chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Device connection issue, Ligament sprain, Underdose, Vaccination site erythema
Clinical narrative: Injection site infection; Sensation of pain and heaviness in her arm, shoulder joint, and elbow joint; Redness at injection site; Deltoid started to swell up; Vaccine didn't go in her arm and instead ran down her arm; Vaccine didn't go in her arm and instead ran down her arm/ needle clogged or malfunctioned; Itching at injection site; Injection site swelling/deltoid started to swell up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INFECTION (Injection site infection), LIGAMENT SPRAIN (Deltoid started to swell up), UNDERDOSE (Vaccine didn't go in her arm and instead ran down her arm), DEVICE CONNECTION ISSUE (Vaccine didn't go in her arm and instead ran down her arm/ needle clogged or malfunctioned) and VACCINATION SITE PRURITUS (Itching at injection site) in a 36-year-old female patient who received mRNA-1273 (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced LIGAMENT SPRAIN (Deltoid started to swell up), UNDERDOSE (Vaccine didn't go in her arm and instead ran down her arm), DEVICE CONNECTION ISSUE (Vaccine didn't go in her arm and instead ran down her arm/ needle clogged or malfunctioned), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (Injection site swelling/deltoid started to swell up) and VACCINATION SITE ERYTHEMA (Redness at injection site). On an unknown date, the patient experienced VACCINATION SITE INFECTION (Injection site infection) and ARTHRALGIA (Sensation of pain and heaviness in her arm, shoulder joint, and elbow joint). At the time of the report, VACCINATION SITE INFECTION (Injection site infection), LIGAMENT SPRAIN (Deltoid started to swell up) and ARTHRALGIA (Sensation of pain and heaviness in her arm, shoulder joint, and elbow joint) outcome was unknown, UNDERDOSE (Vaccine didn't go in her arm and instead ran down her arm), DEVICE CONNECTION ISSUE (Vaccine didn't go in her arm and instead ran down her arm/ needle clogged or malfunctioned) and VACCINATION SITE ERYTHEMA (Redness at injection site) had resolved and VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE SWELLING (Injection site swelling/deltoid started to swell up) had not resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment using  antibiotic for injection site infection was reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site infection, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site infection; Sensation of pain and heaviness in her arm, shoulder joint, and elbow joint; Redness at injection site; Deltoid started to swell up; Vaccine didn't go in her arm and instead ran down her arm; Vaccine didn't go in her arm and instead ran down her arm/ needle clogged or malfunctioned; Itching at injection site; Injection site swelling/deltoid started to swell up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INFECTION (Injection site infection), LIGAMENT SPRAIN (Deltoid started to swell up), UNDERDOSE (Vaccine didn't go in her arm and instead ran down her arm), DEVICE CONNECTION ISSUE (Vaccine didn't go in her arm and instead ran down her arm/ needle clogged or malfunctioned) and VACCINATION SITE PRURITUS (Itching at injection site) in a 36-year-old female patient who received mRNA-1273 (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced LIGAMENT SPRAIN (Deltoid started to swell up), UNDERDOSE (Vaccine didn't go in her arm and instead ran down her arm), DEVICE CONNECTION ISSUE (Vaccine didn't go in her arm and instead ran down her arm/ needle clogged or malfunctioned), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (Injection site swelling/deltoid started to swell up) and VACCINATION SITE ERYTHEMA (Redness at injection site). On an unknown date, the patient experienced VACCINATION SITE INFECTION (Injection site infection) and ARTHRALGIA (Sensation of pain and heaviness in her arm, shoulder joint, and elbow joint). At the time of the report, VACCINATION SITE INFECTION (Injection site infection), LIGAMENT SPRAIN (Deltoid started to swell up) and ARTHRALGIA (Sensation of pain and heaviness in her arm, shoulder joint, and elbow joint) outcome was unknown, UNDERDOSE (Vaccine didn't go in her arm and instead ran down her arm), DEVICE CONNECTION ISSUE (Vaccine didn't go in her arm and instead ran down her arm/ needle clogged or malfunctioned) and VACCINATION SITE ERYTHEMA (Redness at injection site) had resolved and VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE SWELLING (Injection site swelling/deltoid started to swell up) had not resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment using  antibiotic for injection site infection was reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Vaccination site erythema
Clinical narrative: Soreness in the arm; Itchiness; With a red band around their arm 3-4 inches wide starting at the injection site wrapping around the bicep, feels more like sunburn instead of a rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the arm), PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (With a red band around their arm 3-4 inches wide starting at the injection site wrapping around the bicep, feels more like sunburn instead of a rash) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (With a red band around their arm 3-4 inches wide starting at the injection site wrapping around the bicep, feels more like sunburn instead of a rash). On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in the arm) and PRURITUS (Itchiness). At the time of the report, PAIN IN EXTREMITY (Soreness in the arm), PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (With a red band around their arm 3-4 inches wide starting at the injection site wrapping around the bicep, feels more like sunburn instead of a rash) outcome was unknown. Not Provided          Concomitant medications were not reported.  No treatment information was specified.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Somnolence
Clinical narrative: fatigued; hot; fell asleep; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigued), FEELING HOT (hot) and SOMNOLENCE (fell asleep) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced FATIGUE (fatigued), FEELING HOT (hot) and SOMNOLENCE (fell asleep). At the time of the report, FATIGUE (fatigued), FEELING HOT (hot) and SOMNOLENCE (fell asleep) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: received 2 injections in one day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ACCIDENTAL OVERDOSE (received 2 injections in one day) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and UNK) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (received 2 injections in one day). On 30-Mar-2021, ACCIDENTAL OVERDOSE (received 2 injections in one day) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant Medication was available.  No Treatment Medication was available.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Flushing, Headache, Rash
Clinical narrative: Purple bruise at injection site; Pink cheeks; Flushing; Little lump at injection site; Severe rash/ bad rash over her body; Headache; Purple mark at injection site; Felt a heat surge on face/felt a heat surge in her body; Redness facial/ face red; Face blotchy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Felt a heat surge on face/felt a heat surge in her body), ERYTHEMA (Redness facial/ face red), RASH MACULAR (Face blotchy), VACCINATION SITE BRUISING (Purple bruise at injection site) and VACCINATION SITE DISCOLOURATION (Purple mark at injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GERD. Concurrent medical conditions included Thyroid disorder and IBD. Concomitant products included LEVOTHYROXINE, LANSOPRAZOLE (PREVACID), LORATADINE (CLARITINE), BECLOMETASONE DIPROPIONATE (QNASL) and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced FEELING HOT (Felt a heat surge on face/felt a heat surge in her body), ERYTHEMA (Redness facial/ face red), RASH MACULAR (Face blotchy), VACCINATION SITE DISCOLOURATION (Purple mark at injection site), RASH (Severe rash/ bad rash over her body) and HEADACHE (Headache). On an unknown date, the patient experienced VACCINATION SITE BRUISING (Purple bruise at injection site), RASH ERYTHEMATOUS (Pink cheeks), FLUSHING (Flushing) and VACCINATION SITE INDURATION (Little lump at injection site). On 31-Mar-2021, FEELING HOT (Felt a heat surge on face/felt a heat surge in her body), ERYTHEMA (Redness facial/ face red), RASH MACULAR (Face blotchy), VACCINATION SITE DISCOLOURATION (Purple mark at injection site), RASH ERYTHEMATOUS (Pink cheeks), RASH (Severe rash/ bad rash over her body) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE BRUISING (Purple bruise at injection site), FLUSHING (Flushing) and VACCINATION SITE INDURATION (Little lump at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Significant Follow-up received on 08-JUL-2021. The concomitant product and the route of administration was updated. The events were updated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash macular, Vaccination site bruising, Vaccination site discolouration, Vaccination site induration
Clinical narrative: Purple bruise at injection site; Pink cheeks; Flushing; Little lump at injection site; Severe rash/ bad rash over her body; Headache; Purple mark at injection site; Felt a heat surge on face/felt a heat surge in her body; Redness facial/ face red; Face blotchy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Felt a heat surge on face/felt a heat surge in her body), ERYTHEMA (Redness facial/ face red), RASH MACULAR (Face blotchy), VACCINATION SITE BRUISING (Purple bruise at injection site) and VACCINATION SITE DISCOLOURATION (Purple mark at injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GERD. Concurrent medical conditions included Thyroid disorder and IBD. Concomitant products included LEVOTHYROXINE, LANSOPRAZOLE (PREVACID), LORATADINE (CLARITINE), BECLOMETASONE DIPROPIONATE (QNASL) and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced FEELING HOT (Felt a heat surge on face/felt a heat surge in her body), ERYTHEMA (Redness facial/ face red), RASH MACULAR (Face blotchy), VACCINATION SITE DISCOLOURATION (Purple mark at injection site), RASH (Severe rash/ bad rash over her body) and HEADACHE (Headache). On an unknown date, the patient experienced VACCINATION SITE BRUISING (Purple bruise at injection site), RASH ERYTHEMATOUS (Pink cheeks), FLUSHING (Flushing) and VACCINATION SITE INDURATION (Little lump at injection site). On 31-Mar-2021, FEELING HOT (Felt a heat surge on face/felt a heat surge in her body), ERYTHEMA (Redness facial/ face red), RASH MACULAR (Face blotchy), VACCINATION SITE DISCOLOURATION (Purple mark at injection site), RASH ERYTHEMATOUS (Pink cheeks), RASH (Severe rash/ bad rash over her body) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE BRUISING (Purple bruise at injection site), FLUSHING (Flushing) and VACCINATION SITE INDURATION (Little lump at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Significant Follow-up received on 08-JUL-2021. The concomitant product and the route of administration was updated. The events were updated.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: soreness on the arm; minor chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on the arm) and CHILLS (minor chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness on the arm) and CHILLS (minor chills). At the time of the report, PAIN IN EXTREMITY (soreness on the arm) and CHILLS (minor chills) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: low grade fever; chill; muscle pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever), CHILLS (chill), MYALGIA (muscle pain) and HEADACHE (headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PYREXIA (low grade fever), CHILLS (chill), MYALGIA (muscle pain) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, PYREXIA (low grade fever), CHILLS (chill), MYALGIA (muscle pain) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Depressed mood, Headache, Neck pain, Vaccination site pain
Clinical narrative: Felt a little off; Neck pain; Sore injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (Felt a little off), NECK PAIN (Neck pain), VACCINATION SITE PAIN (Sore injection site) and HEADACHE (Headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 636A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced DEPRESSED MOOD (Felt a little off), NECK PAIN (Neck pain), VACCINATION SITE PAIN (Sore injection site) and HEADACHE (Headache). At the time of the report, DEPRESSED MOOD (Felt a little off), NECK PAIN (Neck pain), VACCINATION SITE PAIN (Sore injection site) and HEADACHE (Headache) outcome was unknown.            Concomitant medications were not reported.  No treatment information was specified.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pruritus, Rash
Clinical narrative: Diarrhea; Itchiness in back of tongue; Itchiness - ears; Itchiness - nose; Rash on the left side of the collar bone; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea), PRURITUS (Itchiness in back of tongue), PRURITUS (Itchiness - ears), PRURITUS (Itchiness - nose) and RASH (Rash on the left side of the collar bone) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included Anaphylactic reaction to drug (Anaphylactic reaction to a sulfa based drug.) and Chemotherapy (Finished chemo on 23-DEC-2020). Concurrent medical conditions included Breast cancer.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PRURITUS (Itchiness in back of tongue), PRURITUS (Itchiness - ears), PRURITUS (Itchiness - nose) and RASH (Rash on the left side of the collar bone). On 27-Mar-2021, the patient experienced DIARRHEA (Diarrhea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. On 12-Mar-2021, PRURITUS (Itchiness in back of tongue), PRURITUS (Itchiness - ears) and PRURITUS (Itchiness - nose) had resolved. At the time of the report, DIARRHEA (Diarrhea) outcome was unknown and RASH (Rash on the left side of the collar bone) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  It was reported that patient was also going through radiation for breast cancer at the time of vaccination.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Bursitis, Inflammation, Influenza like illness, Pain, Pain in extremity
Clinical narrative: Shoulder has certainly been inflamed; It turned to right arm; General flu-like symptoms; In left shoulder had severe pain; Bursitis kind of pain; It was on the shoulder capsule, and would radiate down towards the elbow; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Shoulder has certainly been inflamed), PAIN IN EXTREMITY (It turned to right arm), PAIN (It was on the shoulder capsule, and would radiate down towards the elbow), INFLUENZA LIKE ILLNESS (General flu-like symptoms) and PAIN (In left shoulder had severe pain) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.     On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (General flu-like symptoms). On an unknown date, the patient experienced INFLAMMATION (Shoulder has certainly been inflamed), PAIN IN EXTREMITY (It turned to right arm), PAIN (It was on the shoulder capsule, and would radiate down towards the elbow) and BURSITIS (Bursitis kind of pain). an unknown date, the patient experienced PAIN (In left shoulder had severe pain). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency and PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INFLAMMATION (Shoulder has certainly been inflamed), PAIN IN EXTREMITY (It turned to right arm) and INFLUENZA LIKE ILLNESS (General flu-like symptoms) outcome was unknown and PAIN (It was on the shoulder capsule, and would radiate down towards the elbow), PAIN (In left shoulder had severe pain) and BURSITIS (Bursitis kind of pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-066923, MOD-2021-064167 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: follow up received on 24 May 2021. it doesnot contain any new information.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Pain, Tenderness
Clinical narrative: Tenderness; Soreness; Lump; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness), PAIN (Soreness) and NODULE (Lump) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced TENDERNESS (Tenderness), PAIN (Soreness) and NODULE (Lump). At the time of the report, TENDERNESS (Tenderness), PAIN (Soreness) and NODULE (Lump) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment information was specified.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: arm was red; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ERYTHEMA (arm was red) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) for COVID-19 vaccination.     The patient's past medical history included Hypertension and Cholesterol. Concomitant products included high blood pressure medication and cholesterol medication for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (arm was red). At the time of the report, ERYTHEMA (arm was red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: swelling and red rash on site of injection; swelling and red rash on site of injection/ red mark on skin is 5 inches; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelling and red rash on site of injection) and INJECTION SITE RASH (swelling and red rash on site of injection/ red mark on skin is 5 inches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-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 INJECTION SITE SWELLING (swelling and red rash on site of injection) and INJECTION SITE RASH (swelling and red rash on site of injection/ red mark on skin is 5 inches). At the time of the report, INJECTION SITE SWELLING (swelling and red rash on site of injection) and INJECTION SITE RASH (swelling and red rash on site of injection/ red mark on skin is 5 inches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Raised heart beat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Raised heart beat) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Raised heart beat). At the time of the report, HEART RATE INCREASED (Raised heart beat) had not resolved.            Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little soreness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Levothryroxine, METOPROLOL, VALPROATE SEMISODIUM (DIVALPROEX), CALCITRIOL, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), BIOTIN and CALCIUM CITRATE for an unknown indication.    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 (little soreness). At the time of the report, PAIN IN EXTREMITY (little soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Treatment products included ice.   This case was linked to MODERNATX, INC.-MOD-2021-063983 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MODERNATX, INC.-MOD-2021-063983:case for second dose
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: shakes; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Mar-2021 and was forwarded to Moderna on 26-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes) in a 31-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 (No medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (shakes). At the time of the report, TREMOR (shakes) outcome was unknown. Not Provided          Treatment for the event include paracetamol.   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Cough, Headache, Pyrexia
Clinical narrative: Fever; Headache; Loss of taste; Coughing; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache), AGEUSIA (Loss of taste) and COUGH (Coughing) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included Coughing since an unknown date. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 31-Mar-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache), AGEUSIA (Loss of taste) and COUGH (Coughing). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), HEADACHE (Headache), AGEUSIA (Loss of taste) and COUGH (Coughing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid Positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid Positive) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced COVID-19 (Covid Positive). The patient was treated with MONOCLONAL ANTIBODY 17-1A for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid Positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported.   This case was linked to MOD-2021-066629 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Dosing date, batch number and con. med. info. corrected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Not feeling well; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Not feeling well) 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 (Medical history was not provided).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On an unknown date, the patient experienced MALAISE (Not feeling well). At the time of the report, MALAISE (Not feeling well) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: a lot of muscle spasms in the leg and making it hard to walk, and sometimes they are very sharp; This spontaneous case was reported by a physician and describes the occurrence of MUSCLE SPASMS (a lot of muscle spasms in the leg and making it hard to walk, and sometimes they are very sharp) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (a lot of muscle spasms in the leg and making it hard to walk, and sometimes they are very sharp). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (a lot of muscle spasms in the leg and making it hard to walk, and sometimes they are very sharp) 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.   the concomitant medication includes high blood pressure medication and vitamins
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in Arm; This spontaneous case was reported by a physician and describes the occurrence of HYPOAESTHESIA (Numbness in Arm) in a 35-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.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness in Arm). At the time of the report, HYPOAESTHESIA (Numbness in Arm) outcome was unknown. Not Provided      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.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: constant headache; fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (constant headache) and FATIGUE (fatigue) in a 74-year-old female patient 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 was provided).    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 HEADACHE (constant headache) and FATIGUE (fatigue). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at a dose of 1 dosage form; FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Adverse event, at a dose of 1 dosage form and PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED 12 HOUR) for Adverse event, at a dose of 1 dosage form. At the time of the report, HEADACHE (constant headache) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was provided.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: negative [antibody test]; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (negative [antibody test]) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (negative [antibody test]). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (negative [antibody test]) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, SARS-CoV-2 antibody test: negative negative.     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 concomitant medications were given No treatment information was provided   This case was linked to MOD-2021-058244 (E2B Linked Report).; Sender's Comments:  MOD-2021-058244:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Injected limb mobility decreased, Pain in extremity
Clinical narrative: trouble breathing; this time had more pain in arm/hard to move her arm; had trouble moving the arm up and down; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (this time had more pain in arm/hard to move her arm), INJECTED LIMB MOBILITY DECREASED (had trouble moving the arm up and down) and DYSPNOEA (trouble breathing) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019021A and 001A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, METOPROLOL, VALPROATE SEMISODIUM (DIVALPROEX), CALCITRIOL, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN D3, BIOTIN and CALCIUM CITRATE for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced PAIN IN EXTREMITY (this time had more pain in arm/hard to move her arm) and INJECTED LIMB MOBILITY DECREASED (had trouble moving the arm up and down). On an unknown date, the patient experienced DYSPNOEA (trouble breathing). At the time of the report, PAIN IN EXTREMITY (this time had more pain in arm/hard to move her arm), INJECTED LIMB MOBILITY DECREASED (had trouble moving the arm up and down) and DYSPNOEA (trouble breathing) outcome was unknown.            Treatment medicines were not provided. The action taken with mRNA-1273 with the event was considered as not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-063972 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up information received contains significant information.Event outcome updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-063972:case for first dose
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and FATIGUE (fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 28-Mar-2021, the patient experienced CHILLS (Chills) and FATIGUE (fatigue). At the time of the report, CHILLS (Chills) and FATIGUE (fatigue) outcome was unknown. Not Provided          Treatment medication was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling abnormal, Injection site pain, Injection site swelling
Clinical narrative: injection site rash; feels different; injection site pain; injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (injection site rash), FEELING ABNORMAL (feels different), INJECTION SITE PAIN (injection site pain) and INJECTION SITE SWELLING (injection site swelling) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included Lactose intolerance. Concurrent medical conditions included Diabetes, Hypercholesteremia, Drug allergy (fosamax) and Drug allergy (some cholesterol medicine).    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced BURNING SENSATION (injection site rash), FEELING ABNORMAL (feels different), INJECTION SITE PAIN (injection site pain) and INJECTION SITE SWELLING (injection site swelling). At the time of the report, BURNING SENSATION (injection site rash), FEELING ABNORMAL (feels different), INJECTION SITE PAIN (injection site pain) and INJECTION SITE SWELLING (injection site swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Lip blister, Pyrexia, Tongue discolouration, Tooth infection
Clinical narrative: black tongue; very bad infection on left side of jaw; became sick; blisters on the inside of her lips; low grade temperature/ fever; This spontaneous case was reported by a health care professional and describes the occurrence of TOOTH INFECTION (very bad infection on left side of jaw), ILLNESS (became sick), LIP BLISTER (blisters on the inside of her lips), TONGUE DISCOLOURATION (black tongue) and PYREXIA (low grade temperature/ fever) 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 Teeth grinding.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PYREXIA (low grade temperature/ fever). In March 2021, the patient experienced LIP BLISTER (blisters on the inside of her lips). On 25-Mar-2021, the patient experienced TOOTH INFECTION (very bad infection on left side of jaw) and ILLNESS (became sick). On 30-Mar-2021, the patient experienced TONGUE DISCOLOURATION (black tongue). The patient was treated with CLINDAMYCIN on 25-Mar-2021 for Tooth infection, at a dose of 1 dosage form four times per day. At the time of the report, TOOTH INFECTION (very bad infection on left side of jaw), ILLNESS (became sick), LIP BLISTER (blisters on the inside of her lips) and TONGUE DISCOLOURATION (black tongue) outcome was unknown and PYREXIA (low grade temperature/ fever) had not resolved.        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 Concomitant medications were provided.  On 25 Mar 2021, the day she was scheduled for her second Moderna vaccine , the patient reported a major tooth infection described as three of her teeth looked massively infected.  Her doctor told her not to get the second dose vaccine on 25 Mar 2021.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: NNI FU - No new information was provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: slight tightness of the throat; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (slight tightness of the throat) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included CARVEDILOL (COREG), ISOSORBIDE MONONITRATE and NAPROXEN (MOTRIN [NAPROXEN]) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced THROAT TIGHTNESS (slight tightness of the throat). At the time of the report, THROAT TIGHTNESS (slight tightness of the throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Headache, Pyrexia, Vaccination site mass
Clinical narrative: Headache; Fever of 99 Degrees.; Pain Lump in Injection Arm Left Armpit; Pain Lump in Injection Arm (Left) Armpit; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever of 99 Degrees.), VACCINATION SITE MASS (Pain Lump in Injection Arm Left Armpit) and AXILLARY PAIN (Pain Lump in Injection Arm (Left) Armpit) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever of 99 Degrees.), VACCINATION SITE MASS (Pain Lump in Injection Arm Left Armpit) and AXILLARY PAIN (Pain Lump in Injection Arm (Left) Armpit). At the time of the report, HEADACHE (Headache) and PYREXIA (Fever of 99 Degrees.) outcome was unknown and VACCINATION SITE MASS (Pain Lump in Injection Arm Left Armpit) and AXILLARY PAIN (Pain Lump in Injection Arm (Left) Armpit) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Irritable bowel syndrome, Muscle spasms, Pain in extremity
Clinical narrative: stomach feels bad; diarrhea not as watery; cramps; arm sore; severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore), IRRITABLE BOWEL SYNDROME (severe diarrhea), DIARRHOEA (diarrhea not as watery), MUSCLE SPASMS (cramps) and ABDOMINAL PAIN UPPER (stomach feels bad) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 28-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm sore) and IRRITABLE BOWEL SYNDROME (severe diarrhea). On 31-Mar-2021, the patient experienced DIARRHOEA (diarrhea not as watery) and MUSCLE SPASMS (cramps). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach feels bad). At the time of the report, PAIN IN EXTREMITY (arm sore), IRRITABLE BOWEL SYNDROME (severe diarrhea), DIARRHOEA (diarrhea not as watery), MUSCLE SPASMS (cramps) and ABDOMINAL PAIN UPPER (stomach feels bad) outcome was unknown.            Patient received the first dose with lot #lot 013L20A on 27 Feb 2021. She received second dose on Saturday, March 27 at 4p with lot #047A21A. On Sunday she had a sore arm and severe diarrhea. She has had diarrhea ever since. She will sleep fine and then around 3am her stomach feels bad and diarrhea starts. She goes around 3a, 6a, and 7a. Today her stools don't seem as watery but does have some cramps. Patient stated she did have gastro-intestinal issues on Oct 11 and was in the hospital. She has not had any gastro problems since Oct until now. She wants to know how long still diarrhea goes away. She has a call into HCP. Patient stated it was fine for safety to contact. Narrative