Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Pruritus, Vomiting, Weight increased
Clinical narrative: Nausea/vomiting; Nausea/vomiting; hypersensitivity reaction; feel like needles and nails stabbing in my bodies; knuckle joints was attaching; headache; watery bowel; gained weight; back of the neck pain; hammering in my ears, it was painful; I Feel like my arms squeezed in a vice grip; it was painful; I am not feeling well; Lymph node tenderness; needle sensations throughout my body; needle sensations throughout my body; Felt foggy; itching; Tiredness; I experienced chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (watery bowel), WEIGHT INCREASED (gained weight), NECK PAIN (back of the neck pain), EAR PAIN (hammering in my ears, it was painful) and PAIN IN EXTREMITY (I Feel like my arms squeezed in a vice grip) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis, Hypersensitivity, Urticaria, Hay fever and Spondylitis in 2009. Previously administered products included for Product used for unknown indication: tetanus (12 years ago reaction to tetanus vaccine Numbness 3wks in the left side). Past adverse reactions to the above products included Reaction to previous exposure to any vaccine with tetanus. Concurrent medical conditions included Peanut allergy, Latex allergy, Drug allergy (Sulfur), Irritable bowel syndrome (worsening after vaccine), Psoriatic arthritis (worsening after vaccine) and Asthma. Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (LUTERA) for Birth control, OMEGA-3 NOS, MAGNESIUM OXIDE, VITAMINS NOS, VITAMIN C [ASCORBIC ACID] and CYANOCOBALAMIN (B12-VITAMIIN) for Vitamin supplementation.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021 at 1:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced LYMPH NODE PAIN (Lymph node tenderness), PARAESTHESIA (needle sensations throughout my body), HYPOAESTHESIA (needle sensations throughout my body), FEELING ABNORMAL (Felt foggy), PRURITUS (itching), CHILLS (I experienced chills) and FATIGUE (Tiredness). On 09-Apr-2021, the patient experienced DIARRHOEA (watery bowel), WEIGHT INCREASED (gained weight), NECK PAIN (back of the neck pain), EAR PAIN (hammering in my ears, it was painful), PAIN IN EXTREMITY (I Feel like my arms squeezed in a vice grip), PAIN (it was painful), MALAISE (I am not feeling well), MYALGIA (feel like needles and nails stabbing in my bodies), ARTHRALGIA (knuckle joints was attaching) and HEADACHE (headache). On an unknown date, the patient experienced VOMITING (Nausea/vomiting), NAUSEA (Nausea/vomiting) and HYPERSENSITIVITY (hypersensitivity reaction). The patient was treated with LANSOPRAZOLE (PREVACID) ongoing since an unknown date for Irritable bowel syndrome, at an unspecified dose and frequency; LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (watery bowel), WEIGHT INCREASED (gained weight), NECK PAIN (back of the neck pain), EAR PAIN (hammering in my ears, it was painful), PAIN IN EXTREMITY (I Feel like my arms squeezed in a vice grip), PAIN (it was painful), MALAISE (I am not feeling well), MYALGIA (feel like needles and nails stabbing in my bodies), ARTHRALGIA (knuckle joints was attaching) and HEADACHE (headache) had resolved with sequelae and LYMPH NODE PAIN (Lymph node tenderness), PARAESTHESIA (needle sensations throughout my body), HYPOAESTHESIA (needle sensations throughout my body), FEELING ABNORMAL (Felt foggy), PRURITUS (itching), CHILLS (I experienced chills), FATIGUE (Tiredness), VOMITING (Nausea/vomiting), NAUSEA (Nausea/vomiting) and HYPERSENSITIVITY (hypersensitivity reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.     Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Additional info-1 : VAERS- Case upgraded to serious. Recent change in status of chronic condition updated. Concomitant drug details updated. On 07-Jun-2021: Follow-up document received on 07-JUN-2021 contains significant information. Medical history updated.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of ht events a causal relationship cannot be excluded.