Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Amylase normal, Computerised tomogram head, Dizziness, Electrocardiogram normal, Erythema
Clinical narrative: Arm got infected; 2 syncopal episodes; Headache/H/A; Dizziness; Nausea; Allergic reaction to Chicken pox vaccine; Redness and sore arm/the reaction was a local reaction/ redness around injection site; Swelling around injection site; Erythema and rash left posterior arm; Nurse reported that a patient reported an allergic reaction to "some component" in the VARlVAX"/"definitely not an allergic reaction, just a local reaction."; Redness and sore arm/the reaction was a local reaction; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX), as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date not reported).  On an unspecified date, the patient reported an allergic reaction to "some component" in the varicella virus vaccine live (oka/merck) (VARIVAX) (vaccination complication), then; the reporter stated that, the reaction was a local reaction, redness and sore arm (erythema and pain in extremity), and added that "definitely not an allergic reaction, just a local reaction". The outcome of vaccination complication, erythema and pain in extremity was reported as recovered.   The causality assessment between varicella virus vaccine live (oka/merck) (VARIVAX) was reported as related.   This case has been considered non-valid due to the lack of patients' identifiers.  Follow up information was received from a Registered nurse on 01-FEB-2021. This report was now considered valid.   Information concerned to a 28 year old female patient. The patient's current conditions included allergy to latex and petroleum jelly, polycystic ovaries syndrome, gastrooesophageal reflux disease, hypothyroidism, bladder spasm and Type 2 Diabetes mellitus. Concomitant therapies included levothyroxine, metformin, oxybutynin chloride (DITROPAN) and famotidine (PEPCID). Historical vaccine included influenza vaccination.        On 07-DEC-2020, the patient was vaccinated by the trained registered nurse with dose 1 of single use varicella virus vaccine live (oka/merck) (VARIVAX) (lot No. S003446, exp. date 04-FEB-2021), subcutaneously in the left arm. No illness at the time of vaccination.      On 09-DEC-2020, the patient went to the emergency department (ED) since her "arm got infected" (localized infection). The patient was hospitalized. The ED records stated that the patient complaint of 2 syncopal episodes (syncope), H/A (also reported as headache), dizziness, nausea and allergic reaction to chicken pox vaccine (allergy to vaccine). ED provider noted erythema and rash left posterior arm (rash erythematous), redness and swelling around injection site (injection site erythema and injection site swelling). During hospitalization, the patient underwent a computerized tomography head without contrast, electrocardiogram, urinalysis, complete blood count with differential, amylase, comprehensive metabolic panel, lipase, magnesium and all were within normal limits. The patient was given cefalexin (KEFLEX) and doxycycline orally and discharged on an unknown date with prescription for both cefalexin (KEFLEX) 500 mg 4 times daily for 7 days and doxycycline 100 mg, 2 times daily for 7 days. On an unknown date, the patient's symptoms totally resolved.   The reporter considered injection site swelling, localized infection, rash erythematous, allergy to vaccine, nausea, dizziness, headache, syncope, and injection site erythema medically significant events.     The reporter considered injection site swelling, localized infection, rash erythematous, allergy to vaccine, nausea, dizziness, headache, syncope, and injection site erythema to be related to varicella virus vaccine live (Oka/Merck) (VARIVAX).     On 12-JAN-2021, the patient returned to get the second dose of varicella virus vaccine live (oka/merck) (VARIVAX), however the records were reviewed by an advanced practitioner registered nurse, who recommend the patient to not received the second dose.