Sex: F
Vaccine: FLU3, FLUX, PPV, FLU3, PPV
Symptoms: Poor quality sleep
Clinical narrative: This spontaneous case was initially received on 14-Oct-2015. The case report was received from a(n) Non Health Professional and concerns a(n) female patient. Weight: not provided, Height: not provided. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Multiple unspecified allergies to unspecified pain medication. The following drug history information was reported: Unspecified pain medications (Indication:-, Reaction: Drug allergies). For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received Influenza Vaccine on 28-Sep-2015 at noon - unknown stop date, Batch no: not provided, Route of administration: not provided, Dose: no information provided. The patient received AFLURIA on one arm and PNEUMOVAX 23 on the other arm. Additional suspect drug(s): PNEUMOVAX 23, on 28-Sep-2015 at noon - unknown stop date, Batch no: not provided, Route of administration: Intramuscular, Dose: no information provided. The patient was advised that an updated version of the PNEUMOVAX vaccine was required because she got another unspecified pneumonia vaccine 3 years ago. She took a premed dose of 1 unspecified strength of acetaminophen thirty minutes before vaccination and thirty minutes post vaccination. Reaction(s)/event(s) and outcome: On 28-Sep-2015, 6 hours after starting/treatment with Influenza shot, the patient experienced Swelling of her fingers/Hand is still swollen (non serious, outcome: Recovering/Resolving), Burning of her fingers (non serious, outcome: Recovering/Resolving. On 28-Sep-2015, 8 hours after starting/treatment with Influenza shot the patient experienced Not able to move her arm/Inability to move her arm (non serious, outcome: Recovered/Resolved. She tried using a cold pack on her arm, which made "it better", but her hand was still swollen. On 28-Sep-2015, the patient experienced Shoulder started hurting (non serious, outcome: Recovering/Resolving) at this time she took another acetaminophen and it did not work at this point. Her hand is still sore (non serious, outcome: Recovering/Resolving). On the night of 28-Sep-2015, she did not sleep well (non serious, outcome: Recovering/Resolving), and could not move in bed (non serious, outcome: Recovering/Resolving). She also used 'cold water bottles and hot', alternating but only slept for 2 hours (non serious, outcome: Recovering/Resolving). When she woke up on 29-Sep-2015 morning, the patient experienced Could only feel the 1st bend on her fingers (non serious, outcome: Recovering/Resolving). At 26 hours post vaccination, she could lift her arm, but it was still sore though it was getting better. Action taken: Details manually to be entered, Event treatment: Details manually to be entered, Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. please add other relevant test results manually as appropriate. Reporter's assessment: The consumer reporter did not call her doctor because he would advise her to go to the Emergency Room and she stated "I do not want to have a pay so much money, because my arm seems to be getting better". The patient did not die. Case correction (29-Mar-2016): AE 9 re-coded. Case correction (31-Mar-2016): AE 1 re-coded. Case correction (19-Apr-2016): AE 1 verbatim term updated, no change to coding. Company's assessment and comment: no change in assessment. Case correction 03-May-2016: Core assessment for AE 9 with LLT 'numbness in fingers' changed to unlisted. Company evaluation and comment: No change to assessment. Case correction 17-May-2016: AE 2 re-coded to 'hand swelling'. Company evaluation and comment: No change to assessment.