chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: people had worse AEs after the second dose than from the first one; 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 VACCINATION COMPLICATION (people had worse AEs after the second dose than from the first one) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (people had worse AEs after the second dose than from the first one). At the time of the report, VACCINATION COMPLICATION (people had worse AEs after the second dose than from the first one) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications reported.   This case was linked to MODERNATX, INC.-MOD-2021-098231, MODERNATX, INC.-MOD-2021-098231 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098231:Cross linked to MOD-2021-098231 US-MODERNATX, INC.-MOD-2021-098231:cross linked to
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Heart rate, Myalgia
Clinical narrative: Fast heart rate, resting heart rate 104; Her arm hurt extremely badly; Body aches; Headache; Chills; Tired; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Fast heart rate, resting heart rate 104), PAIN IN EXTREMITY (Her arm hurt extremely badly), MYALGIA (Body aches), HEADACHE (Headache) and CHILLS (Chills) in a 24-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.     Concurrent medical conditions included Asthma. Concomitant products included Asthma medication for Asthma, Birth control for Birth control.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Her arm hurt extremely badly), MYALGIA (Body aches), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Tired). On 10-Feb-2021, the patient experienced TACHYCARDIA (Fast heart rate, resting heart rate 104). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Ache, at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (Fast heart rate, resting heart rate 104) had not resolved and PAIN IN EXTREMITY (Her arm hurt extremely badly), MYALGIA (Body aches), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Heart rate: 104 (High) 104.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tachycardia
Clinical narrative: Fast heart rate, resting heart rate 104; Her arm hurt extremely badly; Body aches; Headache; Chills; Tired; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Fast heart rate, resting heart rate 104), PAIN IN EXTREMITY (Her arm hurt extremely badly), MYALGIA (Body aches), HEADACHE (Headache) and CHILLS (Chills) in a 24-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.     Concurrent medical conditions included Asthma. Concomitant products included Asthma medication for Asthma, Birth control for Birth control.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Her arm hurt extremely badly), MYALGIA (Body aches), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Tired). On 10-Feb-2021, the patient experienced TACHYCARDIA (Fast heart rate, resting heart rate 104). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Ache, at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (Fast heart rate, resting heart rate 104) had not resolved and PAIN IN EXTREMITY (Her arm hurt extremely badly), MYALGIA (Body aches), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Heart rate: 104 (High) 104.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pain, Pain in extremity
Clinical narrative: shooting/excruciating pain in her left leg muscle.; can't walk; pain has been shooting/excruciating; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (shooting/excruciating pain in her left leg muscle.), GAIT DISTURBANCE (can't walk) and PAIN (pain has been shooting/excruciating) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (shooting/excruciating pain in her left leg muscle.), GAIT DISTURBANCE (can't walk) and PAIN (pain has been shooting/excruciating). The patient was treated with PARACETAMOL (TYLENOL) for Pain in leg, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (shooting/excruciating pain in her left leg muscle.), GAIT DISTURBANCE (can't walk) and PAIN (pain has been shooting/excruciating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Rash, Urticaria
Clinical narrative: Is inflamed; Large welt; Red; Angry looking left arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Is inflamed), URTICARIA (Large welt), ERYTHEMA (Red) and RASH (Angry looking left arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced INFLAMMATION (Is inflamed), URTICARIA (Large welt), ERYTHEMA (Red) and RASH (Angry looking left arm). At the time of the report, INFLAMMATION (Is inflamed), URTICARIA (Large welt), ERYTHEMA (Red) and RASH (Angry looking left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment was taken for symptoms..
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Started feeling joint pain; Muscle pain on hip, calf and thigh; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Started feeling joint pain) and MYALGIA (Muscle pain on hip, calf and thigh) in an 81-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 032L2DA and 022M2DA) for COVID-19 vaccination. No Medical History was provided by the reporter. Concomitant products included CELECOXIB (CELEBREX) and ACETAMINOPHEN for Pain.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced ARTHRALGIA (Started feeling joint pain) and MYALGIA (Muscle pain on hip, calf and thigh). At the time of the report, ARTHRALGIA (Started feeling joint pain) and MYALGIA (Muscle pain on hip, calf and thigh) had resolved. Not Provided      The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown.       No treatment information was provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up received on 23 APR 2021: Updated Event outcome and product indication. On 20-Jul-2021: Follow up received on 20 JUL 2021: Event outcome provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Diarrhoea, Flatulence
Clinical narrative: diarrhea; gas; Intestinal issues; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), FLATULENCE (gas) and ABDOMINAL PAIN LOWER (Intestinal issues) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced DIARRHOEA (diarrhea), FLATULENCE (gas) and ABDOMINAL PAIN LOWER (Intestinal issues). On 01-Mar-2021, DIARRHOEA (diarrhea), FLATULENCE (gas) and ABDOMINAL PAIN LOWER (Intestinal issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information include bismuth subsalicylate.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Pyrexia
Clinical narrative: fever; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue). On 05-Feb-2021, PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No relevant concomitant medications reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Erythema, Skin discolouration
Clinical narrative: Bright reddish pink circleon her arm; Few pimples; Blemishes; This spontaneous case was reported by a consumer and describes the occurrence of   in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), VALSARTAN, SIMVASTATIN and VITAMINS NOS for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient consulted an HCP and was advised that the symptoms will eventually resolve hence she was not prescribed to take any medication.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: rash at injection site; redness of the injection site; itchy injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at injection site), VACCINATION SITE ERYTHEMA (redness of the injection site) and VACCINATION SITE PRURITUS (itchy injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu vaccine since 06-Oct-2020. Past adverse reactions to the above products included Injection site reaction with flu vaccine.    On 17-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness of the injection site) and VACCINATION SITE PRURITUS (itchy injection site). On 01-Mar-2021, the patient experienced VACCINATION SITE RASH (rash at injection site). At the time of the report, VACCINATION SITE RASH (rash at injection site), VACCINATION SITE ERYTHEMA (redness of the injection site) and VACCINATION SITE PRURITUS (itchy injection site) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up received on 29-FEB-2021. Action taken updated and event outcome updated.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: A very sore arm - right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (A very sore arm - right arm) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (A very sore arm - right arm). At the time of the report, VACCINATION SITE PAIN (A very sore arm - right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Fatigue, Somnolence, Vaccination site pain
Clinical narrative: She slept all day, she hasn't eaten, no appetite; She slept all day, she hasn't eaten, no appetite; She started vomiting, vomited 2-3 times today; Very tired; The shot hurt; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (She slept all day, she hasn't eaten, no appetite), SOMNOLENCE (She slept all day, she hasn't eaten, no appetite), VOMITING (She started vomiting, vomited 2-3 times today), FATIGUE (Very tired) and VACCINATION SITE PAIN (The shot hurt) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 24M20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced DECREASED APPETITE (She slept all day, she hasn't eaten, no appetite), SOMNOLENCE (She slept all day, she hasn't eaten, no appetite), VOMITING (She started vomiting, vomited 2-3 times today), FATIGUE (Very tired) and VACCINATION SITE PAIN (The shot hurt). At the time of the report, DECREASED APPETITE (She slept all day, she hasn't eaten, no appetite), SOMNOLENCE (She slept all day, she hasn't eaten, no appetite), VOMITING (She started vomiting, vomited 2-3 times today), FATIGUE (Very tired) and VACCINATION SITE PAIN (The shot hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.4 (normal) 98.4F.         No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: She slept all day, she hasn't eaten, no appetite; She slept all day, she hasn't eaten, no appetite; She started vomiting, vomited 2-3 times today; Very tired; The shot hurt; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (She slept all day, she hasn't eaten, no appetite), SOMNOLENCE (She slept all day, she hasn't eaten, no appetite), VOMITING (She started vomiting, vomited 2-3 times today), FATIGUE (Very tired) and VACCINATION SITE PAIN (The shot hurt) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 24M20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced DECREASED APPETITE (She slept all day, she hasn't eaten, no appetite), SOMNOLENCE (She slept all day, she hasn't eaten, no appetite), VOMITING (She started vomiting, vomited 2-3 times today), FATIGUE (Very tired) and VACCINATION SITE PAIN (The shot hurt). At the time of the report, DECREASED APPETITE (She slept all day, she hasn't eaten, no appetite), SOMNOLENCE (She slept all day, she hasn't eaten, no appetite), VOMITING (She started vomiting, vomited 2-3 times today), FATIGUE (Very tired) and VACCINATION SITE PAIN (The shot hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.4 (normal) 98.4F.         No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Pyrexia
Clinical narrative: some side effects; has a temperature; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (some side effects) and PYREXIA (has a temperature) 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 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (some side effects) and PYREXIA (has a temperature). At the time of the report, ADVERSE DRUG REACTION (some side effects) and PYREXIA (has a temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. No concomitant and treatment medications were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Feeling abnormal, Hiatus hernia, Hypotension, Myalgia
Clinical narrative: Have this extreme weird sensation to my neck to the back of my mouth and up to my ear,; Hot to touch; Blood pressure lowered (100/60).; Mouth felt like cotton; Had difficulty swallowing; Left side of my body; Very big Hiatal Hernia; Muscle pain; Very red; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Have this extreme weird sensation to my neck to the back of my mouth and up to my ear,), VACCINATION SITE WARMTH (Hot to touch), HYPOTENSION (Blood pressure lowered (100/60).), FEELING ABNORMAL (Mouth felt like cotton) and DYSPHAGIA (Had difficulty swallowing) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hiatal hernia. Concomitant products included METOPROLOL, LISINOPRIL, HYDROCHLOROTHIAZIDE, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), COLECALCIFEROL (D3), UBIDECARENONE (COQ 10) and ASCORBIC ACID (VIT C) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced FEELING ABNORMAL (Have this extreme weird sensation to my neck to the back of my mouth and up to my ear,), VACCINATION SITE WARMTH (Hot to touch), HYPOTENSION (Blood pressure lowered (100/60).), FEELING ABNORMAL (Mouth felt like cotton), DYSPHAGIA (Had difficulty swallowing), PAIN (Left side of my body), HIATUS HERNIA (Very big Hiatal Hernia), MYALGIA (Muscle pain), VACCINATION SITE ERYTHEMA (Very red) and VACCINATION SITE SWELLING (Swollen). At the time of the report, FEELING ABNORMAL (Have this extreme weird sensation to my neck to the back of my mouth and up to my ear,), FEELING ABNORMAL (Mouth felt like cotton) and DYSPHAGIA (Had difficulty swallowing) had resolved and VACCINATION SITE WARMTH (Hot to touch), HYPOTENSION (Blood pressure lowered (100/60).), PAIN (Left side of my body), HIATUS HERNIA (Very big Hiatal Hernia), MYALGIA (Muscle pain), VACCINATION SITE ERYTHEMA (Very red) and VACCINATION SITE SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Have this extreme weird sensation to my neck to the back of my mouth and up to my ear,; Hot to touch; Blood pressure lowered (100/60).; Mouth felt like cotton; Had difficulty swallowing; Left side of my body; Very big Hiatal Hernia; Muscle pain; Very red; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Have this extreme weird sensation to my neck to the back of my mouth and up to my ear,), VACCINATION SITE WARMTH (Hot to touch), HYPOTENSION (Blood pressure lowered (100/60).), FEELING ABNORMAL (Mouth felt like cotton) and DYSPHAGIA (Had difficulty swallowing) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hiatal hernia. Concomitant products included METOPROLOL, LISINOPRIL, HYDROCHLOROTHIAZIDE, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), COLECALCIFEROL (D3), UBIDECARENONE (COQ 10) and ASCORBIC ACID (VIT C) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced FEELING ABNORMAL (Have this extreme weird sensation to my neck to the back of my mouth and up to my ear,), VACCINATION SITE WARMTH (Hot to touch), HYPOTENSION (Blood pressure lowered (100/60).), FEELING ABNORMAL (Mouth felt like cotton), DYSPHAGIA (Had difficulty swallowing), PAIN (Left side of my body), HIATUS HERNIA (Very big Hiatal Hernia), MYALGIA (Muscle pain), VACCINATION SITE ERYTHEMA (Very red) and VACCINATION SITE SWELLING (Swollen). At the time of the report, FEELING ABNORMAL (Have this extreme weird sensation to my neck to the back of my mouth and up to my ear,), FEELING ABNORMAL (Mouth felt like cotton) and DYSPHAGIA (Had difficulty swallowing) had resolved and VACCINATION SITE WARMTH (Hot to touch), HYPOTENSION (Blood pressure lowered (100/60).), PAIN (Left side of my body), HIATUS HERNIA (Very big Hiatal Hernia), MYALGIA (Muscle pain), VACCINATION SITE ERYTHEMA (Very red) and VACCINATION SITE SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Pain at injection site; fever; achiness; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site), PYREXIA (fever ), MYALGIA (achiness), CHILLS (chills) and NAUSEA (nausea) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site), PYREXIA (fever ), MYALGIA (achiness), CHILLS (chills) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Pain at injection site), PYREXIA (fever ), MYALGIA (achiness), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.            Concomitant product use was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Breast feeding
Clinical narrative: breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of BREAST FEEDING (breastfeeding) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced BREAST FEEDING (breastfeeding). At the time of the report, BREAST FEEDING (breastfeeding) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not reported.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Wrong technique in device usage process
Clinical narrative: Pulled needle out too quickly; Vaccine ran down her arm; A spontaneous report was received from a consumer concerning a 38-year-old female consumer, who received Moderna's COVID-19 Vaccine (mRNA-1273) where needle was pulled out too quickly and vaccine ran down arm.  The patient's medical history was not provided. Relevant concomitant medications included seizure medications.  On 13-FEB-2021,The patient received the first of the two planned doses of mRNA-1273  (Batch# 011M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 13-FEB-2021, while receving vaccination, the needle was pulled out too quickly and vaccine ran down arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the event(s) the needle was pulled out too quickly and vaccine ran down arm were unknown.; 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: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Salivary hypersecretion
Clinical narrative: excessive saliva; This spontaneous case was reported by a consumer and describes the occurrence of SALIVARY HYPERSECRETION (excessive saliva) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced SALIVARY HYPERSECRETION (excessive saliva). At the time of the report, SALIVARY HYPERSECRETION (excessive saliva) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: Headache; Dizziness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache) and DIZZINESS (Dizziness) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) 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) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PYREXIA (Fever). On 01-Mar-2021, the patient experienced HEADACHE (Headache) and DIZZINESS (Dizziness). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) was resolving and HEADACHE (Headache) and DIZZINESS (Dizziness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal, Gait disturbance, Headache, Nausea
Clinical narrative: Isn't feeling good; Hard for him to walk straight; Coughing a little; Achy; Nauseous; Headache; Temperature of 101 degrees F; Little soreness to the touch at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Isn't feeling good), GAIT DISTURBANCE (Hard for him to walk straight), COUGH (Coughing a little), PAIN (Achy) and VACCINATION SITE PAIN (Little soreness to the touch at the injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (He had COVID for three weeks in December 2020.) in December 2020. Concomitant products included CUCURBITA PEPO OIL, SERENOA REPENS, ZINC GLUCONATE (SAW PALMETTO [CUCURBITA PEPO OIL;SERENOA REPENS;ZINC GLUCONATE]), ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMINS NOS and LISINOPRIL for an unknown indication.    On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (Little soreness to the touch at the injection site). On 11-Feb-2021, the patient experienced FEELING ABNORMAL (Isn't feeling good), GAIT DISTURBANCE (Hard for him to walk straight), COUGH (Coughing a little), PAIN (Achy), NAUSEA (Nauseous), HEADACHE (Headache) and PYREXIA (Temperature of 101 degrees F). At the time of the report, FEELING ABNORMAL (Isn't feeling good), GAIT DISTURBANCE (Hard for him to walk straight), COUGH (Coughing a little), PAIN (Achy), VACCINATION SITE PAIN (Little soreness to the touch at the injection site), NAUSEA (Nauseous), HEADACHE (Headache) and PYREXIA (Temperature of 101 degrees F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Pyrexia: 101 101 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided.    This case was linked to MOD21-027453 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: Isn't feeling good; Hard for him to walk straight; Coughing a little; Achy; Nauseous; Headache; Temperature of 101 degrees F; Little soreness to the touch at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Isn't feeling good), GAIT DISTURBANCE (Hard for him to walk straight), COUGH (Coughing a little), PAIN (Achy) and VACCINATION SITE PAIN (Little soreness to the touch at the injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (He had COVID for three weeks in December 2020.) in December 2020. Concomitant products included CUCURBITA PEPO OIL, SERENOA REPENS, ZINC GLUCONATE (SAW PALMETTO [CUCURBITA PEPO OIL;SERENOA REPENS;ZINC GLUCONATE]), ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMINS NOS and LISINOPRIL for an unknown indication.    On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (Little soreness to the touch at the injection site). On 11-Feb-2021, the patient experienced FEELING ABNORMAL (Isn't feeling good), GAIT DISTURBANCE (Hard for him to walk straight), COUGH (Coughing a little), PAIN (Achy), NAUSEA (Nauseous), HEADACHE (Headache) and PYREXIA (Temperature of 101 degrees F). At the time of the report, FEELING ABNORMAL (Isn't feeling good), GAIT DISTURBANCE (Hard for him to walk straight), COUGH (Coughing a little), PAIN (Achy), VACCINATION SITE PAIN (Little soreness to the touch at the injection site), NAUSEA (Nauseous), HEADACHE (Headache) and PYREXIA (Temperature of 101 degrees F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Pyrexia: 101 101 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided.    This case was linked to MOD21-027453 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Nausea, Pain in extremity
Clinical narrative: Strange feeling of weakness all of the sudden; A bit nausea; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ASTHENIA (Strange feeling of weakness all of the sudden) and NAUSEA (A bit nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant Medical history Reported.  Concomitant products included INSULIN and VITAMINS NOS for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 01-Mar-2021, the patient experienced ASTHENIA (Strange feeling of weakness all of the sudden) and NAUSEA (A bit nausea). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] on 27-Feb-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), ASTHENIA (Strange feeling of weakness all of the sudden) and NAUSEA (A bit nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: She could barely lift her arm when it was hurting; Arm hurting; Slept from 9pm to 11:30 am; Chills; Fever; Muscle ache/Body ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (She could barely lift her arm when it was hurting), PAIN IN EXTREMITY (Arm hurting), SOMNOLENCE (Slept from 9pm to 11:30 am), CHILLS (Chills) and PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (She could barely lift her arm when it was hurting), PAIN IN EXTREMITY (Arm hurting), SOMNOLENCE (Slept from 9pm to 11:30 am), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Muscle ache/Body ache) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (She could barely lift her arm when it was hurting), PAIN IN EXTREMITY (Arm hurting), SOMNOLENCE (Slept from 9pm to 11:30 am), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Muscle ache/Body ache) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site movement impairment
Clinical narrative: She could barely lift her arm when it was hurting; Arm hurting; Slept from 9pm to 11:30 am; Chills; Fever; Muscle ache/Body ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (She could barely lift her arm when it was hurting), PAIN IN EXTREMITY (Arm hurting), SOMNOLENCE (Slept from 9pm to 11:30 am), CHILLS (Chills) and PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (She could barely lift her arm when it was hurting), PAIN IN EXTREMITY (Arm hurting), SOMNOLENCE (Slept from 9pm to 11:30 am), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Muscle ache/Body ache) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (She could barely lift her arm when it was hurting), PAIN IN EXTREMITY (Arm hurting), SOMNOLENCE (Slept from 9pm to 11:30 am), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Muscle ache/Body ache) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Vomiting
Clinical narrative: Dizzy; Diarrhea; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), DIARRHOEA (Diarrhea) and VOMITING (Throwing up) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure fluctuation (high blood pressure). Concomitant products included LOSARTAN for an unknown indication.    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced DIZZINESS (Dizzy), DIARRHOEA (Diarrhea) and VOMITING (Throwing up). At the time of the report, DIZZINESS (Dizzy), DIARRHOEA (Diarrhea) and VOMITING (Throwing up) outcome was unknown.            No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Rash, Rash macular
Clinical narrative: Rash on chest area only, red dots; Rash on chest area only, red dots; Ongoing headache; Body aches/ body sore; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Rash on chest area only, red dots), RASH (Rash on chest area only, red dots), HEADACHE (Ongoing headache) and MYALGIA (Body aches/ body sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036AZ18) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced RASH MACULAR (Rash on chest area only, red dots), RASH (Rash on chest area only, red dots), HEADACHE (Ongoing headache) and MYALGIA (Body aches/ body sore). On 13-Mar-2021, MYALGIA (Body aches/ body sore) had resolved. At the time of the report, RASH MACULAR (Rash on chest area only, red dots), RASH (Rash on chest area only, red dots) and HEADACHE (Ongoing headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Vaccination site pain
Clinical narrative: back pain; Arm got really sore; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain) and VACCINATION SITE PAIN (Arm got really sore) in a 78-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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced BACK PAIN (back pain) and VACCINATION SITE PAIN (Arm got really sore). At the time of the report, BACK PAIN (back pain) outcome was unknown and VACCINATION SITE PAIN (Arm got really sore) had 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 treatment information was provided. No relevant concomitant medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: constant headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (constant headache) 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 HEADACHE (constant headache). At the time of the report, HEADACHE (constant headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Redness; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness) and PRURITUS (Itchiness) 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 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness) and PRURITUS (Itchiness). The patient was treated with CORTISONE ACETATE for Itching, at a dose of 1 dosage form. At the time of the report, ERYTHEMA (Redness) and PRURITUS (Itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the events included cortisone cream.   Reporter did not allow further contact
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Muscle spasms, Nasal congestion
Clinical narrative: Muscle spasm in lower extremity; Sore throat; Congestion in upper chest; Mild cough; Congestion in upper chest; Nausea; Bad headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle spasm in lower extremity), OROPHARYNGEAL PAIN (Sore throat), UPPER RESPIRATORY TRACT CONGESTION (Congestion in upper chest), COUGH (Mild cough) and NASAL CONGESTION (Congestion in upper chest) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 014MZ0) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Migraine.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced MUSCLE SPASMS (Muscle spasm in lower extremity), OROPHARYNGEAL PAIN (Sore throat), UPPER RESPIRATORY TRACT CONGESTION (Congestion in upper chest), COUGH (Mild cough), NASAL CONGESTION (Congestion in upper chest), NAUSEA (Nausea), HEADACHE (Bad headache) and CHILLS (Chills). At the time of the report, MUSCLE SPASMS (Muscle spasm in lower extremity), OROPHARYNGEAL PAIN (Sore throat), UPPER RESPIRATORY TRACT CONGESTION (Congestion in upper chest), COUGH (Mild cough), NASAL CONGESTION (Congestion in upper chest), NAUSEA (Nausea), HEADACHE (Bad headache) and CHILLS (Chills) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Upper respiratory tract congestion
Clinical narrative: Muscle spasm in lower extremity; Sore throat; Congestion in upper chest; Mild cough; Congestion in upper chest; Nausea; Bad headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle spasm in lower extremity), OROPHARYNGEAL PAIN (Sore throat), UPPER RESPIRATORY TRACT CONGESTION (Congestion in upper chest), COUGH (Mild cough) and NASAL CONGESTION (Congestion in upper chest) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 014MZ0) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Migraine.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced MUSCLE SPASMS (Muscle spasm in lower extremity), OROPHARYNGEAL PAIN (Sore throat), UPPER RESPIRATORY TRACT CONGESTION (Congestion in upper chest), COUGH (Mild cough), NASAL CONGESTION (Congestion in upper chest), NAUSEA (Nausea), HEADACHE (Bad headache) and CHILLS (Chills). At the time of the report, MUSCLE SPASMS (Muscle spasm in lower extremity), OROPHARYNGEAL PAIN (Sore throat), UPPER RESPIRATORY TRACT CONGESTION (Congestion in upper chest), COUGH (Mild cough), NASAL CONGESTION (Congestion in upper chest), NAUSEA (Nausea), HEADACHE (Bad headache) and CHILLS (Chills) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain
Clinical narrative: felt sick and achy after 3 weeks; achy; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick and achy after 3 weeks) and PAIN (achy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) 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 an unknown date, the patient experienced ILLNESS (felt sick and achy after 3 weeks) and PAIN (achy). At the time of the report, ILLNESS (felt sick and achy after 3 weeks) and PAIN (achy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not provided.