chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermal cyst, Extensive swelling of vaccinated limb, Headache, Injected limb mobility decreased, Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 56-year-old female patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020). Concomitant products included UNITHROID, phendimetrazine, LEXAPRO and TYLENOL. On 16th May 05:00, the patient received the 1st dose of SHINGRIX .5 ml. In May 2018 less than a week after receiving SHINGRIX, the patient experienced injected limb mobility decreased, stiff neck and skin cyst. On 16th May 2018, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site warmth, cramp, headache and nausea. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site warmth were not recovered/not resolved and the outcome of the cramp, headache and nausea were recovered/resolved and the outcome of the injected limb mobility decreased, stiff neck and skin cyst were unknown. The reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, cramp, headache and nausea to be related to SHINGRIX. It was unknown if the reporter considered the injected limb mobility decreased, stiff neck and skin cyst to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The redness, swelling and hot to the touch was started in the middle of the night the evening of the vaccination and progressed the next day. The cramping was primarily in the legs and hips and also started that evening. The swelling of the injection site traveled up her neck and it was difficult to move her arm and neck. The events headache, nausea and cramping started to subside on Saturday (19th May 2018). A day before the reporting date, the patient experienced a red circle patch presented further down from the injection site and was moving toward her armpit area, in between shoulder and the armpit. It was also hot to the touch. The patient described it as feeling like there was a ball under her skin and moving down.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Muscle spasms, Musculoskeletal stiffness, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 56-year-old female patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020). Concomitant products included UNITHROID, phendimetrazine, LEXAPRO and TYLENOL. On 16th May 05:00, the patient received the 1st dose of SHINGRIX .5 ml. In May 2018 less than a week after receiving SHINGRIX, the patient experienced injected limb mobility decreased, stiff neck and skin cyst. On 16th May 2018, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site warmth, cramp, headache and nausea. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site warmth were not recovered/not resolved and the outcome of the cramp, headache and nausea were recovered/resolved and the outcome of the injected limb mobility decreased, stiff neck and skin cyst were unknown. The reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, cramp, headache and nausea to be related to SHINGRIX. It was unknown if the reporter considered the injected limb mobility decreased, stiff neck and skin cyst to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The redness, swelling and hot to the touch was started in the middle of the night the evening of the vaccination and progressed the next day. The cramping was primarily in the legs and hips and also started that evening. The swelling of the injection site traveled up her neck and it was difficult to move her arm and neck. The events headache, nausea and cramping started to subside on Saturday (19th May 2018). A day before the reporting date, the patient experienced a red circle patch presented further down from the injection site and was moving toward her armpit area, in between shoulder and the armpit. It was also hot to the touch. The patient described it as feeling like there was a ball under her skin and moving down.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Influenza like illness, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tingling sensation in a 60-year-old male patient who received SHINGRIX. The patient's past medical history included herpes virus infection (the patient has a history of herpes flare ups for which he takes VALTREX. Previously administered products included SHINGRIX (1st dose received). Concomitant products included VALTREX. On 21st May 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 21st May 2018, less than a day after receiving SHINGRIX, the patient experienced stomach discomfort, influenza-like symptoms, fever, pain in arm and tiredness. On 23rd May 2018, the patient experienced tingling sensation. On an unknown date, the outcome of the tingling sensation was not recovered/not resolved and the outcome of the stomach discomfort, influenza-like symptoms, fever, pain in arm and tiredness were unknown. The reporter consider the tingling sensation to be possibly related to SHINGRIX. The reporter considered the stomach discomfort, influenza-like symptoms, fever, pain in arm and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient declined to provide address and could not provide demographics for the pharmacy where he received the injection. The patient reported that after the 2nd dose of SHINGRIX he experienced sore arm, tiredness, flu like symptoms, fever, stomach discomfort. The patient reported that today he was feeling tingling like a herpes flare up was about to occur, tingling was above the left knee.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tingling sensation in a 60-year-old male patient who received SHINGRIX. The patient's past medical history included herpes virus infection (the patient has a history of herpes flare ups for which he takes VALTREX. Previously administered products included SHINGRIX (1st dose received). Concomitant products included VALTREX. On 21st May 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 21st May 2018, less than a day after receiving SHINGRIX, the patient experienced stomach discomfort, influenza-like symptoms, fever, pain in arm and tiredness. On 23rd May 2018, the patient experienced tingling sensation. On an unknown date, the outcome of the tingling sensation was not recovered/not resolved and the outcome of the stomach discomfort, influenza-like symptoms, fever, pain in arm and tiredness were unknown. The reporter consider the tingling sensation to be possibly related to SHINGRIX. The reporter considered the stomach discomfort, influenza-like symptoms, fever, pain in arm and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient declined to provide address and could not provide demographics for the pharmacy where he received the injection. The patient reported that after the 2nd dose of SHINGRIX he experienced sore arm, tiredness, flu like symptoms, fever, stomach discomfort. The patient reported that today he was feeling tingling like a herpes flare up was about to occur, tingling was above the left knee.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Malaise, Pyrexia, Rash
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a 77-year-old female patient who received SHINGRIX (batch LT533, expiry date 11th October 2020). Concurrent medical conditions included hypertension (controlled), hyperlipidemia (stable) and gastroesophageal reflux disease (sable). On 8th May 2018, the patient received the 1st dose of gastroesophageal (intramuscular) .5 ml. On 10th May 2018, 2 days after receiving gastroesophageal, the patient experienced fever, malaise, diarrhea, rash, fatigue and hives. The patient was treated with steroids NOS. SHINGRIX was discontinued. On an unknown date, the outcome of the fever, malaise, diarrhea, rash, fatigue and hives were recovering/resolving. It was unknown if the reporter considered the fever, malaise, diarrhea, rash, fatigue and hives to be related to gastroesophageal. Additional details were provided as follows: The patient was a nonsmoker. The adverse events were not related to medical history or concurrent condition, erroneous administration, suspected transmission of an infectious agent via medicinal product and lack of effect. The patient was symptomatic after receiving SHINGRIX injection. The patient was treated with topical steroid lotion or shampoo. No diagnostic details were provided.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a 77-year-old female patient who received SHINGRIX (batch LT533, expiry date 11th October 2020). Concurrent medical conditions included hypertension (controlled), hyperlipidemia (stable) and gastroesophageal reflux disease (sable). On 8th May 2018, the patient received the 1st dose of gastroesophageal (intramuscular) .5 ml. On 10th May 2018, 2 days after receiving gastroesophageal, the patient experienced fever, malaise, diarrhea, rash, fatigue and hives. The patient was treated with steroids NOS. SHINGRIX was discontinued. On an unknown date, the outcome of the fever, malaise, diarrhea, rash, fatigue and hives were recovering/resolving. It was unknown if the reporter considered the fever, malaise, diarrhea, rash, fatigue and hives to be related to gastroesophageal. Additional details were provided as follows: The patient was a nonsmoker. The adverse events were not related to medical history or concurrent condition, erroneous administration, suspected transmission of an infectious agent via medicinal product and lack of effect. The patient was symptomatic after receiving SHINGRIX injection. The patient was treated with topical steroid lotion or shampoo. No diagnostic details were provided.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Dizziness, Gait inability, Impaired driving ability
Clinical narrative: Extreme dizziness. Vision problem. Muscle weakness. Aching joints. Unable to walk, drive, go upstairs or down due to muscle pain, weakness. Today is May 17th this is the first day since 5/7/18. Had shingles 8/26/16 thru 3/2017 - residual nerve pain to this day. Had the original shingles shot may of 2017 - no reaction at all. Today is 5/25/18 this is the first day I have felt as I did before I had the SHINGRIX shot.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Muscular weakness, Myalgia, Visual impairment
Clinical narrative: Extreme dizziness. Vision problem. Muscle weakness. Aching joints. Unable to walk, drive, go upstairs or down due to muscle pain, weakness. Today is May 17th this is the first day since 5/7/18. Had shingles 8/26/16 thru 3/2017 - residual nerve pain to this day. Had the original shingles shot may of 2017 - no reaction at all. Today is 5/25/18 this is the first day I have felt as I did before I had the SHINGRIX shot.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a adult female patient who received SHINGRIX. On 3rd May 2018, the patient received the 1st dose of SHINGRIX. On 5th May 2018, 2 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth and injection site swelling. In May 2018, the patient experienced chills, fever and influenza-like symptoms. In May 2018, the outcome of the chills was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site swelling, fever and influenza-like symptoms were recovered/resolved. The reporter considered the chills, injection site erythema, injection site warmth, injection site swelling and influenza-like symptoms to be related to SHINGRIX. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on left arm at approximately 11:00 AM. The patient reported that she experienced a fever, chills and flu like symptoms that lasted a day or two after receiving the SHINGRIX vaccine. She also reported a hot, red and swollen area at the injection site that started two days later and stayed for one week. The patient had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a adult female patient who received SHINGRIX. On 3rd May 2018, the patient received the 1st dose of SHINGRIX. On 5th May 2018, 2 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth and injection site swelling. In May 2018, the patient experienced chills, fever and influenza-like symptoms. In May 2018, the outcome of the chills was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site swelling, fever and influenza-like symptoms were recovered/resolved. The reporter considered the chills, injection site erythema, injection site warmth, injection site swelling and influenza-like symptoms to be related to SHINGRIX. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on left arm at approximately 11:00 AM. The patient reported that she experienced a fever, chills and flu like symptoms that lasted a day or two after receiving the SHINGRIX vaccine. She also reported a hot, red and swollen area at the injection site that started two days later and stayed for one week. The patient had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of erythema of extremities in a adult female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was unknown. It was unknown if the reporter considered the erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional showed a picture of patient's erythema on arm post administration. The patient experienced redness over entire back of arm (possibly left arm, judging by picture). The health care professional did not want to file adverse event report before asking the patient first. The information regarding the administration, patient and vaccine were unknown. The reporter did not agree to be followed up from safety department. This case had been linked with US2018GSK093084, reported by the same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site inflammation in a 67-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 22nd May 2019). On 22nd May 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 22nd May 2018, several hours after receiving SHINGRIX, the patient experienced injection site inflammation, injection site erythema, injection site swelling and intramuscular formulation administered by other route. The patient was treated with ADVIL. On an unknown date, the outcome of the injection site inflammation, injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site inflammation, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient inadvertently received SHINGRIX on left arm between 11:41 and 12 pm subcutaneously instead of intramuscular route, which led to incorrect route of drug administration. On the day of vaccination, in the evening, the patient developed inflammation, redness and swelling at the injection site (left arm). Symptoms were still present at the date of reporting. The pharmacist instructed patient to take ADVIL and pharmacist was going to follow up with patient's physician. This was the first time this pharmacist called regarding this situation. Expiration date provided might be expiration date given in pharmacy system and might not be true GSK expiration date of vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. During call back to healthcare professional, the HCP reported that he heard of 2 or 3 reports of patient who developed shingles after receiving SHINGRIX (one reported in case US2018091600), the reporter heard this from another HCP. No additional information was available and HCP did not have time to obtain additional information from other HCP for report but gave permission to be contacted if necessary at a later date. One of the patients received SHINGRIX at a local store. He was unsure if these others had been reported to GlaxoSmithKline. This case was considered as suspected vaccination failure, the details regarding vaccination schedule, TTO (time to onset) and confirmatory laboratory test were not reported. This case has been linked with case US2018091600, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several hours after receiving SHINGRIX, the patient experienced injection site erythema, fatigue, muscle weakness and activities of daily living impaired. On an unknown date, the outcome of the injection site erythema, fatigue and muscle weakness were recovering/resolving and the outcome of the activities of daily living impaired was recovered/resolved. The reporter considered the injection site erythema, fatigue and muscle weakness to be probably related to SHINGRIX. It was unknown if the reporter considered the activities daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The HCP did not have vaccine lot number or expiration date. The healthcare professional (HCP) reported that the patient developed fatigue, muscle weakness, and redness around the injection site several hours after receiving a of SHINGRIX. The vaccine was given at a different facility. The patient was unable to do normal daily activities for 2 days due to the muscle weakness and fatigue. The patients symptoms were improving but have not yet resolved at the time of reporting. The pharmacist recommended the patient use ice for the injection site redness.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Grip strength decreased, Hypoaesthesia, Pain
Clinical narrative: FEELING NUMBNESS IN THE ARM, FEELING AS IF ARM IS FALLING ASLEEP, DROPPING THINGS. STARTED 2 DAYS AFTER SHOT. OTHER THAN THAT SORENESS, RED SPOT.
Age: 4.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient developed fever on the day of vaccines administration. On evaluation patient was also found with right arm deltoid area erythema and mild swelling, non tender and without limitation of range of motion. Tx: Cold compresses in right arm, acetaminophen every 4 hours as needed for fever.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Muscle pain, shivers, headache.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Injection site urticaria, Myalgia, Oral herpes, Pruritus
Clinical narrative: Patient called me 6/1/18 to ask if her allergist could send a prescription for Dose #2 to be given in his office. I asked what her symptoms were and she described them as follows: Muscle soreness, GI upset, a large cold sore on her mouth, mild fever, itching on BOTH arms and SCALP, Hives below the injection site (but not at the injection site).
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient called me 6/1/18 to ask if her allergist could send a prescription for Dose #2 to be given in his office. I asked what her symptoms were and she described them as follows: Muscle soreness, GI upset, a large cold sore on her mouth, mild fever, itching on BOTH arms and SCALP, Hives below the injection site (but not at the injection site).
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Extreme redness and swelling starting in a small area on front of upper left arm (not where shot was given) and then spreading during second day to half of upper left arm, armpit to elbow - hot to the touch. Prescribed Prednisone 20 mg - 2 tabs for 5 days, 1 tab for 5 days.
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: Wrong drug administered
Clinical narrative: Patient should have received PNEUMOVAX 23 vaccine as he had been given PREVNAR 13 one year prior. Instead he was given PREVNAR 13 vaccine again.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever and body aches.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Abnormal behaviour, Blindness, Chills, Disturbance in attention, Headache
Clinical narrative: Very severe headache, loss of vision, and not able to concentrate or know what he was doing. He had a migraine like this over 2 years ago, but it occurred right after getting the vaccination. His headache was bad that morning but it just kept getting worse to where he couldn't even see. He developed a fever and was chilling and aching all over. He was in the bed and not moving for 2 full days. The migraine meds hardly touched the headache, and he did not even remember when we gave him his meds. He was talking out of his head.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Memory impairment, Mobility decreased, Pain, Pyrexia
Clinical narrative: Very severe headache, loss of vision, and not able to concentrate or know what he was doing. He had a migraine like this over 2 years ago, but it occurred right after getting the vaccination. His headache was bad that morning but it just kept getting worse to where he couldn't even see. He developed a fever and was chilling and aching all over. He was in the bed and not moving for 2 full days. The migraine meds hardly touched the headache, and he did not even remember when we gave him his meds. He was talking out of his head.
Age: 46.0
Sex: F
Vaccine: TYP
Symptoms: Pyrexia, Swelling face
Clinical narrative: Fever of 102.1 over 2 days controlled with Advil; facial swelling.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 4 INCHES BELOW THE INJECTION, RECTANGLE SHAPED, DEEP RED PATCH, SOMETIMES ITCHY, APPROXIMATELY 6 INCHES BY 3 INCHES. RESOLVING WITH DESOXIMETASONE CREAM.
Age: 0.42
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: VACCINE GIVEN PRIOR TO RECOMMENDED AGE. NO ADVERSE REACTION NOTED OR REPORTED BY PARENTS.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash pruritic
Clinical narrative: Patient reported shingles symptoms starting 1 week after vaccination. She has an itchy rash and pain under her breast that was diagnosed 5-31-18 as Shingles from her doctor.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient reported shingles symptoms starting 1 week after vaccination. She has an itchy rash and pain under her breast that was diagnosed 5-31-18 as Shingles from her doctor.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, PNC13
Symptoms: Injection site bruising, Injection site discolouration, Injection site induration, Injection site warmth
Clinical narrative: On 5/16/18-MD states resolving Right popliteal capillary hemangioma. On 6/1/18-MD states left thigh has become more warmth and color change to almost bruised appearance-no fever and no hx of insect bites. At 9th month WCC-SQ nodule which showed no redness/tenderness and was felt to be a resolving contusion at site vaccination. Mother worried that the site has become "firm as a rock".
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hyperhidrosis, Pain in extremity, Pyrexia
Clinical narrative: Dizziness, sweating, sore arm, fever.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Anxiety, Injection site erythema, Injection site pain, Injection site warmth, Nausea
Clinical narrative: Patient was administered injection on 5/25/2018. She reports that redness and soreness at site starting the following day. Patient reports that she medicated with ibuprofen for the soreness/ pain and used ice on the site. Patient returned to our office on 6/1/2018 for an appointment regarding a different aliment and informed clinical staff of reaction at that time. There was a 4"x4" circular red area on right deltoid area, in the upper right side of circle was firm area that is warm and tender to touch. Patient states that she had nausea on 5/26/2018 but wasn't sure if this was related to vaccination. States she has felt a little more "anxious" since vaccination. Denies fever or other symptoms.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Decreased eye contact, Decreased interest, Eating disorder, Hyporesponsive to stimuli, Obsessive-compulsive disorder
Clinical narrative: Fever of 103 for 2 days. After fever subsided, he became very limited in what he would eat. Eye contact went away and over the next 12 months I continued to see a period of decline in responsiveness as well as an increase in obsessive behavior from no longer playing with toys but lining them up as well as staring episodes at no one or anything in particular. Eventually he stop responding to his name being called and words he once knew well (Mommy, Daddy, etc.) slowly disseminated. He showed little to no interest in siblings anymore and did not acknowledge our dogs anymore.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Pyrexia, Speech disorder, Staring, Unresponsive to stimuli
Clinical narrative: Fever of 103 for 2 days. After fever subsided, he became very limited in what he would eat. Eye contact went away and over the next 12 months I continued to see a period of decline in responsiveness as well as an increase in obsessive behavior from no longer playing with toys but lining them up as well as staring episodes at no one or anything in particular. Eventually he stop responding to his name being called and words he once knew well (Mommy, Daddy, etc.) slowly disseminated. He showed little to no interest in siblings anymore and did not acknowledge our dogs anymore.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Flushing, Headache
Clinical narrative: Intense Headache, muscle aches, weakness, tired, very sore arm. Chills. Flushed.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Intense Headache, muscle aches, weakness, tired, very sore arm. Chills. Flushed.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Pain from elbow up through shoulder. Vomitting.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site warmth, Pain
Clinical narrative: After the vaccine adminstration patient felt general tiredness and soreness. They noticed redness around the injection site as well which spread further down the arm in the following days. Patient stated that the redness felt warm to the touch. Patient was advised to seek immediate medical attention.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: I became dizzy within a week of receiving the injection. I'm not sure the first date of dizziness, but had a severe case on 4/20/18 after having shot on 4/13/18. I am still having dizzy spells as of 6/1/18. I have been to my primary care physician, an ear, nose and throat doctor and the clinic. I am now going to a vestibular therapist.
Age: 21.0
Sex: F
Vaccine: TD
Symptoms: Chest discomfort, Hypoaesthesia, Injection site hypoaesthesia, Injection site reaction, Paraesthesia
Clinical narrative: Patient reported numbness and tingling from injection site radiating to left side of face and slight chest tightness.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Pain
Clinical narrative: Patient was administered the vaccine in our office at 9:31 AM. Patient presented to the ER of Hospital that evening 12 hours later c/o right shoulder pain. Pain was throbbing. No erythema no swelling and no warmth. No fluctuance present. Pain worse with movement. No obvious signs of infection. Pain management was given and patient was instructed to follow up with Nephrologist the next day. Nephrologist MD
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Patient was to get Tdap, but received DTaP.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Swelling and redness on left deltoid. 2 1/2 in wide x 4 in wide. Stated achy and low grade fever.  Suggested Benadryl
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site pain, Injection site swelling, Injection site warmth, Throat irritation
Clinical narrative: Patient checked in to the Emergency Room at the Hospital on 05/10/18 complaining of allergic reaction after receiving SHINGRIX the previous day. Per patient, she experienced hives all over body and itchy throat 4-5 hours after receiving vaccination on 05/09/18. She also complained of severe pain, swelling and warmth at site of injection on right deltoid.  Denies difficulty breathing or fevers. Denies food allergies or taking any new medications. Patient claimed she did not take Benadryl and that the hives resolved after a couple of hours.  Per medical provider in the ER, it was noted that patient was feeling well with no rash, hives, or redness at injection site noted per physical exam. ER provider unable to determine if zoster vaccine caused reaction. However, per 06/01/18 encounter in the outpatient clinic, hives were noted on trunk of body per medical exam. Patient denies any changes in soaps, detergents, lotions, foods, or anything else. Per patient, she believes reaction to vaccine has still persisted.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient checked in to the Emergency Room at the Hospital on 05/10/18 complaining of allergic reaction after receiving SHINGRIX the previous day. Per patient, she experienced hives all over body and itchy throat 4-5 hours after receiving vaccination on 05/09/18. She also complained of severe pain, swelling and warmth at site of injection on right deltoid.  Denies difficulty breathing or fevers. Denies food allergies or taking any new medications. Patient claimed she did not take Benadryl and that the hives resolved after a couple of hours.  Per medical provider in the ER, it was noted that patient was feeling well with no rash, hives, or redness at injection site noted per physical exam. ER provider unable to determine if zoster vaccine caused reaction. However, per 06/01/18 encounter in the outpatient clinic, hives were noted on trunk of body per medical exam. Patient denies any changes in soaps, detergents, lotions, foods, or anything else. Per patient, she believes reaction to vaccine has still persisted.
Age: 59.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Arthralgia, Impaired work ability, Lethargy, Loss of personal independence in daily activities, Myalgia
Clinical narrative: I awoke the next day, Sunday 5/27/18 with soreness in muscles and joints, and rate them as 7 out of 10 on pain scale. My right deltoid was swollen and very painful (10 out of 10). I was very lethargic, and went back to bed, slept 5 hours, up one hour and back to bed until Monday morning. Same things on Monday 5/28/18. I was not able to do any of my normal activities of living, or my chores. I was somewhat better on Tuesday morning, 5/29/18 and went to work. But was  overcome again by lethargy and ended up laying on the floor there for 3 hours until I was able to drive home. Then slept thru to Wednesday 5/30/18. My joint and muscle pain started to resolve, and I was able to work my regular day. I was normal on Thursday 5/31/18. I am in excellent health, walk 3 miles daily, eat healthy diet, and maintaining normal weight for my height for years. I cannot remember being sick over the last 2 years, including colds. n fact, I do not remember being that sick in years.
Age: 59.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: I awoke the next day, Sunday 5/27/18 with soreness in muscles and joints, and rate them as 7 out of 10 on pain scale. My right deltoid was swollen and very painful (10 out of 10). I was very lethargic, and went back to bed, slept 5 hours, up one hour and back to bed until Monday morning. Same things on Monday 5/28/18. I was not able to do any of my normal activities of living, or my chores. I was somewhat better on Tuesday morning, 5/29/18 and went to work. But was  overcome again by lethargy and ended up laying on the floor there for 3 hours until I was able to drive home. Then slept thru to Wednesday 5/30/18. My joint and muscle pain started to resolve, and I was able to work my regular day. I was normal on Thursday 5/31/18. I am in excellent health, walk 3 miles daily, eat healthy diet, and maintaining normal weight for my height for years. I cannot remember being sick over the last 2 years, including colds. n fact, I do not remember being that sick in years.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Feeling hot, Hyperhidrosis, Injection site erythema, Musculoskeletal stiffness
Clinical narrative: Patient complained of hot/cold body temperatures that she could not regulate accompanied with sweating as well as neck stiffness. Patient also reported blisters in mouth. Patient reports symptoms started 24-48 hours post-injection. Patient also reports she still currently has large red area on arm where vaccine was administered. Patient did not seek medical intervention.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral mucosal blistering, Temperature regulation disorder
Clinical narrative: Patient complained of hot/cold body temperatures that she could not regulate accompanied with sweating as well as neck stiffness. Patient also reported blisters in mouth. Patient reports symptoms started 24-48 hours post-injection. Patient also reports she still currently has large red area on arm where vaccine was administered. Patient did not seek medical intervention.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Crying, Gait disturbance, Immediate post-injection reaction, Injection site pain, Pyrexia
Clinical narrative: Patient is limping. Left thigh is effected. (Crying and extreme pain on administration. Limping afterwards immediately.) Limping is not getting better with time, as would be expected; instead limping is increasing. Also high fever within a few hours of administration..
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Palpitations, Throat tightness
Clinical narrative: Patient reported (after the fact) heart palpitations and the sensation of the throat closing a went to the hospital.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient came back to pharmacy on 6/1/18 after receiving the 2 vaccinations here on 5/26/18. Her left arm was swollen and red. She stated it was also hot to the touch and itchy. Her arm had been that way for several days, she said. I recommended she take a Benadryl orally and place an ice pack on the arm. I also suggested she take an Aleve if the arm was painful or bothersome to her. I asked her if she was allergic to anything and she stated only penicillin. I told her I would put both vaccines on her allergy profile today.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: PATIENT HAD INJECTION SITE REACTION WITH LARGE RED CIRCLE THAT SEEMED TO MOVE FROM DELTOID TO DIFFERENT POSITION ON ARM FROM INJECTION SITE.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: PATIENT HAD INJECTION SITE REACTION WITH LARGE RED CIRCLE THAT SEEMED TO MOVE FROM DELTOID TO DIFFERENT POSITION ON ARM FROM INJECTION SITE.
Age: 28.0
Sex: F
Vaccine: MNQ, YF
Symptoms: Incorrect route of drug administration, Injection site induration
Clinical narrative: Two vaccines (MENACTRA and STAMARIL) were administered on the same day in different arms. MENACTRA was administered by mistake subcutaneously rather than IM.  As a result, induration of the subcutaneous tissue on the left arm (site of MENACTRA vaccine) occurred ~24-36 hours after vaccine.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site hypoaesthesia, Pain in extremity
Clinical narrative: Pain in the left arm, arm is frozen can not move right or left, numbness throughout arm and in hand.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPVHIB, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received double dose of DTaP and IPV. No reaction to vaccines.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness, Irritability, Malaise, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 54-year-old male patient who received SHINGRIX (batch number 32GR4 ?, expiry date 4th July 2020). On 18th May 2018, 13:55, the patient received the 2nd dose of SHINGRIX (intramuscular). On 18th May 2018, less than a day after receiving SHINGRIX, the patient experienced fever, feeling irritated, influenza-like symptoms, general malaise and joint pain. on 19th May 2018, the outcome of the fever, feeling irritated, influenza-like symptoms, general malaise and joint pain were recovered/resolved. The reporter considered the fever, feeling irritated, influenza-like symptoms, general malaise and joint pain were recovered/resolved. The reporter considered the fever, feeling irritated, influenza-like symptoms, general malaise and joint pain to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported on online chat. The patient was administered SHINGRIX in the left deltoid. The patient experienced joint pain, felt cranky, flu-like symptoms along with feeling general malaise and feverish.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chickenpox in a 65-year-old female patient who received SHINGRIX. On 17th May 2018, the patient received SHINGRIX. On 22nd May 2018, 5 days after receiving SHINGRIX, the patient experienced chickenpox. On an unknown date, the outcome of the chickenpox was unknown. It was unknown if the reporter considered the chickenpox to be related to SHINGRIX. Additional details were provided as follows: The pharmacist called to ask if a patient could get the chicken pox virus from receiving SHINGRIX. The health care professional stated that, a patient received SHINGRIX on 17th May 2018 and went to her physician on the day of reporting and was diagnosed with the Chicken pox virus. The pharmacist said the patient's physician told the patient that 1 to 2 percent of patients get the chicken pox virus from SHINGRIX. No further information was provided.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Vomiting
Clinical narrative: Patient received SHINGRIX on 5/30/18. He returned to pharmacy 5/31/18 and reported he had experienced chills on 5/30/18 and vomiting on 5/31/18.
Age: 77.0
Sex: F
Vaccine: HEP
Symptoms: Heart rate increased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of heartbeats increased in a 77-year-old female patient who received ENGERIX B (batch number 294F7, expiry date 11th October 2019). Concurrent medical conditions included palpitation. Concomitant products included omeprazole, propranolol hydrochloride, TRAMADOL/APAP and zolpidem. On 14th May 2018 12:00, the patient received the 1st dose of ENGERIX B (intramuscular) 20 ug. On14th May 2018 18:00, 6 hrs after receiving ENGERIX B, the patient experienced heartbeats increased. On 15th May 2018, the outcome of the heartbeats increased was recovered/resolved. It was unknown if the reporter considered the heartbeats increased to be related to ENGERIX B. Additional details were provided as follows: The patient received SHINGRIX into left arm. The pharmacist reported that the patient experienced a rapid heartbeat after receiving SHINGRIX. The symptoms started around 6 PM that evening. The next morning the patient had a slightly elevated heart rate. The symptoms resolved around noon.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Pt developed redness, pain on 5-23-18, increased redness, warmth and painful. Pt seen 5-26-18 given 1grm ROCEPHIN IM and started on Cephalexin 500mg 1 tan 3x/day F/U as needed.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Nausea, Pain in extremity, Pyrexia
Clinical narrative: 20 minutes after vaccination, I felt light-headed, nauseous, left arm became sore, felt dizzy, felt feverish and weak.
Sex: U
Vaccine: VARZOS
Symptoms: Local reaction, Pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of local reaction in an unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced local reaction and pain. On an unknown date, the outcome of the local reaction and pain were unknown. It was unknown if the reporter considered the local reaction and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The health coach reported to the GSK sales representative that they have had patients that have experienced local reactions to the SHINGRIX vaccine including that it was hurt really bad. No additional details were available.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Headache, Injection site pain, Myalgia
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a 73-year-old female patient who received SHINGRIX. On 22nd May 2018 16:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 22nd May 2018, 4 hrs after receiving SHINGRIX, the patient experienced injection site pain, pain in arm, back pain, muscle soreness, headache, joint pain and nausea. On 23rd May 2018, the patient experienced fever and somnolence. On an unknown date, the outcome of the injection site pain, pain in arm, back pain, muscle soreness, fever, headache, somnolence, joint pain and nausea were not recovered/not resolved. The reporter considered the injection site pain, pain in arm, muscle soreness, fever, headache, somnolence, joint pain and nausea to be probably related to SHINGRIX. It was unknown if the reporter considered the back pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a fever of 102.5 degree F. The patient developed pain at the injection site as well as shooting pain in her back and arms.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a 73-year-old female patient who received SHINGRIX. On 22nd May 2018 16:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 22nd May 2018, 4 hrs after receiving SHINGRIX, the patient experienced injection site pain, pain in arm, back pain, muscle soreness, headache, joint pain and nausea. On 23rd May 2018, the patient experienced fever and somnolence. On an unknown date, the outcome of the injection site pain, pain in arm, back pain, muscle soreness, fever, headache, somnolence, joint pain and nausea were not recovered/not resolved. The reporter considered the injection site pain, pain in arm, muscle soreness, fever, headache, somnolence, joint pain and nausea to be probably related to SHINGRIX. It was unknown if the reporter considered the back pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a fever of 102.5 degree F. The patient developed pain at the injection site as well as shooting pain in her back and arms.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site pain, Insomnia, Lethargy, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling hot in a adult male patient who received SHINGRIX. Concomitant products included ALOQUIN. In February 2018, the patient received the 1st dose of SHINGRIX. In February 2018, less than a week after receiving SHINGRIX, the patient experienced feeling hot, injection site pain and sleeplessness. On an unknown date, the patient experienced lethargy and feeling unwell. On an unknown date, the outcome of the feeling hot, injection site pain, sleeplessness and feeling unwell were recovered/resolved and the outcome of the lethargy was unknown. The reporter considered the feeling hot, injection site pain, lethargy, sleeplessness and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Three months before the date of reporting, the patient received SHINGRIX in the right arm. The patient felt ill for 48 hours following vaccination and then it resolved. The patient described it as feeling feverish but did not have a fever, lethargic, didn't sleep well and pain at the injection site. This case was linked with US2018GSK097942, reported by the same reporter. The patient refused to provide his details and rushed off the phone.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain at injection site for7 full days. Patient said "very painful."