Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site swelling
Clinical narrative: Deep vein thrombosis in right leg; Torn the right calf muscle; Lots of discomfort at vaccination site; Inflammation of the shoulder area; Vaccination site swelling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 20220554269 (Janssen), 2306019 (VAERS).  A 40-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2022 as dose 2 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 06Apr2021 as dose 1, single (Lot number: 1808978), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Tonsils" (not ongoing), notes: Removed at 6 years old; "Asthma" (ongoing), notes: When he was baby; "Non smoker" (ongoing); "Hair growth abnormal" (ongoing), notes: Taking dutasteride 0.7 mg. Concomitant medication(s) included: DUTASTERIDE taken for hair growth abnormal. The following information was reported: ARTHRITIS (non-serious) with onset 06Apr2021, outcome "recovering", described as "Inflammation of the shoulder area"; VACCINATION SITE DISCOMFORT (non-serious) with onset 06Apr2021, outcome "recovering", described as "Lots of discomfort at vaccination site"; VACCINATION SITE SWELLING (non-serious) with onset 06Apr2021, outcome "unknown"; MUSCLE RUPTURE (medically significant) with onset 02Apr2022, outcome "unknown", described as "Torn the right calf muscle"; DEEP VEIN THROMBOSIS (medically significant) with onset 10Apr2022, outcome "recovering", described as "Deep vein thrombosis in right leg". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (07Apr2022) Unknown results; (11Apr2022) Unknown results; Ultrasound scan: (Apr2022) Unknown results.  Clinical course: The patient's past medical history included: tonsils (removed at 6 years old), and concurrent conditions included: asthma (When he was baby), non-smoker, and hair growth abnormal (Taking dutasteride 0.7 mg), and other pre-existing medical conditions included: patient never had blood Clot or Blood issues in his life. The patient had an active or sedentary lifestyle. There was no occult blood in the stool. No previous vaccination. Patient had no illness at the time of vaccination. Patient had no past history similar event and adverse event after any previous vaccinations. Patient had no history of allergy to vaccine, drug, or food. The patient had no history of pre-existing acute illness 30 days prior to vaccination or hospitalization in last. 30 days, with cause and no family history of any disease (relevant- to vaccination) or allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series I) (suspension for injection, route of administration was not reported, batch number: 1808978 expiry: unknown) dose was 1 administered on 06Apr2021 to Left shoulder upper arm muscle for prophylactic vaccination on 06Apr2021, the patient experienced Lots of discomfort: at vaccination site, inflammation of the shoulder area, pain in rotator cuff/sharp pain in the shoulder area, and vaccination site swelling (dose number in series I). Patient had not received an answer from the doctors. Patient reported that he had lots of discomfort, even pain in that shoulder area, sharp pain in the shoulder area, it was when he rotated his arm out or diagonal the rotator cuff area is extremely painful, it got better because of the Physical therapy that he started, he told the therapist, they gave me mobility things to help inflammation of the shoulder area. The patient additionally received non-company suspect pfizer Biontech Covid-19 (Tozinameran), (dose number in series 2) (form of admin, route of admin, and number expiry date were not reported) dose 2 administered on 31Mar2022 for prophylactic vaccination. Concomitant medications included dutasteride 0.7 mg for scalp growth hair regrowth and 0.7 mg, everything else was supplements pre workout supplement, natural supplements. On 02Apr2022, the patient experienced torn the right calf muscle (dose number in series 2). Patient reported that he was running up the hill, despite being athletic, was not warned up at all, and went from sitting position, sprint up the hill, which did not make it his first step was with his left leg and his second step was his right leg, at that point he did something that cause trauma to torn the right calf muscle. The patient reported that the moment it tore, he never torn anything before, the tearing was different feeling, he could not put any weight on my foot, there was complete Iimited mobility for about 5-6 days on 07Apr2022 and 08Apr2022, he started to move more because on 07Apr2022 for MFI (Magnetic resonance imaging) he found he was able to more weight on the ball of my foot, right above my toes on the base the sole of my foot. The bruising got worse between 07Apr2022 and 09Apr2022, none of that was abnormal given the tear, mobility and the pain. He put on calf or stay still the pain will go up, more throbbing, more pain, that was consistent until 10Apr2022 night when the pain got worse the specific area, it was a stabbing sensation, a constant stabbing, sharp pain almost like electrical shock every now and then, he could not sleep, which now he know was because he had a blot clot in right Leg (deep vein thrombosis right Leg) (dose number in series 2) . It was an ultrasound that they found the blood clot in right where he tore the muscle the ultrasound confirmed that, they were concern that there were more, they checked that spot they went up my Leg went up area on the right side, they Checked the other Leg, the speculation is that it could be just the trauma that caused it. On 11Apr2022, when he described it to the doctor (orthopaedic), to rule out blood clot at the vascular office they were very concerned, it was traumatic. He told me to ice it, 5-10 mins on and off, he kept ice, he moved as much, he was putting more weight his foot at that point, because despite possibility of blood clot, it being a grade 1-2 tear, he suggested to move around as much as he could tolerate with the pain , but he was hobbling, very slow and limited movement and still at times he used crutches. He reported that he had been 100 mobile for about 3 weeks, what feels to be 100. Patient had to be careful not to walk too fast, when he with his dog, he had to walk at much slower pace than he used to because he still feels Lots of fatigue in that area, at night when he walk he cannot move as quickly. Patient had a second radiologist look at the results, then physician assistant, PAC never really saw that day. She put me on blood thinner, made spectuation that blood clot was due to trauma, she said it could be or could not be caused by vaccine. No way to know. The next medical person he saw a physical therapist, I have been doing this for 4 weeks . They had not massaged only being doing functional movements, therapeutic movement to bring mobility and strength to lower body both sides. Then he saw his primary physician last week explained her everything and all the medication. She set him to see hematologist middle of July after the blood thinner. Patient reported that he had random throbbing. There are times at night when he had whole of movement, he being and doing physical therapy, stretching, moving daily, there are moments where he expect his leg to be sore maybe even more stiffness, what throws him off is sometimes he had these pulsations right where the trauma is and it moves towards his inner thigh. Sometimes the Back, hamstring he feel these pulses, it feels like but it feels like twitches, but it feels different , it feels very internal so he wonder If the blood Clot was moving, it's like feels like throbbing feels like muscle twitches, they never get worse, like nervous twitch, he think may be it was just stress, it was always his right leg , he never felt anything strange in other parts of his body other than his shoulder, everything that feels strange is in his right side. His left leg tends to be more sore and fatigued but more muscular, with my limited knowledge he do not associate it with blood clot. He do sense something is going with his right leg, even till today because everything has been happening is on right side. Patient reported that swelling was down, his calf got smaller because of the injury. He do bruise easily because of the medication he assume, but sometimes he do not know where the bruise is coming from. Treatment medications (dates unspecified) included: apixaban (4 in one day 2 morning, 2 night, then now patient taking it twice a day). It was reported that more one medical professional told the patient, that this was very rare occurrence and due to receiving the vaccine last year they could not rule out the possibility of it indirectly or directly causing the blood clot. Patient also mentioned he think another other possible cause could be putting ice on it, but other doctor mentioned there is no way the orthopedic doctor could have known there was a blood clot and putting was the best way to help him at that time. The action taken with covid-19 vaccine ad26.cov.s, and Pfizer Biontech covid-19 vaccine (tozinameran) was not applicable. The patient was recovering from deep vein thrombosis in right leg, lots of discomfort at vaccination site swelling was not reported. This report was serious (other medically important condition). Additional information was received from regulatory authority vaccine adverse event reporting system (VAERS) (VAERS reference number 2306019) on 10Jun2022 included information of events ( lots of discomfort at vaccination site, inflammation of the shoulder area, and vaccination site swelling), RRT of Recently tore right calf muscle updated to torn the right calf muscle RRT and PT for deep vein thrombosis updated, Patient's demography (weight, height and ethnicity) , past and current medical history, vaccination date and batch number added, lab details and clinical symptoms, non-company co-suspect booster dose added along with co-suspect due diligence, and treatment details. Report updated. Covid-19 vaccine AD26.COV.S- Torn the right calf muscle, Deep Vein thrombosis in right leg. Causality Assessment: The reporter and company assessed the events Torn the right calf muscle, deep vein thrombosis in right leg, lots discomfort site discomfort at vaccination site, Inflammation of the shoulder area, Vaccination site swelling' as possible with suspect product.   Follow-up attempts are completed. No further information is expected.