chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: soreness/a lot of; swelling in arm; mild redness; This case was reported by a nurse via call center representative and described the occurrence of pain in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABX770AA, expiry date 7th July 2020) for prophylaxis.   On 8th July 2019, the patient received Bexsero. On 8th July 2019, less than a day after receiving Bexsero, the patient experienced pain, swelling arm and erythema. On an unknown date, the outcome of the pain, swelling arm and erythema were not recovered/not resolved.   It was unknown if the reporter considered the pain, swelling arm and erythema to be related to Bexsero.  Additional details were provided as follows: The reporter was the patient's mother. The nurse reported that, after vaccination with Bexsero, the patient experienced soreness, a lot of pain, swelling going down arm, and mild redness. These events were ongoing at the time of this report.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th July 2019, the patient received the 1st dose of Shingrix. On 11th July 2019, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The registered pharmacist reported that the patient received Shingrix and at the time of reporting was diagnosed with Shingles.
Age: 16.0
Sex: F
Vaccine: HPV4, MENB, MNQ
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: Syncopal episode after vaccines administered Patient stood up about 1min after vaccine was given, got dizzy, became pale. Laid her down, checked BP twice- and was ok by physician to leave about 25 min after episode.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination site bruising
Clinical narrative: Patinet doesnot have any symptoms of pain or fever or anythingelse but patient has really bad brusing around the vacination area
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: On 7/14 patient called and complained of round 1/2 golf ball sized warm spot at injection site. On 7/15, patient stopped in pharmacy and the injection site was not raised. Injection site was warm to the touch and smaller in circumference
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Discomfort, Headache, Injection site erythema, Pain in extremity, Pyrexia
Clinical narrative: She had received a vaccine- Quadracel ( DTaP + IPV) 2 days ago on 7/15/19. The following day, she had a fever and headache.  The fever defervesced after a day. Her arm had been hurting since the day of the vaccination. There was redness at the site. No discharge seen. She did complain of discomfort doing some of her activities at the daycare. No runny nose, no cough, no ear ache. No other rash seen on the body.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Myalgia
Clinical narrative: Full-body muscle ache began within a few hours.  Knee and wrist joint ache and elevated temperature followed within 24 hours.
Age: 34.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: Developed "knot" and pain left deltoid area approx 6 days post-vaccination.  Palpable 1x1cm hard area, no redness or swelling, pain to palpation.  Referred to NP for follow-up.  No treatment required.
Age: 60.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Appendicectomy, Appendicitis, Laboratory test abnormal, Platelet transfusion, Thrombocytopenia
Clinical narrative: thrombocytopenia discovered on 7/12 due to emergency room visit for acute appendicitis.  No signs and symptoms of bruising.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Red sore arm at injection site. Day of vaccine administration. Next day : Headache fever diarrhea and she reports going to doctor. She reports getting a steroid dose in the office and given a script for macrobid 1 cap daily x 5 days and using Tylenol 2 every 4 hours for fever
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Electrocardiogram, Immediate post-injection reaction, Injection site pruritus, Musculoskeletal pain
Clinical narrative: -patient experienced pain immediately after shot.  -The pain became worst - over time approx. 1 week after shot area became itchy. Pain and itchiness radiating to left breast and shoulder blade.  -patient is still experiencing slight pain and itching.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus
Clinical narrative: -patient experienced pain immediately after shot.  -The pain became worst - over time approx. 1 week after shot area became itchy. Pain and itchiness radiating to left breast and shoulder blade.  -patient is still experiencing slight pain and itching.
Sex: F
Vaccine: HPV9
Symptoms: Muscle rigidity, Seizure, Syncope
Clinical narrative: patient had a syncopal episode/it looked like her daughter was having a seizure/the patients legs were rigid; This spontaneous report was received from a consumer via sales representative referring to her daughter, an 11 years old Child patient. The patient's current condition, concomitant medication, medical history and historical drugs were unknown.   On 10-JUL-2019, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9)(strength, dose, lot number, expiry date, frequency unknown) via intramuscular route for vaccination (prophylaxis). Co-suspect included unknown vaccine which was administered prior to the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) dose during the same office visit.   On 10-JUL-2019, the patient experienced syncopal episode, and the consumer reported it looked like her daughter was having seizure as she also noted her legs were rigid (seizure). The patient sought medical attention but no treatment was provided for the events. It was unknown whether lab diagnostics/studies were performed. The event was resolved on an unknown date in July 2019. The reporter's causality assessment between the event and the suspect therapy was unknown. There was no product quality complaint(PQC).  Upon internal review, the events seizures was determined to be medically significant.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient was seen in office 1 day after injection. Patient's arm warm to the touch, swollen, red area, no fever. Patient prescribed Medrol pack.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Pt experienced joint pain (albows and knees) following the vaccination. Symptoms came on about 5 hours later and lasted for roughly 24 hours.
Age: 80.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Asthenia, Confusional state, Gait disturbance, Lethargy, Pain in extremity
Clinical narrative: WHEN PATIENT WENT HOME AFTER VACCINATION, STARTED FEELING PAIN IN LEFT ARM THAT STARTED TO SWELL.PATIENT SAYS SIDE EFFECTS THAT INCLUDE HARD TIME WALKING AND CONFUSION LASTED FOR 20-24 HOURS AFTER GETTING VACCINATED.  PATIENT STATES THAT SHE WASN'T ABLE TO DO ANYTHING ON SATURDAY 07/13/19 AND FELT THE PAIN WAS GONE BY SATURDAY NIGHT.  PATIENT STATES THAT SHE DIDN'T HAVE ANY SORENESS IN HER RIGHT ARM OR EXPERIENCED ANY OTHER SYMPTOMS. THERE WAS NO FEVER INVOLVED BUT PATIENT FELT LETHARGIC AND WEAK.
Age: 80.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Peripheral swelling
Clinical narrative: WHEN PATIENT WENT HOME AFTER VACCINATION, STARTED FEELING PAIN IN LEFT ARM THAT STARTED TO SWELL.PATIENT SAYS SIDE EFFECTS THAT INCLUDE HARD TIME WALKING AND CONFUSION LASTED FOR 20-24 HOURS AFTER GETTING VACCINATED.  PATIENT STATES THAT SHE WASN'T ABLE TO DO ANYTHING ON SATURDAY 07/13/19 AND FELT THE PAIN WAS GONE BY SATURDAY NIGHT.  PATIENT STATES THAT SHE DIDN'T HAVE ANY SORENESS IN HER RIGHT ARM OR EXPERIENCED ANY OTHER SYMPTOMS. THERE WAS NO FEVER INVOLVED BUT PATIENT FELT LETHARGIC AND WEAK.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Joint swelling, Malaise
Clinical narrative: Pain and swelling in joints, esp hands and fingers, (primarily joints at base of index fingers and in right index finger) also shoulders, knees, neck, hips and feet hard bumps on top of both feet, but esp right foot. General malaise, tired easily for a couple of weeks
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Activated partial thromboplastin time, Differential white blood cell count, Full blood count, Injection site swelling, International normalised ratio
Clinical narrative: Pt had large localized swelling at the injection site the day after. Then 2 days later he developed hives to upper/lower extremities, buttocks, groin, with mild radiation to face and trunk.  07/15/19 Office Visit.     Suspect likely vaccine reaction. Use prescriptions as directed. Continue to monitor at home and provide comfort. Return for evaluation if current symptoms are not improved in 2-3 days or for any new/concerning symptoms. Hydroxyzine HCl 10 mg/5 mL oral solution - Take 10 mL every 6 hours by oral route as needed.         Prednisolone 15 mg/5 mL oral solution - Take 10 mL twice a day by oral route for 5 days.      .
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Metabolic function test, Prothrombin time, Urine analysis, Urticaria, Vaccination complication
Clinical narrative: Pt had large localized swelling at the injection site the day after. Then 2 days later he developed hives to upper/lower extremities, buttocks, groin, with mild radiation to face and trunk.  07/15/19 Office Visit.     Suspect likely vaccine reaction. Use prescriptions as directed. Continue to monitor at home and provide comfort. Return for evaluation if current symptoms are not improved in 2-3 days or for any new/concerning symptoms. Hydroxyzine HCl 10 mg/5 mL oral solution - Take 10 mL every 6 hours by oral route as needed.         Prednisolone 15 mg/5 mL oral solution - Take 10 mL twice a day by oral route for 5 days.      .
Age: 37.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Axillary pain, Injection site pain, Injection site paraesthesia, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and pain of right upper arm, right arm pit, right back shoulder and front shoulder/base of neck,  warm to touch, mild fever, tingling in shoulder and upper back, nausea
Age: 37.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Nausea, Neck pain, Oedema peripheral, Pyrexia, Swelling
Clinical narrative: Swelling and pain of right upper arm, right arm pit, right back shoulder and front shoulder/base of neck,  warm to touch, mild fever, tingling in shoulder and upper back, nausea
Age: 2.0
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Injection site pain, Pyrexia
Clinical narrative: fever of 101 degrees, sore deltoid sites, especially the dtap site(left)
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Same arm cellulitis, warmth, pain, edema, began approx 8 hours after injection, reaction is more medial and distal than site of injection
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash, Rash erythematous, Skin warm
Clinical narrative: Large red rash on arm over 1 inch in diameter, warmness and pain -- manifested 3 days after administering the vaccine and still present to this day.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Headache,chills,fever greater than 100.5.
Age: 63.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site irritation, Injection site swelling, Injection site warmth
Clinical narrative: Patient called stating that she was having redness, swelling, and irritation at the site of the injection and that it was very warm to the touch. She had severe pain for the couple of days after the vaccinations, but pain had subsided. She came in to the pharmacy and the entirety of her upper deltoid area of her left arm was completely inflamed and warm to the touch. I stated that I strongly recommended her be seen by her PCP or walk-in clinic, but she "doesn't trust them". Patient left and did not indicate whether she would be seeking medical attention.
Age: 63.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Patient called stating that she was having redness, swelling, and irritation at the site of the injection and that it was very warm to the touch. She had severe pain for the couple of days after the vaccinations, but pain had subsided. She came in to the pharmacy and the entirety of her upper deltoid area of her left arm was completely inflamed and warm to the touch. I stated that I strongly recommended her be seen by her PCP or walk-in clinic, but she "doesn't trust them". Patient left and did not indicate whether she would be seeking medical attention.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site movement impairment, Injection site pain, Nuclear magnetic resonance imaging, Product administered at inappropriate site
Clinical narrative: Acute pain of the left shoulder:  On November 17th, the patient had her flu vaccination. She does not watch when she gets injections, but when she got home she thought it was odd that her Band-Aid where she had gotten the injection was very high on her shoulder, almost at the complete angle of her shoulder. The injection she thought was a little more painful than typical, but as it was the high-dose flu, she had attributed it to that. After about two hours, she developed a lot of severe pain in the shoulder area. Over the next few days, this progressed to more generalized left shoulder pain.   inappropriately placed flu vaccination. She does have limitations and abnormalities on her examination. We discussed that our primary goals are to help her control her pain and resume usual function. I have prescribed physical therapy. Obtain MRI for joint assessment. See orthopedics for opinion on possible treatments. They may be familiar with this having happened before. I will institute an incident review and adverse event process. She is to follow-up with me after orthopedics if  he is not seeing any progress. It is okay for her to use Advil PM and Advil plain during the day as well as Tylenol to help mitigate her pain.
Age: 20.0
Sex: M
Vaccine: UNK
Symptoms: Extra dose administered
Clinical narrative: Patient received a JEV booster on 9 July 2019. Today (17July 2019) patient received a second booster due to the Hospital employee not verifying the most updated vaccination record. It was caught after the administration of the vaccine. The patient was informed and then monitored by myself for one hour to observe any adverse effects.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Dyspnoea, Feeling abnormal
Clinical narrative: VACCINE WAS GIVEN AT APPROXIMATELY 10:35AM ON 7/16/19.  AFTER AROUND 10 MINUTES SHE STARTED TO COMPLAIN THAT SHE WAS FEELING DIZZY.  SHE RECIEVED A 50MG DOSE OF BENADRYL AS A PRECAUTION.  AFTER ROUGHLY 1 MINUTE SHE SAID THAT IT WAS GETTING WORSE AND WE LAID HER DOWN.  THE DIZZINESS KEPT GETTING WOSE AND AFTER ABOUT ANOTHER MINUTE, SHE SAID THAT SHE WAS HAVING DIFFICULTY BREATHING AND HER CHEST WAS STARTING TO TIGHTEN UP.  AT THIS POINT EMS WAS CALLED AND A DOSE OF EPINEPHRINE 0.3MG WAS GIVEN IM AT APPROXIMATELY 10:47.  SHE BEGAN TO CATCH HER BREATH AFTER DOSE 1 OF EPINEPHRINE.  EMS ARRIVED AFTER ABOUT 5 MINUTES.  THEY ADMINISTERED A SECOND DOSE OF EPINEPHRINE IN THE AMBULANCE.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Within 24 hours patient reported having a rash that she described as a little bigger than a 50 cent piece. At this time she reported no other symptoms. We reached out to the patient again on 7/17/19 and she reported the rash as spreading. She states that it feels hot, is red and is starting to itch.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: Fever, nausea, fatigue
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Broke out in rash after receiving the second dose. It is going away and no further issues. Did not have reaction to 1st dose
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Antibody test negative, Back pain, C-reactive protein increased, Cardiolipin antibody positive, Chills
Clinical narrative: immediately after injection: CDC grade 3 effects -- myalgia, fatigue, headache, shivering, fever (no GI upset) -- begin, last ~3 days Jan 29-30, 2019: flu-like symptoms -- myalgia, fatigue, headache, shivering, fever; last ~2 days Feb. 22: second Shingrix dose;  CDC grade 3 effects as after first injection begin immediately after injection, last ~3 days March 28: awake with moderate to severe pain at base of neck and at lower back and waist, worsening and radiating over next few days; pain persists through July 1 [see below] April 1: blood work shows slightly elevated CRP (1.3; < 1.0 optimal); Cervical and lumbar x-rays show findings, but Drs. consider them unrelated to reported pain  April 23: myalgia, fatigue, headache, shivering, fever; lasts ~2 days May 1: labs show mildly elevated sed rate (27; 0-20 normal) and CRP (6.4; 0.0-5.0 normal) and significant presence of anticardiolipin AB IgM (31; 0-10 normal; 11-13 equivocal) About May 13: myalgia, fatigue, headache, shivering, low body temp (96.5); lasts 1 day June 12: myalgia, fatigue, headache, shivering, fever (101.0); lasts 1 day June 27: lab work shows sed rate just normal (19; 0-20 normal) normal CRP (7.6; ref. range 0-8.0) [different lab used from May 1, hence different ranges], presence of Phosphatidylserine AB IgM (41; > 35 positive), cardiolipin AB IgG (20; 12-20 indeterminate, 21-80 low to moderate positive), and cardiolipin AB IgM (16; 12-20 indeterminate, 21-80 low to moderate positive): Rheumatologist's working diagnoses is (mild) polymyalgia rheumatica (PMR), prescribes 20mg/day prednisone July 1: pain gone; remains so through present July 10: prednisone reduced to 17.5 mg/day  Symptom monitoring and lab work will continue with goal to tapering prednisone to 0 as labs indicate and symptoms allow  Related note: Lab tests done 12/21/05 (at time of SMA embolectomy): Antibody screen:negative; Cardiolipin AB IgM negative (4.0; neg. < 10.0);                           Cardiolipin AB IgG negative (<4.0; neg. < 10.0)      Query doctors could not answer: Could Shingrex have precipitated immune reaction that lead to the monthly flu-like symptoms and the presumed PMR?
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Immediate post-injection reaction, Influenza like illness, Myalgia
Clinical narrative: immediately after injection: CDC grade 3 effects -- myalgia, fatigue, headache, shivering, fever (no GI upset) -- begin, last ~3 days Jan 29-30, 2019: flu-like symptoms -- myalgia, fatigue, headache, shivering, fever; last ~2 days Feb. 22: second Shingrix dose;  CDC grade 3 effects as after first injection begin immediately after injection, last ~3 days March 28: awake with moderate to severe pain at base of neck and at lower back and waist, worsening and radiating over next few days; pain persists through July 1 [see below] April 1: blood work shows slightly elevated CRP (1.3; < 1.0 optimal); Cervical and lumbar x-rays show findings, but Drs. consider them unrelated to reported pain  April 23: myalgia, fatigue, headache, shivering, fever; lasts ~2 days May 1: labs show mildly elevated sed rate (27; 0-20 normal) and CRP (6.4; 0.0-5.0 normal) and significant presence of anticardiolipin AB IgM (31; 0-10 normal; 11-13 equivocal) About May 13: myalgia, fatigue, headache, shivering, low body temp (96.5); lasts 1 day June 12: myalgia, fatigue, headache, shivering, fever (101.0); lasts 1 day June 27: lab work shows sed rate just normal (19; 0-20 normal) normal CRP (7.6; ref. range 0-8.0) [different lab used from May 1, hence different ranges], presence of Phosphatidylserine AB IgM (41; > 35 positive), cardiolipin AB IgG (20; 12-20 indeterminate, 21-80 low to moderate positive), and cardiolipin AB IgM (16; 12-20 indeterminate, 21-80 low to moderate positive): Rheumatologist's working diagnoses is (mild) polymyalgia rheumatica (PMR), prescribes 20mg/day prednisone July 1: pain gone; remains so through present July 10: prednisone reduced to 17.5 mg/day  Symptom monitoring and lab work will continue with goal to tapering prednisone to 0 as labs indicate and symptoms allow  Related note: Lab tests done 12/21/05 (at time of SMA embolectomy): Antibody screen:negative; Cardiolipin AB IgM negative (4.0; neg. < 10.0);                           Cardiolipin AB IgG negative (<4.0; neg. < 10.0)      Query doctors could not answer: Could Shingrex have precipitated immune reaction that lead to the monthly flu-like symptoms and the presumed PMR?
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Polymyalgia rheumatica, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: immediately after injection: CDC grade 3 effects -- myalgia, fatigue, headache, shivering, fever (no GI upset) -- begin, last ~3 days Jan 29-30, 2019: flu-like symptoms -- myalgia, fatigue, headache, shivering, fever; last ~2 days Feb. 22: second Shingrix dose;  CDC grade 3 effects as after first injection begin immediately after injection, last ~3 days March 28: awake with moderate to severe pain at base of neck and at lower back and waist, worsening and radiating over next few days; pain persists through July 1 [see below] April 1: blood work shows slightly elevated CRP (1.3; < 1.0 optimal); Cervical and lumbar x-rays show findings, but Drs. consider them unrelated to reported pain  April 23: myalgia, fatigue, headache, shivering, fever; lasts ~2 days May 1: labs show mildly elevated sed rate (27; 0-20 normal) and CRP (6.4; 0.0-5.0 normal) and significant presence of anticardiolipin AB IgM (31; 0-10 normal; 11-13 equivocal) About May 13: myalgia, fatigue, headache, shivering, low body temp (96.5); lasts 1 day June 12: myalgia, fatigue, headache, shivering, fever (101.0); lasts 1 day June 27: lab work shows sed rate just normal (19; 0-20 normal) normal CRP (7.6; ref. range 0-8.0) [different lab used from May 1, hence different ranges], presence of Phosphatidylserine AB IgM (41; > 35 positive), cardiolipin AB IgG (20; 12-20 indeterminate, 21-80 low to moderate positive), and cardiolipin AB IgM (16; 12-20 indeterminate, 21-80 low to moderate positive): Rheumatologist's working diagnoses is (mild) polymyalgia rheumatica (PMR), prescribes 20mg/day prednisone July 1: pain gone; remains so through present July 10: prednisone reduced to 17.5 mg/day  Symptom monitoring and lab work will continue with goal to tapering prednisone to 0 as labs indicate and symptoms allow  Related note: Lab tests done 12/21/05 (at time of SMA embolectomy): Antibody screen:negative; Cardiolipin AB IgM negative (4.0; neg. < 10.0);                           Cardiolipin AB IgG negative (<4.0; neg. < 10.0)      Query doctors could not answer: Could Shingrex have precipitated immune reaction that lead to the monthly flu-like symptoms and the presumed PMR?
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Spinal X-ray abnormal
Clinical narrative: immediately after injection: CDC grade 3 effects -- myalgia, fatigue, headache, shivering, fever (no GI upset) -- begin, last ~3 days Jan 29-30, 2019: flu-like symptoms -- myalgia, fatigue, headache, shivering, fever; last ~2 days Feb. 22: second Shingrix dose;  CDC grade 3 effects as after first injection begin immediately after injection, last ~3 days March 28: awake with moderate to severe pain at base of neck and at lower back and waist, worsening and radiating over next few days; pain persists through July 1 [see below] April 1: blood work shows slightly elevated CRP (1.3; < 1.0 optimal); Cervical and lumbar x-rays show findings, but Drs. consider them unrelated to reported pain  April 23: myalgia, fatigue, headache, shivering, fever; lasts ~2 days May 1: labs show mildly elevated sed rate (27; 0-20 normal) and CRP (6.4; 0.0-5.0 normal) and significant presence of anticardiolipin AB IgM (31; 0-10 normal; 11-13 equivocal) About May 13: myalgia, fatigue, headache, shivering, low body temp (96.5); lasts 1 day June 12: myalgia, fatigue, headache, shivering, fever (101.0); lasts 1 day June 27: lab work shows sed rate just normal (19; 0-20 normal) normal CRP (7.6; ref. range 0-8.0) [different lab used from May 1, hence different ranges], presence of Phosphatidylserine AB IgM (41; > 35 positive), cardiolipin AB IgG (20; 12-20 indeterminate, 21-80 low to moderate positive), and cardiolipin AB IgM (16; 12-20 indeterminate, 21-80 low to moderate positive): Rheumatologist's working diagnoses is (mild) polymyalgia rheumatica (PMR), prescribes 20mg/day prednisone July 1: pain gone; remains so through present July 10: prednisone reduced to 17.5 mg/day  Symptom monitoring and lab work will continue with goal to tapering prednisone to 0 as labs indicate and symptoms allow  Related note: Lab tests done 12/21/05 (at time of SMA embolectomy): Antibody screen:negative; Cardiolipin AB IgM negative (4.0; neg. < 10.0);                           Cardiolipin AB IgG negative (<4.0; neg. < 10.0)      Query doctors could not answer: Could Shingrex have precipitated immune reaction that lead to the monthly flu-like symptoms and the presumed PMR?
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Injection site pain, Pain in extremity, Rash, Vaccination complication
Clinical narrative: Vaccine given on 7/9/19 with patient compliant of immediate severe pain at time of injection at injection site that resolved on 7/12/19. Patient states within 5 minutes of injection noticed left under arm, collar bone and upper back pain that started to improve on 7/15/19. On 7/10/19 patient noticed red rash on face. She started taking Benadryl 25 mg on 7/14/19, 3 doses with no improvement. Patient came to the clinic on 7/15/19, diagnosis with adverse vaccine reaction, instructed to continue benadryl every 4 hours and prescribed valacylovir 1gm TID x 7days.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Back pain, Immediate post-injection reaction, Injection site pain, Rash
Clinical narrative: Vaccine given on 7/9/19 with patient compliant of immediate severe pain at time of injection at injection site that resolved on 7/12/19. Patient states within 5 minutes of injection noticed left under arm, collar bone and upper back pain that started to improve on 7/15/19. On 7/10/19 patient noticed red rash on face. She started taking Benadryl 25 mg on 7/14/19, 3 doses with no improvement. Patient came to the clinic on 7/15/19, diagnosis with adverse vaccine reaction, instructed to continue benadryl every 4 hours and prescribed valacylovir 1gm TID x 7days.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Gastrointestinal disorder, Injection site pain, Injection site swelling, Pain
Clinical narrative: I'm an NP working in primary care and have received numerous complaints about s/e to the shingrix vaccine, and I don't know if these are getting reported back to the pharmacies giving the vaccine such that they can complete these reports. I have NOT had the vaccine myself. I'm just reporting that I would say at least 1/2 of my patients that have received the vaccine (always from local pharmacies, as we have not had supply in a long time) c/o significant localized pain and swelling from the injection, and full body aches, sometimes with GI sx.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Immediate post-injection reaction, Injection site pain, Joint swelling
Clinical narrative: I received the injection in my upper left arm and immediately felt it in my upper left wrist. Then after my arm quit being sore after a couple of days, my wrist area continued to be sore and the wrist bone looked swollen. It still looks swollen and it is now 16 days later.  I was given the shot on July 1 and it is now July 17.  During this interim period I also experienced a sore area on my left foot around my arch that started around July 6 or 7th  and then on Sunday, July 14th, my lower back went into a painful spasm. It is still not feeling good although it has improved with rest.  I was totally fine prior to the injection so I'm wondering if there could be a connection to it.  I saw my doctor about my wrist and they said it could be tendinitis but at the time I didn't connect it to the time frame of the injection.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: I received the injection in my upper left arm and immediately felt it in my upper left wrist. Then after my arm quit being sore after a couple of days, my wrist area continued to be sore and the wrist bone looked swollen. It still looks swollen and it is now 16 days later.  I was given the shot on July 1 and it is now July 17.  During this interim period I also experienced a sore area on my left foot around my arch that started around July 6 or 7th  and then on Sunday, July 14th, my lower back went into a painful spasm. It is still not feeling good although it has improved with rest.  I was totally fine prior to the injection so I'm wondering if there could be a connection to it.  I saw my doctor about my wrist and they said it could be tendinitis but at the time I didn't connect it to the time frame of the injection.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Rash
Clinical narrative: her arm got swollen and had rash in her arm, report that the swelling was travelling along her arm. she went to ER on 07/04 was prescribed steroid pack
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient states she had redness/swelling at injection site, fever/chills and headache that resolved the next day. She states she has a lump under her left armpit about the size of the end of her thumb. The lump has persisted through today 7/17/19. She has gone to urgent care and will be having an ultrasound of the area today.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Ultrasound scan
Clinical narrative: Patient states she had redness/swelling at injection site, fever/chills and headache that resolved the next day. She states she has a lump under her left armpit about the size of the end of her thumb. The lump has persisted through today 7/17/19. She has gone to urgent care and will be having an ultrasound of the area today.
Age: 67.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Dizziness, Fall, Head injury, Joint injury, Nausea
Clinical narrative: Client left clinic after receiving 2 shots, drove home and tripped over a metal plate as she got out of her car, lightly bumped her head, scraped her head & knee as she fell, felt dizzy, light headed, nauseated.
Age: 67.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Skin abrasion, X-ray limb
Clinical narrative: Client left clinic after receiving 2 shots, drove home and tripped over a metal plate as she got out of her car, lightly bumped her head, scraped her head & knee as she fell, felt dizzy, light headed, nauseated.
Sex: F
Vaccine: PPV
Symptoms: Blister, Erythema, Headache
Clinical narrative: Blister, around 2cm diameter, redness around blister. No itching, no pain, no fever, normal BP. Mild HA
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Crying, Dyskinesia, Pallor, Seizure like phenomena
Clinical narrative: Seizure like event, for about 45 to 55 seconds, jerking with pallor afterwards. Sitting position, held her to prevent falling, after it subsided, she cried a bit. Denied any headache, pain, dizziness, mother refused ambulance to have daughter checked, had her sitting in front of me for 20 minutes. Explained to mother that I would be filling an adverse report and someone may be contacting her.
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Dysphagia, Guillain-Barre syndrome, Headache, Loss of personal independence in daily activities, Monoplegia
Clinical narrative: Guillian-Barre Syndrome (GBS), Ascending Paralysis, Respiratory Failure, Hospital Diagnosis 5/18/19 Shingrix administered at Pharmacy 5/27/19 complaints of extreme exhaustion, tightness in chest and inability to stand and walk without feeling "I will topple over".  Feeling chest pain earlier in the week twice. 5/28/19 unable to ambulate, difficulty standing, minimal control of right foot, transported by wheelchair to MD office. 5/29/19 bloodwork abnormal, received call to go to ED.  Admitted that day. 5/31/19 extreme pain all over. no use of legs, arms, hands, difficult swallowing, breathing, cardiac status monitored closely 6/1/19 palliative care considered, last rights given by priest. 6/8/19 transferred to ICU due to difficulty breathing, aspiration. 6/11(?)/19 transferred to step down unit 6/17/19 discharged to acute rehab. Within first hour of arriving, GI bleed and back to ED and readmitted, 2 units PRBCs given. 6/24/19 transferred back to acute rehab
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Muscular weakness, Musculoskeletal disorder, Nausea, Nuclear magnetic resonance imaging abnormal, Peripheral swelling
Clinical narrative: Guillian-Barre Syndrome (GBS), Ascending Paralysis, Respiratory Failure, Hospital Diagnosis 5/18/19 Shingrix administered at Pharmacy 5/27/19 complaints of extreme exhaustion, tightness in chest and inability to stand and walk without feeling "I will topple over".  Feeling chest pain earlier in the week twice. 5/28/19 unable to ambulate, difficulty standing, minimal control of right foot, transported by wheelchair to MD office. 5/29/19 bloodwork abnormal, received call to go to ED.  Admitted that day. 5/31/19 extreme pain all over. no use of legs, arms, hands, difficult swallowing, breathing, cardiac status monitored closely 6/1/19 palliative care considered, last rights given by priest. 6/8/19 transferred to ICU due to difficulty breathing, aspiration. 6/11(?)/19 transferred to step down unit 6/17/19 discharged to acute rehab. Within first hour of arriving, GI bleed and back to ED and readmitted, 2 units PRBCs given. 6/24/19 transferred back to acute rehab
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Scan abnormal
Clinical narrative: Guillian-Barre Syndrome (GBS), Ascending Paralysis, Respiratory Failure, Hospital Diagnosis 5/18/19 Shingrix administered at Pharmacy 5/27/19 complaints of extreme exhaustion, tightness in chest and inability to stand and walk without feeling "I will topple over".  Feeling chest pain earlier in the week twice. 5/28/19 unable to ambulate, difficulty standing, minimal control of right foot, transported by wheelchair to MD office. 5/29/19 bloodwork abnormal, received call to go to ED.  Admitted that day. 5/31/19 extreme pain all over. no use of legs, arms, hands, difficult swallowing, breathing, cardiac status monitored closely 6/1/19 palliative care considered, last rights given by priest. 6/8/19 transferred to ICU due to difficulty breathing, aspiration. 6/11(?)/19 transferred to step down unit 6/17/19 discharged to acute rehab. Within first hour of arriving, GI bleed and back to ED and readmitted, 2 units PRBCs given. 6/24/19 transferred back to acute rehab
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Aspiration, Balance disorder, Blood test abnormal, Chest discomfort, Chest pain
Clinical narrative: Guillian-Barre Syndrome (GBS), Ascending Paralysis, Respiratory Failure, Hospital Diagnosis 5/18/19 Shingrix administered at Pharmacy 5/27/19 complaints of extreme exhaustion, tightness in chest and inability to stand and walk without feeling "I will topple over".  Feeling chest pain earlier in the week twice. 5/28/19 unable to ambulate, difficulty standing, minimal control of right foot, transported by wheelchair to MD office. 5/29/19 bloodwork abnormal, received call to go to ED.  Admitted that day. 5/31/19 extreme pain all over. no use of legs, arms, hands, difficult swallowing, breathing, cardiac status monitored closely 6/1/19 palliative care considered, last rights given by priest. 6/8/19 transferred to ICU due to difficulty breathing, aspiration. 6/11(?)/19 transferred to step down unit 6/17/19 discharged to acute rehab. Within first hour of arriving, GI bleed and back to ED and readmitted, 2 units PRBCs given. 6/24/19 transferred back to acute rehab
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Dysphagia, Dyspnoea, Dysstasia, Fatigue, Gait disturbance
Clinical narrative: Guillian-Barre Syndrome (GBS), Ascending Paralysis, Respiratory Failure, Hospital Diagnosis 5/18/19 Shingrix administered at Pharmacy 5/27/19 complaints of extreme exhaustion, tightness in chest and inability to stand and walk without feeling "I will topple over".  Feeling chest pain earlier in the week twice. 5/28/19 unable to ambulate, difficulty standing, minimal control of right foot, transported by wheelchair to MD office. 5/29/19 bloodwork abnormal, received call to go to ED.  Admitted that day. 5/31/19 extreme pain all over. no use of legs, arms, hands, difficult swallowing, breathing, cardiac status monitored closely 6/1/19 palliative care considered, last rights given by priest. 6/8/19 transferred to ICU due to difficulty breathing, aspiration. 6/11(?)/19 transferred to step down unit 6/17/19 discharged to acute rehab. Within first hour of arriving, GI bleed and back to ED and readmitted, 2 units PRBCs given. 6/24/19 transferred back to acute rehab
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Gait inability, Gastrointestinal haemorrhage, Guillain-Barre syndrome, Intensive care, Loss of control of legs
Clinical narrative: Guillian-Barre Syndrome (GBS), Ascending Paralysis, Respiratory Failure, Hospital Diagnosis 5/18/19 Shingrix administered at Pharmacy 5/27/19 complaints of extreme exhaustion, tightness in chest and inability to stand and walk without feeling "I will topple over".  Feeling chest pain earlier in the week twice. 5/28/19 unable to ambulate, difficulty standing, minimal control of right foot, transported by wheelchair to MD office. 5/29/19 bloodwork abnormal, received call to go to ED.  Admitted that day. 5/31/19 extreme pain all over. no use of legs, arms, hands, difficult swallowing, breathing, cardiac status monitored closely 6/1/19 palliative care considered, last rights given by priest. 6/8/19 transferred to ICU due to difficulty breathing, aspiration. 6/11(?)/19 transferred to step down unit 6/17/19 discharged to acute rehab. Within first hour of arriving, GI bleed and back to ED and readmitted, 2 units PRBCs given. 6/24/19 transferred back to acute rehab
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Musculoskeletal disorder, Packed red blood cell transfusion, Pain, Respiratory failure, Wheelchair user
Clinical narrative: Guillian-Barre Syndrome (GBS), Ascending Paralysis, Respiratory Failure, Hospital Diagnosis 5/18/19 Shingrix administered at Pharmacy 5/27/19 complaints of extreme exhaustion, tightness in chest and inability to stand and walk without feeling "I will topple over".  Feeling chest pain earlier in the week twice. 5/28/19 unable to ambulate, difficulty standing, minimal control of right foot, transported by wheelchair to MD office. 5/29/19 bloodwork abnormal, received call to go to ED.  Admitted that day. 5/31/19 extreme pain all over. no use of legs, arms, hands, difficult swallowing, breathing, cardiac status monitored closely 6/1/19 palliative care considered, last rights given by priest. 6/8/19 transferred to ICU due to difficulty breathing, aspiration. 6/11(?)/19 transferred to step down unit 6/17/19 discharged to acute rehab. Within first hour of arriving, GI bleed and back to ED and readmitted, 2 units PRBCs given. 6/24/19 transferred back to acute rehab
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillian-Barre Syndrome (GBS), Ascending Paralysis, Respiratory Failure, Hospital Diagnosis 5/18/19 Shingrix administered at Pharmacy 5/27/19 complaints of extreme exhaustion, tightness in chest and inability to stand and walk without feeling "I will topple over".  Feeling chest pain earlier in the week twice. 5/28/19 unable to ambulate, difficulty standing, minimal control of right foot, transported by wheelchair to MD office. 5/29/19 bloodwork abnormal, received call to go to ED.  Admitted that day. 5/31/19 extreme pain all over. no use of legs, arms, hands, difficult swallowing, breathing, cardiac status monitored closely 6/1/19 palliative care considered, last rights given by priest. 6/8/19 transferred to ICU due to difficulty breathing, aspiration. 6/11(?)/19 transferred to step down unit 6/17/19 discharged to acute rehab. Within first hour of arriving, GI bleed and back to ED and readmitted, 2 units PRBCs given. 6/24/19 transferred back to acute rehab
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Chills, Headache, Myalgia, Pain
Clinical narrative: painful, itchy rash on the left side of her butt; Shingles; felt like the flu; fever; shaking; pain in body; chills; body felt warm to the touch; rash; the rash had blisters as well; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included etanercept (Embrel).   On 11th June 2019, the patient received the 1st dose of Shingrix. In June 2019, 14 days after receiving Shingrix, the patient experienced shingles, influenza like illness, fever, tremor, general body pain, chills, feeling hot, itchy rash and blistery rash. On an unknown date, the patient experienced painful rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles and itchy rash were not recovered/not resolved and the outcome of the influenza like illness, fever, tremor, general body pain and chills were recovered/resolved and the outcome of the feeling hot was unknown and the outcome of the blistery rash and painful rash were recovering/resolving.   It was unknown if the reporter considered the shingles, influenza like illness, fever, tremor, general body pain, chills, feeling hot, itchy rash, blistery rash and painful rash to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received dose of Shingrix in the right arm. After vaccination with Shingrix, the patient experienced flu like symptoms chills, fever, body pain, shaking and her body felt warm to the touch. The patient stated that, 2 weeks after receiving the vaccine, she developed a painful, itchy rash on the left side of her butt and it was going down the left leg. The patient stated that the rash had blisters as well. The patient went to saw her doctor and was diagnosed with Shingles and the doctor gave her Valtrex to keep the rash from spreading. 14 days, after vaccination with Shingrix, the patient experienced itchy rash, shingles and blistery rash. The patient consented to follow up. Emergency room visit was required. There was discrepancy between the outcome reported in the structured field (recovered and not recovered) and the outcome reported in the source document (recovered with sequel and recovering)
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: painful, itchy rash on the left side of her butt; Shingles; felt like the flu; fever; shaking; pain in body; chills; body felt warm to the touch; rash; the rash had blisters as well; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included etanercept (Embrel).   On 11th June 2019, the patient received the 1st dose of Shingrix. In June 2019, 14 days after receiving Shingrix, the patient experienced shingles, influenza like illness, fever, tremor, general body pain, chills, feeling hot, itchy rash and blistery rash. On an unknown date, the patient experienced painful rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles and itchy rash were not recovered/not resolved and the outcome of the influenza like illness, fever, tremor, general body pain and chills were recovered/resolved and the outcome of the feeling hot was unknown and the outcome of the blistery rash and painful rash were recovering/resolving.   It was unknown if the reporter considered the shingles, influenza like illness, fever, tremor, general body pain, chills, feeling hot, itchy rash, blistery rash and painful rash to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received dose of Shingrix in the right arm. After vaccination with Shingrix, the patient experienced flu like symptoms chills, fever, body pain, shaking and her body felt warm to the touch. The patient stated that, 2 weeks after receiving the vaccine, she developed a painful, itchy rash on the left side of her butt and it was going down the left leg. The patient stated that the rash had blisters as well. The patient went to saw her doctor and was diagnosed with Shingles and the doctor gave her Valtrex to keep the rash from spreading. 14 days, after vaccination with Shingrix, the patient experienced itchy rash, shingles and blistery rash. The patient consented to follow up. Emergency room visit was required. There was discrepancy between the outcome reported in the structured field (recovered and not recovered) and the outcome reported in the source document (recovered with sequel and recovering)