chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Glassy eyes, Headache
Clinical narrative: back hurting; small rash on back; fatigue; knees aching; right shoulder hurting; felt like vomiting; headache; achy; shoulder/arm aching, leg pain; eyes glossy; pupils delated; blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), PAIN IN EXTREMITY (shoulder/arm aching, leg pain), GLASSY EYES (eyes glossy), MYDRIASIS (pupils delated) and VISION BLURRED (blurred vision) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 26-Feb-2021, the patient experienced PAIN (achy), PAIN IN EXTREMITY (shoulder/arm aching, leg pain), GLASSY EYES (eyes glossy), MYDRIASIS (pupils delated), VISION BLURRED (blurred vision), NAUSEA (felt like vomiting) and HEADACHE (headache). On 27-Feb-2021, the patient experienced BACK PAIN (back hurting), RASH (small rash on back), FATIGUE (fatigue), ARTHRALGIA (knees aching) and ARTHRALGIA (right shoulder hurting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (achy), GLASSY EYES (eyes glossy), MYDRIASIS (pupils delated), VISION BLURRED (blurred vision), BACK PAIN (back hurting), RASH (small rash on back), NAUSEA (felt like vomiting), FATIGUE (fatigue) and ARTHRALGIA (right shoulder hurting) outcome was unknown and PAIN IN EXTREMITY (shoulder/arm aching, leg pain), HEADACHE (headache) and ARTHRALGIA (knees aching) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received on 29 JUL 2021. Event outcomes were updated.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Mydriasis, Nausea, Pain, Pain in extremity, Rash
Clinical narrative: back hurting; small rash on back; fatigue; knees aching; right shoulder hurting; felt like vomiting; headache; achy; shoulder/arm aching, leg pain; eyes glossy; pupils delated; blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), PAIN IN EXTREMITY (shoulder/arm aching, leg pain), GLASSY EYES (eyes glossy), MYDRIASIS (pupils delated) and VISION BLURRED (blurred vision) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 26-Feb-2021, the patient experienced PAIN (achy), PAIN IN EXTREMITY (shoulder/arm aching, leg pain), GLASSY EYES (eyes glossy), MYDRIASIS (pupils delated), VISION BLURRED (blurred vision), NAUSEA (felt like vomiting) and HEADACHE (headache). On 27-Feb-2021, the patient experienced BACK PAIN (back hurting), RASH (small rash on back), FATIGUE (fatigue), ARTHRALGIA (knees aching) and ARTHRALGIA (right shoulder hurting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (achy), GLASSY EYES (eyes glossy), MYDRIASIS (pupils delated), VISION BLURRED (blurred vision), BACK PAIN (back hurting), RASH (small rash on back), NAUSEA (felt like vomiting), FATIGUE (fatigue) and ARTHRALGIA (right shoulder hurting) outcome was unknown and PAIN IN EXTREMITY (shoulder/arm aching, leg pain), HEADACHE (headache) and ARTHRALGIA (knees aching) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received on 29 JUL 2021. Event outcomes were updated.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: back hurting; small rash on back; fatigue; knees aching; right shoulder hurting; felt like vomiting; headache; achy; shoulder/arm aching, leg pain; eyes glossy; pupils delated; blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), PAIN IN EXTREMITY (shoulder/arm aching, leg pain), GLASSY EYES (eyes glossy), MYDRIASIS (pupils delated) and VISION BLURRED (blurred vision) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 26-Feb-2021, the patient experienced PAIN (achy), PAIN IN EXTREMITY (shoulder/arm aching, leg pain), GLASSY EYES (eyes glossy), MYDRIASIS (pupils delated), VISION BLURRED (blurred vision), NAUSEA (felt like vomiting) and HEADACHE (headache). On 27-Feb-2021, the patient experienced BACK PAIN (back hurting), RASH (small rash on back), FATIGUE (fatigue), ARTHRALGIA (knees aching) and ARTHRALGIA (right shoulder hurting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (achy), GLASSY EYES (eyes glossy), MYDRIASIS (pupils delated), VISION BLURRED (blurred vision), BACK PAIN (back hurting), RASH (small rash on back), NAUSEA (felt like vomiting), FATIGUE (fatigue) and ARTHRALGIA (right shoulder hurting) outcome was unknown and PAIN IN EXTREMITY (shoulder/arm aching, leg pain), HEADACHE (headache) and ARTHRALGIA (knees aching) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received on 29 JUL 2021. Event outcomes were updated.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Burning sensation during injection at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Burning sensation during injection at injection site) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) 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) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (Burning sensation during injection at injection site). At the time of the report, VACCINATION SITE PAIN (Burning sensation during injection at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication and treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Chills, Decreased appetite, Dyspnoea
Clinical narrative: Vomiting; Fever; Chills; Can't stand and weak; No appetite; Headache; Body aches; Chest hurting; Hard to breath; A spontaneous report  was received from a consumer concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events vomiting, pyrexia, chills, asthenia, decreased appetite, headache, pain , chest pain and dyspnea.    The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient experienced the events, vomiting. fever, chills, can't stand and weak, no appetite, headache, body aches, chest hurting, hard to breath.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of events, vomiting, fever,chills,can't stand and weak, no appetite, headache, body aches,chest hurting,hard to breath was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Vomiting; Fever; Chills; Can't stand and weak; No appetite; Headache; Body aches; Chest hurting; Hard to breath; A spontaneous report  was received from a consumer concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events vomiting, pyrexia, chills, asthenia, decreased appetite, headache, pain , chest pain and dyspnea.    The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient experienced the events, vomiting. fever, chills, can't stand and weak, no appetite, headache, body aches, chest hurting, hard to breath.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of events, vomiting, fever,chills,can't stand and weak, no appetite, headache, body aches,chest hurting,hard to breath was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: neck and shoulders were stiff; neck and shoulders were stiff; tired; arm was sore; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), the first episode of MUSCULOSKELETAL STIFFNESS (neck and shoulders were stiff), the second episode of MUSCULOSKELETAL STIFFNESS (neck and shoulders were stiff), HEADACHE (headache) and FATIGUE (tired) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-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) at an unspecified dose. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore) and HEADACHE (headache). On 16-Feb-2021, the patient experienced the first episode of MUSCULOSKELETAL STIFFNESS (neck and shoulders were stiff), the second episode of MUSCULOSKELETAL STIFFNESS (neck and shoulders were stiff) and FATIGUE (tired). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Feb-2021, PAIN IN EXTREMITY (arm was sore), the last episode of MUSCULOSKELETAL STIFFNESS (neck and shoulders were stiff), HEADACHE (headache) and FATIGUE (tired) had resolved. Not Provided          No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: SubQ; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (SubQ) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 032L20A) for COVID-19 vaccination.     The patient's past medical history included Stent placement (Cardiac stint) on 07-Jan-2017. Concurrent medical conditions included Asthma since 01-Jan-1950, Arthritis since 01-Jan-2006, Depression (Major depression) since 01-Jan-1980, Type II diabetes mellitus since 01-Jan-2000 and Drug allergy (Ca++ channel blockers). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) from 01-Jan-2010 to an unknown date for Asthma, CITALOPRAM from 01-Jan-1987 to an unknown date for Depression, METFORMIN HYDROCHLORIDE (METFORMIN [METFORMIN HYDROCHLORIDE]) from 01-Jan-2010 to an unknown date, GLIMEPIRIDE from 01-Jan-2015 to an unknown date and INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN N) from 01-Jan-2010 to an unknown date for Diabetes.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 01-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (SubQ). On 01-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (SubQ) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that second injection of vaccine was less painful than the first.   No treatment medication reported   This case was linked to MOD-2021-031651, MOD-2021-032479, US-MODERNATX, INC.-MOD-2021-032479 (E2B Linked Report). This case was linked to MOD-2021-032594, MOD-2021-032594 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Concomitant medication list updated, medical history was updated; Sender's Comments:  MOD-2021-031651:Crosslinked case: Wife case (1st dose) MOD-2021-032479:Crosslinked case: Wife case (2nd dose) US-MODERNATX, INC.-MOD-2021-032479:Crosslinked case: Same reporter/different patient (husband)
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Dysphagia, Malaise
Clinical narrative: Light headed / dizzy; Numbness in left arm, from the injection site all the way down her arm to her hand; Very week / couldn't get off the couch; Felt sick; Sick to her stomach; Couldn't eat; Overall sick feeling; Nauseous; Arm was a little achy; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sick to her stomach), DYSPHAGIA (Couldn't eat), MALAISE (Overall sick feeling), ASTHENIA (Very week / couldn't get off the couch) and MALAISE (Felt sick) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was a little achy). On 26-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Sick to her stomach), DYSPHAGIA (Couldn't eat), MALAISE (Overall sick feeling) and NAUSEA (Nauseous). On 28-Feb-2021, the patient experienced ASTHENIA (Very week / couldn't get off the couch), MALAISE (Felt sick) and VACCINATION SITE HYPOAESTHESIA (Numbness in left arm, from the injection site all the way down her arm to her hand). On 02-Mar-2021, the patient experienced DIZZINESS (Light headed / dizzy). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Sick to her stomach), DYSPHAGIA (Couldn't eat), MALAISE (Overall sick feeling), ASTHENIA (Very week / couldn't get off the couch), MALAISE (Felt sick), DIZZINESS (Light headed / dizzy), PAIN IN EXTREMITY (Arm was a little achy) and NAUSEA (Nauseous) outcome was unknown and VACCINATION SITE HYPOAESTHESIA (Numbness in left arm, from the injection site all the way down her arm to her hand) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Vaccination site hypoaesthesia
Clinical narrative: Light headed / dizzy; Numbness in left arm, from the injection site all the way down her arm to her hand; Very week / couldn't get off the couch; Felt sick; Sick to her stomach; Couldn't eat; Overall sick feeling; Nauseous; Arm was a little achy; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sick to her stomach), DYSPHAGIA (Couldn't eat), MALAISE (Overall sick feeling), ASTHENIA (Very week / couldn't get off the couch) and MALAISE (Felt sick) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was a little achy). On 26-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Sick to her stomach), DYSPHAGIA (Couldn't eat), MALAISE (Overall sick feeling) and NAUSEA (Nauseous). On 28-Feb-2021, the patient experienced ASTHENIA (Very week / couldn't get off the couch), MALAISE (Felt sick) and VACCINATION SITE HYPOAESTHESIA (Numbness in left arm, from the injection site all the way down her arm to her hand). On 02-Mar-2021, the patient experienced DIZZINESS (Light headed / dizzy). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Sick to her stomach), DYSPHAGIA (Couldn't eat), MALAISE (Overall sick feeling), ASTHENIA (Very week / couldn't get off the couch), MALAISE (Felt sick), DIZZINESS (Light headed / dizzy), PAIN IN EXTREMITY (Arm was a little achy) and NAUSEA (Nauseous) outcome was unknown and VACCINATION SITE HYPOAESTHESIA (Numbness in left arm, from the injection site all the way down her arm to her hand) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Diarrhoea, Headache, Illness
Clinical narrative: sick for 3 weeks; heavy congestion; congestion in her chest; nose cold; cough; headache; nausea; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of   in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 012M20A) for COVID-19 vaccination.     Concomitant products included MELOXICAM, LISINOPRIL and GLIPIZIDE for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient was treated with BENZONATATE ongoing since an unknown date for Cold, at an unspecified dose and frequency.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Nausea
Clinical narrative: sick for 3 weeks; heavy congestion; congestion in her chest; nose cold; cough; headache; nausea; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of   in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 012M20A) for COVID-19 vaccination.     Concomitant products included MELOXICAM, LISINOPRIL and GLIPIZIDE for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient was treated with BENZONATATE ongoing since an unknown date for Cold, at an unspecified dose and frequency.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Erythema, Illness, Influenza like illness
Clinical narrative: still feels like she has a fever that is in and out; left upper arm is red; Left upper arm is swollen; Feels very dizzy; has some chest pains; felt like she got real influenza flu; was very sick; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (felt like she got real influenza flu), ILLNESS (was very sick), PYREXIA (still feels like she has a fever that is in and out) and ERYTHEMA (left upper arm is red) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood disorder. Concomitant products included MORPHINE, ENOXAPARIN SODIUM (LOVENOX [ENOXAPARIN SODIUM]), NORTRIPTYLINE, ZONISAMIDE, FOLIC ACID, METOCLOPRAMIDE, GLYCERYL TRINITRATE (NITROGLYCERIN LINGUAL), CALCIUM CITRATE, COLECALCIFEROL (CALCIUM CITRATE + D3), SIMETHICONE, CLONAZEPAM, VITAMIN B COMPLEX, DOCUSATE SODIUM, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and LEVETIRACETAM (KEPPRA) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 27-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she got real influenza flu) and ILLNESS (was very sick). On 01-Mar-2021, the patient experienced PYREXIA (still feels like she has a fever that is in and out), ERYTHEMA (left upper arm is red), PERIPHERAL SWELLING (Left upper arm is swollen), DIZZINESS (Feels very dizzy) and CHEST PAIN (has some chest pains). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH RELIEF) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (felt like she got real influenza flu), ILLNESS (was very sick), PYREXIA (still feels like she has a fever that is in and out), ERYTHEMA (left upper arm is red), PERIPHERAL SWELLING (Left upper arm is swollen), DIZZINESS (Feels very dizzy) and CHEST PAIN (has some chest pains) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: still feels like she has a fever that is in and out; left upper arm is red; Left upper arm is swollen; Feels very dizzy; has some chest pains; felt like she got real influenza flu; was very sick; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (felt like she got real influenza flu), ILLNESS (was very sick), PYREXIA (still feels like she has a fever that is in and out) and ERYTHEMA (left upper arm is red) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood disorder. Concomitant products included MORPHINE, ENOXAPARIN SODIUM (LOVENOX [ENOXAPARIN SODIUM]), NORTRIPTYLINE, ZONISAMIDE, FOLIC ACID, METOCLOPRAMIDE, GLYCERYL TRINITRATE (NITROGLYCERIN LINGUAL), CALCIUM CITRATE, COLECALCIFEROL (CALCIUM CITRATE + D3), SIMETHICONE, CLONAZEPAM, VITAMIN B COMPLEX, DOCUSATE SODIUM, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and LEVETIRACETAM (KEPPRA) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 27-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she got real influenza flu) and ILLNESS (was very sick). On 01-Mar-2021, the patient experienced PYREXIA (still feels like she has a fever that is in and out), ERYTHEMA (left upper arm is red), PERIPHERAL SWELLING (Left upper arm is swollen), DIZZINESS (Feels very dizzy) and CHEST PAIN (has some chest pains). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH RELIEF) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (felt like she got real influenza flu), ILLNESS (was very sick), PYREXIA (still feels like she has a fever that is in and out), ERYTHEMA (left upper arm is red), PERIPHERAL SWELLING (Left upper arm is swollen), DIZZINESS (Feels very dizzy) and CHEST PAIN (has some chest pains) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye irritation, Headache, Ocular discomfort
Clinical narrative: chills; eyes were burning; tightness between eyes; headache; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (tightness between eyes), EYE IRRITATION (eyes were burning), CHILLS (chills) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Sinus infection on 31-Dec-2020. Concurrent medical conditions included Headache (Had headache before receiving the vaccination.).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced OCULAR DISCOMFORT (tightness between eyes) and HEADACHE (headache). On 11-Feb-2021, the patient experienced EYE IRRITATION (eyes were burning). On 12-Feb-2021, the patient experienced CHILLS (chills). At the time of the report, OCULAR DISCOMFORT (tightness between eyes), EYE IRRITATION (eyes were burning) and CHILLS (chills) outcome was unknown and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. Treatment activities for event was done with Antibiotics.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Hypokinesia, Muscle spasms, Pain in extremity, Pain of skin
Clinical narrative: tenderness in scalp and back of head; barely able to move my leg; diagnosed with muscle spasms; soreness of arm; bruising; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising), HYPOKINESIA (barely able to move my leg), MUSCLE SPASMS (diagnosed with muscle spasms), PAIN OF SKIN (tenderness in scalp and back of head) and PAIN IN EXTREMITY (soreness of arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN, CELECOXIB (CELEXA [CELECOXIB]), MELOXICAM, TRAMADOL and VITAMINS NOS for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced CONTUSION (bruising) and PAIN IN EXTREMITY (soreness of arm). On 18-Feb-2021, the patient experienced HYPOKINESIA (barely able to move my leg) and MUSCLE SPASMS (diagnosed with muscle spasms). On 02-Mar-2021, the patient experienced PAIN OF SKIN (tenderness in scalp and back of head). The patient was treated with METHOCARBAMOL (ROBAXIN) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, CONTUSION (bruising), HYPOKINESIA (barely able to move my leg), MUSCLE SPASMS (diagnosed with muscle spasms), PAIN OF SKIN (tenderness in scalp and back of head) and PAIN IN EXTREMITY (soreness of arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment activities for event included muscle relaxers.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: swelling; extreme itchiness; soreness; redness; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), PRURITUS (extreme itchiness), PAIN (soreness) and ERYTHEMA (redness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced SWELLING (swelling), PRURITUS (extreme itchiness), PAIN (soreness) and ERYTHEMA (redness). The patient was treated with CORTISONE at an unspecified dose and frequency. On 02-Mar-2021, PAIN (soreness) had resolved. At the time of the report, SWELLING (swelling), PRURITUS (extreme itchiness) and ERYTHEMA (redness) outcome was unknown.            No relevant concomitant medications were provided. The action taken for mRNA-1273 was not applicable.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Somnolence
Clinical narrative: Did not sleep much; Slept all day; sleepiness for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepiness for 3 days), SOMNOLENCE (Slept all day) and INSOMNIA (Did not sleep much) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced SOMNOLENCE (sleepiness for 3 days). On 15-Jan-2021, the patient experienced SOMNOLENCE (Slept all day). On 11-Feb-2021, the patient experienced INSOMNIA (Did not sleep much). On 15-Jan-2021, SOMNOLENCE (Slept all day) had resolved. On 17-Jan-2021, SOMNOLENCE (sleepiness for 3 days) had resolved. On 11-Feb-2021, INSOMNIA (Did not sleep much) had resolved.            Treatment includes Tylenol and the patient had hurt all over the body and was resolved.   This case was linked to MOD21-042637, MOD-2021-031653 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain
Clinical narrative: Did not sleep much; Hurt all over; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Did not sleep much) and PAIN (Hurt all over) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced INSOMNIA (Did not sleep much) and PAIN (Hurt all over). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Feb-2021, INSOMNIA (Did not sleep much) and PAIN (Hurt all over) had resolved.            No relevant concomitant medications were provided. The action taken for mRNA-1273 was not applicable.    This case was linked.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Chills, Exposure during pregnancy, Paraesthesia, SARS-CoV-2 test
Clinical narrative: sneezing; chills; nerve sensation limbs; pain at injection site (left); Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of PARAESTHESIA (nerve sensation limbs), SNEEZING (sneezing), EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), CHILLS (chills) and VACCINATION SITE PAIN (pain at injection site (left)) in a 44-year-old female patient (gravida 4, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage in November 2017, Allergy (decreased injections) on 01-Jan-2017, Pregnancy (healthy live, full-term birth) on 16-Sep-2016 and Pregnancy (healthy live, full-term birth) on 09-Aug-2019. Concomitant products included VITAMIN D NOS for Hypovitaminosis, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-Aug-2020 and the estimated date of delivery was 22-May-2021. On 27-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and VACCINATION SITE PAIN (pain at injection site (left)). On 28-Jan-2021, the patient experienced PARAESTHESIA (nerve sensation limbs) and CHILLS (chills). On 27-Feb-2021, the patient experienced SNEEZING (sneezing). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 27-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. On 29-Jan-2021, PARAESTHESIA (nerve sensation limbs), CHILLS (chills) and VACCINATION SITE PAIN (pain at injection site (left)) had resolved. At the time of the report, SNEEZING (sneezing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive. In 2021, Blood glucose: normal normal. In 2021, Ultrasound scan: normal normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The date of positive pregnancy test on 15-Oct-2020 and estimated date of conception was 15-Aug-2020. The patient has an established prenatal care.   This case was linked to MOD-2021-031546 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing, Ultrasound scan, Vaccination site pain
Clinical narrative: sneezing; chills; nerve sensation limbs; pain at injection site (left); Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of PARAESTHESIA (nerve sensation limbs), SNEEZING (sneezing), EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), CHILLS (chills) and VACCINATION SITE PAIN (pain at injection site (left)) in a 44-year-old female patient (gravida 4, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage in November 2017, Allergy (decreased injections) on 01-Jan-2017, Pregnancy (healthy live, full-term birth) on 16-Sep-2016 and Pregnancy (healthy live, full-term birth) on 09-Aug-2019. Concomitant products included VITAMIN D NOS for Hypovitaminosis, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-Aug-2020 and the estimated date of delivery was 22-May-2021. On 27-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and VACCINATION SITE PAIN (pain at injection site (left)). On 28-Jan-2021, the patient experienced PARAESTHESIA (nerve sensation limbs) and CHILLS (chills). On 27-Feb-2021, the patient experienced SNEEZING (sneezing). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 27-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. On 29-Jan-2021, PARAESTHESIA (nerve sensation limbs), CHILLS (chills) and VACCINATION SITE PAIN (pain at injection site (left)) had resolved. At the time of the report, SNEEZING (sneezing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive. In 2021, Blood glucose: normal normal. In 2021, Ultrasound scan: normal normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The date of positive pregnancy test on 15-Oct-2020 and estimated date of conception was 15-Aug-2020. The patient has an established prenatal care.   This case was linked to MOD-2021-031546 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Fatigue, Increased viscosity of upper respiratory secretion, Rash, Sinusitis
Clinical narrative: sinus infection; mucus; tired; back rash; lost sense of taste; A spontaneous report was received from a consumer concerning a 78-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sinus infection, increased viscousity of upper respiratory secretions, fatigue, rash and aguesia.       The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events, sinus infection, mucus, tired, back rash, lost sense of taste.  Treatment details included azithromycin.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of events, sinus infection, mucus,tired,back rash,lost sense of taste was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose, Unevaluable event
Clinical narrative: Needle disconnected from syringe; Majority of dose did not go in arm; Technician experienced backflash; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (Needle disconnected from syringe), UNDERDOSE (Majority of dose did not go in arm) and UNEVALUABLE EVENT (Technician experienced backflash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Feb-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) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced DEVICE CONNECTION ISSUE (Needle disconnected from syringe), UNDERDOSE (Majority of dose did not go in arm) and UNEVALUABLE EVENT (Technician experienced backflash). At the time of the report, DEVICE CONNECTION ISSUE (Needle disconnected from syringe), UNDERDOSE (Majority of dose did not go in arm) and UNEVALUABLE EVENT (Technician experienced backflash) had resolved.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Restless legs syndrome
Clinical narrative: Legs shaky; Weakness; Felt really fatigued; This spontaneous case was reported by a consumer and describes the occurrence of RESTLESS LEGS SYNDROME (Legs shaky), ASTHENIA (Weakness) and FATIGUE (Felt really fatigued) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced RESTLESS LEGS SYNDROME (Legs shaky), ASTHENIA (Weakness) and FATIGUE (Felt really fatigued). At the time of the report, RESTLESS LEGS SYNDROME (Legs shaky), ASTHENIA (Weakness) and FATIGUE (Felt really fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Headache, Injection site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of dizziness (dizzy; lightheaded), headache, diarrhea, chills and injection site pain (pain at injection site (left)) in a 77-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 010A21A) for COVID-19 immunization. No medical history reported. On Mar 2, 2021, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 2, 2021, patient experienced dizziness (dizzy; lightheaded), headache, diarrhea, chills and injection site pain (pain at injection site (left)). The patient treated with Tylenol (paracetamol) on Mar 3, 2021; 4 doses. At the time of the report, dizziness (dizzy; lightheaded), headache, diarrhea, chills and injection site pain (pain at injection site (left)) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.  No concomitant medications reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: Dizzy; Blood pressure, was from 170/94 - 180/111; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) and BLOOD PRESSURE INCREASED (Blood pressure, was from 170/94 - 180/111) in a 79-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DIZZINESS (Dizzy) and BLOOD PRESSURE INCREASED (Blood pressure, was from 170/94 - 180/111). At the time of the report, DIZZINESS (Dizzy) and BLOOD PRESSURE INCREASED (Blood pressure, was from 170/94 - 180/111) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Diarrhoea, Dysphagia, Fatigue, Injection site erythema
Clinical narrative: watery stool; injection site was super itchy; watery stool; injection site redness; nausea; tired; two hard knots at the injection site; 45 Mins after the shot she got tingling all over the body; tight chest; heart racing; tingling tongue and throat; swelling tongue and throat; difficulty swallowing; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (45 Mins after the shot she got tingling all over the body), CHEST DISCOMFORT (tight chest), PALPITATIONS (heart racing), PARAESTHESIA ORAL (tingling tongue and throat) and SWOLLEN TONGUE (swelling tongue and throat) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy and Sulfonamide allergy. Concomitant products included ETHAMBUTOL DIHYDROCHLORIDE (ATB) for Bronchitis.    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 PARAESTHESIA (45 Mins after the shot she got tingling all over the body), CHEST DISCOMFORT (tight chest), PALPITATIONS (heart racing), PARAESTHESIA ORAL (tingling tongue and throat), SWOLLEN TONGUE (swelling tongue and throat), DYSPHAGIA (difficulty swallowing), INJECTION SITE INDURATION (two hard knots at the injection site) and FATIGUE (tired). On 11-Feb-2021, the patient experienced the first episode of DIARRHOEA (watery stool), INJECTION SITE ERYTHEMA (injection site redness) and NAUSEA (nausea). On 12-Feb-2021, the patient experienced the second episode of DIARRHOEA (watery stool) and INJECTION SITE PRURITUS (injection site was super itchy). At the time of the report, PARAESTHESIA (45 Mins after the shot she got tingling all over the body), CHEST DISCOMFORT (tight chest), PALPITATIONS (heart racing), PARAESTHESIA ORAL (tingling tongue and throat), SWOLLEN TONGUE (swelling tongue and throat), DYSPHAGIA (difficulty swallowing), the last episode of DIARRHOEA (watery stool), INJECTION SITE PRURITUS (injection site was super itchy), INJECTION SITE INDURATION (two hard knots at the injection site), INJECTION SITE ERYTHEMA (injection site redness), FATIGUE (tired) and NAUSEA (nausea) outcome was unknown.        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.   Treatment medications were not reported.