chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Dizziness, Feeling hot, Gait disturbance, Headache, Influenza virus test negative
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female patient with no previous illness was vaccinated intramuscularly into the left arm with third dose of GARDASIL (lot # 671994/1537AA) on 06-JUN-2012. On the same day, the patient was also vaccinated intramuscularly into the left arm with second dose of MENACTRA (lot # U4020AA). The patient's medical history included ADD (attention deficit disorder), bipolar, PMDD (premenstrual dysphoric disorder), post traumatic stress syndrome and GERD (gastrooesophageal reflux disease). Concomitant medications included ABILIFY, CELEXA, ALESSE, TAVIST and omeprazole. The patient experienced on dizziness, feeling hot, gait disturbance and headache on 07-JUN-2012. The patient awoke and felt like she was burning up, lightheaded, stumbling across room and a pounding headache. She didn't take temperature but in Urgent care, she was tested for flu but tests negative. So doctor said it was the shots. No redness at shot site. The listing indicated that the events required ER visit but were not serious. No further information is available. The original reporting source was not provided. The VAERS ID # is 457049.
Age: 17.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Rash macular, Rash pruritic
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 years old female patient who was subsequently diagnosed mononucleosis was vaccinated IM with dose 1 GARDASIL (lot # 1354AA, dose not reported) on 06-JUN-2012 into her right arm. Concomitant medications included: the first dose of ADACEL (lot#U4046AA) IM into her left arm on 06-JUN-2012. On 07-JUN-2012 the patient experienced pruritic macular rash on all extremities. The events were resolved with BENADRYL over 3 days. ER visit was required. The reporter considered the events as not serious. The original reporting source was not provided. The VAERS ID# is 457287. No further information is available.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Erythema, Induration, Pain, Skin warm
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 12 years old male patient with prophylaxis. The patient was vaccinated with GARDASIL. No other co-suspects were reported. Concomitant medications included ADACEL and MENACTRA. On 19-JUN-2012 the patient experienced erythema, skin warm, pain and induration. No treatment information was reported. The outcome of erythema, skin warm, pain and induration was unknown. The relatedness for erythema, skin warm, pain and induration was unknown for GARDASIL. Additional information is not expected.
Age: 1.34
Sex: F
Vaccine: FLUX, MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous, Varicella post vaccine
Clinical narrative: Patient developed a high fever on 8/20/2012 which continued through 8/22/2012 when she developed red bumps on her belly, back, and head. I took her to the doctor where it was confirmed that she had chickenpox, after receiving the chickenpox vaccine on 8/13/2012, I was told this was due to the vaccine.
Age: 52.0
Sex: M
Vaccine: JEV1, TDAP
Symptoms: Arthralgia, Laboratory test, Myalgia, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Employee c/o muscle aches and pain to legs when standing, but goes away with walking. In April states increase in pain to his knees with movement. He rates his pain on scale of 0-10 at a 10 level. Employee spouse was given the same vaccines at the same time and had no reaction reported.
Age: 52.0
Sex: M
Vaccine: JEV1, TDAP
Symptoms: Ultrasound scan, X-ray
Clinical narrative: Employee c/o muscle aches and pain to legs when standing, but goes away with walking. In April states increase in pain to his knees with movement. He rates his pain on scale of 0-10 at a 10 level. Employee spouse was given the same vaccines at the same time and had no reaction reported.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 years old female patient with no known allergies. The patient was vaccinated subcutaneous into upper left deltoid with 0.65 ml ZOSTAVAX (lot # 672563/1649AA, expiration date 21-JAN-2013) on 16-APR-2012. No other co-suspects were reported. Concomitant medications included acyclovir, acetaminophen, PERCOCET, clonazepam, lovastatin and amlodipine. Pharmacist stated she read the local paper and found out that client was found dead at her home residence on 18-APR-2012, due to natural causes. Pharmacist stated the patient did have health conditions, unspecified, but she wanted to make sure that no problem existed with this ZOSTAVAX lot number. Lot check was requested by the reporter. Event was considered to be disabling and life-threatening. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEPA, PNC10
Symptoms: Computerised tomogram, Convulsion, Pyrexia
Clinical narrative: Fever, seizure.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: L delt area red swollen, warm to touch-Dad brought child in, and mom pick her up next day. Noticed it was red-child c/o arm hurting-Advised to put ice on/off - Tylenol for pain - if got worse to see PCP.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: L delt area red swollen, warm to touch-Dad brought child in, and mom pick her up next day. Noticed it was red-child c/o arm hurting-Advised to put ice on/off - Tylenol for pain - if got worse to see PCP.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Similar reaction on previous exposure to drug
Clinical narrative: Large circular reaction at site of seasonal flu vaccine injection (left thigh).  Area about 3" diameter.  Red, warm to touch, slightly raised and firm.  Similar reaction to last year's flu vaccine, but we forgot about it until this reaction.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Significant redness and swelling at site where DTAP was given.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Shingles type pain in her body.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Shingles type pain in her body.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect dose administered
Clinical narrative: ADACEL was given 4-3-12 and re-vaccinated on 8/21/2012.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Condition aggravated, Contusion, Packed red blood cell transfusion, Pancytopenia, Platelet transfusion
Clinical narrative: Persistent URI, bruising - pancytopenia requiring platelet and red cell transfusion and stem cell boost of prior stem cell graft.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Stem cell transplant, Upper respiratory tract infection
Clinical narrative: Persistent URI, bruising - pancytopenia requiring platelet and red cell transfusion and stem cell boost of prior stem cell graft.
Sex: U
Vaccine: ADEN_4_7
Symptoms: Skin disorder
Clinical narrative: A report was received from an observational study. This is a safety study using Adenovirus Type 4 and Type 7 Vaccine. Live, Oral. There were 55,989 in the exposed cohort and 55,989 in the unexposed cohort. The date of the surveillance of the exposed group was Oct 2011 to July 2012. The date of the surveillance of the unexposed group was Oct 2010 to July 2011. 685 patients exposed experienced symptoms involving skin; while 769 unexposed patients experienced SYMPTOMS INVOLVING SKIN. Of the exposed patients: Age: 29 were 18 years of age, 561 were between 19-24 years of age, 77 were between 25-29 years of age, 13 were between 30-34 years of age, 3 were between 35-39 years of age, and 2 were between 40-50 years of age. Gender: 220 were female, 465 were male. Of the 769 unexposed patients who experienced SYMPTOMS INVOLVING SKIN, 2 were 17; 49 were 18 years old, 584 were in the 19-24 year age range, 97 were in the 24-29 year range, 25 were in the 30-34 year range, 10 were in the 35-39 year range, and 2 were in the 40-50 year range. 244 were female, 525 were male.
Sex: U
Vaccine: ADEN_4_7
Symptoms: Rash
Clinical narrative: A report was received from an observational study. This is a safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. There were 55,989 in the exposed cohort and 55,989 in the unexposed cohort. The date of the surveillance of the exposed group was Oct 2011 to July 2012. The date of the surveillance of the unexposed group was Oct 2010 to July 2011. Of the 55,989 patients exposed, 2 patients experienced RASH and were hospitalized. Of the 55,989 patients unexposed, 7 patients experienced RASH and were hospitalized. Of the exposed patients who experienced serious RASH, 2 were in the 19-24 year age range, 2 were male. Of the 7 unexposed patients who experienced serious RASH, 1 was age 18; 6 were in age group 19-24; 1 female 6 male.
Sex: U
Vaccine: ADEN_4_7
Symptoms: Syncope
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. There were 55,989 in the exposed cohort and 55,989 in the unexposed cohort. The date of the surveillance of the exposed group was Oct 2011 to July 2012. The date of the surveillance of the unexposed group was Oct 2010 to July 2011. 201 Patients in the exposed cohort experienced syncope, while 250 of the unexposed cohort experienced syncope. Of the 201 patients in the exposed group age: 15 were age 18, 164 were in age group 19-24, 19 were in the age group of 25-29, 3 in age group 30-34. Sex: 69 female, 132 male. Of the 250 in the unexposed group age: 2 were age 17; 11 were age 18, 208 were in the 19-24 age group, 24 were in the 25-29 age group, 3 were in the 30-34 age group; 2 in the 35-39 group. Sex: 59 female, 191 male.
Sex: U
Vaccine: ADEN_4_7
Symptoms: Guillain-Barre syndrome
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. There were 55,989 in the exposed cohort and 55,989 in the unexposed cohort. The date of the surveillance of the exposed group was Oct 2011 to July 2012. The date of the surveillance of the unexposed group was Oct 2010 to July 2011. 3 Patients in the exposed cohort experienced Acute infective polyneuritis, while 2 of the unexposed cohort experienced Acute infective polyneuritis. Of the 3 patients in the exposed group age: 3 were in age group 19-24. Sex: 1 female, 2 male. Of the 2 in the unexposed group age: 2 were in the 19-24 age group. Sex: 0 female, 2 male.
Sex: U
Vaccine: ADEN_4_7
Symptoms: Hyperthyroidism
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. There were 55,989 in the exposed cohort and 55,989 in the unexposed cohort. The date of the surveillance of the exposed group was Oct 2011 to July 2012. The date of the surveillance of the unexposed group was Oct 2010 to July 2011. 8 Patients in the exposed cohort experienced thyrotoxicosis, while 5 of the unexposed cohort experienced thyrotoxicosis. Of the 8 patients in the exposed group age: 6 were in the age group 19-24; 2 were 25-29. Sex: 7 female, 1 male. Of the 5 in the unexposed group age: 4 were in the 19-24 age group; 1 from 30-34 age group. Sex: 2 female, 3 male.
Sex: U
Vaccine: ADEN_4_7
Symptoms: Respiratory failure
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. There were 55,989 in the exposed cohort and 55,989 in the unexposed cohort. The date of the surveillance of the exposed group was Oct 2011 to July 2012. The date of the surveillance of the unexposed group was Oct 2010 to July 2011. 1 Patients in the exposed cohort experienced pulmonary insufficiency, while 2 of the unexposed cohort experienced pulmonary insufficiency. Of the 1 patients in the exposed group age: age group 19-24 Female. Of the 2 unexposed patients 2 were in the age group 19-24. Sex: 2 males.
Sex: U
Vaccine: ADEN_4_7
Symptoms: Adverse event
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. There were 55,989 in the exposed cohort and 55,989 in the unexposed cohort. The date of the surveillance of the exposed group was Oct 2011 to July 2012. The date of the surveillance of the unexposed group was Oct 2010 to July 2011. 47 Patients in the exposed cohort experienced adverse events nos, while 58 of the unexposed cohort experienced adverse events nos. Of the 47 exposed patients age groups: 5 age 18; 37 age group 19-24; 5 age group 25-29. Sex: 19 female, 28 male. Of the 58 unexposed patients age groups: 7 age 18, 42 age group 19-24; 7 age group 25-29; 1 age group 30-34; 1 age group 35-39. Sex: 16 female 42 male.
Sex: U
Vaccine: ADEN_4_7
Symptoms: Poisoning
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. There were 55,989 in the exposed cohort and 55,989 in the unexposed cohort. The date of the surveillance of the exposed group was Oct 2011 to July 2012. The date of the surveillance of the unexposed group was Oct 2010 to July 2011. 3 Patients in the exposed cohort experienced, poisoning unspecified while 2 of the unexposed cohort experienced poisoning unspecified. Of the 3 exposed patients Age Group: 3 were in the 19-24 age group: Sex: 1 Female, 2 male. Of the 2 unexposed patients 2 were in age group 19-24. Sex: 1 female; 1 male.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Amyotrophic lateral sclerosis, Diplegia, Mechanical ventilation, Respiratory muscle weakness
Clinical narrative: This literature report (initial receipt 14-Aug-2012) concerns a 53 year old male patient. This literature report states amyotrophic lateral sclerosis (ALS) has been rarely reported after vaccination. On an unknown date, the patient received influenza vaccination. One month after vaccination, he developed brachial diplegia and respiratory muscles weakness requiring permanent non invasive ventilation. The event outcome was unknown. Reporter's comments: There is no cause-effect relationship between the occurrence of ALS and vaccination.
Sex: U
Vaccine: ADEN_4_7
Symptoms: Encephalitis post immunisation
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. There were 55,989 in the exposed cohort and 55,989 in the unexposed cohort. The date of the surveillance of the exposed group was Oct 2011 to July 2012. The date of the surveillance of the unexposed group was Oct 2010 to July 2011. Of the patients exposed, 1 patient experienced ENCEPHALITIS, IMMUNIZATION. Of the patients unexposed, 1 patient experienced ENCEPHALITIS, IMMUNIZATION. The exposed patient who experienced ENCEPHALITIS, IMMUNIZATION was in the 19-24 year age range, male. Of the unexposed patient who experienced encephalitis was in the 19-24 year old age group, male.
Sex: U
Vaccine: ADEN_4_7
Symptoms: Epilepsy
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. There were 55,989 in the exposed cohort and 55,989 in the unexposed cohort. The date of the surveillance of the exposed group was Oct 2011 to July 2012. The date of the surveillance of the unexposed group was Oct 2010 to July 2011. This case is a report of 8 Patients in the exposed cohort who experienced epilepsy, while 23 of the unexposed cohort experienced epilepsy. Of the 8 patients in the exposed group age: 1 was age 18; 5 were in age group 19-24; 2 were in the age group of 25-29. Sex: 2 female, 6 male. Of the 23 patients in the unexposed group age: 1 was 18; 18 were in the 19-24 age group; 2 were in the 25-29 age group; 2 were in the 30-34 age group. Sex: 6 female; 17 male.
Sex: U
Vaccine: ADEN_4_7
Symptoms: Pneumonia
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. There were 55,989 in the exposed cohort and 55,989 in the unexposed cohort. The date of the surveillance of the exposed group was Oct 2011 to July 2012. The date of the surveillance of the unexposed group was Oct 2010 to July 2011. Of patients exposed, 602 patients experienced pneumonia. Age: 1 was 17; 49 were age 18; 484 were age group 19-24; 60 were age group 25-29; 6 were age group 30-34; 2 were age group 35-39. Sex: 68 female; 534 male. Of the unexposed 1,468 patients experienced pneumonia. Age group: 110 age 18; 1,222 age group 19-24; 114 age group 25-29; 16 age group 30-34; 2 age group 35-39; 4 age group 40-50. Sex: 58 female; 1,410 male.
Sex: U
Vaccine: ADEN_4_7
Symptoms: Pericarditis
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. There were 55,989 in the exposed cohort and 55,989 in the unexposed cohort. The date of the surveillance of the exposed group was Oct 2011 to July 2012. The date of the surveillance of the unexposed group was Oct 2010 to July 2011. Of the 55,989 patients exposed, 1 patient experienced ACUTE PERICARDITIS. Of the 55,989 patients unexposed, 3 patients experienced ACUTE PERICARDITIS. The exposed patient was in the age group 19-24, male. The 3 unexposed patients were from age group 19-24. Sex: 3 males.
Sex: U
Vaccine: ADEN_4_7
Symptoms: Anaphylactic reaction
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. There were 55,989 in the exposed cohort and 55,989 in the unexposed cohort. The date of the surveillance of the exposed group was Oct 2011 to July 2012. The date of the surveillance of the unexposed group was Oct 2010 to July 2011. 20 Patients in the exposed cohort experienced, anaphylactic /other while 22 of the unexposed cohort experienced anaphylactic /other. Of the 20 exposed patients Age Group: 1 was 18; 18 were in age group 20-24; 1 was in age group 25-29. Sex: 6 Female, 14 male. Of the 22 unexposed patients Age group 3 were 18; 15 were 19-24; 4 were 25-29. Sex: 6 female; 16 male.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MM, VARCEL
Symptoms: Body temperature increased, Dizziness, Headache, Vomiting
Clinical narrative: Pt woke at approximately 8:30am (8-17-12) with headache, vomiting, dizziness & temp. 105.2.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: In clinic reporting pain, itching, redness and increased warmth to upper right arm - localized to vaccine site, that began the same evening the vaccine was administered. Patient & parent report gradual increase in these symptoms over past two days, with development of rash to site only. No fever nor difficulty breathing; no seizure activity.
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Pain, Pyrexia
Clinical narrative: Pt c/o fever, body aches, joint pain, body pain.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Patient experienced some mild pain to the left arm several hours after receiving. On 8/22/12, the day after injection, she noticed her arm was sore, swollen and hot to touch. The redness continued to enlarge to 2.25" when she came in on 8/23/12 to have it checked. No known insect bites.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Arthralgia, Herpes zoster, Injection site erythema, Injection site pruritus, Lymphadenopathy
Clinical narrative: Awakened 8/18/12 by severe itching of shingles vaccination site. Raised welt 2 inches in diameter, sore joints, muscles, lymph notes under arm were swollen - 8/19 rash on arm, raised, welt at vaccination site increased to 5" x 2 1/2" 5/23, welt gone rash still on arm and itching has subsided. Denies any fever during this time.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Myalgia, Rash, Urticaria, Vaccination site rash
Clinical narrative: Awakened 8/18/12 by severe itching of shingles vaccination site. Raised welt 2 inches in diameter, sore joints, muscles, lymph notes under arm were swollen - 8/19 rash on arm, raised, welt at vaccination site increased to 5" x 2 1/2" 5/23, welt gone rash still on arm and itching has subsided. Denies any fever during this time.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Tongue disorder, VIIth nerve paralysis
Clinical narrative: Mother reports that child began symptoms on her way home (after administration of vaccine) she reported drooping on one side of face affecting the tongue. Unable to reach mother since her report on 8/20/12 to complete VAERS.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Red warm tender left arm 8x3cm. Red warm tender right arm 12x3cm. KEFLEX 500mg 1Q6 hours x1 wk. BACTRIM DS 2 BID x1wk. ZYVOX 600mg 1 BID x7 days.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt received Tdap and MENVEO on 8/21/2012 on the right deltoid in our facility. Patient RTC on 8/23/2012 and complained redness and swelling on right deltoid. The swelling is 100 mm x 80 mm on right. Pt denies SOB. Pt was evaluated by Dr. and discharge home with no acute distress.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Chest X-ray normal, Cough, Laboratory test normal, Pertussis, Polymerase chain reaction
Clinical narrative: On 8/14/2012 presented with cough x1 month worse in AM. Put on ZPACK. Came back 8/20/12 continued symptoms. Chest xray (-) pertussis PCR (-) sib diagnosed with pertussis at same time. Suspected pertussis.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Pruritus generalised, Pyrexia
Clinical narrative: Patient called me today complaining of raised red/purple area around injection site, fever of 101 degrees F, and an itching all over her body. She received the FLUZONE intradermal injection.
Age: 54.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Approx. 2 inch red circular area R. Deltoid. Area is hard and warm to touch. Told to treat with cold compress to area and Tylenol prn pain. Avoid heavy lifting.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: RED RASH ABOUT TWO INCHES IN CIRCUMFERENCE NEAR INJECTION SITE.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Injection site irritation, Injection site rash
Clinical narrative: Mild bumps and irritation of both thighs.
Age: 37.0
Sex: F
Vaccine: FLUN3
Symptoms: Urticaria
Clinical narrative: Pt developed hives to neck arms and legs approx 2 hours after vaccine was administered. Pt took 1 Benadryl at 1:00pm, before coming to be seen.
Age: 28.0
Sex: M
Vaccine: FLUN3
Symptoms: Paraesthesia
Clinical narrative: Developed tingling bilateral finger tips with no other sx.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Reddish purple, warm to touch, firm area approximately 4 inch diameter on upper left thigh.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was inadvertently administered a dose of Zostavax (not indicated for pediatric patients), instead of a second dose of varicella. No adverse effects were observed. Patient's mother was notified and informed by physician that a second dose of varicella was not required. Patients mother was advised to watch for any site redness and to report to the physician any adverse reactions.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Formication, Herpes zoster, Mammogram normal, Neuralgia
Clinical narrative: Progress pain in nerve root encompassing left breast, left axilla, and along left arm including thumb and thumb side of index finger.  Pain was a burning and crawling sensation that radiated from sternum into axilla; exacerbated by wind or light touch.  Pain continues to this day.  My physician said that symptoms consistent with shingles, but there was never a rash.  Diagnosis: Post Herpetic Neuropathy from Zoster vaccine.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: Progress pain in nerve root encompassing left breast, left axilla, and along left arm including thumb and thumb side of index finger.  Pain was a burning and crawling sensation that radiated from sternum into axilla; exacerbated by wind or light touch.  Pain continues to this day.  My physician said that symptoms consistent with shingles, but there was never a rash.  Diagnosis: Post Herpetic Neuropathy from Zoster vaccine.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: VIIth nerve paralysis
Clinical narrative: Bells Palsy.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Convulsion, Loss of consciousness, Syncope
Clinical narrative: Patient fainted after receiving his vaccines.  During the fainting episode he also had a seizure (vascular).  Put on left side with cold compresses. After regained consciousness and sat up, needed to lay back down.  Not sure is lost consciousness second time.
Age: 0.17
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Fatigue, Injection site pain, Irritability, Vomiting
Clinical narrative: Soreness in right arm after Prevnar injection, mom states child would not use arm to hold anything. Mom stated daughter was cranky, tired and vomited.
Age: 1.01
Sex: F
Vaccine: HEPA, MMRV, PPV
Symptoms: Crying, Decreased appetite, Genital rash, Oral disorder, Pyrexia
Clinical narrative: Fever 102, Hives on the body, Red Rashes all over the body spreading to genital and face area, White coating inside the mouth, loss appetite and cries in sleep.
Age: 1.01
Sex: F
Vaccine: HEPA, MMRV, PPV
Symptoms: Rash erythematous, Rash generalised, Urticaria
Clinical narrative: Fever 102, Hives on the body, Red Rashes all over the body spreading to genital and face area, White coating inside the mouth, loss appetite and cries in sleep.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Patient developed rash on face and ear itched.
Age: 10.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Feeling hot, Nausea
Clinical narrative: Patient became nauseated and felt warm about 5-10 minutes after HPV vaccine was given.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 2 inch pink spot at injection site. Firmness & hot skin at injection site. No treatment necessary.
Age: 12.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Arthralgia, Laboratory test
Clinical narrative: Joints aching at 4:00pm quite a bit of pain. 900mg's 600mg's. Called nurse hotline, ER - under observation. Labs. Hx of Guillain-Barre. 8/21/2012 (Well/still sore).
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Lymphadenopathy
Clinical narrative: Received T-DAP 7/16/12 & developed soreness & redness 24 hr s/p injection. On 7/18/12. Noted left anxiety painful lymphadenopathy. She called 7/18/12 to report & was advised BENADRYL & had no relief. Pt assessed in office by MD 7/19/12 advised MOTRIN 800mg q 8hr & BENADRYL qHS. To call MD if fever/chills or spreading redness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient began vomiting and also endured fever after 1 week of having injections.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Headache, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Initial reaction was pain and immobile arm at injection site. Following day (8/22) had fever, chills, body aches head ache and unclear thinking. 8/23 brought severe swelling and redness from shoulder to elbow, previous symptoms subsided.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Pain, Pyrexia, Thinking abnormal
Clinical narrative: Initial reaction was pain and immobile arm at injection site. Following day (8/22) had fever, chills, body aches head ache and unclear thinking. 8/23 brought severe swelling and redness from shoulder to elbow, previous symptoms subsided.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Axillary pain, Erythema, Injection site pruritus, Rash
Clinical narrative: LOCALIZED REDNESS, RASH, ARM PIT PAIN, ITCHING AT THE SITE.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Borrelia test negative, Immunology test normal, Simplex virus test positive, VIIth nerve paralysis
Clinical narrative: Bells Palsy on right side of face.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Eyelid oedema, Wheezing
Clinical narrative: Wheezing, swelling lt eyelid; Benadryl administered, prompt response, no S.O.B noted, wheezing abated, swelling diminished. Client responded with wheezing after same vaccines in the past.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives on legs, abdomen, chest, back and up to chest.
Age: 0.55
Sex: F
Vaccine: DTAP, HBHEPB, IPV, RVX
Symptoms: Injection site erythema, Injection site swelling, Lethargy
Clinical narrative: Swelling and redness around injection site. Lethargy. Benadryl and cool compress recomended.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site papule, Injection site rash, Injection site vesicles
Clinical narrative: Pt developed a 2cm x 3cm rash that is erythematous with 3-4 papules or vesicles on her right upper thigh.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site joint movement impairment, Injection site pain, Injection site swelling
Clinical narrative: After basketball practice pt developed very strong pain and mild swelling at the site of the vaccine administration; pain severe enough that she is unable to move her arm at the shoulder (refuses).
Age: 57.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Injection site pain, redness, and swelling. Fever for two days following. As of 8/23/12 still red and sore, no fever and not as painful.
Age: 1.26
Sex: F
Vaccine: FLUX, HEPA, HIBV
Symptoms: Crying, Diarrhoea, Dizziness, Fatigue, Irritability
Clinical narrative: Fever 103.1, vomiting, diarrhea, dizziness, (all started afternoon of vaccinations) fussy/crying, tired, hives (started Thursday, 8/23).
Age: 1.26
Sex: F
Vaccine: FLUX, HEPA, HIBV
Symptoms: Pyrexia, Urticaria, Vomiting
Clinical narrative: Fever 103.1, vomiting, diarrhea, dizziness, (all started afternoon of vaccinations) fussy/crying, tired, hives (started Thursday, 8/23).
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Insomnia, Myalgia, Pain
Clinical narrative: 3 weeks post Tdap vaccination to right deltoid IM c/o continued muscle pain especially at night waking her every two hours and noted daily discomfort and unable to lift arm without discomfort.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Gait disturbance, Injection site reaction, Irritability, Mobility decreased
Clinical narrative: 8/21/2012 After leaving office, mom noticed that she favored (R) leg. Pt refuses to bend leg, knee, fusses & whines when mom attempts to bend knee. Favors (R) leg. No fever, lumps, redness or swelling. Adverse reaction to left leg.
Sex: F
Vaccine: HPV4
Symptoms: Myasthenia gravis
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a young female patient of unknown age. The reported stated that a few months ago, the patient talk about she developed myasthenia gravis after receiving GARDASIL (lot #, date and route were unspecified). No other information was available at reporting time. The outcome of patient was unknown. Upon internal review, myasthenia gravis was determined to be medically significant event. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
Clinical narrative: This spontaneous retrospective pregnancy report was received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning to a 21 years old female patient with no pertinent medical history and no drug reactions or allergies, who on 30-MAY-2012, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot number 669795/1317AA, Exp. Date: 13-OCT-2013). No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient LMP was 02-MAY-2012 and the estimated date of delivery (EDD) is 06-FEB-2013, at the first trimester. The registered nurse reported that on 07-JUN-2012, the patient experienced a miscarriage. The patient was admitted to an unspecified hospital but details of the hospitalization were unknown. No treatment information was reported. It was noted that therapy with GARDASIL was discontinued. The patient had fully recovered (unspecified date). The relatedness for patient experienced a miscarriage was unknown for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from registered nurse concerning an increased number of patients with unspecified age, gender, pertinent medical history or drug reaction / allergies. On an unspecified date, the patients were vaccinated with a subcutaneous 0.5 ml dose of PNEUMOVAX23 (lot number not reported). No other co-suspects or concomitant medications were reported. The patients in the practice experienced severe injection site reactions after subcutaneous administration of a dose of PNEUMOVAX23 (dates not reported). The reaction included redness (disability), pain (disability), tenderness (disability), with extensive swelling of the arm from shoulder to elbow (disability). The nurse also added that the pain and tenderness was so severe that "clothing could not touch the skin in the area of the reaction". The patients recovered on unspecified dates. There were not lab diagnostic tests. Treatment was not reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Loss of consciousness, Loss of control of legs
Clinical narrative: Information has been received from a medical assistant concerning a 20 year old female patient who on 22-MAY-2012 was vaccinated IM with a first 0.5 ml dose of GARDASIL suspension (lot # 672232/1495AA Exp 22-AUG-2014). On 22-MAY-2012 the patient who had received her first dose of GARDASIL sat down for 10-15 minutes after receiving the injection, started walking towards the door when her legs gave out. The patient did not receive any treatment or seek any medical attention. AE improved on therapy and on 22-MAY-2012, the patient recovered from the event. Follow-up information has been received from health professional concerning a 20 year old female patient with no illness at the time of vaccination. No other co-suspects were reported. No concomitant medications were reported. It was reported that on 22-MAY-2012 at 16:55 PM, the patient went to check out and passed out. Patient fell against wall. The physician was notified and vitals taken. The patient was given a glass of water. It was reported that the patient was assessed again and allowed to go home. No laboratory diagnostics tests were performed. The patient's outcome was recovered on 22-MAY-2012. The relatedness the patient's events was not reported for GARDASIL. Upon internal review, passed out was considered to be other important medical event. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Hyperhidrosis, Loss of consciousness, Nausea, Pallor
Clinical narrative: Administered Tdap, Varicella, Hep A, MENACTRA vaccines, child doing well, but after administering last vaccine of HPV, became pale & passed out for about 5 seconds, she then sat up & was diaphoretic & nauseated. Dr called to the room & observed child, advised her to lay on her side until she felt better. Approx 30 - 45 mins later she was starting to feel herself again, offered her something to eat (she hadn't had breakfast today), ate a donut & drank some water & was ready to leave, all symptoms resolved, asked mom to please call with update on how she is feeling later this afternoon & she said would. VAERS form will be completed.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: About a 1/2 hour after getting her flu shot, pt. noticed her arm was itching. Once she got home she noticed the injection site was red and puffy, after a couple days redness went away and area turned green.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Contusion, Erythema, Feeling hot, Pain, Pruritus
Clinical narrative: Very red 3 inch area with bruising & itching, hot & painful.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Red area the size of a silver dollar around injection site. No other symptoms.
Age: 86.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness around site, & itching told to ice and BENADRYL cream called Dr - they will call patient.
Age: 86.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Redness around site, & itching told to ice and BENADRYL cream called Dr - they will call patient.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Contusion, Feeling hot, Injection site induration, Injection site nodule, Oedema peripheral
Clinical narrative: Left arm hot, swollen for a few days; hard knot at injection area x several weeks; still has slight bruising.
Age: 1.16
Sex: F
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Eye movement disorder, Febrile convulsion, Full blood count, Hypotonia, Lethargy
Clinical narrative: Fever began 4 hrs after vaccine to 102 degrees F. Approx 10 hrs after vaccine admin. pt with fever to >103 degrees F, as well as (L) eye deviation, decreased responsiveness, decreased tone and lethargy. Pt evaluated in ER for probable febrile seizure and post-ictal state.
Age: 1.16
Sex: F
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Metabolic function test, Postictal state, Pyrexia, Slow response to stimuli
Clinical narrative: Fever began 4 hrs after vaccine to 102 degrees F. Approx 10 hrs after vaccine admin. pt with fever to >103 degrees F, as well as (L) eye deviation, decreased responsiveness, decreased tone and lethargy. Pt evaluated in ER for probable febrile seizure and post-ictal state.
Age: 1.16
Sex: F
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Abnormal behaviour, Asthenia, Blood test normal, Catatonia, Convulsion
Clinical narrative: Fever began 4 hrs after vaccine to 102 degrees F. Approx 10 hrs after vaccine admin. pt with fever to >103 degrees F, as well as (L) eye deviation, decreased responsiveness, decreased tone and lethargy. Pt evaluated in ER for probable febrile seizure and post-ictal state.
Age: 1.16
Sex: F
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Crying, Decreased appetite, Dysstasia, Fatigue, Gait disturbance
Clinical narrative: Fever began 4 hrs after vaccine to 102 degrees F. Approx 10 hrs after vaccine admin. pt with fever to >103 degrees F, as well as (L) eye deviation, decreased responsiveness, decreased tone and lethargy. Pt evaluated in ER for probable febrile seizure and post-ictal state.
Age: 1.16
Sex: F
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Gaze palsy, Irritability, Listless, Mobility decreased, Pyrexia
Clinical narrative: Fever began 4 hrs after vaccine to 102 degrees F. Approx 10 hrs after vaccine admin. pt with fever to >103 degrees F, as well as (L) eye deviation, decreased responsiveness, decreased tone and lethargy. Pt evaluated in ER for probable febrile seizure and post-ictal state.
Age: 1.16
Sex: F
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Screaming, Somnolence, Unresponsive to stimuli
Clinical narrative: Fever began 4 hrs after vaccine to 102 degrees F. Approx 10 hrs after vaccine admin. pt with fever to >103 degrees F, as well as (L) eye deviation, decreased responsiveness, decreased tone and lethargy. Pt evaluated in ER for probable febrile seizure and post-ictal state.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pt came in Monday 8/20/12 for 3 immunizations had MENACTRA in (R) arm, HPV & Tdap in (L) arm. Pt noticed swelling, redness, & slight pain 24 hours later. Dr gave pt prednisone.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal pain
Clinical narrative: Pt called back to pharmacy 8 hours later complaining about severe ball shoulder pain. It was in left arm that I administered the PNEUMOVAX shot.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Electrocardiogram, Headache, Local swelling, Musculoskeletal stiffness
Clinical narrative: The patient reported having cough, sore throat and wheezing within hours of getting vaccine. Neck stiffness, swollen neck and shoulders, headache and wheezing was present on morning of 8/23/12.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Wheezing
Clinical narrative: The patient reported having cough, sore throat and wheezing within hours of getting vaccine. Neck stiffness, swollen neck and shoulders, headache and wheezing was present on morning of 8/23/12.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: Approx 3 hr after receiving flu shot pt developed itchy rash on neck & extremities. Went to urgent care -> prednisone.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Feeling hot, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Red swollen arm around injection site. Pain upon exertion. Radiates heat - cellulitis appearance.
Age: 19.0
Sex: F
Vaccine: FLUN3, HEPA
Symptoms: Syncope
Clinical narrative: Pt experienced a syncopal episode after she received a FLUMIST and a Hep A (HAVRIX) vaccines. Immunizations given in supine position - syncopal event occurred when pt came to sitting position. Placed back in supine position & observed for 20-25 minutes.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Tdap given IM in (L) deltoid. Swelling and redness occurred at injection site 2 days later. Instructed to take PO BENADRYL and ice site. Mom stated that reaction improved within the same afternoon and was fine the next day.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Facial pain, Gingival pain, Glossodynia, Lymphadenopathy
Clinical narrative: - Pain in jaw, teeth, chin, gums, neck& tongue (severe). - Swollen lymph nodes, neck, chin, gums, lower jaw. - Stiffness in jaw, chin, neck, - Hard to breath (tight in neck).
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal discomfort, Musculoskeletal stiffness, Neck pain, Pain in jaw, Toothache
Clinical narrative: - Pain in jaw, teeth, chin, gums, neck& tongue (severe). - Swollen lymph nodes, neck, chin, gums, lower jaw. - Stiffness in jaw, chin, neck, - Hard to breath (tight in neck).
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Cough, Laboratory test abnormal, Nasal congestion, PCO2 decreased
Clinical narrative: 8/20/12 patient presents with cough & congestion x 9 days. Lab pertussis PCR obtained (+) on 8/22/12. Put on ZPACK.
Age: 0.62
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. It was reported that the patient was vaccinated with expired PNEUMOVAX23 (lot # (669380/1397Z), exp 04-AUG-2012) on 15-AUG-2012 (route was unspecified). No adverse effect reported. The outcome of patient was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. It was reported that the patient was vaccinated with expired PNEUMOVAX23 (lot # (669382/1490Z), exp 14-AUG-2012) on 15-AUG-2012 (route was unspecified). No adverse effect reported. The outcome of patient was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: This spontaneous report was received from a office manager (healthcare worker) refers to a female patient of unknown age with none pertinent history. The healthcare worker reported that the patient was vaccinated with a first "standard" dose of GARDASIL, (dose route and Lot # not reported) in approximately 2010 (reported as about 2 years ago). In approximately 2010 (reported as about 2 years ago) the patient experienced numbness in both of her arms. The office manager was "recalling this from about 2 years ago." Verified with the representative that he learned of the event on 24JUL2012. It was reported that the patient did not continue therapy with GARDASIL because of the adverse event. It was also reported that the therapy was not reintroduced. The outcome of numbness in both of her arms was reported as recovered/resolved (recovery date was not reported). Additional information has been requested.
Age: 1.05
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Excoriation, Rash macular, Rash papular, Scab
Clinical narrative: Information has been received from a nurse concerning a 15 month old patient who on 05-MAR-2012 was vaccinated with a dose of GARDASIL (lot# 671427/1217AA). The nurse mentioned that on 06-JUN-2012 the patient had outbreak of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. A lot check has been initiated. Follow-up information received from registered nurse refers to a 15 months old male patient (child) with speech delay, hearing loss, colic and no illness of vaccination. On 05-MAR-2012 at 10:00 AM, the patient was vaccinated with the first dose of VARIVAX subcutaneously in right leg (dose not reported). No other co-suspects were reported. No concomitant medications were reported. On 06-JUN-2012, the patient was seen in clinic, a rash described as "scattered macular and papular rash with a few vesicles mostly excoriated with trace crusting, rash spares face and palms, skin turgor within normal limits (WNL); diagnosed with varicella. No treatment information was reported. No testing was done. The outcome of patient's was recovered/resolved on 03-JUL-2012 ("no rash"). The relatedness for the patient's event was not reported for VARIVAX. Additional information is not expected.