Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Chills, Headache, Pain
Clinical narrative: Her Lung and Chest also hurt; Her Lung and Chest also hurt; she has a rash on her torso and back. The rash looks like measles; She also had Body Ache and a Headache; She felt like she was having a seizure; She also had Body Ache and a Headache; After the Spikevax on 06NOV2023, that same night, she started having severe reactions: Fever 103.3 F, and Chills were so bad that she was not able to pick up the thermometer/08NOV2023, she has a Fever 100 F; After the Spikevax on 06NOV2023, that same night, she started having severe reactions: Fever 103.3 F, and Chills were so bad that she was not able to pick up the thermometer; This spontaneous case was reported by a patient and describes the occurrence of SEIZURE (She felt like she was having a seizure) in a 67-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She had COVID Disease at the end of the year 2020) in 2020.    On 06-Nov-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 06-Nov-2023, the patient experienced SEIZURE (She felt like she was having a seizure) (seriousness criterion medically significant), PAIN (She also had Body Ache and a Headache), PYREXIA (After the Spikevax on 06NOV2023, that same night, she started having severe reactions: Fever 103.3 F, and Chills were so bad that she was not able to pick up the thermometer/08NOV2023, she has a Fever 100 F), CHILLS (After the Spikevax on 06NOV2023, that same night, she started having severe reactions: Fever 103.3 F, and Chills were so bad that she was not able to pick up the thermometer) and HEADACHE (She also had Body Ache and a Headache). On 07-Nov-2023, the patient experienced RASH (she has a rash on her torso and back. The rash looks like measles). On 08-Nov-2023, the patient experienced PULMONARY PAIN (Her Lung and Chest also hurt) and CHEST PAIN (Her Lung and Chest also hurt). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, SEIZURE (She felt like she was having a seizure), PAIN (She also had Body Ache and a Headache), PULMONARY PAIN (Her Lung and Chest also hurt), CHEST PAIN (Her Lung and Chest also hurt), PYREXIA (After the Spikevax on 06NOV2023, that same night, she started having severe reactions: Fever 103.3 F, and Chills were so bad that she was not able to pick up the thermometer/08NOV2023, she has a Fever 100 F), CHILLS (After the Spikevax on 06NOV2023, that same night, she started having severe reactions: Fever 103.3 F, and Chills were so bad that she was not able to pick up the thermometer), RASH (she has a rash on her torso and back. The rash looks like measles) and HEADACHE (She also had Body Ache and a Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2023, Body temperature: 103.3 F. On 08-Nov-2023, Body temperature: 100 F.    Company comment: This is a Spontaneous case concerning a 67-year-old female patient with no relevant medical history reported, who experienced the serious (per medically significant) unexpected AESI of Seizure which occurred on the same day after a dose of mRNA-1273.815 received as the seventh dose for COVID-19 Vaccination. It was reported that she felt like having a seizure along with other non-serious events of Pain, Pulmonary pain, Chest pain, Pyrexia, Chills, Rash and Headache which occurred on the same day and following two days after the same dose. The patient took ibuprofen as treatment. No further clinical information or diagnostic tests results were disclosed for analysis. Concomitant medication was not reported. The benefit-risk relationship of mRNA-1273.815 is not affected by this report.     She reports that she received 6 previous Moderna COVID-19 vaccine and she had some side effects. But after receiving Spikevax she had such severe side effects that was worst than COVID Disease that she had in 2020 prior to vaccination. All previous vaccinations were Moderna Brand COVID-19 vaccines that include dose 1 first Primary monovalent dose on 04FEB2021 (Lot 015M20A) and had side effects, dose 2 include primary monovalent dose on 03MAR2021 (Lot 024C21A) and had side effects, dose 3 first monovalent Booster dose on 21SEP2021 (Lot 024C21A),  2nd Monovalent Booster dose on 12APR2022 (Lot# 005M21A), Dose 5 Bivalent Booster on 13OCT2022 (Lot AS 7165B), dose 6 on Bivalent Moderna on 27MAR2023 (lot# 030G22B). Patient had dose 7 spikevax formula and had side effects worst than COVID disease.  She states that She had COVID Disease at the end of the year 2020.  After the Spikevax on 06NOV2023, that same night, she started having severe reactions fever 103.3 F, and Chills were so bad that she was not able to pick up the thermometer. She felt like she was having a seizure. She also had Body Ache and a Headache. She will not be getting any more Moderna COVID-19 vaccine. She took Motrin and as of that morning, 08NOV2023, she has a Fever 100 F. Her Lung and Chest also hurt. as of 07NOV2023 while in the shower she noticed that she had a rash on her torso and back. The rash looks like measles. She had not seen the doctor yet. Concomitant medications were not reported.   This case was linked to MOD-2023-748695, MOD-2023-748694 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a 67-year-old female patient with no relevant medical history reported, who experienced the serious (per medically significant) unexpected AESI of Seizure which occurred on the same day after a dose of mRNA-1273.815 received as the seventh dose for COVID-19 Vaccination. It was reported that she felt like having a seizure along with other non-serious events of Pain, Pulmonary pain, Chest pain, Pyrexia, Chills, Rash and Headache which occurred on the same day and following two days after the same dose. The patient took ibuprofen as treatment. No further clinical information or diagnostic tests results were disclosed for analysis. Concomitant medication was not reported. The benefit-risk relationship of mRNA-1273.815 is not affected by this report.