chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site induration, Injection site inflammation, Injection site mass
Clinical narrative: Swelling, inflamed (hot), redness (5" diameter), hard lump at injection site. After about a week from injection, blisters appeared on leg (shin), forehead, groin, and has progressed to mouth and tongue. Also, stinging sensation around lips. The blisters come and go.  This has continued until April 3, 2013. Will they ever stop? I am using OTC Benadryl tablets and cream.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pain
Clinical narrative: Swelling, inflamed (hot), redness (5" diameter), hard lump at injection site. After about a week from injection, blisters appeared on leg (shin), forehead, groin, and has progressed to mouth and tongue. Also, stinging sensation around lips. The blisters come and go.  This has continued until April 3, 2013. Will they ever stop? I am using OTC Benadryl tablets and cream.
Age: 1.34
Sex: F
Vaccine: HIBV, MMR
Symptoms: Bacterial test negative, Diarrhoea, Parasite stool test negative, Rotavirus test negative
Clinical narrative: Acute diarrhea that began approximately 7 hours after MMR vaccine.  It began at 7pm and continued throughout the night, saturating her bed and clothes 3-4 times per night.  Continued diarrhea 12x day for 3 weeks.  No vomiting or dehydration, continued drinking goat milk and water. Began giving probiotics 4x a day to replace gut bacteria.  Stopped goat milk 4 days into diarrhea and tried Nutramigen formula in case of lactose intolerance.  No changes.  Dr. told me to go back to using goat milk, possibly try gluten free.  We tried gluten free and continue to do so, with very little change.  Weight has been stable with introduction of fattening gluten free snacks.  Nearly 4 weeks later, we still have 3-4 diarrhea diapers per day.  Have been to hospital for pediatric gastroenterology testing.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 04-MAR-2013, the patient was vaccinated with ZOSTAVAX, .65 ml, subcutaneous (lot number and expiry date not provided). On 28-MAR-2013, 25 days after onset of therapy the patient experienced small rash on her chest. The pharmacist assistant there are no vesicles on the rash, but it is raised and the patient assistant "it burns when it scratch it". The outcome of small rash on her chest and "it burns when I scratch it" was unknown. The reporter did not assess the relationship of small rash on her chest and "it burns when I scratch it" to ZOSTAVAX. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 12 year old patient of unknown gender. On 23-MAR-2013, the patient was vaccinated with a second dose of expired GARDASIL (lot number was reported as 12717, expiry date was 11-DEC-2012, dose and route was not reported). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Cellulitis, Pyrexia
Clinical narrative: This spontaneous report as received from an unspecified type of reporter refers to a female patient of unknown age. On 17-MAR-2013 in the evening the patient was vaccinated with PNEUMOVAX23. The dose number, route of administration, anatomical location, lot number and expiry date were not reported. Concomitant therapies included SYNTHROID for thyroid treatment and estrogens, PREMARIN as hormone medication. On 18-MAR-2013, 2 days after onset of therapy the patient became very weak and developed a low grade fever. The patient was instructed to visit an ER facility where received Cephalexin and was diagnosed with cellulitis. The patient was discharged the same day. The outcome of cellulitis was reported as recovered/resolved, the date of recovery was not reported. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 13 year old female patient. Weight of the patient was reported as 104 (units unspecified). As reported as 64 inches. On 29-OCT-2012, at 14:57:25, the patient was vaccinated with dose 2 of improperly stored (that was exposed to 31 Fahrenheit for up to 68 hours) GARDASIL (lot number and expiry date reported as 672721/0101AE and 10-OCT-2014 respectively), intramuscularly in the left arm at a private doctor office or hospital with the private funds. No concomitant medications were reported. No adverse effects were reported. A signed informed consent form was obtained in which the parent of the patient had signed. This is one of two reports from the same source. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Urticaria
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 24 year old female patient. The patient no pertinent medical history. The patient has penicillin allergy and amoxicillin allergy. On 25-SEP-2012, the patient was vaccinated with first dose of GARDASIL, (lot number reported as H013977, expiry date 19-MAR-2015, route was intramuscular). On 26-NOV-2012, the patient was vaccinated with second dose of GARDASIL, (lot number reported as H013831, expiry date was not reported and route was intramuscular). Concomitant therapies included vitamins (unspecified). On an unknown date in 2012, the patient developed red hives on her stomach and chest which lasted a few days before going away. The patient had no laboratory tests done. There was no treatment provided for the event. The outcome of the event was reported as recovered. The patient sought medical attention (patient called the office). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. No medical history provided. On 26-SEP-2012 the patient was vaccinated (first dose) with GARDASIL (route unknown, lot# unknown). On-20-DEC-2012 the patient received a second dose of GARDASIL. No adverse symptoms were reported. No further information was provided. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 78 year old female patient with FLAGYL allergy and no pertinent medical history. On 19-MAR-2013 the patient was vaccinated with 0.65 ml ZOSTAVAX (lot # H013938, expiry date 25-OCT-2013) subcutaneously. There was no concomitant medication. On 20-MAR-2013, the patient experienced rash which was red and spreading around the injection site area. No laboratory diagnostics studies were performed. The outcome of the event was reported as not recovered/not resolved. The patient had contacted pharmacist for medical attention. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. On an unknown date, the patient was vaccinated with the first two doses of GARDASIL (lot number, expiry date, route and dose were not reported) intramuscularly in the gluteus muscle and no adverse effect reported. Follow up information has been received from the licensed practical nurse refers to the 21 year old female patient. On 23-OCT-2012 at 2:50 PM the patient was vaccinated with the second dose of GARDASIL (lot # 668554/0306AA; expired on 10-MAY-2013 (intramuscular in gluteus). No adverse events reported. The outcome , action taken and causality were not provided at the time of report. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Pruritus, Skin discolouration, Urticaria
Clinical narrative: This spontaneous report was received from a 70 years old female consumer reporting on herself with no pertinent medical history and no drug reactions or allergies who on 04-FEB-2013, was vaccinated with a dose of ZOSTAVAX (dose and lot number not reported). There was no concomitant medication. The consumer reported that she had developed two episodes of reaction on her legs. The first episode began on 28-FEB-2013, and the second episode began around 13-MAR-2013, In both episodes, welts that were dark in color formed on the legs and felt hot and very itchy. The consumer stated that the welts lasted about 6 or 7 days each time and then subsided. In first episode, the welts were about the size of a quarter, and in the second episode the welts were about the size of a silver dollar. It was reported that the second episode was worse that than first. No treatment was given for the experience. The patient did not seek medical attention but planner to see a dermatologist. The relatedness for welts that were dark in color formed on the legs and felt hot and very itchy and ZOSTAVAX was unknown. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Skin discolouration, Skin lesion, Skin warm
Clinical narrative: Information has been received from a 64 year old nurse with blood pressure high reporting about herself who on 12-MAR-2012, was vaccinated with a dose of ZOSTAVAX (Merck), (dose, route and Lot # not reported). Concomitant therapy included LIPITOR and "bp medicine" (manufacturer unknown). On 13-MAR-2012, the patient experienced red, hot, rash on her arm size of a tennis ball after vaccination. The patient reported that the rash went away over time but now she had a black and blue mark on her arm. The patient sought unspecified medical attention. BENADRYL was given for adverse event treatment. At the time of the report the patient's status was not recovered. Follow up information has been received from a physician reporting about 64 year old female patient with history of chickenpox of age 10 and none known drug allergies who was vaccinated with a dose of ZOSTAVAX (Merck), (dose, route and Lot # not reported). Concomitant therapy included LIPITOR, ZOLOFT, ENDOPRIL and TRAVATAN. On 14-MAR-2012 the patient developed 3 cm round, red, warm, raised lesion on left arm reported also as swollen hives type lesion (rash type) on left arm just above elbow. Outcome was not reported. Follow up information was received (28-MAR-2013): Updated the medical history, administrator information and narrative. Changed the onset date of red, hot, rash on her arm into 12-MAR-2012. The patient was treated with Augmentin 500/125 mg, po, TID x 7 days and vesolver. No further information is available.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Urticaria
Clinical narrative: Information has been received from a 64 year old nurse with blood pressure high reporting about herself who on 12-MAR-2012, was vaccinated with a dose of ZOSTAVAX (Merck), (dose, route and Lot # not reported). Concomitant therapy included LIPITOR and "bp medicine" (manufacturer unknown). On 13-MAR-2012, the patient experienced red, hot, rash on her arm size of a tennis ball after vaccination. The patient reported that the rash went away over time but now she had a black and blue mark on her arm. The patient sought unspecified medical attention. BENADRYL was given for adverse event treatment. At the time of the report the patient's status was not recovered. Follow up information has been received from a physician reporting about 64 year old female patient with history of chickenpox of age 10 and none known drug allergies who was vaccinated with a dose of ZOSTAVAX (Merck), (dose, route and Lot # not reported). Concomitant therapy included LIPITOR, ZOLOFT, ENDOPRIL and TRAVATAN. On 14-MAR-2012 the patient developed 3 cm round, red, warm, raised lesion on left arm reported also as swollen hives type lesion (rash type) on left arm just above elbow. Outcome was not reported. Follow up information was received (28-MAR-2013): Updated the medical history, administrator information and narrative. Changed the onset date of red, hot, rash on her arm into 12-MAR-2012. The patient was treated with Augmentin 500/125 mg, po, TID x 7 days and vesolver. No further information is available.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site urticaria, Pruritus
Clinical narrative: Onset of wheal and flare type erythematous reaction in left upper arm around injection site, pruritus with onset 3/29. Resolved 4/3/13.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 year old male patient. The patient was vaccinated with the first dose of GARDASIL (lot # reported as 0636AA; expiry date: 11-AUG-2013) on 14-JUN-2012, the second dose (lot # reported as 0636AA; expiry date: 11-AUG-2013) on 12-JUL-2012 and the third dose (lot # reported as 1745AA; expiry date: 13-SEP-2014) on 17-DEC-2012. The patient is not experiencing any known symptoms. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pruritus, Rash macular, Sleep disorder
Clinical narrative: My appointment on March 18, 2013, with Dr. and the preceding lab work was a routine, semi-annual check up, mainly to determine my current cholesterol numbers. The doctor noticed in his records that I was overdue for my second and final pneumonia vaccination. I had my first vaccination on Nov. 2, 2006, when I was 63 years old. The medical assistant gave me the shot and it was painless, as I commented to her. But about 7 hours later, around suppertime, I felt uncomfortable pain in the left shoulder at the site of the vaccination. I couldn't sleep on that side that night because the pain would awaken me. The next morning I counted 9 unconnected, slightly raised red blotches in my upper arm. Itching was very minor, but the pain and redness continued for 4-5 days. I called the doctor on the 4th day (March 21), but because I had no other adverse effects and the redness was gradually fading, it was determined I needn't come in for an appointment. The nurse did say if I had any breathing problems to go to the ER immediately. By Sunday, March 24, the redness had disappeared. The nurse on the phone suggested taking BENADRYL if I had some, but I didn't. As of this date, I feel fine.
Age: 20.0
Sex: F
Vaccine: SMALL, TYP
Symptoms: Injection site vesicles
Clinical narrative: One vesicle was identified that was approximately 3cm anterior to the location of the vaccine inoculation. This was a suspected inadvertent inoculation. No eye lesions or severe/excessive pain associated with lesion.
Age: 42.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Blister, Blood culture, Full blood count, Injection site erythema, Injection site induration
Clinical narrative: Redness after 24 hrs that progressed in size to span most of her lateral left upper arm. Hard lump at injection site. Weeping, blisters, increased pain. 2 ER visits 1st gave antibiotics KEFLEX and BACTRIM, 2nd visit gave 5 day prednisone treatment.
Age: 42.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site mass, Metabolic function test, Wound secretion
Clinical narrative: Redness after 24 hrs that progressed in size to span most of her lateral left upper arm. Hard lump at injection site. Weeping, blisters, increased pain. 2 ER visits 1st gave antibiotics KEFLEX and BACTRIM, 2nd visit gave 5 day prednisone treatment.
Age: 51.0
Sex: F
Vaccine: HIBV
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a non-healthcare professional (patient) on 13 November 2012. A 51-year-old female patient, who had no illness at the time of vaccination and whose concomitant medications were not reported, received a subcutaneous dose of ACTHIB vaccine (lot number: Unknown) in the back of left arm on 31 October 2102. The patient had allergy to PCN and 'Naproxyn'. On 31 October 2012, at the night of vaccination the patient had chills. The next morning i.e. on 1 November 2012; the patient developed redness, swelling and warmth at the back of the left arm where the vaccine was given. The reaction was bigger than a golf ball. Laboratory investigations were not reported and the patient received BENADRYL and TYLENOL as corrective medications on 31 October 2012. On a unspecified date, the patient had recovered from the chills and on an unspecified date, after the 4 days, the patient had recovered from the redness, swelling and warmth. List of documents held by sender: none.
Age: 0.3
Sex: U
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Pallor
Clinical narrative: Initial report received from health care professional on 04 September 2012. A 04-month-old patient of unspecified demographics, whose concurrent conditions and medical history was not reported, had received DAPTACEL, ACTHIB, IPOL, ROTATEQ and PREVNAR vaccines on unspecified date when the patient was 6 to 8-week-old. The route, site of vaccination and lot number of all vaccines were not reported. On the day of vaccination, the infant's body turned pale and lips remained pink. The episode lasted for 30 to 40 minutes. The next i.e. day after vaccination, the infant had two same episodes of pale body with lips remained pink. The infant had no other symptoms. The event of pale body except lips remained pink had recovered on unspecified date. Corrective treatment was not reported. List of documents held by the sender: None.
Age: 26.0
Sex: F
Vaccine: HIBV
Symptoms: Accidental exposure to product, Eye irritation, Laboratory test, Vision blurred
Clinical narrative: Initial information received from a healthcare professional on 26 July 2012. Local reference no- 12-0425. A 26-years-old female patient whose medical history and concomitant medication were not reported was inadvertently squirted vaccine ACTHIB (Lot number: UH416AA) into eye on 26 July 2012. The reporter stated that she inadvertently squirted vaccine into eye while its administration. She is contact lenses user. She experienced burning sensation in eye and cloudy vision like sheath over eye. She took out her contact lenses and flushed eye. Patient was planning to make appointment to ophthalmologist. Laboratory details and corrective treatment were not reported. The patient continued to experience cloudy vision in eye. Documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient experienced a very sore arm for greater than one month post vaccination.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: SEVERE PAIN / SORENESS AT INJECTION SITE - STARTED OVER 24 HOURS AFTER VACCINATION PER PT. - SEVERE PAIN/DISCOMFORT OVERNIGHT. DISCOMFORT/PAIN CONTINUED 4/3/13 SO SHE CALLED PHARMACY. NO OTHER REACTIONS (FEVER, RASH, HEADACHE, ETC...)
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling, Irritability, Pyrexia
Clinical narrative: Fever, fussiness with crying, swelling and redness on anterior left thigh.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pustular, Varicella
Clinical narrative: About one week after getting the Shingles vaccine, I had an outbreak of chicken pox. Two large pustules opened and several smaller ones which I still have at this date (4/3). No longer itching.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Myalgia, Pain
Clinical narrative: Muscle aches and pains all over body and fatigue.  Lasted approximately 2 days and resolved.  800mg Ibuprofen taken on 02/28/2013 and 03/01/2013.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Myalgia, Pain
Clinical narrative: Muscle aches and pains all over body and fatigue.  Still ongoing.  800mg Ibuprofen taken daily.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Local reaction
Clinical narrative: There was an allergic reaction to the shot on her right thigh causing 4.5" x 2.5" local reaction with redness without any pain or warmth to the touch. No treatment was given, but her father was advised to notify us of any additional reactions and go to the ER if she develops any symptoms of anaphalaxis.
Age: 0.25
Sex: M
Vaccine: HBHEPB, PNC13
Symptoms: Injection site discolouration, Injection site nodule
Clinical narrative: Discolored area on the patients leg with a hard knot that would not go away for quite some time.
Age: 0.5
Sex: F
Vaccine: HBHEPB
Symptoms: Skin mass
Clinical narrative: Patient with a very large knot under the surface of the skin that would not resolve for quite a few weeks.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling face
Clinical narrative: Patient noticed swelling and itchiness mostly on face on morning of April 1, 2013. She continued to feel itchy and swollen mostly on face (less throughout body) through Tuesday April 2, 2013. She took 2 doses of Benadryl tablets on Tuesday evening of April 2, 2013. She took 1 tablet around 6:30 pm and another dose later in the evening. She felt some relief by Wednesday morning April 3, 2013. Patient reported some itchiness of legs/feet on Wednesday morning April 3, 2013. By Wednesday evening at 7:30 PM on April 3, 2013 she reports that symptoms have completely resolved and she is okay.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Oedema mouth
Clinical narrative: Mouth swelling 12 hours after the shot. The patient called us today (3/8/13) to report this happened. She also felt fatigued.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site mass
Clinical narrative: Small 2-3mm lump LUA, not brought to our attention until 3/15/13.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Dizziness, Hypotonia
Clinical narrative: Approx. 5 minutes after receiving vaccine, pt complained of feeling faint, she then went limp & began to seize for about 10 seconds. Paramedics arrived, vitals were stable, pt declined hospitalization. Pt states this has happened in the past w/ blood work.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea, vomiting and a lot of diarrhea. Symptoms started about 3pm March 26, 2013. Vaccine was given 10:30am on March 25, 2013.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Red at site of injection. Swelling x 5 days that went down with ice packs applied to site of injection. When the swelling and redness went down, a bruise was left at the site of injection.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: On 2/5/13 pt. presented with (L) arm pain - states pain began when #2 GARDASIL vaccine was given on 12/18/12.
Age: 64.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Rash pruritic
Clinical narrative: Rash developed on arms, under arms, shins, head. Rash around ZOSTAVAX injection site appeared first about 2 days after injection. Rash spread to other arms/shins about a week later. Rash itches but does not burn or tingle.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 9 mm red raised area at injection site. Rechecked 3/25/13.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Chest X-ray, Cough, Dyspnoea, Injection site erythema, Injection site swelling
Clinical narrative: 3/20/13 GM home at 5:30pm observed rash over entire body (hives), injection site swelling, red & hot, BENADRYL given by GM, lip swelling, coughing & breathing difficulty. To ER at 6pm. Steroid Tx, breathing Tx, nausea med & BENADRYL given by ER & chest X-ray. Home with prednisone. F/U at physician's office on 3-22-13 prednisone stopped.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site warmth, Lip swelling, Rash generalised, Urticaria
Clinical narrative: 3/20/13 GM home at 5:30pm observed rash over entire body (hives), injection site swelling, red & hot, BENADRYL given by GM, lip swelling, coughing & breathing difficulty. To ER at 6pm. Steroid Tx, breathing Tx, nausea med & BENADRYL given by ER & chest X-ray. Home with prednisone. F/U at physician's office on 3-22-13 prednisone stopped.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Urticaria
Clinical narrative: Rash/hives 5 days after 1st and 2nd hep shot.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Silver dollar sized localized allergic reaction.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Injection site pain, Injection site swelling, Swelling
Clinical narrative: Received Tdap 3/20/13. Noted on 3/22/13 that injection site sore and swollen. Felt like a "bruise". Pain and swelling extended to (L) axilla. Used LORTAB she had at home for pain. No fever no other constitutional sx. 3/25/13 checked by nursing staff at this office. No redness, swelling or ecchymosis. Pain resolving.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Not unexpected - reported possible side effect, but parent would like VAERS form done. Patient developed a mild case of chicken pox after vaccine. No treatment necessary or indicated.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Oedema peripheral, Swelling face
Clinical narrative: 5 hrs. after receiving injection, pt experienced facial & left arm swelling and headache. States took BENADRYL & went to sleep. Next day symptoms relieved. Reported incident on 3/27/13.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Red, feverish, rash about 3 inches in diameter on back of left arm where vaccine was administered.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Muscle pain ran down arm to elbow & went back up. Still sore now but not as bad. Pt had to baby arm. As of today still sore.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 1.05
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Warmth, swelling, redness and tender to injection site area approximately 5 x 4 cm. Area marked and oral antibiotics started.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Rash, Rash pruritic
Clinical narrative: Rash located bilateral arms high bicep muscle. Red and itchy rash spreaded to upper back between shoulder blades. Bumps also contain fluid. Symptoms were first noticed 240 after vaccine was administered. Dx at age 17 w/shingles.
Age: 14.0
Sex: M
Vaccine: FLU3, HEPA, HPV4, VARCEL
Symptoms: Headache, Loss of consciousness, Syncope, Urinary incontinence
Clinical narrative: Pt. passed out while leaving clinic. Mild headache, loss of bladder during syncopal episode brought back to exam room and monitored for 25 min.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Pruritus, Pyrexia
Clinical narrative: Sl fever, achy all over, red, raised lump on arm, itchy 2 cm x 4 cm (R) deltoid. KEFLEX 500mg TID x10 days.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness & swollen right arm.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness & swollen (warm to touch) on thigh.
Age: 1.53
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site urticaria, Rash erythematous
Clinical narrative: Red rash and single hive on right thigh. Patient given 6.25mg diphenhydramine and discharge home from clinic w/ parent.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling left deltoid. Started 12-24 hours after injection. No fever 4 cm x 6.5 cm with some induration. KEFLEX 500 mg TID x 10 days.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Injection site cellulitis, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever, headache started on 4/1/13 at nite. Swelling - erythema to inj site. (L) upper arm. Cellulitis 3 cm diameter upper (L) arm.
Age: 1.05
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Rash erythematous
Clinical narrative: 3/19/13 A.M. Mom noticed fine red rash to arms, legs, and trunk with a little bit on cheeks. After he had his batch that evening, it was more red. Denies fever or any signs of distress, stating "He doesn't even act like he feels bad." Mom contacted Health Dept. on 3/20/13. Suggested she notify child's physician. He told her to bring him in if it seemed to get worse, if it went away don't worry about it. It has been going away on it's own.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Tendon disorder
Clinical narrative: Initial case was received from a healthcare professional on 04 January 2013. The reporter for this case is the same as for cases: 2012-10730, 2013-00361 and 2013-00363. A patient (age, birth date, and gender not reported), whose medical history was not reported, received an injection of INFLUENZA VACCINE (manufacturer unknown, (lot number, route, site, side and dose in series not reported) on an unspecified date. On an unspecified date, the patient experienced unspecified "symptoms post flu shot". Laboratory, diagnostic testing or treatments were not reported. The patient's outcome was not reported. Follow-up information received on 29 March 2013 from a healthcare professional. A 34-year-old female patient received an injection of FLUZONE, Sanofi Pasteur (lot number UH731AB) on 08 October 2012. On 10 October 2012, the patient experienced left shoulder pain. The patient had a magnetic resonance imaging (MRI) ON 7 November 2012 and results showed Teres minor tendinosis and thickening of left subscapularis tendon. The patient had an office visit on 12 November 2012. A MEDROL DOSEPAK and physical therapy were prescribed by personal physician on 12 November 2012. The patient was released by personal physician on 18 December 2012 and full recovery was confirmed on 18 December 2012. The patient's outcome was recovered on 18 December 2012. Documents held by sender: None.
Sex: M
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Initial report was received on 28 March 2013 from a consumer, who is also the patient. A male patient who had no illness at the time of vaccination and no known allergies had received on 09 January 2013 an intradermal injection of FLUZONE INTRADERMAL (lot number and site of administration not reported) and an unspecified amount of time later, developed "type B" flu. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer. Caller stated that the "varicella vaccine" (manufacturer unknown) was causing an epidemic of shingles, and she knows 7 people under the age of 50 who have Shingles, including herself, and that it was caused by an unspecified varicella vaccine (manufacturer unknown) being given to children. She stated she knows of a child who got Shingles, but didn't say the child had received this vaccine. She also didn't stated that she knew whether these people, or herself, had actually received the vaccine at all. This report concerns about 6 patients under the age of 50 (gender unknown) who developed shingles. Patient's outcome were unknown. Additional information is not expected. This report is linked with MARRS cases 1304USA001477 and 1304USA000279 same reporter.
Sex: U
Vaccine: MMR
Symptoms: Tuberculin test
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Relevant medical history and concomitant medication were not provided. On 28-MAR-2013 the patient was vaccinated with M-M-R II. Dose, route and frequency were not provided. Lot number was not provided. On 29-MAR-2013, the patient had a TUBERSOL (tuberculin skin test) test administered. No adverse event was reported. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer. Caller stated that the "varicella vaccine" (manufacturer unknown) was causing an epidemic of Shingles, and she knows 7 people under the age of 50 who have Shingles, including herself, and that is was caused by an unspecified varicella vaccine (manufacturer unknown) being given to children. She stated she knows of a child who got Shingles, but didn't say the child had received this vaccine. She also didn't state that she knew whether these people, or herself, had actually received the vaccine at all. This report concerns a child patient (age and gender unknown) who got shingles on an unspecified date. Patient's outcome was unknown. Additional information is not expected. This report is linked with MARRS cases 1304USA000279 and 1304USA001476, same reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Erythema, Herpes zoster, Pruritus
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 59 year old female patient with Sjogren's syndrome and codeine allergy. The patient's medical history included previous shingles outbreak for the past few years and was treated with valacyclovir. It was not diagnosed as Shingles until June 2012. Patient also had a back surgery in July 2012 before the shingles outbreak. Pharmacist stated that the patient got a shingles outbreak every 2-3 months. The therapy reason for use was the patient tired of getting recurrent shingles every couple of months and wanted to lessen the frequency or duration of shingles. So on 21-MAR-2013, the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # H018798, expiry: 15-JAN-2014). Concomitant therapies included PLAQUENIL for Sjogren's syndrome but was told by her rheumatologist, to get the vaccination. On 01-APR-2013, the patient experienced an outbreak of shingles. It was currently limited to her "backside" and was red and itching. The pharmacist mentioned that the patient did take an unspecified antiviral medication on the 10th day after vaccination with ZOSTAVAX. No treatment was given for the event. No laboratory diagnostics studies were performed. Patient sought medical attention (called the pharmacy). The patient's present status was not recovered. The relatedness of the event with ZOSTAVAX was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient over the age of 65 years (unspecified). In approximately March 2013 (a couple of weeks ago), the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous (dose was not reported) for the prevention of shingles. In March 2013, the patient developed a rash around the injection site after receiving ZOSTAVAX. At the time of the report, the patient's outcome of rash around the injection site was unknown. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer reporting on herself (age not reported). Caller stated that the "varicella vaccine" (manufacturer unknown) was causing an epidemic of Shingles, and she knows 7 people under the age of 50 who have Shingles, including herself, and that it was caused by an unspecified varicella vaccine (manufacturer unknown) being given to children. She stated she knows of a child who got Shingles, but didn't say the child had received this vaccine. She also didn't state that she knew whether these people, or herself, had actually received the vaccine at all. Patient's outcome was unknown. Additional information is not expected. This report is linked with MARRS cases 1304USA001476 and 1304USA001477, same reporter.
Age: 19.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL, TYP
Symptoms: Asthenia, Back pain, CSF glucose normal, CSF protein increased, CSF virus no organisms observed
Clinical narrative: On 3 Sep he began to notice muscle fatigue, felt weak, rash, headache and occasional fever. Went to ED on 08 Sep and admitted over night. Per IM headache and Vaccinia. VHC consulted Pictures consistent with non viral pustulosis. 2 days post d/c c/o back pain and leg numbness, and arm numbness. Per neuro back pain due to traumatic LP.
Age: 19.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL, TYP
Symptoms: CSF white blood cell count negative, Computerised tomogram head abnormal, Headache, Hypoaesthesia, Intervertebral disc protrusion
Clinical narrative: On 3 Sep he began to notice muscle fatigue, felt weak, rash, headache and occasional fever. Went to ED on 08 Sep and admitted over night. Per IM headache and Vaccinia. VHC consulted Pictures consistent with non viral pustulosis. 2 days post d/c c/o back pain and leg numbness, and arm numbness. Per neuro back pain due to traumatic LP.
Age: 19.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL, TYP
Symptoms: Muscle fatigue, Nuclear magnetic resonance imaging spinal abnormal, Psoriasis, Pyrexia, Rash
Clinical narrative: On 3 Sep he began to notice muscle fatigue, felt weak, rash, headache and occasional fever. Went to ED on 08 Sep and admitted over night. Per IM headache and Vaccinia. VHC consulted Pictures consistent with non viral pustulosis. 2 days post d/c c/o back pain and leg numbness, and arm numbness. Per neuro back pain due to traumatic LP.
Age: 19.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL, TYP
Symptoms: Red blood cells CSF positive, Sinusitis, Traumatic lumbar puncture, Vaccinia virus infection
Clinical narrative: On 3 Sep he began to notice muscle fatigue, felt weak, rash, headache and occasional fever. Went to ED on 08 Sep and admitted over night. Per IM headache and Vaccinia. VHC consulted Pictures consistent with non viral pustulosis. 2 days post d/c c/o back pain and leg numbness, and arm numbness. Per neuro back pain due to traumatic LP.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4
Symptoms: Amnesia, Convulsion, Epilepsy, Fear, Personality change
Clinical narrative: No history of seizures in the family. First seizure occurred 2 days after vaccination. Personality changed. Taking zonisamide, psychotherapy. On October 3, 2011 Dr. administered an immunization vaccine GARDASIL not only to my son, but to myself as well. I have been having heart palpitations since then, which almost disappeared two months ago. My son had a full fledge convulsion seizure 2 days after the vaccination. He has been taken to the hospital. The second seizure took place on 11-15-2011. I had to take him to the hospital every 2-3 weeks, as the medicine (KEPPRA) didn't work. They put him to the hospital again. Changed the medicine. It still didn't work well, they kept increasing the dosage. His personality changed. He was always a very social, happy child. Very athletic - he competed on a swimming team. After the shot my life turned into hell. My child started having seizures, his personality changed: he became angry and non-social, he refuses to leave the house or communicate with his friends. He refused to go to school. He started exhibiting memory loss. We became regular in the Emergency room. I was not even thinking of reporting this incident to anyone, because all my focus was on my child. He's been going to the therapy sessions at mental health center for almost a year now (no insurance coverage for that, I pay out of pocket), he's taking 600 mg of Zonisamide a day. I think, if the doctors didn't deny the side effect of the vaccine on my child from the very beginning, and started treating not the seizures, but the reason, by giving him some antidote, my son would be healthy and happy now. He's getting better now, but when I ask him if he is the same as he was before the shot, he says, no, may be 75%. I still live in fear of seizures, I have a concern about his future (will he drive, will he be able to live a normal life?). This one shot had a negative effect on our life: physical, emotional, financial.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4
Symptoms: Activities of daily living impaired, Amnesia, Anger, Convulsion, Disturbance in social behaviour
Clinical narrative: No history of seizures in the family. First seizure occurred 2 days after vaccination. Personality changed. Taking zonisamide, psychotherapy. On October 3, 2011 Dr. administered an immunization vaccine GARDASIL not only to my son, but to myself as well. I have been having heart palpitations since then, which almost disappeared two months ago. My son had a full fledge convulsion seizure 2 days after the vaccination. He has been taken to the hospital. The second seizure took place on 11-15-2011. I had to take him to the hospital every 2-3 weeks, as the medicine (KEPPRA) didn't work. They put him to the hospital again. Changed the medicine. It still didn't work well, they kept increasing the dosage. His personality changed. He was always a very social, happy child. Very athletic - he competed on a swimming team. After the shot my life turned into hell. My child started having seizures, his personality changed: he became angry and non-social, he refuses to leave the house or communicate with his friends. He refused to go to school. He started exhibiting memory loss. We became regular in the Emergency room. I was not even thinking of reporting this incident to anyone, because all my focus was on my child. He's been going to the therapy sessions at mental health center for almost a year now (no insurance coverage for that, I pay out of pocket), he's taking 600 mg of Zonisamide a day. I think, if the doctors didn't deny the side effect of the vaccine on my child from the very beginning, and started treating not the seizures, but the reason, by giving him some antidote, my son would be healthy and happy now. He's getting better now, but when I ask him if he is the same as he was before the shot, he says, no, may be 75%. I still live in fear of seizures, I have a concern about his future (will he drive, will he be able to live a normal life?). This one shot had a negative effect on our life: physical, emotional, financial.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4
Symptoms: Palpitations, Personality change, School refusal
Clinical narrative: No history of seizures in the family. First seizure occurred 2 days after vaccination. Personality changed. Taking zonisamide, psychotherapy. On October 3, 2011 Dr. administered an immunization vaccine GARDASIL not only to my son, but to myself as well. I have been having heart palpitations since then, which almost disappeared two months ago. My son had a full fledge convulsion seizure 2 days after the vaccination. He has been taken to the hospital. The second seizure took place on 11-15-2011. I had to take him to the hospital every 2-3 weeks, as the medicine (KEPPRA) didn't work. They put him to the hospital again. Changed the medicine. It still didn't work well, they kept increasing the dosage. His personality changed. He was always a very social, happy child. Very athletic - he competed on a swimming team. After the shot my life turned into hell. My child started having seizures, his personality changed: he became angry and non-social, he refuses to leave the house or communicate with his friends. He refused to go to school. He started exhibiting memory loss. We became regular in the Emergency room. I was not even thinking of reporting this incident to anyone, because all my focus was on my child. He's been going to the therapy sessions at mental health center for almost a year now (no insurance coverage for that, I pay out of pocket), he's taking 600 mg of Zonisamide a day. I think, if the doctors didn't deny the side effect of the vaccine on my child from the very beginning, and started treating not the seizures, but the reason, by giving him some antidote, my son would be healthy and happy now. He's getting better now, but when I ask him if he is the same as he was before the shot, he says, no, may be 75%. I still live in fear of seizures, I have a concern about his future (will he drive, will he be able to live a normal life?). This one shot had a negative effect on our life: physical, emotional, financial.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, MMRV
Symptoms: Convulsion, Pyrexia
Clinical narrative: This spontaneous report as received from a physician via a field employee refers to a 4 year old male patient. The patient had a history of seizures. On 22-MAR-2013 the patient was vaccinated with a dose of PROQUAD (merck) (lot # reported as H015621) (dose and route not reported). Concomitant medications included unspecified vaccines for 4 year old vaccination series. The physician told that the patient developed febrile seizure on 24-MAR-2013 after receiving a dose of PROQUAD (merck). The patient had the fever of 100.9 F and the seizure was brief, short, and "generalized". On an unknown date in Mar 2013, the patient recovered from febrile seizure. The patient sought unspecified medical attention. The causality between febrile seizure and PROQUAD (merck) was not provided. Upon internal review, febrile seizure was determined to medically significant. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, MMRV
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: This spontaneous report as received from a physician via a field employee refers to a 4 year old male patient. The patient had a history of seizures. On 22-MAR-2013 the patient was vaccinated with a dose of PROQUAD (merck) (lot # reported as H015621) (dose and route not reported). Concomitant medications included unspecified vaccines for 4 year old vaccination series. The physician told that the patient developed febrile seizure on 24-MAR-2013 after receiving a dose of PROQUAD (merck). The patient had the fever of 100.9 F and the seizure was brief, short, and "generalized". On an unknown date in Mar 2013, the patient recovered from febrile seizure. The patient sought unspecified medical attention. The causality between febrile seizure and PROQUAD (merck) was not provided. Upon internal review, febrile seizure was determined to medically significant. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Blood heavy metal test, Dysphemia, Speech disorder
Clinical narrative: Stuttering, loss of speech & complete sentences.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Didn't menstruate for 3 months after Gardasil vaccine. Had to get medicine to restart menstrual cycle.
Age: 70.0
Sex: F
Vaccine: JEV1, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, warmth, pain over skin surrounding injection site c/w cellulitis. Treatment given: KEFLEX 500mg TID x 10d follow up 2 days.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Decreased appetite, Fatigue, Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Left upper arm - 4/2/13 small red, swollen area and warm to touch appeared per Mother progressively got worse brought to HD on 4/3/13 area now 4"x9" red, swollen, very warm to touch with small blisters. Reports afebrile but medicated with TYLENOL, decreased appetite, and fatigue. Right upper arm - red, swollen, warm to touch circular 1"-1 1/2" diameter.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Injection site warmth
Clinical narrative: Left upper arm - 4/2/13 small red, swollen area and warm to touch appeared per Mother progressively got worse brought to HD on 4/3/13 area now 4"x9" red, swollen, very warm to touch with small blisters. Reports afebrile but medicated with TYLENOL, decreased appetite, and fatigue. Right upper arm - red, swollen, warm to touch circular 1"-1 1/2" diameter.