Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Feeling abnormal, Influenza A virus test, Influenza B virus test
Clinical narrative: Interchange of vaccine products; Feeling congested and having drainage in her sinus; Felt funky again; Patient took a test at home and tested positive straight away; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt funky again), SINUS CONGESTION (Feeling congested and having drainage in her sinus), COVID-19 (Patient took a test at home and tested positive straight away) 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 nos. 048L21A and 071F21A) for Prophylactic vaccination.     Previously administered products included for Prophylactic vaccination: Janssen Covid-19 Vaccine (Dose on. 1, batch lot no. 1805020, right arm administered in afternoon.) on 15-Mar-2021, Janssen Covid-19 Vaccine (Dose on. 1, batch lot no. 1805020, right arm administered in afternoon, reaction duration 48 hours.) on 15-Mar-2021, Janssen Covid-19 Vaccine (Dose on. 1, batch lot no. 1805020, right arm administered in afternoon, reaction duration 48 hours.) on 15-Mar-2021, Janssen Covid-19 Vaccine (Dose on. 1, batch lot no. 1805020, right arm administered in afternoon, reaction duration 48 hours.) on 15-Mar-2021, Janssen Covid-19 Vaccine (Dose on. 1, batch lot no. 1805020, right arm administered in afternoon, reaction duration 48 hours.) on 15-Mar-2021, Janssen Covid-19 Vaccine (The vaccine really hurt and felt like being injected with poison (dose number in series 1).) on 15-Mar-2021 and Influenza vaccine (It was reported that regularly she got the flu vaccination over the years sometimes had soreness in arm but not a big reaction.). Past adverse reactions to the above products included Chills with Janssen Covid-19 Vaccine; Fever with Janssen Covid-19 Vaccine; Headache with Janssen Covid-19 Vaccine; Injection site pain with Janssen Covid-19 Vaccine; Pain in arm with Influenza vaccine; Photosensitivity reaction with Janssen Covid-19 Vaccine; and Sickness with Janssen Covid-19 Vaccine. Concurrent medical conditions included Allergy (Unspecified allergy) and Depression (Started taking anti-depressant in 2019. continued taking through 2020 and 2021. decided to try hormone replacement therapy and had been effective.). Concomitant products included ETHINYLESTRADIOL;NORETHISTERONE from 02-Apr-2022 to an unknown date for an unknown indication.   On 29-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2022 at 11:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2022, the patient experienced COVID-19 (Patient took a test at home and tested positive straight away). On 04-May-2022, the patient experienced FEELING ABNORMAL (Felt funky again). On 04-May-2022 at 5:30 PM, the patient experienced SINUS CONGESTION (Feeling congested and having drainage in her sinus). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-Apr-2022 to April 2022 for COVID-19 treatment, at a dose of 1 dosage form, morning and evening untill doses end.; FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL CHILDRENS) at a dose of at night to sleep. At the time of the report, FEELING ABNORMAL (Felt funky again) and SINUS CONGESTION (Feeling congested and having drainage in her sinus) had resolved, COVID-19 (Patient took a test at home and tested positive straight away) was resolving 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: not reported Not reported. In January 2022, SARS-CoV-2 test: positive (Positive) Positive. In April 2022, SARS-CoV-2 test: positive (Positive) at home COVID test Positive. On 23-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive. On 05-May-2022, Influenza A virus test: negative (Negative) Negative. On 05-May-2022, Influenza B virus test: negative (Negative) Negative. In May 2022, SARS-CoV-2 test: positive (Positive) at home COVID test Positive. In 2022, SARS-CoV-2 test: negative (Negative) Tested negative after few weeks.         It was reported by the reporter that on 21-Apr-2022 or 22-Apr-2022 patient felt like coming down with head cold, was tired, sleeping a lot. Patient felt doozy and lousy but did not have difficulty in breathing. it was more just congestion, headache and fatigue type symptoms.  The patient took home test and tested positive.   Patient received Paxlovid as treatment which helped the patient feel better everyday after treatment. Patient went to clinic on 5 May 2022 for an additional dose of Paxlovid.  2nd dose of Paxlovid was not advised.  The patient was sent home and told to drink fluids and try to sleep, that helped. the patient felt better and the 2nd set of symptoms from the episode were mostly over.  Patient recovered from sensitivity to light, sick, chills, headache and fever on Mar 2021. The patient was treated with ibuprofen or Aspirin over the counter and did not see any physician for dose number in series 1.  The patient was not pregnant nor 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 father was allergic to eggs and could not have any egg-based vaccines. The patient experience soreness in arm when treated with influenza vaccine for prophylactic vaccination. It was reported that regularly she got the flu vaccination over the years sometime had soreness in arm but not a big reaction   Company Comment: This is a spontaneous case concerning a 49-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 21 days after receiving the second dose of mRNA-1273 vaccine (third COVID-19 vaccine). The patient was treated with Nirmatrelvir/Ritonavir. The event was resolving at the time of the report. Interchange of vaccine products was also reported as the patient received other COVID-19 vaccine (Janssen) as first dose approximately 7 months prior to the first dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-582590 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 49-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 21 days after receiving the second dose of mRNA-1273 vaccine (third COVID-19 vaccine). The patient was treated with Nirmatrelvir/Ritonavir. The event was resolving at the time of the report. Interchange of vaccine products was also reported as the patient received other COVID-19 vaccine (Janssen) as first dose approximately 7 months prior to the first dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.