chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Welt at injection site), RASH (Developed rash on her entire body) and VACCINATION SITE ERYTHEMA (Redness at the site of injection where she developed the welt) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. No relevant concomitant medications reported. No relevant medical history was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE URTICARIA (Welt at injection site), RASH (Developed rash on her entire body) and VACCINATION SITE ERYTHEMA (Redness at the site of injection where she developed the welt). At the time of the report, VACCINATION SITE URTICARIA (Welt at injection site), RASH (Developed rash on her entire body) and VACCINATION SITE ERYTHEMA (Redness at the site of injection where she developed the welt) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details included Prednisolone.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain in extremity
Clinical narrative: Arm was sore; Chills; Aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), CHILLS (Chills) and MYALGIA (Aches) in a 77-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 20-Feb-2021 at 3:30 PM, 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 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore), CHILLS (Chills) and MYALGIA (Aches). On 21-Feb-2021, PAIN IN EXTREMITY (Arm was sore), CHILLS (Chills) and MYALGIA (Aches) had resolved.            No concomitant medications reported.  No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No new information was added.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity, Rash, Vaccination site erythema
Clinical narrative: COVID ARM"; Bruising; Redness; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (COVID ARM"), CONTUSION (Bruising), VACCINATION SITE ERYTHEMA (Redness) and RASH (Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 PAIN IN EXTREMITY (COVID ARM"), CONTUSION (Bruising), VACCINATION SITE ERYTHEMA (Redness) and RASH (Rash). At the time of the report, PAIN IN EXTREMITY (COVID ARM"), CONTUSION (Bruising), VACCINATION SITE ERYTHEMA (Redness) and RASH (Rash) outcome was unknown.            Concomitant information use was not reported.  Treatment information was not provided.   Reporter did not allow further contact
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Rash macular
Clinical narrative: red spot below the injection site; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red spot below the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-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 an unknown date, the patient experienced RASH MACULAR (red spot below the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site). At the time of the report, RASH MACULAR (red spot below the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site) outcome was unknown.            No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: no new information updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Spiked 103 fever), NAUSEA (Nausea), ASTHENIA (weakness) and HYPERHIDROSIS (sweaty all night) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.  The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE, LIRAGLUTIDE (VICTOZA), CANAGLIFLOZIN HEMIHYDRATE, METFORMIN HYDROCHLORIDE (INVOKANA DUO), SIMVASTATIN, OMEPRAZOLE, SERTRALINE, HYDROCHLOROTHIAZIDE, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and MULTIVITAMINS & MINERALS PLUS LUTEIN 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-Feb-2021, the patient experienced PYREXIA (Spiked 103 fever), NAUSEA (Nausea) and HYPERHIDROSIS (sweaty all night). On 26-Feb-2021, the patient experienced ASTHENIA (weakness). The patient was treated with NAPROXEN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PYREXIA (Spiked 103 fever), NAUSEA (Nausea), ASTHENIA (weakness) and HYPERHIDROSIS (sweaty all night) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Pain in extremity
Clinical narrative: sore left arm; "weird feeling" in his stomach; "core down to his chest from stomach felt weak"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm), ABDOMINAL DISCOMFORT ("weird feeling" in his stomach) and ASTHENIA ("core down to his chest from stomach felt weak") in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PREDNISONE, IBRUTINIB, AMOXICILLIN, ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore left arm), ABDOMINAL DISCOMFORT ("weird feeling" in his stomach) and ASTHENIA ("core down to his chest from stomach felt weak"). On 25-Feb-2021, ABDOMINAL DISCOMFORT ("weird feeling" in his stomach) and ASTHENIA ("core down to his chest from stomach felt weak") had resolved. At the time of the report, PAIN IN EXTREMITY (sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Possible side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Possible side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 ADVERSE EVENT (Possible side effects). At the time of the report, ADVERSE EVENT (Possible side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Rash, Rash pruritic
Clinical narrative: Itchy rash; Delayed Rash all over body; Headache; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash), RASH (Delayed Rash all over body), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 011A21A) for COVID-19 vaccination.     No relevant concomitant medications reported. No relevant 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 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). On 01-Mar-2021, the patient experienced RASH PRURITIC (Itchy rash) and RASH (Delayed Rash all over body). At the time of the report, RASH PRURITIC (Itchy rash), RASH (Delayed Rash all over body), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Treatment Medications were not provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE PAIN (Injection site is tender) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE PAIN (Injection site is tender). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site is red) had not resolved and VACCINATION SITE PAIN (Injection site is tender) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient stated she had redness whenever administered with vaccine. Concomitant product use of  blood thinner was reported. No treatment medications provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up received contain no new information.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Vaccination site pain
Clinical narrative: Sore throat; Experienced arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and VACCINATION SITE PAIN (Experienced arm soreness) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Seasonal allergy, Cholesterol blood excessive and Acid reflux (oesophageal). Concomitant products included FAMOTIDINE for Acid reflux (oesophageal), FLUTICASONE and LORATADINE (CLARITIN [LORATADINE]) for Allergy, SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for Asthma, SIMVASTATIN for Hypercholesteremia.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and VACCINATION SITE PAIN (Experienced arm soreness). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and VACCINATION SITE PAIN (Experienced arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives in both arms 10 days after receiving the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (Hives in both arms 10 days after receiving the first dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-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 URTICARIA (Hives in both arms 10 days after receiving the first dose). At the time of the report, URTICARIA (Hives in both arms 10 days after receiving the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported  No treatment was specified
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 37-year-old female patient (gravida 6, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 046A21A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage, Nicotine dependence (social smoking,5-10 cigarettes a month) from 1996 to 2014 and Marijuana use (Tried it a few times as a teen) in 1996. Family history included Trisomy 13 (Patients child has trisomy 13.) since an unknown date and XXX syndrome (Patient's sister has a child with "Trisomy X".) since an unknown date. Concurrent medical conditions included Herpes NOS and Alcohol use (1-3 drinks/day - 3-4 times week) in 2004. Concomitant products included ACYCLOVIR [ACICLOVIR] from 01-Jan-2016 to an unknown date for Herpes NOS, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), INDUSTRIAL METHYLATED SPIRIT (METHYLATED), CALCIUM and MAGNESIUM for an unknown indication.   On 25-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) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 27-Aug-2021. On 25-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 25-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2020, Pregnancy test: Positive.         Treatment information not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Second dose information, estimated due date and other pregnancy details are added.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever - Temperature of 100.0F) and PAIN IN EXTREMITY (Arm Pain) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PYREXIA (Fever - Temperature of 100.0F) and PAIN IN EXTREMITY (Arm Pain). At the time of the report, PYREXIA (Fever - Temperature of 100.0F) and PAIN IN EXTREMITY (Arm Pain) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: arm is extremely sore; arm is red; arm is hot; has been feeling nauseated; feel a knot under the skin; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is extremely sore), VACCINATION SITE ERYTHEMA (arm is red), VACCINATION SITE WARMTH (arm is hot), NAUSEA (has been feeling nauseated) and VACCINATION SITE INDURATION (feel a knot under the skin) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm is extremely sore), VACCINATION SITE ERYTHEMA (arm is red), VACCINATION SITE WARMTH (arm is hot), NAUSEA (has been feeling nauseated) and VACCINATION SITE INDURATION (feel a knot under the skin). At the time of the report, PAIN IN EXTREMITY (arm is extremely sore), VACCINATION SITE ERYTHEMA (arm is red), VACCINATION SITE WARMTH (arm is hot), NAUSEA (has been feeling nauseated) and VACCINATION SITE INDURATION (feel a knot under the skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Gastrooesophageal reflux disease, Headache, Lethargy, Myalgia
Clinical narrative: developed a fever; left arm pain became worse; whole body ached; felt like she had acid reflux; couldn't finish eating; headache; sore left arm; lethargy; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore left arm), LETHARGY (lethargy), HEADACHE (headache), PYREXIA (developed a fever) and PAIN IN EXTREMITY (left arm pain became worse) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma, Sinusitis, Headache, Hormone replacement therapy and Dry eyes. Concomitant products included PROGESTERONE (PROGESTERONE ABBOTT) for Hormone replacement therapy, FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA-D 12 HOUR), MONTELUKAST SODIUM (SINGULAIR), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), AZELASTINE HYDROCHLORIDE (AZELASTINE [AZELASTINE HYDROCHLORIDE]) and CICLOSPORIN (RESTASIS) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced MYALGIA (sore left arm) and LETHARGY (lethargy). On 24-Feb-2021, the patient experienced HEADACHE (headache). On 25-Feb-2021, the patient experienced PYREXIA (developed a fever), PAIN IN EXTREMITY (left arm pain became worse), PAIN (whole body ached), GASTROOESOPHAGEAL REFLUX DISEASE (felt like she had acid reflux) and DECREASED APPETITE (couldn't finish eating). At the time of the report, MYALGIA (sore left arm), LETHARGY (lethargy), HEADACHE (headache), PYREXIA (developed a fever), PAIN IN EXTREMITY (left arm pain became worse), PAIN (whole body ached), GASTROOESOPHAGEAL REFLUX DISEASE (felt like she had acid reflux) and DECREASED APPETITE (couldn't finish eating) outcome was unknown. Not Provided          This case was linked to MOD21-039087 (E2B Linked Report).; Sender's Comments:  MOD21-039087: US-MODERNATX, INC.-MOD-2021-026947:1st dose
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: developed a fever; left arm pain became worse; whole body ached; felt like she had acid reflux; couldn't finish eating; headache; sore left arm; lethargy; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore left arm), LETHARGY (lethargy), HEADACHE (headache), PYREXIA (developed a fever) and PAIN IN EXTREMITY (left arm pain became worse) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma, Sinusitis, Headache, Hormone replacement therapy and Dry eyes. Concomitant products included PROGESTERONE (PROGESTERONE ABBOTT) for Hormone replacement therapy, FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA-D 12 HOUR), MONTELUKAST SODIUM (SINGULAIR), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), AZELASTINE HYDROCHLORIDE (AZELASTINE [AZELASTINE HYDROCHLORIDE]) and CICLOSPORIN (RESTASIS) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced MYALGIA (sore left arm) and LETHARGY (lethargy). On 24-Feb-2021, the patient experienced HEADACHE (headache). On 25-Feb-2021, the patient experienced PYREXIA (developed a fever), PAIN IN EXTREMITY (left arm pain became worse), PAIN (whole body ached), GASTROOESOPHAGEAL REFLUX DISEASE (felt like she had acid reflux) and DECREASED APPETITE (couldn't finish eating). At the time of the report, MYALGIA (sore left arm), LETHARGY (lethargy), HEADACHE (headache), PYREXIA (developed a fever), PAIN IN EXTREMITY (left arm pain became worse), PAIN (whole body ached), GASTROOESOPHAGEAL REFLUX DISEASE (felt like she had acid reflux) and DECREASED APPETITE (couldn't finish eating) outcome was unknown. Not Provided          This case was linked to MOD21-039087 (E2B Linked Report).; Sender's Comments:  MOD21-039087: US-MODERNATX, INC.-MOD-2021-026947:1st dose
Sex: U
Vaccine: COVID19
Symptoms: Acne, Tachycardia
Clinical narrative: Face Acne; Rapid heart rate; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (Face Acne) and TACHYCARDIA (Rapid heart rate) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACNE (Face Acne) and TACHYCARDIA (Rapid heart rate). At the time of the report, ACNE (Face Acne) and TACHYCARDIA (Rapid heart rate) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were provided By the reporter. No Treatment History was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received  contains non-significant information
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Chills, Headache
Clinical narrative: Loss of taste; Loss of smell; Chills; Headaches; Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), CHILLS (Chills) and HEADACHE (Headaches) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), CHILLS (Chills) and HEADACHE (Headaches). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown and AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), CHILLS (Chills) and HEADACHE (Headaches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, SARS-CoV-2 test: positive (Positive) Tested positive for the virus with a mild case.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.   Reporter did not allow further contact
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Loss of taste; Loss of smell; Chills; Headaches; Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), CHILLS (Chills) and HEADACHE (Headaches) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), CHILLS (Chills) and HEADACHE (Headaches). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown and AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), CHILLS (Chills) and HEADACHE (Headaches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, SARS-CoV-2 test: positive (Positive) Tested positive for the virus with a mild case.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Injection site itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itching) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. L016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itching). At the time of the report, VACCINATION SITE PRURITUS (Injection site itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided. Treatment information was not provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain in extremity
Clinical narrative: soreness in her arm; fatigue; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her arm), FATIGUE (fatigue), CHILLS (chills) and NAUSEA (nausea) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020, Cholesterol high (controlled) and Pulmonary edema (fluid in lungs). Concurrent medical conditions included Diabetic, Hypertension, Allergic reaction to antibiotics (amoxicillin), Dust allergy (and mold), Sulfonamide allergy, Drug allergy (Zestril), Drug allergy (Actos), Drug allergy (Avandia) and Drug allergy (Most statins). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), INSULIN LISPRO (HUMALOG), INSULIN GLARGINE (LANTUS) and FUROSEMIDE (LASIX [FUROSEMIDE]) for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness in her arm), FATIGUE (fatigue), CHILLS (chills) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (soreness in her arm), FATIGUE (fatigue), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medications were not reported.  Patient took second dose on 09-FEB-2021.   This case was linked to MOD-2021-026890 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No new information.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site induration, Vaccination site rash
Clinical narrative: Pink ring the size of a nickle; Rash at the injection site that extends to the elbow; Bump at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Pink ring the size of a nickle), VACCINATION SITE INDURATION (Bump at the site of the injection) and VACCINATION SITE RASH (Rash at the injection site that extends to the elbow) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023N20A and 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DIPHENHYDRAMINE and HYDROCORTISONE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE INDURATION (Bump at the site of the injection). On 24-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Pink ring the size of a nickle) and VACCINATION SITE RASH (Rash at the injection site that extends to the elbow). At the time of the report, RASH ERYTHEMATOUS (Pink ring the size of a nickle), VACCINATION SITE INDURATION (Bump at the site of the injection) and VACCINATION SITE RASH (Rash at the injection site that extends to the elbow) outcome was unknown.            No treatment information was specified   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: ollow-up information received)   contains non-significant information
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: hot to touch (vaccination site); injection site turned darker in color; next day it was sore; redness at night, redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to touch (vaccination site)), VACCINATION SITE DISCOLOURATION (injection site turned darker in color), VACCINATION SITE ERYTHEMA (redness at night, redness at injection site) and VACCINATION SITE PAIN (next day it was sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 010A21A) for COVID-19 vaccination.     No relevant concomitant medications reported. No relevant medical history was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at night, redness at injection site). On 26-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch (vaccination site)), VACCINATION SITE DISCOLOURATION (injection site turned darker in color) and VACCINATION SITE PAIN (next day it was sore). At the time of the report, VACCINATION SITE WARMTH (hot to touch (vaccination site)), VACCINATION SITE DISCOLOURATION (injection site turned darker in color), VACCINATION SITE ERYTHEMA (redness at night, redness at injection site) and VACCINATION SITE PAIN (next day it was sore) outcome was unknown.            treatment medicine include antihistamine and Tylenol   This case was linked to MOD-2021-026687 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Looks like a sunburn; Itchy around the injection site; Rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Looks like a sunburn), VACCINATION SITE PRURITUS (Itchy around the injection site) and VACCINATION SITE RASH (Rash around the injection site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant concomitant medications reported. No relevant medical history was reported.    On 23-Feb-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. On 23-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy around the injection site) and VACCINATION SITE RASH (Rash around the injection site). On 01-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Looks like a sunburn). At the time of the report, RASH ERYTHEMATOUS (Looks like a sunburn), VACCINATION SITE PRURITUS (Itchy around the injection site) and VACCINATION SITE RASH (Rash around the injection site) outcome was unknown.            patient did not take medication as treatment.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching started yesterday; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching started yesterday) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history). Concomitant products included CURCUMIN for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced PRURITUS (Itching started yesterday). At the time of the report, PRURITUS (Itching started yesterday) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were Curcumin, some kind of compounded medication for thyroid for drug use for unknown indication.  Treatment details included lotion and some kind of spray.  Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Nausea, Pain
Clinical narrative: sore arm/really sore; chills; nausea; horrible headache; whole body hurting; high temperature (100.9 was the highest; sweating; strong reaction; really sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/really sore), CHILLS (chills), NAUSEA (nausea), HEADACHE (horrible headache) and PAIN (whole body hurting) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031C20A and 062G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included TRAMADOL, ESTRADIOL, PANTOPRAZOLE, LEVOCETIRIZINE, MONTELUKAST, POTASSIUM, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HYDROCHLOROTHIAZIDE) and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-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 PAIN IN EXTREMITY (sore arm/really sore), CHILLS (chills), NAUSEA (nausea), HEADACHE (horrible headache), PAIN (whole body hurting), PYREXIA (high temperature (100.9 was the highest), HYPERHIDROSIS (sweating), VACCINATION COMPLICATION (strong reaction) and PAIN (really sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm/really sore), CHILLS (chills), NAUSEA (nausea), HEADACHE (horrible headache), PAIN (whole body hurting), PYREXIA (high temperature (100.9 was the highest), HYPERHIDROSIS (sweating), VACCINATION COMPLICATION (strong reaction) and PAIN (really sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100.9 100.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-039239 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination complication
Clinical narrative: sore arm/really sore; chills; nausea; horrible headache; whole body hurting; high temperature (100.9 was the highest; sweating; strong reaction; really sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/really sore), CHILLS (chills), NAUSEA (nausea), HEADACHE (horrible headache) and PAIN (whole body hurting) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031C20A and 062G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included TRAMADOL, ESTRADIOL, PANTOPRAZOLE, LEVOCETIRIZINE, MONTELUKAST, POTASSIUM, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HYDROCHLOROTHIAZIDE) and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-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 PAIN IN EXTREMITY (sore arm/really sore), CHILLS (chills), NAUSEA (nausea), HEADACHE (horrible headache), PAIN (whole body hurting), PYREXIA (high temperature (100.9 was the highest), HYPERHIDROSIS (sweating), VACCINATION COMPLICATION (strong reaction) and PAIN (really sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm/really sore), CHILLS (chills), NAUSEA (nausea), HEADACHE (horrible headache), PAIN (whole body hurting), PYREXIA (high temperature (100.9 was the highest), HYPERHIDROSIS (sweating), VACCINATION COMPLICATION (strong reaction) and PAIN (really sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100.9 100.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-039239 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 45 days have gone by after the first dose and the patient didn't receive her 2nd dose; A spontaneous report was received from a consumer concerning a 63-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and 2nd dose 45 days after 1st dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 011j20a) in left arm for prophylaxis of COVID-19 infection.  On 25 Feb 2021, 45 days have gone by after the first dose and the patient didn't receive her 2nd dose.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event patient didn't receive her 2nd dose 45 days have gone was considered recovered.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273  with no associated AEs reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: Headache; Fever of 102 F and may have went higher; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever of 102 F and may have went higher) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M24A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-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 25-Feb-2021, the patient experienced PYREXIA (Fever of 102 F and may have went higher). On 26-Feb-2021, the patient experienced HEADACHE (Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 26-Feb-2021, PYREXIA (Fever of 102 F and may have went higher) had resolved. At the time of the report, HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Body temperature: 102 (High) fever of 102 F..         Concomitant medications were not reported  Treatment using  wet cloth and  ice water was reported   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received contains non-significant information
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dyspnoea, Myalgia
Clinical narrative: Abdominal pain; Difficulty of breathing; Muscle pain; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Difficulty of breathing) and MYALGIA (Muscle pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Anxiety, Asthma, Allergy to antibiotic (septra ), Seafood allergy and Penicillin allergy.   On 20-Feb-2021, the patient received first 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Difficulty of breathing) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form, qid. At the time of the report, ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Difficulty of breathing) and MYALGIA (Muscle pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included currently patient is taking medication for high blood pressure and anxiety.  Treatment information included taking inhaler.  Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Injection site is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site is red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and High cholesterol.    On 17-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 VACCINATION SITE ERYTHEMA (Injection site is red). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication including medication for high blood pressure and cholesterol was reported.  No treatment information was specified.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 ARTHRALGIA (Shoulder pain). At the time of the report, ARTHRALGIA (Shoulder pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided. Concomitant information was not provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-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 25-Feb-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.            Concomitant medications were not reported  No treatment information was specified