chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pharyngeal erythema, Vaccination site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: rash appeared at the injection site, rash was oblong (5" long and 3" wide) in shape; injection site became warm, red, and caky/warm to touch; injection site became warm, red, and caky; injection site became warm, red, and caky; bad firey red sore throat/very odd sore throat; bad firey red sore throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (bad firey red sore throat/very odd sore throat), PHARYNGEAL ERYTHEMA (bad firey red sore throat), VACCINATION SITE WARMTH (injection site became warm, red, and caky), VACCINATION SITE ERYTHEMA (injection site became warm, red, and caky) and VACCINATION SITE SWELLING (injection site became warm, red, and caky) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Bactrim.). Concomitant products included MONTELUKAST for Allergy, ROSUVASTATIN for Cholesterol, VITAMIN D NOS for Osteoporosis.    On 25-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (bad firey red sore throat/very odd sore throat) and PHARYNGEAL ERYTHEMA (bad firey red sore throat). On 08-Mar-2021, the patient experienced VACCINATION SITE WARMTH (injection site became warm, red, and caky), VACCINATION SITE ERYTHEMA (injection site became warm, red, and caky) and VACCINATION SITE SWELLING (injection site became warm, red, and caky). On an unknown date, the patient experienced VACCINATION SITE RASH (rash appeared at the injection site, rash was oblong (5" long and 3" wide) in shape). On 07-Mar-2021, OROPHARYNGEAL PAIN (bad firey red sore throat/very odd sore throat) and PHARYNGEAL ERYTHEMA (bad firey red sore throat) had resolved. At the time of the report, VACCINATION SITE WARMTH (injection site became warm, red, and caky), VACCINATION SITE ERYTHEMA (injection site became warm, red, and caky), VACCINATION SITE SWELLING (injection site became warm, red, and caky) and VACCINATION SITE RASH (rash appeared at the injection site, rash was oblong (5" long and 3" wide) in shape) had resolved.            Treatment details included antibiotics was prescribed but didn't took those medications. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI On 23-Jun-2021: Added patient demographics, added medical history, added concomitant medication
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: rash appeared at the injection site, rash was oblong (5" long and 3" wide) in shape; injection site became warm, red, and caky/warm to touch; injection site became warm, red, and caky; injection site became warm, red, and caky; bad firey red sore throat/very odd sore throat; bad firey red sore throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (bad firey red sore throat/very odd sore throat), PHARYNGEAL ERYTHEMA (bad firey red sore throat), VACCINATION SITE WARMTH (injection site became warm, red, and caky), VACCINATION SITE ERYTHEMA (injection site became warm, red, and caky) and VACCINATION SITE SWELLING (injection site became warm, red, and caky) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Bactrim.). Concomitant products included MONTELUKAST for Allergy, ROSUVASTATIN for Cholesterol, VITAMIN D NOS for Osteoporosis.    On 25-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (bad firey red sore throat/very odd sore throat) and PHARYNGEAL ERYTHEMA (bad firey red sore throat). On 08-Mar-2021, the patient experienced VACCINATION SITE WARMTH (injection site became warm, red, and caky), VACCINATION SITE ERYTHEMA (injection site became warm, red, and caky) and VACCINATION SITE SWELLING (injection site became warm, red, and caky). On an unknown date, the patient experienced VACCINATION SITE RASH (rash appeared at the injection site, rash was oblong (5" long and 3" wide) in shape). On 07-Mar-2021, OROPHARYNGEAL PAIN (bad firey red sore throat/very odd sore throat) and PHARYNGEAL ERYTHEMA (bad firey red sore throat) had resolved. At the time of the report, VACCINATION SITE WARMTH (injection site became warm, red, and caky), VACCINATION SITE ERYTHEMA (injection site became warm, red, and caky), VACCINATION SITE SWELLING (injection site became warm, red, and caky) and VACCINATION SITE RASH (rash appeared at the injection site, rash was oblong (5" long and 3" wide) in shape) had resolved.            Treatment details included antibiotics was prescribed but didn't took those medications. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI On 23-Jun-2021: Added patient demographics, added medical history, added concomitant medication
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Myalgia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of back pain (low-back pain), fatigue and myalgia (muscle pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 036A21A) for COVID-19 immunization. No medical history reported. On Mar 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 9, 2021, patient experienced back pain (low-back pain), fatigue and myalgia (muscle pain). At the time of the report, back pain (low-back pain), fatigue and myalgia (muscle pain): not resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site pain
Clinical narrative: started itching everywhere legs, arm, back.; a little red; her arm hurt a little; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (started itching everywhere legs, arm, back.), ERYTHEMA (a little red) and VACCINATION SITE PAIN (her arm hurt a little) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concomitant products included DICLOFENAC for an unknown indication.    On 28-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 VACCINATION SITE PAIN (her arm hurt a little). On an unknown date, the patient experienced PRURITUS (started itching everywhere legs, arm, back.) and ERYTHEMA (a little red). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PRURITUS (started itching everywhere legs, arm, back.), ERYTHEMA (a little red) and VACCINATION SITE PAIN (her arm hurt a little) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication include Tylenol.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea
Clinical narrative: weak; Breathing is labored; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak) and DYSPNOEA (Breathing is labored) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 09-Mar-2021, the patient experienced ASTHENIA (weak) and DYSPNOEA (Breathing is labored). At the time of the report, ASTHENIA (weak) and DYSPNOEA (Breathing is labored) outcome was unknown.            Treatment information was not provided. Concomitant medication was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Chills, Dizziness, Fatigue
Clinical narrative: increased heart rate; blood pressure increased; fatigue; headahe; muscle pain; vomiting; chills; nausea; Dizziness; weakness; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (increased heart rate), BLOOD PRESSURE INCREASED (blood pressure increased), FATIGUE (fatigue), HEADACHE (headahe) and MYALGIA (muscle pain) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 06-Mar-2021, the patient experienced HEART RATE INCREASED (increased heart rate), BLOOD PRESSURE INCREASED (blood pressure increased), FATIGUE (fatigue), HEADACHE (headahe), MYALGIA (muscle pain), VOMITING (vomiting), CHILLS (chills), NAUSEA (nausea), DIZZINESS (Dizziness) and ASTHENIA (weakness). At the time of the report, HEART RATE INCREASED (increased heart rate), BLOOD PRESSURE INCREASED (blood pressure increased), FATIGUE (fatigue), HEADACHE (headahe), MYALGIA (muscle pain), VOMITING (vomiting), CHILLS (chills), NAUSEA (nausea), DIZZINESS (Dizziness) and ASTHENIA (weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Pepto-Bismol   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Myalgia, Nausea, Vomiting
Clinical narrative: increased heart rate; blood pressure increased; fatigue; headahe; muscle pain; vomiting; chills; nausea; Dizziness; weakness; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (increased heart rate), BLOOD PRESSURE INCREASED (blood pressure increased), FATIGUE (fatigue), HEADACHE (headahe) and MYALGIA (muscle pain) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 06-Mar-2021, the patient experienced HEART RATE INCREASED (increased heart rate), BLOOD PRESSURE INCREASED (blood pressure increased), FATIGUE (fatigue), HEADACHE (headahe), MYALGIA (muscle pain), VOMITING (vomiting), CHILLS (chills), NAUSEA (nausea), DIZZINESS (Dizziness) and ASTHENIA (weakness). At the time of the report, HEART RATE INCREASED (increased heart rate), BLOOD PRESSURE INCREASED (blood pressure increased), FATIGUE (fatigue), HEADACHE (headahe), MYALGIA (muscle pain), VOMITING (vomiting), CHILLS (chills), NAUSEA (nausea), DIZZINESS (Dizziness) and ASTHENIA (weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Pepto-Bismol   Reporter did not allow further contact
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Myalgia, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: muscle pain on my right side, like an extreme muscle pain; fever; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (muscle pain on my right side, like an extreme muscle pain) and PYREXIA (fever) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    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 MYALGIA (muscle pain on my right side, like an extreme muscle pain) and PYREXIA (fever). At the time of the report, MYALGIA (muscle pain on my right side, like an extreme muscle pain) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment- Muscle relaxant
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: redness around the injection site; itchiness around the injection site; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (redness around the injection site) and INJECTION SITE PRURITUS (itchiness around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (redness around the injection site) and INJECTION SITE PRURITUS (itchiness around the injection site). At the time of the report, INJECTION SITE ERYTHEMA (redness around the injection site) and INJECTION SITE PRURITUS (itchiness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Below the site of injection was hot; Below the site of injection was puffy; Belowthe site of injection was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Below the site of injection was hot), VACCINATION SITE SWELLING (Below the site of injection was puffy) and VACCINATION SITE ERYTHEMA (Belowthe site of injection was red) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Below the site of injection was hot), VACCINATION SITE SWELLING (Below the site of injection was puffy) and VACCINATION SITE ERYTHEMA (Belowthe site of injection was red). At the time of the report, VACCINATION SITE WARMTH (Below the site of injection was hot), VACCINATION SITE SWELLING (Below the site of injection was puffy) and VACCINATION SITE ERYTHEMA (Belowthe site of injection was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment details was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: itching that keep you up at night and little soreness at the injection site; little soreness - left arm; rash on the arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching that keep you up at night and little soreness at the injection site), PAIN IN EXTREMITY (little soreness - left arm) and RASH (rash on the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching that keep you up at night and little soreness at the injection site), PAIN IN EXTREMITY (little soreness - left arm) and RASH (rash on the arm). At the time of the report, PRURITUS (itching that keep you up at night and little soreness at the injection site), PAIN IN EXTREMITY (little soreness - left arm) and RASH (rash on the arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided by the reporter. Treatment drugs include creams for an unknown indication. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: No specific follow-up information recorded.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Covid after first dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 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 COVID-19 (Covid after first dose). At the time of the report, COVID-19 (Covid after first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment information was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Gait inability
Clinical narrative: Severe lower back pain; I couldn't walk; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Severe lower back pain) and GAIT INABILITY (I couldn't walk) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) 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 06-Mar-2021, the patient experienced BACK PAIN (Severe lower back pain) and GAIT INABILITY (I couldn't walk). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, BACK PAIN (Severe lower back pain) and GAIT INABILITY (I couldn't walk) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Injection site rash (7inches by 5 inches) 4 days after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Injection site rash (7inches by 5 inches) 4 days after vaccination) 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 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE RASH (Injection site rash (7inches by 5 inches) 4 days after vaccination). At the time of the report, VACCINATION SITE RASH (Injection site rash (7inches by 5 inches) 4 days after vaccination) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Cough, Dyspnoea, Poor quality sleep, Wheezing
Clinical narrative: coughing; Issues breathing; Couldn't sleep; terrible wheezing; "had a bad reaction"; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), DYSPNOEA (Issues breathing), POOR QUALITY SLEEP (Couldn't sleep), WHEEZING (terrible wheezing) and ADVERSE REACTION ("had a bad reaction") in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (MSG and red dye #40 (carries epi pen)).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced COUGH (coughing), DYSPNOEA (Issues breathing), POOR QUALITY SLEEP (Couldn't sleep), WHEEZING (terrible wheezing) and ADVERSE REACTION ("had a bad reaction"). At the time of the report, COUGH (coughing), POOR QUALITY SLEEP (Couldn't sleep), WHEEZING (terrible wheezing) and ADVERSE REACTION ("had a bad reaction") outcome was unknown and DYSPNOEA (Issues breathing) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not provided. Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received on 23-06-2021 contains No significant information
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Got vaccine from  a already thawed vial.; A spontaneous report was received from a health care professional concerning a unspecified years old, male patient who experienced got vaccine from a already thawed vial/PT: wrong product administered.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   On an unknown date in 2021, the patient received their first/second (not specified) of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection.    The patient experienced got vaccine from a already thawed vial on an unknown date in 2021. The reported event was considered medication error.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of event  got vaccine from a already thawed vial was considered resolved.; Reporter's Comments: This report refers to a case of wrong product administered for mRNA-1273, with no associated AEs.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: itchiness; hard a circumference of a golf ball; Redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), INDURATION (hard a circumference of a golf ball) and ERYTHEMA (Redness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PRURITUS (itchiness), INDURATION (hard a circumference of a golf ball) and ERYTHEMA (Redness). At the time of the report, PRURITUS (itchiness), INDURATION (hard a circumference of a golf ball) and ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications include Benadryl cream for an unknown indication. No relevant concomitant medications were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extreme fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included TAMOXIFEN and clindamycin                                                    as needed for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (extreme fatigue). At the time of the report, FATIGUE (extreme fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Glossodynia, Malaise, Neck pain, Pyrexia
Clinical narrative: Covid positive; sore neck; sore tongue; feel sick; Some low fever also (99.5°F); This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid positive), NECK PAIN (sore neck), GLOSSODYNIA (sore tongue), MALAISE (feel sick) and PYREXIA (Some low fever also (99.5°F)) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 28-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) (unknown route) dosage was changed to 2 dosage form. On 01-Mar-2021, the patient experienced NECK PAIN (sore neck), GLOSSODYNIA (sore tongue), MALAISE (feel sick) and PYREXIA (Some low fever also (99.5°F)). On 04-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Covid positive). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid positive), NECK PAIN (sore neck), GLOSSODYNIA (sore tongue), MALAISE (feel sick) and PYREXIA (Some low fever also (99.5°F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, COVID-19: Positive.         No Concomitant medications were provided. No Treatment History was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Covid positive; sore neck; sore tongue; feel sick; Some low fever also (99.5°F); This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid positive), NECK PAIN (sore neck), GLOSSODYNIA (sore tongue), MALAISE (feel sick) and PYREXIA (Some low fever also (99.5°F)) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 28-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) (unknown route) dosage was changed to 2 dosage form. On 01-Mar-2021, the patient experienced NECK PAIN (sore neck), GLOSSODYNIA (sore tongue), MALAISE (feel sick) and PYREXIA (Some low fever also (99.5°F)). On 04-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Covid positive). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid positive), NECK PAIN (sore neck), GLOSSODYNIA (sore tongue), MALAISE (feel sick) and PYREXIA (Some low fever also (99.5°F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, COVID-19: Positive.         No Concomitant medications were provided. No Treatment History was provided.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: worse side effects after the second shot; 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 ADVERSE DRUG REACTION (worse side effects after the second shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (worse side effects after the second shot). At the time of the report, ADVERSE DRUG REACTION (worse side effects after the second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032G20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-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 PAIN IN EXTREMITY (pain in arm). At the time of the report, PAIN IN EXTREMITY (pain in arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Mar-2021 and was forwarded to Moderna on 09-Mar-2021.    A spontaneous report was received from a consumer concerning a female  patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm/pain in extremity.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) sore arm.  Treatment details included Aleve.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Rash, Rash pruritic
Clinical narrative: Fever; Headache; Rash is itchy; Rash is warm to the touch; Full body rash four days after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash is itchy), RASH (Rash is warm to the touch), RASH (Full body rash four days after the vaccine), PYREXIA (Fever) and HEADACHE (Headache) in a 40-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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced RASH PRURITIC (Rash is itchy), RASH (Rash is warm to the touch) and RASH (Full body rash four days after the vaccine). On an unknown date, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, RASH PRURITIC (Rash is itchy), RASH (Rash is warm to the touch), RASH (Full body rash four days after the vaccine), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Not received the second dose after 42 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Not received the second dose after 42 days) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 28-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Not received the second dose after 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Not received the second dose after 42 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This report refers to a case of Inappropriate schedule of vaccine administered for mRNA-1273, lot # unknnown  with no associated AEs.; Sender's Comments: This report refers to a case of Inappropriate schedule of vaccine administeredfor mRNA-1273, lot # unknnown  with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: chills; headache; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of CHILLS (chills) and HEADACHE (headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for an unknown indication.     The patient's past medical history included No adverse event.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced CHILLS (chills) 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, CHILLS (chills) and HEADACHE (headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Concomitant Medication was Provided.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: Stomach aches; Overwhelming fatigue; Fever(as high 101.8); Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach aches), FATIGUE (Overwhelming fatigue), PYREXIA (Fever(as high 101.8)), CHILLS (Chills) and NAUSEA (Nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 030A21A) for COVID-19 vaccination.     No medical history provided.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach aches), FATIGUE (Overwhelming fatigue), PYREXIA (Fever(as high 101.8)), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, ABDOMINAL PAIN UPPER (Stomach aches), FATIGUE (Overwhelming fatigue), PYREXIA (Fever(as high 101.8)), CHILLS (Chills) and NAUSEA (Nausea) had not resolved.            No treatment medications were provided by the reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Injection site bruising, Injection site erythema, Injection site pruritus, Type IV hypersensitivity reaction
Clinical narrative: Milder COVID Arm 2 days post Second Shot; Red Injection Site post second Shot; Itchy Injection Site post second Shot; Blood on the needle Post Second vaccine; Bruising on the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (Blood on the needle Post Second vaccine), INJECTION SITE BRUISING (Bruising on the Injection Site), TYPE IV HYPERSENSITIVITY REACTION (Milder COVID Arm 2 days post Second Shot), INJECTION SITE ERYTHEMA (Red Injection Site post second Shot) and INJECTION SITE PRURITUS (Itchy Injection Site post second Shot) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced DEVICE CONNECTION ISSUE (Blood on the needle Post Second vaccine) and INJECTION SITE BRUISING (Bruising on the Injection Site). On 07-Mar-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Milder COVID Arm 2 days post Second Shot), INJECTION SITE ERYTHEMA (Red Injection Site post second Shot) and INJECTION SITE PRURITUS (Itchy Injection Site post second Shot). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 05-Mar-2021, DEVICE CONNECTION ISSUE (Blood on the needle Post Second vaccine) had resolved. At the time of the report, INJECTION SITE BRUISING (Bruising on the Injection Site), TYPE IV HYPERSENSITIVITY REACTION (Milder COVID Arm 2 days post Second Shot), INJECTION SITE ERYTHEMA (Red Injection Site post second Shot) and INJECTION SITE PRURITUS (Itchy Injection Site post second Shot) outcome was unknown.            Concomitant medications was not reported. Action taken with the mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic, Vaccination site erythema
Clinical narrative: COVID arm (felt hot, prickly); Big red area to upper arm; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (COVID arm (felt hot, prickly)) and VACCINATION SITE ERYTHEMA (Big red area to upper arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011AZ1A and 062G20A) for COVID-19 vaccination.     No medical history was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced DERMATITIS ALLERGIC (COVID arm (felt hot, prickly)) and VACCINATION SITE ERYTHEMA (Big red area to upper arm). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Adverse event, at an unspecified dose and frequency; ASCORBIC ACID, HONEY, PROPOLIS, ZINGIBER OFFICINALE (GINGERONATUR) for Adverse event, at an unspecified dose and frequency and HYDROCORTISONE ACETATE, NEOMYCIN SULFATE (HYDROCORTISONE N) for Adverse event, at an unspecified dose and frequency. On 14-Feb-2021, DERMATITIS ALLERGIC (COVID arm (felt hot, prickly)) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Big red area to upper arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: INJECTION SITE ITCHING; injection site swelling; injection site rash; injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (INJECTION SITE ITCHING), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE RASH (injection site rash) and INJECTION SITE PAIN (injection site soreness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and Flexural for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced INJECTION SITE PRURITUS (INJECTION SITE ITCHING), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE RASH (injection site rash) and INJECTION SITE PAIN (injection site soreness). At the time of the report, INJECTION SITE PRURITUS (INJECTION SITE ITCHING), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE RASH (injection site rash) and INJECTION SITE PAIN (injection site soreness) 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.   No treatment information was provided   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: really bad pain on the arm of the injection for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (really bad pain on the arm of the injection for a couple of days) 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 25-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 PAIN IN EXTREMITY (really bad pain on the arm of the injection for a couple of days). At the time of the report, PAIN IN EXTREMITY (really bad pain on the arm of the injection for a couple of days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications were provided
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: redness; bumpy under the injection site; Rash on upper arm around the injection site (6 inches long).; Itchy around the injection site; Warm to the touch around the injection site; soreness in left arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in left arm), FATIGUE (Fatigue), INJECTION SITE RASH (Rash on upper arm around the injection site (6 inches long).), INJECTION SITE PRURITUS (Itchy around the injection site) and INJECTION SITE WARMTH (Warm to the touch around the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included Prilosec OTC for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in left arm) and FATIGUE (Fatigue). On 27-Feb-2021, the patient experienced INJECTION SITE RASH (Rash on upper arm around the injection site (6 inches long).), INJECTION SITE PRURITUS (Itchy around the injection site) and INJECTION SITE WARMTH (Warm to the touch around the injection site). On 09-Mar-2021, the patient experienced INJECTION SITE SWELLING (bumpy under the injection site). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness). At the time of the report, PAIN IN EXTREMITY (soreness in left arm), FATIGUE (Fatigue), INJECTION SITE RASH (Rash on upper arm around the injection site (6 inches long).), INJECTION SITE PRURITUS (Itchy around the injection site), INJECTION SITE WARMTH (Warm to the touch around the injection site), INJECTION SITE SWELLING (bumpy under the injection site) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Eucerin cream..    Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema
Clinical narrative: redness; bumpy under the injection site; Rash on upper arm around the injection site (6 inches long).; Itchy around the injection site; Warm to the touch around the injection site; soreness in left arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in left arm), FATIGUE (Fatigue), INJECTION SITE RASH (Rash on upper arm around the injection site (6 inches long).), INJECTION SITE PRURITUS (Itchy around the injection site) and INJECTION SITE WARMTH (Warm to the touch around the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included Prilosec OTC for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in left arm) and FATIGUE (Fatigue). On 27-Feb-2021, the patient experienced INJECTION SITE RASH (Rash on upper arm around the injection site (6 inches long).), INJECTION SITE PRURITUS (Itchy around the injection site) and INJECTION SITE WARMTH (Warm to the touch around the injection site). On 09-Mar-2021, the patient experienced INJECTION SITE SWELLING (bumpy under the injection site). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness). At the time of the report, PAIN IN EXTREMITY (soreness in left arm), FATIGUE (Fatigue), INJECTION SITE RASH (Rash on upper arm around the injection site (6 inches long).), INJECTION SITE PRURITUS (Itchy around the injection site), INJECTION SITE WARMTH (Warm to the touch around the injection site), INJECTION SITE SWELLING (bumpy under the injection site) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Eucerin cream..    Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Back pain
Clinical narrative: I am feeling anxiety; back pain-my back is not good; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (I am feeling anxiety) and BACK PAIN (back pain-my back is not good) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 042L20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included METFORMIN for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced ANXIETY (I am feeling anxiety) and BACK PAIN (back pain-my back is not good). At the time of the report, ANXIETY (I am feeling anxiety) and BACK PAIN (back pain-my back is not good) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-021344 (Patient Link).   Reporter did not allow further contact