chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Swelling face
Clinical narrative: Patient reported major reaction of face and eyes swelling and hours after immunization did not seek medical attention. Took BENADRYL and stayed home for 1 day. Has happened previously and was over event within 24 hours.
Age: 1.4
Sex: M
Vaccine: MMR
Symptoms: Blister, Papule, Pruritus, Rash
Clinical narrative: 9/29/13-Very itchy, noticed spots. 9/30/13 - Seen in office - scattered papule vesicles, face, arms, legs, neck, no fever. Rx Benadryl, Aveeno, Tylenol. Child had been exposed previous week.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Pain in extremity, Rash
Clinical narrative: Large red rash (2"x3") on left forearm, looks swollen, is painful, not itchy. Received 2 vaccinations on 10/4, came back to pharmacy on 10/7. Advised patient to take NSAID for inflammation and pain and report back tomorrow if not better.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Pt had flu like symptoms fever and pain at injection site on 10/06/2013 pt has a 2" radius redness at injection site, warm, and inflamed.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Pt had flu like symptoms fever and pain at injection site on 10/06/2013 pt has a 2" radius redness at injection site, warm, and inflamed.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: A baseball size bruise around injection site with a small amount of redness and swelling.  No fever or pain reported.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache
Clinical narrative: Client received the influenza on 9/26/13 at arround 8am, at about 10.30am return with complaint of dizziness, and headache, vitals done all within range, due to dizziness 911 was called and client transfer in stable condition.
Age: 49.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Employee states that she had a 3-4 inch size oblong redness and warmth to right deltoid.  In previous years, it was only a quarter size.  Denies nausea, vomiting, body aches, chills, or fever.  She reported to Occupational Health on 10/4/13 her symptoms.  Counseled on different forms of flu vaccines for future purposes.  She acknowledged understanding and will monitor any potential symptoms in the future from the flu vaccine.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Electrocardiogram normal, Fall, Head injury, Syncope
Clinical narrative: Patient experienced syncope post vaccination and fell and hit his head. When pharmacist responded, patient was conscious, sitting upright and talking. Patient was transported to emergency room via ambulance.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Hot flush, Hyperhidrosis, Pain
Clinical narrative: Achy especially in the arms, tired, chills no fever and hot flushes at least 7 a day.  Today is the 7 of October and the symptoms since to be going away.  The hot flushes lasted 10 minutes to the point where I was perspiring from the waist up.
Age: 19.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Dizziness, Feeling hot
Clinical narrative: "Light headed and felt a little warm." Patient was transported to ER and reported to start to feel a little better when arriving.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Vaccination site inflammation, Vaccination site warmth
Clinical narrative: Inflammation of the vaccination site (redness, warm skin) with a diameter of about 4 inches.  Patient reported that the inflammation was worse yesterday than today.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Hypersensitivity, Lacrimation increased, Ocular hyperaemia, Swelling face
Clinical narrative: 10/02/2013: Left eye became bloodshot, and started watering from the outer corner, and had mucous build up in inner corner. This became worse as the day went on. 10/03/2013: Left side of face was noticeably swollen. Left eyelid was swollen at least three times normal size. The redness, mucous build up and weeping was much worse. My eye did not itch, but the symptoms were very noticeable to everyone I came into contact with. Regular doctor called in anti-biotic eye drops. These did not help. 10/04/2013: Went to eye doctor. Eye doctor prescribed erythromycin ointment and FML drops. This has helped the problem. Eye doctor confirmed this is an allergic reaction.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient noticed he had shingles the day after the vaccine was administered. Went to the ER.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Pain in extremity, Sleep disorder
Clinical narrative: My arm was very difficult to raise and experienced serious pain for 48+ hours. I was unable to sleep due to pain and felt my shoulder and arm were not able to lift, push or pull any weight. I am still experiencing pain even though I am taking Advil.
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Chest pain, Dyspnoea, Lethargy, Pyrexia
Clinical narrative: Very lethargic, severe headache, chest pains, joint pains, hard to breathe, fever, temp:103, bp:150/101, pulse rate:120.
Age: 37.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blister, Condition aggravated, Dyspnoea, Eye swelling, Hemiplegia
Clinical narrative: Vesicles around the shot site in clusters. Edema and erythema around shot site. Vesicles on left side of mouth (same side of shot site). Swelling of eyes. Blurring of vision. Swelling of throat. Pain scale 10 + in shoulder and are followed by paralysis on side of shot site. Difficulty in breathing. Status epilepticus followed.
Age: 37.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site vesicles, Musculoskeletal pain, Pain
Clinical narrative: Vesicles around the shot site in clusters. Edema and erythema around shot site. Vesicles on left side of mouth (same side of shot site). Swelling of eyes. Blurring of vision. Swelling of throat. Pain scale 10 + in shoulder and are followed by paralysis on side of shot site. Difficulty in breathing. Status epilepticus followed.
Age: 37.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pharyngeal oedema, Status epilepticus, Vision blurred
Clinical narrative: Vesicles around the shot site in clusters. Edema and erythema around shot site. Vesicles on left side of mouth (same side of shot site). Swelling of eyes. Blurring of vision. Swelling of throat. Pain scale 10 + in shoulder and are followed by paralysis on side of shot site. Difficulty in breathing. Status epilepticus followed.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt has redness and swelling at the site of inoculation.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left upper arm below the injection site appeared swollen & erythemic.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site erythema, Injection site swelling, Pain, Pruritus
Clinical narrative: Redness and swelling of the R arm surrounding injection site, pain and itching.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash developed on various body parts.
Age: 83.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Patient described significant swelling of arm over widespread area after receiving Pneumovax vaccine. He also said redness spread down his arm.  He did not seek any treatment and said reaction does not hurt and is dissipating.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site urticaria
Clinical narrative: Developed hives all over left arm where injection was given. Took antihistamine & used cold compresses.
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash macular, Rash pruritic
Clinical narrative: Erythematous macular rash on trunk from neck to buttocks and pubis. Within 3 days, rash was coalescing and becoming pruritic.  10/01 saw MD who prescribed Prednisone 20mg x 5 days and Hydroxyzine HCL as needed.  Rash did spread groin and very tops of thighs and underarms and very tops of arms.  Became lighter with medication but still present as of 10/07/2013.
Age: 0.25
Sex: F
Vaccine: HIBV, RV5
Symptoms: Haematochezia, Lethargy
Clinical narrative: Bleeding in stool, extremely lethargic for 10 days.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling at shot site. Swollen and red. Went to urgent care and got antibiotic.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Feeling hot, Hyperhidrosis, Oropharyngeal pain, Pain in extremity
Clinical narrative: Got hot and sweaty, shortness of breath for several hours; at 3:00 AM still short of breath, pain in left arm into my throat; tightness in throat; self-administered Flovent.  Shortness of breath got better so I could sleep. Throat was still tight in the morning. Took 1 Tylenol.  All symptoms are gone by end of 10/6/13.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Got hot and sweaty, shortness of breath for several hours; at 3:00 AM still short of breath, pain in left arm into my throat; tightness in throat; self-administered Flovent.  Shortness of breath got better so I could sleep. Throat was still tight in the morning. Took 1 Tylenol.  All symptoms are gone by end of 10/6/13.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Shaking, Tremors, Chills, High Fever.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Chills, Cold sweat, Muscle spasms
Clinical narrative: I experienced short-lived but painful cramps and cold sweats (phase 1), followed by chills, aches and pains (phase 2).  The first phase lasted only about an hour; the second was much longer (around 4 hours).  Started around 10 that evening.  I was pretty weak the rest of that next day (Saturday).
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling
Clinical narrative: Swelling of upper and lower lips.  Took 25 mg diphenhydramine.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Enema administration, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: ROTAVIRUS vaccine given 9/10/13. Hospitalized 10/4/13 with 1 day hx symptoms. Intussusception diagnosed and reduced with barium study.
Age: 73.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt received Zostavax in left arm on 9/29 around 12:30 PM, Pt called pharmacy on 10/1 around 6:30 PM stating that injection site is "red, itchy, and size of an orange" but denies temperature, pain, or swelling in other parts of body. States feels fine but has watch site grow swollen over past 2 days. Did not recommend hi-antagonist due to medication interaction. Suggested cool dressing and to notify primary care in AM. Pt did not want visit to ER.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site urticaria
Clinical narrative: Patient received Zostavax on 9/9/13. Came into pharmacy on 10/5/13 with large red whelp at injection site. MD confirmed an infection.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Pain, Tremor
Clinical narrative: Employee describes: chills, shaking, body aches, headache for about five or six hours.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash
Clinical narrative: NECK AND SHOULDER RASH. BODY ITCHINESS.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Runny nose, high fever, congestion.
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: PATIENT HAD A RED SKIN RASH AROUND INJECTION SITE. AREA WAS WARM TO THE TOUCH AND THERE WERE 2 SMALL BUMPS (ONE AT TOP AREA AND ONE BELOW AREA.
Age: 0.34
Sex: F
Vaccine: DTPHEP, HIBV, PNC13, RV1
Symptoms: Crying
Clinical narrative: Inconsolable, high-pitched crying for 24 hours.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Patient experienced redness, swelling and pain in the injection arm.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Heart rate increased, Hyperhidrosis
Clinical narrative: Fast heartbeat, dizziness, lightheadedness, diaphoretic and general weakness.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Hypersomnia, Nausea, Vomiting
Clinical narrative: General weakness, nausea, vomiting, slept for more than 24 hours after sleeping the day of the shot (work nights). Effects lasted for 72 hours.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test, Chills, Full blood count, Malaise, Oropharyngeal pain
Clinical narrative: Felt ill within hours of receiving vaccine - fever, chills. Progressed to sore throat and full illness by 9/17/2013. Continued to worsen. Diagnosed with viral pneumonia 09/21/2013.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Pneumonia viral, Pyrexia
Clinical narrative: Felt ill within hours of receiving vaccine - fever, chills. Progressed to sore throat and full illness by 9/17/2013. Continued to worsen. Diagnosed with viral pneumonia 09/21/2013.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pharyngeal oedema, Pruritus generalised
Clinical narrative: Pt feels she is allergic to the shot and had all over body itching and felt as if throat swelling.  There was no swelling or redness at the injection site  she aldo had severe muscle pains.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain
Clinical narrative: Woke up with very sore shoulder, on the same arm that I received the vaccination in. I have a very limited range of motion, and pain when arm is not at side. Pain was worse when I woke up today (10/7/2013), and has stayed constant.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dyspnoea, Fatigue, Headache, Paranasal sinus hypersecretion
Clinical narrative: Cough, trouble breathing, congestion, sinus pressure and drainage, headache, fatigue.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Respiratory tract congestion, Sinus headache
Clinical narrative: Cough, trouble breathing, congestion, sinus pressure and drainage, headache, fatigue.
Age: 36.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Influenza, Pain, Pyrexia
Clinical narrative: After injection soreness followed that was normal.  At 12:00 onset of diarrhea followed by a fever in the afternoon.  Aches and flu symptoms followed for 2 days with fever between 100-103.  Day 3 fever continues to be 101.  After talking with my mother she had exactly the same response to the recent flu shot one week earlier.  She recovered after 4-5 days.  I plan on seeing a primary physician on day 5.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Abasia, Activities of daily living impaired, Electromyogram, Gait disturbance, Nuclear magnetic resonance imaging normal
Clinical narrative: Shooting and stabbing pain started in my right leg and the injection was given in the right side of butt about a hour after injection. Primary Care physician diagnosed me with sciatica after not being able to bare any weight on my right leg.  Dr. prescribed anti inflammatory drugs and pain medicine. I was out of work from the time of injection until 7/22/13. Once I returned to work I couldn't walk on my leg and I've been out since until today. I had an MRI and Xray performed and nothing showed up in those test. I was also given an EMG to test for permanent damage. The pain management Dr. told me to take anxiety medication before the test and I read in a brochure that this could alter the testing therefore I'll be receiving another EMG on 10/24/13. I've been receiving physical therapy from August and still receiving treatment. I was walking on a walker but I've started to walk on my on but with a limp. My period has been irregular since the shot was administered.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Sciatica, Weight bearing difficulty, X-ray normal
Clinical narrative: Shooting and stabbing pain started in my right leg and the injection was given in the right side of butt about a hour after injection. Primary Care physician diagnosed me with sciatica after not being able to bare any weight on my right leg.  Dr. prescribed anti inflammatory drugs and pain medicine. I was out of work from the time of injection until 7/22/13. Once I returned to work I couldn't walk on my leg and I've been out since until today. I had an MRI and Xray performed and nothing showed up in those test. I was also given an EMG to test for permanent damage. The pain management Dr. told me to take anxiety medication before the test and I read in a brochure that this could alter the testing therefore I'll be receiving another EMG on 10/24/13. I've been receiving physical therapy from August and still receiving treatment. I was walking on a walker but I've started to walk on my on but with a limp. My period has been irregular since the shot was administered.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Headache, Loss of consciousness, Mydriasis, Pallor
Clinical narrative: Vasovagal response after administration of vaccine. It was given in the left arm, patient got up & walked 20 steps, stood still, & passed out. Pupils dilated, pale skin coloring, and dizziness with headache.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Presyncope
Clinical narrative: Vasovagal response after administration of vaccine. It was given in the left arm, patient got up & walked 20 steps, stood still, & passed out. Pupils dilated, pale skin coloring, and dizziness with headache.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Rash pruritic, Urticaria
Clinical narrative: Itchy bumps on lower arms.  A few days later, itchy bumps persisted along with red patches in the inner elbow areas, hives on arms and neck.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Inflammation, Mass, Migraine with aura, Ocular hyperaemia
Clinical narrative: Headache starting same day as vaccine. Day 2...9" x 4" inflammation on upper arm with 2 bulls eye red areas measuring 4" in diameter.  Hard lemon sized lump under skin, very hot to the touch. Saw doctor on day 3. Ice packs and Tylenol suggested as well as Benadryl. On day 4 intense itching started. Had to seek medical attention on day 5.  1% hydrocortisone cream added. Saw doctor again on say 6.  Arm is "calming down" but there is still some inflammation, warmth, a hard lump. I also had an ocular migraine the morning of day 4. Still showing signs of reaction.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin warm
Clinical narrative: Headache starting same day as vaccine. Day 2...9" x 4" inflammation on upper arm with 2 bulls eye red areas measuring 4" in diameter.  Hard lemon sized lump under skin, very hot to the touch. Saw doctor on day 3. Ice packs and Tylenol suggested as well as Benadryl. On day 4 intense itching started. Had to seek medical attention on day 5.  1% hydrocortisone cream added. Saw doctor again on say 6.  Arm is "calming down" but there is still some inflammation, warmth, a hard lump. I also had an ocular migraine the morning of day 4. Still showing signs of reaction.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site swelling, Swelling
Clinical narrative: Oct 1 and 2 - swelling. Oct 3 - red, hot, swollen. Patient took BENADRYL 1 BID. Oct 4 - the pharmacist who gave the shot saw upper right arm red and bit swollen. It was around 2 inches below admin site and toward inner arm. Patient took BENADRYL 1 BID. Oct 5 - patient took BENADRYL BID. Oct 6 - patient took BENADRYL in the PM. Oct 7 - a little swollen but not sore.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Cold sweat, Dizziness, Headache, Vomiting
Clinical narrative: Violent headache, dizziness, cold sweats when standing, vomited, some mild lower back pain, all these symptoms lasting until evening about 9:30 PM.  NO FEVER. No illness the next day.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Neck pain, Pain in extremity, Paralysis
Clinical narrative: Patient experienced pain radiating up the neck, down the arm on day 1. Noon on day 3, pain radiated down to the knee and hip on the same side. She also described a transient paralysis on the same side.
Age: 72.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Erythema, Herpes zoster, Rash, Swelling
Clinical narrative: Swelling started Tuesday and redness on Wednesday. Movement OK rash on tricept and wrap to breast on front probable shingles due to location of rash (no rash on deltoid).
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Rash on arm (Rt) 2 days after receiving HPV.
Age: 28.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: Pt received FLUMIST on 27Sep13. Pt found out she was pregnant on 01Oct13. Pt stated she had been pregnant for a couple weeks. Pt has no signs/symptoms of any adverse reaction but was concerned since it is live.
Age: 12.0
Sex: F
Vaccine: HPV4, MMR, MNQ, TDAP, VARCEL
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from a nurse, via company representative, refers to a 12 year old female patient. On 05-SEP-2013 the patient was vaccinated with GARDASIL (lot # J003727, expiration date 07-NOV-2015) (dose and route were not reported) injection. Other suspect therapies included M-M-R II (lot # J002504, expiration date 28-FEB-2015) (dose, route and indication were not reported), (Merck) VARIVAX (lot # J003224, expiration date 15-MAR-2015) (dose, route and indication were not reported), DTaP (unspecified) (lot #33AG5, expiration date 18-SEP-2015) (dose, route and indication were not reported) and MENACTRA (lot # U4556AA, expiration date 04-SEP-2014) (dose, route and indication were not reported). Concomitant therapies included VENTOLIN 9 mcg/once daily. On 05-SEP-2013, after patient received the vaccines she had a seizure and had to be taken to the hospital. It is unknown if the patient was admitted overnight. It was unknown which vaccine was the cause of the seizure. The outcome of seizure was not reported. No lab diagnostics studies were performed. Seizure was considered to be medically significant by the reporter. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dizziness, Headache, Injection site inflammation, Injection site urticaria, Pyrexia
Clinical narrative: Inflamed area at site. 3 cm wheal, lightheadedness, fever, headache.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Immediate post-injection reaction, Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Red, hot lump appeared at site of injection immediately after receiving injection subsided after 3 hours. Reappeared with intense burning and itching 3 days later. Lasted 4 days so far.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Red, hot lump appeared at site of injection immediately after receiving injection subsided after 3 hours. Reappeared with intense burning and itching 3 days later. Lasted 4 days so far.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Started with oblong 1 1/2 x 3 in injection site reaction - warm, hard and red. Followed by headache and 1 1/2 days and soreness in elbows and knees. Then 9/25 blisters around lips up to this date 9/29/13.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip blister
Clinical narrative: Started with oblong 1 1/2 x 3 in injection site reaction - warm, hard and red. Followed by headache and 1 1/2 days and soreness in elbows and knees. Then 9/25 blisters around lips up to this date 9/29/13.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Symptoms of itching and warm area around injection site started Saturday 9/28. From there, the area around injection site started enlarging in size and became increasingly itchy, red and hot. Patient took BENADRYL and gabapentin for symptoms. By 10/1, symptoms improved and area is decreasing in size and redness.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Severe arm pain extending from injection site to fingers; described as burning pain, no bruising, no swelling.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Tenderness
Clinical narrative: 9/19/2013, pt observed red patches and blisters on (R) leg and stomach. Pt also experienced tenderness in stomach area. Pt was on camping trip.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an office manager concerning multiple unspecified patients of unknown age and gender. On unknown dates, multiple unspecified patients were vaccinated with doses of GARDASIL (lot number, expiry date, dose and route unspecified) that may have gone through an unsupported temperature excursion. No concomitant therapy was reported. No adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Rash pruritic
Clinical narrative: 9/27/13 patient stated day after vaccination developed rash over back which itched and had sore achy shoulder patient applied BENADRYL and rash resolved on 9/27.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: 9-27-13 - AFLURIA # R55808 Exp 6-30-14 approx. 15 minutes post injection, experienced facial numbness and (L) arm weakness took BENADRYL 25 mg PO several times throughout next 48 hours - symptoms resolved.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Pain, Pyrexia, Vomiting
Clinical narrative: Severe chills, fever, body and joint pain. Vomiting. Joint pain next day also.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling
Clinical narrative: Patient's arm was extremely swollen, MD gave prednisone 40 mg daily for 4 days.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Chills, Injection site reaction, Local swelling, Nausea, Pyrexia
Clinical narrative: Patient had injection site reaction to Pneumovax. Had a big lump of 4 inches possibly infected. Patient also had nausea, fever, chills.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site discolouration, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Local redness, color and swelling at left deltoid, cellulitis vs local immunization reaction.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Back pain, Headache, Myalgia, Photophobia
Clinical narrative: Patient received HPV and Influenza vaccines on 9-24-2013. Some day developed myalgias, back pain and HA/photophobia. Persisted for at least 72 hours.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Full blood count, Metabolic function test, Unevaluable event
Clinical narrative: Possible seizure 6 days after vaccine.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Headache, Induration, Musculoskeletal stiffness
Clinical narrative: Headache, light bruising, fever, stiff neck, redness and hard know appeared post 24 hours.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Nodule, Pyrexia
Clinical narrative: Headache, light bruising, fever, stiff neck, redness and hard know appeared post 24 hours.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Epistaxis, Headache, Lacrimation increased, Lip swelling
Clinical narrative: On the morning of 10-4-2013 reported headache, temperature of 101.0, nosebleeds with sneezing, puffy lips and face, watery eyes, stuffy nose.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal congestion, Sneezing, Swelling face
Clinical narrative: On the morning of 10-4-2013 reported headache, temperature of 101.0, nosebleeds with sneezing, puffy lips and face, watery eyes, stuffy nose.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: Itching, redness for 72 hours after injection received.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site became swollen, red - size of softball 6 inch by 8 inches, redness 4 days, tender to touch.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site erythema, Pain, Pruritus, Swelling
Clinical narrative: Sore, swollen, hot itchy for 72 hours after vaccine received. Redness around injection site size of baseball.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Erythema, Influenza, Nausea, Pruritus
Clinical narrative: She had softball size area of redness, swelling, itching, rash that lasted for 6 days. Fever of 102 degrees, nausea, upper respiratory coughing, sinus infection, flu.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rash, Sinusitis, Swelling
Clinical narrative: She had softball size area of redness, swelling, itching, rash that lasted for 6 days. Fever of 102 degrees, nausea, upper respiratory coughing, sinus infection, flu.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Itching after 1 hour that lasted for 3 days.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Employee had softball size area around the injection site that became hot, swollen, itchy for three days after injection was received.
Age: 40.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site pain, X-ray limb
Clinical narrative: Left shoulder pain. MD appt. day after. Followed up with Orthopedics.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Headache, Induration, Pain, Swelling
Clinical narrative: Pt has redness, swelling, and softball size wheal that became hard, tender to touch, headache for 24 hours, soreness for 48 hours.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness, Urticaria
Clinical narrative: Pt has redness, swelling, and softball size wheal that became hard, tender to touch, headache for 24 hours, soreness for 48 hours.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Pruritus, Swelling
Clinical narrative: After 48 hours employee had redness, hardness, itchiness, large bump for 3 days.
Age: 1.09
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC13
Symptoms: Irritability, Pyrexia, Rash generalised
Clinical narrative: Bumps all over body. Low Fever, Fussy all started a week after injection. Bumps started on back and spread to other parts of stomach, legs, and arms.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Client sympathetic with itching, hives 1 1/2 hr post Zostavax injection. Took 50 mg Benadryl with relief of Sx. Took 50 more mg in 4 hrs with resumption of Sx. Sx resolved with further incident or need for additional Rx.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Local swelling, Pruritus
Clinical narrative: Warm at site of injection (L) arm itchy, (L) hand swollen, (L) elbow red dorsal side, head itching all over.
Age: 0.18
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Crying, Screaming, Somnolence
Clinical narrative: In for vaccines - given around 11 AM. Crying, screaming over 3 hours, sleeping for 5 minutes then screaming. No fever noted, was not eating - well. Advised to observe and give Ibuprofen. Cried off and on for 14 hrs. Stopped 10/5/13.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: Patient was given vaccines on 10/3/13 in the afternoon, approx 1:30pm. By 8:00pm that evening, mom called to report extensive redness, swelling and pain. He was taken to urgent care on 10/6/13 and dx with cellulitis.
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pain at injection site. Painful to use arm. Taking ALEVE.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Patient was administered shot and shortly after (couple days) began having pain down arm and in joints of fingers, saw DR got Voltaren gel but hasn't had relief. Forgot to mention shot at visit.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: (LD) reaction 20 inches width x 14 1/2 inches length. Red pt seen by provider. Instructed pt to put ice packs and take BENADRYL. If not better to come back.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Blood creatinine normal, Syncope
Clinical narrative: Pt had previous reaction to the flu vaccine, she is not allergic to eggs, > 45 min after vaccination she became faint, vital signs monitored and were stable.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Nausea
Clinical narrative: Pt. contacted pharmacy 3 days after getting vaccine. Reported that night of receiving vaccine became nauseated/diarrhea/faint stomach cramps and symptoms continued Wed, Thurs, Fri, Sat after vaccine given Tues.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Nausea
Clinical narrative: Nausea - approximately 5-10 minutes after getting the shot - still feel nauseated when he reported the side effect (already more than 3 hours) and feel a little warm.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Blood culture negative, C-reactive protein increased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and swelling (R) upper thigh on 9/20/13 pm and 9/21 AM. Warm to touch, very painful. No fevers beyond low grade. Increased pain on 9/22. Mom took him to ER on 9/22. X-ray of knee neg. Labs showed mild bumps in ESR and CRP. Blood culture neg after 5 days.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site warmth, Pyrexia, Red blood cell sedimentation rate increased, X-ray limb normal
Clinical narrative: Redness and swelling (R) upper thigh on 9/20/13 pm and 9/21 AM. Warm to touch, very painful. No fevers beyond low grade. Increased pain on 9/22. Mom took him to ER on 9/22. X-ray of knee neg. Labs showed mild bumps in ESR and CRP. Blood culture neg after 5 days.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Electrocardiogram normal, Hypoaesthesia, Hypoaesthesia eye, Hypoaesthesia oral, Laboratory test normal
Clinical narrative: Shot in left shoulder - within hours numbness in left side cheek - up to eye - left side of lips - left edge of tongue.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: About 5-10 minutes after shot, patient came back and said she felt dizzy. I had the patient sit down and she then said she had severe dizziness and almost passed out in a store the previous week. She thought she felt better today, so she marked our questionnaire as not feeling ill. When I checked back w/ her after 10-15 minutes, she said she felt worse and is nauseated. I offered to call ambulance but she refused and said she wanted to wait a little longer w/ her daughter. When I went back into the pharmacy she and her daughter left.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Hypersomnia, Influenza like illness, Pain
Clinical narrative: Fever, flu-like symptoms (headache), excessive sleep (15+ hrs/day) about 6 days. Body ache/chills.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, flu-like symptoms (headache), excessive sleep (15+ hrs/day) about 6 days. Body ache/chills.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pyrexia
Clinical narrative: Fever of 102, entire arm swelling, redness. Patient was given Keflex.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site swelling, Local swelling
Clinical narrative: Swelling of arm, redness, large bump where shot administered.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness/swelling of left arm bicep area, hot to touch with pink color.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Unevaluable event
Clinical narrative: None reported; patient was in good spirits.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Pt came to pharmacy and said his arm was red and swollen. He was breathing normal. Also, complained of itching on arm. Tx = ice pak throughout day plus hydrocortisone 1% cream. Allergic to BENADRYL.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Bed rest, Lethargy, Nausea, Vomiting
Clinical narrative: Starting having nausea/vomiting and general lethargy starting the evening after receiving the injection. Treated with mostly bedrest.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Pain
Clinical narrative: Patient received flu shot on 10/2/13 at about 730 pm. She said she noticed a rash around the injection site by 11:00 am then next morning. A red injection site reaction  "3 inches in diameter" present 10/4/13 PM when seen at the pharmacy. Site was aching per patient. Was to follow-up with PCP next day.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Pain
Clinical narrative: She experienced muscle cramps/soreness on side of vaccination only. She couldn't lay down on that side. She had to take ibuprofen for the pain which resolved after 1 day. She experienced pain a few hours after vaccine.
Age: 50.0
Sex: U
Vaccine: FLU3
Symptoms: Rash, Rash erythematous
Clinical narrative: Rash on trunk and neck red spots --> started on Sunday morning vacc. Friday night.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia oral, Pruritus
Clinical narrative: Pt says feels itchy and lips tingling no trouble breathing.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Vomiting
Clinical narrative: Vomiting. Dizziness about one hour after shot (also after taking medications) (felt better several hours later).
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Erythema, Injection site pain, Pruritus
Clinical narrative: Pt presented to pharmacy 10/7 w/ redness/itching in band on arm from near the elbow to near the shoulder. Pt stated she had soreness at injection site on day of vaccination but not to the extent of redness that developed 101.5 and persisted to 107F mfg also was contacted 101F.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Headache, Musculoskeletal stiffness, Ocular hyperaemia, Pharyngeal oedema
Clinical narrative: Fever, cough, stiff neck, headache, red eyes, swollen throat, BENADRYL, ZANTAC.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever, cough, stiff neck, headache, red eyes, swollen throat, BENADRYL, ZANTAC.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash on torso approximately 1 hour after leaving the store. Took BENADRYL cleared reaction quickly.
Age: 67.0
Sex: M
Vaccine: PPV, RAB, VARZOS
Symptoms: Erythema, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: On 10/4/13 client reports that on 9/28 in the late afternoon he developed severe swelling on the left arm that   went from injection site down past elbow and it ws bright red and very painful and tender also had generalized body aches and headache. Arm swelling and pain lasted 5 days, body aches and headache lasted 4 days. Arm is still tender to touch otherwise all other symptoms resolved.
Age: 67.0
Sex: M
Vaccine: PPV, RAB, VARZOS
Symptoms: Local swelling, Pain, Pain in extremity, Tenderness
Clinical narrative: On 10/4/13 client reports that on 9/28 in the late afternoon he developed severe swelling on the left arm that   went from injection site down past elbow and it ws bright red and very painful and tender also had generalized body aches and headache. Arm swelling and pain lasted 5 days, body aches and headache lasted 4 days. Arm is still tender to touch otherwise all other symptoms resolved.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Erythema, Fatigue, Headache
Clinical narrative: Flu like symptoms 102.3 degrees F temperature. Whole top of arm red, hive like reaction. Headache, fatigue, chills.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Urticaria
Clinical narrative: Flu like symptoms 102.3 degrees F temperature. Whole top of arm red, hive like reaction. Headache, fatigue, chills.
Age: 49.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Injection site discharge, Musculoskeletal stiffness, Pyrexia
Clinical narrative: At 2:30AM after immunization patient experienced stiff neck, chills, site of ZOSTAVAX injection was raw and oozing clear fluid. Patient developed a 100 temp fever. Took MOTRIN resolved the temp.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Local swelling
Clinical narrative: Pt. had minor swelling of his upper arm and redness. It started the day after he received the injection and the swelling lessened but the redness is the same.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Flushing
Clinical narrative: Facial flushing, dizziness.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a female patient of unknown age refers to herself. On an unknown date the patient was vaccinated with GARDASIL (dose, route and lot number not provided). On an unspecified date the patient became pregnant. The LMP and EDD were not known. The patient stated she was pregnant and wanted to know the symptoms of GARDASIL. Additional information is not expected.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Rash
Clinical narrative: Patient said she had a rash starting from her arm where site received flu immunization all the way on her upper back and her shoulders. It happened on 10/5/13 even though she received vaccine on 10/2/13. She also had eaten food w/ soy sauce she's not sure if it is due to that.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous report was received from a physician who reported that a female patient was vaccinated with VARIVAX (Merck) (lot not reported), and then reported that she was pregnant. The pregnancy outcome was outcome pending. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a female patient of unknown age. The patient's medical history, drug reactions and allergies were not provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number were not provided). Three years ago, approximately in 2010, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot number were not provided). The patient received a second dose of GARDASIL on an unspecified date 3 years ago and now was in the office to receive her third dose. Approximately on 19-SEP-2013, the patient was vaccinated with the third dose of GARDASIL (dose, route and lot number were not provided). No adverse symptoms were reported. Additional information is expected.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, C-reactive protein, Injection site pain, Injection site rash
Clinical narrative: This spontaneous report as received from a 51 year old female registered dietitian with no pertinent medical history and no drug reaction allergies, refers to herself. On 04-SEP-2013 the patient was vaccinated with ZOSTAVAX lot# J002865, expiring 07-JUN-2014, 0.65 ml, subcutaneous. There was no concomitant medication. 4 days after the injection, on 08-SEP-2013, the patient experienced a rash, pain at the injection site, her left knee was in absolute pain, inflammation of her joints which she described as squishy and excruciating inflammation affected her left knee, right shoulder and right wrist bone and finger joints, after receiving ZOSTAVAX. She stated she also had sore throat. She stated that discomfort resolved in all joints (and her throat) after two weeks, with the exception of the right knee with increased in inflammation and pain, and had not resolved. She stated that her large muscle groups felt "full of lactic acid". The patients outcome was reported as recovering. The patient stated that she had never had any joint problems in the past. The patient saw a doctor for medical attention. She stated at an unspecified physician was performing blood tests for rheumatoid arthritis, C-reactive proteins, inflammatory markers and had performed x-ray (results not provided). The casual relationship was not provided. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Musculoskeletal discomfort, Oropharyngeal pain, Rheumatoid factor, X-ray
Clinical narrative: This spontaneous report as received from a 51 year old female registered dietitian with no pertinent medical history and no drug reaction allergies, refers to herself. On 04-SEP-2013 the patient was vaccinated with ZOSTAVAX lot# J002865, expiring 07-JUN-2014, 0.65 ml, subcutaneous. There was no concomitant medication. 4 days after the injection, on 08-SEP-2013, the patient experienced a rash, pain at the injection site, her left knee was in absolute pain, inflammation of her joints which she described as squishy and excruciating inflammation affected her left knee, right shoulder and right wrist bone and finger joints, after receiving ZOSTAVAX. She stated she also had sore throat. She stated that discomfort resolved in all joints (and her throat) after two weeks, with the exception of the right knee with increased in inflammation and pain, and had not resolved. She stated that her large muscle groups felt "full of lactic acid". The patients outcome was reported as recovering. The patient stated that she had never had any joint problems in the past. The patient saw a doctor for medical attention. She stated at an unspecified physician was performing blood tests for rheumatoid arthritis, C-reactive proteins, inflammatory markers and had performed x-ray (results not provided). The casual relationship was not provided. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 83 year old female patient with asthma and no know drug reaction/allergies. On 30-SEP-2013 the patient was vaccinated with a 0.5 ml dose of ZOSTAVAX, subcutaneous (lot number J001695). Concomitant therapies included clonidine, propranolol hydrochloride, VERAMYST nasal spray, clotrimazole and betamethasone topical cream. On 01-OCT-2013, the patient experienced injection site reaction which was raised, red and mildly itchy. The pharmacist stated that the reddened area was approximately 4 inches in diameter. She confirmed that no vesicles were present. No treatment was given for the adverse events. No lab diagnostic tests were performed. The patient sought medical attention at the pharmacy. The outcome of the events was reported as not recovered. The casual relationship was not reported. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician via a company representative refers a now 6 year old female patient. On an unspecified date the patient developed chicken pox after receiving VARIVAX (Merck) (lot# unspecified) (dose, route and location unspecified). The patient had sought medical attention via the parent spoke to the physician. The patient was recovered from the event on an unspecified date. This is one of several reports from the same reporter. Additional information has been requested.