Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Incorrect dose administered, Incorrect route of product administration, Insomnia, Nasopharyngitis
Clinical narrative: Inappropriate dose of drug administered; Nausea; Vomiting; Appetite absent; Abdominal pain localised; Food intolerance; Difficulty sleeping; Anxiety; Pancreatic inflammation; Cold symptoms; Administered by route other than intramuscular; Body fluid retention; Hypertension; This spontaneous case was reported by a consumer and describes the occurrence of PANCREATITIS (Pancreatic inflammation) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059E21A and 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PANCREATIN (CREON) capsule for Pancreatectomy.    The patient's past medical history included Digestion impaired (she could not digest food before taking the CREON medication) in 1993, Hospitalisation (The patient was hospitalized and undergone a surgery in 1993 to clip the tail of her pancreas) and Pancreatic operation (The patient was hospitalized and undergone a surgery in 1993 to clip the tail of her pancreas) in 1993. Concurrent medical conditions included Alcohol use (BEER 1 TO CANS EVERY 2 MONTHS) since 1977, Tobacco user (CIGARETTES 5 STICKS A DAY) since 1977 and Hypertension. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), AMLODIPINE BESYLATE for Blood pressure high, BUSPIRONE HCL for Hypertension, CARBAMAZEPINE (TEGRETOL) for Pain, VITAMIN D2 for Prophylaxis.   In 1993, the patient started PANCREATIN (CREON) (Oral) at an unspecified dose three times a day. On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 27-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. In 2016, the patient experienced HYPERTENSION (Hypertension). In 2019, the patient experienced FLUID RETENTION (Body fluid retention). On 24-Jun-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Administered by route other than intramuscular). In July 2021, the patient experienced PANCREATITIS (Pancreatic inflammation) (seriousness criterion medically significant) and NASOPHARYNGITIS (Cold symptoms). In August 2021, the patient experienced ANXIETY (Anxiety). On 13-Sep-2021, the patient experienced FOOD INTOLERANCE (Food intolerance), INSOMNIA (Difficulty sleeping), DECREASED APPETITE (Appetite absent) and ABDOMINAL PAIN (Abdominal pain localised). On 14-Sep-2021, the patient experienced NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Inappropriate dose of drug administered). In 2019, FLUID RETENTION (Body fluid retention) had resolved. In July 2021, PANCREATITIS (Pancreatic inflammation) and NASOPHARYNGITIS (Cold symptoms) had resolved. On 14-Sep-2021, VOMITING (Vomiting) had resolved. At the time of the report, FOOD INTOLERANCE (Food intolerance), ANXIETY (Anxiety), HYPERTENSION (Hypertension), DECREASED APPETITE (Appetite absent), INCORRECT DOSE ADMINISTERED (Inappropriate dose of drug administered), ABDOMINAL PAIN (Abdominal pain localised) and NAUSEA (Nausea) had not resolved, INSOMNIA (Difficulty sleeping) had resolved and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Administered by route other than intramuscular) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Weight: weight loss.         On an unknown date, the patient experienced medication error/patient only two capsules of Creon medication because only had three capsules left. In 2016, the patient experienced hypertension. In 2019, the patient experienced accumulation of body fluids and swelling of feet. In 2019, the accumulation of body fluids and swelling of feet resolved. In July 2021, the patient experienced mucus in nose, inflammation around pancreas and felt like having cold. In July 2021, the mucus in nose, inflammation around pancreas and felt like having cold resolved. In July, the patient underwent abdominal X-Ray, results were not reported. In august 2021, the patient experienced weight loss, had a lot of stress lately and anxiety. On 13 Sep 2021, the patient experienced could not tolerate food in stomach, could not sleep at night, right side of abdominal pain and no appetite. On 14 Sep 2021, the patient experienced nausea and vomiting. On 14 Sep 2021, the vomiting resolved. On an unknown date, could not sleep at night resolved. the patient only took two capsules of Creon medication because only had 3 capsules left until received refill probably on 13 Sep 2021. Patient also mentioned that due to the abdominal pain had trouble sleeping at night, had no appetite, could not tolerate food in stomach and felt nauseated. Patient also mentioned that might be a week after taking the second dose of the covid 19 vaccine felt like having a flu and had mucus in the nose and only took unknown over the counter medication to manage it.  ABDOMINAL XRAY done in Jul-2021 reports not available. it was unknown if patient was enrolled in a covid-19 vaccine trial. Treatment medications were not reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company Comment- This spontaneous case concerns a female patient aged 54 years with relevant history of Alcohol and Tobacco use (since 1977) and past history of pancreatic surgery in 1993 reported, who experienced the unexpected serious (medically significant) AESI event of Pancreatitis that occurred on unknown date (in July 2021) after second dose of mRNA-1273 vaccination. She also experienced non serious events of anxiety, insomnia, Fluid retention weight loss, nausea, vomiting, food intolerance and abdominal pain. Patient had received initial two doses of same vaccine at an interval of 33 days. Additionally Incorrect route of product administration (Administered by route other than intramuscular) was noted. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Abdominal x ray done in Jul-2021 reports not available. Outcome of the event was resolved at the time of report. Relevant history of Alcohol and Tobacco use remains as risk factors and past history of pancreatic surgery as confounder to the event. The use of concomitant drug CARBAMAZEPINE could be contributory to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement; Sender's Comments: This spontaneous case concerns a female patient aged 54 years with relevant history of Alcohol and Tobacco use (since 1977) and past history of pancreatic surgery in 1993 reported, who experienced the unexpected serious (medically significant) AESI event of Pancreatitis that occurred on unknown date (in July 2021) after second dose of mRNA-1273 vaccination. She also experienced non serious events of anxiety, insomnia, Fluid retention weight loss, nausea, vomiting, food intolerance and abdominal pain. Patient had received initial two doses of same vaccine at an interval of 33 days. Additionally Incorrect route of product administration (Administered by route other than intramuscular) was noted. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Abdominal x ray done in Jul-2021 reports not available. Outcome of the event was resolved at the time of report. Relevant history of Alcohol and Tobacco use remains as risk factors and past history of pancreatic surgery as confounder to the event. The use of concomitant drug CARBAMAZEPINE could be contributory to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement