Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin warm, Sneezing, Tremor
Clinical narrative: started sneezing hard 8 hard sneezes; shaking form head to toe; My arm is sore; diarrhea; I felt dizzy, drunk, drugged, lightheaded; chills; running fever but no thermometer, skin on leg felt hot to the touch; exhausted/tired and rundown; headache; I felt dizzy, drunk, drugged, lightheaded/I felt off; I felt that bad, burning up; This spontaneous case was reported by a patient and describes the occurrence of FEELING DRUNK (I felt dizzy, drunk, drugged, lightheaded/I felt off), BURNING SENSATION (I felt that bad, burning up), SNEEZING (started sneezing hard 8 hard sneezes), TREMOR (shaking form head to toe) and PAIN IN EXTREMITY (My arm is sore) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: J and J (J and J) on 06-Mar-2021, J and J (J and J) on 22-Dec-2021 and Pfizer on 27-Oct-2022. Past adverse reactions to the above products included No adverse event with J and J, J and J and Pfizer.    On 04-Oct-2023 at 9:15 AM, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 04-Oct-2023, the patient experienced FEELING DRUNK (I felt dizzy, drunk, drugged, lightheaded/I felt off), TREMOR (shaking form head to toe), PAIN IN EXTREMITY (My arm is sore), DIARRHOEA (diarrhea), DIZZINESS (I felt dizzy, drunk, drugged, lightheaded), CHILLS (chills), PYREXIA (running fever but no thermometer, skin on leg felt hot to the touch), FATIGUE (exhausted/tired and rundown) and HEADACHE (headache). 04-Oct-2023, the patient experienced BURNING SENSATION (I felt that bad, burning up). On 05-Oct-2023, the patient experienced SNEEZING (started sneezing hard 8 hard sneezes). The patient was treated with IBUPROFEN on 04-Oct-2023 at a dose of 2 equate doses. At the time of the report, FEELING DRUNK (I felt dizzy, drunk, drugged, lightheaded/I felt off), SNEEZING (started sneezing hard 8 hard sneezes), TREMOR (shaking form head to toe), PAIN IN EXTREMITY (My arm is sore), DIARRHOEA (diarrhea), DIZZINESS (I felt dizzy, drunk, drugged, lightheaded), CHILLS (chills), PYREXIA (running fever but no thermometer, skin on leg felt hot to the touch), FATIGUE (exhausted/tired and rundown) and HEADACHE (headache) was resolving and BURNING SENSATION (I felt that bad, burning up) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient got the Spikevax Covid vaccine on 04-Oct-2023 at 09:15 A.M.  In the afternoon, the patient felt off by 4 P.M. She felt dizzy, drunk, drugged, lightheaded at 5 P.M and it got her good. She took 2 equate Ibuprofen at 06:20 P.M. She got sick for 11 hours and called emergency room at 12:27 AM, but did not go, because she did not know if insurance would cover it. She had chills and was uncontrollably shaking from head to toe, had running fever but did not have any thermometer to check, and her skin on leg felt hot to the touch. She felt like she had diarrhea, and so many things went along with this. She was scared to sleep. Patient stated that she called her friend and asked them to check on her. She had plenty of Covid shots and never had a reaction like this. This was patient's first Moderna vaccine. She felt that bad, and was burning up. It kept going on and on. She felt exhausted and felt like she was not going to make it. She had a dull headache throbbing in the head. Around 5 to 5:15 AM, she started sneezing hard and had 8 hard sneezes. Her arm was sore, but not that bad, and this was to be expected. She was tired, and rundown. This reaction was way over the top. Patient could not find lot number on paperwork.  Patient spoke with pharmacist on 04-Oct-2023, who told her that someone else had the same reaction as she did. Patient also reported that she spoke with a pharmacist on 05-Oct-2023, who mentioned that they got the vaccine and that they might feel bad for a few days, but patient was unsure about which product the pharmacist took.   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2023: Non-significant follow-up received and reference numbers added.