Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Therapeutic response unexpected, Vaccination site pain
Clinical narrative: She says that this morning also, she had no desire and no energy to do anything./ lack of energy she is experiencing; her eyes were so heavy that she could hardly keep them open/she could not keep her eyes open; She explains that her entire body feels sore.; She says that her arm was so sore that she couldn't lift it more than 3-4 inches; she felt extremely dizzy and extremely tired/ she felt very tired. She states that she slept in the bed for 14 hours due to the tiredness.; She then realized that all her muscles and joints were sore/Her muscles seem to be aching all over.; She then realized that all her muscles and joints were sore.; She says that she received the shot on her left arm and not only her left arm; she had read somewhere that this virulent somehow works with inflammation and she wonders if this is why her knee felt better. She says that she has been researching all weekend regarding her symptoms.; feeling she describes as malaise; She also had confusion; She had some shortness of breath; She also says that since today she has been experiencing itching. She woke up with both her wrists itching/However, her torso has started to itch as well; only redness due to her itching; She has also been experiencing a sore arm./strangely her right arm feels sore as well./ She says that her arm was so sore; she felt extremely dizzy and extremely tired; She also had a headache on Saturday; She states that her worst symptom is the extreme fatigue/The fatigue was so severe; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling she describes as malaise), CONFUSIONAL STATE (She also had confusion), DYSPNOEA (She had some shortness of breath), PRURITUS (She also says that since today she has been experiencing itching. She woke up with both her wrists itching/However, her torso has started to itch as well) and ERYTHEMA (only redness due to her itching) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069W22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   It was reported that patient had no diagnosis of COVID-19 previously. Patient did not received any other vaccine in the 4 weeks prior to COVID-19 vaccine. The patient's past medical history included Meniscus tear (She did not have to get surgery for it) in October 2022 and Knee swelling in October 2022. Concurrent medical conditions included Allergic sinusitis.   On 05-May-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 06-May-2023, the patient experienced MALAISE (feeling she describes as malaise), CONFUSIONAL STATE (She also had confusion), DYSPNOEA (She had some shortness of breath), PRURITUS (She also says that since today she has been experiencing itching. She woke up with both her wrists itching/However, her torso has started to itch as well), ERYTHEMA (only redness due to her itching), PAIN IN EXTREMITY (She has also been experiencing a sore arm./strangely her right arm feels sore as well./ She says that her arm was so sore), HEADACHE (She also had a headache on Saturday) and FATIGUE (She states that her worst symptom is the extreme fatigue/The fatigue was so severe). 06-May-2023, the patient experienced DIZZINESS (she felt extremely dizzy and extremely tired). On an unknown date, the patient experienced ASTHENIA (She says that this morning also, she had no desire and no energy to do anything./ lack of energy she is experiencing), ASTHENOPIA (her eyes were so heavy that she could hardly keep them open/she could not keep her eyes open), PAIN (She explains that her entire body feels sore.), MOBILITY DECREASED (She says that her arm was so sore that she couldn't lift it more than 3-4 inches), FATIGUE (she felt extremely dizzy and extremely tired/ she felt very tired. She states that she slept in the bed for 14 hours due to the tiredness.), MYALGIA (She then realized that all her muscles and joints were sore/Her muscles seem to be aching all over.), ARTHRALGIA (She then realized that all her muscles and joints were sore.), VACCINATION SITE PAIN (She says that she received the shot on her left arm and not only her left arm) and THERAPEUTIC RESPONSE UNEXPECTED (she had read somewhere that this virulent somehow works with inflammation and she wonders if this is why her knee felt better. She says that she has been researching all weekend regarding her symptoms.). The patient was treated with CALAMINE for Itching, at a dose of Lotion. At the time of the report, MALAISE (feeling she describes as malaise), CONFUSIONAL STATE (She also had confusion), DYSPNOEA (She had some shortness of breath), PRURITUS (She also says that since today she has been experiencing itching. She woke up with both her wrists itching/However, her torso has started to itch as well), ERYTHEMA (only redness due to her itching), PAIN IN EXTREMITY (She has also been experiencing a sore arm./strangely her right arm feels sore as well./ She says that her arm was so sore), DIZZINESS (she felt extremely dizzy and extremely tired), HEADACHE (She also had a headache on Saturday) and FATIGUE (She states that her worst symptom is the extreme fatigue/The fatigue was so severe) had not resolved and ASTHENIA (She says that this morning also, she had no desire and no energy to do anything./ lack of energy she is experiencing), ASTHENOPIA (her eyes were so heavy that she could hardly keep them open/she could not keep her eyes open), PAIN (She explains that her entire body feels sore.), MOBILITY DECREASED (She says that her arm was so sore that she couldn't lift it more than 3-4 inches), FATIGUE (she felt extremely dizzy and extremely tired/ she felt very tired. She states that she slept in the bed for 14 hours due to the tiredness.), MYALGIA (She then realized that all her muscles and joints were sore/Her muscles seem to be aching all over.), ARTHRALGIA (She then realized that all her muscles and joints were sore.), VACCINATION SITE PAIN (She says that she received the shot on her left arm and not only her left arm) and THERAPEUTIC RESPONSE UNEXPECTED (she had read somewhere that this virulent somehow works with inflammation and she wonders if this is why her knee felt better. She says that she has been researching all weekend regarding her symptoms.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2023-723495 (E2B Linked Report). This case was linked to MOD-2023-723495 (Patient Link).  Concomitant product use was not provided by the reporter.  It was reported that patient continues to had some issues that were persistent since receiving the bivalent vaccine. She states that she felt fine throughout the day on Friday and even went to bed in the evening without any issues. However, when she woke up on Saturday morning, she felt extremely dizzy and extremely tired, a feeling she describes as malaise. She had also been experiencing a sore arm. She said that she received the shot on her left arm and not only her left arm, but strangely her right arm feels sore as well. She then realized that all her muscles and joints were sore. She also had confusion, and that is what prompted her to call her family. She says that by the time her daughter in law got to her house, her eyes were so heavy that she could hardly keep them open. She also had a headache on Saturday, but it went away after a few hours on its own, without taking any medications. She had some of shortness breath, but only when she exerted herself by moving around, or trying to make breakfast. When she sat down, she felt okay. She said that this morning also, she had no desire and no energy to do anything. This was frustrating to her because life was busy and there were things that she needs to do. She also says that since today she had been experiencing itching. She woke up with both her wrists itching. She had been using calamine lotion to help with the itch. However, her torso had started to itch as well. She says that there were no bumps or rashes associated with the itching, only redness due to her itching. She said that her arm was so sore that she couldn't lift it more than 3-4 inches. She explains that her entire body feels sore. She states that she was pretty athletic, does yard work herself, and walks daily. Her muscles seem to be aching all over. She states that this was her 5th Moderna COVID-19 shot and that she had received all doses so far that had been recommended by the CDC. She had not had any side effects with any of the other ones, only with the bivalent vaccine. She states that her worst symptom was the extreme fatigue and the lack of energy she is experiencing. Her symptoms were so severe over the weekend, that her family had to check up on her. The fatigue was so severe that she could not keep her eyes open and she felt very tired. She states that she slept in the bed for 14 hours due to the tiredness.    She also mentioned that in OCT2022, she tore her meniscus while exercising. She did not have to get surgery for it, but she continued to have swelling in her knees due to this tear. However, she noticed on Saturday morning (6MAY2023), that her knee was no longer feeling uncomfortable and there was no swelling anymore. She says that she had read somewhere that this virulent somehow works with inflammation and she wonders if this was why her knee felt better. She says that she has been researching all weekend regarding her symptoms.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723495:Monovalent Dose