Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site warmth, Laboratory test, Liver function test, Pain in extremity, Thyroid function test
Clinical narrative: Lightheaded; feeling numb, left arm started throbbing; big red knot at the injection site; feeling numb, left arm started throbbing; swelling went down the left arm and stopped at elbow; Feeling soreness in left arm/Left arm really hurt, hurt too much; swelling red bump which was hard at first, then red and hot; Big red knot at the injection site; swelling red bump which was hard at first, then red and hot; swelling red bump which was hard at first, then red and hot; left arm turned brown and yellowall the way down to the elbow; discoloration and puffiness and strange spot at the injection site; This spontaneous report was received from a 66-year-old female patient referring to herself. The patient's current conditions included glaucoma, irritable bowel and back problem. The patient was allergic to generic TRAVATAN. Concomitant therapies included dorzolamide hydrochloride, timolol maleate, travoprost(TRAVATAN), PROBIOTIC PEARLS, vitamin d (unspecified) and calcium (unspecified). On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (First dose).   On 11-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) second dose (strength, dose, route, lot/batch # and expiration date were not reported) in the left arm for prophylaxis. On the same day, the patient was vaccinated with influenza virus vaccine (unspecified) (reported as flu shot) Yearly, (strength, dose, route, lot/batch # and expiration date were not reported) in the right arm.   On 11-NOV-2019, 30 min after vaccination the patient reported feeling lightheaded and soreness in her left arm (dizziness and pain in extremity). The patient stated that the left arm really hurt, hurt too much to go to emergency room and could not get dressed. At unspecified time, the patient reported feeling numb, left arm started throbbing and crying due to the pain (hypoaesthesia and pain). It was also reported that the patient could not stand up or take a shower. The patient explained that she had a big red knot at the injection site (for pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in her left arm) (injection site nodule and injection site erythema), swelling red bump which was hard at first, then red and hot (injection site induration, injection site mass and injection site warmth), and then swelling went down the left arm and stopped at the elbow (peripheral swelling). On unspecified dates in November 2019 (reported as "during the days following the vaccination"), the patient stated that her left arm turned brown and yellow (skin discolouration) all the way down to the elbow. At the time of this report, the patient was experiencing some discolouration, puffiness and a strange spot at the injection site in her left arm (injection site discolouration). The patient reported that she experienced no reaction in her right arm where she got the unspecified "flu shot".   Ice and heating pad were put on patient's left arm and the patient took oxycodone. Unspecified osteoporosis test, blood work, thyroid test, vitamin d, urine study, bone markers (CTX (C-terminal telopeptide) and CVC (Cardiovascular Continuum)) and liver profile were performed, and the results were unknown. The outcome of pain in extremity, injection site warmth, injection site induration, injection site erythema, injection site discolouration, peripheral swelling, pain, injection site nodule, hypoaesthesia, dizziness, skin discolouration and injection site mass was reported as recovering. The reporter's causality assessment was not provided. Product quality complaint was not involved.