Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Peripheral swelling, Rhinorrhoea, Sensory loss, Somnolence
Clinical narrative: NUMBNESS AT INJECTION SITE; LOSS OF SENSATION IN LEFT ARM; TINGLING AT INJECTION SITE; DIZZINESS; PAIN AT INJECTION SITE/ SORENESS AT INJECTION SITE; INJECTION SITE REDNESS/ REDNESS; CHRONIC FATIGUE/ EXHAUSTION; HEADACHE; NAUSEA; SWELLING AT INJECTION SITE; SPORADIC SHORTNESS OF BREATH; RUNNY NOSE; CONGESTION; RIGIDITY; INABILITY TO CONCENTRATE OR DRIVE PERSONAL/ UNABLE TO FOCUS; SWELLING IN LEFT; MENTAL  FOG; VERTIGO; DISORIENTATION OF TIME; RADIATING OF LEFT SIDE OF BODY; WHEN BENT DOWN BOTH KNEES LOCK DOWN; HARD TO MOVE LEFT ARM WITHIN 1 HOUR OF RECEIVING THE VACCINE; ONSET OF SEVERE ANXIETY ASSOCIATED WITH INITIAL VACCINATION; NIGHTMARES; BODY STIFFENING UP/ STIFFNESS/ STIFFNESS IN UPPER BACK; DROWSINESS; OCCASIONAL LETHARGY; FLASHBACKS; THROWING UP; DUPLICATE PAIN IN OPPOSITE  SHOULDER (RIGHT SHOULDER); ANCILLARY LEGACY EFFECT; INSOMNIA; THROAT CLOSING; AWAKE IN MIDDLE OF NIGHT; WEAKNESS OF ARM; HALLUCINATIONS; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight was 199 pounds, and height was 177.8 centimeters.  The patient's past medical history included congenital enlarged colon, GI tract disorder, large colonic tract removed, hallucinations, severe nausea, vertigo, upset gastrointestinal symptoms, fever, and headache, and concurrent conditions included lactose intolerance, anaphylaxis with peanut based products, non alcohol, non smoker, high blood pressure, high cholesterol, hypothyroidism, allergy to lexapro, effexor, and paxil., allergic to the tdap vaccine, and severe seasonal allergies, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient was previously treated with influenza vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JANSSEN covid -19 vaccine 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 14:15 to left arm for prophylactic vaccination. Concomitant medications included metoprolol for high blood pressure, simvastatin for high cholesterol, levothyroxine for hypothyroid, clonazepam, doxepin, quetiapine fumarate, and venlafaxine hydrochloride.  On MAR-2021, the subject experienced hallucinations. On MAR-2021, the subject experienced throwing up. On MAR-2021, the subject experienced throat closing. On MAR-2021, the subject experienced nightmares. On MAR-2021, the subject experienced body stiffening up/ stiffness/ stiffness in upper back. On MAR-2021, the subject experienced drowsiness. On MAR-2021, the subject experienced occasional lethargy. On MAR-2021, the subject experienced flashbacks. On MAR-2021, the subject experienced awake in middle of night. On MAR-2021, the subject experienced duplicate pain in opposite shoulder (right shoulder). On MAR-2021, the subject experienced ancillary legacy effect. On MAR-2021, the subject experienced insomnia. On MAR-2021, the subject experienced weakness of arm. On 10-MAR-2021, the subject experienced mental fog. On 10-MAR-2021, the subject experienced vertigo. On 10-MAR-2021, the subject experienced disorientation of time. On 10-MAR-2021, the subject experienced radiating of left side of body. On 10-MAR-2021, the subject experienced swelling in left. On 10-MAR-2021, the subject experienced sporadic shortness of breath. On 10-MAR-2021, the subject experienced runny nose. On 10-MAR-2021, the subject experienced congestion. On 10-MAR-2021, the subject experienced when bent down both knees lock down. On 10-MAR-2021, the subject experienced hard to move left arm within 1 hour of receiving the vaccine. On 10-MAR-2021, the subject experienced onset of severe anxiety associated with initial vaccination. On 10-MAR-2021, the subject experienced dizziness. On 10-MAR-2021, the subject experienced rigidity. On 10-MAR-2021, the subject experienced inability to concentrate or drive personal/ unable to focus. On 10-MAR-2021, the subject experienced pain at injection site/ soreness at injection site. On 10-MAR-2021, the subject experienced injection site redness/ redness. On 10-MAR-2021, the subject experienced chronic fatigue/ exhaustion. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced swelling at injection site. On 15-MAR-2021, the subject experienced numbness at injection site. On 15-MAR-2021, the subject experienced loss of sensation in left arm. On 15-MAR-2021, the subject experienced tingling at injection site. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) high, Cholesterol total abnormal NOS (NR: not provided) High, and Thyroid function test (NR: not provided) Hypothyrodism. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mental fog, vertigo, disorientation of time, swelling in left, headache, and nausea on 10-MAR-2021, radiating of left side of body, runny nose, congestion, throat closing, when bent down both knees lock down, hard to move left arm within 1 hour of receiving the vaccine, onset of severe anxiety associated with initial vaccination, nightmares, and weakness of arm, and throwing up on MAR-2021, had not recovered from injection site redness/ redness, pain at injection site/ soreness at injection site, loss of sensation in left arm, numbness at injection site, and tingling at injection site, and the outcome of chronic fatigue/ exhaustion, sporadic shortness of breath, body stiffening up/ stiffness/ stiffness in upper back, drowsiness, occasional lethargy, hallucinations, flashbacks, dizziness, rigidity, duplicate pain in opposite shoulder (right shoulder), insomnia, swelling at injection site, awake in middle of night, ancillary legacy effect and inability to concentrate or drive personal/ unable to focus was not reported. This report was serious (Other Medically Important Condition).  Additional information received from patient on 26/Mar/2021. The following information was updated and incorporated into the case narrative: Additional event added; causality, case seriousness; outcome; person tab updated, vaccination site.; Sender's Comments: 20210320422-Covid-19 vaccine ad26.cov2.s-Hallucination. Follow-up received regarding Clinical Details. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY