chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: X-ray limb normal
Clinical narrative: Patient describes developing right shoulder pain within 48 hours of receiving her 0.5mL FLUCELVAX (SEQ; lot#195248) IM to right deltoid, on 18 December 2017 that has been significant and persistent.  Patient does not recall exact location of vaccine administration, but does not recall receiving the vaccine high on the shoulder. She describes developing significant soreness at the vaccine site (without any observable swelling or redness) that progressed to stiffness and decreased range of motion that has persisted for more than 2 months. She describes the pain as a "dull achy pain" that can be 7 out of 10 in intensity with movement (especially internal rotation of the shoulder) and may be absent or minimal at rest. She notes decreased range of motion mostly with internal rotation. She has tried topical VOLTAREN GEL without any significant improvement. She has not, started any oral NSAIDs. She has not had any physical therapy to date. Workup by her PCM has included plain films and shoulder ultrasound that were reportedly unremarkable. She is currently pending an MRI of the shoulder. She has had a total of 3 PCM visits related to her shoulder pain thus far. Patient queries what can be done for this pain and how long will it last. Patient denies any other known adverse events following immunizations. And until now has received annual influenza vaccine without adverse events.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient reported to PCP that she was feeling like she had the flu again. She reported a sore/swollen arm, fever and "other flu like symptoms".
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was provided with a pediatric dose when an adult dose should have been administered.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Anxiety, Asthenia, Chest pain, Dizziness, Drug screen
Clinical narrative: Employee received her 2nd Hepatitis B shot and began feeling lightheaded, weak nauseated, hot and c/o chest pains. The employee was pale and sweaty. Comfort care measures were implemented by means of allowing the employee to lay down/sit on the examination table as well as giving her ice packs and fluids. The employee stated that she has anxiety and had not eaten since 0900 and that might be the reason why she is feeling this way. She was sent to an outside medical facility for further evaluation. The employee's reaction lasted about an hour while she was still in my care.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Feeling hot, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Employee received her 2nd Hepatitis B shot and began feeling lightheaded, weak nauseated, hot and c/o chest pains. The employee was pale and sweaty. Comfort care measures were implemented by means of allowing the employee to lay down/sit on the examination table as well as giving her ice packs and fluids. The employee stated that she has anxiety and had not eaten since 0900 and that might be the reason why she is feeling this way. She was sent to an outside medical facility for further evaluation. The employee's reaction lasted about an hour while she was still in my care.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a 17 year old female patient. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 11-JAN-2018, the patient was vaccinated with one dose of RECOMBIVAX HB (adult formulation) (thimerosal free) lot number: M040422, expiration date: 07-JUL-2019, for prophylaxis (strength, route and dosage schedule were not reported). On 04-APR-2018, the patient received one dose of a pediatric formulation of RECOMBIVAX HB (pediatric formulation) (thimerosal free) lot number: N006321, expiration date: 08-NOV-2019. No adverse effects were reported.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 05-APR-2018, the patient was concomitantly vaccinated with a dose of VARIVAX (lot # M023379 with expiration date of 01-MAY-2018), and with a dose of PROQUAD (lot # M042502 with expiration date of 17-APR-2018), for prophylaxis (dose, route of administration and anatomical location were not reported). No adverse effects reported.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Skin warm
Clinical narrative: Local burning pain for 24 hours and still hot to touch.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Development of erythema, warmth right upper arm inferior to the site where SHINGRIX was given measuring 8 X 11 centimeters, distinct border.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood culture negative, Computerised tomogram head normal, Culture urine negative, Full blood count normal, Intensive care
Clinical narrative: The patient presented to the ER that evening after receiving the 4-month-old vaccines, "spasming," per ER notes. ER physician reported that parents stated patient's "right arm was stiff/extended with fist clenched and her neck was turned to the left, eyes open." "The episode lasted for an unknown period of time, but somewhere between 2-5 minutes." "The patient was back to baseline by the time she arrived in the ER." Patient developed a seizure in the ER that was witnessed by the ER providers, and patient was given 2 doses of IM VERSED, which eventually stopped the seizure. The infant had a fever in the ER. T-max of 101.2F. Work up was done, which included blood culture, UA, urine culture, CBC, CMP, KUB, and head CT. No abnormalities were found. Patient was admitted to the PICU. No more seizures overnight. Temperature went down and fever did not return. Patient was back to neurological baseline. Neurology was consulted, and it was suspected vaccine-related and has a referral to neurology. Patient was discharged next day.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Metabolic function test normal, Muscle contractions involuntary, Muscle spasms, Musculoskeletal stiffness, Posture abnormal
Clinical narrative: The patient presented to the ER that evening after receiving the 4-month-old vaccines, "spasming," per ER notes. ER physician reported that parents stated patient's "right arm was stiff/extended with fist clenched and her neck was turned to the left, eyes open." "The episode lasted for an unknown period of time, but somewhere between 2-5 minutes." "The patient was back to baseline by the time she arrived in the ER." Patient developed a seizure in the ER that was witnessed by the ER providers, and patient was given 2 doses of IM VERSED, which eventually stopped the seizure. The infant had a fever in the ER. T-max of 101.2F. Work up was done, which included blood culture, UA, urine culture, CBC, CMP, KUB, and head CT. No abnormalities were found. Patient was admitted to the PICU. No more seizures overnight. Temperature went down and fever did not return. Patient was back to neurological baseline. Neurology was consulted, and it was suspected vaccine-related and has a referral to neurology. Patient was discharged next day.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, Seizure, Urinary system x-ray normal, Urine analysis normal, Vaccination complication
Clinical narrative: The patient presented to the ER that evening after receiving the 4-month-old vaccines, "spasming," per ER notes. ER physician reported that parents stated patient's "right arm was stiff/extended with fist clenched and her neck was turned to the left, eyes open." "The episode lasted for an unknown period of time, but somewhere between 2-5 minutes." "The patient was back to baseline by the time she arrived in the ER." Patient developed a seizure in the ER that was witnessed by the ER providers, and patient was given 2 doses of IM VERSED, which eventually stopped the seizure. The infant had a fever in the ER. T-max of 101.2F. Work up was done, which included blood culture, UA, urine culture, CBC, CMP, KUB, and head CT. No abnormalities were found. Patient was admitted to the PICU. No more seizures overnight. Temperature went down and fever did not return. Patient was back to neurological baseline. Neurology was consulted, and it was suspected vaccine-related and has a referral to neurology. Patient was discharged next day.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site nodule, Injection site swelling
Clinical narrative: Parent noted a large bump in area of injection on left thigh. Patient was seen in our office today 4/13/18 and palpated a small nodule type bump. Parent states it is much smaller than the day after the injection.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Injection site inflammation
Clinical narrative: The patient presents inflamation on injection area, she went to the doctor office and he treat the patient adverse reaction as an allergy.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Rash
Clinical narrative: Rash on chest and upper arms started next day - not itchy - raised bumpy. Also pain between shoulder blades on right hand side started on 4/09/18 and subsiding with naproxen.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Feeling abnormal
Clinical narrative: Received vaccine on 4/11/18 @ 6pm. Began having a headache that evening but nothing serious. On 4/12/18 around 10:00am, I began feeling very bad: Headache; Soreness at Site; Rash at Site; Ankles Hurting; Legs aching; Back hurting; Neck hurting; Shivering; Nauseous; Weakness; Temperature 101.6. Fever broke around 6pm on 4/12/18, still felt achy and weak through 4/13 (present).
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site pain, Injection site rash, Nausea, Neck pain
Clinical narrative: Received vaccine on 4/11/18 @ 6pm. Began having a headache that evening but nothing serious. On 4/12/18 around 10:00am, I began feeling very bad: Headache; Soreness at Site; Rash at Site; Ankles Hurting; Legs aching; Back hurting; Neck hurting; Shivering; Nauseous; Weakness; Temperature 101.6. Fever broke around 6pm on 4/12/18, still felt achy and weak through 4/13 (present).
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Received vaccine on 4/11/18 @ 6pm. Began having a headache that evening but nothing serious. On 4/12/18 around 10:00am, I began feeling very bad: Headache; Soreness at Site; Rash at Site; Ankles Hurting; Legs aching; Back hurting; Neck hurting; Shivering; Nauseous; Weakness; Temperature 101.6. Fever broke around 6pm on 4/12/18, still felt achy and weak through 4/13 (present).
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache
Clinical narrative: Received vaccine on 4/11/18 @ 6pm. Began having a headache that evening but nothing serious. On 4/12/18 around 10:00am, I began feeling very bad: Headache; Soreness at Site; Rash at Site; Ankles Hurting; Legs aching; Back hurting; Neck hurting; Shivering; Nauseous; Weakness; Temperature 101.6. Fever broke around 6pm on 4/12/18, still felt achy and weak through 4/13 (present).
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Extreme leg pain for approximately 2 weeks that still hasn't resolved at time of report. Pain has subsided some but knees continue to be very bothersome. Cyclobenzaprine was tried for 6 days.  At time of report diclofenac gel has been prescribed and will begin that treatment today.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: SWELLING ON ARM THAT WAS PRESENT AFTER 1 MONTH.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient has still been experiencing pain in arm near injection site since he got the shot over 2 months ago.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Loss of personal independence in daily activities, Nausea, Pyrexia
Clinical narrative: Woke up the next morning feeling tired (physically tired, not sleepy tired) and a bit of a queasy stomach. Took it easy that morning, but by 1:00 pm was running a fever, which went up to 100.4 for the rest of the day and evening. Stomach was queasy all day and evening. I lay down the entire afternoon and evening. The next day, my fever was gone but I still felt weak, tired and had a queasy stomach. I took it easy all day and was not up to my usual routine. The following day (today), I still felt tired and queasy, but a bit better. I still did not resume my usual activities.
Age: 5.0
Sex: M
Vaccine: DT
Symptoms: Erythema, Skin tightness, Skin warm, Swelling
Clinical narrative: Redness, swelling, tightness, Hot to the touch.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: 2 days after having the vaccine my daughter started having headaches and episodes of vomiting. She does not feel nausea, will just have random episodes of emesis. This continued for 4 weeks, the vomiting has subsided but headaches have not.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site bruising, Insomnia, Rash macular, Skin warm
Clinical narrative: Large bruise at injection site. At first, swollen and red skin. No itching or pain associated in that area. Skin on both arms up to neck exhibited red splotches. Hot to touch and at night before going to bed. Patient has had issues sleeping at night. Advised patient to see physician for further treatment and to let me know the outcome.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Large bruise at injection site. At first, swollen and red skin. No itching or pain associated in that area. Skin on both arms up to neck exhibited red splotches. Hot to touch and at night before going to bed. Patient has had issues sleeping at night. Advised patient to see physician for further treatment and to let me know the outcome.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Pain at the injection site, fever (101.8), chills, muscle aches, headache.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Cyst, Dyspnoea, Oral contusion, Pruritus, Urticaria
Clinical narrative: Shortness of breath. Linear welts with  intense itching. Blue bruise on upper lip. Cyst on upper lip. Symptoms persist on day 7 following vaccine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported, redness, tenderness, swelling, and heat at the site of the injection.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient complains of redness and hotness in the injection site for two days. No fever or any other symptoms. Advised patient to ice the area and take BENADRYL and TYLENOL if needed for the pain.
Sex: U
Vaccine: PNC13
Symptoms: Productive cough
Clinical narrative: Patient states he has been coughing up phlegm about 8 to 10 times daily after getting vaccine.
Sex: M
Vaccine: FLU4
Symptoms: Drooling, Hemiplegia
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of right sided paralysis in a 51-year-old male patient who received Flu Seasonal QIV Dresden. On an unknown date, the patient received Flu Seasonal QIV Dresden at an unknown dose. On an unknown date, unknown after receiving Flu Seasonal QIV Dresden, the patient experienced right sided paralysis (serious criteria GSK medically significant) and drooling. On an unknown date, the outcome of the right sided paralysis and drooling were unknown. It was unknown if the reporter considered the right sided paralysis and drooling to be related to Flu Seasonal QIV Dresden. Additional details were provided as follows: The age at vaccination was not reported. The patient could not move the right side of his body.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received SHINGRIX. On 6th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th February 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm. The patient was treated with TYLENOL. In February 2018, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be almost certainly related to SHINGRIX. Additional information was reported as follows: The healthcare professional reported that, her arm began hurting a couple hours after receiving the SHINGRIX in the left deltoid. The patient took TYLENOL, and the arm hurting took 3-4 days to resolve. This case has been linked with the case US2018GSK063578, reported by the same reporter for the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional reported that there was one patient who experienced flu like symptoms after SHINGRIX which she previously reported to GlaxoSmithKline. Unable to obtain patient identifiers for previously reported adverse event, thus no duplicate case was identified. This case was linked to case US2018056944 and US2018GSK062805, reported by the same reporter.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). On 19th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, 1 day after receiving SHINGRIX, the patient experienced pain in arm and injected limb mobility decreased. In March 2018, the outcome of the pain in arm and injected limb mobility decreased were recovered/resolved. The reporter considered the pain in arm to be related to SHINGRIX. It was unknown if the reporter considered the injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. After receiving SHINGRIX, the patient reported that her left arm was so painful that she could not raise her left arm and this pain was lasted for approximately 3-4 days.
Age: 0.75
Sex: U
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Body temperature increased
Clinical narrative: T-104.3 went to hospital. Vaccines given April 10-18.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received SHINGRIX. On 2nd February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: For tolerance after 2nd dose, please refer case US2018056944. This case has been also linked to case US2018GSK063531, reported by the same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received SHINGRIX. Concomitant products included PRILOSEC, ezetimibe and LEXAPRO. On 2nd April 2018, the patient received SHINGRIX (intramuscular). On 2nd April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, upset stomach, chills, headache and fever. On an unknown date, the outcome of the pain in arm, upset stomach, chills, headache and fever were recovering/resolving. The reporter considered the pain in arm, upset stomach, chills, headache and fever to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on the right arm and later that day, she reported soreness in the arm. Later that night, the patient reported fever, chills, headache and upset stomach. The patient noted that she had every side effect listed in the Package Insert, but she could only verbalize the events listed on this report. At the time of report, the patient noted that the events had only slightly improved.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Approximately 30 seconds following administration of meningococcal vaccine patient complained of itching at injection site. Hives noted surrounding site along with faint erythema, area outlined. Pruritis resolved after 1 min. but hives persisted localized to the outlined area. Denied any difficulty breathing, chest tightness, SOB, throat tightness, difficulty swallowing, tongue swelling, headache, stomach ache, or nausea. Exam at onset of hives and through 45 min. of monitoring following revealed a calm, alert male in NAD with lungs CTA, no diaphoresis, no facial or tongue swelling and no additional area of hives aside from immediately surrounding the site of injection on the upper left arm. VSS. One time dose of diphenhydramine given and instructed to continue Q6h with follow up tomorrow. Instructed to seek immediate care for any of the denied symptoms above or for any other concerns. On 4/12/2018, patient came back into the clinic for a recheck. Hives had nearly resolved.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Anti-cyclic citrullinated peptide antibody negative, Arthralgia, Basophil count normal, Basophil percentage decreased, Blood 25-hydroxycholecalciferol
Clinical narrative: C/O joint pain that stated approx. 5 days after injection. Office visit with FNP on 3-16-18 that included lab, SED rate and CBC. Started on VIMOVO 500-20 mg BID and tramadol 50 mg four times daily, PRN. Pt. returned to office on 3-28-18 with continuing C/O joint pain, myalgia additional lab was ordered, CCP, RA Factor, Vit D 25 hydroxy and was prescribed Prednisone 20 mg daily x 5 days. History of Present Illness (03/28/2018 04:28 PM) The patient is a 21 year old female who presents with joint pain. Symptoms include joint pain, migratory joint pain and decreased range of motion. Symptoms are located in the neck, upper back, lower back, left shoulder, left elbow, left wrist, left metacarpal phalangeal joint, left proximal interphalangeal joint, left distal interphalangeal joint, left hip, left knee, left ankle, left foot, right shoulder, right elbow, right wrist, right metacarpal phalangeal joint, right proximal interphalangeal joint, right distal interphalangeal joint, right hip, right knee, right ankle and right foot. The patient describes the pain as aching. Onset was sudden 3 week(s) ago. Onset followed recent immunization. The symptoms occur constantly. The patient describes this as moderate in severity and worsening. Associated symptoms include myalgia, while associated symptoms do not include muscle weakness. Current treatment includes nonsteroidal anti-inflammatory drugs. History of Present Illness (03/16/2018 10:08 AM) Patient words: all of my joints hurt, but elbows are esp. bad. Had to get meningitis shot recently, so not sure if that caused. Started on Sat. with my back. The patient is a 21 year old female patient who presents with a complaint of Joint pain. The onset of the joint pain has been sudden and has been occurring in a persistent pattern for 1 week. The course has been increasing.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: C-reactive protein increased, Eosinophil count normal, Eosinophil percentage decreased, Full blood count, Granulocyte count
Clinical narrative: C/O joint pain that stated approx. 5 days after injection. Office visit with FNP on 3-16-18 that included lab, SED rate and CBC. Started on VIMOVO 500-20 mg BID and tramadol 50 mg four times daily, PRN. Pt. returned to office on 3-28-18 with continuing C/O joint pain, myalgia additional lab was ordered, CCP, RA Factor, Vit D 25 hydroxy and was prescribed Prednisone 20 mg daily x 5 days. History of Present Illness (03/28/2018 04:28 PM) The patient is a 21 year old female who presents with joint pain. Symptoms include joint pain, migratory joint pain and decreased range of motion. Symptoms are located in the neck, upper back, lower back, left shoulder, left elbow, left wrist, left metacarpal phalangeal joint, left proximal interphalangeal joint, left distal interphalangeal joint, left hip, left knee, left ankle, left foot, right shoulder, right elbow, right wrist, right metacarpal phalangeal joint, right proximal interphalangeal joint, right distal interphalangeal joint, right hip, right knee, right ankle and right foot. The patient describes the pain as aching. Onset was sudden 3 week(s) ago. Onset followed recent immunization. The symptoms occur constantly. The patient describes this as moderate in severity and worsening. Associated symptoms include myalgia, while associated symptoms do not include muscle weakness. Current treatment includes nonsteroidal anti-inflammatory drugs. History of Present Illness (03/16/2018 10:08 AM) Patient words: all of my joints hurt, but elbows are esp. bad. Had to get meningitis shot recently, so not sure if that caused. Started on Sat. with my back. The patient is a 21 year old female patient who presents with a complaint of Joint pain. The onset of the joint pain has been sudden and has been occurring in a persistent pattern for 1 week. The course has been increasing.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Granulocyte percentage, Haematocrit normal, Haemoglobin normal, Joint range of motion decreased, Lymphocyte count normal
Clinical narrative: C/O joint pain that stated approx. 5 days after injection. Office visit with FNP on 3-16-18 that included lab, SED rate and CBC. Started on VIMOVO 500-20 mg BID and tramadol 50 mg four times daily, PRN. Pt. returned to office on 3-28-18 with continuing C/O joint pain, myalgia additional lab was ordered, CCP, RA Factor, Vit D 25 hydroxy and was prescribed Prednisone 20 mg daily x 5 days. History of Present Illness (03/28/2018 04:28 PM) The patient is a 21 year old female who presents with joint pain. Symptoms include joint pain, migratory joint pain and decreased range of motion. Symptoms are located in the neck, upper back, lower back, left shoulder, left elbow, left wrist, left metacarpal phalangeal joint, left proximal interphalangeal joint, left distal interphalangeal joint, left hip, left knee, left ankle, left foot, right shoulder, right elbow, right wrist, right metacarpal phalangeal joint, right proximal interphalangeal joint, right distal interphalangeal joint, right hip, right knee, right ankle and right foot. The patient describes the pain as aching. Onset was sudden 3 week(s) ago. Onset followed recent immunization. The symptoms occur constantly. The patient describes this as moderate in severity and worsening. Associated symptoms include myalgia, while associated symptoms do not include muscle weakness. Current treatment includes nonsteroidal anti-inflammatory drugs. History of Present Illness (03/16/2018 10:08 AM) Patient words: all of my joints hurt, but elbows are esp. bad. Had to get meningitis shot recently, so not sure if that caused. Started on Sat. with my back. The patient is a 21 year old female patient who presents with a complaint of Joint pain. The onset of the joint pain has been sudden and has been occurring in a persistent pattern for 1 week. The course has been increasing.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal
Clinical narrative: C/O joint pain that stated approx. 5 days after injection. Office visit with FNP on 3-16-18 that included lab, SED rate and CBC. Started on VIMOVO 500-20 mg BID and tramadol 50 mg four times daily, PRN. Pt. returned to office on 3-28-18 with continuing C/O joint pain, myalgia additional lab was ordered, CCP, RA Factor, Vit D 25 hydroxy and was prescribed Prednisone 20 mg daily x 5 days. History of Present Illness (03/28/2018 04:28 PM) The patient is a 21 year old female who presents with joint pain. Symptoms include joint pain, migratory joint pain and decreased range of motion. Symptoms are located in the neck, upper back, lower back, left shoulder, left elbow, left wrist, left metacarpal phalangeal joint, left proximal interphalangeal joint, left distal interphalangeal joint, left hip, left knee, left ankle, left foot, right shoulder, right elbow, right wrist, right metacarpal phalangeal joint, right proximal interphalangeal joint, right distal interphalangeal joint, right hip, right knee, right ankle and right foot. The patient describes the pain as aching. Onset was sudden 3 week(s) ago. Onset followed recent immunization. The symptoms occur constantly. The patient describes this as moderate in severity and worsening. Associated symptoms include myalgia, while associated symptoms do not include muscle weakness. Current treatment includes nonsteroidal anti-inflammatory drugs. History of Present Illness (03/16/2018 10:08 AM) Patient words: all of my joints hurt, but elbows are esp. bad. Had to get meningitis shot recently, so not sure if that caused. Started on Sat. with my back. The patient is a 21 year old female patient who presents with a complaint of Joint pain. The onset of the joint pain has been sudden and has been occurring in a persistent pattern for 1 week. The course has been increasing.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Monocyte count normal, Monocyte percentage increased, Myalgia, Platelet count normal, Red blood cell count increased
Clinical narrative: C/O joint pain that stated approx. 5 days after injection. Office visit with FNP on 3-16-18 that included lab, SED rate and CBC. Started on VIMOVO 500-20 mg BID and tramadol 50 mg four times daily, PRN. Pt. returned to office on 3-28-18 with continuing C/O joint pain, myalgia additional lab was ordered, CCP, RA Factor, Vit D 25 hydroxy and was prescribed Prednisone 20 mg daily x 5 days. History of Present Illness (03/28/2018 04:28 PM) The patient is a 21 year old female who presents with joint pain. Symptoms include joint pain, migratory joint pain and decreased range of motion. Symptoms are located in the neck, upper back, lower back, left shoulder, left elbow, left wrist, left metacarpal phalangeal joint, left proximal interphalangeal joint, left distal interphalangeal joint, left hip, left knee, left ankle, left foot, right shoulder, right elbow, right wrist, right metacarpal phalangeal joint, right proximal interphalangeal joint, right distal interphalangeal joint, right hip, right knee, right ankle and right foot. The patient describes the pain as aching. Onset was sudden 3 week(s) ago. Onset followed recent immunization. The symptoms occur constantly. The patient describes this as moderate in severity and worsening. Associated symptoms include myalgia, while associated symptoms do not include muscle weakness. Current treatment includes nonsteroidal anti-inflammatory drugs. History of Present Illness (03/16/2018 10:08 AM) Patient words: all of my joints hurt, but elbows are esp. bad. Had to get meningitis shot recently, so not sure if that caused. Started on Sat. with my back. The patient is a 21 year old female patient who presents with a complaint of Joint pain. The onset of the joint pain has been sudden and has been occurring in a persistent pattern for 1 week. The course has been increasing.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Red blood cell count normal, Red cell distribution width normal, Rheumatoid factor negative, White blood cell count normal
Clinical narrative: C/O joint pain that stated approx. 5 days after injection. Office visit with FNP on 3-16-18 that included lab, SED rate and CBC. Started on VIMOVO 500-20 mg BID and tramadol 50 mg four times daily, PRN. Pt. returned to office on 3-28-18 with continuing C/O joint pain, myalgia additional lab was ordered, CCP, RA Factor, Vit D 25 hydroxy and was prescribed Prednisone 20 mg daily x 5 days. History of Present Illness (03/28/2018 04:28 PM) The patient is a 21 year old female who presents with joint pain. Symptoms include joint pain, migratory joint pain and decreased range of motion. Symptoms are located in the neck, upper back, lower back, left shoulder, left elbow, left wrist, left metacarpal phalangeal joint, left proximal interphalangeal joint, left distal interphalangeal joint, left hip, left knee, left ankle, left foot, right shoulder, right elbow, right wrist, right metacarpal phalangeal joint, right proximal interphalangeal joint, right distal interphalangeal joint, right hip, right knee, right ankle and right foot. The patient describes the pain as aching. Onset was sudden 3 week(s) ago. Onset followed recent immunization. The symptoms occur constantly. The patient describes this as moderate in severity and worsening. Associated symptoms include myalgia, while associated symptoms do not include muscle weakness. Current treatment includes nonsteroidal anti-inflammatory drugs. History of Present Illness (03/16/2018 10:08 AM) Patient words: all of my joints hurt, but elbows are esp. bad. Had to get meningitis shot recently, so not sure if that caused. Started on Sat. with my back. The patient is a 21 year old female patient who presents with a complaint of Joint pain. The onset of the joint pain has been sudden and has been occurring in a persistent pattern for 1 week. The course has been increasing.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 56-year-old female patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020). Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 2nd February 2018, please refer US2018GSK062805). On 2nd April 2018, the patient received the 2nd dose of SHINGRIX. On 3rd April 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, pain, fever, nausea and headache. On an unknown date, the outcome of the influenza-like symptoms was not recovered/not resolved and the outcome of the pain, fever, nausea and headache were unknown. It was unknown if the reporter considered the influenza-like symptoms, pain, fever, nausea and headache to be related to SHINGRIX. Additional details were reported as follows: On 2nd April 2018, at around 3 AM, the patient began to experience flu like symptoms, described as fever (body temperature 101 degree C), achy, nauseous, and headache. At the time of the reporting, the patient did not require any doctor visit or intervention. The patient was not hospitalized, and the symptoms were not considered to be life threatening or disabling. This case has been linked to case US2018GSK063531, reported by the same reporter.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Pain, Product preparation error
Clinical narrative: This case was reported by a physician via out of hour services and described the occurrence of general body pain in a 61-year-old male patient who received SHINGRIX (batch number 33H7C, expiry date 30th January 2020). On 2nd April 2018, the patient received SHINGRIX. On 2nd April 2018, unknown after receiving SHINGRIX, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional details were reported as follows: This case was reported by the patient's wife. The reporter gave the SHINGRIX vaccine liquid adjuvant component to the patient without the vaccine portion in error, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not realize that, the diluent and vaccine were separate because she ordered the vaccine through a pharmacy and they never provided her with the instructions on preparation of the vaccine. The voicemail message cut off before the entire expiration date information was provided (January 30). Follow up information received from physician via call center representative on 3rd April 2018: This case was identified as duplicate of case US2018057012. The case US2018057012 will be deleted and all future correspondence will be added in the present case US2018056946 which stands as case of record for this patient. The duplicate case contained the following additional information: The patient's past medical history included shingles. At 09:00 hours, the patient received the 1st dose of SHINGRIX, intramuscularly in right deltoid. The suspect vaccine expiry date was updated. The reporter inadvertently administered the adjuvant for SHINGRIX alone, without reconstituting with lyophilized component, to the patient. Couple of hours after receiving SHINGRIX, the patient experienced body aches, which lasted the rest of the day. The patient was treated with TYLENOL and ADVIL. The next morning, when the patient woke up, the body aches were gone. The reporter had lot number only for the adjuvant component. The reporter considered the general body pain to be probably related to SHINGRIX.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of a SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 72 or 73 years old. The patient received 1st dose of SHINGRIX on right arm and experienced flu like symptoms. The reporter had denied permission to contact their physician and could not provide any extra information. This case was linked with US2018056966, reported by the same reporter for same patient.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 73-year-old male patient who received Shingles vaccine. Concomitant products included SHINGRIX, folic acid, gabapentin, omeprazole, Rosuvastatin, ZETIA, KLONIPIN, doxepin and PROTONIX. On 2nd April 2018 15:00, the patient received the 2nd dose of Shingles vaccine. In April 2018, 16 hrs 30 min after receiving Shingles vaccine and an unknown time after receiving SHINGRIX, the patient experienced influenza-like symptoms, headache, chills, fever and appetite absent. The patient was treated with Pain Medication. On an unknown date, the outcome of the influenza-like symptoms, headache, chills and fever were recovering/resolving and the outcome of the appetite absent was unknown. The reporter considered the influenza-like symptoms, headache, chills and fever to be almost certainly related to Shingles vaccine. It was unknown if the reporter considered the appetite absent to be related to Shingles vaccine. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on right arm and 2nd dose on left arm. The reporter was the patient calling to report his experience on SHINGRIX and stated that this was the second dose in the series and was experiencing same flu like symptoms that he experienced after the first dose in the series. At 7:30 am, on 3rd April 2018, 16 hours and 30 minutes post vaccination the patient experienced flu like symptoms with headache, fever and chills. The patient stated that, less than a day after vaccination, he did not feel like eating in the morning, on the day of reporting and took pain medications to help relieve the symptoms. The patient had started to feel normal. The reporter had denied permission to contact their physician and could not provide any extra information. This case was linked with US2018GSK063519, reported by the same reporter for same patient.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Bronchitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of bronchitis in a elderly male patient who received SHINGRIX. The patient's past medical history included respiratory disorder. Concurrent medical conditions included artificial cardiac pacemaker user (Implanted pacemaker prior to receiving SHINGRIX) and asthma. Concomitant products included ARNUITY ELLIPTA and PRADAXA. In February 2018, the patient received the 1st dose of SHINGRIX .5 ml. In March 2018, less than a year after receiving SHINGRIX, the patient experienced bronchitis. On an unknown date, the outcome of the bronchitis was recovering/resolving. The reporter considered the bronchitis to be unlikely related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After receiving SHINGRIX, the patient started having some respiratory problems and in March was diagnosed with bronchitis. He asked what the time frame was for receiving the 2nd dose, and if he should go ahead and get it. The patient was provided with the dose and schedule information from the PI and suggested that he spoke with his physician in regards to receiving the 2nd injection. The patient stated that he had respiratory problems which he clarified as being asthma, before receiving SHINGRIX, but he developed bronchitis in March. The patient recently started on ARNUITY but only started six days ago and it was prescribed for his asthma. Patient did not think that there was any causality for him being diagnosed with bronchitis and simply called to find out the dosing schedule for the vaccine. The patient had denied permission to contact their physician.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received SHINGRIX (batch number 4492P, expiry date unknown). Previously administered products included SHINGRIX (refer case US2018057021 for 1st dose). On 2nd April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 2nd April 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm and general body pain. The patient was treated with TYLENOL. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the general body pain was unknown. The reporter considered the pain in arm and general body pain to be almost certainly related to SHINGRIX. Additional information was reported as follows: The healthcare professional reported that, she experienced body aches and her arm began hurting a couple hours after receiving the SHINGRIX in the left deltoid at 13:00 hours. The 2nd dose of SHINGRIX was given just under 8 weeks (1 day early). Expiration date was unknown. At the time of this report, the patient's arm was hurting, but it was not debilitating. The patient began taking TYLENOL on the vaccination date.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Hypersensitivity, Pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of erythema in an unspecified number of patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema, feeling hot, pain and allergic reaction. On an unknown date, the outcome of the erythema, feeling hot, pain and allergic reaction were unknown. It was unknown if the reporter considered the erythema, feeling hot, pain and allergic reaction to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not applicable. The Medical Assistant called on behalf of the prescribing doctor because he had a couple of people who have had some side effects to the vaccine. Several patients have had red and hot larger sites on the shingles vaccine and did not want to receive the second dose because of their allergic reaction. The doctor would like further clinical information about the SHINGRIX side effects faxed to his office if possible. The reporter declined to answer any further questions. The reporter said that he would be the one discussing further related details with GlaxoSmithKline. The reporter described several patients have had red and hot larger sites. The word she mentioned between larger and sites sounded like pore but was not able to clarify this further during the call.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration
Clinical narrative: 5cm by 7cm indurated and erythematous area right shoulder. Treatment is to ice area.
Age: 73.0
Sex: M
Vaccine: FLUC4
Symptoms: Blood test, Computerised tomogram, Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: Pain in left arm and shoulder. Unable to raise arm above head or lift anything substantial.
Age: 73.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain in extremity, Weight bearing difficulty, X-ray
Clinical narrative: Pain in left arm and shoulder. Unable to raise arm above head or lift anything substantial.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Induration, Malaise, Myalgia, Pain in extremity
Clinical narrative: Fever, myalgia, induration, headaches, malaise x2 days. Arm pain, induration, myalgia for 2 wks.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Fever, myalgia, induration, headaches, malaise x2 days. Arm pain, induration, myalgia for 2 wks.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Pain in extremity, Pyrexia, Rash
Clinical narrative: Patient called the following morning complaining of malaise, flu like symptoms and sore arm. She also reported low grade fever of 101. Encouraged her to take tylenolol or ibuprofen for fever and to monitor. Explained all sxs were normal side effects except the fever. 2 days post vaccination patients come in to the pharmacy fever free and feeling fine, but has a large rash around her lower abdomen and back. She explained she has hashimoto's and normally when she gets sicks she develops this rash. She also had just been on an airplane the morning she received the vaccine so she wasn't sure if maybe she was genuinely sick. Gave pt OTC Benadryl and hydrocortisone cream and told pt to monitor.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient stated that she hurt all over from her fingers to her toes. It lasted about 24 hours, starting at 7:00 p.m. the evening of the vaccine and continuing until 7:00 p.m. the next evening. After that, she was fine.