Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Presyncope, Tremor, Vaccination site pain, Vomiting
Clinical narrative: almost passed out/Felt like she was going to pass out; her blood pressure was low; Really bad stomach cramps; she was so dizzy; urge to have bowel movement, such cramps, pain all the way into the uterine area; shaky legs; weak legs; nausea; as soon as it went in it hurt really bad/arm soreness; felt like throwing up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRESYNCOPE (almost passed out/Felt like she was going to pass out) and HYPOTENSION (her blood pressure was low) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gallbladder disorder on 29-Jan-2021 and Gallbladder removal on 19-Apr-2021. Concurrent medical conditions included Indigestion. Concomitant products included FAMOTIDINE (PEPCID AC) for Indigestion, IRON, ASCORBIC ACID (VITAMIN C ACID), PROBIOTICS NOS and VITAMIN D3 for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PRESYNCOPE (almost passed out/Felt like she was going to pass out) (seriousness criterion medically significant), HYPOTENSION (her blood pressure was low) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Really bad stomach cramps), DIZZINESS (she was so dizzy), PAIN (urge to have bowel movement, such cramps, pain all the way into the uterine area), TREMOR (shaky legs), MUSCULAR WEAKNESS (weak legs), NAUSEA (nausea), VACCINATION SITE PAIN (as soon as it went in it hurt really bad/arm soreness) and VOMITING (felt like throwing up). On 06-Apr-2021, PRESYNCOPE (almost passed out/Felt like she was going to pass out), HYPOTENSION (her blood pressure was low), ABDOMINAL PAIN UPPER (Really bad stomach cramps), DIZZINESS (she was so dizzy), PAIN (urge to have bowel movement, such cramps, pain all the way into the uterine area), TREMOR (shaky legs), MUSCULAR WEAKNESS (weak legs), NAUSEA (nausea), VACCINATION SITE PAIN (as soon as it went in it hurt really bad/arm soreness) and VOMITING (felt like throwing up) had resolved.            Treatment includes Zofran and IV medications. On 06-Apr-2021 at 7.30 PM, the patient got the second dose of vaccine and as soon as it went in it hurt really bad. After the medication was pushed the patient had instant nausea, almost passed out, really bad stomach cramps. The pharmacist did not want her driving home because she was so dizzy. At 7:50pm the patient had urge to have bowel movement, such cramps, pain all the way into the uterine area, felt like throwing up, felt like going to pass out so she got off the toilet and was crawling on the floor because the patient had super shaky legs and weak legs. The patient's husband said get dressed and we're going to the ER. He ended up calling the ambulance which took her to the ER. In the ambulance, they started IV, the patient" blood pressure was low, and gave Zofran under the tongue. The patient said Zofran helped so much that within15 minutes it took the extreme nausea away. At the ER, around 8:40, the patient was feeling a lot better. The doctor in the ER said that people with inflamed GI were having the same problems with the Moderna vaccine. The patient experienced these symptoms from 7:30-9:20 pm and by 9:30pm the patient was completely fine. She went home and even had a snack. The patient did not have an ounce of arm soreness or any other symptoms after that. The patient's first gall bladder attack was on 29-Jan-2021. On 06-Apr-2021 at 4.30 PM the patient had a gall bladder scan. On 19-Apr-2021, the patient had a gall bladder removal. Patient could not eat or drink for 6 hours prior to scan. She said she did hydrate before the shot.   Action taken with mRNA-1273 in response to the event was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD21-079818, MOD21-079820, MOD21-079821, -MOD-2021-083836; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MOD21-079818: MOD21-079820: MOD21-079821: -MOD-2021-083836:DOSE 1