Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Infusion site urticaria, Nerve block, Procedural vomiting, Surgery, Swollen tongue
Clinical narrative: NEUROMA; SWOLLEN TONGUE; WHITE TONGUE; IMMUNE SYSTEM DISORDER; LEFT FOOT LOOKED WHITE/LOSS OF PIGMENTATION; FELT HOT AND COLD; SKIN TINGLING/ LEFT FOOT FELT TINGLING; INFUSION SITE INFECTION; NAUSEA; VOMITING; This spontaneous report received from a patient concerned a 61 year old adult male. The patient's weight was 69.85 kilograms, and height was 72 inches. The patient's past medical history included: foot surgery (both feet), knee surgery, appendectomy, nausea, vomiting, impetigo (had in 3rd grade), rash on the face (the patient stated took a biopsy, it was a rash that felt like taking a piece of thread and dragging it across face. Red scaly, thought patient was having a severe reaction to Covid, the patient was on Triamcinolone, Mupirocin and Cephalexin a month or two before the 1st vaccine) and flu, and concurrent conditions included: heart valve defect, impetigo contagious, boils (impetigo, and boils both contagious and keeps on repeating), Morton neuroma (the patient stated it was inflammation of the main nerves on the pads of the foot, it was a result of the fat loss. The right foot was more prominent, and the patient had that procedure before), severe soy allergy, food allergy (green bean, bean sprouts, coffee gives nausea and vomiting), non-smoker, alcohol use (one drink per week) and immunocompromised, and other pre-existing medical conditions included: no adverse event after any previous vaccination, no vaccine and drug allergies. The patient had mild symptoms before 30 days prior to vaccination (booster dose). The family history included sister that had lupus, she had a kidney transplant, older brother had high blood pressure, the patient's mother had hives and did not had food allergies. The patient had no family history of allergy. The patient had no other suspected causes including co-administered vaccine(s)/risk factors. The patient had no substance abuse or use. The patient was working in banking. On an unspecified date before MAR-2020, the patient stated he saw cardiologist right before covid. The cardiologist saw a hiccup, that showed up in EKG (Electrocardiography). The patient had to wore heart monitor for 2 days. The echo (echocardiogram) showed cyst on the thyroid. The patient went to thyroid expert. The patient saw another cardiologist, had a stress test, nuclear test and sonogram, EKG, pressure of veins both arms and feet. Outcome of heart was 21 years younger than the chronological age. Patient had never tested positive for COVID. The patient had past history of similar event (patient had never taken the flu shot, when he did get the flu, he was under dressed, exposed). The patient had previously received ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride, zinc, and magnesium hydroxide. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number: 1805022, expiry: unknown) dose was not reported, 1 total, administered at left deltoid on 08-MAR-2021 for covid-19 prophylaxis. Patient stated that he was calling due to the fact that he was sick previous to the vaccine but the vaccine seemed to help him get better. He stated that he tolerated the vaccine well and that since then he was about six months in. Patient stated that he was not recovering but rather his condition was worsening. He had seen 4 doctors recently and 3 whom he saw a year ago. He was terrific prior to the vaccine. The vaccine was great but then he was not so great and seem to be going back to the past where he was pre vaccination. He stated that his antibody level had never been above 28. The patient reported a low antibody level of 36-38 (consumer's partner had an antibody count of 140, and his friends had counted over 400), antibody test and result was 22 units unspecified. The patient was tested on 24-JUL-2021, received results on 07-AUG-2021. On 24-JUL-2021, the patient was tested with antibody test- IgG which showed low antibody level 36- 38 (partial responder to therapy). The patient also experienced weight loss from 165 lbs to 142 lbs (after receiving Janssen vaccine primary vaccination lost all his body fat, I lost 10 to 14 pounds, no body knew why). The patient stated that the vaccine increased his metabolism. Adipose filler (referring to injection procedure of fat) was added to both feet injectable for fat loss. Leneva that was for the feet somebody else's fat that was been sterilized and injected into patient. He ate ice-cream daily at bedtime for weight gain.   On Aug-2021, the patient experienced right foot neuroma (his right food began hurting (date asked but unknown), he used to be a runner but with the pain in his right foot, it was painful to walk, they had to inject adipose filler to his right foot which felt great but 3 to 4 months later, all the fat dissolved, then they cut the bones shorter, cut the nerves and put in a screw to offset the pressure on the bones (dose number in series 1). The clinical diagnosis of the right foot condition was neuroma, the patient stated that condition of his right foot was improving however the screw does not allow toes to bend at one point but pain was lessened and still undergoing physiotherapy to reduce swelling when not walking). The patient had blood test on 27-AUG-2021 and the date on the report was 28-AUG-2021, with results ABS TD19 plus lymph (result 382 reference range: 12-645), ABS CD3 (result 1230 reference range 622-2402), ABS (absolute) CD4 plus helper (result 826 reference range 254-1519), percent CD19 plus lymphs (result 19.1 percent reference range 3.3 to 25.4 percent), percent CD3 plus lymphs (result 61.5 percent reference range 57.5 to 87.2 percent), percent CD4 plus lymphs (result 41.3 percent reference range 30.8 to 58.5 percent), CD4 / CD8 ratio (result 2.05 reference range 0.92 to 3.72), hemoglobulin (result 16.5 reference range 13.0 to 17.7), platelets (result 31 reference range 150 to 450)(dose number in series 1). Laboratory data (dates unspecified) included: SARS-CoV-2 test (NR: not provided) negative. The patient stated that skin became drier, putting on a lot of face cream. The patient stated that been to dermatologist as well. The dermatologist prescribed Triamcinolone Acetonide. The patient stated that he did not have to scratch. But felt his skin crawling and splotchy, it appears on knee, chest, front and back but never on the face, it was red and tingling. The patient stated that he would touch that and which would turn red. Last year after initial injection in AUG-2021, calluses was starting on the left foot (dose number in series 1). It was reported that the fat pad on patient feet was dissolved and got injections of adipose fat 1.5 vials. The patient went to many doctors, a cardiologist, cause they were looking for heart inflammation. The doctors told patient that everything was good, and no heart inflammation was found. The outcome of the increased metabolism, skin became drier, Skin tingling, low antibody count, calluses on left foot, low platelet counts, skin crawling and splotchy and weight loss was not reported and was recovering from neuroma. The patient received booster covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number: 1855194, expiry: unknown) dose was not reported, 1 total, administered on 19-NOV-2021 for covid-19 prophylaxis. Concomitant medications included ascorbic acid/chondroitin sulfate/curcuma longa root/glucosamine sulfate/manganese gluconate, Vitamin supplements C, Zinc, Fe, D, B, E and fish oil, charcoal on occasion.  On an unspecified date patient was confirmed with clinical condition called neuroma and on 24-DEC-2021 patient had surgery, vomiting afterwards and second foot surgery nerve block. As a result, patient's tongue was often swollen, and that turned white (dose number in series 2). The patient stated that he thought it was allergy. The patient's doctor thought it was allergic reaction to anesthesia. The patient stated IV (intra venous) in his left arm, 3 days later (27-DEC-2021), the patient stated where they connected the IV the marking was raised like a welt and the surgeon, anesthesiologist, his primary care provided thought it looked worse, like an infection (infusion site infection).  The surgeon said looked like they had trouble finding the vein. It was raised and purple. The Primary care provider said infection, they recommended hydrocortisone. It was not itching, 10 days gone then, the vein looked like double in width it looks normal at the time of reporting, not black and blue. Antibiotic, Cephalexin was given to patient for surgery, doctor extended the prescription. Patient stated that after taking Duexis, pain pill, started throwing-up (after foot surgeries both times).  On the week of 10-MAY-2022, patient Left foot felt tingling also felt hot and cold  (dose number in series 2). On 19-MAY-2022, the left foot looked white so the patient thought it is something related to blood flow so on same day patient went to cardiologist who did blood pressure test on extremities and ankles, it was ok, the doctor thought it was food allergies. Patient told the doctor that he did not eat any new food that could trigger any allergies so the doctor ordered blood work and it came back normal, when asked about the date of blood work, patient answered last week. Patient exposed feet to the sun and it tanned but 2 days later the tan went away and the foot looked white again (dose number in series 2). The doctor ruled out vitiligo and diagnosed the condition as immune system related but the patient thinks that the immune system issue is related to receiving the Janssen COVID-19 vaccine that is his own perception but the doctor did not say it is related to receiving the Janssen COVID-19 vaccine. The loss of pigmentation started between the first and second left toes then to the dorsal side of the left big toes then spread to between toes 2,3 and 4 and now the top side of the left foot is turning white which the patient described as strange. The right foot is not affected by pigmentation issues but had an extensive surgery in AUG-2021, and it is undergoing physiotherapy (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from infusion site infection, and the outcome of surgery, swollen tongue, white tongue, skin tingling/ left foot felt tingling, nausea, vomiting, felt hot and cold, left foot looked white/loss of pigmentation and immune system disorder was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20210829077. This case, from the same reporter is linked to 20220137233, 20220136407 and 20220617665.  Additional information was received from patient on 31-AUG-2022. The following information was updated and incorporated into the case narrative: patient concomitant condition (immunocompromised), past drugs (multivitamins, zinc, magnesium) added, patient weight updated from 71.66 to 69.85 kilograms. Upon review the following information was updated: vaccine indication updated to covid-19 prophylaxis, batch number statement removed.; Sender's Comments: V4- This version updates-  patient concomitant condition (immunocompromised), past drugs (multivitamins, zinc, magnesium) added, patient weight updated from 71.66 to 69.85 kilograms. Upon review the following information was updated: vaccine indication updated to covid-19 prophylaxis, batch number statement removed. This follow up information received does not alter the assessment of prior company causality of previously reported events.  20220114730-COVID-19 VACCINE AD26.COV2.S-Neuroma Follow-up received regarding Clinical Details. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.(Concurrent condition of neuroma)