Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain in extremity, Skin wrinkling, Sleep disorder
Clinical narrative: bell's palsy; wrinkles in right eye was very smooth; patient nerves felt like little electricity lines zapping through constantly/still feels like cranial 7 nerves are on fire; most severe ice pick headache/headaches happened in bed while laying down/headaches feel dangerous; heart muscle is a little sore; felt like the biggest wasp in the world stung her head; painful cranial nerve felt like it was on fire (5minutes)/still throbbed a little/hot lava runnign through that nerve for 20 minutes/still nerve pain; afraid to go to sleep; sore arm; A spontaneous report  was received from a consumer concerning a 66 year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm, severe ice pick headache, felt like the biggest wasp in the world stung her head,  nerve pain, afraid to go to sleep, most severe ice pick headache/headaches happened in bed while laying down/headaches feel dangerous, patient nerves felt like little electricity lines zapping through constantly/still feels like cranial 7 nerves are on fire, bell's palsy, wrinkles in right eye was very smooth, patient feels pressure in her brain/scared there may be swelling in her brain and heart muscle is a little sore.     The patient's medical history included COVID-19 and concomitant medication included Vitamin B12.  On 24-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011A21A) intramuscularly on left deltoid for prophylaxis of COVID-19 infection.   On 25-FEB-2021, one day after receiving mRNA-1273, patient started to experience sore arm.  On 26-FEB-2021 patient had severe severe ice pick headache, it felt like the biggest wasp in the world stung her head. She states that it was so painful, and it scarred her. Patient claims she searched it up and it was the cranial 7 nerve from her temple to the back of her head that was on fire which lasted for 5 minutes.  The next day 27-FEB-2021 patient states the headache was gone however the nerve still throbbed a little and she was afraid to go to sleep that night. She then woke up that same night with severe ice pick headaches that were slamming into her head.  On 28-FEB-2021 the patient took protective measures and got up early and did not experience anything on that day. On 1-MAR-2021, she accidentally touched her husband's forehead with her head lightly and had the most severe ice pick headache (like hot lava running through that nerve for 20 minutes). It alleviated when she took two Advil's.  The next morning 2-MAR-2021 the patient nerves felt like little electricity lines zapping through constantly. Patient had looked up Bell's Palsy within our clinical trials and when she went to the doctors on 3-MAR-2021, they said the wrinkles in the right eye was very smooth compared to the left but her eyes were not drooping), doctors believed it to be Bell's palsy and prescribed her Gabapentin, and Zovirax.  Since then her ice picks have left but there is still nerve pain. She feels like the cranial 7 nerves are still on fire. All her headaches happened in bed while laying down. Patient states that the headaches feel dangerous and feel like they will cause her permanent damage. Patient still feels pressure in her brain and is scared there may be swelling in her brain.  Treatment medications included Advil, Gabapentin, and Zovarax.  Seriousness criteria included medically significant events.  Action taken with mRNA-1273 in response to the events was not reported.    Outcome of the event sore arm, severe ice pick headache, felt like the biggest wasp in the world stung her head,  nerve pain, afraid to go to sleep, most severe ice pick headache/headaches happened in bed while laying down/headaches feel dangerous, patient nerves felt like little electricity lines zapping through constantly/still feels like cranial 7 nerves are on fire were considered recovered but bell's palsy, wrinkles in right eye was very smooth, patient feels pressure in her brain/scared there may be swelling in her brain and heart muscle is a little sore were considered unknown.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the mRNA-1273 and the reported events and excluding all other etiology, a causal relationship cannot be excluded.  Headache is consistent with the known safety profile of he vaccine.