Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Feeling abnormal, Insomnia, Interchange of vaccine products, Maternal exposure during pregnancy
Clinical narrative: Did not sleep at all; Extreme pain in arms and legs; Both arms and legs were swollen /hands swelled and ballooned up; Felt like no blood in arm; Arms weak and hurting; Interchange of vaccine products; Revaccination with different COVID-19 vaccine; Hives from head to toe all over their body; Itchy; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of INSOMNIA (Did not sleep at all), PAIN IN EXTREMITY (Extreme pain in arms and legs), PERIPHERAL SWELLING (Both arms and legs were swollen /hands swelled and ballooned up), FEELING ABNORMAL (Felt like no blood in arm) and MUSCULAR WEAKNESS (Arms weak and hurting) in a 34-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Drug use for unknown indication: Pfizer (Patient received first 3 doses of Pfizer vaccine.). Past adverse reactions to the above products included No adverse event with Pfizer. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and IRON for an unknown indication.    On 16-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 18-Oct-2022. On 09-May-2022, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 16-Sep-2022, the patient experienced PRURITUS (Itchy). On 17-Sep-2022, the patient experienced INSOMNIA (Did not sleep at all) (seriousness criterion hospitalization), PAIN IN EXTREMITY (Extreme pain in arms and legs) (seriousness criterion hospitalization), PERIPHERAL SWELLING (Both arms and legs were swollen /hands swelled and ballooned up) (seriousness criterion hospitalization), FEELING ABNORMAL (Felt like no blood in arm) (seriousness criterion hospitalization), MUSCULAR WEAKNESS (Arms weak and hurting) (seriousness criterion hospitalization) and URTICARIA (Hives from head to toe all over their body). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and ALUMINIUM HYDROXIDE, MAGNESIUM TRISILICATE, SODIUM ALGINATE (PEPCID [ALUMINIUM HYDROXIDE;MAGNESIUM TRISILICATE;SODIUM ALGINATE]) at an unspecified dose and frequency. On 09-May-2022, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, INSOMNIA (Did not sleep at all), PAIN IN EXTREMITY (Extreme pain in arms and legs), PERIPHERAL SWELLING (Both arms and legs were swollen /hands swelled and ballooned up), FEELING ABNORMAL (Felt like no blood in arm), MUSCULAR WEAKNESS (Arms weak and hurting), URTICARIA (Hives from head to toe all over their body), PRURITUS (Itchy), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) to be related. No further causality assessments were provided for INSOMNIA (Did not sleep at all), PAIN IN EXTREMITY (Extreme pain in arms and legs), PERIPHERAL SWELLING (Both arms and legs were swollen /hands swelled and ballooned up), FEELING ABNORMAL (Felt like no blood in arm), MUSCULAR WEAKNESS (Arms weak and hurting), URTICARIA (Hives from head to toe all over their body), PRURITUS (Itchy) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy).    It was reported that patient was almost 36 weeks pregnant. Patient received first 3 doses of Pfizer vaccine. Patient received Bivalent booster of Moderna and felt uncomfortable overnight. Patient received first booster vaccine of Moderna on 09-May-2022, with batch number - 056M21A. Patient was admitted to emergency department and treated with e steroids and fluids. Patient was discharged post treatment. Health care professionals from ER guessed adverse reactions were due to Moderna booster. Company comment- This is a spontaneous case of interchange of vaccine products (received 3 doses of Pfizer vaccine and a booster dose of mRNA 1273 vaccine) concerning a 34-year-old pregnant patient, with no reported medical history, who experienced maternal exposure during pregnancy at 36 weeks of gestation, who experienced the unexpected and serious (hospitalization) events of insomnia, pain in extremity, peripheral swelling, feeling abnormal and muscular weakness the following day a dose of mRNA-1273.222 vaccine, given as a fifth dose of COVID vaccine schedule, was administered. It was reported patient did not sleep at all the night of the following day vaccine was given because she had extreme pain in arms and legs, hands swelled and ballooned up and both arms and legs were swollen. She said it felt like no blood in arm and arms were weak and hurting. She went to the emergency room, and they check her out and ruled out a bunch of things and guessed it was an adverse reaction to the booster. Steroids, Pepcid (aluminum hydroxide, magnesium trisilicate, sodium alginate) and fluids were given and then she was discharged. Patient´s pregnancy state can contribute to the events insomnia, pain in extremity and peripheral swelling. The benefit-risk relationship of the mRNA-1273.222 is not affected by this report.; Sender's Comments: This is a spontaneous case of interchange of vaccine products (received 3 doses of Pfizer vaccine and a booster dose of mRNA 1273 vaccine) concerning a 34-year-old pregnant patient, with no reported medical history, who experienced maternal exposure during pregnancy at 36 weeks of gestation, who experienced the unexpected and serious (hospitalization) events of insomnia, pain in extremity, peripheral swelling, feeling abnormal and muscular weakness the following day a dose of mRNA-1273.222 vaccine, given as a fifth dose of COVID vaccine schedule, was administered. It was reported patient did not sleep at all the night of the following day vaccine was given because she had extreme pain in arms and legs, hands swelled and ballooned up and both arms and legs were swollen. She said it felt like no blood in arm and arms were weak and hurting. She went to the emergency room, and they check her out and ruled out a bunch of things and guessed it was an adverse reaction to the booster. Steroids, Pepcid (aluminum hydroxide, magnesium trisilicate, sodium alginate) and fluids were given and then she was discharged. Patient´s pregnancy state can contribute to the events insomnia, pain in extremity and peripheral swelling. The benefit-risk relationship of the mRNA-1273.222 is not affected by this report.