chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Ear pain, Hyperhidrosis, Musculoskeletal stiffness
Clinical narrative: Arm became sore and stiff within a couple hours and continued for about 2 days, within 24 hours began to feel chills and sweating (lasted about 12 hours), temperature was 99.7 during that time, 3 days in began to feel pain in head (sinuses, ear, jaw and lower teeth-all confined to the left side), neck on left side remains stiff, nose continues to run only on left side, all these symptoms come and go-they are not constant.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pain in jaw, Rhinorrhoea, Sinus pain, Toothache
Clinical narrative: Arm became sore and stiff within a couple hours and continued for about 2 days, within 24 hours began to feel chills and sweating (lasted about 12 hours), temperature was 99.7 during that time, 3 days in began to feel pain in head (sinuses, ear, jaw and lower teeth-all confined to the left side), neck on left side remains stiff, nose continues to run only on left side, all these symptoms come and go-they are not constant.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS, SEVERE ABDOMINAL PAIN, NO FEVER LASTING 3-4 DAYS.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema of eyelid, Hot flush, Lacrimation increased, Pruritus generalised
Clinical narrative: Approximately 1 minute after injecting vaccine, patient complained of feeling flush, hot, and general body itch. Observed redness around the eyes and eyes were watering. Gave the patient a cold compress and 25mg of diphenhydramine. Approximately 5 minutes later the patient said she was feeling better. After another 15 minutes she was still feeling ok and left the pharmacy with her parents. I advised the parents to keep an eye on their daughter and continue the diphenhydramine. If the patient's condition got worse or lasted the next day I advised them to take her to the emergency room. I call the patient's mother the next day and she reported that the patient had fully recovered.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RVX
Symptoms: Apnoea, Cyanosis, Sleep apnoea syndrome, Sleep study abnormal, X-ray with contrast upper gastrointestinal tract abnormal
Clinical narrative: 2/23/2017 - received a phone call from my mother while I was at work. The baby had turned blue and quit breathing during her nap. My mother turned her stomach down over her arm and ran to my grandmother in the next room (retired RN). Before my grandfather could call for an ambulance, my grandmother/mother got patient breathing again by dipping her bottom in water. I went home and took the baby to the hospital where the ERMD called the event a BRUE (brief resolved unexplained event) and stated that she was low risk for SIDS and sent us home.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RVX
Symptoms: Alopecia, Candida nappy rash, Eczema, Infection, Laboratory test normal
Clinical narrative: The night of her vaccinations 4/6/17 - I awoke in the middle of the night to check on patient. She was extremely hot to the touch. Checked her temp 104-105 degree fever. The baby was lethargic and unable to really respond to me. I stripped her clothing down to a diaper and applied room temperature watered towel to her skin to help. My mother was calling EMS. Baby was still lethargic when EMS arrived - their thermometer did not read appropriately as it showed 98 something - when we arrived at the ER it was still 103-104 degrees having come down some with some skin to skin type intervention. The ER said that it was absolutely not the vaccines and that it was a viral or bacterial infection and sent us home with instructions to start an antibiotic and take TYLENOL/MOTRIN. We went to pediatrician the next day with some rash like bumps appearing on patient's trunk. Her pediatrician again claimed that there was no reaction to the vaccine but said it resembled HFM or Coxsackie virus. She did not have spots on her face, hands, or feet. Continually ran fever on and off for the next couple weeks. Then she broke out in blisters on her face which was later diagnosed as Eczema and cradle cap. She lost a lot of her beautiful hair at this point. I have multiple pictures of her before, during, and after treatment. The doctors recommended hydrocortisone and AQUAPHOR for treatment of her face and scalp leaving my baby in mittens.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RVX
Symptoms: Lethargy, Pyrexia, Rash, Rash pruritic, Seborrhoeic dermatitis
Clinical narrative: The night of her vaccinations 4/6/17 - I awoke in the middle of the night to check on patient. She was extremely hot to the touch. Checked her temp 104-105 degree fever. The baby was lethargic and unable to really respond to me. I stripped her clothing down to a diaper and applied room temperature watered towel to her skin to help. My mother was calling EMS. Baby was still lethargic when EMS arrived - their thermometer did not read appropriately as it showed 98 something - when we arrived at the ER it was still 103-104 degrees having come down some with some skin to skin type intervention. The ER said that it was absolutely not the vaccines and that it was a viral or bacterial infection and sent us home with instructions to start an antibiotic and take TYLENOL/MOTRIN. We went to pediatrician the next day with some rash like bumps appearing on patient's trunk. Her pediatrician again claimed that there was no reaction to the vaccine but said it resembled HFM or Coxsackie virus. She did not have spots on her face, hands, or feet. Continually ran fever on and off for the next couple weeks. Then she broke out in blisters on her face which was later diagnosed as Eczema and cradle cap. She lost a lot of her beautiful hair at this point. I have multiple pictures of her before, during, and after treatment. The doctors recommended hydrocortisone and AQUAPHOR for treatment of her face and scalp leaving my baby in mittens.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RVX
Symptoms: Skin warm, Unresponsive to stimuli, Urine analysis normal
Clinical narrative: The night of her vaccinations 4/6/17 - I awoke in the middle of the night to check on patient. She was extremely hot to the touch. Checked her temp 104-105 degree fever. The baby was lethargic and unable to really respond to me. I stripped her clothing down to a diaper and applied room temperature watered towel to her skin to help. My mother was calling EMS. Baby was still lethargic when EMS arrived - their thermometer did not read appropriately as it showed 98 something - when we arrived at the ER it was still 103-104 degrees having come down some with some skin to skin type intervention. The ER said that it was absolutely not the vaccines and that it was a viral or bacterial infection and sent us home with instructions to start an antibiotic and take TYLENOL/MOTRIN. We went to pediatrician the next day with some rash like bumps appearing on patient's trunk. Her pediatrician again claimed that there was no reaction to the vaccine but said it resembled HFM or Coxsackie virus. She did not have spots on her face, hands, or feet. Continually ran fever on and off for the next couple weeks. Then she broke out in blisters on her face which was later diagnosed as Eczema and cradle cap. She lost a lot of her beautiful hair at this point. I have multiple pictures of her before, during, and after treatment. The doctors recommended hydrocortisone and AQUAPHOR for treatment of her face and scalp leaving my baby in mittens.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Red warm to touch sore at administration site.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injected limb mobility decreased, Nausea, Nodule, Peripheral swelling, Pyrexia
Clinical narrative: High fever (103.5 F), nausea & vomiting; SHINGRIX arm knotted feeling with swelling; couldn't lift SHINGRIX arm for 3 weeks after the shot.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Vomiting
Clinical narrative: High fever (103.5 F), nausea & vomiting; SHINGRIX arm knotted feeling with swelling; couldn't lift SHINGRIX arm for 3 weeks after the shot.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Infertility female, Pyrexia
Clinical narrative: Fever, chronic fatigue, infertility.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Pt states arm became red, swollen, and warm to the touch from shoulder to elbow the next morning when she woke up. She was instructed to take an antihistamine and continue to watch the area. She stated her arm does look a little better since she first noticed it.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Dental caries, Facial pain, Gingival pain, Injection site pain, Mouth ulceration
Clinical narrative: Original side effect was pain at the injection site followed by pain in the left portion of my chest.  Nine days after the injection I was eating lunch and started to have acute pain above my teeth in my gums and below my right eye radiating from my nose to my ear. Although I had no specific pain in any of my teeth, because of the location, I thought it was from my teeth. The pain would come and go and subsided with ibuprofen. I went to the dentist the same day and he found cavities in the molars in the same area. Over the course of five days, he fixed the cavities. After the cavities were fixed the pain did not subside. Three days ago, I noticed what seems to be an ulcer between my gum and my cheek at the point where the pain is centered. Today I noticed a new smaller ulcer on my bottom inside lip on the same side. Speaking to my doctor he thought it could be shingles. When he mentioned shingles, the light bulb went on regarding my recent vaccine.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Original side effect was pain at the injection site followed by pain in the left portion of my chest.  Nine days after the injection I was eating lunch and started to have acute pain above my teeth in my gums and below my right eye radiating from my nose to my ear. Although I had no specific pain in any of my teeth, because of the location, I thought it was from my teeth. The pain would come and go and subsided with ibuprofen. I went to the dentist the same day and he found cavities in the molars in the same area. Over the course of five days, he fixed the cavities. After the cavities were fixed the pain did not subside. Three days ago, I noticed what seems to be an ulcer between my gum and my cheek at the point where the pain is centered. Today I noticed a new smaller ulcer on my bottom inside lip on the same side. Speaking to my doctor he thought it could be shingles. When he mentioned shingles, the light bulb went on regarding my recent vaccine.
Age: 52.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Pain of skin, Pruritus
Clinical narrative: 4 inch rash at site of injection. Rash is raised. Itches and skin pain down right arm and hands.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Fever 99.6, max, sore arm, fatigue, dizziness (probably from the fever) this has lasted two days, so far.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site swelling, Pyrexia
Clinical narrative: Patient came to pharmacy complaining that after receiving vaccine by 8 hrs pt had the chills, fever and headache took 2 ADVIL then symptoms improved. Also arm swelling at site of injection after 4 hrs also improved.
Sex: F
Vaccine: HEPAB
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received TWINRIX. On an unknown date, the patient received the 1st dose of TWINRIX. On an unknown date, unknown after receiving TWINRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to TWINRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient felt a real stabbing pain after vaccination. This case has been linked with US2018GSK072862, reported by the same reporter, for same patient for 2nd dose.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Pain, soreness, swelling at the site of injection, headache, muscle aches, fever, shivering, fatigue, hives. Fever was close to 102 - by the third day fever was gone, felt much better but hives remain.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Urticaria
Clinical narrative: Pain, soreness, swelling at the site of injection, headache, muscle aches, fever, shivering, fatigue, hives. Fever was close to 102 - by the third day fever was gone, felt much better but hives remain.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Burning sensation, Injection site pain, Myalgia, Neck pain
Clinical narrative: Burning at time of injection at site in left shoulder. Sore shoulder muscle for 48 hours. Pain on lifting arm for 48 hrs. After 48 hrs post injection, the back of my head and upper neck area felt a slight burning sensation and mild neck pain at base of skull down to middle of back. Has not gone away after 11 days the burning mild pain sensation remains and has spread to my jaw on both sides and to the skin on both sides of my neck. I have been taking 400 ibuprofen 2x per day with little relief. Reported online to physician. Will call Dr tomorrow AM.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in jaw, Pain of skin
Clinical narrative: Burning at time of injection at site in left shoulder. Sore shoulder muscle for 48 hours. Pain on lifting arm for 48 hrs. After 48 hrs post injection, the back of my head and upper neck area felt a slight burning sensation and mild neck pain at base of skull down to middle of back. Has not gone away after 11 days the burning mild pain sensation remains and has spread to my jaw on both sides and to the skin on both sides of my neck. I have been taking 400 ibuprofen 2x per day with little relief. Reported online to physician. Will call Dr tomorrow AM.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus generalised, Urticaria
Clinical narrative: At 11:30 I awoke to burning and itching over my entire body from my feet to my hands. I then broke out in hives with the heaviest amount on the feet and hands, inner arms from wrist to shoulders, my back and my stomach.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Muscular weakness, Myalgia
Clinical narrative: Headache, chills, nausea, muscle pain, muscle weakness, shivering, extreme fatigue, beginning 5 hours after injection, and lasting 40 hours.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Headache, chills, nausea, muscle pain, muscle weakness, shivering, extreme fatigue, beginning 5 hours after injection, and lasting 40 hours.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: TRUMENBA was given as an alternative to MENACTRA. No adverse reaction reported to this facility.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: 100 degree fever, chills.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: No adverse event
Clinical narrative: TRUMENBA was given as an alternative to MENACTRA or MENVEO. No adverse reaction reported to this facility.
Age: 11.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: TRUMENBA was given as an alternative to MENACTRA or MENVEO. No adverse reaction reported to this facility.
Age: 11.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: TRUMENBA was given as an alternative to MENACTRA or MENVEO. No adverse reactions reported to this facility.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia, Asthenia, Musculoskeletal stiffness
Clinical narrative: Patient awoke next morning after receiving vaccine with large and small joint polyarthralgia, stiffness, and weakness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral, Pruritus, Swollen tongue, Urticaria
Clinical narrative: Tongue swelling, lip tingling, total body hives (itching with welts). Treated with multiple doses of BENADRYL. At 12 hrs tongue and lip sensations were gone. At 36 hrs still have welts, but itching is gone (still using BENADRYL).
Age: 11.0
Sex: F
Vaccine: HPV9, MENB, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: TRUMENBA was given as an alternative to MENVEO or MENACTRA. No adverse reactions reported to this facility.
Age: 18.0
Sex: F
Vaccine: MENB, TDAP, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: TRUMENBA was given as an alternative to MENACTRA or MENVEO. No adverse reaction reported to this facility.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MENB
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: TRUMENBA was given as an alternative to MENACTRA or MENVEO. No adverse reaction reported to this facility.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: TRUMENBA was given as an alternative to MENACTRA or MENVEO. No adverse reactions reported to this facility.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MMR
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: TRUMENBA was given as an alternative to MENACTRA or MENVEO. No adverse reactions reported to this facility.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: PATIENT HAS A 2 INCH CIRCULAR RED, FIRM LUMP ON THE FRONT OF HER ARM SEVERAL INCHES AWAY FROM THE INJECTION SITE. IT IS RED AND WARM TO THE TOUCH. IT DOES NOT ITCH.
Age: 52.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Discomfort, Lymphadenopathy
Clinical narrative: Pt woke up yesterday and has swollen glands under her armpits and both sides of her jaw. They are uncomfortable. Today they seem to be similar size. Patient is treating glands with anti-inflammatories (ADVIL) and monitoring. If it doesn't get better or gets worse, she will go be seen by MD.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction
Clinical narrative: 25 cm size, warm, red, indurated area at shot size, local reaction not likely infection.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: 3-4 INCH RED RASH AROUND INJECTION SITE, PAIN, INFLAMMATION.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Pain in extremity
Clinical narrative: Patient remained in the store after administration. She returned to RX dept approximately 20-30 minutes after the shot saying that she felt like her lips were swelling. No rash, hives, itching, nor swelling or reaction at injection site. No dyspnea or cough or difficulty swallowing. Stated she cannot take diphenhydramine due to a heart condition (could not recall name of condition) but that her doctor told her ZYRTEC was ok. Gave patient 10mg cetirizine tablet. Patient had told us she is afraid of needles before the shot was given. Patient told us after lip began swelling that she is prone to panic attacks and thought she might be starting one, but she seemed to keep herself calm throughout. She called her family to come get her since she was told not to drive. After sitting with her for 30 minutes with no changes or progression, patient said she thought she was OK. I told her it is recommended that they take her to the ER even if she feels OK right now due to risk the reaction might continue. I called patient on 4/29/18 and she says she went to a nearby urgent care with her family after leaving store and they gave her an oral syrup (did not know what) that would stop the reaction. She reports that swelling did continue until she went to the urgent care. Also reports arm soreness. However, she thinks the swelling as of today has gone down mostly.
Age: 42.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site reaction
Clinical narrative: Patient developed a reaction at the site and surrounding area of the VARIVAX injection.
Age: 26.0
Sex: F
Vaccine: MNQ
Symptoms: Axillary pain, Swelling
Clinical narrative: Left armpit started to get painful on the evening of 4/28/2018, the day when the MCV shot was administered. The next morning of 4/29/2018, the armpit already appears swollen with intensified pain in the area even without movement. No medications have been taken neither a hospital call/visit.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rash erythematous, Rash pruritic
Clinical narrative: Patient calls pharmacy 2 hours after SHINGRIX administration to patient's right deltoid muscle reporting concerns of itchy red rash developing on feet. Pharmacist confirms okay to use hydrocortisone cream and BENADRYL to help reaction; confirms no trouble breathing or shortness of breath; asks patient to follow up with pharmacist or doctor if worsening. Patient arrives at pharmacy hour later showing pharmacist symptoms. Both feet, lower calves/shins, upper knee and leg of left leg now developed bright red, swollen, puffy, itchy. Symptoms not being subsided by OTC medications. Still no reports of trouble breathing. Pharmacist instructed patient and friend/driver to report to emergency room, gave them administration information sheet and CDC SHINGRIX guide to give to ER.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Roughly 36 hours after injection my son woke up with his left thigh swollen, itchy, tender, and hot to the touch. Went to the ER where they diagnosed cellulitis. Swelling has continued throughout the day and is still spreading. ER doctor prescribed 10 days of antibiotics.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site extravasation, Injection site pain
Clinical narrative: Once needle was inserted into patient she pulled from needle and medication filled the inject-safe barrier bandage, because she said that it felt like a burning sensation that lasted just at the injection site just seconds. No redness or blood at site. She said she felt the poke.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary mass, Axillary pain, Injection site rash, Injection site swelling, Lymph node pain
Clinical narrative: 4/19/18 at 9pm: extremely painful left arm; 4/20/18 at 5:30am: woke up with extremely painful tangerine-sized lump in left armpit; 4/21/18 at 6am: woke up with extremely painful and swollen gland in neck on left side and sore throat on left side; also rash and swelling at injection site. 4/22/18: rash continued to grow to approximately 1.5? wide by 3? tall; 4/29/18: evidence of rash still present but is fading.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pain in extremity, Rash
Clinical narrative: 4/19/18 at 9pm: extremely painful left arm; 4/20/18 at 5:30am: woke up with extremely painful tangerine-sized lump in left armpit; 4/21/18 at 6am: woke up with extremely painful and swollen gland in neck on left side and sore throat on left side; also rash and swelling at injection site. 4/22/18: rash continued to grow to approximately 1.5? wide by 3? tall; 4/29/18: evidence of rash still present but is fading.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Syncope
Clinical narrative: Patient fainted few minutes after administering VARIVAX shot. Immediately 911 was called. But recovered immediately in few seconds. He was stabilized Parents were there when vaccine was administered. Patient's father actually helped during the vaccine was being administered to keep patient calm and relaxed. Patient's father also helped during stabilizing child. No allergic reaction, no Shortness of breath, no itching/hives was reported during the event. Patient Fainted for few second and got back to normal in few seconds. 911 (Paramedic team) arrived in few minutes they asked few question to patient and his father. As patient was feeling normal patient's father denied help from Pharmacy team and as well as 911 team. Patient was asked to wait for at least 15 minutes. They waited for more than 15 minutes in our waiting area. Patient was continuously monitored by pharmacy team. Patient was completely stabilized and feeling normal before they left Facility. Patient was referred to his physician for further medical evaluation.
Age: 52.0
Sex: M
Vaccine: FLUX, FLU4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 52.0
Sex: M
Vaccine: FLUX, FLU4
Symptoms: Guillain-Barre syndrome, Pneumonia
Clinical narrative: None stated.
Age: 52.0
Sex: M
Vaccine: FLUX, FLU4
Symptoms: Unevaluable event
Clinical narrative: Diagnosed with Guillain Barre February 15, 2018.
Age: 52.0
Sex: M
Vaccine: FLUX, FLU4
Symptoms: Guillain-Barre syndrome, Pneumonia
Clinical narrative: Diagnosed with Guillain Barre February 15, 2018.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Patient reported fever of about 101 that came on this afternoon ...along with muscle aching.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Disorientation, Hypoaesthesia
Clinical narrative: Patient reported fever of about 101 that came on this afternoon ...along with muscle aching.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Nuclear magnetic resonance imaging, Pyrexia, Visual impairment
Clinical narrative: Patient reported fever of about 101 that came on this afternoon ...along with muscle aching.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Hot flush, Pain in extremity, Visual impairment
Clinical narrative: Pt felt dizzy, light headed, hot flushes, very painful arm, vision changes (disturbance).
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Feeling hot, Flushing, Injection site pain, Visual impairment
Clinical narrative: Pt felt dizzy, light headed, hot flushes, very painful arm, vision changes (disturbance).
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a elderly male patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020). 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 fever and chills. On an unknown date, the outcome of the fever and chills were unknown. It was unknown if the reporter considered the fever and chills to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional was the patient. The patient experienced fever and chills that lasted for 4 to 5 hours. He reported that other patients in his office reported the same symptoms. The reporter did not have any additional patient information. The batch number for the suspect vaccine SHINGRIX was reported as 4402P, however it was changed to 4492P as per latest sales data sheet. This case has been linked with case US2018GSK068241, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a adult male patient who received SHINGRIX. In April 2018, the patient received SHINGRIX. In April 2018, less than a month after receiving SHINGRIX, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was unknown. The reporter considered the erythema of extremities to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller's husband received the SHINGRIX vaccine a few days ago and developed a red mark about 2 to 3 inches in diameter on his arm.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Product administered at inappropriate site
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 86-year-old female patient who received SHINGRIX. Previously administered products included SHINGRIX (1st dose, vaccinated on the patient's unknown deltoid). On 12th April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 12th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and injection site erythema were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional information was reported as follows: The patient reported that she had received her second SHINGRIX vaccine at a local pharmacy. When she had her second dose of SHINGRIX, the pharmacist gave her the vaccine intramuscularly on her triceps, which led to vaccine administered at inappropriate site. The patient was having pain and redness below the injection site, radiating down to her elbow. She also reported that her injection site was sore after vaccination with the 2nd dose. Her prescribing information had advised her to receive a third dose of the SHINGRIX to compensate her second dose that was not given in the right place. The details of the physician was provided.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: 24 hours after shot, Pt. presented with a fever of 102. Pt. felt like flu symptoms, chills, aches, fever. 48 hours after shot, Pt. developed stomach ache, loss of appetite, fatigue. Injection area swollen and red, area was hot, itchy and painful, also headache.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 24 hours after shot, Pt. presented with a fever of 102. Pt. felt like flu symptoms, chills, aches, fever. 48 hours after shot, Pt. developed stomach ache, loss of appetite, fatigue. Injection area swollen and red, area was hot, itchy and painful, also headache.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: 24 hours after shot, Pt. presented with a fever of 102. Pt. felt like flu symptoms, chills, aches, fever. 48 hours after shot, Pt. developed stomach ache, loss of appetite, fatigue. Injection area swollen and red, area was hot, itchy and painful, also headache.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Chromaturia, Erythema, Inflammation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a 84-year-old male patient who received SHINGRIX. Concomitant products included Aspirin, potassium chloride, omeprazole, Lisinopril/Hydrochlorothiazide, oxaprozin, prednisone and simvastatin. On 13th April 2018 11:00, the patient received the 1st dose of SHINGRIX .5 ml. On 14th April 2018, 1 days after receiving SHINGRIX, the patient experienced erythema, chest pain and inflammation. On 15th April 2018, the patient experienced red urine. On an unknown date, the outcome of the erythema was recovering/resolving and the outcome of the red urine, chest pain and inflammation were not recovered/not resolved. The reporter considered the erythema, red urine, chest pain and inflammation to be related to SHINGRIX. Additional details were provided as follows: The patient reported that he developed inflammation below the injection site. He started noticing symptoms on Saturday on 14th April 2018. On 15th April 2018 he observed red urine on early morning Sunday. His urine color had cleared up now, but had turned into more darker color. The patient counseled to follow up with his health care provider.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Headache, Injection site pain, Musculoskeletal pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received SHINGRIX. Concurrent medical conditions included general body pain (the patient woke up Friday with body aches and thought she was over tired). Concomitant products included Calcium, Probiotics, COQ10, fish oil, FLONASE SENSIMIST, LEXAPRO and vitamin C plus D. On 14th April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 14th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 15th April 2018, the patient experienced general body pain, shoulder pain and headache. On 16th April 2018, the patient experienced chest pain. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the general body pain, shoulder pain, chest pain and headache were recovering/resolving. The reporter considered the injection site pain to be probably related to SHINGRIX. The reporter considered the general body pain, shoulder pain, chest pain and headache to be possibly related to SHINGRIX. Additional details were provided as follows: At 12:00, the patient received SHINGRIX on left deltoid. The patient had a stabbing pain at the injection site and had soreness in her left shoulder and pain on the left side of her body. On 15th April 2018, 1 day after receiving SHINGRIX, the patient experienced pain localized and headache. At the time of reporting, the patient had dull ache on her side in the region near the bottom of her ribs.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin abnormal, Hypersensitivity vasculitis, Macule, Pallor, Rash
Clinical narrative: This case was reported by a consumer and described the occurrence of hypersensitivity vasculitis in a 82-year-old female patient who received SHINGRIX. On 13th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th February 2018, 1 days after receiving SHINGRIX, the patient experienced hypersensitivity vasculitis (serious criteria GSK medically significant), macule, skin biopsy abnormal, pallor, rash, macular rash and itchy rash. In February 2018, the outcome of the rash, macular rash and itchy rash were recovered/resolved. On an unknown date, the outcome of the hypersensitivity vasculitis, macule, skin biopsy abnormal and pallor were recovered/resolved. It was unknown if the reporter considered the hypersensitivity vasculitis, macule, skin biopsy abnormal, pallor, rash, macular rash and itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient had no prior vaccinations. The age at vaccination was not reported, however, it could be 81 or 82 years old. The patient received SHINGRIX vaccine on left arm. The patient developed pruritic rash on bilateral lower extremities. On 15th February 2018, the rash was evaluated that showed blanchiry and erythematous macules. On 16th February 2018, increasing area of legs involved so patient returned to office for reevaluation and had nonblanchiry macules. On the same day, biopsy was done and patch report showed leukocytoclastic vasculitis. The rash resolved over following 5 days.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash macular, Rash pruritic
Clinical narrative: This case was reported by a consumer and described the occurrence of hypersensitivity vasculitis in a 82-year-old female patient who received SHINGRIX. On 13th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th February 2018, 1 days after receiving SHINGRIX, the patient experienced hypersensitivity vasculitis (serious criteria GSK medically significant), macule, skin biopsy abnormal, pallor, rash, macular rash and itchy rash. In February 2018, the outcome of the rash, macular rash and itchy rash were recovered/resolved. On an unknown date, the outcome of the hypersensitivity vasculitis, macule, skin biopsy abnormal and pallor were recovered/resolved. It was unknown if the reporter considered the hypersensitivity vasculitis, macule, skin biopsy abnormal, pallor, rash, macular rash and itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient had no prior vaccinations. The age at vaccination was not reported, however, it could be 81 or 82 years old. The patient received SHINGRIX vaccine on left arm. The patient developed pruritic rash on bilateral lower extremities. On 15th February 2018, the rash was evaluated that showed blanchiry and erythematous macules. On 16th February 2018, increasing area of legs involved so patient returned to office for reevaluation and had nonblanchiry macules. On the same day, biopsy was done and patch report showed leukocytoclastic vasculitis. The rash resolved over following 5 days.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin abnormal, Erythema, Hypersensitivity vasculitis, Macule, Pallor
Clinical narrative: This case was reported by a consumer and described the occurrence of hypersensitivity vasculitis in a 82-year-old female patient who received SHINGRIX. On 13th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th February 2018, 1 days after receiving SHINGRIX, the patient experienced hypersensitivity vasculitis (serious criteria GSK medically significant), macule, skin biopsy abnormal, pallor, rash, macular rash and itchy rash. In February 2018, the outcome of the rash, macular rash and itchy rash were recovered/resolved. On an unknown date, the outcome of the hypersensitivity vasculitis, macule, skin biopsy abnormal and pallor were recovered/resolved. It was unknown if the reporter considered the hypersensitivity vasculitis, macule, skin biopsy abnormal, pallor, rash, macular rash and itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient had no prior vaccinations. The age at vaccination was not reported, however, it could be 81 or 82 years old. The patient received SHINGRIX vaccine on left arm. The patient developed pruritic rash on bilateral lower extremities. On 15th February 2018, the rash was evaluated that showed blanchiry and erythematous macules. On 16th February 2018, increasing area of legs involved so patient returned to office for reevaluation and had nonblanchiry macules. On the same day, biopsy was done and patch report showed leukocytoclastic vasculitis. The rash resolved over following 5 days.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash macular, Rash pruritic, Skin test negative
Clinical narrative: This case was reported by a consumer and described the occurrence of hypersensitivity vasculitis in a 82-year-old female patient who received SHINGRIX. On 13th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th February 2018, 1 days after receiving SHINGRIX, the patient experienced hypersensitivity vasculitis (serious criteria GSK medically significant), macule, skin biopsy abnormal, pallor, rash, macular rash and itchy rash. In February 2018, the outcome of the rash, macular rash and itchy rash were recovered/resolved. On an unknown date, the outcome of the hypersensitivity vasculitis, macule, skin biopsy abnormal and pallor were recovered/resolved. It was unknown if the reporter considered the hypersensitivity vasculitis, macule, skin biopsy abnormal, pallor, rash, macular rash and itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient had no prior vaccinations. The age at vaccination was not reported, however, it could be 81 or 82 years old. The patient received SHINGRIX vaccine on left arm. The patient developed pruritic rash on bilateral lower extremities. On 15th February 2018, the rash was evaluated that showed blanchiry and erythematous macules. On 16th February 2018, increasing area of legs involved so patient returned to office for reevaluation and had nonblanchiry macules. On the same day, biopsy was done and patch report showed leukocytoclastic vasculitis. The rash resolved over following 5 days.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 60-year-old female patient who received SHINGRIX. Co-suspect products included VALTREX unknown for shingles. Previously administered products included ZOSTAVAX (5 to 10 years ago). Concomitant products included lorazepam. On 29th March 2018, the patient received the 1st dose of SHINGRIX. On 6th April 2018, the patient started VALTREX 1 g 3 times daily (3 g daily). On 1st April 2018, 3 days after receiving SHINGRIX and not applicable after starting VALTREX, the patient experienced shingles. In April 2018, the patient experienced injection site swelling, injection site erythema, injection site pain, injection site warmth, eruption, burning lips, pain and facial swelling. The action taken with VALTREX was unknown. On an unknown date, the outcome of the shingles was recovering/resolving and the outcome of the injection site swelling, injection site erythema, injection site pain, injection site warmth, eruption, burning lips, pain and facial swelling were unknown. It was unknown if the reporter considered the shingles, injection site swelling, injection site erythema, injection site pain, injection site warmth, eruption, burning lips, pain and facial swelling to be related to SHINGRIX. It was unknown if the reporter considered the eruption, burning lips, pain and facial swelling to be related to VALTREX. Additional details were provided as follows: Concomitant medication included as BENADRYL and unknown medication (none). The patient received SHINGRIX in left arm. Less than a week after receiving SHINGRIX, the patient experienced swelling of a 3 inch area, redness and pain at the injection site. She states it was also hot, like there was fever in the area. The patient stated that, she did not see her physician until later because she was told by the pharmacist that the vaccine could not cause shingles, as it was not a live vaccine. She stated her dermatologist tested her and diagnosed her with Shingles on 4/6 and prescribed 7 days of VALTREX. The patient stated that, less than a month after receiving SHINGRIX and VALTREX, initially the bumps on her right cheek, ear and burning upper lip got worse when first placed on VALTREX. She stated no new lesions were present but still painful, her cheek was still swollen on the right side.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site swelling, Injection site warmth, Oral discomfort
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 60-year-old female patient who received SHINGRIX. Co-suspect products included VALTREX unknown for shingles. Previously administered products included ZOSTAVAX (5 to 10 years ago). Concomitant products included lorazepam. On 29th March 2018, the patient received the 1st dose of SHINGRIX. On 6th April 2018, the patient started VALTREX 1 g 3 times daily (3 g daily). On 1st April 2018, 3 days after receiving SHINGRIX and not applicable after starting VALTREX, the patient experienced shingles. In April 2018, the patient experienced injection site swelling, injection site erythema, injection site pain, injection site warmth, eruption, burning lips, pain and facial swelling. The action taken with VALTREX was unknown. On an unknown date, the outcome of the shingles was recovering/resolving and the outcome of the injection site swelling, injection site erythema, injection site pain, injection site warmth, eruption, burning lips, pain and facial swelling were unknown. It was unknown if the reporter considered the shingles, injection site swelling, injection site erythema, injection site pain, injection site warmth, eruption, burning lips, pain and facial swelling to be related to SHINGRIX. It was unknown if the reporter considered the eruption, burning lips, pain and facial swelling to be related to VALTREX. Additional details were provided as follows: Concomitant medication included as BENADRYL and unknown medication (none). The patient received SHINGRIX in left arm. Less than a week after receiving SHINGRIX, the patient experienced swelling of a 3 inch area, redness and pain at the injection site. She states it was also hot, like there was fever in the area. The patient stated that, she did not see her physician until later because she was told by the pharmacist that the vaccine could not cause shingles, as it was not a live vaccine. She stated her dermatologist tested her and diagnosed her with Shingles on 4/6 and prescribed 7 days of VALTREX. The patient stated that, less than a month after receiving SHINGRIX and VALTREX, initially the bumps on her right cheek, ear and burning upper lip got worse when first placed on VALTREX. She stated no new lesions were present but still painful, her cheek was still swollen on the right side.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash, Swelling face
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 60-year-old female patient who received SHINGRIX. Co-suspect products included VALTREX unknown for shingles. Previously administered products included ZOSTAVAX (5 to 10 years ago). Concomitant products included lorazepam. On 29th March 2018, the patient received the 1st dose of SHINGRIX. On 6th April 2018, the patient started VALTREX 1 g 3 times daily (3 g daily). On 1st April 2018, 3 days after receiving SHINGRIX and not applicable after starting VALTREX, the patient experienced shingles. In April 2018, the patient experienced injection site swelling, injection site erythema, injection site pain, injection site warmth, eruption, burning lips, pain and facial swelling. The action taken with VALTREX was unknown. On an unknown date, the outcome of the shingles was recovering/resolving and the outcome of the injection site swelling, injection site erythema, injection site pain, injection site warmth, eruption, burning lips, pain and facial swelling were unknown. It was unknown if the reporter considered the shingles, injection site swelling, injection site erythema, injection site pain, injection site warmth, eruption, burning lips, pain and facial swelling to be related to SHINGRIX. It was unknown if the reporter considered the eruption, burning lips, pain and facial swelling to be related to VALTREX. Additional details were provided as follows: Concomitant medication included as BENADRYL and unknown medication (none). The patient received SHINGRIX in left arm. Less than a week after receiving SHINGRIX, the patient experienced swelling of a 3 inch area, redness and pain at the injection site. She states it was also hot, like there was fever in the area. The patient stated that, she did not see her physician until later because she was told by the pharmacist that the vaccine could not cause shingles, as it was not a live vaccine. She stated her dermatologist tested her and diagnosed her with Shingles on 4/6 and prescribed 7 days of VALTREX. The patient stated that, less than a month after receiving SHINGRIX and VALTREX, initially the bumps on her right cheek, ear and burning upper lip got worse when first placed on VALTREX. She stated no new lesions were present but still painful, her cheek was still swollen on the right side.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Post vaccination autoinoculation
Clinical narrative: AUTO INOCULATION - LESIONS ON TRANSFERRED TO FACE. ALSO REPORTED FEVER, CHILLS, MYALGIAS.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chills, Myalgia, Post vaccination autoinoculation, Pyrexia, Skin lesion
Clinical narrative: AUTO INOCULATION - LESIONS ON TRANSFERRED TO FACE. ALSO REPORTED FEVER, CHILLS, MYALGIAS.