Sex: M
Vaccine: FLUX, PNC20
Symptoms: Magnetic resonance imaging normal, Oedema, Pain, Sleep disorder, X-ray normal
Clinical narrative: Extreme edema; Swelling; Pain; Inability to move/ Inability to walk; Disturbance of sleep; Inability to work; Inability to walk, unable to do physical activities; allergic reaction; uncomfortable; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Borderline diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for glucose tolerance impaired. The following information was reported: OEDEMA (non-serious), outcome "unknown", described as "Extreme edema"; SWELLING (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown"; GAIT INABILITY (non-serious), outcome "unknown", described as "Inability to move/ Inability to walk"; SLEEP DISORDER (non-serious), outcome "unknown", described as "Disturbance of sleep"; IMPAIRED WORK ABILITY (non-serious), outcome "unknown", described as "Inability to work"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "Inability to walk, unable to do physical activities"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction"; DISCOMFORT (non-serious), outcome "unknown", described as "uncomfortable". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain. Additional information: The patient is also the reporter. Consumer stated, "I had an adverse reaction to Prevnar 20 shot given to me at a (Withheld) healthcare facility. I had it before. Extreme edema, swelling, pain, inability to move, the reaction persisted for over 6 weeks, disturbance of sleep, inability to work, inability to walk, unable to do physical activities. I went to multiple physicians, ER, I went to have an MRI (Magnetic resonance imaging). It was a horrible reaction, very uncomfortable, very disturbing. I decided I would report it." Consumer stated, "My weight is 275 pounds more or less (As consumer was unsure hence not captured in tab)." Consumer stated, "No, I went to vaccination clinic. I did not do it. They provided the shot, the nurse provided the shot inside (Withheld) facility. I was just given the shot. I wasn't given the contents, I didn't self administer it. It was provided to me by (Withheld)employee". Dose, Indication and Route of administration: Consumer stated, "No, I know nothing about it. Just received that, hat's all I did." Medical conditions: Consumer stated, "I am a borderline diabetic." Concomitant medications: Consumer stated, "I do take medication." Name of Medication: Consumer stated, "For diabetes, I sometimes take Metformin." Laboratory work: Consumer stated, "Yes, this event occurred 07Sep2022 and it persisted until December." Treatment: Consumer stated, "They did not offer any treatment or medication for it. Only for symptomatic treatment of pain they offered Opioids (Further name of Opioid was not clarified over the call hence suspect captured as Unspecified Opioids), I declined. They didn't provide anything, I do have a friend who is Endocrinologist who was amazed that they didn't offer any kind of anti-inflammatory treatment. I saw a number of specialists and follow up because of this and following this up was documented. It's in my medical records. I was seen by 5 or 6 different physicians including MRI." Prior vaccinations (Within 4 weeks): Consumer stated, "I am thinking, I can't remember whether I had a Flu shot before or had a Flu shot after (As consumer was unsure hence Unspecified Flu Shot captured as suspect and event captured as per verbatim). I may have had the Flu shot before. I don't remember the date." Reassurance: Consumer stated, "Well, obviously because I don't know (Intent: MI Query), it was suggested by a couple of physicians that I may have either had an allergic reaction or something affected by autoimmunity in relationship to the shot. I don't really know and I don't know whether I have an autoimmunity issue or whether this is an adverse reaction to the shot itself. It's not a common reaction, it's not listed in the CDC or the FDA list of adverse reactions directly. Not as a severe symptoms, they only discussed mild symptoms and so several doctors they would have mine to look at the reactions, the severity of my symptoms did not match anything there. So they did not know. No one could make a definitive diagnosis, but it was all happen stance, because it occurred immediately within 24 hours after the shot, obviously related to the shot. So, I don't know whether it had to do with the adverse reaction of the medication or induced reaction, induced to some autoimmune response or whether it was a traumatic injury due to the shot. Although, there was no physical as there was no bruising, there was no bleeding, nothing appeared on X-ray and nothing appeared on MRI."  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.