Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Interchange of vaccine products, Lethargy, Malaise, Myalgia, Vaccination site pain
Clinical narrative: Interchange of Vaccine products; revaccination with different covid 19 vaccine; Muscle pains; Had feelings of suicide; Lethargy/Patient felt lethargic and slept from 2pm to 9pm; malaise; Felt hot and cold; Patient had an exacerbation of her depression. Her depression was more severe than usual; Pain in the internal part of her arm; Adverse Reactions of a sore right arm; This spontaneous case was reported by a patient and describes the occurrence of DEPRESSION SUICIDAL (Had feelings of suicide) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Drug use for unknown indication: Pfizer COVID-19 vaccine (Dose 2) and Pfizer COVID-19 vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine. Concurrent medical conditions included Depression (since the age of 5) and Sleep disturbance. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 13-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Sep-2022, the patient experienced VACCINATION SITE PAIN (Adverse Reactions of a sore right arm). On 14-Sep-2022, the patient experienced AXILLARY PAIN (Pain in the internal part of her arm). On 16-Sep-2022, the patient experienced LETHARGY (Lethargy/Patient felt lethargic and slept from 2pm to 9pm), MALAISE (malaise), FEELING OF BODY TEMPERATURE CHANGE (Felt hot and cold) and DEPRESSION (Patient had an exacerbation of her depression. Her depression was more severe than usual). On 17-Sep-2022, the patient experienced DEPRESSION SUICIDAL (Had feelings of suicide) (seriousness criterion medically significant) and MYALGIA (Muscle pains). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of Vaccine products) and COVID-19 IMMUNISATION (revaccination with different covid 19 vaccine). In September 2022, DEPRESSION SUICIDAL (Had feelings of suicide) and DEPRESSION (Patient had an exacerbation of her depression. Her depression was more severe than usual) had resolved. At the time of the report, LETHARGY (Lethargy/Patient felt lethargic and slept from 2pm to 9pm), MALAISE (malaise), FEELING OF BODY TEMPERATURE CHANGE (Felt hot and cold), AXILLARY PAIN (Pain in the internal part of her arm), VACCINATION SITE PAIN (Adverse Reactions of a sore right arm), MYALGIA (Muscle pains), INTERCHANGE OF VACCINE PRODUCTS (Interchange of Vaccine products) and COVID-19 IMMUNISATION (revaccination with different covid 19 vaccine) outcome was unknown.            No treatment information mentioned. On 06-Dec-2021, the patient received first booster dose of Moderna COVID-19 vaccine (Lot number: 014F21A, expiration date: 23-Mar-2022) on right  arm. On 30-May-2022, the patient received second booster dose of Moderna COVID-19 vaccine (Lot number:056A22A, expiration date: 07-Sep-2022) on right arm.For the sore right arm, the patient had put ice on her arm. It was reported that patient had depression which was more severe than usual. On 17-Sep-2022, the patient was angry, crying, and had feelings of suicide. The patient stated that she had no intentions of hurting herself currently. These symptoms lasted for a week and were what the patient called a Tsunami of Depression. Patient had muscle pain. Not interested in doing anything. On Sep-2022 patient started to felt depressed wanted to do something about it. On 22-Sep-2022 patient felt better with crying. On 22-Sep-2022, the feeling of desperations was over. On 23-Sep-2022, patient felt less depressed than the day before. Patient was not feeling social. Patient felt lethargic and slept for 2 pm to 9 pm. On 25-Sep-2022, the patient felt much better. Symptoms of Depression aggravated were reported as decreased interest , Social problem , depressed mood , anger,crying and feeling abnormal.  Company Comment: This spontaneous case concerns a 73 year old female patient with relevant medical history of Depression since 5 years of age and with sleep disturbance. This patient received two doses of Covid 19 vaccine Pfizer as primary series with no reported adverse events and two doses of mRNA-1273 vaccine as two booster doses. This patient experienced Serious ( medically significant ) unexpected event of Depression Suicidal ( had feelings of suicide) . This event occurred 4 days post vaccination with a dose of  mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5). This was accompanied by other non-serious events of depression ( Depression  Aggravated) . lethargy , malaise , feeling of body temperature change , vaccination site pain , axillary pain and myalgia .  It was reported that  the patient had an exacerbation of her depression.  Her depression was more severe than usual , the patient was angry, crying, and had feelings of suicide.  The patient says that she has no intentions of hurting herself currently. These symptoms lasted for a week and were what the patient calls a Tsunami of Depression.,  Muscle pains. and she was not interested in anything. The patient started to feel desperate and wanted to do something about this. Five days after the onset of the events the patient felt better  and  the patient was able to force herself to  go out to dinner with her daughter. Events of Interchange of Vaccine Products and Covid 19 Immunization ( re-vaccination with a different Covid 19 vaccine)  also occurred.  Outcome of the event Depression Suicidal  was resolved, depression was recovering  while for the other events it was unknown. The history of depression and sleep disturbance are considered as confounders for the events depression , Depression suicidal. The benefit -risk relationship of  mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5).    This case was linked to MOD-2022-650961, MOD-2022-650962 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2022: Follow up received with no new information; Sender's Comments: This spontaneous case concerns a 73 year old female patient with relevant medical history of Depression since 5 years of age and with sleep disturbance. This patient received two doses of Covid 19 vaccine Pfizer as primary series with no reported adverse events and two doses of mRNA-1273 vaccine as two booster doses. This patient experienced Serious ( medically significant ) unexpected event of Depression Suicidal ( had feelings of suicide) . This event occurred 4 days post vaccination with a dose of  mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5). This was accompanied by other non-serious events of depression ( Depression  Aggravated) . lethargy , malaise , feeling of body temperature change , vaccination site pain , axillary pain and myalgia .  It was reported that  the patient had an exacerbation of her depression.  Her depression was more severe than usual , the patient was angry, crying, and had feelings of suicide.  The patient says that she has no intentions of hurting herself currently. These symptoms lasted for a week and were what the patient calls a Tsunami of Depression.,  Muscle pains. and she was not interested in anything. The patient started to feel desperate and wanted to do something about this. Five days after the onset of the events the patient felt better  and  the patient was able to force herself to  go out to dinner with her daughter. Events of Interchange of Vaccine Products and Covid 19 Immunization ( re-vaccination with a different Covid 19 vaccine)  also occurred.  Outcome of the event Depression Suicidal  was resolved, depression was recovering  while for the other events it was unknown. The history of depression and sleep disturbance are considered as confounders for the events depression , Depression suicidal. The benefit -risk relationship of  mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5).