chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Fatigue, Gait disturbance, Impaired work ability, Inflammation, Influenza
Clinical narrative: On the first day after the flu shot I experienced flu symptoms. Body ache, fatigue, diarrhea which escalated in 2 weeks to inflammation on both arms and legs. I could not reach with my arms and turn a key in my car to start or any movement to use my wrist. I had difficulty walking due to swelling of joints and muscles. I made a non-emergency appointment and blood and urine test were done. A physician called me and said I had a UTI and ask if I had loose bowel movement and I replied, "Yes". I was referred to the Rheumatologist and had additional test run and was prescribed Prednisone 20mg for 1 week then down to 10mg. My Condition continued and doctor's couldn't verify my condition happened due to flu shot. Before the flu shot, I pointed out to my PCP that before the vaccine I was healthy: lower blood pressure, low cholesterol, low glucose. I cut milk and gluten which canceled any asthma symptoms that I had not used an inhaler for asthma since October 2013 and did not see a doctor much. Soon after the vaccine I needed to see a orthopedic physician due to continuing swelling of my right arm showed a bicep tear. My inflammation rate fluctuated with medication and as doctor tried to taper me from steroids the other medication seem to increase the pain. I currently on my 3rd medication with the steroids to control my ESR & C-Reactive Protein levels. At one point place on 5 months disability by physician. On 3/28/2018 I talked to my Primary Care Physician to talk about the prolong inflammation and my response to some of the medications. If I should continue trying other medication and because of inflammation my joints have serious affects. Walking is difficult and was advised by one of the orthopedic doctor that I was seeing that I need a hip replacement. We talked about the flu vaccine or UTI being the possible cause and has placed that in my medical records. She also is placing me on disability a month at a time to see if any new medication will help. Again I have never seen so many different physician as I have had to with this reaction after the vaccine in 9/27/2016.  I haven't been able to work or look conscientiously for work and was let go from my job in April 2017.
Age: 59.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Joint swelling, Laboratory test, Mobility decreased, Muscle swelling, Pain
Clinical narrative: On the first day after the flu shot I experienced flu symptoms. Body ache, fatigue, diarrhea which escalated in 2 weeks to inflammation on both arms and legs. I could not reach with my arms and turn a key in my car to start or any movement to use my wrist. I had difficulty walking due to swelling of joints and muscles. I made a non-emergency appointment and blood and urine test were done. A physician called me and said I had a UTI and ask if I had loose bowel movement and I replied, "Yes". I was referred to the Rheumatologist and had additional test run and was prescribed Prednisone 20mg for 1 week then down to 10mg. My Condition continued and doctor's couldn't verify my condition happened due to flu shot. Before the flu shot, I pointed out to my PCP that before the vaccine I was healthy: lower blood pressure, low cholesterol, low glucose. I cut milk and gluten which canceled any asthma symptoms that I had not used an inhaler for asthma since October 2013 and did not see a doctor much. Soon after the vaccine I needed to see a orthopedic physician due to continuing swelling of my right arm showed a bicep tear. My inflammation rate fluctuated with medication and as doctor tried to taper me from steroids the other medication seem to increase the pain. I currently on my 3rd medication with the steroids to control my ESR & C-Reactive Protein levels. At one point place on 5 months disability by physician. On 3/28/2018 I talked to my Primary Care Physician to talk about the prolong inflammation and my response to some of the medications. If I should continue trying other medication and because of inflammation my joints have serious affects. Walking is difficult and was advised by one of the orthopedic doctor that I was seeing that I need a hip replacement. We talked about the flu vaccine or UTI being the possible cause and has placed that in my medical records. She also is placing me on disability a month at a time to see if any new medication will help. Again I have never seen so many different physician as I have had to with this reaction after the vaccine in 9/27/2016.  I haven't been able to work or look conscientiously for work and was let go from my job in April 2017.
Age: 59.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Peripheral swelling, Red blood cell sedimentation rate abnormal, Urinary tract infection, Urine analysis abnormal
Clinical narrative: On the first day after the flu shot I experienced flu symptoms. Body ache, fatigue, diarrhea which escalated in 2 weeks to inflammation on both arms and legs. I could not reach with my arms and turn a key in my car to start or any movement to use my wrist. I had difficulty walking due to swelling of joints and muscles. I made a non-emergency appointment and blood and urine test were done. A physician called me and said I had a UTI and ask if I had loose bowel movement and I replied, "Yes". I was referred to the Rheumatologist and had additional test run and was prescribed Prednisone 20mg for 1 week then down to 10mg. My Condition continued and doctor's couldn't verify my condition happened due to flu shot. Before the flu shot, I pointed out to my PCP that before the vaccine I was healthy: lower blood pressure, low cholesterol, low glucose. I cut milk and gluten which canceled any asthma symptoms that I had not used an inhaler for asthma since October 2013 and did not see a doctor much. Soon after the vaccine I needed to see a orthopedic physician due to continuing swelling of my right arm showed a bicep tear. My inflammation rate fluctuated with medication and as doctor tried to taper me from steroids the other medication seem to increase the pain. I currently on my 3rd medication with the steroids to control my ESR & C-Reactive Protein levels. At one point place on 5 months disability by physician. On 3/28/2018 I talked to my Primary Care Physician to talk about the prolong inflammation and my response to some of the medications. If I should continue trying other medication and because of inflammation my joints have serious affects. Walking is difficult and was advised by one of the orthopedic doctor that I was seeing that I need a hip replacement. We talked about the flu vaccine or UTI being the possible cause and has placed that in my medical records. She also is placing me on disability a month at a time to see if any new medication will help. Again I have never seen so many different physician as I have had to with this reaction after the vaccine in 9/27/2016.  I haven't been able to work or look conscientiously for work and was let go from my job in April 2017.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash macular
Clinical narrative: Patient experiencing red, blotchy rash 2 days past injection. Rash is on trunk and arms at this time.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site pain, Injection site swelling
Clinical narrative: Patient states his injection site swelled to the size of a tennis ball, was sore to the touch, felt a little out of sorts for 1 day, swelling lasted 5-6 days.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity, Product administered at inappropriate site
Clinical narrative: ONGOING PAIN AND DECREASED RANGE OF MOTION OF LEFT ARM FOLLOWING INJECTION 8 DAYS AGO. INJECTION GIVEN IN POSTERIOR SHOULDER VERSUS MID DELTOID. {form filled out on 04/03/18-online form filled out 04/06/18}. TREATMENT: ROM EXERCISES; IBUPROFEN, ICE. CONTINUE TO MONITOR IF NO IMPROVEMENT RTC IN 1 WEEK FOR FURTHER EVALUATION AND IMAGING.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient had varicella in his left arm on 3/29 and MMR in his right arm on 3/29. Yesterday he developed a fever of 101, today it went down to 99 but now his left arm is red, swollen, and painful to touch. Mom said the red ring area is about the size of the palm of her hand. Advised mom to use cold compresses, hydrocortisone/BENADRYL for itching, TYLENOL/MOTRIN PRN pain/fever. Mom declined appt, will monitor at home. Advised mom to call back with new/worsening Sx developed.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received Tdap immunization (booster). Later that evening Pt noticed swelling, edema, hot spot on injection site. Reaction continued for several days , "about 4 days". Pt. presented 4/6/18 to pharmacist to discuss a large bruised area where injection was given. Site was decompressed with bruising in a 5cm x 7.5 cm area on the upper left arm. Pt stated it did not hurt but had some sense of increased heat remaining at injection site.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient came into the pharmacy on 4-6-18 to show me her arm, it was swollen the diameter of a softball. It was warm and itchy. She said the evening she received the shot she got a headache and nausea & vomiting. She took 2 doses of EXCEDRIN and did get some relief.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Patient came into the pharmacy on 4-6-18 to show me her arm, it was swollen the diameter of a softball. It was warm and itchy. She said the evening she received the shot she got a headache and nausea & vomiting. She took 2 doses of EXCEDRIN and did get some relief.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: Patient's daughter came to the pharmacy at 5:30PM  on 4/5/2018 and informed us patient died.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash morbilliform, Rash pruritic, Streptococcus test negative, Tonsillar hypertrophy
Clinical narrative: Itchy rash that looks like measles. Daughter had only been up about an hour when she started complaining that she was itchy. I looked at her and saw the rash. I called her doctor where she got the shot but she isn't open on Fridays. They recommended urgent care clinic. We went and they checked her for strep because her tonsils were also swollen and it was negative. They gave me a script for CLARITIN and a steroid. Told me to come back if it got worse.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: Pt has a red lightly blistered rash on her face. Patient went to doctor and he gave her VALTREX 1gm. She was taking VALTREX 500mg on 03.22/2018 but indicated that she never got shingles before.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site swelling, Injection site warmth, Oral discomfort
Clinical narrative: Pt has a red lightly blistered rash on her face. Patient went to doctor and he gave her VALTREX 1gm. She was taking VALTREX 500mg on 03.22/2018 but indicated that she never got shingles before.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash, Swelling face
Clinical narrative: Pt has a red lightly blistered rash on her face. Patient went to doctor and he gave her VALTREX 1gm. She was taking VALTREX 500mg on 03.22/2018 but indicated that she never got shingles before.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Fever 100.9 day after vaccine, headache, soreness and redness at injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Pain on injection site, shivering, fever on same day of immunization up to 2 days after.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Insomnia
Clinical narrative: Headache, unable to sleep, joint pain.
Age: 71.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site haematoma, Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: Patient said that she had difficulty sleeping on 4/4/18 after receiving the vaccine. She also had soreness in her right arm. She already had a doctor's appointment scheduled for 4/5/18, so she mentioned it to her medical provider at her visit. She had on a shirt with tight sleeves, so her medical provider palpated it through the fabric of her shirt. She felt like it was a hematoma and instructed her to alternate ice and warm compresses. On the morning of 4/6/18, her arm was still sore and there a swollen red band encircling her arm radiating from the injection site. She presented to the pharmacy on 4/6/18 and the injection site did not look red or have discharge. The red band encircling her arm was hot to the touch. She visited her medical provider again on 4/6. They gave her a steroid injection, instructed her to take diphenhydramine OTC and sent in an antibiotic, Cephalexin to take for five days. She was instructed to go to the ER the following day on 4/7/18 if her symptoms had not improved because the doctor's office would be closed on the weekend.
Age: 71.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain in extremity
Clinical narrative: Patient said that she had difficulty sleeping on 4/4/18 after receiving the vaccine. She also had soreness in her right arm. She already had a doctor's appointment scheduled for 4/5/18, so she mentioned it to her medical provider at her visit. She had on a shirt with tight sleeves, so her medical provider palpated it through the fabric of her shirt. She felt like it was a hematoma and instructed her to alternate ice and warm compresses. On the morning of 4/6/18, her arm was still sore and there a swollen red band encircling her arm radiating from the injection site. She presented to the pharmacy on 4/6/18 and the injection site did not look red or have discharge. The red band encircling her arm was hot to the touch. She visited her medical provider again on 4/6. They gave her a steroid injection, instructed her to take diphenhydramine OTC and sent in an antibiotic, Cephalexin to take for five days. She was instructed to go to the ER the following day on 4/7/18 if her symptoms had not improved because the doctor's office would be closed on the weekend.
Age: 56.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Myalgia, Polymyalgia rheumatica
Clinical narrative: Patient states that approximately 2 days following vaccine, she developed pain in joints and muscles. Was diagnosed with polymyalgia rheumatica, and has been treated with prednisone since.
Age: 56.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Autoimmune disorder, Inflammatory marker increased, Joint stiffness, Myalgia, Pain
Clinical narrative: Patient states that approximately 2 days following vaccine, she developed pain in joints and muscles. Was diagnosed with polymyalgia rheumatica, and has been treated with prednisone since.
Age: 56.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Polymyalgia rheumatica
Clinical narrative: Patient states that approximately 2 days following vaccine, she developed pain in joints and muscles. Was diagnosed with polymyalgia rheumatica, and has been treated with prednisone since.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMRV, PNC13
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient inadvertently received 0.5 mL flu vaccine instead of 0.25 mL flu vaccine. No other symptoms noted or reported to us by parent. Mother was informed of error immediately after it occurred.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Peripheral swelling, Pruritus, Rash, Tenderness
Clinical narrative: LEFT ARM HAS BIG BUMP, RASH, ITCHY, HARD TO TOUCH, TENDER, GETTING WORSE SINCE DAY OF INJECTION.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Balance disorder, Chills, Culture throat negative, Diarrhoea
Clinical narrative: I received the vaccine around 4 PM on Friday 3/30/2018 and woke up Sunday morning (4/1/2018) feeling very ill. By Sunday night I developed a fever of 103.9, weakness, severe pharyngitis into the ear, body aches and chills. Monday I went to see my PCP because I was concerned it was strep, but the rapid test was negative. Monday afternoon I developed nasal congestion and rhinitis, nausea, and diarrhea in addition to continued fever, weakness, body aches and chills. I was unable to eat, or drink and only urinated twice Monday and twice Tuesday. By Weds I was started to feel a little better, but was still weak. I am continuing to slowly recover and returned to work for half a day on Thurs and Fri (today). I am still feeling a little unsteady and weak, and my throat is still slightly sore but is tolerable. I am now concerned about receiving the 2nd and 3rd doses of the vaccine.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Feeding disorder, Malaise, Nasal congestion, Nausea, Oropharyngeal pain
Clinical narrative: I received the vaccine around 4 PM on Friday 3/30/2018 and woke up Sunday morning (4/1/2018) feeling very ill. By Sunday night I developed a fever of 103.9, weakness, severe pharyngitis into the ear, body aches and chills. Monday I went to see my PCP because I was concerned it was strep, but the rapid test was negative. Monday afternoon I developed nasal congestion and rhinitis, nausea, and diarrhea in addition to continued fever, weakness, body aches and chills. I was unable to eat, or drink and only urinated twice Monday and twice Tuesday. By Weds I was started to feel a little better, but was still weak. I am continuing to slowly recover and returned to work for half a day on Thurs and Fri (today). I am still feeling a little unsteady and weak, and my throat is still slightly sore but is tolerable. I am now concerned about receiving the 2nd and 3rd doses of the vaccine.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Pharyngitis, Pyrexia, Rhinitis, Streptococcus test negative
Clinical narrative: I received the vaccine around 4 PM on Friday 3/30/2018 and woke up Sunday morning (4/1/2018) feeling very ill. By Sunday night I developed a fever of 103.9, weakness, severe pharyngitis into the ear, body aches and chills. Monday I went to see my PCP because I was concerned it was strep, but the rapid test was negative. Monday afternoon I developed nasal congestion and rhinitis, nausea, and diarrhea in addition to continued fever, weakness, body aches and chills. I was unable to eat, or drink and only urinated twice Monday and twice Tuesday. By Weds I was started to feel a little better, but was still weak. I am continuing to slowly recover and returned to work for half a day on Thurs and Fri (today). I am still feeling a little unsteady and weak, and my throat is still slightly sore but is tolerable. I am now concerned about receiving the 2nd and 3rd doses of the vaccine.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Urine output decreased
Clinical narrative: I received the vaccine around 4 PM on Friday 3/30/2018 and woke up Sunday morning (4/1/2018) feeling very ill. By Sunday night I developed a fever of 103.9, weakness, severe pharyngitis into the ear, body aches and chills. Monday I went to see my PCP because I was concerned it was strep, but the rapid test was negative. Monday afternoon I developed nasal congestion and rhinitis, nausea, and diarrhea in addition to continued fever, weakness, body aches and chills. I was unable to eat, or drink and only urinated twice Monday and twice Tuesday. By Weds I was started to feel a little better, but was still weak. I am continuing to slowly recover and returned to work for half a day on Thurs and Fri (today). I am still feeling a little unsteady and weak, and my throat is still slightly sore but is tolerable. I am now concerned about receiving the 2nd and 3rd doses of the vaccine.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Diarrhoea, Myalgia
Clinical narrative: The evening of the vaccine I got a stomach ache. The next day I had low energy, fever, chills, nausea. The morning of the 2nd day I had diarrhea and super achy muscles.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: The evening of the vaccine I got a stomach ache. The next day I had low energy, fever, chills, nausea. The morning of the 2nd day I had diarrhea and super achy muscles.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Malaise, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: Intense rhinorrhea, sneezing, malaise, joint pain, fever.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site urticaria, Nausea
Clinical narrative: Chills, some nausea, hives around injection site, persistent soreness around injection site.
Age: 52.0
Sex: M
Vaccine: DTP
Symptoms: Back pain, Balance disorder, Dizziness, Dyspnoea, Epistaxis
Clinical narrative: Nausea, unbalance, dizziness, nose bleeds, severe fatigue and drowsiness, shortness of breath, difficulty breathing, irregular heart beat, back pain and discomfort, swelling of face and fainting.
Age: 52.0
Sex: M
Vaccine: DTP
Symptoms: Fatigue, Heart rate irregular, Musculoskeletal discomfort, Nausea, Somnolence
Clinical narrative: Nausea, unbalance, dizziness, nose bleeds, severe fatigue and drowsiness, shortness of breath, difficulty breathing, irregular heart beat, back pain and discomfort, swelling of face and fainting.
Age: 52.0
Sex: M
Vaccine: DTP
Symptoms: Swelling face, Syncope
Clinical narrative: Nausea, unbalance, dizziness, nose bleeds, severe fatigue and drowsiness, shortness of breath, difficulty breathing, irregular heart beat, back pain and discomfort, swelling of face and fainting.
Sex: M
Vaccine: VARZOS
Symptoms: Eye pain, Fear, Headache, Loss of personal independence in daily activities, Middle insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache unilateral in a male patient who received SHINGRIX. On 26th March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm, activities of daily living impaired, nocturnal awakening, eye pain and fear. On 26th March 2018, the patient experienced headache unilateral. The patient was treated with TYLENOL. On an unknown date, the outcome of the headache unilateral, pain in arm, activities of daily living impaired, nocturnal awakening, eye pain and fear were not recovered/not resolved. It was unknown if the reporter considered the headache unilateral, pain in arm, activities of daily living impaired, nocturnal awakening, eye pain and fear to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. By the end of the day of vaccination, the patient experienced a mild headache on the left side. The patient's arm was also tender from the injection which was expected by him. The headache had become concerning, which was why the patient was searching side effects and writing to GlaxoSmithKline. It was limiting his activities and waking him at night. The patient was maximizing use of TYLENOL just to remain functional. It was a specific location in the left side of the patient's head and affecting his left eye. This scared the patient and he asked if it was serious. At the time of reporting, this was still troublesome. The patient asked if this would stop and would it happen when he would receive the 2nd dose?
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache unilateral in a male patient who received SHINGRIX. On 26th March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm, activities of daily living impaired, nocturnal awakening, eye pain and fear. On 26th March 2018, the patient experienced headache unilateral. The patient was treated with TYLENOL. On an unknown date, the outcome of the headache unilateral, pain in arm, activities of daily living impaired, nocturnal awakening, eye pain and fear were not recovered/not resolved. It was unknown if the reporter considered the headache unilateral, pain in arm, activities of daily living impaired, nocturnal awakening, eye pain and fear to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. By the end of the day of vaccination, the patient experienced a mild headache on the left side. The patient's arm was also tender from the injection which was expected by him. The headache had become concerning, which was why the patient was searching side effects and writing to GlaxoSmithKline. It was limiting his activities and waking him at night. The patient was maximizing use of TYLENOL just to remain functional. It was a specific location in the left side of the patient's head and affecting his left eye. This scared the patient and he asked if it was serious. At the time of reporting, this was still troublesome. The patient asked if this would stop and would it happen when he would receive the 2nd dose?
Age: 0.33
Sex: F
Vaccine: DTAPIPV, RV1
Symptoms: Drug administered to patient of inappropriate age, Injection site abscess
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 4-month-old female patient who received KINRIX. Concomitant products included Rotavirus vaccine. On 16th February 2018, the patient received KINRIX (intramuscular). On 16th February 2018, less than a day after receiving KINRIX, the patient experienced injection site pain and inappropriate age at vaccine administration. On an unknown date, the outcome of the injection site pain and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the injection site pain to be related to KINRIX. Additional details were provided as follows: A 4 month old patient received an injection of KINRIX on leg, which led to inappropriate age at vaccine administration. The patient also received an unspecified rotavirus oral vaccine and other unspecified routine vaccinations on the same date.
Age: 21.0
Sex: U
Vaccine: MENB
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Injection site reaction
Clinical narrative: Pt developed bursitis in (L) upper arm. Pain in shoulder a few hours after injection. Pain continued x 10 days with limited range of motion of shoulder. Saw orthopedic surgeon at home. Rx with prednisone orally and PT. Sx resolved after 5-6 weeks. No disability.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 63-year-old male patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). On 27th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 28th March 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site swelling were not recovered/not resolved. The reporter considered the injection site erythema, injection site warmth and injection site swelling to be possibly related to SHINGRIX. Additional information was reported as follows: The case was reported by the registered pharmacist (RPh). The patient received SHINGRIX in left deltoid.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid disorder, Hordeolum
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of eyelid disorder in a 72-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 30th March 2018, the patient received SHINGRIX (intramuscular). On 31st March 2018, 1 days after receiving SHINGRIX, the patient experienced eyelid disorder. The patient was treated with Eye Drop Medication and antihistamine, antihistamine, antihistamine, Antihistamine. On an unknown date, the outcome of the eyelid disorder was recovering/resolving. The reporter considered the eyelid disorder to be possibly related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. The patient received SHINGRIX vaccine on the left arm. The next day after SHINGRIX vaccination, the patient noted a bump on her eyelid. The pharmacist described it as stye-like. The patient used an unspecified over the counter eye drop with an antihistamine and there was slight improvement.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Gastrointestinal disorder, Headache
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 71-year-old male patient who received SHINGRIX (batch number P539L, expiry date 30th January 2020). On 29th March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced fatigue, gastrointestinal disorder and headache. On an unknown date, the outcome of the fatigue, gastrointestinal disorder and headache were unknown. The reporter considered the fatigue, gastrointestinal disorder and headache to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient experienced fatigue, headache and gastrointestinal problems. The heath care professional was unsure when the symptoms began, if the patient required an emergency room or doctor visit, hospitalization, intervention, or if the symptoms were disabling. No further information was available.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Tremor
Clinical narrative: This case was reported by a consumer and described the occurrence of chills in a 64-year-old female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced chills and tremor. On an unknown date, the outcome of the chills and tremor were unknown. It was unknown if the reporter considered the chills and tremor to be related to SHINGRIX. Additional details were provided as follows: The patient was the reporter's mother. The patient after receiving SHINGRIX got the chills or shakes later that evening of vaccination.
Age: 43.0
Sex: M
Vaccine: MENB, MNQ, PPV
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 43-year-old male patient who received BEXSERO (batch number 160601A, expiry date 31st July 2018). The patient's past medical history included splenectomy. Concomitant products included MENVEO and PNEUMOVAX. On 22nd February 2018, the patient received the 1st dose of BEXSERO (intramuscular). In February 2018, 12 hrs after receiving BEXSERO, the patient experienced fever and influenza-like symptoms. On an unknown date, the outcome of the fever and influenza-like symptoms were recovered/resolved. The reporter considered the fever and influenza-like symptoms to be related to BEXSERO. Additional details were provided as follows: On 22nd February 2018, the patient received MENVEO as concomitant medication. On 22nd February 2018, the patient received PNEUMOVAX as concomitant medication. The health care professional reported that the patient received 1st dose of BEXSERO and developed a severe fever and flu like symptoms about 12 hours after receiving the BEXSERO vaccine. The health care professional was confident that BEXSERO caused the adverse events.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. The reporter considered the pain in arm to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional stated that the patient experienced sore arm or hurting after SHINGRIX. The healthcare professional did not have the details about the patient (site of vaccination, severity, etc) because different person reported this adverse event to the pharmacist. The reported batch number (BSEK2) for SHINGRIX did not exist and was updated to B5EK2 as per sales database. This case has been linked with case US2018055975, reported by the same reporter.
Age: 56.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Myalgia, Polymyalgia rheumatica
Clinical narrative: Auto-immune disorder, Polymyalgia Rheumatica, was triggered by shot and within two days of injection large muscles in arm/shoulders and legs/quadriceps were aching, and joints were stiff. Pain when sitting, standing up, reaching for or grasping objects, even pain when turning over in bed or trying to raise covers. After a week or so, I emailed doctor's office and was told to try OTC ibuprofen/anti-inflammatory, heat, stretching and to contact office if symptoms didn't improve. (I don't usually take medication, so tried for a week to not use the ibuprofen - then eventually took it, as pain got more severe.) No improvement, and finally saw doctor on Dec. 19th. Dr. diagnosed PMR (and directed blood test to confirm). She immediately prescribed 20 mgs of Prednisone, and Meloxicam, 15 mgs.
Age: 56.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Autoimmune disorder, Inflammatory marker increased, Joint stiffness, Myalgia, Pain
Clinical narrative: Auto-immune disorder, Polymyalgia Rheumatica, was triggered by shot and within two days of injection large muscles in arm/shoulders and legs/quadriceps were aching, and joints were stiff. Pain when sitting, standing up, reaching for or grasping objects, even pain when turning over in bed or trying to raise covers. After a week or so, I emailed doctor's office and was told to try OTC ibuprofen/anti-inflammatory, heat, stretching and to contact office if symptoms didn't improve. (I don't usually take medication, so tried for a week to not use the ibuprofen - then eventually took it, as pain got more severe.) No improvement, and finally saw doctor on Dec. 19th. Dr. diagnosed PMR (and directed blood test to confirm). She immediately prescribed 20 mgs of Prednisone, and Meloxicam, 15 mgs.
Age: 56.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Polymyalgia rheumatica
Clinical narrative: Auto-immune disorder, Polymyalgia Rheumatica, was triggered by shot and within two days of injection large muscles in arm/shoulders and legs/quadriceps were aching, and joints were stiff. Pain when sitting, standing up, reaching for or grasping objects, even pain when turning over in bed or trying to raise covers. After a week or so, I emailed doctor's office and was told to try OTC ibuprofen/anti-inflammatory, heat, stretching and to contact office if symptoms didn't improve. (I don't usually take medication, so tried for a week to not use the ibuprofen - then eventually took it, as pain got more severe.) No improvement, and finally saw doctor on Dec. 19th. Dr. diagnosed PMR (and directed blood test to confirm). She immediately prescribed 20 mgs of Prednisone, and Meloxicam, 15 mgs.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Sore left shoulder for 10 days, very large hard feverish lump at injection site. Treatment was TYLENOL to ease pain.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammatory marker increased, Rash, Rash vesicular
Clinical narrative: Broke out with rash that had blister-like bumps. It occurred on legs and arms. Inflammation levels were high.
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Varicella
Clinical narrative: Localized outbreak of varicella at injection site.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site pain, Insomnia
Clinical narrative: First night sleeplessness; 36 hours generally feeling crappy; 6 days tenderness at injection site.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: Body Aches all over, headache, fever, sore shoulder muscles and joint.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Blood creatine phosphokinase increased, Blood creatinine normal, Blood urea normal, Chromaturia, Discomfort
Clinical narrative: No symptoms noted on day of vaccination 3/29/2018. The vaccine was given in the left deltoid muscle without an complication. On 3/30/2018, a sore swollen left deltoid muscle was noted with waking at 5am. By around 8 pm, the discomfort extended toward a reactive lymph node in the left axilla along with tender slightly raised red streaks. My urine began to display a pink tinge. On 3/31/2018, Dr. evaluated me at the Medical Walk In unit at about 9:30 am. The streaking of skin over the shoulder hadn't progressed significantly, and the tenderness was unchanged. Throughout the day the streaks faded and the swelling/tenderness subsided. My urine darkened significantly, appearing like red wine by evening. I didn't display any edema or swelling. I had no dysuria or urinary frequency or incontinence throughout the episode. On 4/1/2018, my arm and axilla were back to baseline. My urine was dark red and foamy. On 4/2/2018, my PCP Dr. evaluated me.  My arm discomfort and discoloration was not present. My urine had begun to clear a bit although there was a tinge of pink. On 4/3/2018, my urine appeared to be back to normal.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Injection site swelling, International normalised ratio increased, Limb discomfort
Clinical narrative: No symptoms noted on day of vaccination 3/29/2018. The vaccine was given in the left deltoid muscle without an complication. On 3/30/2018, a sore swollen left deltoid muscle was noted with waking at 5am. By around 8 pm, the discomfort extended toward a reactive lymph node in the left axilla along with tender slightly raised red streaks. My urine began to display a pink tinge. On 3/31/2018, Dr. evaluated me at the Medical Walk In unit at about 9:30 am. The streaking of skin over the shoulder hadn't progressed significantly, and the tenderness was unchanged. Throughout the day the streaks faded and the swelling/tenderness subsided. My urine darkened significantly, appearing like red wine by evening. I didn't display any edema or swelling. I had no dysuria or urinary frequency or incontinence throughout the episode. On 4/1/2018, my arm and axilla were back to baseline. My urine was dark red and foamy. On 4/2/2018, my PCP Dr. evaluated me.  My arm discomfort and discoloration was not present. My urine had begun to clear a bit although there was a tinge of pink. On 4/3/2018, my urine appeared to be back to normal.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Prostatic specific antigen normal, Red blood cells urine positive, Skin discolouration, Tenderness, Urine abnormality
Clinical narrative: No symptoms noted on day of vaccination 3/29/2018. The vaccine was given in the left deltoid muscle without an complication. On 3/30/2018, a sore swollen left deltoid muscle was noted with waking at 5am. By around 8 pm, the discomfort extended toward a reactive lymph node in the left axilla along with tender slightly raised red streaks. My urine began to display a pink tinge. On 3/31/2018, Dr. evaluated me at the Medical Walk In unit at about 9:30 am. The streaking of skin over the shoulder hadn't progressed significantly, and the tenderness was unchanged. Throughout the day the streaks faded and the swelling/tenderness subsided. My urine darkened significantly, appearing like red wine by evening. I didn't display any edema or swelling. I had no dysuria or urinary frequency or incontinence throughout the episode. On 4/1/2018, my arm and axilla were back to baseline. My urine was dark red and foamy. On 4/2/2018, my PCP Dr. evaluated me.  My arm discomfort and discoloration was not present. My urine had begun to clear a bit although there was a tinge of pink. On 4/3/2018, my urine appeared to be back to normal.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Urobilinogen urine increased
Clinical narrative: No symptoms noted on day of vaccination 3/29/2018. The vaccine was given in the left deltoid muscle without an complication. On 3/30/2018, a sore swollen left deltoid muscle was noted with waking at 5am. By around 8 pm, the discomfort extended toward a reactive lymph node in the left axilla along with tender slightly raised red streaks. My urine began to display a pink tinge. On 3/31/2018, Dr. evaluated me at the Medical Walk In unit at about 9:30 am. The streaking of skin over the shoulder hadn't progressed significantly, and the tenderness was unchanged. Throughout the day the streaks faded and the swelling/tenderness subsided. My urine darkened significantly, appearing like red wine by evening. I didn't display any edema or swelling. I had no dysuria or urinary frequency or incontinence throughout the episode. On 4/1/2018, my arm and axilla were back to baseline. My urine was dark red and foamy. On 4/2/2018, my PCP Dr. evaluated me.  My arm discomfort and discoloration was not present. My urine had begun to clear a bit although there was a tinge of pink. On 4/3/2018, my urine appeared to be back to normal.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Dyspnoea, Dyspnoea exertional, Feeling abnormal, Mobility decreased
Clinical narrative: Pretty sudden,  difficulty with respirations, any walking getting very winded, extreme weakness in lower ext x 1 week. Off balance, having to use arms to lift legs, funny feeling in toes, not able to lift legs.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness
Clinical narrative: Pretty sudden,  difficulty with respirations, any walking getting very winded, extreme weakness in lower ext x 1 week. Off balance, having to use arms to lift legs, funny feeling in toes, not able to lift legs.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Patient states had 4 inch diameter redness/rash around injection site that was red/swelling/itchy. Patient experienced minor discomfort, but was fine after a week, the rash at injection site went away.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Patient states had 4 inch diameter redness/rash around injection site that was red/swelling/itchy. Patient experienced minor discomfort, but was fine after a week, the rash at injection site went away.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient experienced aches, chills, fever 12 hours after receiving SHINGRIX. Patient also complained of arm soreness for 4 days.
Age: 32.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Impaired work ability, Influenza like illness
Clinical narrative: I woke up in the middle of the night after receiving the 2nd round of the shingles vaccine with chills and felt feverish. When I got up in the morning, I felt flu like symptoms - general malaise, nausea, and feverish. Throughout the morning it got worse and by about noon I was lightheaded and unable to work. I clocked my fever at 101.1. I took a nap and took some aspirin and my fever was gone by about 3-4pm that day. I was tired and still felt flu-ish the rest of the evening but after sleeping through the night I felt fine the next day. The site of the vaccine shot (upper left arm) was very red, felt warm and hard, and had raised red welts around it, about 1" plus radius around the injection for the first day. The second day the shot site was red and warm and tender but clearly improving. It remained warm and red/slightly swollen for two more days. I also had a reaction after the first round of the shingles vaccine that was similar, but quite a bit more mild. I didn't notice anything besides soreness at the injection site but I felt like I had a 24 hr flu after the first shot (nausea, exhaustion, feverish). I've never had any allergies or reactions before to medicine or vaccines other than basic soreness where I received a shot.
Age: 32.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: I woke up in the middle of the night after receiving the 2nd round of the shingles vaccine with chills and felt feverish. When I got up in the morning, I felt flu like symptoms - general malaise, nausea, and feverish. Throughout the morning it got worse and by about noon I was lightheaded and unable to work. I clocked my fever at 101.1. I took a nap and took some aspirin and my fever was gone by about 3-4pm that day. I was tired and still felt flu-ish the rest of the evening but after sleeping through the night I felt fine the next day. The site of the vaccine shot (upper left arm) was very red, felt warm and hard, and had raised red welts around it, about 1" plus radius around the injection for the first day. The second day the shot site was red and warm and tender but clearly improving. It remained warm and red/slightly swollen for two more days. I also had a reaction after the first round of the shingles vaccine that was similar, but quite a bit more mild. I didn't notice anything besides soreness at the injection site but I felt like I had a 24 hr flu after the first shot (nausea, exhaustion, feverish). I've never had any allergies or reactions before to medicine or vaccines other than basic soreness where I received a shot.
Age: 32.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Malaise, Middle insomnia, Nausea, Pyrexia
Clinical narrative: I woke up in the middle of the night after receiving the 2nd round of the shingles vaccine with chills and felt feverish. When I got up in the morning, I felt flu like symptoms - general malaise, nausea, and feverish. Throughout the morning it got worse and by about noon I was lightheaded and unable to work. I clocked my fever at 101.1. I took a nap and took some aspirin and my fever was gone by about 3-4pm that day. I was tired and still felt flu-ish the rest of the evening but after sleeping through the night I felt fine the next day. The site of the vaccine shot (upper left arm) was very red, felt warm and hard, and had raised red welts around it, about 1" plus radius around the injection for the first day. The second day the shot site was red and warm and tender but clearly improving. It remained warm and red/slightly swollen for two more days. I also had a reaction after the first round of the shingles vaccine that was similar, but quite a bit more mild. I didn't notice anything besides soreness at the injection site but I felt like I had a 24 hr flu after the first shot (nausea, exhaustion, feverish). I've never had any allergies or reactions before to medicine or vaccines other than basic soreness where I received a shot.