chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Body ache; Headache; extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), HEADACHE (Headache) and FATIGUE (extremely tired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 10A21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety, Bipolar disorder and Arthritis. Concomitant products included CLONAZEPAM for Anxiety, DICLOFENAC SODIUM for Arthritis, LAMOTRIGINE (LAMICTAL) for Bipolar disorder.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced MYALGIA (Body ache), HEADACHE (Headache) and FATIGUE (extremely tired). At the time of the report, MYALGIA (Body ache), HEADACHE (Headache) and FATIGUE (extremely tired) outcome was unknown.            Treatment information not provided.   Action taken with mRNA-1273 in response to the events was not applicable    This case was linked to US-MODERNATX, INC.-MOD-2021-076526 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076526:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Cluster headache, Facial pain, Fatigue, Headache, Insomnia
Clinical narrative: cluster headaches; headaches got worse and worse and worse; not getting any sleep at night; tired; facial pain; Trigeminal neuralgia; phantom pains; This spontaneous case was reported by a consumer and describes the occurrence of TRIGEMINAL NEURALGIA (Trigeminal neuralgia), PHANTOM LIMB SYNDROME (phantom pains), CLUSTER HEADACHE (cluster headaches), HEADACHE (headaches got worse and worse and worse) and INSOMNIA (not getting any sleep at night) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PHANTOM LIMB SYNDROME (phantom pains). On an unknown date, the patient experienced TRIGEMINAL NEURALGIA (Trigeminal neuralgia), CLUSTER HEADACHE (cluster headaches), HEADACHE (headaches got worse and worse and worse), INSOMNIA (not getting any sleep at night), FATIGUE (tired) and FACIAL PAIN (facial pain). At the time of the report, TRIGEMINAL NEURALGIA (Trigeminal neuralgia), PHANTOM LIMB SYNDROME (phantom pains), CLUSTER HEADACHE (cluster headaches), HEADACHE (headaches got worse and worse and worse), INSOMNIA (not getting any sleep at night), FATIGUE (tired) and FACIAL PAIN (facial pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Phantom limb syndrome, Trigeminal neuralgia
Clinical narrative: cluster headaches; headaches got worse and worse and worse; not getting any sleep at night; tired; facial pain; Trigeminal neuralgia; phantom pains; This spontaneous case was reported by a consumer and describes the occurrence of TRIGEMINAL NEURALGIA (Trigeminal neuralgia), PHANTOM LIMB SYNDROME (phantom pains), CLUSTER HEADACHE (cluster headaches), HEADACHE (headaches got worse and worse and worse) and INSOMNIA (not getting any sleep at night) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PHANTOM LIMB SYNDROME (phantom pains). On an unknown date, the patient experienced TRIGEMINAL NEURALGIA (Trigeminal neuralgia), CLUSTER HEADACHE (cluster headaches), HEADACHE (headaches got worse and worse and worse), INSOMNIA (not getting any sleep at night), FATIGUE (tired) and FACIAL PAIN (facial pain). At the time of the report, TRIGEMINAL NEURALGIA (Trigeminal neuralgia), PHANTOM LIMB SYNDROME (phantom pains), CLUSTER HEADACHE (cluster headaches), HEADACHE (headaches got worse and worse and worse), INSOMNIA (not getting any sleep at night), FATIGUE (tired) and FACIAL PAIN (facial pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: blood sugars became extremely high; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (blood sugars became extremely high) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 21-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED (blood sugars became extremely high). On 24-Mar-2021, BLOOD GLUCOSE INCREASED (blood sugars became extremely high) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.    Treatment information was not provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-076498 (E2B Linked Report).; Sender's Comments:  MOD-2021-076498:sister's case
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Myalgia, Nausea, Pyrexia
Clinical narrative: could not walk,; nausea; weakness, over weakness; muscle pain; fever; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (could not walk,), NAUSEA (nausea), ASTHENIA (weakness, over weakness), MYALGIA (muscle pain) and PYREXIA (fever) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 038B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included OMEPRAZOLE for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced GAIT DISTURBANCE (could not walk,), NAUSEA (nausea), ASTHENIA (weakness, over weakness), MYALGIA (muscle pain) and PYREXIA (fever). At the time of the report, GAIT DISTURBANCE (could not walk,), NAUSEA (nausea), ASTHENIA (weakness, over weakness), MYALGIA (muscle pain) and PYREXIA (fever) outcome was unknown.            Concomitant product use was provided by the reporter as High blood pressure medications, Heart medication. Treatment information was provided as paracetamol.   This case was linked to INC.-MOD-2021-076479, MOD21-075779, INC.-MOD-2021-076575, INC.-MOD-2021-076603 (E2B Linked Report).; Sender's Comments:   INC.-MOD-2021-076479:1st dose vaccine MOD21-075779:Crosslink, INC.-MOD-2021-076603:2nd dose vaccine - husband  INC.-MOD-2021-076575:2nd dose vaccine - husband
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: Next day after first shot she stayed home because she felt a bit off, kind of not her; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FEELING ABNORMAL (Next day after first shot she stayed home because she felt a bit off, kind of not her) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Arthritis. Concomitant products included MELOXICAM and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 10-Mar-2021, the patient experienced FEELING ABNORMAL (Next day after first shot she stayed home because she felt a bit off, kind of not her). On 10-Mar-2021, FEELING ABNORMAL (Next day after first shot she stayed home because she felt a bit off, kind of not her) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication includes Blood pressure medicine and allergy medication.   This case was linked to US-MODERNATX, INC.-MOD-2021-076503 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076503:2nd dose case
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested COVID-19 positive after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested COVID-19 positive after receiving the vaccine) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included No adverse event (No medical history reported.).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced COVID-19 (Tested COVID-19 positive after receiving the vaccine). At the time of the report, COVID-19 (Tested COVID-19 positive after receiving the vaccine) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, COVID-19: positive positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant or treatment medications reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: little mark in her arm that then turned into a rash/ horrible rash on both arms, back, legs and stomach/rash itches like crazy; soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm) and RASH (little mark in her arm that then turned into a rash/ horrible rash on both arms, back, legs and stomach/rash itches like crazy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 03-Jul-2010 and Graves' disease since May 2016. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN HCT) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    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 PAIN IN EXTREMITY (soreness in the arm). On 17-Feb-2021, the patient experienced RASH (little mark in her arm that then turned into a rash/ horrible rash on both arms, back, legs and stomach/rash itches like crazy). The patient was treated with PREDNISOLONE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (soreness in the arm) and RASH (little mark in her arm that then turned into a rash/ horrible rash on both arms, back, legs and stomach/rash itches like crazy) 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.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Updated laboratory data, added dose 2 details for suspect product, treatment medications and event details was added. On 07-May-2021: fallow up in patient tab  patient race height weight and medical history was added in product tab concomitant drug dose route of administration and one new drug allagra  was added On 10-May-2021: no newinformation
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity, Pyrexia
Clinical narrative: "arm pain"; Three doses were left out at ambient room temperature past there beyond use date; "slight fever"; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY ("arm pain"), EXPIRED PRODUCT ADMINISTERED (Three doses were left out at ambient room temperature past there beyond use date) and PYREXIA ("slight fever") in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY ("arm pain"), EXPIRED PRODUCT ADMINISTERED (Three doses were left out at ambient room temperature past there beyond use date) and PYREXIA ("slight fever"). On 12-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Three doses were left out at ambient room temperature past there beyond use date) had resolved. At the time of the report, PAIN IN EXTREMITY ("arm pain") and PYREXIA ("slight fever") 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 product use was not provided by the reporter.   Treatment information was not provided.   This case was linked to MOD21-075527, MOD21-075517, MOD21-074055, MOD21-075351, MOD21-075500, MOD21-075532, MOD21-075544, MOD21-075549 (E2B Linked Report). This case was linked to MOD-2021-076892 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up reported: After following up with the patient she is believes that she received a viable dose. No follow up needed at this time. VAERS with significant info On 28-Jul-2021: Follow-up information received on 28 Jul 2021 contains non-significant information.; Sender's Comments:  MOD21-075527:Cross linked case MOD21-075517:Cross linked case MOD21-074055:Cross linked case MOD21-075351:Cross linked case MOD21-075500:Cross linked case MOD21-075532:Cross linked case MOD21-075544:Cross linked case MOD21-075549:Cross linked case
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood urine present
Clinical narrative: Back soreness; red blood in urine; Shoulder soreness; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back soreness), BLOOD URINE PRESENT (red blood in urine) and ARTHRALGIA (Shoulder soreness) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced BACK PAIN (Back soreness), BLOOD URINE PRESENT (red blood in urine) and ARTHRALGIA (Shoulder soreness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Back soreness), BLOOD URINE PRESENT (red blood in urine) and ARTHRALGIA (Shoulder soreness) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. ? Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Oropharyngeal discomfort
Clinical narrative: swollen eyes and blood; discomfort on her throat; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (swollen eyes and blood) and OROPHARYNGEAL DISCOMFORT (discomfort on her throat) 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 clot forming.    On 31-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 EYE SWELLING (swollen eyes and blood) and OROPHARYNGEAL DISCOMFORT (discomfort on her throat). At the time of the report, EYE SWELLING (swollen eyes and blood) and OROPHARYNGEAL DISCOMFORT (discomfort on her throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Illness, Pain
Clinical narrative: severe ice pick headache; not feeling well; soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (not feeling well), PAIN (soreness) and HEADACHE (severe ice pick headache) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis.    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced ILLNESS (not feeling well) and PAIN (soreness). On an unknown date, the patient experienced HEADACHE (severe ice pick headache). At the time of the report, ILLNESS (not feeling well), PAIN (soreness) and HEADACHE (severe ice pick headache) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Lymphadenopathy, Myalgia, Pain
Clinical narrative: body ache; muscle ache; swollen lymph nodes; joint ache; fatigue; soreness; redness; hot to touch on the area of the injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (body ache), MYALGIA (muscle ache), LYMPHADENOPATHY (swollen lymph nodes), ARTHRALGIA (joint ache) and FATIGUE (fatigue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was provided.).    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (body ache), MYALGIA (muscle ache), LYMPHADENOPATHY (swollen lymph nodes), ARTHRALGIA (joint ache), FATIGUE (fatigue), VACCINATION SITE PAIN (soreness), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE WARMTH (hot to touch on the area of the injection). At the time of the report, PAIN (body ache), MYALGIA (muscle ache), LYMPHADENOPATHY (swollen lymph nodes), ARTHRALGIA (joint ache), FATIGUE (fatigue), VACCINATION SITE PAIN (soreness), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE WARMTH (hot to touch on the area of the injection) outcome was unknown.            No concomitant medications were provided. Treatment medications included paracetamol. Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: body ache; muscle ache; swollen lymph nodes; joint ache; fatigue; soreness; redness; hot to touch on the area of the injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (body ache), MYALGIA (muscle ache), LYMPHADENOPATHY (swollen lymph nodes), ARTHRALGIA (joint ache) and FATIGUE (fatigue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was provided.).    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (body ache), MYALGIA (muscle ache), LYMPHADENOPATHY (swollen lymph nodes), ARTHRALGIA (joint ache), FATIGUE (fatigue), VACCINATION SITE PAIN (soreness), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE WARMTH (hot to touch on the area of the injection). At the time of the report, PAIN (body ache), MYALGIA (muscle ache), LYMPHADENOPATHY (swollen lymph nodes), ARTHRALGIA (joint ache), FATIGUE (fatigue), VACCINATION SITE PAIN (soreness), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE WARMTH (hot to touch on the area of the injection) outcome was unknown.            No concomitant medications were provided. Treatment medications included paracetamol. Action taken with mRNA-1273 in response to the events was not Applicable.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, International normalised ratio decreased, International normalised ratio increased, Joint swelling, Peripheral swelling
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of arthralgia (joint pain), increased international normalised ratio (INR spiked to 9), decreased international normalised ratio (INR gone down to 5), joint swelling (slight swelling in wrist) and peripheral swelling (slight swelling in fingers) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included no adverse event. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced arthralgia (joint pain), increased international normalised ratio (INR spiked to 9), decreased international normalised ratio (INR gone down to 5), joint swelling (slight swelling in wrist) and peripheral swelling (slight swelling in fingers). At the time of the report, arthralgia (joint pain), increased international normalised ratio (INR spiked to 9), decreased international normalised ratio (INR gone down to 5), joint swelling (slight swelling in wrist) and peripheral swelling (slight swelling in fingers) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: tired; diarrhea all day/loose stool; headache all day; patient is not 100%; extreme headache turned into a migraine headache; nausea; vomit; pain; cold; chills; achy; felt really bad; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt really bad), DIARRHOEA (diarrhea), FATIGUE (tired), PAIN (achy) and MIGRAINE (extreme headache turned into a migraine headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041BV1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLONAZEPAM for Anxiety, DICLOFENAC SODIUM for Arthritis, LAMOTRIGINE (LAMICTAL) for Bipolar disorder.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced FEELING ABNORMAL (felt really bad), DIARRHOEA (diarrhea) and PAIN (achy). On 14-Apr-2021, the patient experienced MIGRAINE (extreme headache turned into a migraine headache), NAUSEA (nausea), VOMITING (vomit), PAIN (pain), NASOPHARYNGITIS (cold), CHILLS (chills), HEADACHE (headache all day) and MALAISE (patient is not 100%). On an unknown date, the patient experienced FATIGUE (tired) and DIARRHOEA (diarrhea all day/loose stool). At the time of the report, FEELING ABNORMAL (felt really bad), DIARRHOEA (diarrhea), FATIGUE (tired), PAIN (achy), MIGRAINE (extreme headache turned into a migraine headache), NAUSEA (nausea), VOMITING (vomit), PAIN (pain), NASOPHARYNGITIS (cold), CHILLS (chills), DIARRHOEA (diarrhea all day/loose stool), HEADACHE (headache all day) and MALAISE (patient is not 100%) outcome was unknown.            Treatment include Tylenol, Advil sinus Pressure and Ice application.   This case was linked to US-MODERNATX, INC.-MOD-2021-076508 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076508:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Migraine, Nasopharyngitis, Nausea, Pain
Clinical narrative: tired; diarrhea all day/loose stool; headache all day; patient is not 100%; extreme headache turned into a migraine headache; nausea; vomit; pain; cold; chills; achy; felt really bad; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt really bad), DIARRHOEA (diarrhea), FATIGUE (tired), PAIN (achy) and MIGRAINE (extreme headache turned into a migraine headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041BV1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLONAZEPAM for Anxiety, DICLOFENAC SODIUM for Arthritis, LAMOTRIGINE (LAMICTAL) for Bipolar disorder.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced FEELING ABNORMAL (felt really bad), DIARRHOEA (diarrhea) and PAIN (achy). On 14-Apr-2021, the patient experienced MIGRAINE (extreme headache turned into a migraine headache), NAUSEA (nausea), VOMITING (vomit), PAIN (pain), NASOPHARYNGITIS (cold), CHILLS (chills), HEADACHE (headache all day) and MALAISE (patient is not 100%). On an unknown date, the patient experienced FATIGUE (tired) and DIARRHOEA (diarrhea all day/loose stool). At the time of the report, FEELING ABNORMAL (felt really bad), DIARRHOEA (diarrhea), FATIGUE (tired), PAIN (achy), MIGRAINE (extreme headache turned into a migraine headache), NAUSEA (nausea), VOMITING (vomit), PAIN (pain), NASOPHARYNGITIS (cold), CHILLS (chills), DIARRHOEA (diarrhea all day/loose stool), HEADACHE (headache all day) and MALAISE (patient is not 100%) outcome was unknown.            Treatment include Tylenol, Advil sinus Pressure and Ice application.   This case was linked to US-MODERNATX, INC.-MOD-2021-076508 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076508:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: tired; diarrhea all day/loose stool; headache all day; patient is not 100%; extreme headache turned into a migraine headache; nausea; vomit; pain; cold; chills; achy; felt really bad; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt really bad), DIARRHOEA (diarrhea), FATIGUE (tired), PAIN (achy) and MIGRAINE (extreme headache turned into a migraine headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041BV1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLONAZEPAM for Anxiety, DICLOFENAC SODIUM for Arthritis, LAMOTRIGINE (LAMICTAL) for Bipolar disorder.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced FEELING ABNORMAL (felt really bad), DIARRHOEA (diarrhea) and PAIN (achy). On 14-Apr-2021, the patient experienced MIGRAINE (extreme headache turned into a migraine headache), NAUSEA (nausea), VOMITING (vomit), PAIN (pain), NASOPHARYNGITIS (cold), CHILLS (chills), HEADACHE (headache all day) and MALAISE (patient is not 100%). On an unknown date, the patient experienced FATIGUE (tired) and DIARRHOEA (diarrhea all day/loose stool). At the time of the report, FEELING ABNORMAL (felt really bad), DIARRHOEA (diarrhea), FATIGUE (tired), PAIN (achy), MIGRAINE (extreme headache turned into a migraine headache), NAUSEA (nausea), VOMITING (vomit), PAIN (pain), NASOPHARYNGITIS (cold), CHILLS (chills), DIARRHOEA (diarrhea all day/loose stool), HEADACHE (headache all day) and MALAISE (patient is not 100%) outcome was unknown.            Treatment include Tylenol, Advil sinus Pressure and Ice application.   This case was linked to US-MODERNATX, INC.-MOD-2021-076508 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076508:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: Shortness of breath; Soreness; Swollen arm; Neck ache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), PAIN IN EXTREMITY (Soreness), PERIPHERAL SWELLING (Swollen arm), NECK PAIN (Neck ache) and CHILLS (Chills) 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 (No reported medical history).   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath), PAIN IN EXTREMITY (Soreness), PERIPHERAL SWELLING (Swollen arm), NECK PAIN (Neck ache) and CHILLS (Chills). At the time of the report, DYSPNOEA (Shortness of breath), PAIN IN EXTREMITY (Soreness), PERIPHERAL SWELLING (Swollen arm), NECK PAIN (Neck ache) and CHILLS (Chills) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; "tired for a couple days after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and FATIGUE ("tired for a couple days after receiving the vaccine) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LISINOPRIL for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced FATIGUE ("tired for a couple days after receiving the vaccine). On 30-Mar-2021, the patient experienced PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN for Fever, at an unspecified dose and frequency. On 15-Mar-2021, FATIGUE ("tired for a couple days after receiving the vaccine) had resolved. On 11-Apr-2021, PYREXIA (fever) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (normal) Negative x 3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient went to the emergency room and diagnostic tests showed elevated C-reactive protein (CRP) and elevated liver enzymes.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Cough, Dysgeusia, Headache, Influenza like illness
Clinical narrative: like a metallic taste; feels like he had a bad cold; coughs; still has no taste and it has been 2 weeks; got a real nasty taste down deep/fells like it is coming out of throat/ lungs; does not feel that great; a sore arm; headache; felt like he had the flu but was not throwing up; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like he had the flu but was not throwing up), DYSGEUSIA (like a metallic taste), NASOPHARYNGITIS (feels like he had a bad cold), COUGH (coughs) and AGEUSIA (still has no taste and it has been 2 weeks) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031BZHA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like he had the flu but was not throwing up), PAIN IN EXTREMITY (a sore arm) and HEADACHE (headache). On 01-Apr-2021, the patient experienced DYSGEUSIA (like a metallic taste), NASOPHARYNGITIS (feels like he had a bad cold), COUGH (coughs), AGEUSIA (still has no taste and it has been 2 weeks), TASTE DISORDER (got a real nasty taste down deep/fells like it is coming out of throat/ lungs) and MALAISE (does not feel that great). The patient was treated with IBUPROFEN at an unspecified dose and frequency and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (felt like he had the flu but was not throwing up), NASOPHARYNGITIS (feels like he had a bad cold), COUGH (coughs) and PAIN IN EXTREMITY (a sore arm) outcome was unknown, DYSGEUSIA (like a metallic taste), AGEUSIA (still has no taste and it has been 2 weeks) and MALAISE (does not feel that great) had not resolved and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient did not take any concomitant medications. Treatment also included unspecified mucus release pills.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis, Pain in extremity, Taste disorder
Clinical narrative: like a metallic taste; feels like he had a bad cold; coughs; still has no taste and it has been 2 weeks; got a real nasty taste down deep/fells like it is coming out of throat/ lungs; does not feel that great; a sore arm; headache; felt like he had the flu but was not throwing up; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like he had the flu but was not throwing up), DYSGEUSIA (like a metallic taste), NASOPHARYNGITIS (feels like he had a bad cold), COUGH (coughs) and AGEUSIA (still has no taste and it has been 2 weeks) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031BZHA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like he had the flu but was not throwing up), PAIN IN EXTREMITY (a sore arm) and HEADACHE (headache). On 01-Apr-2021, the patient experienced DYSGEUSIA (like a metallic taste), NASOPHARYNGITIS (feels like he had a bad cold), COUGH (coughs), AGEUSIA (still has no taste and it has been 2 weeks), TASTE DISORDER (got a real nasty taste down deep/fells like it is coming out of throat/ lungs) and MALAISE (does not feel that great). The patient was treated with IBUPROFEN at an unspecified dose and frequency and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (felt like he had the flu but was not throwing up), NASOPHARYNGITIS (feels like he had a bad cold), COUGH (coughs) and PAIN IN EXTREMITY (a sore arm) outcome was unknown, DYSGEUSIA (like a metallic taste), AGEUSIA (still has no taste and it has been 2 weeks) and MALAISE (does not feel that great) had not resolved and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient did not take any concomitant medications. Treatment also included unspecified mucus release pills.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscle spasms, Nausea
Clinical narrative: Cramping; Extreme fatigue; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramping), FATIGUE (Extreme fatigue), HEADACHE (Headache) and NAUSEA (Nausea) in a 63-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Cramping), FATIGUE (Extreme fatigue), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, MUSCLE SPASMS (Cramping), FATIGUE (Extreme fatigue), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up information received and Outcomes updated.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: minor headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (minor headache) and PAIN IN EXTREMITY (sore arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ECOTRIN), MULTIVITAMIN & MINERAL, CARBINOXAMINE MALEATE (OMEGA 100) and PARACETAMOL (TYLENOL) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HEADACHE (minor headache) and PAIN IN EXTREMITY (sore arm). On 19-Mar-2021, HEADACHE (minor headache) and PAIN IN EXTREMITY (sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Headache, Myalgia, Nausea
Clinical narrative: Overall feeling little unusual; fever - 102F; little nauea; head was hurting whenever he stands up or turns hid head faster; muscle aches/body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Overall feeling little unusual), PYREXIA (fever - 102F), NAUSEA (little nauea), HEADACHE (head was hurting whenever he stands up or turns hid head faster) and MYALGIA (muscle aches/body aches) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 11-Apr-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 11-Apr-2021, the patient experienced FEELING ABNORMAL (Overall feeling little unusual), PYREXIA (fever - 102F), NAUSEA (little nauea), HEADACHE (head was hurting whenever he stands up or turns hid head faster) and MYALGIA (muscle aches/body aches). On 11-Apr-2021, PYREXIA (fever - 102F) had resolved. At the time of the report, FEELING ABNORMAL (Overall feeling little unusual), NAUSEA (little nauea), HEADACHE (head was hurting whenever he stands up or turns hid head faster) and MYALGIA (muscle aches/body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Body temperature: 102 °f High.         No concomitant medications were reported.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not Applicable
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Overall feeling little unusual; fever - 102F; little nauea; head was hurting whenever he stands up or turns hid head faster; muscle aches/body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Overall feeling little unusual), PYREXIA (fever - 102F), NAUSEA (little nauea), HEADACHE (head was hurting whenever he stands up or turns hid head faster) and MYALGIA (muscle aches/body aches) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 11-Apr-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 11-Apr-2021, the patient experienced FEELING ABNORMAL (Overall feeling little unusual), PYREXIA (fever - 102F), NAUSEA (little nauea), HEADACHE (head was hurting whenever he stands up or turns hid head faster) and MYALGIA (muscle aches/body aches). On 11-Apr-2021, PYREXIA (fever - 102F) had resolved. At the time of the report, FEELING ABNORMAL (Overall feeling little unusual), NAUSEA (little nauea), HEADACHE (head was hurting whenever he stands up or turns hid head faster) and MYALGIA (muscle aches/body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Body temperature: 102 °f High.         No concomitant medications were reported.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not Applicable
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Fever blister; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Fever blister) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Fever blister. Concomitant products included VITAMINS NOS (MULTIVITAMINUM) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced ORAL HERPES (Fever blister). At the time of the report, ORAL HERPES (Fever blister) had not resolved.            Treatment include Abreva topical ointment on it Action taken with mRNA-1273 in response to the events were Not Applicable
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypokinesia, Pruritus, Urticaria, Vaccination site pain
Clinical narrative: Severe Hives Started from her waist and spread all over the body; Itching All over the Body; Allergic Reaction; Sore Injection Site; Could Not Lift the Right Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Injection Site), HYPOKINESIA (Could Not Lift the Right Arm), URTICARIA (Severe Hives Started from her waist and spread all over the body), PRURITUS (Itching All over the Body) and HYPERSENSITIVITY (Allergic Reaction) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore Injection Site) and HYPOKINESIA (Could Not Lift the Right Arm). On 21-Mar-2021, the patient experienced URTICARIA (Severe Hives Started from her waist and spread all over the body), PRURITUS (Itching All over the Body) and HYPERSENSITIVITY (Allergic Reaction). On 15-Mar-2021, VACCINATION SITE PAIN (Sore Injection Site) and HYPOKINESIA (Could Not Lift the Right Arm) had resolved. On 23-Mar-2021, URTICARIA (Severe Hives Started from her waist and spread all over the body) and PRURITUS (Itching All over the Body) had resolved. At the time of the report, HYPERSENSITIVITY (Allergic Reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Treatment Corticosteroid cream and HCP suggested to take Diphenhydramine and Ranitidine the night before the second dose.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Additional information received on 18 May 2021 contains non-significant information
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: fever blister appear on her lip; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (fever blister appear on her lip) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Fever blister (History of fever blisters) since an unknown date.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ORAL HERPES (fever blister appear on her lip). On 21-Mar-2021, ORAL HERPES (fever blister appear on her lip) had resolved.            Concomitant medication use was not reported.  Patient used Abreva topical ointment for treatment of the event.    This case was linked to US-MODERNATX, INC.-MOD-2021-076534 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076534:1st dose
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Covid Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid Arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE REACTION (Covid Arm). At the time of the report, VACCINATION SITE REACTION (Covid Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant or treatment medications provided.