Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypertension, Injection site pain, Knee arthroplasty, Loss of personal independence in daily activities, Neuralgia
Clinical narrative: Blood Pressure also had increased after she developed DVT/ 203/110 mmHg; since then she has a bit of Tachycardia Heart Beat 105-110BPM at rest/ today heart rate is high again (105BPM); she may have had very light myocarditis; After knee surgery, she developed complicated DVT; after all shots she had a sore left Arm injection site; Light Headache; she has nerve pain (neuropathic pain) and can not move the skin on right lower leg; She states that 3.5 months after Bivalent Booster, She had right knee replacement (33rd lifetime surgery) on 10APR2023; This spontaneous case was reported by a nurse and describes the occurrence of DEEP VEIN THROMBOSIS POSTOPERATIVE (After knee surgery, she developed complicated DVT), NEURALGIA (she has nerve pain (neuropathic pain) and can not move the skin on right lower leg), HYPERTENSION (Blood Pressure also had increased after she developed DVT/ 203/110 mmHg) and MYOCARDITIS (she may have had very light myocarditis) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ACETYLSALICYLIC ACID (ASPIRIN [ACETYLSALICYLIC ACID]) for an unknown indication.    The patient's past medical history included COVID-19 (Follow up chest X-ray post COVID disease was normal.) on 06-Sep-2020, Pancreas disorder (Pancreas issues that resolved prior to vaccination) and Myocarditis (mild Myocarditis after COVID disease, prior to first primary vaccine). Previously administered products included for Product used for unknown indication: FLU shot; for Myocarditis: Bystolic (she took for 18 months). Past adverse reactions to the above products included No adverse event with Bystolic and FLU shot. Concurrent medical conditions included Osteoarthritis (10+years) and Hypothyroidism (diagnosed 10 years ago). Concomitant products included LEVOTHYROXINE for Hypothyroidism, PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOLE [PANTOPRAZOLE SODIUM SESQUIHYDRATE]), CHLORDIAZEPOXIDE HYDROCHLORIDE, CLIDINIUM BROMIDE (LIBRAX [CHLORDIAZEPOXIDE HYDROCHLORIDE;CLIDINIUM BROMIDE]) and ONDANSETRON (ZOFRAN [ONDANSETRON]) for an unknown indication.   On 27-Dec-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 an unknown date, the patient started ACETYLSALICYLIC ACID (ASPIRIN [ACETYLSALICYLIC ACID]) (unknown route) 325 milligram twice a day. On 10-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced KNEE ARTHROPLASTY (She states that 3.5 months after Bivalent Booster, She had right knee replacement (33rd lifetime surgery) on 10APR2023). On 05-May-2023, the patient experienced NEURALGIA (she has nerve pain (neuropathic pain) and can not move the skin on right lower leg) (seriousness criterion medically significant). On an unknown date, the patient experienced DEEP VEIN THROMBOSIS POSTOPERATIVE (After knee surgery, she developed complicated DVT) (seriousness criterion medically significant), HYPERTENSION (Blood Pressure also had increased after she developed DVT/ 203/110 mmHg) (seriousness criterion medically significant), TACHYCARDIA (since then she has a bit of Tachycardia Heart Beat 105-110BPM at rest/ today heart rate is high again (105BPM)), MYOCARDITIS (she may have had very light myocarditis) (seriousness criterion medically significant), VACCINATION SITE PAIN (after all shots she had a sore left Arm injection site) and HEADACHE (Light Headache). The patient was treated with RIVAROXABAN (XARELTO) for DVT, at an unspecified dose and frequency. At the time of the report, DEEP VEIN THROMBOSIS POSTOPERATIVE (After knee surgery, she developed complicated DVT), HYPERTENSION (Blood Pressure also had increased after she developed DVT/ 203/110 mmHg), MYOCARDITIS (she may have had very light myocarditis), KNEE ARTHROPLASTY (She states that 3.5 months after Bivalent Booster, She had right knee replacement (33rd lifetime surgery) on 10APR2023), VACCINATION SITE PAIN (after all shots she had a sore left Arm injection site) and HEADACHE (Light Headache) outcome was unknown and NEURALGIA (she has nerve pain (neuropathic pain) and can not move the skin on right lower leg) and TACHYCARDIA (since then she has a bit of Tachycardia Heart Beat 105-110BPM at rest/ today heart rate is high again (105BPM)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2023, Heart rate: 105 heart beats per minute. On an unknown date, Blood pressure measurement: 203/110 mmHg. On an unknown date, Chest X-ray: Normal. On an unknown date, Electrocardiogram: Normal. On an unknown date, Heart rate: a bit of Tachycardia Heart Beat 105-110BPM at rest.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered DEEP VEIN THROMBOSIS POSTOPERATIVE (After knee surgery, she developed complicated DVT) to have an unknown relationship. No further causality assessments were provided for NEURALGIA (she has nerve pain (neuropathic pain) and can not move the skin on right lower leg), HYPERTENSION (Blood Pressure also had increased after she developed DVT/ 203/110 mmHg), TACHYCARDIA (since then she has a bit of Tachycardia Heart Beat 105-110BPM at rest/ today heart rate is high again (105BPM)), MYOCARDITIS (she may have had very light myocarditis), KNEE ARTHROPLASTY (She states that 3.5 months after Bivalent Booster, She had right knee replacement (33rd lifetime surgery) on 10APR2023), VACCINATION SITE PAIN (after all shots she had a sore left Arm injection site) and HEADACHE (Light Headache).    The patient had received other unspecified vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient received first Primary monovalent dose on 06JAN2021 (Lot# 037K20A). second Primary monovalent dose on 03FEB2021 (Lot# 043L20A). First Monovalent Booster dose on 24AUG2021 (Lot# 004F21A), second Booster dose (Monovalent) on 19APR2022  (Lot# 057M21A).  Patient stated that after all shots she had a sore left Arm injection site and she might have taken Advil or Tylenol. She might have had Light Headache after all shots but does not remember clearly. It was reported that 3.5 months after Bivalent Booster, She had right knee replacement, after the knee surgery she was using compression stocking. After the knee surgery, she developed complicated DVT. She had 4 emergency room visits and 2 cardiologist visits. She stated that prior to DVT, she used to run, cycling and was active, but now she can no longer do that. She was not sure if it is related to vaccine or surgery. The patient had Doppler, results not reported. Before going to the hospital for DVT, her right leg Increased in weight. About 14 LBs liquid in the right leg. Patient used to run, cycling and was active, but now she can no longer do that.  Company Comment: This is a spontaneous case concerning a 66-year-old, female patient with a body mass index of 47, previously vaccinated with 4 doses of mRNA.1273 vaccine and history of previous knee surgeries and myocarditis, who experienced the unexpected serious (medically significant) AESI of deep vein thrombosis postoperative, unexpected serious (medically significant) events of Neuralgia and hypertension among other non-serious events. It is reported that 3.5 months after the administration of the booster dose of mRNA-1273.222 vaccine (Original/Omicron BA.4/5) patient had a knee replacement. She was being treated with Aspirin 325mg twice a day and compression stocking, but she developed a deep vein thrombosis. She was prescribed Xarelto. About one month after surgery, patient had nerve pain (neuropathic pain) and cannot move the skin on right lower leg. Patient also has an increased in previous tachycardia and had hypertension (203/110 mmHg) with a normal electrocariogram. Past medical history of myocarditis and COVID-19 are confounders for the event hypertension. BMI of 47 is a contributory risk factor for this event as well as for the events deep vein thrombosis. Knee surgery is the major alternative explanation for the events DVT and neuralgia, however, mRNA-1273.222 vaccine could not be excluded. The benefit-risk relationship of mRNA-1273.222 vaccine (Original/Omicron BA.4/5)  is not affected by this report.   This case was linked to MOD-2023-723300 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 66-year-old, female patient with a body mass index of 47, previously vaccinated with 4 doses of mRNA.1273 vaccine and history of previous knee surgeries and myocarditis, who experienced the unexpected serious (medically significant) AESI of deep vein thrombosis postoperative, unexpected serious (medically significant) events of Neuralgia and hypertension among other non-serious events. It is reported that 3.5 months after the administration of the booster dose of mRNA-1273.222 vaccine (Original/Omicron BA.4/5) patient had a knee replacement. She was being treated with Aspirin 325mg twice a day and compression stocking, but she developed a deep vein thrombosis. She was prescribed Xarelto. About one month after surgery, patient had nerve pain (neuropathic pain) and cannot move the skin on right lower leg. Patient also has an increased in previous tachycardia and had hypertension (203/110 mmHg) with a normal electrocariogram. Past medical history of myocarditis and COVID-19 are confounders for the event hypertension. BMI of 47 is a contributory risk factor for this event as well as for the events deep vein thrombosis. Knee surgery is the major alternative explanation for the events DVT and neuralgia, however, mRNA-1273.222 vaccine could not be excluded. The benefit-risk relationship of mRNA-1273.222 vaccine (Original/Omicron BA.4/5)  is not affected by this report.