chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain, Pain in extremity
Clinical narrative: Achy all over her body; Extremely sore arm; Chills; Dull headache; Muscle ache; Has 98.7°F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy all over her body), PAIN IN EXTREMITY (Extremely sore arm), CHILLS (Chills), HEADACHE (Dull headache) and MYALGIA (Muscle ache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20 and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN (Achy all over her body), PAIN IN EXTREMITY (Extremely sore arm), HEADACHE (Dull headache), MYALGIA (Muscle ache) and PYREXIA (Has 98.7°F). 03-Mar-2021, the patient experienced CHILLS (Chills). At the time of the report, PAIN (Achy all over her body), PAIN IN EXTREMITY (Extremely sore arm), CHILLS (Chills), HEADACHE (Dull headache), MYALGIA (Muscle ache) and PYREXIA (Has 98.7°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Pyrexia: 98.7°f (High) 98.7°F.         No treatment information was provided. No relevant concomitant medications reported
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Achy all over her body; Extremely sore arm; Chills; Dull headache; Muscle ache; Has 98.7°F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy all over her body), PAIN IN EXTREMITY (Extremely sore arm), CHILLS (Chills), HEADACHE (Dull headache) and MYALGIA (Muscle ache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20 and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN (Achy all over her body), PAIN IN EXTREMITY (Extremely sore arm), HEADACHE (Dull headache), MYALGIA (Muscle ache) and PYREXIA (Has 98.7°F). 03-Mar-2021, the patient experienced CHILLS (Chills). At the time of the report, PAIN (Achy all over her body), PAIN IN EXTREMITY (Extremely sore arm), CHILLS (Chills), HEADACHE (Dull headache), MYALGIA (Muscle ache) and PYREXIA (Has 98.7°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Pyrexia: 98.7°f (High) 98.7°F.         No treatment information was provided. No relevant concomitant medications reported
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Vaccination site pain
Clinical narrative: hurts all over; pain in arm of injection; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in arm of injection), ARTHRALGIA (joint pain) and PAIN (hurts all over) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (patient has lump and had breast cancer were noted.) and Lupus-like syndrome since an unknown date.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain in arm of injection), ARTHRALGIA (joint pain) and PAIN (hurts all over). At the time of the report, VACCINATION SITE PAIN (pain in arm of injection), ARTHRALGIA (joint pain) and PAIN (hurts all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No relevant concomitant medications reported.    This case was linked to MOD-2021-035881 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Scheduled for their second dose of the Moderna COVID-19 vaccine 8 days after their first shot; A spontaneous report  was received from a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was scheduled for their second dose of the Moderna COVID-19 vaccine 8 days after their first shot.   The patient's medical history was not provided by the reporter. No Concomitant medications reported.  On 25 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011A21A) intramuscularly for prophylaxis of COVID-19 infection.   A patient called stating that they were scheduled for their second dose of the Moderna COVID-19 vaccine today (8 days) after their first shot.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: chills; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and MYALGIA (muscle pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced CHILLS (chills) and MYALGIA (muscle pain). At the time of the report, CHILLS (chills) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up received on 9 JULY 2021 and contain non significant information.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Positive for COVID 1 week after the 1st dose of moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive for COVID 1 week after the 1st dose of moderna vaccine) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive for COVID 1 week after the 1st dose of moderna vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive for COVID 1 week after the 1st dose of moderna vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, SARS-CoV-2 test positive: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided.  No treatment medication were provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.            No treatment information was provided. No relevant concomitant medications reported
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Feeling cold, Vomiting
Clinical narrative: Felt terrible; Felt cold; Had a temperature; Threw up; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt terrible), FEELING COLD (Felt cold), BODY TEMPERATURE (Had a temperature) and VOMITING (Threw up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 014M20A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced FEELING ABNORMAL (Felt terrible), FEELING COLD (Felt cold), BODY TEMPERATURE (Had a temperature) and VOMITING (Threw up). At the time of the report, FEELING ABNORMAL (Felt terrible), FEELING COLD (Felt cold), BODY TEMPERATURE (Had a temperature) and VOMITING (Threw up) outcome was unknown.            Treatment information included Tylenol for symptoms
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Keeps getting headaches around head ear to ear; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Keeps getting headaches around head ear to ear) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 08L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Keeps getting headaches around head ear to ear). At the time of the report, HEADACHE (Keeps getting headaches around head ear to ear) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue
Clinical narrative: didn't want anything to eat; cold chill; feel tired; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (cold chill), FATIGUE (feel tired) and DECREASED APPETITE (didn't want anything to eat) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 Vaccination.     No Medical History information was reported.   On 08-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 08-Jan-2021, the patient experienced CHILLS (cold chill) and FATIGUE (feel tired). On an unknown date, the patient experienced DECREASED APPETITE (didn't want anything to eat). At the time of the report, CHILLS (cold chill), FATIGUE (feel tired) and DECREASED APPETITE (didn't want anything to eat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events were unknown.   This case was linked to MOD-2021-023940 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2021: No specific follow-up information recorded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Discomfort, Headache
Clinical narrative: Felt different; Sore shoulder; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Felt different), ARTHRALGIA (Sore shoulder), HEADACHE (Headache) and CHILLS (Chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (Felt different), ARTHRALGIA (Sore shoulder), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, DISCOMFORT (Felt different), ARTHRALGIA (Sore shoulder), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications reported.    Reporter did not allow further contact
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Sore arm; Body aches; Headaches; Nausea; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), HEADACHE (Headaches), NAUSEA (Nausea), PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced MYALGIA (Body aches), HEADACHE (Headaches), NAUSEA (Nausea), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, MYALGIA (Body aches), HEADACHE (Headaches), NAUSEA (Nausea), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; Body aches; Headaches; Nausea; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), HEADACHE (Headaches), NAUSEA (Nausea), PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced MYALGIA (Body aches), HEADACHE (Headaches), NAUSEA (Nausea), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, MYALGIA (Body aches), HEADACHE (Headaches), NAUSEA (Nausea), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: felt achy; This spontaneous case was reported by a physician and describes the occurrence of PAIN (felt achy) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ADALIMUMAB for Psoriatic arthritis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (felt achy). At the time of the report, PAIN (felt achy) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information provided
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Feeling of body temperature change, Nausea
Clinical narrative: very weak; hot and cold; fever 100.1; extreme chills; could not get out of bed; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very weak), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), PYREXIA (fever 100.1), CHILLS (extreme chills) and FATIGUE (could not get out of bed) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 042l20al) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced ASTHENIA (very weak), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), PYREXIA (fever 100.1), CHILLS (extreme chills), FATIGUE (could not get out of bed) and NAUSEA (nauseated). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Mar-2021, FEELING OF BODY TEMPERATURE CHANGE (hot and cold), PYREXIA (fever 100.1), CHILLS (extreme chills) and NAUSEA (nauseated) had resolved. On 05-Mar-2021, ASTHENIA (very weak) and FATIGUE (could not get out of bed) had resolved.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: very weak; hot and cold; fever 100.1; extreme chills; could not get out of bed; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very weak), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), PYREXIA (fever 100.1), CHILLS (extreme chills) and FATIGUE (could not get out of bed) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 042l20al) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced ASTHENIA (very weak), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), PYREXIA (fever 100.1), CHILLS (extreme chills), FATIGUE (could not get out of bed) and NAUSEA (nauseated). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Mar-2021, FEELING OF BODY TEMPERATURE CHANGE (hot and cold), PYREXIA (fever 100.1), CHILLS (extreme chills) and NAUSEA (nauseated) had resolved. On 05-Mar-2021, ASTHENIA (very weak) and FATIGUE (could not get out of bed) had resolved.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dysgeusia, Headache, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Loss of taste; Tasted sugar or chocolate, it tested like chemicals; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), AGEUSIA (Loss of taste), DYSGEUSIA (Tasted sugar or chocolate, it tested like chemicals) and HEADACHE (headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concurrent medical conditions included Sulfonamide allergy. Concomitant products included VITAMIN D NOS, ZINC and CEFALEXIN MONOHYDRATE (LEXIPRON) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 18-Feb-2021, the patient experienced HEADACHE (headache). On 19-Feb-2021, the patient experienced AGEUSIA (Loss of taste) and DYSGEUSIA (Tasted sugar or chocolate, it tested like chemicals). At the time of the report, PAIN IN EXTREMITY (sore arm), AGEUSIA (Loss of taste) and HEADACHE (headache) outcome was unknown and DYSGEUSIA (Tasted sugar or chocolate, it tested like chemicals) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment medication was provided.  Patient reported that she took second dose at about 5 and half week after the first dose, and she did not had any adverse events.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Email was added, Outcome of the event Dysgeusia was updated to recovered.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Enlarged uvula, Heart rate, Heart rate irregular
Clinical narrative: Swelling throat / throat swelled; Itching over body; Dizziness; weak; Lip swelling; Tongue swelling; uvula swelling; Heart rate irregular; Throat discomfort; palpitations; larynx swelling; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Swelling throat / throat swelled), PRURITUS (Itching over body), DIZZINESS (Dizziness), ASTHENIA (weak) and LIP SWELLING (Lip swelling) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21AA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hives and Hay fever. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 03-Mar-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021 at 11:45 AM, the patient experienced PHARYNGEAL SWELLING (Swelling throat / throat swelled), PRURITUS (Itching over body), DIZZINESS (Dizziness), ASTHENIA (weak), LIP SWELLING (Lip swelling), SWOLLEN TONGUE (Tongue swelling), ENLARGED UVULA (uvula swelling), HEART RATE IRREGULAR (Heart rate irregular), OROPHARYNGEAL DISCOMFORT (Throat discomfort), PALPITATIONS (palpitations) and LARYNGITIS (larynx swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 04-Mar-2021, PHARYNGEAL SWELLING (Swelling throat / throat swelled) and PRURITUS (Itching over body) had resolved. On 03-Jun-2021, DIZZINESS (Dizziness), ASTHENIA (weak), LIP SWELLING (Lip swelling), SWOLLEN TONGUE (Tongue swelling), ENLARGED UVULA (uvula swelling), HEART RATE IRREGULAR (Heart rate irregular), OROPHARYNGEAL DISCOMFORT (Throat discomfort), PALPITATIONS (palpitations) and LARYNGITIS (larynx swelling) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Heart rate: irregular Irregular.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant Follow up appended on 22-Jul-2021. Updated: Reporter, Patient (Allergies and Lab data), Product (For vaccine updated facility type and name and added concomitant drug), Event (added newevents and causality updated) and Narrative updated.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Laryngitis, Lip swelling, Oropharyngeal discomfort, Palpitations, Pharyngeal swelling
Clinical narrative: Swelling throat / throat swelled; Itching over body; Dizziness; weak; Lip swelling; Tongue swelling; uvula swelling; Heart rate irregular; Throat discomfort; palpitations; larynx swelling; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Swelling throat / throat swelled), PRURITUS (Itching over body), DIZZINESS (Dizziness), ASTHENIA (weak) and LIP SWELLING (Lip swelling) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21AA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hives and Hay fever. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 03-Mar-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021 at 11:45 AM, the patient experienced PHARYNGEAL SWELLING (Swelling throat / throat swelled), PRURITUS (Itching over body), DIZZINESS (Dizziness), ASTHENIA (weak), LIP SWELLING (Lip swelling), SWOLLEN TONGUE (Tongue swelling), ENLARGED UVULA (uvula swelling), HEART RATE IRREGULAR (Heart rate irregular), OROPHARYNGEAL DISCOMFORT (Throat discomfort), PALPITATIONS (palpitations) and LARYNGITIS (larynx swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 04-Mar-2021, PHARYNGEAL SWELLING (Swelling throat / throat swelled) and PRURITUS (Itching over body) had resolved. On 03-Jun-2021, DIZZINESS (Dizziness), ASTHENIA (weak), LIP SWELLING (Lip swelling), SWOLLEN TONGUE (Tongue swelling), ENLARGED UVULA (uvula swelling), HEART RATE IRREGULAR (Heart rate irregular), OROPHARYNGEAL DISCOMFORT (Throat discomfort), PALPITATIONS (palpitations) and LARYNGITIS (larynx swelling) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Heart rate: irregular Irregular.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant Follow up appended on 22-Jul-2021. Updated: Reporter, Patient (Allergies and Lab data), Product (For vaccine updated facility type and name and added concomitant drug), Event (added newevents and causality updated) and Narrative updated.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swollen tongue
Clinical narrative: Swelling throat / throat swelled; Itching over body; Dizziness; weak; Lip swelling; Tongue swelling; uvula swelling; Heart rate irregular; Throat discomfort; palpitations; larynx swelling; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Swelling throat / throat swelled), PRURITUS (Itching over body), DIZZINESS (Dizziness), ASTHENIA (weak) and LIP SWELLING (Lip swelling) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21AA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hives and Hay fever. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 03-Mar-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021 at 11:45 AM, the patient experienced PHARYNGEAL SWELLING (Swelling throat / throat swelled), PRURITUS (Itching over body), DIZZINESS (Dizziness), ASTHENIA (weak), LIP SWELLING (Lip swelling), SWOLLEN TONGUE (Tongue swelling), ENLARGED UVULA (uvula swelling), HEART RATE IRREGULAR (Heart rate irregular), OROPHARYNGEAL DISCOMFORT (Throat discomfort), PALPITATIONS (palpitations) and LARYNGITIS (larynx swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 04-Mar-2021, PHARYNGEAL SWELLING (Swelling throat / throat swelled) and PRURITUS (Itching over body) had resolved. On 03-Jun-2021, DIZZINESS (Dizziness), ASTHENIA (weak), LIP SWELLING (Lip swelling), SWOLLEN TONGUE (Tongue swelling), ENLARGED UVULA (uvula swelling), HEART RATE IRREGULAR (Heart rate irregular), OROPHARYNGEAL DISCOMFORT (Throat discomfort), PALPITATIONS (palpitations) and LARYNGITIS (larynx swelling) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Heart rate: irregular Irregular.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant Follow up appended on 22-Jul-2021. Updated: Reporter, Patient (Allergies and Lab data), Product (For vaccine updated facility type and name and added concomitant drug), Event (added newevents and causality updated) and Narrative updated.
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: received more liquid than expected; A spontaneous report was received from a consumer concerning a female patient of unknown age, who received the first dose of the Moderna's COVID-19 vaccine (mRNA-1273) and experienced receiving more liquid than expected (accidental overdose).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, the patient received the first of two planned doses of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  The patient stated that she thought she received more liquid than expected.  No AEs were reported, and no treatment medications were reported.  Action taken with mRNA-1273 was not reported.  The outcome of the event, accidental overdose was considered recovered.; Reporter's Comments: This report refers to a case of accidental overdose for mRNA-1273 (lot # unknown) with no associated AEs reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Rapid heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heartbeat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0102A1A) for COVID-19 vaccination.     Concurrent medical conditions included Arrhythmia. Concomitant products included METOPROLOL for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced HEART RATE INCREASED (Rapid heartbeat). At the time of the report, HEART RATE INCREASED (Rapid heartbeat) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy; Delayed rash reaction under her right breast; very slightly painful; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy), RASH (Delayed rash reaction under her right breast) and RASH (very slightly painful) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Partial mastectomy (Right-side partial mastectomy in 2007) in 2007. Concurrent medical conditions included Drug allergy (Allergic to Darvocet), Drug allergy (Narcotics (with Tylenol).), Hypertension, High cholesterol and Sinus infection. Concomitant products included LISINOPRIL, ATORVASTATIN and MONTELUKAST for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Itchy), RASH (Delayed rash reaction under her right breast) and RASH (very slightly painful). The patient was treated with CORTISONE at an unspecified dose and frequency and BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN TOPICAL) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Itchy), RASH (Delayed rash reaction under her right breast) and RASH (very slightly painful) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-036167 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21 and 042120A) for COVID-19 vaccination.     Concomitant products included MELOXICAM and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            On 4 Mar 2021, the patient experienced the event sore arm after 2nd dose. She did not take her arthritis medication on either days when the vaccine was administered she said since it is an anti-inflammatory. Wants to know if she can restart the medication now.  Treatment details included has not taken anything yet but plans on trying acetaminophen after call completes.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event sore arm was unknown.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Aggression, Feeling hot, Pruritus, Rash, Skin burning sensation
Clinical narrative: Delayed reaction to the vaccine; Burning rash all over the body/Burning; Itching/Itchy; Got very aggressive; Rash with a hot feeling; Rush all over his side/Rash appeared on both sides of his body; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Delayed reaction to the vaccine), SKIN BURNING SENSATION (Burning rash all over the body/Burning), PRURITUS (Itching/Itchy), AGGRESSION (Got very aggressive) and FEELING HOT (Rash with a hot feeling) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Skin disorder NOS (He had urticarias occasionally.).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Delayed reaction to the vaccine), SKIN BURNING SENSATION (Burning rash all over the body/Burning), PRURITUS (Itching/Itchy), AGGRESSION (Got very aggressive), FEELING HOT (Rash with a hot feeling) and RASH (Rush all over his side/Rash appeared on both sides of his body). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Delayed reaction to the vaccine), SKIN BURNING SENSATION (Burning rash all over the body/Burning), PRURITUS (Itching/Itchy), AGGRESSION (Got very aggressive), FEELING HOT (Rash with a hot feeling) and RASH (Rush all over his side/Rash appeared on both sides of his body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Delayed reaction to the vaccine; Burning rash all over the body/Burning; Itching/Itchy; Got very aggressive; Rash with a hot feeling; Rush all over his side/Rash appeared on both sides of his body; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Delayed reaction to the vaccine), SKIN BURNING SENSATION (Burning rash all over the body/Burning), PRURITUS (Itching/Itchy), AGGRESSION (Got very aggressive) and FEELING HOT (Rash with a hot feeling) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Skin disorder NOS (He had urticarias occasionally.).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Delayed reaction to the vaccine), SKIN BURNING SENSATION (Burning rash all over the body/Burning), PRURITUS (Itching/Itchy), AGGRESSION (Got very aggressive), FEELING HOT (Rash with a hot feeling) and RASH (Rush all over his side/Rash appeared on both sides of his body). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Delayed reaction to the vaccine), SKIN BURNING SENSATION (Burning rash all over the body/Burning), PRURITUS (Itching/Itchy), AGGRESSION (Got very aggressive), FEELING HOT (Rash with a hot feeling) and RASH (Rush all over his side/Rash appeared on both sides of his body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itchy all over the body; Rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy all over the body) and RASH (Rash all over the body) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PRURITUS (Itchy all over the body) and RASH (Rash all over the body). At the time of the report, PRURITUS (Itchy all over the body) and RASH (Rash all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation. Concomitant products included RIVAROXABAN (XARELTO) for Atrial fibrillation.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       They did not want to stay on the phone to give more details. No treatment details reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-035979 (E2B Linked Report).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Rash erythematous, Rash pruritic
Clinical narrative: Had a rash on the back and legs and it itches; Little red bumps appeared and itches like crazy, severely on the back and top of the tights; Inappropriate schedule of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Had a rash on the back and legs and it itches), RASH ERYTHEMATOUS (Little red bumps appeared and itches like crazy, severely on the back and top of the tights) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine). On 05-Mar-2021, the patient experienced RASH PRURITIC (Had a rash on the back and legs and it itches) and RASH ERYTHEMATOUS (Little red bumps appeared and itches like crazy, severely on the back and top of the tights). On 04-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine) had resolved. At the time of the report, RASH PRURITIC (Had a rash on the back and legs and it itches) and RASH ERYTHEMATOUS (Little red bumps appeared and itches like crazy, severely on the back and top of the tights) outcome was unknown.            No concomitant medication reported. Treatment medications included diphenhydramine.  On 01-Jun-2021, the patient reported they visited a doctor and dermatologist for their rash and itching. These events are now thought to be caused by psoriasis, and the patient is now being treated for psoriasis (unknown treatment).  Company Comment: Based on 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 MOD-2021-070522, MOD-2021-070522 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: TCR added. Event information updated.; Sender's Comments: Based on 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.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Pain in extremity, Pruritus
Clinical narrative: Itchy; Red patchy area; Headache; Right arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), PAIN IN EXTREMITY (Right arm sore), ERYTHEMA (Red patchy area) and HEADACHE (Headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 023M20A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Right arm sore) and HEADACHE (Headache). On 19-Feb-2021, the patient experienced PRURITUS (Itchy) and ERYTHEMA (Red patchy area). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Feb-2021, PAIN IN EXTREMITY (Right arm sore) had resolved. At the time of the report, PRURITUS (Itchy), ERYTHEMA (Red patchy area) and HEADACHE (Headache) had resolved.            Patient is taking medication for Cholestrol   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received  contains significant information ; outcome of the events updated
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Constipation, Diarrhoea
Clinical narrative: hardening of her bowel; a little stomach pain; loosening of her bowels; kidney infection; yeast infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONSTIPATION (hardening of her bowel), ABDOMINAL PAIN UPPER (a little stomach pain), DIARRHOEA (loosening of her bowels), KIDNEY INFECTION (kidney infection) and FUNGAL INFECTION (yeast infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported. ).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced KIDNEY INFECTION (kidney infection) and FUNGAL INFECTION (yeast infection). On 04-Mar-2021, the patient experienced CONSTIPATION (hardening of her bowel), ABDOMINAL PAIN UPPER (a little stomach pain) and DIARRHOEA (loosening of her bowels). At the time of the report, CONSTIPATION (hardening of her bowel), ABDOMINAL PAIN UPPER (a little stomach pain), DIARRHOEA (loosening of her bowels), KIDNEY INFECTION (kidney infection) and FUNGAL INFECTION (yeast infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was unknown  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.   Reporter did not allow further contact; 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.