chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Arrhythmia, Autopsy, Blood chloride increased, Blood creatinine increased, Blood culture positive
Clinical narrative: Found dead in bed in a.m. by family.  Pathologist stated cause of death as consistent with cardiac insufficiency, due to cardiac arrhythmia, due to probable early cardiomyopathy.  Child Death Review Team felt this death was consistent with a diagnosis of sudden cardiac death.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Blood glucose decreased, Blood potassium increased, Blood sodium normal, Blood urea normal, Body fluid analysis
Clinical narrative: Found dead in bed in a.m. by family.  Pathologist stated cause of death as consistent with cardiac insufficiency, due to cardiac arrhythmia, due to probable early cardiomyopathy.  Child Death Review Team felt this death was consistent with a diagnosis of sudden cardiac death.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Cardiac failure, Cardiomyopathy, Death, Drug screen negative, Microscopy
Clinical narrative: Found dead in bed in a.m. by family.  Pathologist stated cause of death as consistent with cardiac insufficiency, due to cardiac arrhythmia, due to probable early cardiomyopathy.  Child Death Review Team felt this death was consistent with a diagnosis of sudden cardiac death.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Streptococcus test positive, Sudden cardiac death
Clinical narrative: Found dead in bed in a.m. by family.  Pathologist stated cause of death as consistent with cardiac insufficiency, due to cardiac arrhythmia, due to probable early cardiomyopathy.  Child Death Review Team felt this death was consistent with a diagnosis of sudden cardiac death.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Asthenia, Balance disorder, Hyperhidrosis, Hypotonia, Lip discolouration
Clinical narrative: Client within view. Guardian called out client was going to vomit. Client seen going unresponsive. Quiet, Pale but did assist with lowering to floor. Client laid on side. Diaphoretic, lips dusky, flaccid, rare tremoring of muscles. B/P 80/40 Ap 88 strong. Opened eyes to name.  After a few minutes able to answer questions. States he did not eat breakfast this am and was apprehensive of injections. Client given water and crackers. Denies anything, states feeling fine but remains pale, and unsteady when sitting. Laid back down on floor and checked frequently. Remains awake but weak. B/P 104/74. Remained in clinic for 45 minutes after the episode. Telephone call to physician's office to report occurrence.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pallor, Tremor
Clinical narrative: Client within view. Guardian called out client was going to vomit. Client seen going unresponsive. Quiet, Pale but did assist with lowering to floor. Client laid on side. Diaphoretic, lips dusky, flaccid, rare tremoring of muscles. B/P 80/40 Ap 88 strong. Opened eyes to name.  After a few minutes able to answer questions. States he did not eat breakfast this am and was apprehensive of injections. Client given water and crackers. Denies anything, states feeling fine but remains pale, and unsteady when sitting. Laid back down on floor and checked frequently. Remains awake but weak. B/P 104/74. Remained in clinic for 45 minutes after the episode. Telephone call to physician's office to report occurrence.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: Patient began to fell dizzy approximately 3 minutes post injection, then promptly fainted. Pt was laid down on exam table at which time he was noted to appear pale. Pt was at this time speaking and answered questions appropriately.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash erythematous, Rash papular
Clinical narrative: Called on-call pediatric nurse at 8/22/11 6:55pm 1 yr old with fever x 1 day which has resolved. Developed red, raised tiny rash to face, chest, and legs. Mom states rash looks like heat bumps. No discomfort to child. Norm behavior. Eating and drinking well. Family has convinced mom rash is the measles. MMR vaccine given 8/11/2011. Denies new detergent or medication. Was introduced to baked beans yesterday. Afebrile. No cough, vomiting, diarrhea, rash inside mouth, or redness to eyes. Seen on 8/23/11 at 10am at Clinic. Pt awake, afebrile, generalized red papular rash, no other symptoms. Discharged from visit with orders to monitor rash, RTC if it worsens. No meds rx.
Age: 1.3
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Rash erythematous
Clinical narrative: red rash on face with redness around eyes, pt given solumedrol 40 mg IM and Benadryl oral no complications recovered fully
Age: 62.0
Sex: F
Vaccine: YF
Symptoms: Neuritis, Paraesthesia
Clinical narrative: Pt. developed tingling paresthesia in both feet and to a lesser degree in both hands 26 days after vaccination. No clear weakness of any limb, no pain. No rash or fever. Pt. was referred to a neurologist who diagnosed pt. with mild generalized auotimmune neuritis secondary to recent vaccination.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, TDAP, VARCEL
Symptoms: Dermatitis allergic, Hypersensitivity, Injection site rash, Injection site vesicles, Lip swelling
Clinical narrative: Mother stated child awoke with swollen lips "looked like duck bill", scattered rash, with a specific blister area on right arm, upper deltoid area.  No fever or other complaints.  Went to ER.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: sudden vomiting
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Nasal congestion, Rash vesicular, Rhinorrhoea, Skin lesion
Clinical narrative: Pt reports that she broke out in vesicular rash resulting in multiple lesions nose, lips, lower face plus single lesion on neck behind left ear and a single lesion on left arm about 2-3 days after receiving Tdap and VZV immunizations. Also c/o onset of nasal congestion and runny nose but no fever at same time as rash.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, PNC
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Vaccination site haematoma
Clinical narrative: Received Dtap left deltoid Tues. a.m.  On Wed, 8/10/11, left arm bruised around vaccination site.  Sat. night, 8/13/11, site appeared blistery and rashy and was golf ball sized.  Mon., 8/15/11, site was only slightly red.  by Tues. 8/16/11, it was completely gone.  No fever at any time.  No treatment done.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pain, Pruritus, Rash erythematous, Rash papular, Rash vesicular
Clinical narrative: Erythemic, vesicular and papular lesions along lines of L2 and L3 dermatomes at anterior to posterior right thigh. Papular lesions confluent over two, approx. 14x5cm areas.  Pt. describes painful and itchy symptoms onset before rash appeared on 8/20/2011.  Treatment included antiviral medication (Valtrex, 500mg tab, 2 po bid x 7 days) and oral antihistamine for sleeping (cyproheptadine, 4 mg po tid prn itching).
Age: 0.84
Sex: F
Vaccine: FLUX, MMR, MMR, VARCEL
Symptoms: Irritability, Pyrexia, Rash erythematous, Varicella
Clinical narrative: small red spots, fussiness, low fever by 08/22/2011, numerous (>10) obvious chicken pox marks, 100.6 fever.
Age: 0.84
Sex: F
Vaccine: FLUX, MMR, MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: small red spots, fussiness, low fever by 08/22/2011, numerous (>10) obvious chicken pox marks, 100.6 fever.
Age: 1.25
Sex: F
Vaccine: FLUX, MMR, MMR, VARCEL
Symptoms: Irritability, Pyrexia, Rash erythematous, Varicella
Clinical narrative: Pt. had MMR, VARIVAX on 8/15/11 vesicular, papular rash started 8/21/11.
Age: 1.25
Sex: F
Vaccine: FLUX, MMR, MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: Pt. had MMR, VARIVAX on 8/15/11 vesicular, papular rash started 8/21/11.
Age: 30.0
Sex: M
Vaccine: RAB
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia, Paraesthesia oral
Clinical narrative: Paresthesia rt. cheek, jaw and tip of tongue. Observation.
Age: 1.27
Sex: M
Vaccine: VARCEL
Symptoms: Arthropod bite, Pyrexia, Rash, Rash erythematous, Rash generalised
Clinical narrative: Patient had a rash that began on August 4, 2010 that covered both arms and both legs and there were a few spots on his belly and back. The rash look like red hives. They bumps were elevated. I took him to the pediatrican's office for the first of three total visits that same day. The doctor's office told me to treat patient with Benadryl. The second day of the rash patient spiked a fever of 102 and I took him to the doctor's office on 8/6/2010. On day three of the rash it began to spend all over his entire body including in his head and ears. I took him for the third time on 8/8/2010. The consensus of the 3 office visits was undetermined. The nurse on the first visit was convinced that it was a reaction to the chicken pox vaccine. The doctor's never came to a conclusion. One said insect bites which I strongly disagreed with and another same that it was a reaction that was undetermined and the last was unsure...I strongly feel it was a reaction to the chicken pox vaccine.
Age: 1.27
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria, Vaccination complication
Clinical narrative: Patient had a rash that began on August 4, 2010 that covered both arms and both legs and there were a few spots on his belly and back. The rash look like red hives. They bumps were elevated. I took him to the pediatrican's office for the first of three total visits that same day. The doctor's office told me to treat patient with Benadryl. The second day of the rash patient spiked a fever of 102 and I took him to the doctor's office on 8/6/2010. On day three of the rash it began to spend all over his entire body including in his head and ears. I took him for the third time on 8/8/2010. The consensus of the 3 office visits was undetermined. The nurse on the first visit was convinced that it was a reaction to the chicken pox vaccine. The doctor's never came to a conclusion. One said insect bites which I strongly disagreed with and another same that it was a reaction that was undetermined and the last was unsure...I strongly feel it was a reaction to the chicken pox vaccine.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Induration, Oedema peripheral
Clinical narrative: I noticed the swollen right arm around 3:00 p.m. which is the time child is out of school. The arm is very hard and swollen from armpit to elbow. Took him back to HD where shots were given, they looked and said give pain med, ice, and monitor for 48 hours.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: I noticed the swollen right arm around 3:00 p.m. which is the time child is out of school. The arm is very hard and swollen from armpit to elbow. Took him back to HD where shots were given, they looked and said give pain med, ice, and monitor for 48 hours.
Age: 14.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Bladder dysfunction, Convulsion, Dizziness, Dyskinesia, Eye movement disorder
Clinical narrative: Patient was administered Hep A vaccine about 1:30 and at about 1:35pm he was standing in the hallway, he was dizzy and felt tired and proceeded to fall to his left to the floor.  He proceeded to convulse in his neck, legs eyes and tongue and lost control of his bladder.  He would not respond for about 30 sec. without opening his eyes.  He then opened his eyes and pupils were dilated, they returned to normal size and he was able to answer all questions from the nurse.  The nurses had him sit up, staying on the floor, his face was ashen for several minutes.  He was given a cup of water and was observed by the nurse for about 10-15 afterwards.
Age: 14.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Fall, Fatigue, Mydriasis, Pallor, Tongue disorder
Clinical narrative: Patient was administered Hep A vaccine about 1:30 and at about 1:35pm he was standing in the hallway, he was dizzy and felt tired and proceeded to fall to his left to the floor.  He proceeded to convulse in his neck, legs eyes and tongue and lost control of his bladder.  He would not respond for about 30 sec. without opening his eyes.  He then opened his eyes and pupils were dilated, they returned to normal size and he was able to answer all questions from the nurse.  The nurses had him sit up, staying on the floor, his face was ashen for several minutes.  He was given a cup of water and was observed by the nurse for about 10-15 afterwards.
Age: 14.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient was administered Hep A vaccine about 1:30 and at about 1:35pm he was standing in the hallway, he was dizzy and felt tired and proceeded to fall to his left to the floor.  He proceeded to convulse in his neck, legs eyes and tongue and lost control of his bladder.  He would not respond for about 30 sec. without opening his eyes.  He then opened his eyes and pupils were dilated, they returned to normal size and he was able to answer all questions from the nurse.  The nurses had him sit up, staying on the floor, his face was ashen for several minutes.  He was given a cup of water and was observed by the nurse for about 10-15 afterwards.
Age: 14.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Convulsion, Syncope, Urinary incontinence
Clinical narrative: Patient was administered Hep A vaccine about 1:30 and at about 1:35pm he was standing in the hallway, he was dizzy and felt tired and proceeded to fall to his left to the floor.  He proceeded to convulse in his neck, legs eyes and tongue and lost control of his bladder.  He would not respond for about 30 sec. without opening his eyes.  He then opened his eyes and pupils were dilated, they returned to normal size and he was able to answer all questions from the nurse.  The nurses had him sit up, staying on the floor, his face was ashen for several minutes.  He was given a cup of water and was observed by the nurse for about 10-15 afterwards.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Convulsion, Dyskinesia, Fall, Mydriasis, Unresponsive to stimuli
Clinical narrative: Patient was administered her Hep A vaccine at about 1:30pm and was sitting on the exam bed talking normally at about 1:33pm she proceeded to rock forward and jerk to the left causing her to fall of the bed onto her head and landed on her back.  Her neck, arms and legs were convulsing.  She did not respond to her name for about 10 seconds.  She opened her eyes and her pupils were dilated.  She was able to answer the questions the nurses asked of her.  She was examined for any neck injury and was moved back to the exam bed to sit and was given a cup of water.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Generalised erythema, Pain, Pruritus generalised, Skin warm, Swelling
Clinical narrative: Received varicella at 1500 on 08/16/11. Developed generalized swelling and redness by the afternoon of 8/17/11. Experienced warmness to touch, pain and itching in the generalized area of the immunization. Resolved as of 08/22/11.
Age: 3.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Pruritus
Clinical narrative: Pt received Hep A #2 & Varicella #1. With 1-2 minutes her face became red & puffy, face & head very itchy. Hives to face & head. 1 tsp of BENADRYL was given within 1 minute & Dr evaluated child. After 45 min child sym gone & she & mother went home.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Abasia, Dizziness, Feeling hot, Headache, Nausea
Clinical narrative: Patient had sudden onset of headache, nausea with vomiting x 4 episodes, felt dizzy - unable to walk, hot, had itching on head (no rash). F/U on 8/15/2011 at clinic (n/v dizzy f/u).
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Vomiting
Clinical narrative: Patient had sudden onset of headache, nausea with vomiting x 4 episodes, felt dizzy - unable to walk, hot, had itching on head (no rash). F/U on 8/15/2011 at clinic (n/v dizzy f/u).
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Bacterial test, Blood culture, CSF culture, Culture stool, Culture urine
Clinical narrative: 7 days after vaccination developed irritability & poor feeding. No emesis/fever. Seen ED/admitted.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Feeding disorder of infancy or early childhood, Irritability, Polymerase chain reaction, Rotavirus test negative, White blood cell count normal
Clinical narrative: 7 days after vaccination developed irritability & poor feeding. No emesis/fever. Seen ED/admitted.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: (L) arm painful to touch and hot, 13cmx10cm erythema no induration noted. Dr is aware. Per mom no fever, (L) arm ROM wnl sore at times.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Pruritus, Skin warm
Clinical narrative: Patient experienced erythema in injection arm - diffuse at site and spread to below elbow. Patient reported warmth and itching. Pharmacist recommended patient go to MD.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: Electroencephalogram, Guillain-Barre syndrome, Lyme disease, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Hep A rec'd/(R) arm on 5-13-2011. 6/7/11 - 16 y/o c/o aches and pain -> (L) side facial paralysis 6/7/11 adm hospital Dx "Lyme Disease" 7/11 - 7/18 adm hospital Dx Guillain Barre.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: VIIth nerve paralysis
Clinical narrative: Hep A rec'd/(R) arm on 5-13-2011. 6/7/11 - 16 y/o c/o aches and pain -> (L) side facial paralysis 6/7/11 adm hospital Dx "Lyme Disease" 7/11 - 7/18 adm hospital Dx Guillain Barre.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Convulsion
Clinical narrative: Case number PHEH2011US01456 is an initial spontaneous report received from a health care professional (medical assistant) on 11 Aug 2011. This report refers to a 19 year old male patient. He was vaccinated with MENVEO (batch number: A10047) intramuscularly on an unspecified date. He experienced a seizure after vaccination on 05 Aug 2011. The outcome was not reported.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Pallor, Tinnitus
Clinical narrative: Pale, ringing in the ears, lightheadedness.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Dizziness, Dyspnoea, Hyperhidrosis
Clinical narrative: Pt presented w/SOB, cough, dizziness, & diaphoresis. Given diphenhydramine 50mg PO onsite.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Paraesthesia oral, Rash
Clinical narrative: 15 min. after vaccine, pt presented w/ rash on left arm and tingling/swollen lips. Gave pt 50mg diphenhydramine & asked pt to remain for 30 min. Pt symptoms resolved. She left the pharmacy stating she was ok.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin discolouration, Skin exfoliation
Clinical narrative: Pt returned 3 days after injection to show RPh a dollar size rectangle red area. The center had a half dollar (coin) size yellow/pale area. Not painful. OTC pain med & or BENADRYL suggested.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Splotchy, red rash appeared on face following vaccination. Hx of previous vaccines without incident. No other symptoms/AdRS - Advised use of diphenhydramine, famotidine, topical cold pack.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Pruritus, Rash generalised, Rash maculo-papular
Clinical narrative: Maculopapular rash on body and extremities, itching. Treatment: ZYRTEC 10 mg, 1 tab PO daily, and BENADRYL.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Pt got cellulitis per ER Dr 3 days after the shot. Pt is receiving antibiotics: sxs are resolved after 24 hours.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Swelling, redness, hot to the touch, to (R) leg. Measuring 6"x5". Feeling itchy 2 days after immunizations were given. Tx: KEFLEX, BENADRYL, PRELONE, ibuprofen.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient given ZOSTAVAX in left upper arm 8/12/11. Patient came in 8/22/11 for appt with shingles on right leg. Patient's husband (caretaker) stated rash developed on 8/20/11.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Immune system disorder, Musculoskeletal stiffness, Myalgia, Pain, Pyrexia
Clinical narrative: Severe immunologic reaction to tetanus vaccine. Awoke on 7/16/2011 with severe pain, muscle stiffness and pain, breakthrough fever after taking Ibuprofen and TYLENOL. Reported to primary doctor on Mon July 18, 2011.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Vaccination complication
Clinical narrative: Severe immunologic reaction to tetanus vaccine. Awoke on 7/16/2011 with severe pain, muscle stiffness and pain, breakthrough fever after taking Ibuprofen and TYLENOL. Reported to primary doctor on Mon July 18, 2011.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Child fell in lobby about 15 min before Imm & hit head. Had redness on forehead & (L) cheek. Pt was very active & alert during vs at health dept. PEERL. Mom was advised to see PCP due to pt history. Imm given. Mom reports 2 hrs later child had seizure, 911 was called & pt airlifted to hospital where he was hospitalized x 4 days.
Age: 0.37
Sex: F
Vaccine: DTAP
Symptoms: Fontanelle bulging, Pyrexia, White blood cell count normal
Clinical narrative: 8/4 - Fever 102-103 degrees. Hospital: 8/5 - Fever 103 degrees. Bulging Fontanelle, given ROCEPHIN. 8/6 - Fever 101-102  on TYLENOL, swollen fontanelle. 8/7 - Fever 100 degrees, fontanelle still raised, white. 8/8 - Fever 99 degrees off TYLENOL.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture abnormal, Paraesthesia
Clinical narrative: Began to feel numbness and tingling in hands and feet within 1 week could barely walk. Went to ER on Jan 16 2011 where I was diagnosed with Guillain Barre syndrome. The only thing I did different was get the flu shot. I was hospitalized and sent to rehabilitation center where I had to learn to do everything again. It's 7 months later and I'm still recovering.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Excoriation, Fall, Gingival bleeding, Lip pain
Clinical narrative: Pt was sitting upright on the exam table after receiving GARDASIL #3 and Hep A #1. She was waiting the 15 minute period for GARDASIL, when she fainted. I was a few feet away at my work station and heard her fall. I ran into the exam room - pt was post-syncopal, lying on her left side, and appeared to have fallen onto her left chin/lip area. I made sure her C-spine was protected, airway was open, and kept pt on her side until she awoke a few seconds later. Her left lower lip was swollen with superficial abrasion, not requiring sutures. Pt's front left upper tooth and the tooth next to it bled around the gumline. The teeth were not loose. She did have pain when teeth were palpated. Ice was immediately applied to teeth and lip. I did a neurological exam and she remained dizzy. There were no other neurological deficits. Pt indicated that she did not have pain anywhere else on her body except her mouth/chin/lip area. She denied neck or extremity pain. I stayed with the patient first lying on the ground for 5 minutes, then sitting upright on the ground for another 5 minutes, then sitting in a chair for 5 minutes. Pt was then moved back to the exam table to lie down for 10 more minutes due to mild dizziness. I had her mother call her dentist for an emergency visit this afternoon. Pt indicated that her dizziness resolved and she was able to walk without dizziness. Mother was in a hurry to get pt to the dentist. I called mom later in the evening to check on the pt, see separate entry into EMR. Adverse reaction form for GARDASIL completed. Incident report form completed. Office manager notified to counsel nurse regarding the need to lie patients down for 15 minutes after receiving GARDASIL. Mom also told me later that patient fainted after she received GARDASIL #2 and had lab work done at her last office visit with her previous doctor. Dr. spoke with pt's mother to check on pt. Saw the dentist, no fx. Has recheck with dentist next week to make sure all is okay. Her lip is getting more swollen. No emesis. She kept down a smoothie this evening. Mom says that she is resting and sleeping now. Recommended to mom that she do neuro checks (explained this to mom) every 2 hours tonight. To ER if any emesis, neurological abnormalities, etc. Informed mom that we are filling out an adverse reaction form for the GARDASIL.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Lip swelling, Neurological examination abnormal, Oral pain, Syncope, Toothache
Clinical narrative: Pt was sitting upright on the exam table after receiving GARDASIL #3 and Hep A #1. She was waiting the 15 minute period for GARDASIL, when she fainted. I was a few feet away at my work station and heard her fall. I ran into the exam room - pt was post-syncopal, lying on her left side, and appeared to have fallen onto her left chin/lip area. I made sure her C-spine was protected, airway was open, and kept pt on her side until she awoke a few seconds later. Her left lower lip was swollen with superficial abrasion, not requiring sutures. Pt's front left upper tooth and the tooth next to it bled around the gumline. The teeth were not loose. She did have pain when teeth were palpated. Ice was immediately applied to teeth and lip. I did a neurological exam and she remained dizzy. There were no other neurological deficits. Pt indicated that she did not have pain anywhere else on her body except her mouth/chin/lip area. She denied neck or extremity pain. I stayed with the patient first lying on the ground for 5 minutes, then sitting upright on the ground for another 5 minutes, then sitting in a chair for 5 minutes. Pt was then moved back to the exam table to lie down for 10 more minutes due to mild dizziness. I had her mother call her dentist for an emergency visit this afternoon. Pt indicated that her dizziness resolved and she was able to walk without dizziness. Mother was in a hurry to get pt to the dentist. I called mom later in the evening to check on the pt, see separate entry into EMR. Adverse reaction form for GARDASIL completed. Incident report form completed. Office manager notified to counsel nurse regarding the need to lie patients down for 15 minutes after receiving GARDASIL. Mom also told me later that patient fainted after she received GARDASIL #2 and had lab work done at her last office visit with her previous doctor. Dr. spoke with pt's mother to check on pt. Saw the dentist, no fx. Has recheck with dentist next week to make sure all is okay. Her lip is getting more swollen. No emesis. She kept down a smoothie this evening. Mom says that she is resting and sleeping now. Recommended to mom that she do neuro checks (explained this to mom) every 2 hours tonight. To ER if any emesis, neurological abnormalities, etc. Informed mom that we are filling out an adverse reaction form for the GARDASIL.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Pt was sitting upright on the exam table after receiving GARDASIL #3 and Hep A #1. She was waiting the 15 minute period for GARDASIL, when she fainted. I was a few feet away at my work station and heard her fall. I ran into the exam room - pt was post-syncopal, lying on her left side, and appeared to have fallen onto her left chin/lip area. I made sure her C-spine was protected, airway was open, and kept pt on her side until she awoke a few seconds later. Her left lower lip was swollen with superficial abrasion, not requiring sutures. Pt's front left upper tooth and the tooth next to it bled around the gumline. The teeth were not loose. She did have pain when teeth were palpated. Ice was immediately applied to teeth and lip. I did a neurological exam and she remained dizzy. There were no other neurological deficits. Pt indicated that she did not have pain anywhere else on her body except her mouth/chin/lip area. She denied neck or extremity pain. I stayed with the patient first lying on the ground for 5 minutes, then sitting upright on the ground for another 5 minutes, then sitting in a chair for 5 minutes. Pt was then moved back to the exam table to lie down for 10 more minutes due to mild dizziness. I had her mother call her dentist for an emergency visit this afternoon. Pt indicated that her dizziness resolved and she was able to walk without dizziness. Mother was in a hurry to get pt to the dentist. I called mom later in the evening to check on the pt, see separate entry into EMR. Adverse reaction form for GARDASIL completed. Incident report form completed. Office manager notified to counsel nurse regarding the need to lie patients down for 15 minutes after receiving GARDASIL. Mom also told me later that patient fainted after she received GARDASIL #2 and had lab work done at her last office visit with her previous doctor. Dr. spoke with pt's mother to check on pt. Saw the dentist, no fx. Has recheck with dentist next week to make sure all is okay. Her lip is getting more swollen. No emesis. She kept down a smoothie this evening. Mom says that she is resting and sleeping now. Recommended to mom that she do neuro checks (explained this to mom) every 2 hours tonight. To ER if any emesis, neurological abnormalities, etc. Informed mom that we are filling out an adverse reaction form for the GARDASIL.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Flatulence, Gastric dilatation
Clinical narrative: Patient called the pharmacy from home around 6 pm complaining of stomach pain; but no localized reaction. I recommended TYLENOL. The patient stated she had hydrocodone & took one. She called back around 7:30 pm stating that her stomach was swollen. I recommended that she go to the hospital. I f/u with the patient on 8/23/11 & she stated that ER Dr. thought it was gas. Patient stated that she has a doctor appointment this afternoon. Pt. reports persistent pain & swelling as of 11:30 am on 8/23/11.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Oedema peripheral, Pyrexia
Clinical narrative: 1) fever x 3 days. 2) arm swelling x 3 days. 3) muscle aches.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Immediate post-injection reaction, Incoherent, Syncope
Clinical narrative: Patient became dizzy immediately after administration of MENACTRA. Patient had a brief period of syncope and incoherence while sitting on the table. Vital signs monitored for 20 min & ammonium inhalant utilized with prompt recovery of the patient.
Age: 1.24
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Immediate post-injection reaction, Injection site urticaria
Clinical narrative: Immediately following routine injection child developed approx. 5cm area of distinct localized hives at the injection site. 12.5mg p.o. BENADRYL & ice pack given with resolution of rash within approximately 30 mins after injection.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV2, MMR, MNQ, TDAP, VARCEL
Symptoms: Asthenia, Dizziness, Headache, Nausea, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of headache in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included HAVRIX (GlaxoSmithKline), MENACTRA (Sanofi), MMR II (Merck), ADACEL (Sanofi) and VARIVAX (Merck) all given on 12 April 2011. There were no concurrent medications. On 12 April 2011 the subject received 1st dose of CERVARIX at 0.5 ml in the left arm. On the night of 12 April 2011, less than one day after vaccination with CERVARIX, the subject experienced headache, dizziness, nausea, arm pain, tactile fever and body weakness. At the time of reporting the events were improved. Follow-up information received on 13 May 2011 indicated that the events resolved.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV2, MMR, MNQ, TDAP, VARCEL
Symptoms: Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of headache in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included HAVRIX (GlaxoSmithKline), MENACTRA (Sanofi), MMR II (Merck), ADACEL (Sanofi) and VARIVAX (Merck) all given on 12 April 2011. There were no concurrent medications. On 12 April 2011 the subject received 1st dose of CERVARIX at 0.5 ml in the left arm. On the night of 12 April 2011, less than one day after vaccination with CERVARIX, the subject experienced headache, dizziness, nausea, arm pain, tactile fever and body weakness. At the time of reporting the events were improved. Follow-up information received on 13 May 2011 indicated that the events resolved.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Anaphylactic reaction, Chest pain, Cough, Hypersensitivity, Incorrect route of drug administration
Clinical narrative: This case was retrieved from the VAERS database on 20 June 2011, under reference number (VAERS ID 289347). A 5-year-old female patient, with a history of milk and egg allergies (extreme sensitivity), cold-induced asthma, prior allergic reaction, anaphylaxis, and antibiotic allergies (SEPTRA, Omnicef and Penicillin, had received the following vaccinations on 28 August 2007: a fifth injection of DAPTACEL (lot number C2657AA); a second injection of IPOL (lot reported as z1009, not a valid sanofi pasteur lot number number); a second injection of VARIVAX (Merck, lot number 1006U); and a second injection of HAVRIX vaccine (GlaxoSmithKline, lot number AHAVB181AA). All vaccines were reported as being administered intradermally. The patient was not ill at the time of vaccination. Within 10 minutes of vaccination, the patient developed anaphylaxis, reported as throat swelling, coughing, wheezing, chest pain, and mucous drainage. She was treated in her physician's office with Epi Jr, Albuterol via spacer, 2 tablets of BENADRYL, XOPENEX via nebulizer. She was stabilized, and transferred via ambulance to the emergency department. While en route, the patient developed anaphylaxis again, with symptoms of body hives, wheezing, coughing, and high fever. She received another dose of epinephrine and albuterol, and was given oxygen and ORAPED. Upon arrival in the emergency department, she was observed to have coughing, vomiting, wheezing, and increased phlegm. She was treated with intravenous steroids and diphenhydramine, and MOTRIN for fever. She was observed for 6 hours in the emergency department, and after improving was discharged to home. The final diagnosis was acute allergic reaction; outcome was reported as recovered. According to the reporter, the event was life-threatening. A corrective version was created on 30 June 2011 with the same latest receipt date as the prior version (20 June 2011) in order to add to the narrative above that a second injection of HAVRIX vaccine (GlaxoSmithKline, lot number AHAVB181AA) was also administered on 28 August 2007.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Increased upper airway secretion, Pharyngeal oedema, Pyrexia, Sinus operation, Urticaria
Clinical narrative: This case was retrieved from the VAERS database on 20 June 2011, under reference number (VAERS ID 289347). A 5-year-old female patient, with a history of milk and egg allergies (extreme sensitivity), cold-induced asthma, prior allergic reaction, anaphylaxis, and antibiotic allergies (SEPTRA, Omnicef and Penicillin, had received the following vaccinations on 28 August 2007: a fifth injection of DAPTACEL (lot number C2657AA); a second injection of IPOL (lot reported as z1009, not a valid sanofi pasteur lot number number); a second injection of VARIVAX (Merck, lot number 1006U); and a second injection of HAVRIX vaccine (GlaxoSmithKline, lot number AHAVB181AA). All vaccines were reported as being administered intradermally. The patient was not ill at the time of vaccination. Within 10 minutes of vaccination, the patient developed anaphylaxis, reported as throat swelling, coughing, wheezing, chest pain, and mucous drainage. She was treated in her physician's office with Epi Jr, Albuterol via spacer, 2 tablets of BENADRYL, XOPENEX via nebulizer. She was stabilized, and transferred via ambulance to the emergency department. While en route, the patient developed anaphylaxis again, with symptoms of body hives, wheezing, coughing, and high fever. She received another dose of epinephrine and albuterol, and was given oxygen and ORAPED. Upon arrival in the emergency department, she was observed to have coughing, vomiting, wheezing, and increased phlegm. She was treated with intravenous steroids and diphenhydramine, and MOTRIN for fever. She was observed for 6 hours in the emergency department, and after improving was discharged to home. The final diagnosis was acute allergic reaction; outcome was reported as recovered. According to the reporter, the event was life-threatening. A corrective version was created on 30 June 2011 with the same latest receipt date as the prior version (20 June 2011) in order to add to the narrative above that a second injection of HAVRIX vaccine (GlaxoSmithKline, lot number AHAVB181AA) was also administered on 28 August 2007.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Vomiting, Wheezing
Clinical narrative: This case was retrieved from the VAERS database on 20 June 2011, under reference number (VAERS ID 289347). A 5-year-old female patient, with a history of milk and egg allergies (extreme sensitivity), cold-induced asthma, prior allergic reaction, anaphylaxis, and antibiotic allergies (SEPTRA, Omnicef and Penicillin, had received the following vaccinations on 28 August 2007: a fifth injection of DAPTACEL (lot number C2657AA); a second injection of IPOL (lot reported as z1009, not a valid sanofi pasteur lot number number); a second injection of VARIVAX (Merck, lot number 1006U); and a second injection of HAVRIX vaccine (GlaxoSmithKline, lot number AHAVB181AA). All vaccines were reported as being administered intradermally. The patient was not ill at the time of vaccination. Within 10 minutes of vaccination, the patient developed anaphylaxis, reported as throat swelling, coughing, wheezing, chest pain, and mucous drainage. She was treated in her physician's office with Epi Jr, Albuterol via spacer, 2 tablets of BENADRYL, XOPENEX via nebulizer. She was stabilized, and transferred via ambulance to the emergency department. While en route, the patient developed anaphylaxis again, with symptoms of body hives, wheezing, coughing, and high fever. She received another dose of epinephrine and albuterol, and was given oxygen and ORAPED. Upon arrival in the emergency department, she was observed to have coughing, vomiting, wheezing, and increased phlegm. She was treated with intravenous steroids and diphenhydramine, and MOTRIN for fever. She was observed for 6 hours in the emergency department, and after improving was discharged to home. The final diagnosis was acute allergic reaction; outcome was reported as recovered. According to the reporter, the event was life-threatening. A corrective version was created on 30 June 2011 with the same latest receipt date as the prior version (20 June 2011) in order to add to the narrative above that a second injection of HAVRIX vaccine (GlaxoSmithKline, lot number AHAVB181AA) was also administered on 28 August 2007.
Age: 52.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Gait disturbance, Muscle spasms, Muscular weakness, Pain
Clinical narrative: Muscle weakness, sore leg tendon.
Age: 52.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Tenderness
Clinical narrative: Muscle weakness, sore leg tendon.
Age: 52.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Muscular weakness, Tendon pain
Clinical narrative: Muscle weakness, sore leg tendon.
Age: 14.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Bladder dysfunction, Convulsion, Dizziness, Dyskinesia, Eye movement disorder
Clinical narrative: He collapsed and then seizured and lost his fluids.
Age: 14.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Fall, Fatigue, Mydriasis, Pallor, Tongue disorder
Clinical narrative: He collapsed and then seizured and lost his fluids.
Age: 14.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Unresponsive to stimuli
Clinical narrative: He collapsed and then seizured and lost his fluids.
Age: 14.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Convulsion, Syncope, Urinary incontinence
Clinical narrative: He collapsed and then seizured and lost his fluids.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Tdap (ADACEL) given RA IM - 3min later welts developed at site & pt c/o pruritis. Swollen FNP notified 25mg BENADRYL PO given. 8/17/11 09AM pt has no adverse effects per mother. Welts et itching resolved last NOC.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Breath sounds abnormal, Diarrhoea, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt received PNEUMOVAX 23 at physical 8-17-11. On 8/18, pt called stating she had been vomiting, had hives, itching and diarrhea since the night before. Pt took BENADRYL. Pt seen in office 8/18. Had coarse bronchial breath sounds. Site tender, warm, erythematous raised 5 cm area. (L) arm slightly enlarged. Rx cetirizine in am. BENADRYL at night. Prednisone taper.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pruritus, Urticaria, Vomiting
Clinical narrative: Pt received PNEUMOVAX 23 at physical 8-17-11. On 8/18, pt called stating she had been vomiting, had hives, itching and diarrhea since the night before. Pt took BENADRYL. Pt seen in office 8/18. Had coarse bronchial breath sounds. Site tender, warm, erythematous raised 5 cm area. (L) arm slightly enlarged. Rx cetirizine in am. BENADRYL at night. Prednisone taper.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on right side of body in dermatome pattern
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Developed large urticaria about 12 hrs after injection - located over arms, abd, back, chest and scalp. Resolved with BENADRYL over 24-36 hrs.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning an approximately 15 month old male patient, who on an unspecified date was vaccinated with a dose of MMR II (Lot # not reported). The nurse reported that the patient might have developed autism after receiving MMR II. The nurse reported that the patient developed the autism around 15 months of age and the patient's mother had suspected MMR II. The nurse indicated that the patient's mother reported that the patient was doing much better. The patient was identified as currently being 7 years of age. The nurse had only spoken with the patient's mother on the phone. The patient sought medical attention, contact office. At the time of the report the patient was recovering. Upon internal review autism was considered to be other important medical event. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning "at least 30 children" with no pertinent medical history who were vaccinated with MMR II (lot# unknown). There was no concomitant medication. The consumer reported that she knew "at least 30 children" who had been diagnosed with autism after the children had received the MMR II injection (dose unspecified and route unspecified). No specific details regarding each child was provided. It was unknown if the patients sought any medical attention. Upon internal review, autism was considered as an Other Important Medical event. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: DTAP, MEN
Symptoms: Feeling hot, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Felt very hot, slight fever, headache and sore throat
Age: 12.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: MOM STATES CHILD HAD HIVES AND A SWOLLEN ARM, INFORMED NURSE TODAY THAT CLIENT HAD MENINGITIS VACCINE ON 8-13-2011 BUT FAILED TO PRESENT TO NURSE AT VISIT ON 8-22-2011.  MOM TOOK CHILD TO LOCAL ER FOR TREATMENT
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: fever 104
Age: 14.0
Sex: F
Vaccine: HPVX
Symptoms: Fatigue, Full blood count, Lymphadenopathy, Metabolic function test
Clinical narrative: chain of swollen lymph nodes down neck, extreme fatigue
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Parent noted redness and swelling within 24 hours of vaccine administration. Within 48 hours client began transient episodes of hives. Hives episode recurred over a 2 day period. Parent denied fever, difficulty breathing.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Severe rash only on right arm from shoulder to wrist. Treated with prescriptions valacyclovir and methylprednisolone.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: Swollen arm/itchy; pt. will take BENADRYL & monitor.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Nausea
Clinical narrative: 9:48 am Patient received TdaP (L) and then MENACTRA (R) and stated she felt dizzy and passed out on exam table. O2 stats and vital signs were taken and patient continued to rest on exam table with c/o feeling dizzy and sick to stomach. 10:15a 911 was called to transport patient to ER for c/o dizziness and nausea.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Swelling face, Throat tightness
Clinical narrative: Throat started closing, face swelling, coughing & went to E.R. Got BENADRYL shot. Went to E.R. approximately 4 hrs later.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Fatigue, Headache, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Low grade fever, headache, fatigue. Sore throat, nausea. Taking MOTRIN prn.
Age: 29.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Member woke up morning following vaccination w/ swelling, redness, pain, hot to touch extending from vaccination site to elbow. Member saw PCM on 8-11-11 & was given steroid, ABX, BENADRYL.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Skin lesion
Clinical narrative: 6cm area of erythema, noted left lateral thigh. 2cm area of raised, red lesions left lateral thigh.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: (B) inner thigh redness, swelling, pain lasting from 4:00p to 8:00pm using BENADRYL. Still has small bumps.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Swelling, redness, 1" bump at injection site (L) SQ.
Age: 62.0
Sex: M
Vaccine: UNK
Symptoms: Injection site swelling
Clinical narrative: Hot swollen upper outer arm from injection site (R) deltoid to elbow - relieved by ice packs T 99.4.
Age: 16.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site urticaria, Muscle swelling
Clinical narrative: 3.5 inch x 1/2cm circular urticarial swelling on (R) triceps. Mild tenderness and erythema. Symptoms started today. Cold compresses TID.
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperhidrosis, Pallor, Syncope, Tremor, Vision blurred
Clinical narrative: Pt. fainted for a few minutes after receiving ADACEL. Pale, sweating. Mother saw him shaking, also blurred vision. Paramedics were called, returned to consciousness. Vital signs normal, refused to transport to ER.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness/soreness at injection site. Pain started the night she received vaccine. Redness started two days later. Continued (redness/soreness) up to present.