Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nail disorder, Oxygen saturation, Pain assessment, Pain in extremity, SARS-CoV-2 test
Clinical narrative: NAIL BREAKAGE; HAIR LOSS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; LEFT ARM PAIN/LEFT FOOT PAIN; HEADACHE; LEFT RIB CAGE PAIN; LEFT HIP PAIN; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 132 pounds, and height was 64 inches. The patient's concurrent conditions included: high blood pressure, and migraines, and other pre-existing medical conditions included: Patient was not pregnant at the time of reporting. The patient experienced passed out when treated with sumatriptan.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-APR-2021 in left arm for prophylactic vaccination. Concomitant medications included irbesartan for high blood pressure, and ergocalciferol.  On unspecified date in APR-2021, patient experienced headache that started 2 weeks after receiving the vaccine. She described it as a constant throbbing headache like it had its own pulse and it was located in the entire head generally and lasted 24/7 all day long. She would wake up and go to sleep with a headache and sometimes could not sleep due to the headache. The headache went away in late on an unspecified date in JUN-2021. It was an 8/10 pain level. She went to emergency room (ER) and had blood work ((unknown panel, including blood test for blood clots) and was normal. She was told that she was probably experiencing a migraine. Patient stated that she had migraines when she was young before having kids/during menstruation, but it has been 20 years since and she never had one lasting more than a day. In the emergency room (ER) she was given a migraine cocktail of 3 medications combined but had no relief. She was in the emergency room (ER) for 6 hours then discharged home. She noted that she lied that the headache was a little better after the medications because she just wanted to be discharged home. She followed up with her primary care provider in MAY-2021.  On 01-APR-2021, the patient had left arm pain. She stated that the pain was located at the injection site only and noted that there was no lump or pain with pressing on the injection site. She said the pain was a sharp pain and the pain level was 3/10 without movement and 9-10/10 with movement. She noted that the pain was especially present when she moves her arm backwards like to fasten her bra or wash her back. She noted that she had been checked for frozen shoulder and it was not the case, as her shoulder/ elbow/arm joints were fine. She can move her arm in circles and in front of her and twist her arm but she cannot move it back. She saw her primary care provider (PCP) in MAY-2021 and was advised to do physical therapy and to take Ibuprofen and another medication (name unknown). She stated that she only takes the medication when she cannot stand the pain and sometimes takes Tylenol for the pain as well. She noted that she requires pain medication especially if she reaches her arm back at times when she forgets her limitations. There was no improvement or worsening since onset. She did not do physical therapy.  On unspecified date in APR-2021, the patient had left hip pain and left rib cage pain that started 2 weeks after receiving the vaccine. She describes the pain as constant and dull, 5-6/10 pain level. There has been no improvement or worsening since onset. She noted that her rib cage feels like she got hit with something, like she was beat up and it feels very tender. Patient had left foot pain that occurred once in a while and feels like she ran a lot. She denied pain in the right foot. She noted it feels like the pain from the ribs moves all the way down to the foot. She noted that the pain level was 4-5/10 and it went away after a few hours.  Patient was an active person who does yoga and exercises. The caller also saw her primary care provider (PCP) in JUN-2021 and was supposed to follow-up in 6 weeks but could not see her doctor in person due to contracting Covid-19. The caller stated that she underwent Covid-19 testing on a weekly basis due to her job. On 20-APR-2021, Laboratory data included: Blood test (NR: not provided) Normal. She tested positive at her worksite on 27-JUN-2021 (suspected covid-19 infection and suspected clinical vaccination failure). She was not sure if the test was a polymerase chain reaction (PCR) test or rapid test. She noted that she waited 1 day for the result. She developed the symptoms like cough, fever, nausea, diarrhea, no sense of smell or taste, body aches, hair loss, nail breakage, a sensation of cob webs in the throat and no phlegm but a lot of thick saliva. She stated that she was sick in bed for 6 weeks and 3 weeks were very bad but her oxygen levels never dropped below 96%. She was managed at home with telephone follow-up with her primary care provider (PCP)and nurse. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) Never dropped below 96%. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on JUN-2021, had not recovered from left arm pain/left foot pain, left hip pain, and left rib cage pain, and the outcome of hair loss, nail breakage, suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211004833-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS