Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Blood pressure increased, Blood pressure measurement, Facial paralysis, Hypoaesthesia
Clinical narrative: LEFT SIDE OF FACE PARALYZED; PAIN IN LEFT ARMPITS; FEELING PAIN IN LEFT CHEST MUSCLE; BP 144/88; WEAKNESS OF LEFT ARM AND LEFT LEG; NUMBNESS (LEFT CHEST MUSCLE, LEFT JAW, TEETH, LEFT ARMPIT, LEFT ARM AND LEFT LEG); NUMBNESS OF LIPS; FELT LIKE A PUNCH/BURNT IN THE INJECTION SITE; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: Chronic obstructive pulmonary disease (COPD), occasional alcohol use and non smoker. The patient had no known allergies and had no history of drug abuse or illicit drug usage. The patient previously received covid-19 vaccine ad26.cov2.s for prophylactic vaccination (series 1 from an unspecified manufacturer).  The patient received booster dose of covid-19 vaccine ad26.cov2.s (Janssen series 2) (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 13-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-NOV-2021, the patient felt burning sensation when being injected, "felt like a punch in the injection site." The patient stayed in observation for 15 minutes. Within 5-10 minutes, the patient started feeling pain and numbness in left chest muscle and left armpit. He mentioned this to the nursing staff that administered vaccine. They took his vital signs, and blood pressure was 144/88. The patient was not known for high blood pressure. The patient was offered water, took a sip and realized his lips were numb and left jaw and teeth went numb. The nurse advised him to go to the emergency room (ER). By that time his left arm and left leg were weak and numb. They did not know if it was due to injection or if he was having stroke, and they gave him TPA (alteplase), a blood clotting medication. During the entire time in ER, his whole left side of face was paralyzed. The patient was admitted to the hospital on 13-NOV-2021, stayed for 4 days and was discharged on 16-NOV-2021. At the time of reporting his left jaw still felt numb, "like I had a lot of lidocaine." Numbness on lips was recurrent, "comes and goes." It was stated that after 2-3 days, affected limbs started to get better and that by the 4th or 5th day they were fine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left side of face paralyzed, pain in left armpits, feeling pain in left chest muscle, weakness of left arm and left leg, and numbness (left chest muscle, left jaw, teeth, left armpit, left arm and left leg all subsumed under numbness) on NOV-2021, was recovering from numbness of lips, and the outcome of BP 144/88 and felt like a punch/burnt in the injection site was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211145305-covid-19 vaccine ad26.cov2.s- left side of face paralyzed, pain in left armpits, feeling pain in left chest muscle,  BP 144/88. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20211145305-covid-19 vaccine ad26.cov2.s-weakness of left arm and left leg, numbness (left chest muscle, left jaw, teeth, left armpit, left arm and left leg), numbness of lips, felt like a punch/burnt in the injection site . This event(s) is labeled per RSI and is therefore considered potentially related.