Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram, Condition aggravated, Diplegia, Heart rate, Hypoaesthesia
Clinical narrative: It's affecting the nerves in my arms an the left arm it travels into my breast, into my left breast/I think it's affecting the nervous system in my arm and it's spreading.; My left arm burns all the time. It aches all the time. I don't know what's in that lump that's on my arm, in the muscle where he gave me the shot, but it's getting bigger; The patient was wondering if the vaccine made her bones and joints hurt as the pain was traveling/The patient believes it is traveling to her bones because went from one arm to the other.; condition aggravated; her range of motion is getting more limited; huge lump in the muscle where they administered the shot/another big lump in her arm/a larger lump in the patient's shoulder; fingers go numb on my left hand/The left one, and the right one both go numb and the left one is the one that has more pain than the right one; a lot of pain in both of her shoulders, not just one/I got booster shot in December of 2022 and I started experiencing a lot of pain in my shoulder, both of my shoulders/After I got the vaccine, my shoulders, both of my shoulders started hurting/The; lymph glands have gone crazy and began to swell in different locations/her lymph glands have gone crazy and began to swell in different locations under the patient's armpits and down along the veins inside her elbow; pain has spread into other locations of my arm/pain now has graduated down my arm and into the back of my arm/The pain goes all the way down the left arm, go to the inside and over the top of the forearm, and down in the patient's fingers; The patient is having paralysis in her arms and her hands; she got vertigo as a result of the vaccine which started in DEC2022 and JAN2023; lipoma; swollen on each arm/little glands and stuff have been swelling under my arms/there's a water pocket on the top of my right shoulder that fills up and then it goes away and then it comes back again with fluid; This spontaneous case was reported by a patient and describes the occurrence of DIPLEGIA (The patient is having paralysis in her arms and her hands) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1) on 22-Oct-2021 and Moderna COVID-19 Vaccine (Dose 2) on 22-Nov-2021; for Product used for unknown indication: flu shot on 22-Oct-2021 and measles shot (got a measles shot when patient was a kid). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine; and No adverse event with flu shot and measles shot. Concurrent medical conditions included Lipoma (Diagnosed it as a small lipoma. It was nine centimeters and it hurts all the time. It just aches and aches and aches. And it's on her left arm as well. But it never did bother her until she got the COVID shot.) since 2016 and Disability.    On 20-Dec-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Dec-2022, the patient experienced DIPLEGIA (The patient is having paralysis in her arms and her hands) (seriousness criterion medically significant), VERTIGO (she got vertigo as a result of the vaccine which started in DEC2022 and JAN2023), LIPOMA (lipoma), PERIPHERAL SWELLING (swollen on each arm/little glands and stuff have been swelling under my arms/there's a water pocket on the top of my right shoulder that fills up and then it goes away and then it comes back again with fluid), VACCINATION SITE MASS (huge lump in the muscle where they administered the shot/another big lump in her arm/a larger lump in the patient's shoulder), HYPOAESTHESIA (fingers go numb on my left hand/The left one, and the right one both go numb and the left one is the one that has more pain than the right one), ARTHRALGIA (a lot of pain in both of her shoulders, not just one/I got booster shot in December of 2022 and I started experiencing a lot of pain in my shoulder, both of my shoulders/After I got the vaccine, my shoulders, both of my shoulders started hurting/The), LYMPHADENOPATHY (lymph glands have gone crazy and began to swell in different locations/her lymph glands have gone crazy and began to swell in different locations under the patient's armpits and down along the veins inside her elbow) and PAIN IN EXTREMITY (pain has spread into other locations of my arm/pain now has graduated down my arm and into the back of my arm/The pain goes all the way down the left arm, go to the inside and over the top of the forearm, and down in the patient's fingers). On an unknown date, the patient experienced CONDITION AGGRAVATED (condition aggravated), HYPOKINESIA (her range of motion is getting more limited), NERVE INJURY (It's affecting the nerves in my arms an the left arm it travels into my breast, into my left breast/I think it's affecting the nervous system in my arm and it's spreading.), BURNING SENSATION (My left arm burns all the time. It aches all the time. I don't know what's in that lump that's on my arm, in the muscle where he gave me the shot, but it's getting bigger) and BONE PAIN (The patient was wondering if the vaccine made her bones and joints hurt as the pain was traveling/The patient believes it is traveling to her bones because went from one arm to the other.). The patient was treated with DIMENHYDRINATE (DRAMAMINE) in February 2023 at an unspecified dose and frequency. At the time of the report, DIPLEGIA (The patient is having paralysis in her arms and her hands), VERTIGO (she got vertigo as a result of the vaccine which started in DEC2022 and JAN2023), LIPOMA (lipoma), PERIPHERAL SWELLING (swollen on each arm/little glands and stuff have been swelling under my arms/there's a water pocket on the top of my right shoulder that fills up and then it goes away and then it comes back again with fluid), HYPOKINESIA (her range of motion is getting more limited), VACCINATION SITE MASS (huge lump in the muscle where they administered the shot/another big lump in her arm/a larger lump in the patient's shoulder), NERVE INJURY (It's affecting the nerves in my arms an the left arm it travels into my breast, into my left breast/I think it's affecting the nervous system in my arm and it's spreading.), HYPOAESTHESIA (fingers go numb on my left hand/The left one, and the right one both go numb and the left one is the one that has more pain than the right one) and PAIN IN EXTREMITY (pain has spread into other locations of my arm/pain now has graduated down my arm and into the back of my arm/The pain goes all the way down the left arm, go to the inside and over the top of the forearm, and down in the patient's fingers) had not resolved and CONDITION AGGRAVATED (condition aggravated), BURNING SENSATION (My left arm burns all the time. It aches all the time. I don't know what's in that lump that's on my arm, in the muscle where he gave me the shot, but it's getting bigger), BONE PAIN (The patient was wondering if the vaccine made her bones and joints hurt as the pain was traveling/The patient believes it is traveling to her bones because went from one arm to the other.), ARTHRALGIA (a lot of pain in both of her shoulders, not just one/I got booster shot in December of 2022 and I started experiencing a lot of pain in my shoulder, both of my shoulders/After I got the vaccine, my shoulders, both of my shoulders started hurting/The) and LYMPHADENOPATHY (lymph glands have gone crazy and began to swell in different locations/her lymph glands have gone crazy and began to swell in different locations under the patient's armpits and down along the veins inside her elbow) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Normal. On an unknown date, Blood test: (Negative) Patient didn't have that Hodgkin's lymphoma or lymphoid lymphatic cancer so that came back negative.. On an unknown date, Computerised tomogram: The general surgeon talked to the patient about the lipoma but he also informed her about another big lump in her arm which was shown in the CT scan. and CT scan of her breasts confirmed there was nothing in her lungs.. On an unknown date, Heart rate: Normal. On an unknown date, Ultrasound scan: 9 cm of lipoma. Massive lump was found and it was bigger than the lipoma which was located in the shoulder..     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered VERTIGO (she got vertigo as a result of the vaccine which started in DEC2022 and JAN2023) to be related. No further causality assessments were provided for DIPLEGIA (The patient is having paralysis in her arms and her hands), LIPOMA (lipoma), PERIPHERAL SWELLING (swollen on each arm/little glands and stuff have been swelling under my arms/there's a water pocket on the top of my right shoulder that fills up and then it goes away and then it comes back again with fluid), CONDITION AGGRAVATED (condition aggravated), HYPOKINESIA (her range of motion is getting more limited), VACCINATION SITE MASS (huge lump in the muscle where they administered the shot/another big lump in her arm/a larger lump in the patient's shoulder), NERVE INJURY (It's affecting the nerves in my arms an the left arm it travels into my breast, into my left breast/I think it's affecting the nervous system in my arm and it's spreading.), BURNING SENSATION (My left arm burns all the time. It aches all the time. I don't know what's in that lump that's on my arm, in the muscle where he gave me the shot, but it's getting bigger), BONE PAIN (The patient was wondering if the vaccine made her bones and joints hurt as the pain was traveling/The patient believes it is traveling to her bones because went from one arm to the other.), HYPOAESTHESIA (fingers go numb on my left hand/The left one, and the right one both go numb and the left one is the one that has more pain than the right one), ARTHRALGIA (a lot of pain in both of her shoulders, not just one/I got booster shot in December of 2022 and I started experiencing a lot of pain in my shoulder, both of my shoulders/After I got the vaccine, my shoulders, both of my shoulders started hurting/The), LYMPHADENOPATHY (lymph glands have gone crazy and began to swell in different locations/her lymph glands have gone crazy and began to swell in different locations under the patient's armpits and down along the veins inside her elbow) and PAIN IN EXTREMITY (pain has spread into other locations of my arm/pain now has graduated down my arm and into the back of my arm/The pain goes all the way down the left arm, go to the inside and over the top of the forearm, and down in the patient's fingers).    No concomitant medications were reported. The patient stated that she was doing fine until she got that third shot and then muscle in her left shoulder has begun to deteriorate, it was getting hard and was spreading. She started having gland problems on her right shoulder and there was a water pocket on the top of the right shoulder that fills up and then it goes away and then it comes back again with fluid and then there's some glands on the inside of her arm where veins are, where you bend your elbows, they're swollen on each arm, both arms and then pituitary glands under her arms. She went in one of them got really big and it seems like it went down a little bit. Pain travels all down into her forearm on her left arm, her biceps, elbows everywhere. It makes her thumbs hurt. Her doctor refused to remove lipoma after ultrasound. The discomfort had gone on now for 15 months and it gotten worse. Both shoulders started aching in the rotator cup, eventually thought they would go away but it never did and they only gotten worse. The right arm still bothers and sometimes really hard pain in one spot. It just hurts so bad. It was deep pain in her shoulder and was very painful almost in one spot. And the pain now has graduated down the arm and into the back of the arm and sometimes on the right hand too, but the left hand was worse. It was reported that she does not feel like any kind of an adverse reaction with her heart, but felt like it was going in that direction because it would make her left breast and her lungs feel weird on left side. So it was traveling whatever it was doing to her nervous system. She used to have the flu shot every single year but she had surgery in 2023 in which she remained in there for a couple of days and haven't taken the shot that year. She stated that she felt the lump as she felt hurt which led her to the thought that another piece of lipoma traveled but the doctor has ruled out the possibility of being a lipoma.   This case was linked to US-MODERNATX, INC.-MOD-2024-764658 (E2B Linked Report).  Company Comment: This is a spontaneous case concerning a 61-year-old female patient, with medical history of Lipoma (diagnosed as a small lipoma in 2016), who experienced the serious (due to medically significant) unexpected event of DIPLEGIA, together with other non-serious events,  which started on the same day after a dose of mRNA-1273 BIVALENT .222 (ORIGINAL AND OMICRON BA.4/BA.5)vaccine, received as the third dose of COVID-19 vaccination. Doses 1 and 2 were with Moderna COVID-19 Vaccine.  The patient stated that she was doing fine until she got that third shot and then muscle in her left shoulder has begun to deteriorate, it was getting hard and was spreading. She started having gland problems on her right shoulder and there was a water pocket on the top of the right shoulder that fills up and then it goes away and then it comes back again with fluid and then there's some glands on the inside of her arm. She went in one of them got really big and it seems like it went down a little bit. Pain traveled down into her forearm on her left arm, her biceps, elbows everywhere. It makes her thumbs hurt. Her doctor refused to remove lipoma after ultrasound. The discomfort had gone on now for 15 months and it gotten worse. Both shoulders started aching in the rotator cup, eventually thought they would go away but it never did. The right arm still bothers and sometimes really hard pain. It was deep pain in her shoulder, and now has graduated down the arm and into the back of the arm and sometimes on the right hand too, but the left hand was worse. It was reported that she does not feel like any kind of an adverse reaction with her heart, but felt like it was going in that direction because it would make her left breast and her lungs feel weird on left side. So it was traveling whatever it was doing to her nervous system. She stated that she felt the lump hurt, which led her to the thought that another piece of lipoma traveled but the doctor has ruled out the possibility of being a lipoma. Outcome of the event was reported as not recovered. The mentioned medical history remains as a confounder. The benefit-risk relationship ofmRNA-1273 BIVALENT .222 (ORIGINAL AND OMICRON BA.4/BA.5)vaccine  is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2024: Live follow up received contains no new information. On 02-Apr-2024: Live follow up was received with no new significant information. On 02-Apr-2024: Live significant follow up received and added secondary reporter, medical history.  Added the event condition aggravated. Added start date of the event lipoma, pain in extremity, arthralgia, hypoaesthesia, peripheral swelling. Updated narrative. On 02-Apr-2024: Live significant follow up received. Added reporter. Added event lipoma, vaccination site mass, Hypoaesthesia. Reference ID added. Updated Narrative. On 02-Apr-2024: Live significant follow up received. Added product start date, event start date and start date of the historical vaccines and references updated. On 04-Apr-2024: Live significant follow up received and added reporter. Added onset date for vaccination site mass, Lymphadenopathy. Added the events paralysis and vertigo and treatment drug.; Sender's Comments: Company Comment: This is a spontaneous case concerning a 61-year-old female patient, with medical history of Lipoma (diagnosed as a small lipoma in 2016), who experienced the serious (due to medically significant) unexpected event of DIPLEGIA, together with other non-serious events,  which started on the same day after a dose of mRNA-1273 BIVALENT .222 (ORIGINAL AND OMICRON BA.4/BA.5)vaccine, received as the third dose of COVID-19 vaccination. Doses 1 and 2 were with Moderna COVID-19 Vaccine.  The patient stated that she was doing fine until she got that third shot and then muscle in her left shoulder has begun to deteriorate, it was getting hard and was spreading. She started having gland problems on her right shoulder and there was a water pocket on the top of the right shoulder that fills up and then it goes away and then it comes back again with fluid and then there's some glands on the inside of her arm. She went in one of them got really big and it seems like it went down a little bit. Pain traveled down into her forearm on her left arm, her biceps, elbows everywhere. It makes her thumbs hurt. Her doctor refused to remove lipoma after ultrasound. The discomfort had gone on now for 15 months and it gotten worse. Both shoulders started aching in the rotator cup, eventually thought they would go away but it never did. The right arm still bothers and sometimes really hard pain. It was deep pain in her shoulder, and now has graduated down the arm and into the back of the arm and sometimes on the right hand too, but the left hand was worse. It was reported that she does not feel like any kind of an adverse reaction with her heart, but felt like it was going in that direction because it would make her left breast and her lungs feel weird on left side. So it was traveling whatever it was doing to her nervous system. She stated that she felt the lump hurt, which led her to the thought that another piece of lipoma traveled but the doctor has ruled out the possibility of being a lipoma. Outcome of the event was reported as not recovered. The mentioned medical history remains as a confounder. The benefit-risk relationship ofmRNA-1273 BIVALENT .222 (ORIGINAL AND OMICRON BA.4/BA.5)vaccine  is not affected by this report. US-MODERNATX, INC.-MOD-2024-764658:Same reporter differernt patient