chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: had gotten sick; Positive COVID-19 test; Coughing; Temperature of 100 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (had gotten sick), SARS-COV-2 TEST POSITIVE (Positive COVID-19 test), COUGH (Coughing) and PYREXIA (Temperature of 100 degrees Fahrenheit) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced MALAISE (had gotten sick), SARS-COV-2 TEST POSITIVE (Positive COVID-19 test), COUGH (Coughing) and PYREXIA (Temperature of 100 degrees Fahrenheit). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (had gotten sick), SARS-COV-2 TEST POSITIVE (Positive COVID-19 test), COUGH (Coughing) and PYREXIA (Temperature of 100 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100 degree fahrenheit. On an unknown date, SARS-CoV-2 test: Positive and Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications also include Z-pack The patient was scheduled for his second dose of the vaccine on 23MAR2021-24MAR2021.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Hypoaesthesia, Pain in extremity
Clinical narrative: arm feels a bit numb-like; change in voice; cough; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), PAIN IN EXTREMITY (sore arm), HYPOAESTHESIA (arm feels a bit numb-like) and DYSPHONIA (change in voice) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced COUGH (cough) and PAIN IN EXTREMITY (sore arm). On 31-Mar-2021, the patient experienced HYPOAESTHESIA (arm feels a bit numb-like) and DYSPHONIA (change in voice). At the time of the report, COUGH (cough), PAIN IN EXTREMITY (sore arm), HYPOAESTHESIA (arm feels a bit numb-like) and DYSPHONIA (change in voice) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were  provided by Reporter. No Treatment Medications were  provided by Reporter.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Vaccination site warmth
Clinical narrative: Red arm; Warm arm; Little rash around IS; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red arm), VACCINATION SITE WARMTH (Warm arm) and RASH (Little rash around IS) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced ERYTHEMA (Red arm), VACCINATION SITE WARMTH (Warm arm) and RASH (Little rash around IS). At the time of the report, ERYTHEMA (Red arm), VACCINATION SITE WARMTH (Warm arm) and RASH (Little rash around IS) outcome was unknown. Not Provided          Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash macular, Swelling face
Clinical narrative: severe allergic reaction; blotchy rash on face; swelling face; This spontaneous case was reported by a nurse and describes the occurrence of HYPERSENSITIVITY (severe allergic reaction), RASH MACULAR (blotchy rash on face) and SWELLING FACE (swelling face) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (severe allergic reaction), RASH MACULAR (blotchy rash on face) and SWELLING FACE (swelling face). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (severe allergic reaction), RASH MACULAR (blotchy rash on face) and SWELLING FACE (swelling face) 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.   A week later the race and face swelling reoccurred by worse causing the patient to need prednisone the HCP also emphasizes the patient did not receive any dermatological fillers.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B211A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced DIZZINESS (lightheadedness). At the time of the report, DIZZINESS (lightheadedness) was resolving. Not Provided          No concomitant medications were reported.   No corrective treatment was provided.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic product effect decreased
Clinical narrative: Cortisone administered after one week of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC PRODUCT EFFECT DECREASED (Cortisone administered after one week of vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC PRODUCT EFFECT DECREASED (Cortisone administered after one week of vaccination). At the time of the report, THERAPEUTIC PRODUCT EFFECT DECREASED (Cortisone administered after one week of vaccination) had resolved.     Company comment: Causality for this event is not applicable; Sender's Comments: Causality for this event is not applicable
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Asthenia, Chest pain, Dizziness
Clinical narrative: dizziness; chest pain; weakness; Patient received a 1ml dose; This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received a 1ml dose), DIZZINESS (dizziness), CHEST PAIN (chest pain) and ASTHENIA (weakness) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 30-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (Patient received a 1ml dose). On 31-Mar-2021, the patient experienced DIZZINESS (dizziness), CHEST PAIN (chest pain) and ASTHENIA (weakness). At the time of the report, ACCIDENTAL OVERDOSE (Patient received a 1ml dose), DIZZINESS (dizziness), CHEST PAIN (chest pain) and ASTHENIA (weakness) 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Asthma, Diarrhoea, Dizziness, Head discomfort
Clinical narrative: major dizziness/felt light headed/felt like she might pass out; involuntarily shaking; she didn't think she could get out of bed to walk; a little itchy at injection site; rash at the injection site; injection site pain; full blown, intense headache; rash - redness at the injection site; was scared and cried; an electrical feeling that was spinning in her head really fast; heaviness over her head; diarrhea; minor asthma; throbbing; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN (throbbing), ASTHMA (minor asthma), DIZZINESS (major dizziness/felt light headed/felt like she might pass out) and TREMOR (involuntarily shaking) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included fluticasone/salmeterol                                         inhaler BID and ALBUTEROL [SALBUTAMOL] 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 (throbbing). On 28-Feb-2021, the patient experienced ASTHMA (minor asthma). On 01-Mar-2021, the patient experienced DIARRHOEA (diarrhea). On 02-Mar-2021, the patient experienced VERTIGO (an electrical feeling that was spinning in her head really fast), HEAD DISCOMFORT (heaviness over her head) and TENSION (was scared and cried). On an unknown date, the patient experienced DIZZINESS (major dizziness/felt light headed/felt like she might pass out), TREMOR (involuntarily shaking), ASTHENIA (she didn't think she could get out of bed to walk), VACCINATION SITE PRURITUS (a little itchy at injection site), VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE PAIN (injection site pain), HEADACHE (full blown, intense headache) and VACCINATION SITE ERYTHEMA (rash - redness at the injection site). The patient was treated with GUAIFENESIN (MUCINEX) at a dose of 600 mg and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), PAIN (throbbing), ASTHMA (minor asthma), VERTIGO (an electrical feeling that was spinning in her head really fast), HEAD DISCOMFORT (heaviness over her head) and TENSION (was scared and cried) outcome was unknown. Not Provided      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.   This case was linked to US-MODERNATX, INC.-MOD-2021-063929 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-063929:crosslinked with second dose
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Tension, Tremor, Vaccination site erythema
Clinical narrative: major dizziness/felt light headed/felt like she might pass out; involuntarily shaking; she didn't think she could get out of bed to walk; a little itchy at injection site; rash at the injection site; injection site pain; full blown, intense headache; rash - redness at the injection site; was scared and cried; an electrical feeling that was spinning in her head really fast; heaviness over her head; diarrhea; minor asthma; throbbing; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN (throbbing), ASTHMA (minor asthma), DIZZINESS (major dizziness/felt light headed/felt like she might pass out) and TREMOR (involuntarily shaking) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included fluticasone/salmeterol                                         inhaler BID and ALBUTEROL [SALBUTAMOL] 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 (throbbing). On 28-Feb-2021, the patient experienced ASTHMA (minor asthma). On 01-Mar-2021, the patient experienced DIARRHOEA (diarrhea). On 02-Mar-2021, the patient experienced VERTIGO (an electrical feeling that was spinning in her head really fast), HEAD DISCOMFORT (heaviness over her head) and TENSION (was scared and cried). On an unknown date, the patient experienced DIZZINESS (major dizziness/felt light headed/felt like she might pass out), TREMOR (involuntarily shaking), ASTHENIA (she didn't think she could get out of bed to walk), VACCINATION SITE PRURITUS (a little itchy at injection site), VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE PAIN (injection site pain), HEADACHE (full blown, intense headache) and VACCINATION SITE ERYTHEMA (rash - redness at the injection site). The patient was treated with GUAIFENESIN (MUCINEX) at a dose of 600 mg and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), PAIN (throbbing), ASTHMA (minor asthma), VERTIGO (an electrical feeling that was spinning in her head really fast), HEAD DISCOMFORT (heaviness over her head) and TENSION (was scared and cried) outcome was unknown. Not Provided      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.   This case was linked to US-MODERNATX, INC.-MOD-2021-063929 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-063929:crosslinked with second dose
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vertigo
Clinical narrative: major dizziness/felt light headed/felt like she might pass out; involuntarily shaking; she didn't think she could get out of bed to walk; a little itchy at injection site; rash at the injection site; injection site pain; full blown, intense headache; rash - redness at the injection site; was scared and cried; an electrical feeling that was spinning in her head really fast; heaviness over her head; diarrhea; minor asthma; throbbing; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN (throbbing), ASTHMA (minor asthma), DIZZINESS (major dizziness/felt light headed/felt like she might pass out) and TREMOR (involuntarily shaking) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included fluticasone/salmeterol                                         inhaler BID and ALBUTEROL [SALBUTAMOL] 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 (throbbing). On 28-Feb-2021, the patient experienced ASTHMA (minor asthma). On 01-Mar-2021, the patient experienced DIARRHOEA (diarrhea). On 02-Mar-2021, the patient experienced VERTIGO (an electrical feeling that was spinning in her head really fast), HEAD DISCOMFORT (heaviness over her head) and TENSION (was scared and cried). On an unknown date, the patient experienced DIZZINESS (major dizziness/felt light headed/felt like she might pass out), TREMOR (involuntarily shaking), ASTHENIA (she didn't think she could get out of bed to walk), VACCINATION SITE PRURITUS (a little itchy at injection site), VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE PAIN (injection site pain), HEADACHE (full blown, intense headache) and VACCINATION SITE ERYTHEMA (rash - redness at the injection site). The patient was treated with GUAIFENESIN (MUCINEX) at a dose of 600 mg and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), PAIN (throbbing), ASTHMA (minor asthma), VERTIGO (an electrical feeling that was spinning in her head really fast), HEAD DISCOMFORT (heaviness over her head) and TENSION (was scared and cried) outcome was unknown. Not Provided      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.   This case was linked to US-MODERNATX, INC.-MOD-2021-063929 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-063929:crosslinked with second dose
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug was not reported.   Treatment for the event was not reported.   This case was linked to MOD-2021-063893, MOD21-065883 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: arm spasm; This spontaneous case was reported by an other caregiver and describes the occurrence of MUSCLE SPASMS (arm spasm) in a 58-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 effect.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced MUSCLE SPASMS (arm spasm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (arm spasm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No other medication reported.     This case was linked to MOD-2021-063890 (E2B Linked Report).; Sender's Comments:  MOD-2021-063890:wife
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: low grade fever 99.6°F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever 99.6°F) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Fever. Concomitant products included SIMVASTATIN for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (low grade fever 99.6°F). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PYREXIA (low grade fever 99.6°F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Rash papular, Skin warm
Clinical narrative: red rash on back, stomach, arms and legs, and rash is slightly raised, concentrated of red; rash is warm to touch; Sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (red rash on back, stomach, arms and legs, and rash is slightly raised, concentrated of red), SKIN WARM (rash is warm to touch), PAIN IN EXTREMITY (Sore arm) and FATIGUE (fatigue) in a 52-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 Rash (reported she has noticed that when she has something going on with her immune system, she has had rashes in the past).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced RASH PAPULAR (red rash on back, stomach, arms and legs, and rash is slightly raised, concentrated of red), SKIN WARM (rash is warm to touch), PAIN IN EXTREMITY (Sore arm) and FATIGUE (fatigue). The patient was treated with FAMOTIDINE (PEPCID AC) for Adverse event, at an unspecified dose and frequency; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at an unspecified dose and frequency; QUERCETIN for Adverse event, at an unspecified dose and frequency and URTICA DIOICA ROOT (STINGING NETTLE ROOT) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PAPULAR (red rash on back, stomach, arms and legs, and rash is slightly raised, concentrated of red), SKIN WARM (rash is warm to touch), PAIN IN EXTREMITY (Sore arm) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events included Allegra, Pepcid, querstine, and stinging nettle (over the counter medicine). Concomitant medication was not reported.; Sender'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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: vaccine leaked out; This spontaneous case was reported by a health care professional and describes the occurrence of UNDERDOSE (vaccine leaked out) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced UNDERDOSE (vaccine leaked out). On 31-Mar-2021, UNDERDOSE (vaccine leaked out) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not applicable.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: body pain; headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body pain), HEADACHE (headache) and PYREXIA (Fever) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced MYALGIA (body pain), HEADACHE (headache) and PYREXIA (Fever). On 22-Mar-2021, MYALGIA (body pain) and PYREXIA (Fever) had resolved. At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medications were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neuralgia
Clinical narrative: Nerve pain; Body pain; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Nerve pain) and MYALGIA (Body pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     The patient's past medical history included Neuropathy, Fibromyalgia and Restless leg syndrome.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced NEURALGIA (Nerve pain) and MYALGIA (Body pain). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, NEURALGIA (Nerve pain) and MYALGIA (Body pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included blood pressure and Cholesterol medicines.     This case was linked to US-MODERNATX, INC.-MOD-2021-063949 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up received on 13 May 2021 and contains non-significant information. On 25-May-2021: Follow-up received on 25 May 2021 and contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-063949:Second Dose
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Rash erythematous, Vaccination site mass
Clinical narrative: red rash on her left arm; knot like bump at injection site; very sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash on her left arm), VACCINATION SITE MASS (knot like bump at injection site), PAIN IN EXTREMITY (very sore arm) and HEADACHE (headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concomitant products included INSULIN DEGLUDEC (TRESIBA), PANTOPRAZOLE, TIZANIDINE, TAPENTADOL HYDROCHLORIDE (NUCYNTA) and DULAGLUTIDE (TRULICITY) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red rash on her left arm), VACCINATION SITE MASS (knot like bump at injection site), PAIN IN EXTREMITY (very sore arm) and HEADACHE (headache). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (red rash on her left arm), VACCINATION SITE MASS (knot like bump at injection site), PAIN IN EXTREMITY (very sore arm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash macular
Clinical narrative: red blotches on the calf of the left leg, then closer to the knee,bigger one in her upper left arm, then on top of the right foot; Itching around the ankle; Very red spots on the leg, upper arm, upper foot, on top of the toe area; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (red blotches on the calf of the left leg, then closer to the knee,bigger one in her upper left arm, then on top of the right foot), PRURITUS (Itching around the ankle) and ERYTHEMA (Very red spots on the leg, upper arm, upper foot, on top of the toe area) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis. Concomitant products included DENOSUMAB (PROLIA) for Osteoporosis.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, 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 experienced RASH MACULAR (red blotches on the calf of the left leg, then closer to the knee,bigger one in her upper left arm, then on top of the right foot), PRURITUS (Itching around the ankle) and ERYTHEMA (Very red spots on the leg, upper arm, upper foot, on top of the toe area). The patient was treated with TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID)) (topical) for Itching, at a dose of 0.5 %. At the time of the report, RASH MACULAR (red blotches on the calf of the left leg, then closer to the knee,bigger one in her upper left arm, then on top of the right foot), PRURITUS (Itching around the ankle) and ERYTHEMA (Very red spots on the leg, upper arm, upper foot, on top of the toe area) outcome was unknown.            Action taken with mRNA-1273 in response to the events were not applicable.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus, Rash macular, Swelling, Vaccination site pain
Clinical narrative: Swelling; Arm hurted; Itching; Big red spot, firm, baseball size area; Warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurted), PRURITUS (Itching), RASH MACULAR (Big red spot, firm, baseball size area), FEELING HOT (Warm to the touch) and SWELLING (Swelling) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Grass allergy and Allergy to plants. Concomitant products included CELECOXIB, HYDROCHLOROTHIAZIDE, SIMVASTATIN, OMEPRAZOLE, MONTELUKAST and LEVOTHYROXINE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm hurted). 24-Mar-2021, the patient experienced PRURITUS (Itching), RASH MACULAR (Big red spot, firm, baseball size area) and FEELING HOT (Warm to the touch). On 31-Mar-2021, the patient experienced SWELLING (Swelling). At the time of the report, VACCINATION SITE PAIN (Arm hurted), PRURITUS (Itching), RASH MACULAR (Big red spot, firm, baseball size area), FEELING HOT (Warm to the touch) and SWELLING (Swelling) had resolved.            It was reported that the patient arm hurt initially for a couple of days but went away and actively experiencing symptoms that started 31-Mar-2021, of itching, big red spot, firm, baseball size area, and warm to the touch since. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information received on 13-May-2021 contains information regarding onset date and outcome of the events.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash macular, Vaccination site pain
Clinical narrative: Red Spot; Itchiness; Achiness; Soreness in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red Spot), PRURITUS (Itchiness), PAIN (Achiness) and VACCINATION SITE PAIN (Soreness in injection arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 022M20A) for COVID-19 vaccination.     Concomitant products included RIVAROXABAN (XARELTO), FLECAINIDE, LEVOTHYROXINE, OMEPRAZOLE, METOPROLOL and AMLODIPINE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (Achiness) and VACCINATION SITE PAIN (Soreness in injection arm). On 27-Mar-2021, the patient experienced RASH MACULAR (Red Spot) and PRURITUS (Itchiness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RASH MACULAR (Red Spot) had not resolved and PRURITUS (Itchiness), PAIN (Achiness) and VACCINATION SITE PAIN (Soreness in injection arm) outcome was unknown.            Action taken with mRNA-1273 in response to the events were not applicable.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Illness
Clinical narrative: headache; sweats; chills; being sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (being sick), HEADACHE (headache), HYPERHIDROSIS (sweats) and CHILLS (chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21N) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced ILLNESS (being sick). On 26-Mar-2021, the patient experienced HEADACHE (headache), HYPERHIDROSIS (sweats) and CHILLS (chills). At the time of the report, ILLNESS (being sick), HEADACHE (headache), HYPERHIDROSIS (sweats) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Hypokinesia, Nausea, Vaccination site pain
Clinical narrative: pregnancy; inability to lift after taking the first dose; extreme soreness; nausea; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnancy), HYPOKINESIA (inability to lift after taking the first dose), VACCINATION SITE PAIN (extreme soreness) and NAUSEA (nausea) in a 38-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 17-Oct-2020 and the estimated date of delivery was 24-Jul-2021. On 18-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy), HYPOKINESIA (inability to lift after taking the first dose), VACCINATION SITE PAIN (extreme soreness) and NAUSEA (nausea). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 18-Mar-2021, EXPOSURE DURING PREGNANCY (pregnancy) had resolved. At the time of the report, HYPOKINESIA (inability to lift after taking the first dose), VACCINATION SITE PAIN (extreme soreness) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Flatulence
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA and FLATULENCE in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 DIARRHOEA and FLATULENCE. At the time of the report, DIARRHOEA and FLATULENCE outcome was unknown. Not Provided.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Night sweats, Pyrexia, Tremor
Clinical narrative: appeared some trembling in the body, sometimes on a hand, some other times in the whole bodypatient said she does not know if the trembling are like chills or due to the weakness in her wholebody she is experiencing; Weakness in  her whole body; sweated that night; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (appeared some trembling in the body, sometimes on a hand, some other times in the whole bodypatient said she does not know if the trembling are like chills or due to the weakness in her wholebody she is experiencing), ASTHENIA (Weakness in  her whole body), NIGHT SWEATS (sweated that night), PYREXIA (Fever) and CHILLS (Chills) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced TREMOR (appeared some trembling in the body, sometimes on a hand, some other times in the whole bodypatient said she does not know if the trembling are like chills or due to the weakness in her wholebody she is experiencing), ASTHENIA (Weakness in  her whole body), NIGHT SWEATS (sweated that night), PYREXIA (Fever) and CHILLS (Chills). On 21-Mar-2021, NIGHT SWEATS (sweated that night) and PYREXIA (Fever) had resolved. At the time of the report, TREMOR (appeared some trembling in the body, sometimes on a hand, some other times in the whole bodypatient said she does not know if the trembling are like chills or due to the weakness in her wholebody she is experiencing), ASTHENIA (Weakness in  her whole body) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment drug included TYLENOL from 21-MAR-2021 to 22-MAR-2021   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: The patient denied any further follow ups.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Feeling abnormal, Herpes zoster
Clinical narrative: I went to urgent care yesterday, and it is diagnosed as Shingles; She felt terrible/feel really bad; later my back started to broke out; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (She felt terrible/feel really bad), BACK PAIN (later my back started to broke out) and HERPES ZOSTER (I went to urgent care yesterday, and it is diagnosed as Shingles) 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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced FEELING ABNORMAL (She felt terrible/feel really bad) and BACK PAIN (later my back started to broke out). On 30-Mar-2021, the patient experienced HERPES ZOSTER (I went to urgent care yesterday, and it is diagnosed as Shingles). At the time of the report, FEELING ABNORMAL (She felt terrible/feel really bad), BACK PAIN (later my back started to broke out) and HERPES ZOSTER (I went to urgent care yesterday, and it is diagnosed as Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. Treatment information was not provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Heart rate increased, Nausea
Clinical narrative: Almost fainted; Dizziness; Weakness; Difficulty breathing; Increased heart rate; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Almost fainted), DIZZINESS (Dizziness), ASTHENIA (Weakness), DYSPNOEA (Difficulty breathing) and HEART RATE INCREASED (Increased heart rate) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PRESYNCOPE (Almost fainted), DIZZINESS (Dizziness), ASTHENIA (Weakness), DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Increased heart rate) and NAUSEA (Nauseous). At the time of the report, PRESYNCOPE (Almost fainted), DIZZINESS (Dizziness), ASTHENIA (Weakness), DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Increased heart rate) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  Treatment included Tylenol.  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.; Sender'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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: Almost fainted; Dizziness; Weakness; Difficulty breathing; Increased heart rate; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Almost fainted), DIZZINESS (Dizziness), ASTHENIA (Weakness), DYSPNOEA (Difficulty breathing) and HEART RATE INCREASED (Increased heart rate) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PRESYNCOPE (Almost fainted), DIZZINESS (Dizziness), ASTHENIA (Weakness), DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Increased heart rate) and NAUSEA (Nauseous). At the time of the report, PRESYNCOPE (Almost fainted), DIZZINESS (Dizziness), ASTHENIA (Weakness), DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Increased heart rate) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  Treatment included Tylenol.  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.; Sender'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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site reaction, Lip dry, Lip pain, Oral discomfort
Clinical narrative: pain moves to the underside of her arm; vaccination arm started to hurt near the injection site; normal reaction; achy legs; her lips started feeling like sand paper, they were super dry; lips burning a little bit; little tiny sore on lip; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (achy legs), LIP DRY (her lips started feeling like sand paper, they were super dry), ORAL DISCOMFORT (lips burning a little bit), LIP PAIN (little tiny sore on lip) and PAIN IN EXTREMITY (pain moves to the underside of her arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL for Blood pressure management, ATORVASTATIN and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (achy legs) and INJECTION SITE REACTION (normal reaction). On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain moves to the underside of her arm) and INJECTION SITE PAIN (vaccination arm started to hurt near the injection site). On an unknown date, the patient experienced LIP DRY (her lips started feeling like sand paper, they were super dry), ORAL DISCOMFORT (lips burning a little bit) and LIP PAIN (little tiny sore on lip). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (achy legs), PAIN IN EXTREMITY (pain moves to the underside of her arm), INJECTION SITE REACTION (normal reaction) and INJECTION SITE PAIN (vaccination arm started to hurt near the injection site) outcome was unknown and LIP DRY (her lips started feeling like sand paper, they were super dry), ORAL DISCOMFORT (lips burning a little bit) and LIP PAIN (little tiny sore on lip) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included fish oil,multivitamins,and atorvastatin for cholesterol.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain moves to the underside of her arm; vaccination arm started to hurt near the injection site; normal reaction; achy legs; her lips started feeling like sand paper, they were super dry; lips burning a little bit; little tiny sore on lip; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (achy legs), LIP DRY (her lips started feeling like sand paper, they were super dry), ORAL DISCOMFORT (lips burning a little bit), LIP PAIN (little tiny sore on lip) and PAIN IN EXTREMITY (pain moves to the underside of her arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL for Blood pressure management, ATORVASTATIN and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (achy legs) and INJECTION SITE REACTION (normal reaction). On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain moves to the underside of her arm) and INJECTION SITE PAIN (vaccination arm started to hurt near the injection site). On an unknown date, the patient experienced LIP DRY (her lips started feeling like sand paper, they were super dry), ORAL DISCOMFORT (lips burning a little bit) and LIP PAIN (little tiny sore on lip). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (achy legs), PAIN IN EXTREMITY (pain moves to the underside of her arm), INJECTION SITE REACTION (normal reaction) and INJECTION SITE PAIN (vaccination arm started to hurt near the injection site) outcome was unknown and LIP DRY (her lips started feeling like sand paper, they were super dry), ORAL DISCOMFORT (lips burning a little bit) and LIP PAIN (little tiny sore on lip) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included fish oil,multivitamins,and atorvastatin for cholesterol.