Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Injection site pain, Joint range of motion decreased, Limb discomfort, Loss of personal independence in daily activities
Clinical narrative: STOMACH PAIN; CONSTIPATION; SMALL BLOOD CLOT (A LARGE RED SPOT ON HER ARM); LOW BLOOD PRESSURE; LOW BLOOD COUNT; FEVER; FELT BLOWN OFF; WEAKNESS; LOW HEMOGLOBIN; MENTAL FATIGUE/ END OF DAY TIRED MENTALLY; COULD NOT LIFT ARMS ABOVE HEAD/ COULD NOT KEEP ARMS UP; PALE; LACK OF RESPONSE TO REFLEXES/ NO RESPONSE TO THE REFLEX TEST ON KNEE AND ELBOW; PAIN IN LEGS /PAIN IN ARM / ARMS WERE HURTING; NOT FEELING GREAT/ DID NOT FEEL WELL FOR MONTHS/ DID NOT FEEL GOOD FOR A LONG TIME; TROUBLE FOCUSING/ PROBLEM WITH FOCUSING; NEEDED NAPS TO GET THROUGH THE DAY/ TAKING NAPS IN MIDDLE WORK DAY; COULD NOT STAND LONG PERIODS; EXTREME FATIGUE/ TIREDNESS/ EXHAUSTED; SHORTNESS OF BREATH/ COULD NOT BREATH/ OUT OF BREATH; ACHES AND PAINS; SORE ARM BUT NOT TERRIBLE; This spontaneous report received from a patient concerned a 56 year old female of an unspecified race and ethnic origin.  The patient's height, and weight were not reported. The patient's concurrent conditions included: menopause prior to vaccine, and hypertension.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: an unknown date in APR-2021) dose was not reported, with frequency time 1 total administered on 13-MAR-2021 on left arm for prophylactic vaccination. Concomitant medications included benazepril hydrochloride for hypertension, and metoprolol for hypertension. On14-MAR-2021 (Sunday), the patient experienced sore arm but was not terrible. On 15-MAR-2021 (Monday), the patient had aches/pains/tired. Then proceeded to get worse. On the same day, the patient experienced shortness of breath. On 22-Mar-2021 (within a week), she was feeling really tired, was not feeling great, had a problem with focusing. On the same day, the patient was needed naps to get through the day/ taking naps in middle work day, her arms were hurting, and had pain in legs. The patient was standing at sink, she had to lean; however, she could not stand. In the week of 29-MAR-2021, the patient got so bad that she could not carry a basket of clothes up steps, could not breath, and was out of breath. Her boss said that she was not with it. On 29-MAR-2021, the patient experienced mental fatigue, weakness, and she could not lift arms above head. On the same day, the patient was pale, had lack of response to reflexes, and had low hemoglobin. On 01-APR-2021 (Thursday), the patient was washing hair in shower and could not keep arms up as they were so tired. The patient ended up sitting down, got out crawled in bed. The patient was exhausted and could not breath. On 02-APR-2021 (Friday), the patient called physician and was told to get Covid-19 test. On the same day, the patient had a Covid-19 swab (Covid-19 virus test) and the result was negative. On 05-APR-2021, the patient went to see family physician where the physician noted that the patient was pale and had no response to the reflex test on knee and elbow. On the same day, the patient's blood pressure was low. She ran a STAT blood test which showed hemoglobin was so low at 6 (which should be above 12). Within an hour, she told her that she needed to go to emergency room. The patient visited an emergency room due to low hemoglobin. The patient received a blood transfusion for low hemoglobin. A second attempt was made for blood transfusion; however, the patient experienced a fever and was advised to stop the treatment. The patient told all the doctors that all this started after the vaccine. On the same day, the patient felt blown off (feeling abnormal). At emergency room, the patient felt like she had a bleed. She had told them that there were no signs of blood. On 05-Apr-2021, the patient was admitted due to low blood count (low hemoglobin) and the patient was stabilized. On 07-Apr-2021 (Wednesday), the patient had an upper gastrointestinal (GI) and colonoscopy which showed that results were fine. Chest X-ray was performed and its result was clear. On the same day, Covid-19 swab (Covid-19 virus test) was also negative. Computerised tomography (CAT) scan of body cavity showed no signs of bleeding. It was decided to treat problem and not diagnose. On the same day, the patient was given iron and so on. In hospital, the patient had 4 or 5 iron transfusions. On 09-APR-2021 (Wednesday), the patient was going to be released; however, the nurse noticed a large red spot on her arm. On the same day, sonogram was performed and a small blood clot was found. On 10-Apr-2021, the patient was discharged to home. The patient was hospitalized for 5 days. The patient did not feel well for months and did not feel good for a long time. The patient was on medication to try to bring blood up, ferrous sulphate 325 milligram, 1 capsule 3 times a day prescribed but skipped dose due to stomach pain and constipation. The patient required Colace (docusate sodium) to help with the constipation. At the time of this report, the patient was still tired, hemoglobin now at 12 (unit not reported), end of day tired mentally, still had minor issue with focus, still had occasional shortness of breath on exertion, still had difficulty standing for long periods like holding phone to ear for long phone call as arm was fatigued. The patient had never felt the same since the shot.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from small blood clot (a large red spot on her arm), and low blood pressure on 10-APR-2021, aches and pains, pain in legs /pain in arm / arms were hurting, and sore arm but not terrible, could not lift arms above head/ could not keep arms up, pale, and lack of response to reflexes/ no response to the reflex test on knee and elbow on 01-MAY-2021, and extreme fatigue/ tiredness/ exhausted, and weakness on 01-SEP-2021, was recovering from mental fatigue/ end of day tired mentally, and low hemoglobin, had not recovered from not feeling great/ did not feel well for months/ did not feel good for a long time, trouble focusing/ problem with focusing, needed naps to get through the day/ taking naps in middle work day, could not stand long periods, and shortness of breath/ could not breath/ out of breath, and the outcome of fever, felt blown off, stomach pain, constipation and low blood count was not reported.  This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211145342-Covid-19 vaccine ad26.cov2.s-small blood clot (a large red spot on her arm),  Low hemoglobin, low blood pressure  Low blood count, aches and pains,  trouble focusing/ problem with focusing, needed naps to get through the day/ taking naps in middle work day,  could not stand long periods, shortness of breath/ could not breath/ out of breath,  mental fatigue/ end of day tired mentally,  could not lift arms above head/ could not keep arms up,  pale, lack of response to reflexes/ no response to the reflex test on knee and elbow, felt blown off, stomach pain, constipation, 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).  20211145342-Covid-19 vaccine ad26.cov2.s-pain in legs /pain in arm / arms were hurting, Not feeling great/ did not feel well for months/ did not feel good for a long time, fever, extreme fatigue/ tiredness/ exhausted, weakness,.. This event(s) is labeled per RSI and is therefore considered potentially related.