Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pruritus, Rash, Sciatica
Clinical narrative: Somewhere between 20JUN2022 and 04JUL2022, the patient passed away; tinea corpus; osteoarthritis/Knee pain,hip/hip pain bilaterally/back pain; sciatica; rash; itch; Interchange of vaccine products; reported she had not been feeling well/had not been feeling well since she had received the Moderna vaccine; severe leg pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Somewhere between 20JUN2022 and 04JUL2022, the patient passed away) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A22B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient had never diagnosed with COVID positive test or diagnosis. and No other vaccines were given to the patient within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Thyroid cancer (Started on 2019 or 2020 (Unsure of exact date) and Cancer in remission) in February 2022. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1, Lot number: EM9809) on 13-Feb-2021, Pfizer (Dose 2, Lot number: EN6206) on 06-Mar-2021, Pfizer (Dose 1st booster, Lot number: FJ1620) on 18-Nov-2021, Simvastatin (elevated LFTs) and Cholestyramine (Cholestyramine (tight throat and abdomen)). Past adverse reactions to the above products included LFTs raised with Simvastatin; No adverse event with PFIZER BIONTECH COVID-19 VACCINE, Pfizer and Pfizer; and Throat tightness with Cholestyramine. Concurrent medical conditions included Drug allergy (Allergy to Cholestyramine, Simvastatin and Timolol), Penicillin allergy (Penicillin (vaginal infection)), Type 2 diabetes mellitus (Started 15 years ago), Blood pressure high (Started 20 years ago or so (Unsure of exact date) and currently in Stable condition), Obesity (Started 40 years ago (Unsure of exact date) and improved, with weight loss of about 17-18 lbs in 3 months from FEB2022 to MAY2022) and Glaucoma (Eye drops possibly for glaucoma). Concomitant products included DORZOLAMIDE for Glaucoma, AMLODIPINE, ACETYLSALICYLIC ACID (ASPIRINE), CLOTRIMAZOLE, COD LIVER OIL [COD-LIVER OIL], FLUOCINONIDE, MENTHOL, ZINC OXIDE (GOLD BOND), HYDROCHLOROTHIAZIDE, INSULIN LISPRO, INSULIN, KETOCONAZOLE, INSULIN GLARGINE (LANTUS), LATANOPROST, LEVOTHYROXINE, LEVOTHYROXINE SODIUM (SYNTHROID), LISINOPRIL, METFORMIN, CALCIUM, MAGNESIUM, ZINC, CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and CYANOCOBALAMIN (VIT B12) for an unknown indication.    On 25-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2022, the patient experienced MALAISE (reported she had not been feeling well/had not been feeling well since she had received the Moderna vaccine) and PAIN IN EXTREMITY (severe leg pain). On an unknown date, the patient experienced DEATH (Somewhere between 20JUN2022 and 04JUL2022, the patient passed away) (seriousness criteria death and medically significant), BODY TINEA (tinea corpus), OSTEOARTHRITIS (osteoarthritis/Knee pain,hip/hip pain bilaterally/back pain), SCIATICA (sciatica), RASH (rash), PRURITUS (itch) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash and Itch, at an unspecified dose and frequency; LIDOCAINE (LIDODERM) at an unspecified dose and frequency; DICLOFENAC (topical) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain, at a dose of UNK, prn. The patient died on an unknown date. The cause of death was not reported. An autopsy was performed, but no results were provided. At the time of death, BODY TINEA (tinea corpus), OSTEOARTHRITIS (osteoarthritis/Knee pain,hip/hip pain bilaterally/back pain), SCIATICA (sciatica), RASH (rash), PRURITUS (itch), MALAISE (reported she had not been feeling well/had not been feeling well since she had received the Moderna vaccine), PAIN IN EXTREMITY (severe leg pain) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PAIN IN EXTREMITY (severe leg pain) to be related. No further causality assessments were provided for DEATH (Somewhere between 20JUN2022 and 04JUL2022, the patient passed away), BODY TINEA (tinea corpus), OSTEOARTHRITIS (osteoarthritis/Knee pain,hip/hip pain bilaterally/back pain), SCIATICA (sciatica), RASH (rash), PRURITUS (itch), MALAISE (reported she had not been feeling well/had not been feeling well since she had received the Moderna vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products).    Patient height was reported as 5/4.5  Patient concomitant medications included Multivitamins with Iron and Neocin and Allergy tablet as needed.  Patient had severe leg pain on the evening after receiving the vaccine. The pain had continued, and she had not been feeling well up until 13-Jun-2022. Patient then visited urgent care on 20-Jun-2022 to get a diagnosis and treatment for the leg pain she was experiencing. The urgent care report stated the patient's diagnoses as hip pain bilaterally, tinea corpus, hip, knee, back pain, osteoarthritis, and sciatica.  Urgent care also prescribed medicine for rash and itch for the patient. However, caller was not aware of this complaint. Somewhere between 20-Jun-2022 and 04-Jul-2022, the patient passed away. Her deceased body was found on 04-Jul-2022 at her residence after a wellness check was performed. The exact date of death of patient is unknown. The medical examiner stated that the patient had passed away at least several days before being discovered. Toxicology was performed and however, the result will not be available for 90 days. The medical examiner has also stated that the patient's body had decayed enough, that if a clot was the suspect in the death, it would not be identified due to the decomposition of the body. Patient had not been feeling well since she had received the Moderna vaccine. The reporter thought that patient's leg pain could have been since she was running errands on 25-May-2022. She states that this could be a potential severe, rare side effect of the vaccine and finds it necessary to report it.  Company Comment This spontaneous case concerns an 82-year-old female patient, with concurrent medical conditions of Type 2 diabetes mellitus, Blood pressure high, Obesity and past medical history of Thyroid cancer (Started on 2019 or 2020 and Cancer in remission in February 2022), who experienced the serious Fatal unexpected event of Death (Somewhere between 20JUN2022 and 04JUL2022, the patient passed away) and other non-serious events which occurred approximately after 25 days of fourth dose of mRNA-1273 vaccine in the covid-19 vaccination series. An autopsy was performed and the result and further details were not  provided. Patient had severe leg pain on the evening after receiving the vaccine. The pain continued for 20 days later consulted and diagnosed as hip pain bilaterally, tinea corpus, hip, knee, back pain, osteoarthritis, and sciatica with medicine for rash and itch. Somewhere between 20-Jun-2022 and 04-Jul-2022, the patient passed away and identified by wellness check. The medical examiner has stated that the patient's body had decayed enough, that if a clot was the suspect in the death, it would not be identified due to the decomposition of the body.  It was also noted that patient received 3 doses with PFIZER BIONTECH COVID-19 VACCINE prior to current vaccination (interchange of vaccine products). Patient's Concurrent medical conditions of Type 2 diabetes mellitus, Blood pressure high, Obesity and   elderly age could be the risk factors and Thyroid cancer (Started on 2019 or 2020 and Cancer in remission in February 2022) could be contributing factors for the event death. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an 82-year-old female patient, with concurrent medical conditions of Type 2 diabetes mellitus, Blood pressure high, Obesity and past medical history of Thyroid cancer (Started on 2019 or 2020 and Cancer in remission in February 2022), who experienced the serious Fatal unexpected event of Death (Somewhere between 20JUN2022 and 04JUL2022, the patient passed away) and other non-serious events which occurred approximately after 25 days of fourth dose of mRNA-1273 vaccine in the covid-19 vaccination series. An autopsy was performed and the result and further details were not  provided. Patient had severe leg pain on the evening after receiving the vaccine. The pain continued for 20 days later consulted and diagnosed as hip pain bilaterally, tinea corpus, hip, knee, back pain, osteoarthritis, and sciatica with medicine for rash and itch. Somewhere between 20-Jun-2022 and 04-Jul-2022, the patient passed away and identified by wellness check.The medical examiner has stated that the patient's body had decayed enough, that if a clot was the suspect in the death, it would not be identified due to the decomposition of the body.  It was also noted that patient received 3 doses with PFIZER BIONTECH COVID-19 VACCINE prior to current vaccination (interchange of vaccine products). Patient's Concurrent medical conditions of Type 2 diabetes mellitus, Blood pressure high, Obesity and   elderly age could be the risk factors and Thyroid cancer (Started on 2019 or 2020 and Cancer in remission in February 2022) could be contributing factors for the event death. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Somewhere between 20JUN2022 and 04JUL2022, the patient passed away