Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Appetite disorder, Arthralgia, Asthenia, Chills, Feeling cold
Clinical narrative: her legs feel weak, especially the right one; feels very shakey; kidneys hurt; appetite has been affected; she was so cold that she couldn't get warm; then she felt like she was on fire; patient has pain in her joints, body and spine; could hardly move or walk; felt so weak; she was so thirsty, has unusual thirst; chills; sweats, more sweaty than anything; Initial information regarding this unsolicited valid non-serious case via The Agency (reference number: 00296975) was received from a consumer and transmitted to Sanofi 01-Oct-2020.  This case involved a 50 years old female patient for whom appetite has been affected (Appetite disorder), patient has pain in her joints, body and spine (Pain), she was so thirsty, has unusual thirst (Thirst), chills, sweats, more sweaty than anything (Hyperhidrosis), her legs feel weak, especially the right one (Muscular weakness), kidneys hurt (Renal pain), feels very shaky (Nervousness) and reported that she was so cold that she couldn't get warm (Feeling cold), then she felt like she was on fire (Feeling hot), felt so weak (Asthenia) and could hardly move or walk (Movement disorder), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.   On 29-Sep-2020 at 14:00, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7011JA, expiry date: 30-Jun-2020) via intramuscular route in the right arm for prophylactic vaccination.  No other vaccines were administered.   It was reported that immediately after the vaccine was administered, everything was fine, the patient went on her typical walk of the day and did not feel too bad.   On 29-Sep-2020 at 22:00, she was so cold that she could not get warm (Feeling cold), 8 hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE. That lasted until about 4am, then she felt like she was on fire (Feeling hot) until about 09:00.  On 29-Sep-2020, the patient so thirsty (Thirst), but felt so weak (Asthenia) and achey that she could hardly move or walk, she had pain in her joints, body and spine (Pain), she had unusual thirst (Thirst), chills and sweats (Hyperhidrosis), the same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On 30-Sep-2020, she was more sweaty than anything (Hyperhidrosis), and the sweats lasted all night, her kidneys hurt (Renal pain), and her appetite has been affected (Appetite disorder), 10 hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On 01-Oct-2020, she feels like the vaccine affected my nervous system, because she felt very shakey (Nervousness) and her joints did not feel right. She still had sweats and her legs feel weak, especially the right one (Muscular weakness), 1 day 10 hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  The patient stated that the experience had been scary.   Relevant laboratory data were not reported.  Final diagnosis was could hardly move or walk, felt so weak, then she felt like she was on fire, feels very shakey, sweats, more sweaty than anything, chills, she was so thirsty, has unusual thirst, patient has pain in her joints, body and spine, appetite has been affected, she was so cold that she couldn't get warm, kidneys hurt and her legs feel weak, especially the right one.   No corrective treatment was received.  At the time of reporting, the outcome was unknown for the reported events.