chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood potassium decreased, Blood sodium normal, Blood urea decreased, C-reactive protein normal, CSF culture
Clinical narrative: 5/21/2019 noted tickling sensation on the left ear. 5/22/2019 woke up L face droop including forehead. Decreased sensation L face, drooling. Dysphagia because she could not feel the food. Symptoms continued for about 1 week but no improved severity. Saw her GP and she started her on decadron 4mg PO and referred for MRI next morning (5/29). Also had severe pressure sensation on the face.  Saw Dr. on 5/30 continued on 4mg of decadron. Over about 1 1/2 week her facial weakness had improved. Recovered eye closure, drooling stopped. Had persistent numbness on the face side of the face, mouth and tongue extending to forehead and mid skull.   Decreased decadron 6/21/2019 to 2mg Currently on decadron 2mg; since decreasing the dose her she has had partial recurrence of her symptoms.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: CSF glucose increased, CSF immunoglobulin G index, CSF oligoclonal band, CSF protein normal, CSF red blood cell count positive
Clinical narrative: 5/21/2019 noted tickling sensation on the left ear. 5/22/2019 woke up L face droop including forehead. Decreased sensation L face, drooling. Dysphagia because she could not feel the food. Symptoms continued for about 1 week but no improved severity. Saw her GP and she started her on decadron 4mg PO and referred for MRI next morning (5/29). Also had severe pressure sensation on the face.  Saw Dr. on 5/30 continued on 4mg of decadron. Over about 1 1/2 week her facial weakness had improved. Recovered eye closure, drooling stopped. Had persistent numbness on the face side of the face, mouth and tongue extending to forehead and mid skull.   Decreased decadron 6/21/2019 to 2mg Currently on decadron 2mg; since decreasing the dose her she has had partial recurrence of her symptoms.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: CSF white blood cell count negative, Carbon dioxide normal, Central nervous system lesion, Chest X-ray, Cryptococcus test
Clinical narrative: 5/21/2019 noted tickling sensation on the left ear. 5/22/2019 woke up L face droop including forehead. Decreased sensation L face, drooling. Dysphagia because she could not feel the food. Symptoms continued for about 1 week but no improved severity. Saw her GP and she started her on decadron 4mg PO and referred for MRI next morning (5/29). Also had severe pressure sensation on the face.  Saw Dr. on 5/30 continued on 4mg of decadron. Over about 1 1/2 week her facial weakness had improved. Recovered eye closure, drooling stopped. Had persistent numbness on the face side of the face, mouth and tongue extending to forehead and mid skull.   Decreased decadron 6/21/2019 to 2mg Currently on decadron 2mg; since decreasing the dose her she has had partial recurrence of her symptoms.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Cytomegalovirus test negative, Discomfort, Double stranded DNA antibody, Drooling, Dysphagia
Clinical narrative: 5/21/2019 noted tickling sensation on the left ear. 5/22/2019 woke up L face droop including forehead. Decreased sensation L face, drooling. Dysphagia because she could not feel the food. Symptoms continued for about 1 week but no improved severity. Saw her GP and she started her on decadron 4mg PO and referred for MRI next morning (5/29). Also had severe pressure sensation on the face.  Saw Dr. on 5/30 continued on 4mg of decadron. Over about 1 1/2 week her facial weakness had improved. Recovered eye closure, drooling stopped. Had persistent numbness on the face side of the face, mouth and tongue extending to forehead and mid skull.   Decreased decadron 6/21/2019 to 2mg Currently on decadron 2mg; since decreasing the dose her she has had partial recurrence of her symptoms.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear discomfort, Enterovirus test negative, Eosinophil count decreased, Eosinophil percentage decreased, Escherichia test negative
Clinical narrative: 5/21/2019 noted tickling sensation on the left ear. 5/22/2019 woke up L face droop including forehead. Decreased sensation L face, drooling. Dysphagia because she could not feel the food. Symptoms continued for about 1 week but no improved severity. Saw her GP and she started her on decadron 4mg PO and referred for MRI next morning (5/29). Also had severe pressure sensation on the face.  Saw Dr. on 5/30 continued on 4mg of decadron. Over about 1 1/2 week her facial weakness had improved. Recovered eye closure, drooling stopped. Had persistent numbness on the face side of the face, mouth and tongue extending to forehead and mid skull.   Decreased decadron 6/21/2019 to 2mg Currently on decadron 2mg; since decreasing the dose her she has had partial recurrence of her symptoms.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis, Facial paresis, Glomerular filtration rate normal, Glycosylated haemoglobin normal, Haematocrit decreased
Clinical narrative: 5/21/2019 noted tickling sensation on the left ear. 5/22/2019 woke up L face droop including forehead. Decreased sensation L face, drooling. Dysphagia because she could not feel the food. Symptoms continued for about 1 week but no improved severity. Saw her GP and she started her on decadron 4mg PO and referred for MRI next morning (5/29). Also had severe pressure sensation on the face.  Saw Dr. on 5/30 continued on 4mg of decadron. Over about 1 1/2 week her facial weakness had improved. Recovered eye closure, drooling stopped. Had persistent numbness on the face side of the face, mouth and tongue extending to forehead and mid skull.   Decreased decadron 6/21/2019 to 2mg Currently on decadron 2mg; since decreasing the dose her she has had partial recurrence of her symptoms.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Haemoglobin decreased, Herpes simplex test negative, Human herpes virus 6 serology negative, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: 5/21/2019 noted tickling sensation on the left ear. 5/22/2019 woke up L face droop including forehead. Decreased sensation L face, drooling. Dysphagia because she could not feel the food. Symptoms continued for about 1 week but no improved severity. Saw her GP and she started her on decadron 4mg PO and referred for MRI next morning (5/29). Also had severe pressure sensation on the face.  Saw Dr. on 5/30 continued on 4mg of decadron. Over about 1 1/2 week her facial weakness had improved. Recovered eye closure, drooling stopped. Had persistent numbness on the face side of the face, mouth and tongue extending to forehead and mid skull.   Decreased decadron 6/21/2019 to 2mg Currently on decadron 2mg; since decreasing the dose her she has had partial recurrence of her symptoms.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza virus test negative, Listeria test, Lymphocyte count decreased, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal
Clinical narrative: 5/21/2019 noted tickling sensation on the left ear. 5/22/2019 woke up L face droop including forehead. Decreased sensation L face, drooling. Dysphagia because she could not feel the food. Symptoms continued for about 1 week but no improved severity. Saw her GP and she started her on decadron 4mg PO and referred for MRI next morning (5/29). Also had severe pressure sensation on the face.  Saw Dr. on 5/30 continued on 4mg of decadron. Over about 1 1/2 week her facial weakness had improved. Recovered eye closure, drooling stopped. Had persistent numbness on the face side of the face, mouth and tongue extending to forehead and mid skull.   Decreased decadron 6/21/2019 to 2mg Currently on decadron 2mg; since decreasing the dose her she has had partial recurrence of her symptoms.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Mean cell haemoglobin decreased, Mean cell volume decreased, Mean platelet volume normal, Monocyte count normal, Monocyte percentage increased
Clinical narrative: 5/21/2019 noted tickling sensation on the left ear. 5/22/2019 woke up L face droop including forehead. Decreased sensation L face, drooling. Dysphagia because she could not feel the food. Symptoms continued for about 1 week but no improved severity. Saw her GP and she started her on decadron 4mg PO and referred for MRI next morning (5/29). Also had severe pressure sensation on the face.  Saw Dr. on 5/30 continued on 4mg of decadron. Over about 1 1/2 week her facial weakness had improved. Recovered eye closure, drooling stopped. Had persistent numbness on the face side of the face, mouth and tongue extending to forehead and mid skull.   Decreased decadron 6/21/2019 to 2mg Currently on decadron 2mg; since decreasing the dose her she has had partial recurrence of her symptoms.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Neisseria test, Neutrophil count normal, Neutrophil percentage increased, Nuclear magnetic resonance imaging brain abnormal, Platelet count normal
Clinical narrative: 5/21/2019 noted tickling sensation on the left ear. 5/22/2019 woke up L face droop including forehead. Decreased sensation L face, drooling. Dysphagia because she could not feel the food. Symptoms continued for about 1 week but no improved severity. Saw her GP and she started her on decadron 4mg PO and referred for MRI next morning (5/29). Also had severe pressure sensation on the face.  Saw Dr. on 5/30 continued on 4mg of decadron. Over about 1 1/2 week her facial weakness had improved. Recovered eye closure, drooling stopped. Had persistent numbness on the face side of the face, mouth and tongue extending to forehead and mid skull.   Decreased decadron 6/21/2019 to 2mg Currently on decadron 2mg; since decreasing the dose her she has had partial recurrence of her symptoms.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Protein total decreased, Red blood cell count decreased, Red blood cell sedimentation rate normal, Red cell distribution width increased, Scan with contrast
Clinical narrative: 5/21/2019 noted tickling sensation on the left ear. 5/22/2019 woke up L face droop including forehead. Decreased sensation L face, drooling. Dysphagia because she could not feel the food. Symptoms continued for about 1 week but no improved severity. Saw her GP and she started her on decadron 4mg PO and referred for MRI next morning (5/29). Also had severe pressure sensation on the face.  Saw Dr. on 5/30 continued on 4mg of decadron. Over about 1 1/2 week her facial weakness had improved. Recovered eye closure, drooling stopped. Had persistent numbness on the face side of the face, mouth and tongue extending to forehead and mid skull.   Decreased decadron 6/21/2019 to 2mg Currently on decadron 2mg; since decreasing the dose her she has had partial recurrence of her symptoms.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Sensory loss, Streptococcus test negative, Treponema test negative, Varicella virus test negative, Viral test negative
Clinical narrative: 5/21/2019 noted tickling sensation on the left ear. 5/22/2019 woke up L face droop including forehead. Decreased sensation L face, drooling. Dysphagia because she could not feel the food. Symptoms continued for about 1 week but no improved severity. Saw her GP and she started her on decadron 4mg PO and referred for MRI next morning (5/29). Also had severe pressure sensation on the face.  Saw Dr. on 5/30 continued on 4mg of decadron. Over about 1 1/2 week her facial weakness had improved. Recovered eye closure, drooling stopped. Had persistent numbness on the face side of the face, mouth and tongue extending to forehead and mid skull.   Decreased decadron 6/21/2019 to 2mg Currently on decadron 2mg; since decreasing the dose her she has had partial recurrence of her symptoms.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Vitamin B12 increased, Vitamin E, West Nile virus test negative, White blood cell count normal
Clinical narrative: 5/21/2019 noted tickling sensation on the left ear. 5/22/2019 woke up L face droop including forehead. Decreased sensation L face, drooling. Dysphagia because she could not feel the food. Symptoms continued for about 1 week but no improved severity. Saw her GP and she started her on decadron 4mg PO and referred for MRI next morning (5/29). Also had severe pressure sensation on the face.  Saw Dr. on 5/30 continued on 4mg of decadron. Over about 1 1/2 week her facial weakness had improved. Recovered eye closure, drooling stopped. Had persistent numbness on the face side of the face, mouth and tongue extending to forehead and mid skull.   Decreased decadron 6/21/2019 to 2mg Currently on decadron 2mg; since decreasing the dose her she has had partial recurrence of her symptoms.
Age: 66.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Asthenia, Cheilitis, Feeling hot, Headache, Hypersomnia
Clinical narrative: Patient woke up day after vaccines with a headache, potential fever (was warm but didn't take temperature), was weak, and slept almost all day during the day. The next day a rash developed on upper lip and above upper lip. The rash was not painful or itchy. RPH recommended Benadryl.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Penile rash, Rash vesicular
Clinical narrative: Vesicular rash on penis and right flank which could have been shingles. Started 2 days after Shingrix vaccine. Resolved without treatment in 5 days.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Day after receiving vaccine she noted swelling to area around injection site, slightly warmer to touch and slightly tender to palpation.  Iduration of 8.25cm x 6.5cm noted around injection site.   Denied pain to site with activity.  Denies fever, body aches, or chills.
Age: 58.0
Sex: F
Vaccine: RAB
Symptoms: Muscle spasms
Clinical narrative: Client complained of leg cramps when walking long distance five days after receiving Rabies vaccine and Rabies IG.
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: Acne, Cough, Pyrexia, Rash, Respiratory tract congestion
Clinical narrative: On August 16, patient had high fever, cough and congestion. Took him to the doctor and was prescribed Albuterol inhalation. After 2 days , patient developed 2-4 pimple like rash in the face, trunk area and  after 2 days, it kept on increasing all  over his scalp, face, limbs, trunk.
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: Varicella post vaccine
Clinical narrative: On August 16, patient had high fever, cough and congestion. Took him to the doctor and was prescribed Albuterol inhalation. After 2 days , patient developed 2-4 pimple like rash in the face, trunk area and  after 2 days, it kept on increasing all  over his scalp, face, limbs, trunk.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination complication, Vertigo
Clinical narrative: Patient states that 2 days after he received the vaccination he was in the ER thinking he was having a stroke. It turned out to be severe vertigo. He has followed up with his PCP and an ENT who believe that it was an adverse reaction to the vaccine
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Lethargy, Myalgia
Clinical narrative: flu like illness diffuse myalgia lethargy headache
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Injection site reaction, Injection site warmth, Pruritus
Clinical narrative: Patient started itching on left arm on 08/25/19. Today, patient noticed red, inflamed area on arm moving down left arm. Called pharmacy and pharmacist told patient to come in for it to be examined. Appears to be injection site reaction starting at site of injection moving down patient's arm. Warm to the touch. Patient's physician was notified. Nurse stated to have us draw a line around the red area and to instruct the patient to take diphenhydramine and the nurse would follow-up. Pharmacist did do so and made recommendation to take diphenhydramine. Patient is aware to contact physician's office if swelling moves outside of marked lines and if the nurse did not reach out to her in within 2 days.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Pain in extremity
Clinical narrative: Immediate "space cadet" type feeling. Maybe feeling like getting the flu. Very sore left arm for over a week. Lived on ice and ibuprofen for 10 days.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Balance disorder
Clinical narrative: THIRTEEN YEAR OLD BOY LOST BALANCE 10 MINUTES AFTER RECEIVING IMMUNIZATION, HIS DAD CAUGHT HIM AND WE LET HIM SIT ON THE FLOOR A FEW MORE MINUTES TO ENSURE HE DID NOT HAVE A SEVERE FALL IN TRYING TO GET BACK UP NO LOSS OF CONSCIOUSNESS OCCURRED, RPH OFFERED PATIENT WATER AND RECOMMENDED FATHER CONTACT PRIMARY CARE PROVIDER AND URGENT CARE.   THE FATHER REPORTED THIS HAPPENS TO THE PATIENT SOMETIMES SINCE PUBERTY HE LOSES BALANCE. HOWEVER, BEFORE ADMINISTRATION WHEN ASKED QUESTION #4 DIRECTLY (EVER FAINTED OR FELT DIZZY AFTER IMMUNIZATION) THE FATHER SAID NO  I CALLED THE MOTHER AT 5:50 PM SHE REPORTS NO HEADACHE, NAUSEA OR VOMITING HAS OCCURRED AND THE PARENTS ARE CHOOSING TO NOT SEEK MEDICAL ATTENTION AT THIS TIME AS THEY BOTH THINK IT IS NOT RELATED TO THE VACCINE
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Febrile convulsion, Loss of consciousness, Muscle twitching, Pyrexia, Rash morbilliform
Clinical narrative: Within 2 hours of receiving the MMR vaccine my daughter had a total of 4 Febrile seizures witching ~ 20 minute time frame. She had to receive CPR and oxygen to regain consciousness and was transported to Hospital. 2.5 days later she still has a consistent fever and has developed measles type rash
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Resuscitation
Clinical narrative: Within 2 hours of receiving the MMR vaccine my daughter had a total of 4 Febrile seizures witching ~ 20 minute time frame. She had to receive CPR and oxygen to regain consciousness and was transported to Hospital. 2.5 days later she still has a consistent fever and has developed measles type rash
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: She stated that she was experiencing full body excruciating pain and high fever. She described the pain as being more painful than giving birth.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: She said she broke out into a rash from her ear down to the side of her cheek. She said it was very mild and lasted about a week. No new lotions/detergents/makeup during this time
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Immobile, Rheumatoid arthritis
Clinical narrative: patient stated he had a flare up of his rheumatoid arthritis in his knee 2 days after the received the vaccine.  He said the flare up was so bad that he was immobile for about 7 days..  the flare up resolved after 7 days. he did not seek out treatment.
Age: 66.0
Sex: M
Vaccine: FLUA3
Symptoms: Diplopia, Dizziness, Vision blurred
Clinical narrative: Patient reported about a week after receiving the vaccine he started to experience blurred and double vision. Patient must drive with eyepath and gets dizzy do to vision issues he believes resulted from vaccination. Patient is seeing ophthalmologist and doing lab testing to rule out any other possible causes but strongly believes it is due to vaccination as no other changes in medication or disease states has been notable in this time period.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient reports a head-to-toe rash with pervasive itching. He has been treated with benadryl and prednisone. He is still currently having itching 10 days later.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: pt came down with a high fever (102 degrees) during the evening on the day after her vaccination
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Pain, Skin tightness
Clinical narrative: Patient cannot lift his arm since he got the first dose of shingrix. he gets pain when lifting arm and cannot raise arm fully. pain and tightness is present at the injection site.
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Body temperature increased, Crying, Fatigue, Irritability, Rash
Clinical narrative: Temperature of 101.2 stayed for 48 hours; Severe Rash on Face, Neck, chest and legs (I have a photo); Extreme Fussiness (hysterical crying for over 3 hours); and Fatigue
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site warmth, Pyrexia
Clinical narrative: Patient came to the pharmacy consultation window on 08/26/2019 to inform us that her and her husband have both received their second shingrix shot. Afterwards she informed me that she had an infection from the shot she received from us on 05/10/2019. She described it as a red spot with heat in it and a mild fever that presented about 2 days after she received it. She said that she waited another 3-4 days after it presented and decided to go to the ER. She described it to me at that point as being red from close to her elbow to shoulder with heat and she also still had a fever. The people at the ER told her it was from the bandage we used and possibly a piece was injected. I informed her that we've had these bandages for probably 5 years and have never heard of that happening. I told her that I have seen a similar reaction occur as an adverse reaction before.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: patient experienced significant pain, swelling, reddness, and itching at injection site.  Size was 3 inches long x 2 inches wide.  patient also reported at raised bump in the center of the site.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient had severe syncope and stated she fainted 10 hours after receiving the flu vaccine
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Confusional state, Disorientation, Dizziness, Eye movement disorder, Nausea
Clinical narrative: patient fainted (syncope) for approx 5-10 seconds. Eyes rolled in back of head and was non-responsive. Kept patient from falling over and attempted to lie patient onto floor. She then woke up disoriented and confused. Had called 911 as a precaution. Patient refused treatment from EMTs said she felt sick to stomach and lightheaded. Symptoms resolved withing 5-10 minutes. Followed up with patient 2 hours later and she said she was having no further issues.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: patient fainted (syncope) for approx 5-10 seconds. Eyes rolled in back of head and was non-responsive. Kept patient from falling over and attempted to lie patient onto floor. She then woke up disoriented and confused. Had called 911 as a precaution. Patient refused treatment from EMTs said she felt sick to stomach and lightheaded. Symptoms resolved withing 5-10 minutes. Followed up with patient 2 hours later and she said she was having no further issues.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient got shingles after recieving the vaccine. Dr wanted her to have the vaccine due to her repeatedly having shingles in the past (12 times).
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: 8/24/19 SMALL RED MARK  8/26/19 BIG RED MARK ABOUT 6 INCH X 1.5INCH
Age: 82.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal disorder
Clinical narrative: Patient states severe pain immediately upon injection. Trouble moving and using arm. Pain has subsided over time last 6 days but pain is still significant.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Fibromyalgia, Inappropriate schedule of product administration
Clinical narrative: This second shingrix vaccination was taken until 7 months after the first one because of the persistent fibromyalgia pain from the first vaccination which lasted for nearly 6 months.   Refer to Temporary VAERS E=Report No 163960 which was filed on 2019-04-02.   It is now about 2 weeks after this second shingrix vaccination - the fibromyalgia flareup has subsided and was only bad for a few days.  So far, so good.
Age: 18.0
Sex: M
Vaccine: HPV9, MMR
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: patient was given hpv vaccine (im) first in right arm, then MMR vaccine (sc) in left arm. syncopy occurred shortly following administration of MMR vaccine. patient recovered after a few minutes.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: SEVERE REDNESS AND SWELLING ON ENTIRE LEFT ARM
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Feeling abnormal, Urticaria
Clinical narrative: Couple of hours after receiving immunizations, she started to get hives, her chest was burning and having minimal chest pain. The next day was out of breath and that night Trouble breathing. Hives continue to happen off and on. Patient has continued not to feel Normal and chest tight.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Blood pressure fluctuation, Dizziness, Fall, Paraesthesia, Skin abrasion
Clinical narrative: Patient Became Faint and started to Fall. Her mom caught her as she was falling. Slight abrasion above Right eye From hitting wall Dizzy, unresponsive, now when sitting says her hands are still tingly
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Patient Became Faint and started to Fall. Her mom caught her as she was falling. Slight abrasion above Right eye From hitting wall Dizzy, unresponsive, now when sitting says her hands are still tingly
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: pt. has Shingles, diagnosed by MD on 8/12/19 - severe case
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 15cmX15cm area of erythema and slight swelling to (R) upper arm no pain, no fever, no other symptoms
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth, Local reaction
Clinical narrative: 8/21/19 - Pt returned to clinic for 11:00AM. evaluation of Rt Arm, sx of local reaction: Rt arm red, swollen, warm with vesicular reaction. Dr. sent Pt to ED to Rule out infection vs necrotizing fasciitis. 8/26/19. Pt returned to Clinic follow up ED visit. Treated for Local skin infection with cephalexin antibiotics. Rt arm improved.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Skin infection
Clinical narrative: 8/21/19 - Pt returned to clinic for 11:00AM. evaluation of Rt Arm, sx of local reaction: Rt arm red, swollen, warm with vesicular reaction. Dr. sent Pt to ED to Rule out infection vs necrotizing fasciitis. 8/26/19. Pt returned to Clinic follow up ED visit. Treated for Local skin infection with cephalexin antibiotics. Rt arm improved.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: When printing the vaccine administration record for the patient in August, it was noticed that a 3rd Shingrix vaccine was given. We filled out the error report. It seems the patient had requested another vaccine but it was missed that two doses were given the year before due to multiple billing attempts until the prescription went through. No adverse event occurred to the patient.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Abdominal discomfort, Aspartate aminotransferase normal, Diarrhoea, Differential white blood cell count, Full blood count
Clinical narrative: One week after vaccine developed fever, rash starting on face & moving down to trunk and arms. Fever of up to 101.6 (R) lasted 6 days & rash started to fade on 6th day. Had stomach upset, diarrhea, rhinitis & sore throat also.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Metabolic function test, Oropharyngeal pain, Pyrexia, Rash, Respiratory viral panel
Clinical narrative: One week after vaccine developed fever, rash starting on face & moving down to trunk and arms. Fever of up to 101.6 (R) lasted 6 days & rash started to fade on 6th day. Had stomach upset, diarrhea, rhinitis & sore throat also.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Rhinitis, Streptococcus test negative, White blood cell count decreased
Clinical narrative: One week after vaccine developed fever, rash starting on face & moving down to trunk and arms. Fever of up to 101.6 (R) lasted 6 days & rash started to fade on 6th day. Had stomach upset, diarrhea, rhinitis & sore throat also.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Mobility decreased, Nausea
Clinical narrative: Chills, pain in arm of injection administration. General bodyaches, nausea, vomiting. Bodyaches so bad she felt she couldn't move had to crawl to bathroom. Vomited 3 times. Also with headache. 8/18 - took 2 Advil which helped headache. Able to take PO. 8/19 - Still tired but much better.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Vomiting
Clinical narrative: Chills, pain in arm of injection administration. General bodyaches, nausea, vomiting. Bodyaches so bad she felt she couldn't move had to crawl to bathroom. Vomited 3 times. Also with headache. 8/18 - took 2 Advil which helped headache. Able to take PO. 8/19 - Still tired but much better.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Received Proquad Vaccine & pt experienced redness & swelling around site. Lasted 3 days treated for cellulitis with Cefdinir.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Severe Headache, body aches, nausea, slight fever, chills Duration was five days. Shingles vaccine Zoster RZV Recombinant
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Erythema, Pyrexia
Clinical narrative: 8/20 pt had low grade fever 100.5. Treated with Tylenol. Mom called RN 8/22 & informed it was most likely MMRV side effect. 8/23 red patch formed with fever 103, went to ER given Keflex, Red patch grew 8/24 Urgent Care & her Tx with clindamycin, red spot better fever gone
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Injection site swelling
Clinical narrative: PT RTO 8/14/19 after shots done 8/13/19. Pt had large area of swelling on RT measuring 19cm x 10cm.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Feeling abnormal, Pain
Clinical narrative: slightly sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on 19th April 2019, refer Case US2019116892).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient reported that his 2nd dose was not bad as 1st dose. The patient had slightly sore arm.  It was reported that on next day patient carried out like normal. The patient worked in back yard for several hours in the hot sun and felt pretty much normal. The patient reported that within couple of days, he totally back to normal. The case been linked to the case US2019116892,  reported by same reporter for same patient.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Feeling abnormal, Hypersomnia, Pain, Pain in extremity
Clinical narrative: slightly sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on 19th April 2019, refer Case US2019116892).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient reported that his 2nd dose was not bad as 1st dose. The patient had slightly sore arm.  It was reported that on next day patient carried out like normal. The patient worked in back yard for several hours in the hot sun and felt pretty much normal. The patient reported that within couple of days, he totally back to normal. The case been linked to the case US2019116892,  reported by same reporter for same patient.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Somnolence
Clinical narrative: slightly sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on 19th April 2019, refer Case US2019116892).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient reported that his 2nd dose was not bad as 1st dose. The patient had slightly sore arm.  It was reported that on next day patient carried out like normal. The patient worked in back yard for several hours in the hot sun and felt pretty much normal. The patient reported that within couple of days, he totally back to normal. The case been linked to the case US2019116892,  reported by same reporter for same patient.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: slightly sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on 19th April 2019, refer Case US2019116892).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient reported that his 2nd dose was not bad as 1st dose. The patient had slightly sore arm.  It was reported that on next day patient carried out like normal. The patient worked in back yard for several hours in the hot sun and felt pretty much normal. The patient reported that within couple of days, he totally back to normal. The case been linked to the case US2019116892,  reported by same reporter for same patient.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Emotional disorder, Eye irritation, Headache, Nausea, Nervousness
Clinical narrative: nausea; headache; completely out-of-character nervous/ emotional outburst; completely out-of-character nervous/ emotional outburst; head buzz; This case was reported by a consumer and described the occurrence of nausea in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of ophthalmic herpes simplex (1st dose received in June 2019, refer linked case US2019AMR150995).   On 14th August 2019, the patient received the 2nd dose of Shingrix. On 15th August 2019, 1 days after receiving Shingrix, the patient experienced nausea, headache, nervous, emotional distress and noises in head. On an unknown date, the outcome of the nausea, headache, nervous, emotional distress and noises in head were unknown.   It was unknown if the reporter considered the nausea, headache, nervous, emotional distress and noises in head to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced a completely out-of-character nervous or emotional outburst. The patient's 50 yesr old wife mentioned that she had never seen the patient react this way at any time. This was definitely a once in a lifetime event. The patient's reaction was not against her but, related to a minor situation. The patient's wife was puzzled and wondered what could have triggered this response. The patient related to her that before the event he was feeling nauseated with a head buzz. The emotional outburst came a few minutes later and was directed towards a benign question from a coworker. The patient reported that he did not and had never taken, nonprescribed drugs nor, do he drink alcohol. They were both befuddled until she mentioned that the only difference in his routine was the Shingrix shot the day before the adverse event.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Ocular hyperaemia
Clinical narrative: nausea; headache; completely out-of-character nervous/ emotional outburst; completely out-of-character nervous/ emotional outburst; head buzz; This case was reported by a consumer and described the occurrence of nausea in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of ophthalmic herpes simplex (1st dose received in June 2019, refer linked case US2019AMR150995).   On 14th August 2019, the patient received the 2nd dose of Shingrix. On 15th August 2019, 1 days after receiving Shingrix, the patient experienced nausea, headache, nervous, emotional distress and noises in head. On an unknown date, the outcome of the nausea, headache, nervous, emotional distress and noises in head were unknown.   It was unknown if the reporter considered the nausea, headache, nervous, emotional distress and noises in head to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced a completely out-of-character nervous or emotional outburst. The patient's 50 yesr old wife mentioned that she had never seen the patient react this way at any time. This was definitely a once in a lifetime event. The patient's reaction was not against her but, related to a minor situation. The patient's wife was puzzled and wondered what could have triggered this response. The patient related to her that before the event he was feeling nauseated with a head buzz. The emotional outburst came a few minutes later and was directed towards a benign question from a coworker. The patient reported that he did not and had never taken, nonprescribed drugs nor, do he drink alcohol. They were both befuddled until she mentioned that the only difference in his routine was the Shingrix shot the day before the adverse event.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Emotional distress, Headache, Nausea, Nervousness, Tinnitus
Clinical narrative: nausea; headache; completely out-of-character nervous/ emotional outburst; completely out-of-character nervous/ emotional outburst; head buzz; This case was reported by a consumer and described the occurrence of nausea in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of ophthalmic herpes simplex (1st dose received in June 2019, refer linked case US2019AMR150995).   On 14th August 2019, the patient received the 2nd dose of Shingrix. On 15th August 2019, 1 days after receiving Shingrix, the patient experienced nausea, headache, nervous, emotional distress and noises in head. On an unknown date, the outcome of the nausea, headache, nervous, emotional distress and noises in head were unknown.   It was unknown if the reporter considered the nausea, headache, nervous, emotional distress and noises in head to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced a completely out-of-character nervous or emotional outburst. The patient's 50 yesr old wife mentioned that she had never seen the patient react this way at any time. This was definitely a once in a lifetime event. The patient's reaction was not against her but, related to a minor situation. The patient's wife was puzzled and wondered what could have triggered this response. The patient related to her that before the event he was feeling nauseated with a head buzz. The emotional outburst came a few minutes later and was directed towards a benign question from a coworker. The patient reported that he did not and had never taken, nonprescribed drugs nor, do he drink alcohol. They were both befuddled until she mentioned that the only difference in his routine was the Shingrix shot the day before the adverse event.
Sex: F
Vaccine: DTAP, HPV9, MNQ, MNQ, HPVX, MNQ, TDAP
Symptoms: Dyspnoea, Swelling face, Urticaria
Clinical narrative: symptoms worsened with facial swelling; localized urticaria/ hives; Initial information received on 16-Aug-2019 regarding an unsolicited valid serious case received from a other health professional.  This case involves a 12 years old female patient who experienced localized urticaria and facial swelling, while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) 0.5 mL IM right arm and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP), (non-Sanofi) 0.5 mL IM left arm  on 14-Aug-2019 during routine vaccinations  On 14-Aug-2019, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6208AB (Expiry date 08-Jul-2020) via intramuscular route in the left arm.  On 14-Aug-2019 at 1:41 PM, the patient developed a serious localized urticaria (urticaria) same day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. At 2:33 PM, her symptoms worsened with facial swelling (swelling face) same day following vaccination. These events were assessed as medically significant.  (Other relevant tests included no lab data.) Final diagnosis was facial swelling and localized urticaria.  The patient was treated with Decadron (dexamethasone) 4mg intramuscular and Benadryl (diphenhydramine) 25 mg orally At 233 PM, her symptoms worsened with facial swelling and she was given epinephrine 0.3 intramuscular. EMS was called at 235 PM, and the patient taken to  Hospital. Patient returned to clinic on Thursday (15Aug2019) because the hives came back and was given epinephrine 0.3 mg auto-injector as needed, cetirizine 10 mg orally daily, ranitidine hcl 150 mg orally twice daily and Singulair (montelukast)10 mg orally daily and told to return to the emergency room if the symptoms return.  The event outcome is reported as Unknown for localized urticaria and facial swelling.  List of documents held by sender: none.; Sender's Comments: This case concerns a young patient who presented with localized urticaria and facial swelling same day after vaccination. The time to onset is compatible and the events are expected with this vaccine. However, allergic history and tolerance to previous vaccinations are important points to consider in this case, which is missing at present. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: DTAP, HPV9, MNQ, MNQ, HPVX, MNQ, TDAP
Symptoms: Swelling face, Urticaria
Clinical narrative: symptoms worsened with facial swelling; localized urticaria/ hives; Initial information received on 16-Aug-2019 regarding an unsolicited valid serious case received from a other health professional.  This case involves a 12 years old female patient who experienced localized urticaria and facial swelling, while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) 0.5 mL IM right arm and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP), (non-Sanofi) 0.5 mL IM left arm  on 14-Aug-2019 during routine vaccinations  On 14-Aug-2019, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6208AB (Expiry date 08-Jul-2020) via intramuscular route in the left arm.  On 14-Aug-2019 at 1:41 PM, the patient developed a serious localized urticaria (urticaria) same day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. At 2:33 PM, her symptoms worsened with facial swelling (swelling face) same day following vaccination. These events were assessed as medically significant.  (Other relevant tests included no lab data.) Final diagnosis was facial swelling and localized urticaria.  The patient was treated with Decadron (dexamethasone) 4mg intramuscular and Benadryl (diphenhydramine) 25 mg orally At 233 PM, her symptoms worsened with facial swelling and she was given epinephrine 0.3 intramuscular. EMS was called at 235 PM, and the patient taken to  Hospital. Patient returned to clinic on Thursday (15Aug2019) because the hives came back and was given epinephrine 0.3 mg auto-injector as needed, cetirizine 10 mg orally daily, ranitidine hcl 150 mg orally twice daily and Singulair (montelukast)10 mg orally daily and told to return to the emergency room if the symptoms return.  The event outcome is reported as Unknown for localized urticaria and facial swelling.  List of documents held by sender: none.; Sender's Comments: This case concerns a young patient who presented with localized urticaria and facial swelling same day after vaccination. The time to onset is compatible and the events are expected with this vaccine. However, allergic history and tolerance to previous vaccinations are important points to consider in this case, which is missing at present. Based upon the reported information, the role of the vaccine cannot be assessed.