Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, COVID-19, Feeling abnormal, Interchange of vaccine products, Pain in extremity
Clinical narrative: COVID-19/ lethargic/very tired/headaches; Interchange of vaccine products; Arm was Sore; Felt Funky; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19/ lethargic/very tired/headaches), PAIN IN EXTREMITY (Arm was Sore), FEELING ABNORMAL (Felt Funky) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for Prophylactic vaccination.  Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.  The patient was not breastfeeding at the time of this report. The patient was left handed. The patient was not aware of being around anybody that had covid-19 prior to coming down with it and was not really sure where she picked it up. The patient did not think she got COVID-19 prior to being vaccinated. The patient had no history of diabetes, hypertension, heart disease, auto-immune disorder or immunosuppressive disorder etc. The patient had no illness at the time of vaccination and no past history of similar events. Patient had no allergy to vaccine drug or food, had no pre-existing acute illness 30 days prior to vaccination, and no history of hospitalization in last 30 days. The patient had no other suspected causes including co-administered vaccines / risk factors.  The patient's past medical history included Injection site pain on 15-Mar-2021, Sickness in 2021, Chills in 2021, Fever in 2021, Headache in 2021, Photosensitivity in 2021, Vaccination failure in 2021 and Exposure to SARS-CoV-2 (Upon returning from travel, the patient's son had cold symptoms. The patient's son and herself were tested and both came back positive) in January 2022. Previously administered products included for Prophylactic vaccination: influenza vaccine (It was reported that regularly she got the flu vaccination over the years sometime had soreness in arm but not a big reaction.). Past adverse reactions to the above products included Pain in arm with influenza vaccine. Family history included Egg allergy (Patient's father was allergic to eggs and could not have any egg based vaccines.). Concurrent medical conditions included Allergy NOS, Depression (Started takin anti-depressant in 2019, continued taking through 2020 and 2021 decided to try hormone replacement therapy and had been effective.) and Sleep problem. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE for Sleep problem, VITAMINS NOS (USANA AO PRO) for an unknown indication.  On 15-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 29-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Arm was Sore) and FEELING ABNORMAL (Felt Funky). On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). In January 2022, the patient experienced COVID-19 (COVID-19/ lethargic/very tired/headaches). At the time of the report, COVID-19 (COVID-19/ lethargic/very tired/headaches) had resolved and PAIN IN EXTREMITY (Arm was Sore), FEELING ABNORMAL (Felt Funky) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: results not reported Results not reported. In January 2022, SARS-CoV-2 test: positive (Positive) positive. In 2022, SARS-CoV-2 test: negative (Negative) tested negative after few weeks..  The patient's additional concomitant medications included hormone replacement therapy drug for depression and Niva (ethinylestradiol/norethisterone, 1-5 MG-MCG). It was reported that patient was not aware of an issue with the vaccine temperature/storage/transport. For the side effects from dose 1 Janssen vaccine, the patient might have taken Motrin (Ibuprofen) or Aspirin (could not recall), over the counter and did not visit a physician. It was reported that after dose 2 vaccine, there was no fever or nothing big. In Oct-2021 or Nov-2021 she had annual physical, and blood work then, not related to any COVID or COVID symptoms. On Jan-2022 patient had first COVID test by PCR test and the symptoms included lethargic, very tired, headaches without cold symptoms. After a few weeks, it was resolved, patient tested negative again and had no symptoms. No treatment details were reported.  Company comment: This spontaneous case concerns a 49-year-old female patient, with exposure to SARS-CoV-2 and with previous vaccination of COVID-19 VACCINE NRVV AD26 (JNJ 78436735), who experienced the non-serious, unexpected adverse event of special interest COVID-19. Other non-serious events were also reported immediately following vaccination. Interchange of vaccine products was specified as an additional event wherein the patient received the single dose COVID-19 vaccine of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) 8 months prior to mRNA-1273. The COVID-19 infection occurred approximately 3 months after receiving the first dose of mRNA-1273 (dose 2 in series). The patient was exposed to her son who initially exhibited cold symptoms after a travel. She then presented with lethargy, tiredness and headaches. COVID-19 PCR testing was performed for her and her son, and results came back positive. Treatment details were not provided in the case although the infection was reported resolved after an unknown duration. The patient's exposure from a relative with positive travel history and eventual positive COVID-19 test, and primary vaccination with co-suspect COVID-19 VACCINE NRVV AD26 (JNJ 78436735) remain as confounders for contracting the infection. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.  This case was linked to MOD-2022-581871.; Sender's Comments: This spontaneous case concerns a 49-year-old female patient, with exposure to SARS-CoV-2 and with previous vaccination of COVID-19 VACCINE NRVV AD26 (JNJ 78436735), who experienced the non-serious, unexpected adverse event of special interest COVID-19. Other non-serious events were also reported immediately following vaccination. Interchange of vaccine products was specified as an additional event wherein the patient received the single dose COVID-19 vaccine of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) 8 months prior to mRNA-1273. The COVID-19 infection occurred approximately 3 months after receiving the first dose of mRNA-1273 (dose 2 in series). The patient was exposed to her son who initially exhibited cold symptoms after a travel. She then presented with lethargy, tiredness and headaches. COVID-19 PCR testing was performed for her and her son, and results came back positive. Treatment details were not provided in the case although the infection was reported resolved after an unknown duration. The patient's exposure from a relative with positive travel history and eventual positive COVID-19 test, and primary vaccination with co-suspect COVID-19 VACCINE NRVV AD26 (JNJ 78436735) remain as confounders for contracting the infection. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.