Received Aug 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
couldn't think through her process; Heart pain; felt like she couldn't breathe; was hyperventilating; she wasn't feeling good; waking with abdominal pain; woke with her heart racing and heart pain; Sick back pain; weird pain in her spine; she woke with numbness in her arm; A weird electrical feeling in her hand; Headache/headaches began again/she's continued to have episodes of crazy headaches/weird brain pain; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (couldn't think through her process) and ANGINA PECTORIS (Heart pain) in a 39-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENTAL IMPAIRMENT (couldn't think through her process) (seriousness criterion medically significant), ANGINA PECTORIS (Heart pain) (seriousness criterion medically significant), DYSPNOEA (felt like she couldn't breathe), HYPERVENTILATION (was hyperventilating), MALAISE (she wasn't feeling good), ABDOMINAL PAIN (waking with abdominal pain), PALPITATIONS (woke with her heart racing and heart pain), BACK PAIN (Sick back pain), SPINAL PAIN (weird pain in her spine), HYPOAESTHESIA (she woke with numbness in her arm), PARAESTHESIA (A weird electrical feeling in her hand), MYALGIA (Body aches) and HEADACHE (Headache/headaches began again/she's continued to have episodes of crazy headaches/weird brain pain). At the time of the report, MENTAL IMPAIRMENT (couldn't think through her process), ANGINA PECTORIS (Heart pain), DYSPNOEA (felt like she couldn't breathe), HYPERVENTILATION (was hyperventilating), MALAISE (she wasn't feeling good), ABDOMINAL PAIN (waking with abdominal pain), PALPITATIONS (woke with her heart racing and heart pain), BACK PAIN (Sick back pain), SPINAL PAIN (weird pain in her spine), HYPOAESTHESIA (she woke with numbness in her arm) and PARAESTHESIA (A weird electrical feeling in her hand) outcome was unknown, MYALGIA (Body aches) had resolved and HEADACHE (Headache/headaches began again/she's continued to have episodes of crazy headaches/weird brain pain) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication information was not provided. Patient experienced a bad reaction to the Moderna Covid Vaccine and wanted information in regards to the Pfizer Covid pill. Patient reported adverse effects after receiving Paxlovid. Patient experienced headache and body aches and weird episodes once per week for four weeks. Patient woke up with numbness in her arm, and felt like she couldn't breathe and was hyperventilating. Patient had a weird electrical feeling in her hand. On the next morning, she wasn't feeling good, so, she went to the hospital. The hospital staff did not believe that she was having an adverse reaction to the vaccine but she was given IV fluids and then began to feel better. The headaches began again and patient had this weird brain pain and couldn't think through her process. Patient reported going to bed and having a dream and then waking with abdominal pain. On the next night, when she slept, she had another dream but during this time, she woke with her heart racing and heart pain, so then she went back to the emergency room visit. Patient did not state outcome of this emergency room visit. Patient continued to have episodes of crazy headaches. Patient purchased something with which she could check blood pressure and oxygen level. Patient was also having sick back pain, weird pain in her spine and felt like crap from January to March. Reporter did not allow further contact; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.