arm that was below the site of injection after 2nd dose of BEXSERO. On 23rd March 2018, the patient came to the physician and was still experiencing the same symptom at that time. The physician gave the patient BENADRYL and cold compresses as of 23rd March, 2018. The patient required emergency room visit. No additional information was provided.