chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm was sore for a few days at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore for a few days at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm was sore for a few days at the injection site). At the time of the report, VACCINATION SITE PAIN (arm was sore for a few days at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Patient endorsed to feeling fine
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Dyspnoea, Tachycardia
Clinical narrative: fast heart beats; confusion; difficulty breathing; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (fast heart beats), CONFUSIONAL STATE (confusion), DYSPNOEA (difficulty breathing) and DIZZINESS (dizziness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced TACHYCARDIA (fast heart beats), CONFUSIONAL STATE (confusion), DYSPNOEA (difficulty breathing) and DIZZINESS (dizziness). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 20-Jan-2021, TACHYCARDIA (fast heart beats), CONFUSIONAL STATE (confusion), DYSPNOEA (difficulty breathing) and DIZZINESS (dizziness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itch at injection site; Significant red area at the injection site; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itch at injection site), VACCINATION SITE ERYTHEMA (Significant red area at the injection site) and INJECTION SITE RASH (Rash at injection site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itch at injection site), VACCINATION SITE ERYTHEMA (Significant red area at the injection site) and INJECTION SITE RASH (Rash at injection site). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itch at injection site), VACCINATION SITE ERYTHEMA (Significant red area at the injection site) and INJECTION SITE RASH (Rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: Additional information updates. Patient initials added. Patient demographics were added. Added treatment medications. Added New events.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Only had aches for the first days; A spontaneous report was received from a consumer concerning his cousin, of an unspecified age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced aches for the first days / pain. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, prior to the onset of the event, the patient received their planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. The route of administration and dose number was not provided.  On an unknown date post vaccination, the patient had aches for the first days.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash; A spontaneous report (United States) was received from a Consumer concerning a 79-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itchy rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 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 Jan 2021, the patient experienced the event(s) itchy rash.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), itchy rash was unknown..
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 102.3F; A spontaneous report was received from a consumer concerning a 68-years-old, male patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced event fever 102.3F/pyrexia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 JAN 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 12 FEB 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 016M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Feb 2021, the patient reported fever 102.3F. On 23 Feb 2021, temperature down to 98-99F because of Tylenol.  Treatment for the event included tylenol.  The patient received both scheduled doses of mRNA-1273 prior to the event(s), therefore action taken with the drug in response to the event(s) is not applicable.  The outcome of the event fever 102.3 F was resolved.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain, Paraesthesia, Pyrexia
Clinical narrative: fever, aches, and a headache; fever, aches, and a headache; fever, aches, and a headache; patient feels woozy; head tingles; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever, aches, and a headache), PAIN (fever, aches, and a headache), HEADACHE (fever, aches, and a headache), DIZZINESS (patient feels woozy) and PARAESTHESIA (head tingles) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever, aches, and a headache), PAIN (fever, aches, and a headache), HEADACHE (fever, aches, and a headache), DIZZINESS (patient feels woozy) and PARAESTHESIA (head tingles). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever, aches, and a headache), PAIN (fever, aches, and a headache), HEADACHE (fever, aches, and a headache), DIZZINESS (patient feels woozy) and PARAESTHESIA (head tingles) outcome was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Chills, Erythema, Lip blister, Muscle mass
Clinical narrative: fever blisters on her mouth; arm is still swollen; arm is still sore; felt like a baseball in her muscle; arm is red; mouth is sore; little ulcers on her tongue and mouth; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of LIP BLISTER (fever blisters on her mouth), PERIPHERAL SWELLING (arm is still swollen), PAIN IN EXTREMITY (arm is still sore), MUSCLE MASS (felt like a baseball in her muscle) and ERYTHEMA (arm is red) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced LIP BLISTER (fever blisters on her mouth), PERIPHERAL SWELLING (arm is still swollen), PAIN IN EXTREMITY (arm is still sore), MUSCLE MASS (felt like a baseball in her muscle), ERYTHEMA (arm is red), STOMATITIS (mouth is sore), APHTHOUS ULCER (little ulcers on her tongue and mouth), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, LIP BLISTER (fever blisters on her mouth), PERIPHERAL SWELLING (arm is still swollen), PAIN IN EXTREMITY (arm is still sore), MUSCLE MASS (felt like a baseball in her muscle), ERYTHEMA (arm is red), STOMATITIS (mouth is sore), APHTHOUS ULCER (little ulcers on her tongue and mouth), PYREXIA (fever) and CHILLS (chills) 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.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Stomatitis
Clinical narrative: fever blisters on her mouth; arm is still swollen; arm is still sore; felt like a baseball in her muscle; arm is red; mouth is sore; little ulcers on her tongue and mouth; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of LIP BLISTER (fever blisters on her mouth), PERIPHERAL SWELLING (arm is still swollen), PAIN IN EXTREMITY (arm is still sore), MUSCLE MASS (felt like a baseball in her muscle) and ERYTHEMA (arm is red) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced LIP BLISTER (fever blisters on her mouth), PERIPHERAL SWELLING (arm is still swollen), PAIN IN EXTREMITY (arm is still sore), MUSCLE MASS (felt like a baseball in her muscle), ERYTHEMA (arm is red), STOMATITIS (mouth is sore), APHTHOUS ULCER (little ulcers on her tongue and mouth), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, LIP BLISTER (fever blisters on her mouth), PERIPHERAL SWELLING (arm is still swollen), PAIN IN EXTREMITY (arm is still sore), MUSCLE MASS (felt like a baseball in her muscle), ERYTHEMA (arm is red), STOMATITIS (mouth is sore), APHTHOUS ULCER (little ulcers on her tongue and mouth), PYREXIA (fever) and CHILLS (chills) 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.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Started feeling itchy at injection site; Red circle at injection site; Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE PRURITUS (Started feeling itchy at injection site) and VACCINATION SITE ERYTHEMA (Red circle at injection site) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M2OA) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Started feeling itchy at injection site) and VACCINATION SITE ERYTHEMA (Red circle at injection site). The patient was treated with CEREVEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm hurt) had not resolved and VACCINATION SITE PRURITUS (Started feeling itchy at injection site) and VACCINATION SITE ERYTHEMA (Red circle at injection site) outcome was unknown.        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.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Patient reported rash on her inner thighs and abdomen; Patient reported hives mostly on the right side of the body on her right arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Patient reported hives mostly on the right side of the body on her right arm) and RASH (Patient reported rash on her inner thighs and abdomen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included DOXYCYCLINE for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) COVID-19 vaccine. On 02-Feb-2021, the patient experienced URTICARIA (Patient reported hives mostly on the right side of the body on her right arm). On an unknown date, the patient experienced RASH (Patient reported rash on her inner thighs and abdomen). At the time of the report, URTICARIA (Patient reported hives mostly on the right side of the body on her right arm) was resolving and RASH (Patient reported rash on her inner thighs and abdomen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Chills; Fever; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and VOMITING (Vomiting) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and VOMITING (Vomiting). At the time of the report, CHILLS (Chills), PYREXIA (Fever) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Gait disturbance, Tremor
Clinical narrative: feeling unsteady; doesn't feel ok/had to go back to bed; he is shacking; chills; very tired; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (feeling unsteady), FEELING ABNORMAL (doesn't feel ok/had to go back to bed), TREMOR (he is shacking), CHILLS (chills) and FATIGUE (very tired) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 001A21A) for COVID-19 vaccination.     The patient's past medical history included Dementia. Concomitant products included ATORVASTATIN, AMLODIPINE, CLOPIDOGREL, DONEPEZIL HCL and MEMANTINE.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced GAIT DISTURBANCE (feeling unsteady), FEELING ABNORMAL (doesn't feel ok/had to go back to bed), TREMOR (he is shacking), CHILLS (chills) and FATIGUE (very tired). At the time of the report, GAIT DISTURBANCE (feeling unsteady), FEELING ABNORMAL (doesn't feel ok/had to go back to bed), TREMOR (he is shacking), CHILLS (chills) and FATIGUE (very tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain, Swelling, Vaccination site mass
Clinical narrative: Hard Lump,Lump increased in size; Pain; Redness,Redness became larger; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness,Redness became larger), VACCINATION SITE MASS (Hard Lump,Lump increased in size), SWELLING (Swelling) and PAIN (Pain) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced ERYTHEMA (Redness,Redness became larger) and SWELLING (Swelling). On 03-Feb-2021, the patient experienced VACCINATION SITE MASS (Hard Lump,Lump increased in size) and PAIN (Pain). At the time of the report, ERYTHEMA (Redness,Redness became larger), VACCINATION SITE MASS (Hard Lump,Lump increased in size), SWELLING (Swelling) and PAIN (Pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Positive COVID-19 test; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Positive COVID-19 test) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Positive COVID-19 test). At the time of the report, COVID-19 (Positive COVID-19 test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2020, SARS-CoV-2 test positive: positive (Positive) Patient received moderna first dose after two days , tested positive for COVID-19..     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.; Sender's Comments: Based on the established profile for mRNA-1273, a causal association between the event of COVID-19 and the product administration is assessed as unlikely.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pulpitis dental
Clinical narrative: swelling behind her teeth; This spontaneous case was reported by a consumer and describes the occurrence of PULPITIS DENTAL (swelling behind her teeth) in an 80-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.    On 22-Feb-2021, ] prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273  Batch number not provided intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 22-Feb-2021, the patient experienced PULPITIS DENTAL (swelling behind her teeth).  Action taken with the mRNA-1273 in response to events was not reported   On 22 -FEB-2021, the outcome of events developed swelling behind her teeth was not reported.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Arm started to turn red, size of a dollar; This spontaneous case was reported by a health care professional and describes the occurrence of ERYTHEMA (Arm started to turn red, size of a dollar) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event, Hypertension and Cholesterol.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced ERYTHEMA (Arm started to turn red, size of a dollar). On 29-Jan-2021, ERYTHEMA (Arm started to turn red, size of a dollar) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report received from a consumer, concerning herself (68-year-old female patient), who was administered the Moderna COVID-19 vaccine (mRNA-1273) and experienced fever, headache, nausea and vomiting. The patient's medical history and concomitant history not provided. No lab data reported. On Feb 1, 2021, patient received the first of two planned doses of mRNA-1273 (lot# 007M20A), intramuscularly, in left arm, for prophylaxis of COVID-19 infection. On Feb 2, 2021, patient experienced fever, headache, nausea and vomiting; with outcome of unknown. The treatment history was not provided. The action taken with the first dose of mRNA-1273 in response to the event: not reported. Sender's comments: Based on the current available information, which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the known safety profile of mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, Pain in extremity
Clinical narrative: Left Arm hurts a Little,; Left Arm hurts a Little, Stomach Ache, Nausea, Diarrhea; Left Arm hurts a Little, Stomach Ache, Nausea, Diarrhea; Nausea,; A spontaneous report was received from a consumer  concerning an 80 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed a stomach ache/abdominal pain upper, her left arm hurt/pain in extremity, nausea, and diarrhea.  The patient's medical history included Crohn's disease.  No relevant concomitant medications were reported.   On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient's arm hurt after receiving the vaccine on 22 Jan 2021.  She also experienced a stomach ache, nausea, and diarrhea for nine days.  She treated the events with meclizine.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events stomach ache, nausea, and diarrhea were not reported.  The outcome of the event arm pain was recovered/resolved on 25 Jan 2021.  Reporter causality for the events was not provided.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Nausea is consistent with the known safety profile of mRNA-1273.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Rash, Urticaria, Vaccination site rash
Clinical narrative: strange feeling on tongue; hives; Rash on legs; Rash on opposite arm; Rash on injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (strange feeling on tongue), RASH (Rash on opposite arm), RASH (Rash on legs), VACCINATION SITE RASH (Rash on injection arm) and URTICARIA (hives) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 24-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash on opposite arm).   On 27-Jan-2021, the patient experienced RASH (Rash on legs). On an unknown date, the patient experienced PARAESTHESIA ORAL (strange feeling on tongue), VACCINATION SITE RASH (Rash on injection arm) and URTICARIA (hives).   On 28-Jan-2021, RASH (Rash on opposite arm) had resolved.   On 31-Jan-2021, RASH (Rash on legs) had resolved. At the time of the report, PARAESTHESIA ORAL (strange feeling on tongue) and URTICARIA (hives) outcome was unknown and VACCINATION SITE RASH (Rash on injection arm) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: sore in her r arm; chills; headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore in her r arm), CHILLS (chills) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore in her r arm), CHILLS (chills) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore in her r arm), CHILLS (chills) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache and chills are consistent with the known safety profile of mRNA-1273   Reporter did not allow further contact; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache and chills are consistent with the known safety profile of mRNA-1273
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swelling in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling in her arm). At the time of the report, PERIPHERAL SWELLING (Swelling in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use and treatment information was not provided.   This case was linked to MOD-2021-024495 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Reporter contact information is updated.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Pyrexia, Sluggishness
Clinical narrative: a little sluggish; tested positive for COVID; fever of 99.6 that night; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (a little sluggish), COVID-19 (tested positive for COVID) and PYREXIA (fever of 99.6 that night) in a 59-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 historical condition was reported).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PYREXIA (fever of 99.6 that night). On 16-Jan-2021, the patient experienced COVID-19 (tested positive for COVID). On an unknown date, the patient experienced SLUGGISHNESS (a little sluggish). At the time of the report, SLUGGISHNESS (a little sluggish), COVID-19 (tested positive for COVID) and PYREXIA (fever of 99.6 that night) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Body temperature: 99.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Injection site erythema, Urticaria
Clinical narrative: Welt at injection site; Bigger spot of redness; Felt tired; Red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Welt at injection site), ERYTHEMA (Bigger spot of redness), INJECTION SITE ERYTHEMA (Red at injection site) and FATIGUE (Felt tired) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1414) for an unknown indication.     The patient's past medical history included No adverse event (No historical condition was reported.).    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Red at injection site). On 23-Feb-2021, the patient experienced URTICARIA (Welt at injection site), ERYTHEMA (Bigger spot of redness) and FATIGUE (Felt tired). At the time of the report, URTICARIA (Welt at injection site), ERYTHEMA (Bigger spot of redness), INJECTION SITE ERYTHEMA (Red at injection site) and FATIGUE (Felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historical condition was reported).    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: fever 102.5; chills; body aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 102.5), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever 102.5), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headaches). At the time of the report, PYREXIA (fever 102.5), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headaches) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itching on the injection site; Rash on injection site; Red injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching on the injection site), VACCINATION SITE RASH (Rash on injection site) and VACCINATION SITE ERYTHEMA (Red injection site) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Allergic reaction to antibiotics (ciprofloxacin) and Iodine allergy.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching on the injection site), VACCINATION SITE RASH (Rash on injection site) and VACCINATION SITE ERYTHEMA (Red injection site). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itching on the injection site), VACCINATION SITE RASH (Rash on injection site) and VACCINATION SITE ERYTHEMA (Red injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: mild symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (mild symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (mild symptoms). At the time of the report, ADVERSE REACTION (mild symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Heart rate increased
Clinical narrative: Sore arm; Dizziness; Diarrhea; Weakness; Fast heart; Chills; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), ASTHENIA (Weakness) and HEART RATE INCREASED (Fast heart) in a 58-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.     The patient's past medical history included No adverse event (no historical condition was reported).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), ASTHENIA (Weakness), HEART RATE INCREASED (Fast heart), CHILLS (Chills) and VOMITING (vomiting). At the time of the report, PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), ASTHENIA (Weakness), HEART RATE INCREASED (Fast heart), CHILLS (Chills) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Sore arm; Dizziness; Diarrhea; Weakness; Fast heart; Chills; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), ASTHENIA (Weakness) and HEART RATE INCREASED (Fast heart) in a 58-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.     The patient's past medical history included No adverse event (no historical condition was reported).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), ASTHENIA (Weakness), HEART RATE INCREASED (Fast heart), CHILLS (Chills) and VOMITING (vomiting). At the time of the report, PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), ASTHENIA (Weakness), HEART RATE INCREASED (Fast heart), CHILLS (Chills) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Injection site pain, Nausea, Vomiting
Clinical narrative: diarrhea; Nausea; Vomiting; arm of injection was sore and booming; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), INJECTION SITE PAIN (arm of injection was sore and booming), NAUSEA (Nausea) and VOMITING (Vomiting) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025120A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced INJECTION SITE PAIN (arm of injection was sore and booming). On 29-Jan-2021, the patient experienced DIARRHOEA (diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Injection site pain, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), INJECTION SITE PAIN (arm of injection was sore and booming), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: The injection site is red; The injection site is itchy; The injection site is raised; This spontaneous case was reported by an other and describes the occurrence of INJECTION SITE ERYTHEMA (The injection site is red), INJECTION SITE PRURITUS (The injection site is itchy) and INJECTION SITE SWELLING (The injection site is raised) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (The injection site is red), INJECTION SITE PRURITUS (The injection site is itchy) and INJECTION SITE SWELLING (The injection site is raised). At the time of the report, INJECTION SITE ERYTHEMA (The injection site is red), INJECTION SITE PRURITUS (The injection site is itchy) and INJECTION SITE SWELLING (The injection site is raised) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: loose bowels; waves of stomach pain, starts at the top of my stomach, under the breast down to the belly button; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (waves of stomach pain, starts at the top of my stomach, under the breast down to the belly button) and DIARRHOEA (loose bowels) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029620A and 016M20A) for COVID-19 vaccination.     The patient's past medical history included Acid reflux (oesophageal). Concurrent medical conditions included Hiatal hernia, Blood pressure high and High cholesterol. Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) and CALCIUM CARBONATE, MAGNESIUM HYDROXIDE (ROLAIDS [CALCIUM CARBONATE;MAGNESIUM HYDROXIDE]) for Acid reflux (oesophageal), LOSARTAN POTASSIUM and METOPROLOL TARTRATE for Blood pressure high, PARACETAMOL (TYLENOL) for Hiatal hernia, ROSUVASTATIN CALCIUM for High cholesterol, LEVOTHYROXINE for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (waves of stomach pain, starts at the top of my stomach, under the breast down to the belly button). On 04-Feb-2021, the patient experienced DIARRHOEA (loose bowels). At the time of the report, ABDOMINAL PAIN UPPER (waves of stomach pain, starts at the top of my stomach, under the breast down to the belly button) and DIARRHOEA (loose bowels) had resolved. Not Provided          No treatment information was provided.  The patient stated that it was minor adverse event and may not have been caused by the Moderna injection, since it occurred after she received one of the injection.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received with Medical history, suspect product dosing details, Concomitant drug, and event information, reporter causality and narrative information was updated.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Malaise, Myalgia, Nausea
Clinical narrative: not been feeling good; stomach sick; bloated stomach; feverish; aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not been feeling good), ABDOMINAL DISCOMFORT (stomach sick), ABDOMINAL DISTENSION (bloated stomach), PYREXIA (feverish) and MYALGIA (aches) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M201A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PROBIOTICS NOS for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced MALAISE (not been feeling good), ABDOMINAL DISCOMFORT (stomach sick), ABDOMINAL DISTENSION (bloated stomach), PYREXIA (feverish), MYALGIA (aches) and NAUSEA (nausea). At the time of the report, MALAISE (not been feeling good), ABDOMINAL DISCOMFORT (stomach sick), ABDOMINAL DISTENSION (bloated stomach) and PYREXIA (feverish) outcome was unknown, MYALGIA (aches) had resolved and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug included blood pressure medications and vitamins.  Treatment information was not provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: not been feeling good; stomach sick; bloated stomach; feverish; aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not been feeling good), ABDOMINAL DISCOMFORT (stomach sick), ABDOMINAL DISTENSION (bloated stomach), PYREXIA (feverish) and MYALGIA (aches) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M201A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PROBIOTICS NOS for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced MALAISE (not been feeling good), ABDOMINAL DISCOMFORT (stomach sick), ABDOMINAL DISTENSION (bloated stomach), PYREXIA (feverish), MYALGIA (aches) and NAUSEA (nausea). At the time of the report, MALAISE (not been feeling good), ABDOMINAL DISCOMFORT (stomach sick), ABDOMINAL DISTENSION (bloated stomach) and PYREXIA (feverish) outcome was unknown, MYALGIA (aches) had resolved and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug included blood pressure medications and vitamins.  Treatment information was not provided.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Abdominal pain; Sweats; Chills; A fever of >100; Headache; Fatigue/tiredness; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal pain), HYPERHIDROSIS (Sweats), CHILLS (Chills), PYREXIA (A fever of >100) and HEADACHE (Headache) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (Abdominal pain), HYPERHIDROSIS (Sweats), CHILLS (Chills), PYREXIA (A fever of >100), HEADACHE (Headache), FATIGUE (Fatigue/tiredness) and MYALGIA (Muscle aches). At the time of the report, ABDOMINAL PAIN (Abdominal pain), HYPERHIDROSIS (Sweats), CHILLS (Chills), PYREXIA (A fever of >100), HEADACHE (Headache), FATIGUE (Fatigue/tiredness) and MYALGIA (Muscle aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: >100 (High) a fever of >100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.