chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: Flu-like symptoms 2 days after vaccination that resolved. Left upper arm with erythema and warmth and mild edema extending distally about 15 cm in length, 9.5 cm in diameter, no streaking, no tenderness, slight itching. Final outcome not known yet.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Mobility decreased, Pain, Skin warm
Clinical narrative: CC - redness, soreness, hot to touch, pain, difficult to move arm - referred to PCP which referred her to ER. Treat with Antibiotics and discharged with DX of cellulitis.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Induration, Injection site erythema, Injection site rash, Pain
Clinical narrative: His wife called around May 24 and talked to me about patient has had a fever for a few days as well as his arm is hot, sore, red, and hard to the touch. He took an OTC to help with the fever and pain. He did stop in on May 25th. I saw a visible red rash from the injection site running along horizontally on the anterior part of the arm. There was no visible rash going around to the posterior side. I did not touch it but he said it was still a little sore, not so hot anymore, but still hard to the touch. I told him I will place a VAERS report as he is a physician assistant and is aware of the procedure.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rash erythematous, Skin warm
Clinical narrative: His wife called around May 24 and talked to me about patient has had a fever for a few days as well as his arm is hot, sore, red, and hard to the touch. He took an OTC to help with the fever and pain. He did stop in on May 25th. I saw a visible red rash from the injection site running along horizontally on the anterior part of the arm. There was no visible rash going around to the posterior side. I did not touch it but he said it was still a little sore, not so hot anymore, but still hard to the touch. I told him I will place a VAERS report as he is a physician assistant and is aware of the procedure.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Insomnia, Pain, Pyrexia
Clinical narrative: Patient stated that she had severe headaches, body pain, insomnia, and fever for a few days.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Secondary transmission
Clinical narrative: I was given the shingle vaccine on the 16 of April and my niece came down with chicken pox that same week and was hospitalized. My niece is 54 years old and has Down Syndrome she has a weak immune system I had no idea she was in danger of getting the disease just thought you should know.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Discharge, Influenza, Laboratory test, Rash morbilliform, Rash papular
Clinical narrative: 4/24 started with flu sypmtoms 4/25 started to notice measle like rash continued flu sypmtoms which resolved later that evening  rash continued up to this date rash progressed from measle -like, to raised papular lesion (tiny) with white head that had white fluid with a grain of sand like material. Rash was extremely itchy.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: 4/24 started with flu sypmtoms 4/25 started to notice measle like rash continued flu sypmtoms which resolved later that evening  rash continued up to this date rash progressed from measle -like, to raised papular lesion (tiny) with white head that had white fluid with a grain of sand like material. Rash was extremely itchy.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient injections site was red, swollen, hard, and warm to touch. Patient states the injection site is painful.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: 3 hours after receiving vaccines a fever of 103.1 degrees Fahrenheit appeared.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Chest X-ray normal, Influenza virus test negative, Irritability, Postictal state, Pyrexia
Clinical narrative: 5/8/18 with fussiness, followed by seizure, per mom lasted about 20 minutes, with appropriate post-ictal state, ED evaluation with temp 105 down to normal after TYLENOL po, exam benign, CXR negative, rapid flu negative as of 5/26/18, mom reports no more seizures but patient still with intermittent fevers to 103, no URI sxs rash vomiting diarrhea joint swelling or other focal sxs, fevers resolve with tylenol or ibuprofen - is eating well, happy and active.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Seizure
Clinical narrative: 5/8/18 with fussiness, followed by seizure, per mom lasted about 20 minutes, with appropriate post-ictal state, ED evaluation with temp 105 down to normal after TYLENOL po, exam benign, CXR negative, rapid flu negative as of 5/26/18, mom reports no more seizures but patient still with intermittent fevers to 103, no URI sxs rash vomiting diarrhea joint swelling or other focal sxs, fevers resolve with tylenol or ibuprofen - is eating well, happy and active.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pyrexia, Rash generalised
Clinical narrative: Patient stated had allergic reaction, started with feeling under the weather that day (Thur), on following  Mon high fever started which persisted for couple of days then rash developed couple days later. Rash started on arms, progressed to chest then legs and neck/face. Rash got progressively worst and pt went to see md. They treated her with IV steroids and antihistamines. Patient stated still has full body rash and still getting treatment but symptoms are getting better.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Vaccine (SHINGRIX) given 5/24/18. On 5/26/18 patient noticed 4in red circle around injection site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Redness and swelling around QUADRACEL vaccine site.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Within 30 minutes of receiving the vaccine the patients arm became red hot and swollen from the shoulder to the elbow, had a fever of 101 degrees, had severe muscle and body aches and a headache. These side effects have persisted through today (5/27/18). She has been taking acetaminophen for these symptoms as directed by her physician. She could not take ibuprofen because she is on warfarin.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Headache, Myalgia, Pain, Peripheral swelling
Clinical narrative: Within 30 minutes of receiving the vaccine the patients arm became red hot and swollen from the shoulder to the elbow, had a fever of 101 degrees, had severe muscle and body aches and a headache. These side effects have persisted through today (5/27/18). She has been taking acetaminophen for these symptoms as directed by her physician. She could not take ibuprofen because she is on warfarin.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: Within 30 minutes of receiving the vaccine the patients arm became red hot and swollen from the shoulder to the elbow, had a fever of 101 degrees, had severe muscle and body aches and a headache. These side effects have persisted through today (5/27/18). She has been taking acetaminophen for these symptoms as directed by her physician. She could not take ibuprofen because she is on warfarin.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extensive swelling of vaccinated limb, Headache, Influenza like illness, Injection site erythema, Injection site warmth
Clinical narrative: Within 30 minutes of receiving the vaccine the patients arm became red hot and swollen from the shoulder to the elbow, had a fever of 101 degrees, had severe muscle and body aches and a headache. These side effects have persisted through today (5/27/18). She has been taking acetaminophen for these symptoms as directed by her physician. She could not take ibuprofen because she is on warfarin.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Within 30 minutes of receiving the vaccine the patients arm became red hot and swollen from the shoulder to the elbow, had a fever of 101 degrees, had severe muscle and body aches and a headache. These side effects have persisted through today (5/27/18). She has been taking acetaminophen for these symptoms as directed by her physician. She could not take ibuprofen because she is on warfarin.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Incorrect route of drug administration, Influenza like illness, Injection site erythema
Clinical narrative: Patient experienced fatigue and increase in temperature the night following the vaccination. She also experienced redness and swelling at the injection site, which was stated to be worse the next morning. Patient went to doctors office and received a Ketorolac injection, which was stated to help with pain, redness, and swelling. Patient was advised to take cetirizine rather than BENADRYL to help with reducing symptoms.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site induration, Injection site swelling, Injection site warmth, Myalgia, Neck pain
Clinical narrative: Patient experienced fatigue and increase in temperature the night following the vaccination. She also experienced redness and swelling at the injection site, which was stated to be worse the next morning. Patient went to doctors office and received a Ketorolac injection, which was stated to help with pain, redness, and swelling. Patient was advised to take cetirizine rather than BENADRYL to help with reducing symptoms.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient experienced fatigue and increase in temperature the night following the vaccination. She also experienced redness and swelling at the injection site, which was stated to be worse the next morning. Patient went to doctors office and received a Ketorolac injection, which was stated to help with pain, redness, and swelling. Patient was advised to take cetirizine rather than BENADRYL to help with reducing symptoms.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Fatigue, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient experienced fatigue and increase in temperature the night following the vaccination. She also experienced redness and swelling at the injection site, which was stated to be worse the next morning. Patient went to doctors office and received a Ketorolac injection, which was stated to help with pain, redness, and swelling. Patient was advised to take cetirizine rather than BENADRYL to help with reducing symptoms.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Inflammation, Rash erythematous
Clinical narrative: My daughter received the shot on 5/23/2018 and on 5/25/2018 she noticed a rash like area on the right side of her stomach. Cortisone cream was applied. It isn't painful nor itchy. By 5/26/2018, the rash was worse (more inflammed red and raised). Benadryl given.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Aphonia, Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: I had a lot of soreness  in my arm on the day of the shot. The following day I got very sick which lasted for about a week. I lost my voice and had a lot of congestion. I think I had a fever at one point and had some body aches.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Respiratory tract congestion
Clinical narrative: I had a lot of soreness  in my arm on the day of the shot. The following day I got very sick which lasted for about a week. I lost my voice and had a lot of congestion. I think I had a fever at one point and had some body aches.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Pain in left upper arm, weakness of left upper arm.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe pain in area of injection and difficulty lifting arm.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Headache. Arm hurts (like bruise from being punched). Chills. Slight fever. (Had similar side effects with dose 1.)
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site nerve damage, Injection site swelling
Clinical narrative: The vaccine was received in my right arm the morning of 06/27/2017; By afternoon, from the injection site to my elbow was swollen. I returned to the pharmacy, same day as injection was given. Pharmacist instructed me to apply ice and stated, " that he must have hit a nerve." I called my PMD, Dr, the following day. All visits are documented.  I visited the PMD on 6/28/17, 10/18/17, 12/14/17, 3/26/18, 5/20/18. I was told at each visit that there was nothing that could be done and a nerve was hit. The PMD agreed with the pharmacist in that a nerve was hit.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Myalgia, Night sweats, Pain
Clinical narrative: Sore arm, muscle ache, fatigue. sore arm after a few hours, then muscle ache generally all over. Extreme fatigue. Sweating during the night. very tired and kind of achey the next dat till about 4:00pm. Overall symptons kicked in in about 4 hours and last 24 hours although vaccine site still sore 48 hours later.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm, muscle ache, fatigue. sore arm after a few hours, then muscle ache generally all over. Extreme fatigue. Sweating during the night. very tired and kind of achey the next dat till about 4:00pm. Overall symptons kicked in in about 4 hours and last 24 hours although vaccine site still sore 48 hours later.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: FLU-LIKE SYMPTOMS (BODY ACHES, FEVERISH, NAUSEA) FOR 48 HOURS POST VACCINATION.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Lymphadenopathy, Malaise, Myalgia
Clinical narrative: Fever, malaise, diffuse myalgia/arthralgia, injection site erythema and calor, ipsilateral axillary adenopathy.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, malaise, diffuse myalgia/arthralgia, injection site erythema and calor, ipsilateral axillary adenopathy.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: After receiving the first dose of SHINGRIX, the patient developed a mild case of shingles above her right eye approximately 1 month after immunization. The patient was evaluated by her doctor and was given Valtrex. The patient is still having symptoms of the shingles today on 5/27/18.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Pain, itching, swelling and rash at site.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral discomfort
Clinical narrative: Burning sensation in mouth without any lesions, on roof of mouth, along gum lines and tongue.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: The patient had a red rash at the injection site. He said it wasn't painful.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Crying, Fatigue, Vomiting
Clinical narrative: Vomiting three times, crying, exhaustion. Treatment is rest and hydration and watching carefully.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Pain in extremity, Rash erythematous
Clinical narrative: Patient has a red raised rash in the shape of a circle near the tricep region of her left arm. It was confirmed that the injection was given in the deltoid muscle. She states her arm is very sore and the area is tender. She has been treating with ibuprofen and will be applying hydrocortisone cream.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Pain at injection site; then 2 1/2-inch diameter redness, swelling, and heat below injection site. Within 8 hours, body aching, headache, weakness, fatigue, shivers, which lasted 30+ hours. Gradually getting better, but pain and redness continue below injection site.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Pain at injection site; then 2 1/2-inch diameter redness, swelling, and heat below injection site. Within 8 hours, body aching, headache, weakness, fatigue, shivers, which lasted 30+ hours. Gradually getting better, but pain and redness continue below injection site.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: PER THE CUSTOMER EXPLANATION RASH STARTED  ON HER LEFT SHOULDER AN HOUR AFTER INJECTION AND THEN  RASH SPREAD TO BOTH LEGS NEXT MORNING.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Computerised tomogram head normal, Computerised tomogram normal, Electroencephalogram normal, Seizure
Clinical narrative: 2 brief generalized seizures 2 days after vaccines. Admitted to hospital.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Pain
Clinical narrative: (This shot was the second; there was no adverse reaction to the first.) I felt weak, dizzy, achy, fatigued, had a headache and ran a low-grade fever. It started on the morning following the shot and lasted throughout the day. I took an analgesic at  night before bedtime. When I got up the next day, the only remnant of what I had experienced was a much milder headache. I took an acetaminophen which relieved the headache; by noon, all symptoms were gone.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: (This shot was the second; there was no adverse reaction to the first.) I felt weak, dizzy, achy, fatigued, had a headache and ran a low-grade fever. It started on the morning following the shot and lasted throughout the day. I took an analgesic at  night before bedtime. When I got up the next day, the only remnant of what I had experienced was a much milder headache. I took an acetaminophen which relieved the headache; by noon, all symptoms were gone.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Muscle spasms, Muscle tightness, Myalgia
Clinical narrative: Muscle pains in back, muscle tightness, spasm, trouble breathing resulted in a hospital admission where the patient was given IV medications and kept overnight for observation.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Lethargy, Pyrexia
Clinical narrative: Patient reported fever of 100 degrees Fahrenheit for 1 day, aches, lethargy, and lack of appetite.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Injection site swelling
Clinical narrative: The patient's husband states that starting the date after the vaccine there was swelling around the injection site. I advised the patient to go to urgent care. The doctor diagnosed her with an infection and prescribed clindamycin 300mg three times daily.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Constipation, Diarrhoea, Flatulence
Clinical narrative: Patient experienced bloating, gas, constipation and also occasional diarrhea.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pruritus, Peripheral swelling
Clinical narrative: Arm swelled and turned red and itchy at and around the injection site. Patient followed up with primary care doctor who prescribed Prednisone, Hydroxyzine, and NORCO.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: The patient had swelling in his arm and pain. It went to lower arm. The pt was taking TYLENOL and it didn't help. The pt went to the ER a few days later and they gave him antibiotic which the pt stated help and swelling is going down.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient presented redness over a 3 inch radius around injection site. The onset was 12 hrs after administration and lasted for 5 days. Patient started to apply Benadryl cream (OTC) on day 2 and the redness subsided by the 5th day.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral mucosal blistering, Rash
Clinical narrative: Evening of 5/26/18 pt noted blistering rash under right breast. It is not painful or itching.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: Fever. Chills/real bad. Muscle aches and pains all over. Fatigue.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Shaking chills, fever, headache, extreme tiredness, stomach ache/nausea, pain and redness at injection site.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Pyrexia, Tremor
Clinical narrative: Shaking chills, fever, headache, extreme tiredness, stomach ache/nausea, pain and redness at injection site.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness of site of Injection, still spreading after 5 days even after use of an ice pack. Recommended to go to ER.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Injection site reaction. Redness 2 inch in diameter, pain, warm to the touch. Pt also says Blood sugar had increased significantly since getting shot.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Axillary pain, Fatigue, Feeling abnormal, Headache, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received SHINGRIX. On 11th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, general body pain, axillary lymph nodes enlarged, fever and headache. On an unknown date, the outcome of the injection site pain, general body pain, axillary lymph nodes enlarged, fever and headache were recovering/resolving. It was unknown if the reporter considered the injection site pain, general body pain, axillary lymph nodes enlarged, fever and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid and experienced pain at the injection site, headache, body ache, and swollen axillary lymph nodes. Healthcare provider reported that, the patient felt this was the, "worst thing she's ever been through". Healthcare provider did not consider the patient's symptoms were life threatening or disabling, and no hospitalization or intervention was required.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Lymphadenopathy, Myalgia, Oedema peripheral, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received SHINGRIX. On 11th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, general body pain, axillary lymph nodes enlarged, fever and headache. On an unknown date, the outcome of the injection site pain, general body pain, axillary lymph nodes enlarged, fever and headache were recovering/resolving. It was unknown if the reporter considered the injection site pain, general body pain, axillary lymph nodes enlarged, fever and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid and experienced pain at the injection site, headache, body ache, and swollen axillary lymph nodes. Healthcare provider reported that, the patient felt this was the, "worst thing she's ever been through". Healthcare provider did not consider the patient's symptoms were life threatening or disabling, and no hospitalization or intervention was required.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Injection site pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received SHINGRIX. On 11th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, general body pain, axillary lymph nodes enlarged, fever and headache. On an unknown date, the outcome of the injection site pain, general body pain, axillary lymph nodes enlarged, fever and headache were recovering/resolving. It was unknown if the reporter considered the injection site pain, general body pain, axillary lymph nodes enlarged, fever and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid and experienced pain at the injection site, headache, body ache, and swollen axillary lymph nodes. Healthcare provider reported that, the patient felt this was the, "worst thing she's ever been through". Healthcare provider did not consider the patient's symptoms were life threatening or disabling, and no hospitalization or intervention was required.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Contusion, Injection site bruising, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received SHINGRIX. On 11th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, general body pain, axillary lymph nodes enlarged, fever and headache. On an unknown date, the outcome of the injection site pain, general body pain, axillary lymph nodes enlarged, fever and headache were recovering/resolving. It was unknown if the reporter considered the injection site pain, general body pain, axillary lymph nodes enlarged, fever and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid and experienced pain at the injection site, headache, body ache, and swollen axillary lymph nodes. Healthcare provider reported that, the patient felt this was the, "worst thing she's ever been through". Healthcare provider did not consider the patient's symptoms were life threatening or disabling, and no hospitalization or intervention was required.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Rash, Rash maculo-papular
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020). The patient's past medical history included celiac disease. On 3rd May 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 3rd May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and injection site swelling. On 4th May 2018, the patient experienced maculopapular rash and widespread rash. The patient was treated with antihistamine. On an unknown date, the outcome of the injection site pain, injection site swelling, maculopapular rash and widespread rash were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site swelling, maculopapular rash and widespread rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm and on the same day developed soreness and swelling at injection site. Next day after vaccination, the patient experienced maculopapular, diffuse rash over torso. The patient was treated with and antihistamine and has since recovered. The patient required emergency room visit. No further information was reported regarding the event.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling, Rash, Rash generalised, Rash maculo-papular
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020). The patient's past medical history included celiac disease. On 3rd May 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 3rd May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and injection site swelling. On 4th May 2018, the patient experienced maculopapular rash and widespread rash. The patient was treated with antihistamine. On an unknown date, the outcome of the injection site pain, injection site swelling, maculopapular rash and widespread rash were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site swelling, maculopapular rash and widespread rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm and on the same day developed soreness and swelling at injection site. Next day after vaccination, the patient experienced maculopapular, diffuse rash over torso. The patient was treated with and antihistamine and has since recovered. The patient required emergency room visit. No further information was reported regarding the event.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Muscular weakness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 74-year-old female patient who received SHINGRIX. Concomitant products included biotin, FOSAMAX, ZYRTEC, Calcium Unknown, Levothyroxine, COLACE, Fiber Gummies and melatonin. On 30th April 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular) 50 ug. On 30th April 2018, immediately after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the patient experienced injected limb mobility decreased and weight bearing difficulty. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the injected limb mobility decreased and weight bearing difficulty were not recovered/not resolved. The reporter considered the injection site erythema to be related to SHINGRIX. The reporter considered the injected limb mobility decreased and weight bearing difficulty to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. The patient received women multivitamin and potassium concomitantly. The caller reported that she got SHINGRIX and had redness at the injection site immediately following the injection. About 5-7 days after the injection the patient noticed that she was unable to raise her right arm all the way. The patient was also unable to lift weights with her right arm. At the time of reporting the patient was unable to raise her arm above shoulder height, but using her left arm, she was physically able to lift it. The patient's arm did not hurt at all, just would not move or support weight. The patient said it might be getting incrementally better at the time of reporting.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site erythema, Weight bearing difficulty
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 74-year-old female patient who received SHINGRIX. Concomitant products included biotin, FOSAMAX, ZYRTEC, Calcium Unknown, Levothyroxine, COLACE, Fiber Gummies and melatonin. On 30th April 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular) 50 ug. On 30th April 2018, immediately after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the patient experienced injected limb mobility decreased and weight bearing difficulty. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the injected limb mobility decreased and weight bearing difficulty were not recovered/not resolved. The reporter considered the injection site erythema to be related to SHINGRIX. The reporter considered the injected limb mobility decreased and weight bearing difficulty to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. The patient received women multivitamin and potassium concomitantly. The caller reported that she got SHINGRIX and had redness at the injection site immediately following the injection. About 5-7 days after the injection the patient noticed that she was unable to raise her right arm all the way. The patient was also unable to lift weights with her right arm. At the time of reporting the patient was unable to raise her arm above shoulder height, but using her left arm, she was physically able to lift it. The patient's arm did not hurt at all, just would not move or support weight. The patient said it might be getting incrementally better at the time of reporting.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site tenderness in a 73-year-old female patient who received SHINGRIX. Concomitant products included Metformin, atenolol, CRESTOR, MICARDIS, Venlafaxine, CELEBREX, glimepiride and JANUVIA. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, 1 day after receiving SHINGRIX, the patient experienced injection site tenderness (serious criteria disability), generalized aching (serious criteria disability), myalgia (serious criteria disability), sleeplessness (serious criteria disability), shoulder pain and bedridden. On an unknown date, the outcome of the injection site tenderness was recovered/resolved and the outcome of the generalized aching, myalgia and sleeplessness were recovering/resolving and the outcome of the shoulder pain and bedridden were unknown. The reporter considered the injection site tenderness to be related to SHINGRIX. It was unknown if the reporter considered the generalized aching, myalgia, sleeplessness, shoulder pain and bedridden to be related to SHINGRIX. Additional information was reported as follows: The reporter was a physician who was calling to report on behalf of his wife (the patient). The patient took ELISINE and Vitamins as concomitant medications. The reporter stated that the patient received the SHINGRIX vaccine in early May 2018. The reporter stated that the next day after receiving the vaccine, the patient experienced injection site tenderness that lasted 1 to 2 days then resolved. He stated that approximately 1 week after receiving the SHINGRIX vaccine, the patient experienced generalized aches and pains and severe myalgia. He stated that the aches and pains and myalgia were so bad that she could hardly get out of bed. The reporter also stated that the patient's symptoms are gradually getting better but she still has pockets of intense pain in the shoulder. Less than a month after vaccination, the patient experienced sleeplessness, shoulder pain and bedridden. He stated that in his opinion it was disabling to the patient because she had really suffered and was still sort of disabled from the symptoms, till the time of reporting. The reporter stated that the patient cannot sleep as a result of the pain and she was usually a good sleeper. The reporter has also provided the contact details of Doctor of Medicines (MD), where he stated that the doctor changed his jobs and took 1 month off, so he should be available on the provided contact number and facility after 1st June.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bedridden, Injection site pain, Insomnia, Musculoskeletal pain, Myalgia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site tenderness in a 73-year-old female patient who received SHINGRIX. Concomitant products included Metformin, atenolol, CRESTOR, MICARDIS, Venlafaxine, CELEBREX, glimepiride and JANUVIA. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, 1 day after receiving SHINGRIX, the patient experienced injection site tenderness (serious criteria disability), generalized aching (serious criteria disability), myalgia (serious criteria disability), sleeplessness (serious criteria disability), shoulder pain and bedridden. On an unknown date, the outcome of the injection site tenderness was recovered/resolved and the outcome of the generalized aching, myalgia and sleeplessness were recovering/resolving and the outcome of the shoulder pain and bedridden were unknown. The reporter considered the injection site tenderness to be related to SHINGRIX. It was unknown if the reporter considered the generalized aching, myalgia, sleeplessness, shoulder pain and bedridden to be related to SHINGRIX. Additional information was reported as follows: The reporter was a physician who was calling to report on behalf of his wife (the patient). The patient took ELISINE and Vitamins as concomitant medications. The reporter stated that the patient received the SHINGRIX vaccine in early May 2018. The reporter stated that the next day after receiving the vaccine, the patient experienced injection site tenderness that lasted 1 to 2 days then resolved. He stated that approximately 1 week after receiving the SHINGRIX vaccine, the patient experienced generalized aches and pains and severe myalgia. He stated that the aches and pains and myalgia were so bad that she could hardly get out of bed. The reporter also stated that the patient's symptoms are gradually getting better but she still has pockets of intense pain in the shoulder. Less than a month after vaccination, the patient experienced sleeplessness, shoulder pain and bedridden. He stated that in his opinion it was disabling to the patient because she had really suffered and was still sort of disabled from the symptoms, till the time of reporting. The reporter stated that the patient cannot sleep as a result of the pain and she was usually a good sleeper. The reporter has also provided the contact details of Doctor of Medicines (MD), where he stated that the doctor changed his jobs and took 1 month off, so he should be available on the provided contact number and facility after 1st June.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site tenderness in a 73-year-old female patient who received SHINGRIX. Concomitant products included Metformin, atenolol, CRESTOR, MICARDIS, Venlafaxine, CELEBREX, glimepiride and JANUVIA. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, 1 day after receiving SHINGRIX, the patient experienced injection site tenderness (serious criteria disability), generalized aching (serious criteria disability), myalgia (serious criteria disability), sleeplessness (serious criteria disability), shoulder pain and bedridden. On an unknown date, the outcome of the injection site tenderness was recovered/resolved and the outcome of the generalized aching, myalgia and sleeplessness were recovering/resolving and the outcome of the shoulder pain and bedridden were unknown. The reporter considered the injection site tenderness to be related to SHINGRIX. It was unknown if the reporter considered the generalized aching, myalgia, sleeplessness, shoulder pain and bedridden to be related to SHINGRIX. Additional information was reported as follows: The reporter was a physician who was calling to report on behalf of his wife (the patient). The patient took ELISINE and Vitamins as concomitant medications. The reporter stated that the patient received the SHINGRIX vaccine in early May 2018. The reporter stated that the next day after receiving the vaccine, the patient experienced injection site tenderness that lasted 1 to 2 days then resolved. He stated that approximately 1 week after receiving the SHINGRIX vaccine, the patient experienced generalized aches and pains and severe myalgia. He stated that the aches and pains and myalgia were so bad that she could hardly get out of bed. The reporter also stated that the patient's symptoms are gradually getting better but she still has pockets of intense pain in the shoulder. Less than a month after vaccination, the patient experienced sleeplessness, shoulder pain and bedridden. He stated that in his opinion it was disabling to the patient because she had really suffered and was still sort of disabled from the symptoms, till the time of reporting. The reporter stated that the patient cannot sleep as a result of the pain and she was usually a good sleeper. The reporter has also provided the contact details of Doctor of Medicines (MD), where he stated that the doctor changed his jobs and took 1 month off, so he should be available on the provided contact number and facility after 1st June.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Injection site pain, Musculoskeletal pain, Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 81-year-old male patient who received SHINGRIX. Previously administered products included ZOSTAVAX vaccine (received in 2014). Concomitant products included carvedilol, Baby Aspirin, COUMADIN, Pravastatin, Warfarin, Losartan and LASIX. On 4th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 14 days after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the patient experienced shoulder pain and muscle pain. The patient was treated with medication unknown Ice Pack (Nos) and TYLENOL. On an unknown date, the outcome of the shoulder pain, injection site pain and muscle pain were unchanged. The reporter considered the shoulder pain, injection site pain and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient was receiving blood pressure medication concomitantly. The patient was administered SHINGRIX in the left arm in the morning and experienced pain in his shoulder and bicep area. The patient experienced soreness at the injection site initially than it started to spread to his biceps and both shoulders. TYLENOL but he had experienced no improvement. The patient claimed that he reported his experienced to VAERS.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 81-year-old male patient who received SHINGRIX. Previously administered products included ZOSTAVAX vaccine (received in 2014). Concomitant products included carvedilol, Baby Aspirin, COUMADIN, Pravastatin, Warfarin, Losartan and LASIX. On 4th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 14 days after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the patient experienced shoulder pain and muscle pain. The patient was treated with medication unknown Ice Pack (Nos) and TYLENOL. On an unknown date, the outcome of the shoulder pain, injection site pain and muscle pain were unchanged. The reporter considered the shoulder pain, injection site pain and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient was receiving blood pressure medication concomitantly. The patient was administered SHINGRIX in the left arm in the morning and experienced pain in his shoulder and bicep area. The patient experienced soreness at the injection site initially than it started to spread to his biceps and both shoulders. TYLENOL but he had experienced no improvement. The patient claimed that he reported his experienced to VAERS.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Musculoskeletal pain, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received SHINGRIX. The patient's past medical history included diabetes. Previously administered products included ZOSTAVAX (in 2014). Concomitant products included pravastatin, glipizide and WELCHOL. On 4th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 14 days after receiving SHINGRIX, the patient experienced injection site pain and shoulder pain. The patient was treated with TYLENOL and Ice Pack (Nos). On an unknown date, the outcome of the injection site pain and shoulder pain were unchanged. The reporter considered the injection site pain and shoulder pain to be related to SHINGRIX. Additional details were provided as follows: Concomitant products included cholesterol medication. The reporter reported that, his wife received the SHINGRIX vaccine in the morning in left arm and experienced pain in her shoulder and bicep area. She experienced soreness at the injection site initially and then it started to spread to her biceps and both shoulders. The patient's pharmacist recommended an Ice pack and TYLENOL but she had experienced no improvement.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received SHINGRIX. The patient's past medical history included diabetes. Previously administered products included ZOSTAVAX (in 2014). Concomitant products included pravastatin, glipizide and WELCHOL. On 4th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 14 days after receiving SHINGRIX, the patient experienced injection site pain and shoulder pain. The patient was treated with TYLENOL and Ice Pack (Nos). On an unknown date, the outcome of the injection site pain and shoulder pain were unchanged. The reporter considered the injection site pain and shoulder pain to be related to SHINGRIX. Additional details were provided as follows: Concomitant products included cholesterol medication. The reporter reported that, his wife received the SHINGRIX vaccine in the morning in left arm and experienced pain in her shoulder and bicep area. She experienced soreness at the injection site initially and then it started to spread to her biceps and both shoulders. The patient's pharmacist recommended an Ice pack and TYLENOL but she had experienced no improvement.