Sex: F
Vaccine: FLU4
Symptoms: Erythema, Full blood count, Hypersensitivity, Mobility decreased, Pain in extremity
Clinical narrative: A red spot near that swollen area; Begins to feel pain in the vaccinated arm/pain on her right arm; Arm get swollen/swollen a medium size ball in the forearm appears to be like a chopped bee/swelling on her right arm/large amount of swelling; Pain meds they gave her for this gave her ulcers; Lack of movement on her right arm/cannot move her fingers; Suffered an allergic reaction; This non-serious spontaneous case, initially received on 11-Feb-2018, was reported by a pharmacist and concerns a 64-year-old, adult female patient.  The patient's current conditions included diabetics and allergy to seafood. The patient never had an allergic reaction to a vaccine in the past.  On 19-Jan-2018, the patient was administered Afluria (TIV) (influenza vaccine, dose, route of administration, anatomical location, batch number, expiry date: not reported) for an unknown indication.  On 19-Jan-2018, the patient developed pain in the vaccinated arm, for which she medication herself with 2 Panadols (paracetamol) and lidocaine cream. The patient's arm had swollen (described as a medium size ball in forearm appears to be like a chopped bee), a red spot appeared near the swollen area and lack of movement in the right arm. The patient had to visit emergency room. The reaction occurred in the forearm, far away from the site of vaccination. The physician stated, that the event was an adverse reaction to the vaccine and had not suggested any other tests. The patient visited rheumatologist, who stated that the events were probably due to hurricane and the patient told him that, it was due to the flu shot. The patient had hemogram test (complete blood count) done but the result was not reported. She stated that her physician told her that, she has had a large amount of swelling and now she cannot move her fingers. The patient had to do homemade medications and ice packs. She needed to visit another physician and get Cannabis. She could not afford any of that. She also stated that, the pain medications they gave her caused ulcers and needed to visit gastroenterologists for testing.  The outcome of the events was not reported.  Follow-up information received on 25-Apr-2018: The case 201801648 (deletion case) was identified as duplicate to the case 201800464 (retained case). Hence, all the information from the case 201801648 (deletion case) was merged into the retained case 201800464 and the case 201801648 will be deleted. Reporter information and events (injected limb mobility decreased and hypersensitivity) were added, LLT for the event 'pain in extremity' was changed from pain in arm to painful R arm in retained case 201800464.  Follow-up received from the reporter on 20-Jun-2018: The patient visited rheumatologist, who stated that the events were probably due to hurricane (as reported) and the patient told him that, it was due to the flu shot. The patient had to do homemade medications and ice packs. The patient had hemogram test (complete blood count) done but the result was not reported. Added verbatim large amount of swelling' in the event peripheral swelling and for the event injected limb mobility decreased as cannot move her fingers'. She needed to go to another physician and get Cannabis. She also stated that, the pain medications they gave caused her ulcers (added as new event) and needed to visit gastroenterologists for testing. The narrative was amended accordingly.   Update on 27-Jul-2018: Non-significant case correction was performed with Agency 20-Jun-2018: The case comment was changed from " A 64-year-old female patient with current condition included diabetics and allergy to seafood developed pain, swelling, redness and lack of movement on her right arm. Causality of the events is related, considering the temporal relationship and as possibility of flu vaccine to cause the events. The causality of the event large amount of swelling is unassessable due to lack of onset latency" to "A 64-year-old female patient with diabetics and allergy to seafood developed pain, swelling, redness and lack of movement on her right arm on the same day after vaccination with Afluria TIV. Causality of the events is related, considering the temporal relationship and as possibility of flu vaccine to cause the events. The event ulcer was assessed as not related to the suspect vaccine as the event can be explained by the pain medications".  Update on 10-Aug-2018: Non-significant case correction was performed with Agency 20-Jun-2018: The sentence in the narrative was corrected  on 19-Jan-2018, the patient developed pain in the vaccinated arm, for which she took self-medication with 2 doses of Panadol (paracetamol) and lidocaine cream' to on 19-Jan-2018, the patient developed pain in the vaccinated arm, for which she medication herself with 2 Panadols (paracetamol) and lidocaine cream'. The case comment was accordingly.  Update on 29-AUG-2018: Non-significant case correction was performed with Agency 20-JUN-2018. The case comment was amended.; Reporter's Comments: A 64-year-old, female patient with diabetics and allergy to seafood and lack of movement on her right arm, on the same day after vaccination with Afluria TIV. Causality of the events is related, considering the temporal relationship and as possibility of flu vaccine to cause the events. The event ulcer was assessed as not related to the suspect vaccine as the event can be explained by the pain medications.