chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-May-2021 and was forwarded to Moderna on 06-May-2021.    This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had resolved.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness in the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 MYALGIA (soreness in the arm). At the time of the report, MYALGIA (soreness in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pharmacist reported that she administered the second dose of the vaccine two weeks earlier) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pharmacist reported that she administered the second dose of the vaccine two weeks earlier). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pharmacist reported that she administered the second dose of the vaccine two weeks earlier) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported.  Treatment information was not provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: swollen thing on her Injection area; injection area has redness that is bigger than the inject site; it hurts a little bit; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swollen thing on her Injection area), INJECTION SITE ERYTHEMA (injection area has redness that is bigger than the inject site) and INJECTION SITE PAIN (it hurts a little bit) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced INJECTION SITE SWELLING (swollen thing on her Injection area), INJECTION SITE ERYTHEMA (injection area has redness that is bigger than the inject site) and INJECTION SITE PAIN (it hurts a little bit). At the time of the report, INJECTION SITE SWELLING (swollen thing on her Injection area), INJECTION SITE ERYTHEMA (injection area has redness that is bigger than the inject site) and INJECTION SITE PAIN (it hurts a little bit) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment information was not provided.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysmenorrhoea, Dyspnoea
Clinical narrative: painful menstruation; difficulty of breathing; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (painful menstruation), DYSPNOEA (difficulty of breathing) and CHILLS (Chills) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced DYSPNOEA (difficulty of breathing) and CHILLS (Chills). On 08-May-2021, the patient experienced DYSMENORRHOEA (painful menstruation). At the time of the report, DYSMENORRHOEA (painful menstruation), DYSPNOEA (difficulty of breathing) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with response to the events were not applicable.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Magnetic resonance imaging, Myalgia, Sinusitis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Inflammation of sinus cavity), FATIGUE (Really tired), MYALGIA (Arm was not that sore) and HEADACHE (Headache worsened) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00321A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine and Pollen allergy.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced FATIGUE (Really tired) and MYALGIA (Arm was not that sore). On 01-May-2021, the patient experienced HEADACHE (Headache worsened). On 06-May-2021, the patient experienced SINUSITIS (Inflammation of sinus cavity). At the time of the report, SINUSITIS (Inflammation of sinus cavity), FATIGUE (Really tired), MYALGIA (Arm was not that sore) and HEADACHE (Headache worsened) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: Inflammation of sinus cavity.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included Rizatriptan, Flonase, Claritin, Nasacort, Aleve and Advil   This case was linked to US-MODERNATX, INC.-MOD-2021-114194 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114194:
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives all over his body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over his body) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B4A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-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 URTICARIA (hives all over his body). At the time of the report, URTICARIA (hives all over his body) 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.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: TCR added
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dark circles under eyes, Eczema, Fatigue, Pain in extremity
Clinical narrative: face looks like it has eczema all over; red, bumpy, raised,looks like hives; patch under her left eye that looks like a crescent moon; face is burning and is tender.; face is burning and is tender; She was also fatigued.; felt like she had rail road spikes in her arms/it was very sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (felt like she had rail road spikes in her arms/it was very sore), ECZEMA (face looks like it has eczema all over), URTICARIA (red, bumpy, raised,looks like hives), DARK CIRCLES UNDER EYES (patch under her left eye that looks like a crescent moon) and BURNING SENSATION (face is burning and is tender.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergy (allergic to Sulfa) and Latex allergy. Concomitant products included LOSARTAN for an unknown indication.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PAIN IN EXTREMITY (felt like she had rail road spikes in her arms/it was very sore) and FATIGUE (She was also fatigued.). On 08-May-2021, the patient experienced ECZEMA (face looks like it has eczema all over), URTICARIA (red, bumpy, raised,looks like hives), DARK CIRCLES UNDER EYES (patch under her left eye that looks like a crescent moon), BURNING SENSATION (face is burning and is tender.) and TENDERNESS (face is burning and is tender). At the time of the report, PAIN IN EXTREMITY (felt like she had rail road spikes in her arms/it was very sore), ECZEMA (face looks like it has eczema all over), URTICARIA (red, bumpy, raised,looks like hives), DARK CIRCLES UNDER EYES (patch under her left eye that looks like a crescent moon), BURNING SENSATION (face is burning and is tender.), TENDERNESS (face is burning and is tender) and FATIGUE (She was also fatigued.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment History was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Non-significant follow up appended
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Urticaria
Clinical narrative: face looks like it has eczema all over; red, bumpy, raised,looks like hives; patch under her left eye that looks like a crescent moon; face is burning and is tender.; face is burning and is tender; She was also fatigued.; felt like she had rail road spikes in her arms/it was very sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (felt like she had rail road spikes in her arms/it was very sore), ECZEMA (face looks like it has eczema all over), URTICARIA (red, bumpy, raised,looks like hives), DARK CIRCLES UNDER EYES (patch under her left eye that looks like a crescent moon) and BURNING SENSATION (face is burning and is tender.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergy (allergic to Sulfa) and Latex allergy. Concomitant products included LOSARTAN for an unknown indication.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PAIN IN EXTREMITY (felt like she had rail road spikes in her arms/it was very sore) and FATIGUE (She was also fatigued.). On 08-May-2021, the patient experienced ECZEMA (face looks like it has eczema all over), URTICARIA (red, bumpy, raised,looks like hives), DARK CIRCLES UNDER EYES (patch under her left eye that looks like a crescent moon), BURNING SENSATION (face is burning and is tender.) and TENDERNESS (face is burning and is tender). At the time of the report, PAIN IN EXTREMITY (felt like she had rail road spikes in her arms/it was very sore), ECZEMA (face looks like it has eczema all over), URTICARIA (red, bumpy, raised,looks like hives), DARK CIRCLES UNDER EYES (patch under her left eye that looks like a crescent moon), BURNING SENSATION (face is burning and is tender.), TENDERNESS (face is burning and is tender) and FATIGUE (She was also fatigued.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment History was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Non-significant follow up appended
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Sleep disorder
Clinical narrative: problems sleeping; Body ache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (problems sleeping), CHILLS (Chills) and MYALGIA (Body ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced SLEEP DISORDER (problems sleeping) and MYALGIA (Body ache). At the time of the report, SLEEP DISORDER (problems sleeping), CHILLS (Chills) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the second dose 21 days after the first; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose 21 days after the first) 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 07-May-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) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose 21 days after the first). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose 21 days after the first) had resolved.            No concomitant medications reported. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Spinal pain
Clinical narrative: Spinal Pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (Spinal Pain) and PYREXIA (Fever) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (to Gold, Zolof, Buspirone and Electrogel). Concomitant products included OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), AMITRIPTYLINE, METOPROLOL, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and MELATONIN for an unknown indication.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced PYREXIA (Fever). On 08-May-2021, the patient experienced SPINAL PAIN (Spinal Pain). At the time of the report, SPINAL PAIN (Spinal Pain) and PYREXIA (Fever) outcome was unknown.            Treatment information included Ibuprofen and Alka Seltzer tablets.   Action taken with response to the events were not applicable.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Flu-like symptoms; Fever; Fatigue; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Body aches) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Body aches). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Body aches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Muscle twitching, Somnolence
Clinical narrative: chills; extreme sleepiness; leg twitching; received 2nd dose 3 months after 1st dose; dull head ache; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (dull head ache), VACCINATION SITE PAIN (arm pain), CHILLS (chills), SOMNOLENCE (extreme sleepiness) and MUSCLE TWITCHING (leg twitching) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced HEADACHE (dull head ache) and VACCINATION SITE PAIN (arm pain). On 09-Apr-2021, the patient experienced CHILLS (chills), SOMNOLENCE (extreme sleepiness), MUSCLE TWITCHING (leg twitching) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 3 months after 1st dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 26-Jan-2021, VACCINATION SITE PAIN (arm pain) had resolved. On 28-Jan-2021, HEADACHE (dull head ache) had resolved. On 09-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 3 months after 1st dose) had resolved. On 11-Apr-2021, CHILLS (chills), SOMNOLENCE (extreme sleepiness) and MUSCLE TWITCHING (leg twitching) had resolved. Not Provided          This case was linked to MOD-2021-114225 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: chills; extreme sleepiness; leg twitching; received 2nd dose 3 months after 1st dose; dull head ache; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (dull head ache), VACCINATION SITE PAIN (arm pain), CHILLS (chills), SOMNOLENCE (extreme sleepiness) and MUSCLE TWITCHING (leg twitching) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced HEADACHE (dull head ache) and VACCINATION SITE PAIN (arm pain). On 09-Apr-2021, the patient experienced CHILLS (chills), SOMNOLENCE (extreme sleepiness), MUSCLE TWITCHING (leg twitching) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 3 months after 1st dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 26-Jan-2021, VACCINATION SITE PAIN (arm pain) had resolved. On 28-Jan-2021, HEADACHE (dull head ache) had resolved. On 09-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 3 months after 1st dose) had resolved. On 11-Apr-2021, CHILLS (chills), SOMNOLENCE (extreme sleepiness) and MUSCLE TWITCHING (leg twitching) had resolved. Not Provided          This case was linked to MOD-2021-114225 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypotension
Clinical narrative: left leg completely numb; felt his blood pressure was lower than usual; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (left leg completely numb) and HYPOTENSION (felt his blood pressure was lower than usual) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced HYPOAESTHESIA (left leg completely numb) and HYPOTENSION (felt his blood pressure was lower than usual). At the time of the report, HYPOAESTHESIA (left leg completely numb) and HYPOTENSION (felt his blood pressure was lower than usual) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. Concomitant medications were not provided.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nosebleed/2nd episode of nose bleed after receiving 1st dose of Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EPISTAXIS (nosebleed/2nd episode of nose bleed after receiving 1st dose of Moderna vaccine) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced EPISTAXIS (nosebleed/2nd episode of nose bleed after receiving 1st dose of Moderna vaccine). At the time of the report, EPISTAXIS (nosebleed/2nd episode of nose bleed after receiving 1st dose of Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment include applied pressure for nose bleed 2nd time.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: AE information reported. Contact information updated. Significant follow up appended. Concomitant drug was updated.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Arthritis flare ups; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis flare ups) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Arthritis flare ups). At the time of the report, ARTHRITIS (Arthritis flare ups) 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 assessment.  No concomitant medications were reported. Treatment information was not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Decreased appetite, Dizziness, Gait disturbance, Nausea
Clinical narrative: symptoms worsened; Light headedness; Nausea; Vertigo; loss of appetite due to nausea,couldn't eat; couldn't walk due to nausea; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), DECREASED APPETITE (loss of appetite due to nausea,couldn't eat), GAIT DISTURBANCE (couldn't walk due to nausea), DIZZINESS (Light headedness) and CONDITION AGGRAVATED (symptoms worsened) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] and LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL) for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced VERTIGO (Vertigo), DECREASED APPETITE (loss of appetite due to nausea,couldn't eat), GAIT DISTURBANCE (couldn't walk due to nausea) and NAUSEA (Nausea). On 06-May-2021, the patient experienced DIZZINESS (Light headedness). On an unknown date, the patient experienced CONDITION AGGRAVATED (symptoms worsened). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, VERTIGO (Vertigo), DECREASED APPETITE (loss of appetite due to nausea,couldn't eat), GAIT DISTURBANCE (couldn't walk due to nausea), DIZZINESS (Light headedness), CONDITION AGGRAVATED (symptoms worsened) and NAUSEA (Nausea) outcome was unknown. Not Provided          Concomitant products included MULTIVITAMIN [VITAMINS NOS] and LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL)  Treatment mediation like IBUPROFEN was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Non significant follow up received on 08-JUN-2021, No new information.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: symptoms worsened; Light headedness; Nausea; Vertigo; loss of appetite due to nausea,couldn't eat; couldn't walk due to nausea; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), DECREASED APPETITE (loss of appetite due to nausea,couldn't eat), GAIT DISTURBANCE (couldn't walk due to nausea), DIZZINESS (Light headedness) and CONDITION AGGRAVATED (symptoms worsened) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] and LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL) for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced VERTIGO (Vertigo), DECREASED APPETITE (loss of appetite due to nausea,couldn't eat), GAIT DISTURBANCE (couldn't walk due to nausea) and NAUSEA (Nausea). On 06-May-2021, the patient experienced DIZZINESS (Light headedness). On an unknown date, the patient experienced CONDITION AGGRAVATED (symptoms worsened). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, VERTIGO (Vertigo), DECREASED APPETITE (loss of appetite due to nausea,couldn't eat), GAIT DISTURBANCE (couldn't walk due to nausea), DIZZINESS (Light headedness), CONDITION AGGRAVATED (symptoms worsened) and NAUSEA (Nausea) outcome was unknown. Not Provided          Concomitant products included MULTIVITAMIN [VITAMINS NOS] and LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL)  Treatment mediation like IBUPROFEN was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Non significant follow up received on 08-JUN-2021, No new information.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Rash, Skin warm, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hive-like rash, hives on stomach), SKIN WARM (left hand warm), INFLAMMATION (left hand inflamed) and RASH (spreading rash (left forearm), rash on left forearm and hand areas) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for an unknown indication. On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced URTICARIA (hive-like rash, hives on stomach), SKIN WARM (left hand warm), INFLAMMATION (left hand inflamed) and RASH (spreading rash (left forearm), rash on left forearm and hand areas). At the time of the report, URTICARIA (hive-like rash, hives on stomach), SKIN WARM (left hand warm), INFLAMMATION (left hand inflamed) and RASH (spreading rash (left forearm), rash on left forearm and hand areas) outcome was unknown. Not Provided. Patient was placed on a prednisone taper. Treatment information provided was drug free allergy relief product. Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Significant follow up vaccination date.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Asthenia, Back pain, Chest pain, Decreased appetite
Clinical narrative: chest pain that comes and goes; shortness of breath; pain in both lower legs; has no energy; feels so cold in her feet; abdominal distension; lost her appetite; Headache; nausea; extreme fatigue; back pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain that comes and goes), DYSPNOEA EXERTIONAL (shortness of breath), PAIN IN EXTREMITY (pain in both lower legs), ASTHENIA (has no energy) and PERIPHERAL COLDNESS (feels so cold in her feet) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Patient is allergic to some pain medication like dilaudid.).   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BACK PAIN (back pain). On 04-May-2021, the patient experienced CHEST PAIN (chest pain that comes and goes), DYSPNOEA EXERTIONAL (shortness of breath), PAIN IN EXTREMITY (pain in both lower legs), ASTHENIA (has no energy), PERIPHERAL COLDNESS (feels so cold in her feet), ABDOMINAL DISTENSION (abdominal distension), DECREASED APPETITE (lost her appetite), HEADACHE (Headache), NAUSEA (nausea) and FATIGUE (extreme fatigue). On 02-May-2021, BACK PAIN (back pain) had resolved. At the time of the report, CHEST PAIN (chest pain that comes and goes), DYSPNOEA EXERTIONAL (shortness of breath), PAIN IN EXTREMITY (pain in both lower legs), ASTHENIA (has no energy), PERIPHERAL COLDNESS (feels so cold in her feet), ABDOMINAL DISTENSION (abdominal distension), DECREASED APPETITE (lost her appetite), HEADACHE (Headache), NAUSEA (nausea) and FATIGUE (extreme fatigue) outcome was unknown.            Concomitant medication included an unspecified cholesterol medication.   Treatment for the events included paracetamol and ibuprofen.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: chest pain that comes and goes; shortness of breath; pain in both lower legs; has no energy; feels so cold in her feet; abdominal distension; lost her appetite; Headache; nausea; extreme fatigue; back pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain that comes and goes), DYSPNOEA EXERTIONAL (shortness of breath), PAIN IN EXTREMITY (pain in both lower legs), ASTHENIA (has no energy) and PERIPHERAL COLDNESS (feels so cold in her feet) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Patient is allergic to some pain medication like dilaudid.).   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BACK PAIN (back pain). On 04-May-2021, the patient experienced CHEST PAIN (chest pain that comes and goes), DYSPNOEA EXERTIONAL (shortness of breath), PAIN IN EXTREMITY (pain in both lower legs), ASTHENIA (has no energy), PERIPHERAL COLDNESS (feels so cold in her feet), ABDOMINAL DISTENSION (abdominal distension), DECREASED APPETITE (lost her appetite), HEADACHE (Headache), NAUSEA (nausea) and FATIGUE (extreme fatigue). On 02-May-2021, BACK PAIN (back pain) had resolved. At the time of the report, CHEST PAIN (chest pain that comes and goes), DYSPNOEA EXERTIONAL (shortness of breath), PAIN IN EXTREMITY (pain in both lower legs), ASTHENIA (has no energy), PERIPHERAL COLDNESS (feels so cold in her feet), ABDOMINAL DISTENSION (abdominal distension), DECREASED APPETITE (lost her appetite), HEADACHE (Headache), NAUSEA (nausea) and FATIGUE (extreme fatigue) outcome was unknown.            Concomitant medication included an unspecified cholesterol medication.   Treatment for the events included paracetamol and ibuprofen.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness
Clinical narrative: chest pain that comes and goes; shortness of breath; pain in both lower legs; has no energy; feels so cold in her feet; abdominal distension; lost her appetite; Headache; nausea; extreme fatigue; back pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain that comes and goes), DYSPNOEA EXERTIONAL (shortness of breath), PAIN IN EXTREMITY (pain in both lower legs), ASTHENIA (has no energy) and PERIPHERAL COLDNESS (feels so cold in her feet) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Patient is allergic to some pain medication like dilaudid.).   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BACK PAIN (back pain). On 04-May-2021, the patient experienced CHEST PAIN (chest pain that comes and goes), DYSPNOEA EXERTIONAL (shortness of breath), PAIN IN EXTREMITY (pain in both lower legs), ASTHENIA (has no energy), PERIPHERAL COLDNESS (feels so cold in her feet), ABDOMINAL DISTENSION (abdominal distension), DECREASED APPETITE (lost her appetite), HEADACHE (Headache), NAUSEA (nausea) and FATIGUE (extreme fatigue). On 02-May-2021, BACK PAIN (back pain) had resolved. At the time of the report, CHEST PAIN (chest pain that comes and goes), DYSPNOEA EXERTIONAL (shortness of breath), PAIN IN EXTREMITY (pain in both lower legs), ASTHENIA (has no energy), PERIPHERAL COLDNESS (feels so cold in her feet), ABDOMINAL DISTENSION (abdominal distension), DECREASED APPETITE (lost her appetite), HEADACHE (Headache), NAUSEA (nausea) and FATIGUE (extreme fatigue) outcome was unknown.            Concomitant medication included an unspecified cholesterol medication.   Treatment for the events included paracetamol and ibuprofen.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose not scheduled, past 42 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose not scheduled, past 42 days) 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 07-Mar-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose not scheduled, past 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose not scheduled, past 42 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.   Reporter did not allow further contact
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: I was sick; has not received second dose, more than 36 days have passed since first dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I was sick) and PRODUCT DOSE OMISSION ISSUE (has not received second dose, more than 36 days have passed since first dose) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TRAZODONE and PAROXETINE HYDROCHLORIDE (PAXIL CR) for an unknown indication.    On 09-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 ILLNESS (I was sick) and PRODUCT DOSE OMISSION ISSUE (has not received second dose, more than 36 days have passed since first dose). At the time of the report, ILLNESS (I was sick) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (has not received second dose, more than 36 days have passed since first dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient thought he had COVID-19 (not tested)  Treatment medication included Advil. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Tenderness
Clinical narrative: local reaction such itching after the 1st shot; local reaction such tenderness after the 1st shot; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (local reaction such itching after the 1st shot) and TENDERNESS (local reaction such tenderness after the 1st shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No medical history provided by the patient.  Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Allergy, MULTIVITAMIN [VITAMINS NOS] and ZINC for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 02-Apr-2021, the patient experienced PRURITUS (local reaction such itching after the 1st shot) and TENDERNESS (local reaction such tenderness after the 1st shot). On 09-Apr-2021, PRURITUS (local reaction such itching after the 1st shot) and TENDERNESS (local reaction such tenderness after the 1st shot) had resolved. 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 MOD-2021-114226 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Eye contusion
Clinical narrative: black eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE CONTUSION (black eye) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced EYE CONTUSION (black eye). At the time of the report, EYE CONTUSION (black eye) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  Patient reported that she did not take any medication for the black eye and that there was nothing to add for further follow up.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Event outcome updated.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Joint swelling, Rash erythematous
Clinical narrative: Rash faded into bruising; red rash on torso, legs, inner arms; swollen left wrist; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash on torso, legs, inner arms), JOINT SWELLING (swollen left wrist) and CONTUSION (Rash faded into bruising) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 043B21A) for COVID-19 vaccination.     no medical history was provided by the reporter.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced RASH ERYTHEMATOUS (red rash on torso, legs, inner arms) and JOINT SWELLING (swollen left wrist). On an unknown date, the patient experienced CONTUSION (Rash faded into bruising). At the time of the report, RASH ERYTHEMATOUS (red rash on torso, legs, inner arms), JOINT SWELLING (swollen left wrist) and CONTUSION (Rash faded into bruising) outcome was unknown. Not Provided          No concomitant medications was provided. patient received the treatment includes : steroid IV, prednisone.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: NNI , Non significant follow up
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Peripheral swelling
Clinical narrative: chest is swelling; left arm too ( swelling); under his arm ( swelling); This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest is swelling), PERIPHERAL SWELLING (left arm too ( swelling)) and PERIPHERAL SWELLING (under his arm ( swelling)) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced CHEST DISCOMFORT (chest is swelling), PERIPHERAL SWELLING (left arm too ( swelling)) and PERIPHERAL SWELLING (under his arm ( swelling)). At the time of the report, CHEST DISCOMFORT (chest is swelling), PERIPHERAL SWELLING (left arm too ( swelling)) and PERIPHERAL SWELLING (under his arm ( swelling)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant  information was  provided. Treatment drugs include anti-inflammatory medication.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Fever 100.5 temp; sore arm; red mark at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 100.5 temp), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (red mark at injection site) in a 74-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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PYREXIA (Fever 100.5 temp), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (red mark at injection site). On 31-Mar-2021, PYREXIA (Fever 100.5 temp) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (red mark at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Body temperature: 100.5 mmHg (High) Fever 100.5 temp.         The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable  No concomitant medications were reported  No treatment drugs were reported   This case was linked to MOD-2021-049557 (Patient Link).