chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling hot, Gastrointestinal pain, Influenza like illness, Peripheral coldness
Clinical narrative: Intestinal cramps; Diarrhea; Felt like flu; Hand and feet were cold; Face felt hot; This spontaneous case was reported by a patient and describes the occurrence of GASTROINTESTINAL PAIN (Intestinal cramps), DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Felt like flu), PERIPHERAL COLDNESS (Hand and feet were cold) and FEELING HOT (Face felt hot) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced GASTROINTESTINAL PAIN (Intestinal cramps), DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Felt like flu), PERIPHERAL COLDNESS (Hand and feet were cold) and FEELING HOT (Face felt hot). The patient was treated with BISMUTH SUBSALICYLATE at an unspecified dose and frequency. At the time of the report, GASTROINTESTINAL PAIN (Intestinal cramps), DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Felt like flu), PERIPHERAL COLDNESS (Hand and feet were cold) and FEELING HOT (Face felt hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is taking other medications.  Treatment medications included Pepto bismol (Bismuth subsalicylate).
Sex: U
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Lips swelling; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Lips swelling) 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-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced LIP SWELLING (Lips swelling). At the time of the report, LIP SWELLING (Lips swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  Patient got Moderna vaccine on Sunday, 07 Mar 2021 and woke up with lips swelling on 09 Mar 2021 morning.  No treatment information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Nausea, Productive cough, Vomiting
Clinical narrative: Splitting up phlegm; Upset tummy; Vomiting; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (Splitting up phlegm), ABDOMINAL DISCOMFORT (Upset tummy), VOMITING (Vomiting) and NAUSEA (Nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PRODUCTIVE COUGH (Splitting up phlegm), ABDOMINAL DISCOMFORT (Upset tummy), VOMITING (Vomiting) and NAUSEA (Nausea). At the time of the report, PRODUCTIVE COUGH (Splitting up phlegm), ABDOMINAL DISCOMFORT (Upset tummy), VOMITING (Vomiting) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient has a history of diabetes and on insulin.  Patient has experienced vomiting and nausea consistently in the morning and at night. Patient was spitting up phlegm and has an upset tummy.  No treatment information was provided.   This case was linked to MOD-2021-040002 (E2B Linked Report).; Sender's Comments:  MOD-2021-040002:partner case
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Myalgia, Vaccination site pain
Clinical narrative: Diarrhea; Stomach cramps; Stomach pain; Body ache; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramps), ABDOMINAL PAIN UPPER (Stomach pain), MYALGIA (Body ache) and VACCINATION SITE PAIN (Pain at injection site) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramps), ABDOMINAL PAIN UPPER (Stomach pain), MYALGIA (Body ache) and VACCINATION SITE PAIN (Pain at injection site). At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramps), ABDOMINAL PAIN UPPER (Stomach pain), MYALGIA (Body ache) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient did not receive treatment.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     The patient's past medical history included Hip surgery (Still having difficulty with the hip) in 2020. Concurrent medical conditions included Heart disorder.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). At the time of the report, VACCINATION SITE PAIN (vaccination site pain) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant medications were reported.  No Treatment information was reported.   This case was linked to MOD-2021-104604 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Patient's date of birth, medical history, outcome of first dose event were added. On 22-Jul-2021: Follow-up contains new information. Vaccine information for second dose was added.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Oral herpes, Pain in extremity, Swelling
Clinical narrative: herpes blister right in front of mouth on lower lip; sore arm; little swelling; little headache; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (herpes blister right in front of mouth on lower lip), PAIN IN EXTREMITY (sore arm), SWELLING (little swelling), HEADACHE (little headache) and FATIGUE (tiredness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     .  Concurrent medical conditions included Blood pressure and Allergy.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced ORAL HERPES (herpes blister right in front of mouth on lower lip), PAIN IN EXTREMITY (sore arm), SWELLING (little swelling), HEADACHE (little headache) and FATIGUE (tiredness). At the time of the report, ORAL HERPES (herpes blister right in front of mouth on lower lip), PAIN IN EXTREMITY (sore arm), SWELLING (little swelling), HEADACHE (little headache) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure pills and allergy pills (unspecified).  Treatment information was not provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain, Sinusitis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Little ache), SINUSITIS (Sinuses started burning and hot), NAUSEA (Some nausea (continuing a little)) and FATIGUE (Tired) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SINUSITIS (Sinuses started burning and hot). On an unknown date, the patient experienced PAIN (Little ache), NAUSEA (Some nausea (continuing a little)) and FATIGUE (Tired). At the time of the report, PAIN (Little ache), SINUSITIS (Sinuses started burning and hot), NAUSEA (Some nausea (continuing a little)) and FATIGUE (Tired) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication information is not provided. Treatment medication information is not provided. On 01-mar-2021 patient visited a dentist after which sinuses started burning and hot.  The patient is due for the  second dose tomorrow 11Mar2021.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: sore arm; fever; muscle pain; chills; vomiting; nausea; headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (fever), MYALGIA (muscle pain), CHILLS (chills) and VOMITING (vomiting) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (fever), MYALGIA (muscle pain), CHILLS (chills), VOMITING (vomiting), NAUSEA (nausea) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and ONDANSETRON (ZOFRAN MELT) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (fever), MYALGIA (muscle pain), CHILLS (chills), VOMITING (vomiting), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment  includes Tylenol, Motrin, Zofran.  No relevant concomitant medications reported.   Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: sore arm; fever; muscle pain; chills; vomiting; nausea; headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (fever), MYALGIA (muscle pain), CHILLS (chills) and VOMITING (vomiting) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (fever), MYALGIA (muscle pain), CHILLS (chills), VOMITING (vomiting), NAUSEA (nausea) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and ONDANSETRON (ZOFRAN MELT) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (fever), MYALGIA (muscle pain), CHILLS (chills), VOMITING (vomiting), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment  includes Tylenol, Motrin, Zofran.  No relevant concomitant medications reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Product storage error
Clinical narrative: Arm soreness; Administered moderna vaccine that was in pre drawn syringe for over 6 hours; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and PRODUCT STORAGE ERROR (Administered moderna vaccine that was in pre drawn syringe for over 6 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported adverse event).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PRODUCT STORAGE ERROR (Administered moderna vaccine that was in pre drawn syringe for over 6 hours). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness). At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown and PRODUCT STORAGE ERROR (Administered moderna vaccine that was in pre drawn syringe for over 6 hours) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: Follow up received included No New Information.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Pruritus
Clinical narrative: Diarrhoea; itching; fatigue; weak; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea), PRURITUS (itching), FATIGUE (fatigue) and ASTHENIA (weak) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 036A21A) for COVID-19 vaccination.     Concomitant products included GLIPIZIDE and VITAMINS NOS for an unknown indication.   On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced DIARRHOEA (Diarrhoea), PRURITUS (itching), FATIGUE (fatigue) and ASTHENIA (weak). At the time of the report, DIARRHOEA (Diarrhoea), PRURITUS (itching), FATIGUE (fatigue) and ASTHENIA (weak) had not resolved. Not Provided          No treatment was provided as per the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ears were ringing; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ears were ringing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced TINNITUS (ears were ringing). At the time of the report, TINNITUS (ears were ringing) outcome was unknown. Not Provided          No concomitant medication reported   No treatment medication reported
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Rash
Clinical narrative: had problem with her back(across her back) after 2nd dose; Rash on sisters back; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (had problem with her back(across her back) after 2nd dose) and RASH (Rash on sisters back) in a 70-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (had problem with her back(across her back) after 2nd dose) and RASH (Rash on sisters back). At the time of the report, MUSCULOSKELETAL DISCOMFORT (had problem with her back(across her back) after 2nd dose) and RASH (Rash on sisters back) had not resolved. Unknown          Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant product use was not provided by the reporter.   Treatment information was not provided.   This case was linked to MOD-2021-039961 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: F/U received on 08 MAT 2021,New event was added.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Depression, Diarrhoea, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: intestinal stuff; felt like he was going to die; sweats; vomiting; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (intestinal stuff), DEPRESSION (felt like he was going to die), HYPERHIDROSIS (sweats), VOMITING (vomiting) and NAUSEA (nausea) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031N20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DIARRHOEA (intestinal stuff), DEPRESSION (felt like he was going to die), HYPERHIDROSIS (sweats), VOMITING (vomiting), NAUSEA (nausea) and PYREXIA (fever). At the time of the report, DIARRHOEA (intestinal stuff), DEPRESSION (felt like he was going to die), HYPERHIDROSIS (sweats), VOMITING (vomiting), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: intestinal stuff; felt like he was going to die; sweats; vomiting; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (intestinal stuff), DEPRESSION (felt like he was going to die), HYPERHIDROSIS (sweats), VOMITING (vomiting) and NAUSEA (nausea) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031N20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DIARRHOEA (intestinal stuff), DEPRESSION (felt like he was going to die), HYPERHIDROSIS (sweats), VOMITING (vomiting), NAUSEA (nausea) and PYREXIA (fever). At the time of the report, DIARRHOEA (intestinal stuff), DEPRESSION (felt like he was going to die), HYPERHIDROSIS (sweats), VOMITING (vomiting), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Cystitis
Clinical narrative: bladder infection; This spontaneous case was reported by a patient and describes the occurrence of CYSTITIS (bladder infection) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A214) for COVID-19 immunisation.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CYSTITIS (bladder infection). At the time of the report, CYSTITIS (bladder infection) 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.   Concomitant product use was not provided by the reporter.   Treatment medication included antibiotics.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity
Clinical narrative: Arm soreness; Administered moderna vaccine that was in pre drawn syringe for over 6 hours; A spontaneous report was received from a nurse concerning a 164 patients (88 Females and 76 Males) of unspecified age (40 to 80 years), who received Moderna's COVID-19 vaccine (mRNA-1273) and most of them experienced arm soreness. All patients were administrated with vaccine that was in pre drawn syringe for more than 6 hours.  The patients' medical history was not  provided by the reporter. Concomitant medications were not reported.  On 24 Feb 2021 to 25 Feb 2021, prior to the onset of the events, the patients received their first of two planned doses of mRNA-1273 (Lot number: 014M20A ) unknown route of administration in the unknown site for prophylaxis of COVID-19 infection. 164 doses were administered from vaccine that was in pre drawn syringe for more than 6 hours. It was reported that a VAERS report was filed.  The last dose administered was reported as 2.5 hours after 6 hour mark.    On unknown date, after receiving mRNA-1273, the patient experienced arm soreness.    Treatment for the events were not included.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of arm soreness was unknown and for 164 doses were administered after 6 hours mark  was considered resolved.; Reporter's Comments: This report refers to a case of expired product administrated for mRNA-1273, lot #014M20A, which occurred for 164 patients. Additionally, most of them experienced arm soreness. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: she had no appetite; weakness; fatigue; breathless; anxiety; she was very sleepy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (breathless), ANXIETY (anxiety), DECREASED APPETITE (she had no appetite), SOMNOLENCE (she was very sleepy) and ASTHENIA (weakness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD. Concurrent medical conditions included Emphysema.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SOMNOLENCE (she was very sleepy). On 03-Mar-2021, the patient experienced DYSPNOEA (breathless) and ANXIETY (anxiety). On 04-Mar-2021, the patient experienced DECREASED APPETITE (she had no appetite), ASTHENIA (weakness) and FATIGUE (fatigue). At the time of the report, DYSPNOEA (breathless), ANXIETY (anxiety), DECREASED APPETITE (she had no appetite), SOMNOLENCE (she was very sleepy), ASTHENIA (weakness) and FATIGUE (fatigue) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: she had no appetite; weakness; fatigue; breathless; anxiety; she was very sleepy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (breathless), ANXIETY (anxiety), DECREASED APPETITE (she had no appetite), SOMNOLENCE (she was very sleepy) and ASTHENIA (weakness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD. Concurrent medical conditions included Emphysema.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SOMNOLENCE (she was very sleepy). On 03-Mar-2021, the patient experienced DYSPNOEA (breathless) and ANXIETY (anxiety). On 04-Mar-2021, the patient experienced DECREASED APPETITE (she had no appetite), ASTHENIA (weakness) and FATIGUE (fatigue). At the time of the report, DYSPNOEA (breathless), ANXIETY (anxiety), DECREASED APPETITE (she had no appetite), SOMNOLENCE (she was very sleepy), ASTHENIA (weakness) and FATIGUE (fatigue) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swelling in the lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swelling in the lymph nodes) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swelling in the lymph nodes). At the time of the report, LYMPHADENOPATHY (swelling in the lymph nodes) outcome was unknown.            No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Hard at site; Raised at site; Sore at site; Pain at site; Redness at site; Hard at site; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VACCINATION SITE INDURATION (Hard at site), the second episode of VACCINATION SITE INDURATION (Hard at site), VACCINATION SITE PAIN (Pain at site), VACCINATION SITE ERYTHEMA (Redness at site) and VACCINATION SITE SWELLING (Raised at site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic fatigue (symptoms worse after the vaccine) in 1990 and Epstein-Barr virus infection in 1990. Concomitant products included SERTRALINE, DOXYCYCLINE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced the first episode of VACCINATION SITE INDURATION (Hard at site), VACCINATION SITE PAIN (Pain at site) and VACCINATION SITE ERYTHEMA (Redness at site). On 10-Mar-2021, the patient experienced the second episode of VACCINATION SITE INDURATION (Hard at site), VACCINATION SITE SWELLING (Raised at site) and VACCINATION SITE PAIN (Sore at site). On 25-Feb-2021, VACCINATION SITE PAIN (Pain at site) and VACCINATION SITE ERYTHEMA (Redness at site) had resolved. On 14-Mar-2021, last episode of VACCINATION SITE INDURATION (Hard at site), VACCINATION SITE SWELLING (Raised at site) and VACCINATION SITE PAIN (Sore at site) had resolved.            ON 10mar2021, post vaccination, the patient reported that she experienced pain, swelling, redness at the injection site. No treatment medication was reported.       Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11-May-2021 will be processed with initial report. Follow-up updated patient demographics, concomitant medications, adverse events start/stop dates and outcome. On 14-Jun-2021: No specific follow-up information recorded.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Myalgia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (fatigue), MYALGIA (muscle aches), DIZZINESS (dizziness), FATIGUE (bad fatigue) and ARTHRALGIA (joint pain) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 032L20A) for an unknown indication. The occurrence of additional non-serious events is detailed below. 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 28-Feb-2021, the patient experienced MYALGIA (muscle aches), DIZZINESS (dizziness), FATIGUE (bad fatigue) and ARTHRALGIA (joint pain). On an unknown date, the patient experienced FATIGUE (fatigue), CHILLS (chills) and PYREXIA (mild fever). At the time of the report, FATIGUE (fatigue), CHILLS (chills) and PYREXIA (mild fever) outcome was unknown and MYALGIA (muscle aches), DIZZINESS (dizziness), FATIGUE (bad fatigue) and ARTHRALGIA (joint pain) had not resolved.    The patient stated that symptoms are ongoing, but getting better. No concomitant medication provided. Treatment inulded  ibuprofen
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (fatigue), MYALGIA (muscle aches), DIZZINESS (dizziness), FATIGUE (bad fatigue) and ARTHRALGIA (joint pain) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 032L20A) for an unknown indication. The occurrence of additional non-serious events is detailed below. 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 28-Feb-2021, the patient experienced MYALGIA (muscle aches), DIZZINESS (dizziness), FATIGUE (bad fatigue) and ARTHRALGIA (joint pain). On an unknown date, the patient experienced FATIGUE (fatigue), CHILLS (chills) and PYREXIA (mild fever). At the time of the report, FATIGUE (fatigue), CHILLS (chills) and PYREXIA (mild fever) outcome was unknown and MYALGIA (muscle aches), DIZZINESS (dizziness), FATIGUE (bad fatigue) and ARTHRALGIA (joint pain) had not resolved.    The patient stated that symptoms are ongoing, but getting better. No concomitant medication provided. Treatment inulded  ibuprofen
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Vaccination site lymphadenopathy
Clinical narrative: arm is itching; sore arm; swollen lymph node on injection site arm; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (arm is itching), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE LYMPHADENOPATHY (swollen lymph node on injection site arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (arm is itching), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE LYMPHADENOPATHY (swollen lymph node on injection site arm). At the time of the report, PRURITUS (arm is itching), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE LYMPHADENOPATHY (swollen lymph node on injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 10-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved.            After the first dose my arm was sore, as expected. It lasted 2-2.5 days.  Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-039887 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: has not received the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has not received the 2nd dose) 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 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not received the 2nd dose). On 10-Mar-2021, PRODUCT DOSE OMISSION ISSUE (has not received the 2nd dose) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. uknown) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included POTASSIUM and VITAMIN D NOS for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) had not resolved.            Concomitant medications reported include, blood pressure medicine.  Treatment details include, diphenhydramine and OTC lotion.   This case was linked to MOD-2021-148318 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Throat irritation
Clinical narrative: a scratchy throat, redness in her arm and itchiness in all of her body; a scratchy throat, redness in her arm and itchiness in all of her body; a scratchy throat, redness in her arm and itchiness in all of her body; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (a scratchy throat, redness in her arm and itchiness in all of her body), PRURITUS (a scratchy throat, redness in her arm and itchiness in all of her body) and RASH ERYTHEMATOUS (a scratchy throat, redness in her arm and itchiness in all of her body) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced THROAT IRRITATION (a scratchy throat, redness in her arm and itchiness in all of her body), PRURITUS (a scratchy throat, redness in her arm and itchiness in all of her body) and RASH ERYTHEMATOUS (a scratchy throat, redness in her arm and itchiness in all of her body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, THROAT IRRITATION (a scratchy throat, redness in her arm and itchiness in all of her body), PRURITUS (a scratchy throat, redness in her arm and itchiness in all of her body) and RASH ERYTHEMATOUS (a scratchy throat, redness in her arm and itchiness in all of her body) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that she is allergic to other substances. Concomitant products include Blood pressure and Thyroid medication. Treatment medication include Benadryl and Tylenol.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: fever 100F; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 100F) and FATIGUE (fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PYREXIA (fever 100F) and FATIGUE (fatigue). At the time of the report, PYREXIA (fever 100F) and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Pyrexia: 100 (Inconclusive) 100F.         No concomitant medications were reported. Treatment included Ibuprofen tablet.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Feeling sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-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 MALAISE (Feeling sick). At the time of the report, MALAISE (Feeling sick) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information in response to events was not provided.   This case was linked to MOD-2021-036271 (E2B Linked Report).; Sender's Comments:  MOD-2021-036271:For the same reporter (Daughter case)
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance
Clinical narrative: stabbing pain in the back; he can barely walk because of the pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (stabbing pain in the back) and GAIT DISTURBANCE (he can barely walk because of the pain) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 026A21A) for COVID-19 immunisation.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced BACK PAIN (stabbing pain in the back) and GAIT DISTURBANCE (he can barely walk because of the pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BACK PAIN (stabbing pain in the back) and GAIT DISTURBANCE (he can barely walk because of the pain) had not resolved.            Concomitant medications were not reported. Patient received Tylenol as treatment medication.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Flatulence, Malaise
Clinical narrative: Pain in her stomach; No appetite today; Woke up not feeling good; Major diarrhea; She has a lot of gas, gassy symptoms; Threw up twice; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Pain in her stomach), DECREASED APPETITE (No appetite today), MALAISE (Woke up not feeling good), DIARRHOEA (Major diarrhea) and FLATULENCE (She has a lot of gas, gassy symptoms) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Pain in her stomach), DECREASED APPETITE (No appetite today), MALAISE (Woke up not feeling good), DIARRHOEA (Major diarrhea), FLATULENCE (She has a lot of gas, gassy symptoms) and VOMITING (Threw up twice). The patient was treated with SIMETICONE (GAS-X) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Pain in her stomach), DECREASED APPETITE (No appetite today), MALAISE (Woke up not feeling good), DIARRHOEA (Major diarrhea), FLATULENCE (She has a lot of gas, gassy symptoms) and VOMITING (Threw up twice) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information included "The caller states her mother had gas pills called simethicone (Gas-X)."
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Pain in her stomach; No appetite today; Woke up not feeling good; Major diarrhea; She has a lot of gas, gassy symptoms; Threw up twice; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Pain in her stomach), DECREASED APPETITE (No appetite today), MALAISE (Woke up not feeling good), DIARRHOEA (Major diarrhea) and FLATULENCE (She has a lot of gas, gassy symptoms) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Pain in her stomach), DECREASED APPETITE (No appetite today), MALAISE (Woke up not feeling good), DIARRHOEA (Major diarrhea), FLATULENCE (She has a lot of gas, gassy symptoms) and VOMITING (Threw up twice). The patient was treated with SIMETICONE (GAS-X) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Pain in her stomach), DECREASED APPETITE (No appetite today), MALAISE (Woke up not feeling good), DIARRHOEA (Major diarrhea), FLATULENCE (She has a lot of gas, gassy symptoms) and VOMITING (Threw up twice) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information included "The caller states her mother had gas pills called simethicone (Gas-X)."
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: dizziness; Headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache) and DIZZINESS (dizziness) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) 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 11-Feb-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced DIZZINESS (dizziness). At the time of the report, HEADACHE (Headache) had not resolved and DIZZINESS (dizziness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.