Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Dental discomfort, Discomfort, Expired product administered
Clinical narrative: felt very sick; Cramps on the left foot / cramps from sole of the foot to the head; his foot is in pain; all his foot gets numb to the bottom; left arm swell; vaccine knocked him; discomfort in his chest; discomfort in his head; discomfort in his leg; discomfort in his sight; discomfort in his teeth; ost two teeth after blood extraction because patient was weakened; knee gets numbed and I fall; the vaccine he received was bad and expired; knee is still in pain / knee bends a lot; Head hurts daily/ Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt very sick), MUSCLE SPASMS (Cramps on the left foot / cramps from sole of the foot to the head), PAIN IN EXTREMITY (his foot is in pain), HYPOAESTHESIA (all his foot gets numb to the bottom) and PERIPHERAL SWELLING (left arm swell) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (felt very sick), MUSCLE SPASMS (Cramps on the left foot / cramps from sole of the foot to the head), PAIN IN EXTREMITY (his foot is in pain), HYPOAESTHESIA (all his foot gets numb to the bottom), PERIPHERAL SWELLING (left arm swell), FEELING ABNORMAL (vaccine knocked him), CHEST DISCOMFORT (discomfort in his chest), HEAD DISCOMFORT (discomfort in his head), LIMB DISCOMFORT (discomfort in his leg), DISCOMFORT (discomfort in his sight), DENTAL DISCOMFORT (discomfort in his teeth), TOOTH LOSS (ost two teeth after blood extraction because patient was weakened), FALL (knee gets numbed and I fall), EXPIRED PRODUCT ADMINISTERED (the vaccine he received was bad and expired), ARTHRALGIA (knee is still in pain / knee bends a lot) and HEADACHE (Head hurts daily/ Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (felt very sick), MUSCLE SPASMS (Cramps on the left foot / cramps from sole of the foot to the head), PAIN IN EXTREMITY (his foot is in pain), HYPOAESTHESIA (all his foot gets numb to the bottom), PERIPHERAL SWELLING (left arm swell), FEELING ABNORMAL (vaccine knocked him), CHEST DISCOMFORT (discomfort in his chest), HEAD DISCOMFORT (discomfort in his head), LIMB DISCOMFORT (discomfort in his leg), DISCOMFORT (discomfort in his sight), DENTAL DISCOMFORT (discomfort in his teeth), TOOTH LOSS (ost two teeth after blood extraction because patient was weakened), FALL (knee gets numbed and I fall), ARTHRALGIA (knee is still in pain / knee bends a lot) and HEADACHE (Head hurts daily/ Headache) had not resolved and EXPIRED PRODUCT ADMINISTERED (the vaccine he received was bad and expired) had resolved.            No concomitant product information was provided.  The patient had to go to the hospital to treat symptoms. In the hospital patient stayed for 4 hours and received a massage with a cream and Tylenol. Patient said that lost two teeth after blood extraction because patient was weakened. Patient was healthy before and never received vaccines or blood extractions. His knee is still in pain after he took the vaccine. His knee bends a lot and his foot is in pain, all his foot gets numb to the bottom and he had many black veins. The hospital said it was nothing. Three days after getting the vaccine his left arm swell, he put a cream there and it went away. And a week to 2 weeks later he started having headaches and the vaccine knocked him. He had discomfort in his chest, head, leg, sight, teeth. He was worried the most about his leg. He states the vaccine he received was bad and expired. Patient said that symptoms had not subsided and had nothing before getting the vaccine.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-237342, MOD-2021-237342 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Significant follow-up appended on 28-Jul-2021: Updated Event (Pain in Extremity, Hypoaesthesia, Peripheral Swelling, Feeling Abnormal, Chest Discomfort, Head Discomfort, Limb Discomfort, Discomfort, Dental Discomfort and Arthralgia) and Narrative. On 29-Jul-2021: Follow up received on 29-Jul-2021: Updated Event (added- Tooth Loss, Fall and Expired Product Administered), Product (added treatment drug) and Narrative.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.