Sex: F
Vaccine: COVID19
Symptoms: Influenza virus test, Insomnia, Loss of personal independence in daily activities, Oxygen saturation, Pain
Clinical narrative: FLUID IN RIGHT LUNGS (FELT LIKE DROWNING); ANAL LEAKAGE; WEAKNESS/CAN NOT LIFT ANYTHING OVER 5 POUNDS; HEADACHE; BODY ACHES; LACK OF APPETITE; NOT ABLE TO SLEEP; BLURRED VISION; HIGH FEVER; NOT ABLE TO WALK; UNABLE TO DO HOUSEWORK; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight was 91.6 pounds, and height was not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease (COPD), non-smoker, and non-alcoholic. The patient had no drug known allergies, no drug abuse or illicit drug usage. The patient was not pregnant at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: Unknown) dose was not reported, 1 total administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021 (that day after receiving shot), the patient had mild fever and body aches, but later she felt better until 13-APR-2021 morning. On 13-APR-2021, while driving, her head hit and she did not thought she would make it home. She experienced blurry vision and she pulled off to the side of the road. She felt feverish for which she took paracetamol (Tylenol) and drove back to home. Later, she experience, body aches, fever, lack of appetite and she could not able to walk. Her leg recover after 6 day but her arms and rest of body continued to ache. On 15-APR-2021, she developed shortness of breath (her COPD but has never had shortness of breath to this extend where she had to be on oxygen), cough, headache, and body aches. She was not even able to do housework. She contacted her doctor. Her lab test was performed which included COVID-19 rapid test (NR: not provided) received possible positive, influenza (flu) virus test (NR: not provided) as negative, and streptococcus identification test (NR: not provided) as negative On 19-APR-2021, her lab test was performed again include, COVID-19 virus test (NR: not provided) Negative, Influenza virus test (NR: not provided) as negative, and streptococcus identification test (NR: not provided) as negative. On 20-APR-2021, she developed low oxygen saturation. Her pulmonary imaging procedure was performed and diagnosed with fluid present in her right lungs which she felt like she was drowning. On 02-MAY-2021, she admitted to the hospital. She went 2 days without talking. In hospital, she was stuck with the needle and drained her. During hospitalization was not able to sleep and she received zolpidem tartrate (Ambien). On 07-MAY-2021, she was discharge from the hospital with with low grade fever, has no strength that she can not lift anything over 5 pounds. since  14-MAY-2021, she also had oxygen has been as low as 90%. On 15-MAY-2021, she experienced anal leakage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not able to sleep, and headache on 17-MAY-2021, and blurred vision on 13-APR-2021, was recovering from high fever, body aches, lack of appetite, and fluid in right lungs (felt like drowning), had not recovered from weakness/can not lift anything over 5 pounds, and anal leakage, and the outcome of not able to walk and unable to do housework was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000180209. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria). based on the PQC evaluation/investigation performed.; Sender's Comments: V0-20210540104-covid-19 vaccine ad26.cov2.s -Fluid in right lung-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, UNDERLYING DISEASE.