Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Dyspepsia, Dyspnoea, Dysuria, Fatigue
Clinical narrative: Slept all day the next day after 2nd booster; Difficulty Breathing; Can not bend and pick up things up after 2nd booster; Shaky hands after 2nd booster; pain in the right breast, pain traveled to left breast; Sinus clogging; Stomach pain  after 2nd booster; Acid Pain after 2nd booster; Cloudy urine after 2nd booster; Dark yellow urine after 2nd booster; Burning on urination  after 2nd booster; pain traveled to left lymph node; Diarrhea twice after 2nd booster; Fever at nights (not measured) Chills/she was sick and tired; Joint pain; pain traveled to toes; Tired after 2nd booster; This spontaneous case was reported by a patient and describes the occurrence of HYPERSOMNIA (Slept all day the next day after 2nd booster), DYSPNOEA (Difficulty Breathing), MOVEMENT DISORDER (Can not bend and pick up things up after 2nd booster), TREMOR (Shaky hands after 2nd booster) and BREAST PAIN (pain in the right breast, pain traveled to left breast) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B27A, 033C21A, 022M20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from 18-Mar-2021 to 01-Apr-2021. Family history included Diabetes (patient does not have these medical conditions.) since an unknown date, Blood pressure high (patient does not have these medical conditions.) since an unknown date and Heart disease, unspecified (patient does not have these medical conditions.) since an unknown date. Concurrent medical conditions included Asthma and Hypothyroidism. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2022, the patient experienced DYSPNOEA (Difficulty Breathing), MOVEMENT DISORDER (Can not bend and pick up things up after 2nd booster), TREMOR (Shaky hands after 2nd booster), BREAST PAIN (pain in the right breast, pain traveled to left breast), SINUS DISORDER (Sinus clogging), ABDOMINAL PAIN UPPER (Stomach pain  after 2nd booster), DYSPEPSIA (Acid Pain after 2nd booster), URINE ABNORMALITY (Cloudy urine after 2nd booster), CHROMATURIA (Dark yellow urine after 2nd booster), DYSURIA (Burning on urination  after 2nd booster), LYMPH NODE PAIN (pain traveled to left lymph node), DIARRHOEA (Diarrhea twice after 2nd booster), PYREXIA (Fever at nights (not measured) Chills/she was sick and tired), ARTHRALGIA (Joint pain), PAIN IN EXTREMITY (pain traveled to toes) and FATIGUE (Tired after 2nd booster). On 14-Jul-2022, the patient experienced HYPERSOMNIA (Slept all day the next day after 2nd booster). On 13-Jul-2022, DIARRHOEA (Diarrhea twice after 2nd booster) had resolved. On 14-Jul-2022, HYPERSOMNIA (Slept all day the next day after 2nd booster), ABDOMINAL PAIN UPPER (Stomach pain  after 2nd booster) and DYSPEPSIA (Acid Pain after 2nd booster) had resolved. On 17-Jul-2022, URINE ABNORMALITY (Cloudy urine after 2nd booster), CHROMATURIA (Dark yellow urine after 2nd booster) and DYSURIA (Burning on urination  after 2nd booster) had resolved. On 18-Jul-2022, BREAST PAIN (pain in the right breast, pain traveled to left breast), SINUS DISORDER (Sinus clogging), LYMPH NODE PAIN (pain traveled to left lymph node), ARTHRALGIA (Joint pain) and PAIN IN EXTREMITY (pain traveled to toes) had resolved. At the time of the report, DYSPNOEA (Difficulty Breathing), TREMOR (Shaky hands after 2nd booster) and FATIGUE (Tired after 2nd booster) outcome was unknown, MOVEMENT DISORDER (Can not bend and pick up things up after 2nd booster) had not resolved and PYREXIA (Fever at nights (not measured) Chills/she was sick and tired) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jul-2022, Blood pressure measurement: Blood pressure increased (when got up150/90mmHG)..         On Thursday, 14JUL2022, patient slept all day. The patient had received first booster dose of Moderna vaccine on 26-OCT-2021. The patient had received second booster dose of Moderna vaccine on 13-JUL-2022. Patient on 18JUL2022 felt a little better but still tired. After the 2nd primary shot, asthma got worst, used Albuterol at least twice a day (Prior to vaccination only used as needed once a year).  Company comment: This spontaneous case concerns a 53-year-old female patient with relevant medical history of COVID 19 who experienced the unexpected non-serious AESI of Hypersomnia on 1 day after administration of second booster dose of mRNA-1273 Vaccine. Patient also experienced other non-serious events of fever and fatigue. The event resolved on the same day. Medical history of COVID 19 and concurrent events fever and fatigue could be cofounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event retained non-serious as per medical judgement.   This case was linked to MOD-2022-609325 (Patient Link).; Sender's Comments: This spontaneous case concerns a 53-year-old female patient with relevant medical history of COVID 19 who experienced the unexpected non-serious AESI of Hypersomnia on 1 day after administration of second booster dose of mRNA-1273 Vaccine. Patient also experienced other non-serious events of fever and fatigue. The event resolved on the same day. Medical history of COVID 19 and concurrent events fever and fatigue could be cofounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event retained non-serious as per medical judgement.