chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Formication, Insomnia, Pruritus
Clinical narrative: Pt described feeling very achy in her hips and back and she was unable to sleep due to the pain. She stated she had to get her walker back out in order to walk. This started 2 days after she received the vaccine on 5/27/2018 and resolved about a week after the symptoms stopped. She also described feeling like there was something crawling all over her and itching all over. When she reported the adverse symptoms to us at the pharmacy it was 6/28/2018 and she  stated she still had a little  itching.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised, Walking aid user
Clinical narrative: Pt described feeling very achy in her hips and back and she was unable to sleep due to the pain. She stated she had to get her walker back out in order to walk. This started 2 days after she received the vaccine on 5/27/2018 and resolved about a week after the symptoms stopped. She also described feeling like there was something crawling all over her and itching all over. When she reported the adverse symptoms to us at the pharmacy it was 6/28/2018 and she  stated she still had a little  itching.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Dysuria, Fatigue, Pain
Clinical narrative: Severe fatigue and body aches. Severe difficulty to urinate, even after having taken both Cialis and Flomax, which normally would restore normal urinary function. This lasted about two days. It is less severe in the third day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia
Clinical narrative: Muscle and joint pain, low grade fever (99.7 degrees F), headache.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Impaired driving ability, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient stated that approximately 2.5 hours after getting vaccine that she experience arm pain. The pain intensified over the next few hours. By 4pm the day the vaccine was given she was not able to move her arm at all. The pain radiated from her shoulder/neck area all the way down through her elbow and even slightly to her wrist. Patient has had other medical issues in the past that caused her pain and she said she has never experienced pain this bad. She could not drive for several days, as her arm almost had a numb feeling and she could not move it fast enough to steer or operate a vehicle safely. After about a week, the pain has subsided but patient wanted us to report because of the severity.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Patient got vaccine and within a few days had all the classic side effects such as pain, redness, swelling at injection site. However, she also developed small blisters around the injection site that were painful to the touch, red and inflamed.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Rash papular
Clinical narrative: Patient got vaccine and within a few days had all the classic side effects such as pain, redness, swelling at injection site. However, she also developed small blisters around the injection site that were painful to the touch, red and inflamed.
Age: 2.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Erythema, Lacrimation increased, Lethargy, Pruritus, Pyrexia
Clinical narrative: Very high fever, lethargy within 7hrs of injection. Also two types of systemic rash presented, one being raised small bumps occurring within 7hrs of injection; covering entire legs, tops of feet and forearms. Additional rash too, palms of hand flat, red spots. Patient itching as well. Likewise, very runny/drippy nose and VERY red nose with watery eye discharge too. Patient Not very content.
Age: 2.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Rash, Rash erythematous, Rhinorrhoea
Clinical narrative: Very high fever, lethargy within 7hrs of injection. Also two types of systemic rash presented, one being raised small bumps occurring within 7hrs of injection; covering entire legs, tops of feet and forearms. Additional rash too, palms of hand flat, red spots. Patient itching as well. Likewise, very runny/drippy nose and VERY red nose with watery eye discharge too. Patient Not very content.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine, Pain
Clinical narrative: I tried to call customer but was not able to get in touch with her. The pharmacy on duty that spoke with her said she complained of pain and soreness, and migraines, and she went to see her doctor about reaction.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity, Pruritus, Swelling, Tenderness
Clinical narrative: Arm VERY sore and tender; Red mark several inches from injection site; Pt says raised and itchy and tender.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and slight pain at injection site. Redness approximately 1/2 inch outside of injection site.
Age: 70.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Chills, Injection site oedema, Malaise, Oedema, Pyrexia
Clinical narrative: Edema; chills. Acetaminophen 1 gm once, sodium chloride 1 liter units once.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Delirium, Malaise, Pain, Pruritus
Clinical narrative: Friday 6/22 no adverse event. Saturday 6/23 sick in every cell of body, pain all over. Sunday 6/24 bedridden-delirious-painful extreme itching.
Age: 41.0
Sex: M
Vaccine: HEPAB
Symptoms: Bradycardia, Dizziness, Hyperhidrosis, Loss of consciousness, Vomiting
Clinical narrative: Less than 5 mins after receiving the vaccine the pt reported feeling dizzy, moments later he lost consciousness for approximately 10 sec, he was bradycardic but didn't lose a pulse. He awoke became diaphoretic and soon after vomited. he was lying down with knees and legs in the air. BP 90/50. HR 57. He reported being "back to normal" 15 mins after.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Skin reaction
Clinical narrative: Small red area at 6:30 pm on 6-25-2018. Big red area on left leg, and raised area noticed on 6/26/2018 about 4:00 pm today 2 inches long 3 inches across.
Age: 23.0
Sex: F
Vaccine: HEPAB
Symptoms: Neurogenic shock, Syncope
Clinical narrative: Upon vaccination patient was fine however when patient was leaving pharmacy at parking lot patient fainted due to vasovagal shock.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Pt received PNEUMOVAX on 6/19, on 6/23 at 2am, pt notice swelling, inflammation, redness, warmth to touch, on the upper part of arm that was injected with the vaccine. Pain level 3/10. Pt was advise to take OTC ADVIL TID and apply cool compress. The arm became less swollen on 6/22, but certain swelling still occur in other parts of the same arm. Will cont to monitor.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt. presented two days after injection with swelling, erythema, warmth and tenderness at injection site. Tx plan: continue BENADRYL, hydrocortisone cream and cool compress, monitor.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site swelling, Pain, Pyrexia
Clinical narrative: Low grade fever. Swelling at injection site and down arm to elbow. Headache. Body aches. Treatment: cold compresses, TYLENOL.
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Injected limb mobility decreased, Peripheral swelling
Clinical narrative: Can't move (L) arm after pneumonia 23 vaccine. Chills with slight swelling of left arm. Right arm measuring 11" and left 11.5". Left arm cannot move after PNEUMOVAX 6/21/18. Seen in office after PNEUMOVAX yesterday. She is second pt to have same reaction-chills and slight swelling of left arm before injection site. No nausea or vomiting. Can barely abduct arm for me to measure-right arm 11 in at deltoid; left is 11.5 in. Temp 98.8 hear has used TYLENOL with ice but no relief. Heat helped a little. Will order meloxicam and gabapentin. If no relief in 3 days, MRI of shoulder. Advised to move shoulder as much as possible. Will report ADR to FDA. Prednisone 20 mg tablet, gabapentin 100 mg capsule.
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Extra dose administered, Injected limb mobility decreased, Injection site pain, Mobility decreased, Nausea
Clinical narrative: Can't move (L) arm after pneumonia 23 vaccine. Chills with slight swelling of left arm. Right arm measuring 11" and left 11.5". Left arm cannot move after PNEUMOVAX 6/21/18. Seen in office after PNEUMOVAX yesterday. She is second pt to have same reaction-chills and slight swelling of left arm before injection site. No nausea or vomiting. Can barely abduct arm for me to measure-right arm 11 in at deltoid; left is 11.5 in. Temp 98.8 hear has used TYLENOL with ice but no relief. Heat helped a little. Will order meloxicam and gabapentin. If no relief in 3 days, MRI of shoulder. Advised to move shoulder as much as possible. Will report ADR to FDA. Prednisone 20 mg tablet, gabapentin 100 mg capsule.
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Can't move (L) arm after pneumonia 23 vaccine. Chills with slight swelling of left arm. Right arm measuring 11" and left 11.5". Left arm cannot move after PNEUMOVAX 6/21/18. Seen in office after PNEUMOVAX yesterday. She is second pt to have same reaction-chills and slight swelling of left arm before injection site. No nausea or vomiting. Can barely abduct arm for me to measure-right arm 11 in at deltoid; left is 11.5 in. Temp 98.8 hear has used TYLENOL with ice but no relief. Heat helped a little. Will order meloxicam and gabapentin. If no relief in 3 days, MRI of shoulder. Advised to move shoulder as much as possible. Will report ADR to FDA. Prednisone 20 mg tablet, gabapentin 100 mg capsule.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Asthenia, Chest discomfort, Chills
Clinical narrative: Experienced fever of 104 with severe muscle pain, extreme weakness, terrible headache, shivering, belly cramping and pain. Redness at injection site the size of half dollar with feverish hot to touch; dizziness with extreme stomach upset with neck gland discomfort and tightness in chest with a cough.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Dizziness, Headache, Injection site erythema, Injection site warmth
Clinical narrative: Experienced fever of 104 with severe muscle pain, extreme weakness, terrible headache, shivering, belly cramping and pain. Redness at injection site the size of half dollar with feverish hot to touch; dizziness with extreme stomach upset with neck gland discomfort and tightness in chest with a cough.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain, Myalgia, Pyrexia
Clinical narrative: Experienced fever of 104 with severe muscle pain, extreme weakness, terrible headache, shivering, belly cramping and pain. Redness at injection site the size of half dollar with feverish hot to touch; dizziness with extreme stomach upset with neck gland discomfort and tightness in chest with a cough.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypersomnia, Impaired work ability, Influenza, Injection site pain
Clinical narrative: I was injected with my 2nd dose of SHINGRIX 5mcg. The pain in my arm was unusually high, and remained so to the point I had a hard time sleeping that night. The next day I felt I had a serious case of the flu - body aches and muscle pain, and headache to the point I left work a few hours early. When I got home, I got in bed and slept for 5 hours. Woke for a light dinner, and then slept for the next 8 hours. I went to work a few hours late and by mid day, was feeling significantly better. My arm is better but still sore to touch the area administered. My husband had his 2nd dose of SHINGRIX at the same time, and other than commenting on the immediate pain and through the night, his pain was almost disappeared although still sore to the touch. I also had more side affects with the first dose than my husband. I was nauseous with that one, but not the 2nd. Sincerely, patient.
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Myalgia, Pain, Pain in extremity
Clinical narrative: I was injected with my 2nd dose of SHINGRIX 5mcg. The pain in my arm was unusually high, and remained so to the point I had a hard time sleeping that night. The next day I felt I had a serious case of the flu - body aches and muscle pain, and headache to the point I left work a few hours early. When I got home, I got in bed and slept for 5 hours. Woke for a light dinner, and then slept for the next 8 hours. I went to work a few hours late and by mid day, was feeling significantly better. My arm is better but still sore to touch the area administered. My husband had his 2nd dose of SHINGRIX at the same time, and other than commenting on the immediate pain and through the night, his pain was almost disappeared although still sore to the touch. I also had more side affects with the first dose than my husband. I was nauseous with that one, but not the 2nd. Sincerely, patient.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling
Clinical narrative: Patient reported swelling and rash after SHINGRIX first dose. She said the rash has lasted about a week.
Age: 43.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Erythema, Infection, Injection site swelling, Pain in extremity
Clinical narrative: Arm was swollen, red, hot, sore, throbbing, painful and couldn't sleep as it hurt so bad. I Had to go to urgent care 4 days after vaccine was given as it was getting worse. I was put on caphelexin 500 mg 3x a day for 10days,  fluconazole, and MEDROL pack for 6 Days.
Age: 43.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Pruritus, Skin discolouration, Skin warm
Clinical narrative: Arm was swollen, red, hot, sore, throbbing, painful and couldn't sleep as it hurt so bad. I Had to go to urgent care 4 days after vaccine was given as it was getting worse. I was put on caphelexin 500 mg 3x a day for 10days,  fluconazole, and MEDROL pack for 6 Days.
Age: 43.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Pain, Pain in extremity, Peripheral swelling, Skin reaction
Clinical narrative: Arm was swollen, red, hot, sore, throbbing, painful and couldn't sleep as it hurt so bad. I Had to go to urgent care 4 days after vaccine was given as it was getting worse. I was put on caphelexin 500 mg 3x a day for 10days,  fluconazole, and MEDROL pack for 6 Days.
Age: 43.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm
Clinical narrative: Arm was swollen, red, hot, sore, throbbing, painful and couldn't sleep as it hurt so bad. I Had to go to urgent care 4 days after vaccine was given as it was getting worse. I was put on caphelexin 500 mg 3x a day for 10days,  fluconazole, and MEDROL pack for 6 Days.
Age: 82.0
Sex: M
Vaccine: FLUA3, FLUA3
Symptoms: Injection site mass, Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 07-Apr-2018 by Seqirus from VAERS (VAERS ID: 733683), concerns 82-year-old, male patient. On 27-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: unknown, anatomical location: right arm, batch number: none, expiry date: not reported). On 28-Sep-2017, the next day of vaccination, the patient experienced soreness in arm and lump at the injection site. The patient experienced pain while lifting arm, which affected range of motion. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: My symptoms included a sore left arm with moderate pain, redness (rash) and swelling where the shot was given. I also was tired, and experienced muscle pain, fever, and some shivering. I was prepared this time and knowing I would probably not feel well, I had nothing planned for the day after the vaccine. The symptoms were not as severe as after the first dose of SHINGRIX in April. I did take a TYLENOL on Tuesday night and it helped with the fever and pain. I got the vaccine on Tuesday June 26, 2018 and by Thursday June 28 I was feeling much better. However, my shoulder was still very red with a bigger than baseball size rash. On Friday, June 29, that was also better.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: My symptoms included a sore left arm with moderate pain, redness (rash) and swelling where the shot was given. I also was tired, and experienced muscle pain, fever, and some shivering. I was prepared this time and knowing I would probably not feel well, I had nothing planned for the day after the vaccine. The symptoms were not as severe as after the first dose of SHINGRIX in April. I did take a TYLENOL on Tuesday night and it helped with the fever and pain. I got the vaccine on Tuesday June 26, 2018 and by Thursday June 28 I was feeling much better. However, my shoulder was still very red with a bigger than baseball size rash. On Friday, June 29, that was also better.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: My symptoms included a sore left arm with moderate pain, redness (rash) and swelling where the shot was given. I also was tired, and experienced muscle pain, fever, and some shivering. I was prepared this time and knowing I would probably not feel well, I had nothing planned for the day after the vaccine. The symptoms were not as severe as after the first dose of SHINGRIX in April. I did take a TYLENOL on Tuesday night and it helped with the fever and pain. I got the vaccine on Tuesday June 26, 2018 and by Thursday June 28 I was feeling much better. However, my shoulder was still very red with a bigger than baseball size rash. On Friday, June 29, that was also better.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Myalgia, Pyrexia
Clinical narrative: My symptoms included a sore left arm with moderate pain, redness (rash) and swelling where the shot was given. I also was tired, and experienced muscle pain, fever, and some shivering. I was prepared this time and knowing I would probably not feel well, I had nothing planned for the day after the vaccine. The symptoms were not as severe as after the first dose of SHINGRIX in April. I did take a TYLENOL on Tuesday night and it helped with the fever and pain. I got the vaccine on Tuesday June 26, 2018 and by Thursday June 28 I was feeling much better. However, my shoulder was still very red with a bigger than baseball size rash. On Friday, June 29, that was also better.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Borrelia test negative, CSF protein increased, Computerised tomogram, Disturbance in attention, Guillain-Barre syndrome
Clinical narrative: Patient received vaccine at his pharmacy on 4/17/18, and on 5/2/18 began having progressive insomnia, delusions, extreme muscle weakness in lower extremities with progressive paresthesias, which eventually led to the diagnosis of Guillain-Barre Syndrome. This was successfully treated after a number of Emergency Room visits (determining cause of his symptoms) and a hospital stay at Medical Center (Admitted 5/10/18 and discharged to acute rehab facility on 5/25/18). The patient is recovering well, has regained most of his mobility back with some lingering nerve weakness according to his neurologist.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hallucination, auditory, Muscular weakness, Nuclear magnetic resonance imaging brain
Clinical narrative: Patient received vaccine at his pharmacy on 4/17/18, and on 5/2/18 began having progressive insomnia, delusions, extreme muscle weakness in lower extremities with progressive paresthesias, which eventually led to the diagnosis of Guillain-Barre Syndrome. This was successfully treated after a number of Emergency Room visits (determining cause of his symptoms) and a hospital stay at Medical Center (Admitted 5/10/18 and discharged to acute rehab facility on 5/25/18). The patient is recovering well, has regained most of his mobility back with some lingering nerve weakness according to his neurologist.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, CSF protein increased, Delusion, Guillain-Barre syndrome, Insomnia
Clinical narrative: Patient received vaccine at his pharmacy on 4/17/18, and on 5/2/18 began having progressive insomnia, delusions, extreme muscle weakness in lower extremities with progressive paresthesias, which eventually led to the diagnosis of Guillain-Barre Syndrome. This was successfully treated after a number of Emergency Room visits (determining cause of his symptoms) and a hospital stay at Medical Center (Admitted 5/10/18 and discharged to acute rehab facility on 5/25/18). The patient is recovering well, has regained most of his mobility back with some lingering nerve weakness according to his neurologist.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Muscular weakness, Paraesthesia
Clinical narrative: Patient received vaccine at his pharmacy on 4/17/18, and on 5/2/18 began having progressive insomnia, delusions, extreme muscle weakness in lower extremities with progressive paresthesias, which eventually led to the diagnosis of Guillain-Barre Syndrome. This was successfully treated after a number of Emergency Room visits (determining cause of his symptoms) and a hospital stay at Medical Center (Admitted 5/10/18 and discharged to acute rehab facility on 5/25/18). The patient is recovering well, has regained most of his mobility back with some lingering nerve weakness according to his neurologist.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Joint range of motion decreased, Pain, Pain in extremity, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 20th April 2018, the patient received SHINGRIX. On 20th April 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm and shoulder pain. On an unknown date, the patient experienced injected limb mobility decreased, stiffness and activities of daily living impaired. The patient was treated with Cortisone and ALEVE. On an unknown date, the outcome of the pain in arm and shoulder pain were unchanged and the outcome of the injected limb mobility decreased, stiffness and activities of daily living impaired were unknown.It was unknown if the reporter considered the pain in arm, stiffness and activities of daily living impaired to be related to SHINGRIX. The reporter considered the injected limb mobility decreased and shoulder pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient reported soreness in the arm, beginning a few hours later. As time progressed, the pain became worse at the injection site. It had also radiated to the shoulder. The pain persisted, and he was losing range of motion and could not do some of other daily activities, such as swimming. The patient consulted an orthopedic surgeon on 11th June 2018. An X-Ray was taken, and was not remarkable. The physician did inject cortisone into the shoulder joint. There was no effect on reducing pain or stiffness. The patient did note that massage sometimes helps for a little bit, and that an occasional ALEVE would provide only temporary relief.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Discomfort, Pain, Pain in extremity, X-ray limb
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 20th April 2018, the patient received SHINGRIX. On 20th April 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm and shoulder pain. On an unknown date, the patient experienced injected limb mobility decreased, stiffness and activities of daily living impaired. The patient was treated with Cortisone and ALEVE. On an unknown date, the outcome of the pain in arm and shoulder pain were unchanged and the outcome of the injected limb mobility decreased, stiffness and activities of daily living impaired were unknown.It was unknown if the reporter considered the pain in arm, stiffness and activities of daily living impaired to be related to SHINGRIX. The reporter considered the injected limb mobility decreased and shoulder pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient reported soreness in the arm, beginning a few hours later. As time progressed, the pain became worse at the injection site. It had also radiated to the shoulder. The pain persisted, and he was losing range of motion and could not do some of other daily activities, such as swimming. The patient consulted an orthopedic surgeon on 11th June 2018. An X-Ray was taken, and was not remarkable. The physician did inject cortisone into the shoulder joint. There was no effect on reducing pain or stiffness. The patient did note that massage sometimes helps for a little bit, and that an occasional ALEVE would provide only temporary relief.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 20th April 2018, the patient received SHINGRIX. On 20th April 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm and shoulder pain. On an unknown date, the patient experienced injected limb mobility decreased, stiffness and activities of daily living impaired. The patient was treated with Cortisone and ALEVE. On an unknown date, the outcome of the pain in arm and shoulder pain were unchanged and the outcome of the injected limb mobility decreased, stiffness and activities of daily living impaired were unknown.It was unknown if the reporter considered the pain in arm, stiffness and activities of daily living impaired to be related to SHINGRIX. The reporter considered the injected limb mobility decreased and shoulder pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient reported soreness in the arm, beginning a few hours later. As time progressed, the pain became worse at the injection site. It had also radiated to the shoulder. The pain persisted, and he was losing range of motion and could not do some of other daily activities, such as swimming. The patient consulted an orthopedic surgeon on 11th June 2018. An X-Ray was taken, and was not remarkable. The physician did inject cortisone into the shoulder joint. There was no effect on reducing pain or stiffness. The patient did note that massage sometimes helps for a little bit, and that an occasional ALEVE would provide only temporary relief.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: X-ray
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 20th April 2018, the patient received SHINGRIX. On 20th April 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm and shoulder pain. On an unknown date, the patient experienced injected limb mobility decreased, stiffness and activities of daily living impaired. The patient was treated with Cortisone and ALEVE. On an unknown date, the outcome of the pain in arm and shoulder pain were unchanged and the outcome of the injected limb mobility decreased, stiffness and activities of daily living impaired were unknown.It was unknown if the reporter considered the pain in arm, stiffness and activities of daily living impaired to be related to SHINGRIX. The reporter considered the injected limb mobility decreased and shoulder pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient reported soreness in the arm, beginning a few hours later. As time progressed, the pain became worse at the injection site. It had also radiated to the shoulder. The pain persisted, and he was losing range of motion and could not do some of other daily activities, such as swimming. The patient consulted an orthopedic surgeon on 11th June 2018. An X-Ray was taken, and was not remarkable. The physician did inject cortisone into the shoulder joint. There was no effect on reducing pain or stiffness. The patient did note that massage sometimes helps for a little bit, and that an occasional ALEVE would provide only temporary relief.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included drug allergy (MSG allergy). On 15th June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site itching, injection site erythema and injection site warmth. On 15th June 2018, the patient experienced intramuscular formulation administered by other route and vaccine administered at inappropriate site. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site itching, injection site erythema and injection site warmth were recovering/resolving and the outcome of the intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site itching, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a bad reaction, clarified as pain, redness, warmth, swelling, and itching at the injection site. The health care professional reported that, the vaccine was given in the back of the arm and might have been administered subcutaneously, which led to vaccine administered at inappropriate site and incorrect route of vaccine administration. The patient was seen by her primary care physician but no emergency room visit was required. As treatment, the patient was given BENADRYL. The patient's symptoms were not considered life threatening or disabling. The vaccine was not administered by the reporting health care professional or facility.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included drug allergy (MSG allergy). On 15th June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site itching, injection site erythema and injection site warmth. On 15th June 2018, the patient experienced intramuscular formulation administered by other route and vaccine administered at inappropriate site. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site itching, injection site erythema and injection site warmth were recovering/resolving and the outcome of the intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site itching, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a bad reaction, clarified as pain, redness, warmth, swelling, and itching at the injection site. The health care professional reported that, the vaccine was given in the back of the arm and might have been administered subcutaneously, which led to vaccine administered at inappropriate site and incorrect route of vaccine administration. The patient was seen by her primary care physician but no emergency room visit was required. As treatment, the patient was given BENADRYL. The patient's symptoms were not considered life threatening or disabling. The vaccine was not administered by the reporting health care professional or facility.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Product administered at inappropriate site
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included drug allergy (MSG allergy). On 15th June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site itching, injection site erythema and injection site warmth. On 15th June 2018, the patient experienced intramuscular formulation administered by other route and vaccine administered at inappropriate site. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site itching, injection site erythema and injection site warmth were recovering/resolving and the outcome of the intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site itching, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a bad reaction, clarified as pain, redness, warmth, swelling, and itching at the injection site. The health care professional reported that, the vaccine was given in the back of the arm and might have been administered subcutaneously, which led to vaccine administered at inappropriate site and incorrect route of vaccine administration. The patient was seen by her primary care physician but no emergency room visit was required. As treatment, the patient was given BENADRYL. The patient's symptoms were not considered life threatening or disabling. The vaccine was not administered by the reporting health care professional or facility.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Lip swelling, Pruritus, Swelling face, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 7-month-old female patient who received SHINGRIX for prophylaxis. Previously administered products included zoster vaccine (received years before the date of reporting). On 16th June 2018 10:00, the patient received the 1st dose of SHINGRIX (intramuscular). In June 2018, 1 day after receiving SHINGRIX, the patient experienced hives, pruritus and fever. On 17th June 2018, the patient experienced lip swelling and facial swelling. The patient was treated with ZYRTEC and antihistamine. On an unknown date, the outcome of the hives, lip swelling, facial swelling, pruritus and fever were recovering/resolving. The reporter considered the hives, lip swelling, facial swelling, pruritus and fever to be probably related to SHINGRIX. Additional details were provided as follows: The health care professional does not have lot number or expiration or further patient details because she was not at work. The patient experienced low grade fever. She took an antihistamine after experiencing hives, itching and low grade fever on next day of vaccination in the morning and then took another ZYRTEC around 4:30pm that day when the hives came back,  the patient went to the emergency room for treatment after she experienced swelling of face and lips around dinner time that day. The symptoms were probably not disabling or life threatening. She spoke to patient on Tuesday and the patient was recovering from adverse events at that time. The patient never had reaction like this before, not even to older zoster vaccine that she received years ago.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lip swelling, Prurigo, Pyrexia, Swelling face, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 7-month-old female patient who received SHINGRIX for prophylaxis. Previously administered products included zoster vaccine (received years before the date of reporting). On 16th June 2018 10:00, the patient received the 1st dose of SHINGRIX (intramuscular). In June 2018, 1 day after receiving SHINGRIX, the patient experienced hives, pruritus and fever. On 17th June 2018, the patient experienced lip swelling and facial swelling. The patient was treated with ZYRTEC and antihistamine. On an unknown date, the outcome of the hives, lip swelling, facial swelling, pruritus and fever were recovering/resolving. The reporter considered the hives, lip swelling, facial swelling, pruritus and fever to be probably related to SHINGRIX. Additional details were provided as follows: The health care professional does not have lot number or expiration or further patient details because she was not at work. The patient experienced low grade fever. She took an antihistamine after experiencing hives, itching and low grade fever on next day of vaccination in the morning and then took another ZYRTEC around 4:30pm that day when the hives came back,  the patient went to the emergency room for treatment after she experienced swelling of face and lips around dinner time that day. The symptoms were probably not disabling or life threatening. She spoke to patient on Tuesday and the patient was recovering from adverse events at that time. The patient never had reaction like this before, not even to older zoster vaccine that she received years ago.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 16th June 2018, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, generalized rash and enlargement of lymph nodes. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the generalized rash was not recovered/not resolved and the outcome of the enlargement of lymph nodes was unknown. The reporter considered the injection site pain to be related to SHINGRIX. The reporter considered the generalized rash and enlargement of lymph nodes to be possibly related to SHINGRIX. Additional information was received as follows: On Saturday, the patient received SHINGRIX on the left deltoid. The patient experienced soreness at the site the night of vaccination that had gradually gotten better. She noted that, on next day (Sunday), it was the worst day for the soreness. Two days after the vaccination, the patient experienced the rash on the vaccinated arm and that had spread over her body. Till the reporting time, the patient had the rash. The patient also experienced swelling of lymph nodes under her vaccinated arm. The patient had taken BENADRYL on the day of reporting and placed a phone call to her doctor. The healthcare professional information was not asked.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Lymphadenopathy, Rash generalised
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 16th June 2018, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, generalized rash and enlargement of lymph nodes. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the generalized rash was not recovered/not resolved and the outcome of the enlargement of lymph nodes was unknown. The reporter considered the injection site pain to be related to SHINGRIX. The reporter considered the generalized rash and enlargement of lymph nodes to be possibly related to SHINGRIX. Additional information was received as follows: On Saturday, the patient received SHINGRIX on the left deltoid. The patient experienced soreness at the site the night of vaccination that had gradually gotten better. She noted that, on next day (Sunday), it was the worst day for the soreness. Two days after the vaccination, the patient experienced the rash on the vaccinated arm and that had spread over her body. Till the reporting time, the patient had the rash. The patient also experienced swelling of lymph nodes under her vaccinated arm. The patient had taken BENADRYL on the day of reporting and placed a phone call to her doctor. The healthcare professional information was not asked.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema
Clinical narrative: REDNESS AROUND INJECTION ABOUT 3 INCHES IN DIAMETER. PATIENT WAS GIVEN DIPHENHYDRAMINE 12.5MG/5ML - 10 ML FOUR TIMES A DAY. LINE WAS DRAWN AROUND SITE AND PATIENT AND MOTHER WERE TO RETURN TO HOSPITAL IF AREA ENLARGED OR FAILED TO RESOLVE. PATIENT WAS NOT IN ANY DISTRESS.
Age: 5.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from an office manager, referring to a 5 years old patient of unknown gender. It was reported none concomitant medications, none medical history and none drug reactions or allergies. On an unspecified date in 2018 (reported as "in the last 3 weeks"), the patient was vaccinated with (wistar ra 27-3) M-M-R II and Oka/Merck VARIVAX both subcutaneously in the same leg (strength, doses, dose numbers, lot numbers and expiration date were not reported), for prophylaxis. Other suspect therapies included a DILUENT MRK INJ (lot number and expiration date were not reported). In 2018, the patient reported tenderness, warmth, swelling and a lump at injection site. It was reported that treatment was not given for the adverse events; however, it was also stated that the treatment given was ice to the injection site for the patient. Lab diagnostics or studies were not performed and the patient sought medical attention by contacting the office. The outcome of injection site mass, injection site swelling, injection site pain and injection site warmth was unknown. The causality assessment between (wistar ra 27-3) M-M-R II, Oka/Merck VARIVAX, the DILUENT MRK INJ and the aforementioned events was not provided. This is one of two reports received from the same reporter. As of 28-JUN-2018, all telephone attempts to obtain follow-up information have been unsuccessful. Sender's Comments: US-009507513-1804USA007907.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a 13 month old patient of an unknown gender. The patient's medical history, concurrent conditions or concomitant medication were not reported. On 30-MAY-2018, the patient was vaccinated with improperly stored doses of Oka/Merck VARIVAX lot # N024568, expiration date 07-SEP-2019 or lot # N029631, expiration date 23-OCT-2019, for prophylaxis (dosage information and route of administration were not informed). Other suspect therapies included MERCK STERILE DILUENT lot # M029682, expiration date 12-JAN-2019. No adverse effects were reported. It was also reported that the temperature and time frame were -14°C to -10°C (-12.7°C) for 20 minutes. There was no previous temperature excursion. A "data logger" was involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1806USA012318: US-009507513-1806USA012317: US-009507513-1806USA012319: US-009507513-1806USA012316.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 14-JUN-2018, the patient was vaccinated with an expired Oka-Merck PROQUAD, lot # M046943, expired date 27-MAY-2018, by subcutaneous route, (dose number and anatomical location were not reported), for prophylaxis. No adverse effects were reported.