Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Diarrhoea, Electrocardiogram, Headache, Myalgia
Clinical narrative: Purple purpura on the arms/great big areas of purple purpura; Cramping in the stomach; Constipation; Diarrhea; Achiness in the back and legs, from top to bottom; Achiness in the back and legs, from top to bottom; Rash all over the face that sounded like sunburn purpura to the patient/rash on the head that was like baby's cradle cap, it was flaky/Rash would burn and  itch; Hives on the neck and chin on both sides/hives were very painful because it was in the hairline; Had splitting headaches that encompassed the entire head/headache for 3 days/felt like head was going to explode; Splitting headaches that went down to the back of the neck; heart symptoms included pounding of the heart, felt like the heart was flipping; Muscle aches continued for 6 months/really bad muscle ache/the muscles were the worst/muscle aches/muscles in the body hurts pretty bad; Joint pain still continued along with the muscles/joint pain in the lower part of the body/feels achy nodes inside of the knees; patient felt that all the bones and muscles in the body hurts pretty bad; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (patient felt that all the bones and muscles in the body hurts pretty bad), BACK PAIN (Achiness in the back and legs, from top to bottom), NECK PAIN (Splitting headaches that went down to the back of the neck), PALPITATIONS (heart symptoms included pounding of the heart, felt like the heart was flipping) and PURPURA (Purple purpura on the arms/great big areas of purple purpura) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 013B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No other vaccines  were given to the patient within 1 month prior to administration of Moderna COVID-19 vaccine. The patient had never been diagnosed or tested positive for COVID-19 disease. The patient did not have a medical history of myocarditis/pericarditis. The patient did not remember if the high blood pressure episode was before or after Moderna vaccination, and it was not related to the vaccine.  Concurrent medical conditions included Unspecified disorder of knee joint (Already had two bad knees, took prednisone and diclofenac for it), Allergy to antibiotic (Allergic to Tetracycline and related drugs), Drug allergy (Morphine allergy), Drug allergy (Keflex allergy), Drug allergy (Ancef allergy), Blood pressure high (patient had 1 episode of high blood pressure but did not remember the timeline) and Arthritis (recent status change : joint pain, and painful nodes in the knees). Concomitant products included HYDROCHLOROTHIAZIDE, CITALOPRAM, OXYBUTYNIN, OSTEO BI-FLEX TRIPLE STRENGTH WITH VITAMIN D, CORTISONE, METOPROLOL SUCCINATE (TOPROL) and VITAMIN D3 for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced NECK PAIN (Splitting headaches that went down to the back of the neck) and HEADACHE (Had splitting headaches that encompassed the entire head/headache for 3 days/felt like head was going to explode). In May 2021, the patient experienced BONE PAIN (patient felt that all the bones and muscles in the body hurts pretty bad), PALPITATIONS (heart symptoms included pounding of the heart, felt like the heart was flipping), MYALGIA (Muscle aches continued for 6 months/really bad muscle ache/the muscles were the worst/muscle aches/muscles in the body hurts pretty bad) and ARTHRALGIA (Joint pain still continued along with the muscles/joint pain in the lower part of the body/feels achy nodes inside of the knees). On an unknown date, the patient experienced BACK PAIN (Achiness in the back and legs, from top to bottom), PURPURA (Purple purpura on the arms/great big areas of purple purpura), ABDOMINAL PAIN UPPER (Cramping in the stomach), CONSTIPATION (Constipation), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Achiness in the back and legs, from top to bottom), RASH PRURITIC (Rash all over the face that sounded like sunburn purpura to the patient/rash on the head that was like baby's cradle cap, it was flaky/Rash would burn and  itch) and URTICARIA (Hives on the neck and chin on both sides/hives were very painful because it was in the hairline). The patient was treated with PREDNISONE for Joint pain, at an unspecified dose and frequency; DICLOFENAC for Muscle pain, at a dose of 50 milligram three times a day and OMEPRAZOLE for Stomach upset, at a dose of 40 milligram. On 14-May-2021, NECK PAIN (Splitting headaches that went down to the back of the neck) and HEADACHE (Had splitting headaches that encompassed the entire head/headache for 3 days/felt like head was going to explode) had resolved. In June 2021, PALPITATIONS (heart symptoms included pounding of the heart, felt like the heart was flipping) had resolved. At the time of the report, BONE PAIN (patient felt that all the bones and muscles in the body hurts pretty bad), BACK PAIN (Achiness in the back and legs, from top to bottom), PURPURA (Purple purpura on the arms/great big areas of purple purpura), PAIN IN EXTREMITY (Achiness in the back and legs, from top to bottom), MYALGIA (Muscle aches continued for 6 months/really bad muscle ache/the muscles were the worst/muscle aches/muscles in the body hurts pretty bad) and ARTHRALGIA (Joint pain still continued along with the muscles/joint pain in the lower part of the body/feels achy nodes inside of the knees) had not resolved and ABDOMINAL PAIN UPPER (Cramping in the stomach), CONSTIPATION (Constipation), DIARRHOEA (Diarrhea), RASH PRURITIC (Rash all over the face that sounded like sunburn purpura to the patient/rash on the head that was like baby's cradle cap, it was flaky/Rash would burn and  itch) and URTICARIA (Hives on the neck and chin on both sides/hives were very painful because it was in the hairline) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, Electrocardiogram: normal (normal) Electrocardiogram result turned out fine.. On 27-May-2021, Electrocardiogram: normal (normal) Electrocardiogram result turned out fine. On 15-Jun-2021, Cardiac stress test: normal (normal) Heart test results turned out completely normal.. On 23-Jun-2021, Cardiac stress test: normal (normal) Heart test results turned out completely normal..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant medications also included vitamin without iron, 1 tablet every morning. The patient had a bad reaction to the vaccine but was feeling much better now and symptoms gradually resolved. After experiencing headache, the patient had started to experience heart problems around the week of 10-May-2021. On 18-May-2021, the patient was still having the pounding and pain.  The heart specialist thought that the heart symptoms were related to myocarditis. The heart symptoms resolved around 23-Jun-2021. The orthopedic physician reported that the symptoms of achiness in the back and legs might have been caused by the vaccine. The therapy of prednisone and diclofenac worked like a miracle drug for the patient. The patient got too many side effects from diclofenac, so the patient weaned herself off of it. The rash kept coming and going for the patient. It felt like the patient's face was sandpaper down to under the chin. The patient went to the dermatologist about three times and they just could not get rid of it as nothing prescribed by them worked. The purpura popped up for no reason, again went away and again popped up. The patient reported that it did not looked good on the patient and the patient had to wear long sleeves. Some of the symptoms still continued for the patient since 2 weeks after the second shot. The patient reported that the patient needs to get knees replacement even before the vaccination. The patient was considering to discontinue Diclofenac treatment due to potential side effects that the patient heard about that drug. There were no other potential causes for the cardiac signs and symptoms because the symptoms did not show up in the testing and the patient did not experience similar event in the past. The clinical outcome indicated no official diagnosis of Myocarditis.  Company Comment: This case concerns a 74-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious AESI of Purpura, unspecified days after receiving a dose of mRNA-1273 vaccine.  It was reported that some of the symptoms continued even after the second dose of mRNA-1273 vaccine.  It was also reported that the clinical outcome indicated no official diagnosis of Myocarditis.  The event had not resolved.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: The follow up information received contains significant information that included updated patient's medical history, addition of new events of bone pain, back pain, pain in extremity and updated narrative.; Sender's Comments: This case concerns a 74-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious AESI of Purpura, unspecified days after receiving a dose of mRNA-1273 vaccine.  It was reported that some of the symptoms continued even after the second dose of mRNA-1273 vaccine.  It was also reported that the clinical outcome indicated no official diagnosis of Myocarditis.  The event had not resolved.  The benefit-risk relationship of mRNA-1273 is not affected by this report.