chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: FLUC3
Symptoms: Dyspnoea, Feeling hot, Heart rate increased, Hypoaesthesia oral, Throat irritation
Clinical narrative: Within minutes body was extremely hot, throat felt weird and lips went numb. This shot was administered by my employer (it's an annual requirement to stay employed). They gave me Benadryl and symptoms improved. Within 20-minutes symptoms returned stronger and included shortness of breath. EPI was administered. Symptoms remained and my heart rate increased. I was then transported via ambulance to the hospital for additional treatment (fluids, Benadryl, prednisone, Pepcid). Discharged with Benadryl and Pepcid for 5 days (still in progress).
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Sluggishness
Clinical narrative: Approx 2 hours after receipt of 2nd of a series of 3 Hep B vaccines, employee felt dizziness and sluggish.  Employee rested for approx 1 hour and symptoms are still present. Employee stated that she felt the same way from her 1st Hep B vaccine but did not realize it was a reaction from the vaccine until this event occurred.  On the 2nd day after her 1st Hep B vaccine, employee stated her condition worsened and she felt nausea but did not vomit. On the third day after the first Hep B vaccine, employee made a full recovery.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: Swelling, pain.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccination site pain, Vaccination site rash
Clinical narrative: Initial rash and pain at vaccine site (left arm) about 30 hour later entire left arm in severe pain from vaccine site to fingertips - pain lasted for 10 hours before slowly subsiding.
Age: 30.0
Sex: F
Vaccine: DTAP, FLUX, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Chills, low-grade fever, aches/pains, area of injection red/swollen/tender.. Administered cephalexin 500mg oral capsule on 9/20/2014.
Age: 30.0
Sex: F
Vaccine: DTAP, FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Chills, low-grade fever, aches/pains, area of injection red/swollen/tender.. Administered cephalexin 500mg oral capsule on 9/20/2014.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pustular
Clinical narrative: Have large about nickel to quarter size red bumps with white pus areas around my left ankle.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Pt. had body aches, headache - felt very feverish for about 48 hours after getting the vaccine.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: A large welt (1" x 3" as described by pt) developed at injection site after ZOSTAVAX injection.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Muscle contractions involuntary, Muscular weakness, Pain in extremity
Clinical narrative: Immediately upon injection the patient complained of a loss of muscle control and pain and numbness in left arm. Symptoms started to improve within minutes and within 24 hours the only remaining symptom was some muscle weakness. Patient has refused medical care.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema multiforme, Joint swelling, Pyrexia
Clinical narrative: 2 weeks after flu vaccine, developed erythema multiforme-like rash, fever, joint swelling.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Swelling face, Throat irritation, Wheezing
Clinical narrative: Patient reported scratchy throat in the evening following vaccination. By morning, swelling of face and eyelids and wheezing were occurring.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Eye swelling
Clinical narrative: Presented 1 pm 9/20/14 with swelling of both eyes, below and above each eye, mild tightness in chest. Moderate swelling of eyes started this AM.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness and warm to touch at injection site - progressively worsening over week time course. Patient was given BENADRYL as treatment by physician.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Arrhythmia, Electrocardiogram normal
Clinical narrative: Patient receive FLUZONE HIGH DOSE and a day later experience changes in heart rhythm. After checking with doctor found changes in EKG and may think it could be flu shot. Patient is not treated with anything and she doesn't experience anything anymore. Will follow-up.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased appetite, Dizziness, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Felt nauseous, woozy, low grade fever, sweats, no appetite x36 hrs.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local reaction, Skin warm
Clinical narrative: 4 inch by 2 inch red, warm local reaction.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Back injury, Fall, Feeling hot, Hyperhidrosis, Loss of consciousness
Clinical narrative: The night vaccine was administered fainted twice, sweating and hot when she got up in night. Husband found twice unconscious. Hurt back due to fall.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: The night vaccine was administered fainted twice, sweating and hot when she got up in night. Husband found twice unconscious. Hurt back due to fall.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling abnormal, Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: On 9-19-14 patient presented an apparent adverse reaction approx. 24 hours after receiving PNEUMOVAX 23 and FLUVIRIN on the left upper arm; area was red, warm to the touch and sore lump underneath the skin. Patient complained of feeling lousy and achy all over. Patient went to urgent care and returned with 3 prescriptions.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Vaccination complication
Clinical narrative: On 9-19-14 patient presented an apparent adverse reaction approx. 24 hours after receiving PNEUMOVAX 23 and FLUVIRIN on the left upper arm; area was red, warm to the touch and sore lump underneath the skin. Patient complained of feeling lousy and achy all over. Patient went to urgent care and returned with 3 prescriptions.
Age: 38.0
Sex: F
Vaccine: DTAP
Symptoms: Abdominal pain upper, Chills, Erythema, Headache, Hyperhidrosis
Clinical narrative: Pain, swelling, headache, stomach ache, nausea, chills, redness whole arm, sweating, can't move arm as normal, skin very hot.
Age: 38.0
Sex: F
Vaccine: DTAP
Symptoms: Mobility decreased, Nausea, Pain, Skin warm, Swelling
Clinical narrative: Pain, swelling, headache, stomach ache, nausea, chills, redness whole arm, sweating, can't move arm as normal, skin very hot.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Heart rate increased
Clinical narrative: Rapid heartbeat, dizziness.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Pain
Clinical narrative: Started to feel burning sensation at previous shingles site which progressed to very painful for 9 hours. Following day less painful.
Age: 68.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: PNEUMOVAX23 VIAL RIGHT SHOULDER SORENESS COULD NOT SLEEP NEXT MORNING AND FOLLOWING DAY SORENESS REDNESS AND SEVERE SWELLING OF BICEP AND TRICEP ALSO NUMBNESS IN RIGHT HAND FIRST DAY AFTER WHICH DID PASS.
Age: 56.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction:  Red, raised, oval, hot-to-the-touch, itchy, 4-6 inches.  No treatment needed.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Arm became sore and felt warm. The next morning it was red and seems to be spreading.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Chills, Cough, Decreased appetite, Headache
Clinical narrative: Employee received injectable influenza vaccination on 17Sep14. Stated started feeling sore throat, congestion, nonproductive cough, tight chest, headaches, body aches, loss of appetite during the evening of 17Sep14. Unable to sleep during the night, reported feeling sweaty with chills. Currently still feeling the same symptoms as above also nausea with vomiting x 1 today (nausea started 18Sep14). Site of injection noted to have outline of band-aid, employee reported same reaction during April 2013 post-op with steri-strip and tegaderm. Possible sensitivity to adhesive.  Employee reports site has improved since band-aid removed. Employee states took robitussin DM, pseudoephedrine, Motrin, Celebrex on 17Sep14 without relief.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperhidrosis, Insomnia, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Employee received injectable influenza vaccination on 17Sep14. Stated started feeling sore throat, congestion, nonproductive cough, tight chest, headaches, body aches, loss of appetite during the evening of 17Sep14. Unable to sleep during the night, reported feeling sweaty with chills. Currently still feeling the same symptoms as above also nausea with vomiting x 1 today (nausea started 18Sep14). Site of injection noted to have outline of band-aid, employee reported same reaction during April 2013 post-op with steri-strip and tegaderm. Possible sensitivity to adhesive.  Employee reports site has improved since band-aid removed. Employee states took robitussin DM, pseudoephedrine, Motrin, Celebrex on 17Sep14 without relief.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Respiratory tract congestion, Vomiting
Clinical narrative: Employee received injectable influenza vaccination on 17Sep14. Stated started feeling sore throat, congestion, nonproductive cough, tight chest, headaches, body aches, loss of appetite during the evening of 17Sep14. Unable to sleep during the night, reported feeling sweaty with chills. Currently still feeling the same symptoms as above also nausea with vomiting x 1 today (nausea started 18Sep14). Site of injection noted to have outline of band-aid, employee reported same reaction during April 2013 post-op with steri-strip and tegaderm. Possible sensitivity to adhesive.  Employee reports site has improved since band-aid removed. Employee states took robitussin DM, pseudoephedrine, Motrin, Celebrex on 17Sep14 without relief.
Age: 29.0
Sex: M
Vaccine: TTOX
Symptoms: Body temperature increased, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: PATIENT STATED HE HAD HARDING, RAISED AREA AND SORENESS TO INJECTION SITE (RIGHT ARM) AFTER LEAVING CENTER. HE NOTICED THAT HIS BODY TEMPERATURE WAS ELEVATED ON 3 SEPARATE TIMES TO BE AT 99.7 AFTER RECEIVING TETANUS SHOT OVER A FEW WEEKS, ALSO STATED THAT HE WAS NOT FEELING SICK. PATIENT SAID HE TOOK IBUPROFEN TO RELIEVE THE SORENESS IN RIGHT ARM.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Pruritus generalised, Urticaria
Clinical narrative: Itching at injection site for two or three days.  Over the next 3 weeks progressed itching over entire body resulting in hives.  Sought medical attention 9-21-2014.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Erythema, Fatigue, Presyncope
Clinical narrative: Given FLUZONE HD 2014-2015 (49281039565) then shoulder bright red ellipse (4x8 inches), weakness/exhaustion for 4 to 12 days afterwards.  Sudden onset dizziness/near fainting on 09/20 or 12 days later, which is very similar to incident back in 1986 after 2 weeks after having the flu then (which then caused a horrible auto accident).  Many women in 1986 had fainting from the flu. We conclude that patient should never take the High Dose; her late physician only gave her a "half dose."  The pharmacy person said everyone over 65 was supposed to get the High Dose.  This should not be recommended so broadly.  I had the HD with no ill effects.---husband (age 71).  If she had fainted at the wheel, this would be a Life Threatening Illness!
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Dizziness, Influenza virus test negative, Local swelling, Nausea, Pruritus
Clinical narrative: Itchy, swelling feet and hands, nausea, vomiting, dizzy, hives all over body face hand feet.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Streptococcus test negative, Urticaria, Vomiting
Clinical narrative: Itchy, swelling feet and hands, nausea, vomiting, dizzy, hives all over body face hand feet.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Musculoskeletal stiffness, Pain, Pyrexia, Rash erythematous
Clinical narrative: site red raised bumps, fever 100, body aches stiffness neck, shoulder,arm all on the left side were got shot.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: REDNESS, SWELLING AND HEAT AT SITE OF INJECTION.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pharyngeal oedema, Pyrexia
Clinical narrative: Swelling of throat, fever and chills. 4 hours after injection of FLUZONE HD 2014-2015.  Fever was controlled with acetaminophen.  Throat swelling lasted approximately 4 hours.
Age: 19.0
Sex: F
Vaccine: HPVX
Symptoms: Asthenia, Back pain, Chills, Dysphagia, Fatigue
Clinical narrative: Extreme fatigue, weakness, fever, chills. That night extreme night sweats had to shower 4 times that night. Chills, fever. Saturday fever over 104 degrees good part of the day causing fever blisters on lip (pictures taken) and throat begins to have problems. Sunday swollen glands in neck huge and full of pus. Could not swallow just spit saliva out all day. Skin sensitive, lower back hurting. Extreme pain and sicker then I have ever been in my life. Called the on call doctor Saturday to tell her I had a bad reaction. She brushed it off as nothing. I called immediately Monday morning upon doctors office opening again tell them I am in trouble sick bad need help. They had me come in at 9:45. They were shocked at how sick I was. They prescribed steroids for the tonsils to go down. Antibiotics, now added to that amoxicillin. Throat is not all the way back down even though I am finished with the steroids. Now what! Need help. I don't know if I have life long lasting effects. I just know I am still sick now today.
Age: 19.0
Sex: F
Vaccine: HPVX
Symptoms: Hyperaesthesia, Lymph gland infection, Lymphadenopathy, Malaise, Night sweats
Clinical narrative: Extreme fatigue, weakness, fever, chills. That night extreme night sweats had to shower 4 times that night. Chills, fever. Saturday fever over 104 degrees good part of the day causing fever blisters on lip (pictures taken) and throat begins to have problems. Sunday swollen glands in neck huge and full of pus. Could not swallow just spit saliva out all day. Skin sensitive, lower back hurting. Extreme pain and sicker then I have ever been in my life. Called the on call doctor Saturday to tell her I had a bad reaction. She brushed it off as nothing. I called immediately Monday morning upon doctors office opening again tell them I am in trouble sick bad need help. They had me come in at 9:45. They were shocked at how sick I was. They prescribed steroids for the tonsils to go down. Antibiotics, now added to that amoxicillin. Throat is not all the way back down even though I am finished with the steroids. Now what! Need help. I don't know if I have life long lasting effects. I just know I am still sick now today.
Age: 19.0
Sex: F
Vaccine: HPVX
Symptoms: Oral herpes, Pain, Pyrexia, Tonsillar hypertrophy
Clinical narrative: Extreme fatigue, weakness, fever, chills. That night extreme night sweats had to shower 4 times that night. Chills, fever. Saturday fever over 104 degrees good part of the day causing fever blisters on lip (pictures taken) and throat begins to have problems. Sunday swollen glands in neck huge and full of pus. Could not swallow just spit saliva out all day. Skin sensitive, lower back hurting. Extreme pain and sicker then I have ever been in my life. Called the on call doctor Saturday to tell her I had a bad reaction. She brushed it off as nothing. I called immediately Monday morning upon doctors office opening again tell them I am in trouble sick bad need help. They had me come in at 9:45. They were shocked at how sick I was. They prescribed steroids for the tonsils to go down. Antibiotics, now added to that amoxicillin. Throat is not all the way back down even though I am finished with the steroids. Now what! Need help. I don't know if I have life long lasting effects. I just know I am still sick now today.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives in many places on body.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Lymphadenopathy
Clinical narrative: Extremely swollen lymph gland behind left ear.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, X-ray normal
Clinical narrative: Pt called and stated that her elbow on the arm of injection was very red and painful.  Pt went in to see nurse practioner, that concluded the pt had developed cellulitis due to Fluzone HD and Pneumovax 23 injected in same arm.  Prescriber wrote a rx for Keflex 500 every 8 hours for 10 days
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Insomnia, Malaise, Nasal congestion, Rhinorrhoea, Sluggishness
Clinical narrative: Felt sluggish, nose draining could not sleep well with stuffy nose.  I can manage OK but it is a sense of not feeling well.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: Vertigo
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test normal, Computerised tomogram normal, Dizziness, Headache, Migraine
Clinical narrative: Initial onset was dull headache behind my left eye and remained unresponsive to 1000 mg doses of Tylenol for the next few days.  The pain remained a fairly consistent dull ache, but on Friday, September 19 the pain became excruciating, and led to light headedness and vomiting.  At this point, due to the non-responsiveness of the headache to OTC pain medications, I went to the ER.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Initial onset was dull headache behind my left eye and remained unresponsive to 1000 mg doses of Tylenol for the next few days.  The pain remained a fairly consistent dull ache, but on Friday, September 19 the pain became excruciating, and led to light headedness and vomiting.  At this point, due to the non-responsiveness of the headache to OTC pain medications, I went to the ER.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Blister, Pruritus generalised, Rash generalised
Clinical narrative: Itching on legs, arm pits, back, head, arms and groin progressed to a rash in the same areas. The itching and rash was more pronounced the next morning (Sunday) along with small blisters scattered around. Started taking 50mg Benadryl every 4 hours which provided some relief. Itching and blisters very annoying. Going to see doctor Monday morning.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Injected limb mobility decreased, Injection site rash, Oropharyngeal pain, Pain in extremity
Clinical narrative: Patient called and said has had sore throat and fatigue since immunization. Left arm has been very sore and could barely lift it. Patient complains of 5-6 nickel sized bumps around injection site of left arm.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Headache, Local swelling, Nausea
Clinical narrative: Localized swelling, redness, streaking, nausea, very tender, upper arm, chills, low grade fever, headache.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Tenderness, Urticaria
Clinical narrative: Localized swelling, redness, streaking, nausea, very tender, upper arm, chills, low grade fever, headache.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, tenderness at site of injection.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Difficulty breathing - pt went to ER and received breathing treatment (unknown medication).
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Local swelling, Mobility decreased, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: High fever, swollen arm, sore/hard to move R neck and arm.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity
Clinical narrative: Arm was red and sore for 3 days. She put ice on it.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Asthenia, Decreased appetite, Dyspnoea, Heart rate increased
Clinical narrative: Patient received shot on 9/16/14, and on 9/17/2014 woke up feeling sick. Extremely weak, had to crawl to the restroom, rapid heart beat, shortness of breath, no appetite, heavy sweats, rash on the left arm and sore for 2 days could even use rt, arm was hot to the touch.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Malaise, Pain in extremity, Rash, Skin warm
Clinical narrative: Patient received shot on 9/16/14, and on 9/17/2014 woke up feeling sick. Extremely weak, had to crawl to the restroom, rapid heart beat, shortness of breath, no appetite, heavy sweats, rash on the left arm and sore for 2 days could even use rt, arm was hot to the touch.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain
Clinical narrative: Patient reported extreme pain on both shoulder blades. She said the vaccines were administered "too high". Pain severity lessened a little when patient ame in today. She has been taking her prescribed NORCO 10/325 mg and BACLOFEN to ease it.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pruritus, Rash, Urticaria
Clinical narrative: Pt received influenza vaccine 9/16/14 approx. 3 PM. Pt reports seeing rash/hives form on arms the following day, worsening as the days passed. The rash spread to both arms, chest, waist, back, itchy eyes. Pt came into pharmacy 9/21/14. No changes to medications. Pt sent to urgent care and received Rx for prednisone taper.
Sex: U
Vaccine: FLU3
Symptoms: Local swelling, Rash
Clinical narrative: Patient showed up with rash/swollen arm. Was told to check with MD. MD was informed. Was put on BENADRYL.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. On an unspecified date the patient was inadvertently vaccinated with an expire dose of ZOSTAVAX, (lot# and dose were not provided). No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a consumer's husband refers to a female patient of unknown age. On unknown dates the patient were vaccinated with the first 2 doses of GARDASIL (lot #, expiration, dose unspecified). The reporter stated the second shot was given in approximately 2013 (about a year ago). Two months later after the patient received the second shot, she found out she was pregnant and did not receive the third shot. The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) was not known. Since then pregnancy had resolved. No side effects were reported. Therapy with GARDASIL was discontinued. The patient had sought medical attention. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 18 year old male patient. In approximately September 2013 ("about 1 year ago"), the patient was vaccinated with first dose of GARDASIL 0.5 ml, intramuscualr in the left deltoid. On 12-SEP-2014 ("today") the patient was vaccinated with second dose of GARDASIL 0.5 ml, intramuscular in the left deltoid. No adverse effects reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: This spontaneous report as received from a physician refers to a 14 year old female patient with asthma, contact dermatitis, pulmonary stenosis and pulmonary regurgitation. The patient's medical history included urticaria. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (injection, lot #, dose and route were not provided) in series for the reason of "age appropriate". And the patient developed a localized rash on an unspecified date. Patient was administered the second dose of GARDASIL (dose, lot #, expiration date and route not reported) series on 05-AUG-2014 and developed a localized rash from her elbow to wrist in the center of her right forearm on 06-AUG-2014. Patient sought medical attention to physician at the office on 06-AUG-2014. Treatment included HYDROCORTISONE and BENADRYL. Rash resolved within 1 to 2 days (on approximately 08-AUG-2014). The outcome of the "localized rash developed on an unspecified date" was not provided. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 year old patient of unknown gender. On 09-SEP-2014 the patient was vaccinated with an improperly stored dose of PROQUAD (strength unknown, 0.5 ml, subcutaneous) exposed to -8 degree for two hours. This is one of several reports received from the same reporter (linked to 1409USA007877). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. On 15-AUG-2014 the patient was vaccinated with an expired dose of MMR II (dose not reported, lot # H014646, expiration date 01-AUG-2014, subcutaneously). No known adverse effects. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: TD, TD
Symptoms: Paraesthesia
Clinical narrative: 07-09-14 1000 - Tingling opposite arm (like my arm fell asleep) went away same day. 7/10 and 7/11, opposite arm and upper back feel like I have a bad sunburm, but there is no rash or markings. (Started 07/10/14 2:00 pm). 7-14-14 "Everything is back to normal. I'm just fine!
Age: 26.0
Sex: F
Vaccine: TD, TD
Symptoms: Paraesthesia, Sensory disturbance
Clinical narrative: 07-09-14 1000 - Tingling opposite arm (like my arm fell asleep) went away same day. 7/10 and 7/11, opposite arm and upper back feel like I have a bad sunburm, but there is no rash or markings. (Started 07/10/14 2:00 pm). 7-14-14 "Everything is back to normal. I'm just fine!
Age: 4.0
Sex: U
Vaccine: DTAPIPV, MMRV, MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 year old patient of unknown gender. On 09-SEP-2014 the patient was vaccinated with an improperly stored dose of (oka-merck) PROQUAD (strength unknown, 0.5 ml, subcutaneous) exposed to -8 degrees for two hours. No adverse effect was reported. The nurse also reported that another patient was vaccinated with (oka-merck) PROQUAD that was improperly stored (see MARRS 1409USA006566). This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, MMRV, MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 year old patient of unknown gender. On 09-SEP-2014 the patient was vaccinated with an improperly stored dose of (oka-merck) PROQUAD (strength unknown, 0.5 ml, subcutaneous) exposed to -8 degrees for two hours. No adverse effect was reported. The nurse also reported that another patient was vaccinated with (oka-merck) PROQUAD that was improperly stored (see MARRS 1409USA006566). This is one of several reports from the same reporter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Discomfort, Dizziness
Clinical narrative: Friday: fatigue. Saturday: headaches. Sunday: couldn't sleep, congestion, headache, chills, soreness, upset stomach, tiredness, sore throat, dizziness, diarrhea, whining, discomfort.
Age: 26.0
Sex: F
Vaccine: FLUN4
Symptoms: Fatigue, Headache, Insomnia, Irritability, Oropharyngeal pain
Clinical narrative: Friday: fatigue. Saturday: headaches. Sunday: couldn't sleep, congestion, headache, chills, soreness, upset stomach, tiredness, sore throat, dizziness, diarrhea, whining, discomfort.
Age: 26.0
Sex: F
Vaccine: FLUN4
Symptoms: Pain, Respiratory tract congestion
Clinical narrative: Friday: fatigue. Saturday: headaches. Sunday: couldn't sleep, congestion, headache, chills, soreness, upset stomach, tiredness, sore throat, dizziness, diarrhea, whining, discomfort.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Erythema, Gait disturbance, Headache, Local swelling
Clinical narrative: Dizziness & staggering; terrible headache;sleepy; fever of 105; area on arm red and swollen & still is but has shifted to side of arm. Applied cold packs which has helped.  Took 2 Aleve 9/20/2014 around noon.  Slept from 8PM 9/19/2014 until 7:30PM on 9/20/2014 (with brief times of awakening)  then back to bed by 10:00 PM same day.  Better today but arm is still red & swollen.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Somnolence
Clinical narrative: Dizziness & staggering; terrible headache;sleepy; fever of 105; area on arm red and swollen & still is but has shifted to side of arm. Applied cold packs which has helped.  Took 2 Aleve 9/20/2014 around noon.  Slept from 8PM 9/19/2014 until 7:30PM on 9/20/2014 (with brief times of awakening)  then back to bed by 10:00 PM same day.  Better today but arm is still red & swollen.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site pain, Insomnia, Malaise, Musculoskeletal pain
Clinical narrative: Pain near injection site (right arm) for 40 hours; pain in left neck and shoulder for 36 hours; general feeling of malaise for 36 hours; headache for 36 hours; insomnia during two nights.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain
Clinical narrative: Pain near injection site (right arm) for 40 hours; pain in left neck and shoulder for 36 hours; general feeling of malaise for 36 hours; headache for 36 hours; insomnia during two nights.
Age: 0.47
Sex: M
Vaccine: MMR
Symptoms: Autism, Autism spectrum disorder, Childhood disintegrative disorder, Speech disorder developmental
Clinical narrative: My son was perfectly healthy and was hitting all his milestones appropriately until he was given the MMR vaccine at 6 months of age. He then stopped hitting milestones and regressed in his development. He was diagnosed with Pervasive Developmental Disorder at age 3 and officially diagnosed with Autism at age 5. He was non-verbal until age 6.
Age: 32.0
Sex: M
Vaccine: HEP, MMR, TDAP
Symptoms: Blood test normal, Computerised tomogram normal, Convulsion, Dizziness, Electrocardiogram normal
Clinical narrative: Muscle cramps on 9/17, multiple seizures lasting a few minutes on 9/19 and 9/20. Wheezing, fever, nausea, soreness, itching all over, muscle weakness, dizziness all throughout.
Age: 32.0
Sex: M
Vaccine: HEP, MMR, TDAP
Symptoms: Muscle spasms, Muscular weakness, Nausea, Pain, Pruritus generalised
Clinical narrative: Muscle cramps on 9/17, multiple seizures lasting a few minutes on 9/19 and 9/20. Wheezing, fever, nausea, soreness, itching all over, muscle weakness, dizziness all throughout.
Age: 32.0
Sex: M
Vaccine: HEP, MMR, TDAP
Symptoms: Pyrexia, Urine analysis normal, Wheezing
Clinical narrative: Muscle cramps on 9/17, multiple seizures lasting a few minutes on 9/19 and 9/20. Wheezing, fever, nausea, soreness, itching all over, muscle weakness, dizziness all throughout.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site pain, Musculoskeletal pain, Musculoskeletal stiffness, Nausea
Clinical narrative: Headache, Nausea, Vomiting, bilateral shoulder, bil shoulder, neck pain/stiffness
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Vomiting
Clinical narrative: Headache, Nausea, Vomiting, bilateral shoulder, bil shoulder, neck pain/stiffness
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Apparent life threatening event
Clinical narrative: Acute Life Threatening Event.
Age: 50.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Headache, Hyperaesthesia, Immune system disorder, Injection site erythema
Clinical narrative: Patient (pt) was not ill and was vaccinated 9/18/14 5PM with Pneumovax 23 INJ 25/0.5 MERCK and Fluzone QUAD14-15 INJ SAN. By 9/19 @ 9AM pt was complaining of general malaise. Timeline was a steady increase of deep muscle aches and pains beginning in neck and flowing steadily downward thru both arms, spine, ribs, to waistline, as the day progressed. Headache onset by 9/19 @ 3PM. Skin surfaces from waist up to neck progressively sensitive and painful with severe pain @ both injection sites. Pt took temp @ 5PM & 99.6. Treated with 1000mg Tylenol and ice packs on injection sites & joints. Fever increased over evening as did muscle pain accompanied by severe joint pain. On 9/20 pt unable to get out of bed, headache increased, fever increased to 100.5. A local inflammation reaction developed at both inj sites by noon 9/20. It was redness of several inches with pain. Skin treated with ice packs. By evening of 9/20 fever increased to 101.3. Treated with 1250 mg Tylenol. On morning of 9/21 the local reaction at the Quad flu vaccine site had diminished. The local reaction at the pneumovax site increased with severe redness and very hot to the touch. On 9/21 the fever decreased to 99.3 by evening but the pneumovax site persisted with increasing swelling, heat, redness, despite ice packs. That site began severe itching. On morning of 9/22 fever had decreased to 98.8, but the local reaction to Pneumovax continued and is approx. 5 inches long down the bicep and wraps completely around (encircles) the bicep. The lower portion (bottom) of the bicep appears to suffer from edema. Treated with Benadryl gel as it feels more like a local allergic reaction at this point than systemic. Overall, the administration of these two vaccines at the same time caused a significant systemic immune reaction that put a healthy 50 year old man in bed with a fever of 101, with a concern that this could be too much for some immunocompromised or elderly individuals.
Age: 50.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site hypersensitivity, Injection site inflammation, Injection site oedema, Injection site pain, Injection site pruritus
Clinical narrative: Patient (pt) was not ill and was vaccinated 9/18/14 5PM with Pneumovax 23 INJ 25/0.5 MERCK and Fluzone QUAD14-15 INJ SAN. By 9/19 @ 9AM pt was complaining of general malaise. Timeline was a steady increase of deep muscle aches and pains beginning in neck and flowing steadily downward thru both arms, spine, ribs, to waistline, as the day progressed. Headache onset by 9/19 @ 3PM. Skin surfaces from waist up to neck progressively sensitive and painful with severe pain @ both injection sites. Pt took temp @ 5PM & 99.6. Treated with 1000mg Tylenol and ice packs on injection sites & joints. Fever increased over evening as did muscle pain accompanied by severe joint pain. On 9/20 pt unable to get out of bed, headache increased, fever increased to 100.5. A local inflammation reaction developed at both inj sites by noon 9/20. It was redness of several inches with pain. Skin treated with ice packs. By evening of 9/20 fever increased to 101.3. Treated with 1250 mg Tylenol. On morning of 9/21 the local reaction at the Quad flu vaccine site had diminished. The local reaction at the pneumovax site increased with severe redness and very hot to the touch. On 9/21 the fever decreased to 99.3 by evening but the pneumovax site persisted with increasing swelling, heat, redness, despite ice packs. That site began severe itching. On morning of 9/22 fever had decreased to 98.8, but the local reaction to Pneumovax continued and is approx. 5 inches long down the bicep and wraps completely around (encircles) the bicep. The lower portion (bottom) of the bicep appears to suffer from edema. Treated with Benadryl gel as it feels more like a local allergic reaction at this point than systemic. Overall, the administration of these two vaccines at the same time caused a significant systemic immune reaction that put a healthy 50 year old man in bed with a fever of 101, with a concern that this could be too much for some immunocompromised or elderly individuals.
Age: 50.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site swelling, Injection site warmth, Local reaction, Malaise, Mobility decreased
Clinical narrative: Patient (pt) was not ill and was vaccinated 9/18/14 5PM with Pneumovax 23 INJ 25/0.5 MERCK and Fluzone QUAD14-15 INJ SAN. By 9/19 @ 9AM pt was complaining of general malaise. Timeline was a steady increase of deep muscle aches and pains beginning in neck and flowing steadily downward thru both arms, spine, ribs, to waistline, as the day progressed. Headache onset by 9/19 @ 3PM. Skin surfaces from waist up to neck progressively sensitive and painful with severe pain @ both injection sites. Pt took temp @ 5PM & 99.6. Treated with 1000mg Tylenol and ice packs on injection sites & joints. Fever increased over evening as did muscle pain accompanied by severe joint pain. On 9/20 pt unable to get out of bed, headache increased, fever increased to 100.5. A local inflammation reaction developed at both inj sites by noon 9/20. It was redness of several inches with pain. Skin treated with ice packs. By evening of 9/20 fever increased to 101.3. Treated with 1250 mg Tylenol. On morning of 9/21 the local reaction at the Quad flu vaccine site had diminished. The local reaction at the pneumovax site increased with severe redness and very hot to the touch. On 9/21 the fever decreased to 99.3 by evening but the pneumovax site persisted with increasing swelling, heat, redness, despite ice packs. That site began severe itching. On morning of 9/22 fever had decreased to 98.8, but the local reaction to Pneumovax continued and is approx. 5 inches long down the bicep and wraps completely around (encircles) the bicep. The lower portion (bottom) of the bicep appears to suffer from edema. Treated with Benadryl gel as it feels more like a local allergic reaction at this point than systemic. Overall, the administration of these two vaccines at the same time caused a significant systemic immune reaction that put a healthy 50 year old man in bed with a fever of 101, with a concern that this could be too much for some immunocompromised or elderly individuals.
Age: 50.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Myalgia, Pyrexia
Clinical narrative: Patient (pt) was not ill and was vaccinated 9/18/14 5PM with Pneumovax 23 INJ 25/0.5 MERCK and Fluzone QUAD14-15 INJ SAN. By 9/19 @ 9AM pt was complaining of general malaise. Timeline was a steady increase of deep muscle aches and pains beginning in neck and flowing steadily downward thru both arms, spine, ribs, to waistline, as the day progressed. Headache onset by 9/19 @ 3PM. Skin surfaces from waist up to neck progressively sensitive and painful with severe pain @ both injection sites. Pt took temp @ 5PM & 99.6. Treated with 1000mg Tylenol and ice packs on injection sites & joints. Fever increased over evening as did muscle pain accompanied by severe joint pain. On 9/20 pt unable to get out of bed, headache increased, fever increased to 100.5. A local inflammation reaction developed at both inj sites by noon 9/20. It was redness of several inches with pain. Skin treated with ice packs. By evening of 9/20 fever increased to 101.3. Treated with 1250 mg Tylenol. On morning of 9/21 the local reaction at the Quad flu vaccine site had diminished. The local reaction at the pneumovax site increased with severe redness and very hot to the touch. On 9/21 the fever decreased to 99.3 by evening but the pneumovax site persisted with increasing swelling, heat, redness, despite ice packs. That site began severe itching. On morning of 9/22 fever had decreased to 98.8, but the local reaction to Pneumovax continued and is approx. 5 inches long down the bicep and wraps completely around (encircles) the bicep. The lower portion (bottom) of the bicep appears to suffer from edema. Treated with Benadryl gel as it feels more like a local allergic reaction at this point than systemic. Overall, the administration of these two vaccines at the same time caused a significant systemic immune reaction that put a healthy 50 year old man in bed with a fever of 101, with a concern that this could be too much for some immunocompromised or elderly individuals.
Age: 8.0
Sex: F
Vaccine: MMR
Symptoms: Leukaemia, Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a nurse refers to an 8 year old female patient. Patient's medical history and concurrent condition was not reported. On 25-FEB-2010 the patient was vaccinated with dose 1 of M-M-R II dose: 0.5 ml (millilitres), subcutaneous, (in the past) and dose 2 on 10-DEC-2010. Patient's concomitant medication was reported as none. Approximately on an unknown date in 2014 (also reported as now has negative titers for MMR), the patient experienced negative titers for MMR and on an unknown date experienced leukemia (hospitalization and medically significant). The nurse stated that this patient was in remission from leukemia. The nurse did not know when the patient was diagnosed with leukemia. The nurse believed that the patient has been hospitalized at some point related to leukemia, but had no information about when or where the patient was hospitalized. The nurse stated that the patient received treatment for leukemia but did not know what treatments the patient received. Patient's laboratory results were unspecified by the reporter. The outcome of the events was unknown. Reporter's causality assessment was not provided. Upon internal review the event leukemia is considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Caesarean section, Foetal heart rate deceleration, Neonatal disorder, Viral titre decreased
Clinical narrative: This literature marketed retrospective pregnancy report as received from a physician refers to a female patient of unknown age. Information was received from a published article. A case of congenital rubella syndrome in a child born to a vaccinated woman who had not traveled internationally. In 2008, a full-term boy was born with microcephaly and a petechial rash. The infant's mother reported no rash illness, travel history, or known contact with ill persons during the first 4 months of pregnancy. She lived with her 2 other children and the case-patient's father, who had not traveled internationally during the mother's pregnancy. In 2002, the case-patient's mother had an equivocal rubella virus IgG titer of 5 and in 2003 received measles with M-M-R II vaccine. Vaccination status of the father was unknown. Maternal rubella virus IgG titer at 4 months' gestation was >400 IU/mL. The infant was delivered by urgent cesarean section because of cardiac decelerations during labor. Apgar scores at 1 and 5 minutes were 9 (of 10 total). At birth, the child weighed 2.7 kg (10th percentile), and he was 48.25 cm (15th percentile) in length and had a head circumference of 31.75 cm (<3rd percentile). He had a petechial rash on the face, back, and upper extremities and a systolic heart murmur. No jaundice or hepatosplenomegaly was noted. On 2003 the patient was vaccinated with M-M-R II (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date the patient experienced lack of immunity after vaccination. The clinical features and laboratory results for this case were most consistent with CRS, although initial testing was delayed until the infant was 6.5 months of age. Clinical findings for the case-patient (microcephaly, developmental delay, congenital heart disease) were compatible with CRS and met 3 of the Council of State and Territorial Epidemiologists' laboratory criteria for a confirmed case of CRS. CRS occurs rarely in children of women with a history of vaccination or documented immunity by rubella virus titer. When CRS does occur, it is frequently a result of asymptomatic rubella reinfection in the mother (5,6). In this case-patient, CRS was likely the result of 2 rare events: his mother's lack of immunity after vaccination and her exposure to rubella in a highly immune population. When the infant was 7.5 months of age, RT-PCR was positive for 1 of 2 specimens. However, when the infant was 10 and 12 months of age, RT-PCR was negative, as were culture results when the infant was 7.5 and 10 months of age. These findings are consistent with the diagnosis of CRS because for around 50% of children with CRS, culture results are negative by 3 months of age. The action taken with the therapy with M-M-R II was unknown. The outcome of the events was unknown. This case is linked to case number 1409USA007576 via mother baby link. Additional information has been requested.
Age: 1.06
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Autism
Clinical narrative: Signs and symptoms of autism - resulted later at 18 months being diagnosed with autism.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Autism, Autism spectrum disorder
Clinical narrative: Autistic symptoms; later diagnosed with PDD (pervasive developmental disorder, which is on the low end of the spectrum for autism).
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Myalgia
Clinical narrative: Muscle pain and severe bruising. Bruising is resolving and patient is managing pain with APAP.
Age: 5.0
Sex: M
Vaccine: DTAP, MMRV, DTAP, MMRV
Symptoms: Nausea, Presyncope
Clinical narrative: 3 minutes after injection of vaccines, patient had a vagal reaction that lasted about 10 seconds.  No injuries to patient.  Patient then stated he felt nauseated.  Placed patient in chair.  Gave water and crackers.  Had ancillary staff contact Pediatric NP, Clinic Supervisor and ADN.  BP stable.  Waited 20 minutes.  Patient's mother asked to contact Pediatrician or go to Emergency room as needed.  Patient blood pressure taken.  BP at 84/62 prior to leaving clinic.
Age: 5.0
Sex: M
Vaccine: DTAP, MMRV, DTAP, MMRV
Symptoms: Nausea
Clinical narrative: 3 minutes after injection of vaccines, patient had a vagal reaction that lasted about 10 seconds.  No injuries to patient.  Patient then stated he felt nauseated.  Placed patient in chair.  Gave water and crackers.  Had ancillary staff contact Pediatric NP, Clinic Supervisor and ADN.  BP stable.  Waited 20 minutes.  Patient's mother asked to contact Pediatrician or go to Emergency room as needed.  Patient blood pressure taken.  BP at 84/62 prior to leaving clinic.
Age: 5.0
Sex: M
Vaccine: DTAP, MMRV, DTAP, MMRV
Symptoms: Nausea, Presyncope
Clinical narrative: Pt had vagal response 3 minutes after PROQUAD and DTAP administration that lasted 10 seconds. Pt then felt nauseous. Placed in chair. Put used cloth on head, gave crackers, water. Contacted pediatric NP. Waited for 20 minutes. No S/s of distress. Instructed mom to contact Pediatrician or go to ER as needed.
Age: 5.0
Sex: M
Vaccine: DTAP, MMRV, DTAP, MMRV
Symptoms: Nausea
Clinical narrative: Pt had vagal response 3 minutes after PROQUAD and DTAP administration that lasted 10 seconds. Pt then felt nauseous. Placed in chair. Put used cloth on head, gave crackers, water. Contacted pediatric NP. Waited for 20 minutes. No S/s of distress. Instructed mom to contact Pediatrician or go to ER as needed.
Age: 57.0
Sex: M
Vaccine: FLUC3
Symptoms: Asthenia, Constipation, Decreased appetite, Dizziness, Eye pain
Clinical narrative: Fever 102 -103. Headache behind eyes.  Sensitivity to light.  Nausea.  Constipation. Loss of appetite.  Lightheaded/dizzy and weak.
Age: 57.0
Sex: M
Vaccine: FLUC3
Symptoms: Nausea, Photophobia, Pyrexia
Clinical narrative: Fever 102 -103. Headache behind eyes.  Sensitivity to light.  Nausea.  Constipation. Loss of appetite.  Lightheaded/dizzy and weak.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Delusion, Pyrexia
Clinical narrative: Fever, chills, delusions.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Shaking chills, fever 101 degrees, muscle aches, headache, weakness.