Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, SARS-CoV-2 test, Sinusitis, Somnolence
Clinical narrative: Reaction/Symptoms/had a reaction and symptoms/body building up with the vaccine and triggering such a response; Not getting better; Started to feel achy/was still achy,continued to be achy for couple of days, had aches/ pains/Pain is bad/achy all over; All her bones hurt; Had vibrant shakes/whole body shook for 20 mins to half hour; Laid down and fell asleep for a while; Was still achy and felt cold/thought it was a normal reaction from the covid vaccine; Had nasal congestion; Sick; Sinus infection; Weak/tired and weak; Terrific pain from right knee to thigh up to the hip area there was pain; Felt she was wiped out/tired/feels tired and weak; Wakes up at 2am and has really bad muscle pain in both knees; positive covid test on 26Nov2021; positive covid test on 26Nov2021; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive covid test on 26Nov2021), DRUG INEFFECTIVE (positive covid test on 26Nov2021), VACCINATION COMPLICATION (Reaction/Symptoms/had a reaction and symptoms/body building up with the vaccine and triggering such a response), MALAISE (Not getting better) and PAIN (Started to feel achy/was still achy,continued to be achy for couple of days, had aches/ pains/Pain is bad/achy all over) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 029L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement (Knee replacement surgery) in 2019.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Nov-2021, the patient experienced COVID-19 (positive covid test on 26Nov2021) and DRUG INEFFECTIVE (positive covid test on 26Nov2021). On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction/Symptoms/had a reaction and symptoms/body building up with the vaccine and triggering such a response), MALAISE (Not getting better), PAIN (Started to feel achy/was still achy,continued to be achy for couple of days, had aches/ pains/Pain is bad/achy all over), BONE PAIN (All her bones hurt), TREMOR (Had vibrant shakes/whole body shook for 20 mins to half hour), SOMNOLENCE (Laid down and fell asleep for a while), FEELING COLD (Was still achy and felt cold/thought it was a normal reaction from the covid vaccine), NASAL CONGESTION (Had nasal congestion), ILLNESS (Sick), SINUSITIS (Sinus infection), ASTHENIA (Weak/tired and weak), PAIN IN EXTREMITY (Terrific pain from right knee to thigh up to the hip area there was pain), FATIGUE (Felt she was wiped out/tired/feels tired and weak) and MYALGIA (Wakes up at 2am and has really bad muscle pain in both knees). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain, at a dose of UNK UNK, bid; VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency; VITAMIN D3 at an unspecified dose and frequency; MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for Sinus infection, at an unspecified dose and frequency and AMOXICILLIN at an unspecified dose and frequency. At the time of the report, COVID-19 (positive covid test on 26Nov2021), DRUG INEFFECTIVE (positive covid test on 26Nov2021), VACCINATION COMPLICATION (Reaction/Symptoms/had a reaction and symptoms/body building up with the vaccine and triggering such a response), MALAISE (Not getting better), PAIN (Started to feel achy/was still achy,continued to be achy for couple of days, had aches/ pains/Pain is bad/achy all over), BONE PAIN (All her bones hurt), TREMOR (Had vibrant shakes/whole body shook for 20 mins to half hour), SOMNOLENCE (Laid down and fell asleep for a while), FEELING COLD (Was still achy and felt cold/thought it was a normal reaction from the covid vaccine), NASAL CONGESTION (Had nasal congestion), ILLNESS (Sick), SINUSITIS (Sinus infection), ASTHENIA (Weak/tired and weak), PAIN IN EXTREMITY (Terrific pain from right knee to thigh up to the hip area there was pain), FATIGUE (Felt she was wiped out/tired/feels tired and weak) and MYALGIA (Wakes up at 2am and has really bad muscle pain in both knees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive.         The patient stated that she did not have any reactions from the 1st and 2nd dose. The patient stated that she received her booster shot of Moderna vaccine and had a reaction and symptoms. The patient stated that she was not getting better, came back from work early as she started to feel achy and felt she was wiped out as she was achy all over, all her bones hurt and had vibrant shakes. The patient stated that her whole body shook for 20 mins to half hour and the patient then laid down and fell asleep for a while. The patient stated that she was still achy and felt cold but did not have a fever and thought it was a normal reaction from the COVID-19 vaccine The patient reported that she continued to be achy for couple of days, had nasal congestion, had aches and pains and called her doctor as she has never been sick. The patient stated that for the past 2 nights in early morning, feels tired and weak. The patient also stated that she wakes up at 2am and has really bad muscle pain in both knees which was terrific pain from right knee to thigh up to the hip area there was pain. The patient described the muscle pain being similar to the pain she experienced when she had knee replacement surgery 2 years ago and stated that's how bad the pain was. No concomitant product use was provided by the reporter. CC: This case concerns a 79 y/o F ,  with no relevant medical history reported, who experienced  Non-serious, AESI , unexpected event of Covid 19 which occurred 6 days after vaccination with the 3rd dose of  Moderna Covid 19 vaccineand 9 months 21 days after vaccination with the 2nd dose .This was also accompanied by other Non-serious, unexpected events of Drug ineffective ,This case was also  accompanied by other non-serious events. . The re-challenge is not applicable since these events occurred after the 3rd dose and no more additional doses will be administered. The benefit -risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 79 year old female with no relevant medical history reported, who experienced  Non-serious, AESI , unexpected event of Covid 19 which occurred 6 days after vaccination with the 3rd dose of mRNA-1273 vaccine (  Moderna Covid 19 vaccine )  and 9 months 21 days after vaccination with the 2nd dose .This was also accompanied by other Non-serious, unexpected events of Drug ineffective ,This case was also  accompanied by other non-serious events. . The re-challenge is not applicable since these events occurred after the 3rd dose and no more additional doses will be administered and also the outcome of the events was unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.