Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | U8862DA | IM / LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT / LA |
on the day of administration, caller noticed a taste in her mouth; reported severe gas; reported severe gas. Caller noted that the gas caused swelling; gas pain was worse in her mid body; difficulty sitting, laying, and noted difficulty turning from side to side; pain as feeling like broken bones in her body. She also noted pain in her neck; pain in her neck; flank hernia on her left side that was so "jacked up; displacement of her spinal cord. Caller noted injury to these areas from past events, but the gas buildup exacerbated the problem; condition aggravated; discomfort in her hips, knees, and ankles; slight uneasiness in stomach and bowel system; Initial information received on 28-Oct-2025 regarding an unsolicited valid non-serious case received from a Patient. This case involves a 78-year-old female patient who experienced slight uneasiness in stomach and bowel system, on the day of administration, caller noticed a taste in her mouth, reported severe gas, caller noted that the gas caused swelling, gas pain was worse in her mid body, difficulty sitting, laying, and noted difficulty turning from side to side, pain as feeling like broken bones in her body, she also noted pain in her neck, pain in her neck, flank hernia on her left side that was so "jacked up, displacement of her spinal cord. caller noted injury to these areas from past events, but the gas buildup exacerbated the problem, condition aggravated and discomfort in her hips, knees, and ankles after receiving influenza USP trival A-B high dose subvirion vaccine [Fluzone HD]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant: no other immunization On 23-Oct-2025, the patient received an unknown dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (strength, expiry date, lot number not reported) via unknown route in the left arm for Influenza immunization. Information regarding batch number corresponding to the one at time of event occurrence is requested. On 23-OCT-2025 the patient developed slight uneasiness in stomach and bowel system (abdominal discomfort) (latency: on same day). On 24-OCT-2025 the patient developed on the day of administration, caller noticed a taste in her mouth (taste disorder), reported severe gas (flatulence), caller noted that the gas caused swelling (swelling), gas pain was worse in her mid body (abdominal pain upper), difficulty sitting, laying, and noted difficulty turning from side to side (mobility decreased), pain as feeling like broken bones in her body. she also noted pain in her neck (pain), pain in her neck (neck pain), flank hernia on her left side that was so "jacked up (abdominal hernia), displacement of her spinal cord. caller noted injury to these areas from past events, but the gas buildup exacerbated the problem (intervertebral disc displacement), condition aggravated and discomfort in her hips, knees, and ankles (limb discomfort) (latency: 1 day) It was reported, On the day of administration, caller noticed a taste in her mouth and a slight uneasiness in stomach and bowel system. The next day, caller reported severe gas. Caller noted that the gas caused swelling. The gas pain was worse in her mid body, but she noted discomfort in her hips, knees, and ankles. Caller stated that she was unable to burp or flatulate to help relieve the pressure from the gas. She noted difficulty sitting, laying, and noted difficulty turning from side to side. She described the pain as feeling like broken bones in her body. She also noted pain in her neck. She felt like a blown up tire. Caller described a flank hernia on her left side that was so jacked up she had to have a chiropractic treatment to assist with the displacement of her spinal cord. Caller noted injury to these areas from past events, but the gas buildup exacerbated the problem. Caller noted that she is very active and independent. She did not contact her healthcare provider because she tried to take care of the problem on her own and did not want to have x-rays taken. The gas pain/buildup in her body lasted approximately 3.5 to 4 days Action taken was not applicable. Treatment: Chiropractor appointment, moved around to break down the gas It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Recovered / Resolved on an unknown date in October 2025 for the event Abdominal pain upper and unknown for all rest events.