chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Fever; Feeling warm; Flushed; Headache; Chills; Swelling at the injection site; Tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling warm), FLUSHING (Flushed), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE SWELLING (Swelling at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Glaucoma, Asthma and Allergy.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced FEELING HOT (Feeling warm), FLUSHING (Flushed), HEADACHE (Headache), CHILLS (Chills), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Tenderness at injection site). On 09-Feb-2021, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) from 08-Feb-2021 to 09-Feb-2021 for Headache and Fever, at a dose of 1 dosage form. On 10-Feb-2021, PYREXIA (Fever) had resolved. At the time of the report, FEELING HOT (Feeling warm), FLUSHING (Flushed), HEADACHE (Headache) and CHILLS (Chills) was resolving and VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Tenderness at injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Body temperature: 100.8 (Inconclusive) 100.8F. On 09-Feb-2021, Body temperature: 100.1 (Inconclusive) 100.1F.         The concomitant medication included blood pressure medication, glaucoma eye drops, asthma medication and allergy medication. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2021: Patient history were added. The concomitant medication details added.The product first dose details was added. The event outcome of feeling hot, flushing, headache and chills were updated to resolving and the treatment information updated.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: arm soreness; fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), FATIGUE (fatigue) and CHILLS (Chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness), FATIGUE (fatigue) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (arm soreness), FATIGUE (fatigue) and CHILLS (Chills) outcome was unknown.            No concomitant medications were taken. No treatment medication was taken.   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pallor, Rash
Clinical narrative: the next two days I was very very pale and very very fatigued; developed a rash, not hives but a rash on my arms, some of my trunk, and my back; I was completely wiped out; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PALLOR (the next two days I was very very pale and very very fatigued), RASH (developed a rash, not hives but a rash on my arms, some of my trunk, and my back) and FATIGUE (I was completely wiped out) in a 61-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALLOR (the next two days I was very very pale and very very fatigued), RASH (developed a rash, not hives but a rash on my arms, some of my trunk, and my back) and FATIGUE (I was completely wiped out). At the time of the report, PALLOR (the next two days I was very very pale and very very fatigued), RASH (developed a rash, not hives but a rash on my arms, some of my trunk, and my back) and FATIGUE (I was completely wiped out) 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.   Treatment for the events included antibiotics.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: terrible headache; Temperature of 104 degrees, the next day temperature is 103 degrees; she had a temperature of 104 degrees with chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature of 104 degrees, the next day temperature is 103 degrees), CHILLS (she had a temperature of 104 degrees with chills) and HEADACHE (terrible headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PYREXIA (Temperature of 104 degrees, the next day temperature is 103 degrees) and CHILLS (she had a temperature of 104 degrees with chills). On 07-Feb-2021, the patient experienced HEADACHE (terrible headache). At the time of the report, PYREXIA (Temperature of 104 degrees, the next day temperature is 103 degrees), CHILLS (she had a temperature of 104 degrees with chills) and HEADACHE (terrible headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Body temperature: 104 degrees (High) 104 degrees. On 07-Feb-2021, Body temperature: 103 degrees (High) 103 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: The significant follow up received in which outcome of the event was updated(Unknown to Recovered).Added lab data from initial source document.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: reaction to the vaccine that was received about 10 days ago; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (reaction to the vaccine that was received about 10 days ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     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 VACCINATION SITE REACTION (reaction to the vaccine that was received about 10 days ago). At the time of the report, VACCINATION SITE REACTION (reaction to the vaccine that was received about 10 days ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Felt itch again, plus hard bump and redness in the IS; Felt itch again, plus hard bump and redness in the IS; Felt itch again, plus hard bump and redness in the IS; noticed in the IS itch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Felt itch again, plus hard bump and redness in the IS), VACCINATION SITE PRURITUS (noticed in the IS itch), VACCINATION SITE INDURATION (Felt itch again, plus hard bump and redness in the IS) and VACCINATION SITE PRURITUS (Felt itch again, plus hard bump and redness in the IS) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (noticed in the IS itch). On 08-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Felt itch again, plus hard bump and redness in the IS), VACCINATION SITE INDURATION (Felt itch again, plus hard bump and redness in the IS) and VACCINATION SITE PRURITUS (Felt itch again, plus hard bump and redness in the IS). At the time of the report, VACCINATION SITE ERYTHEMA (Felt itch again, plus hard bump and redness in the IS), VACCINATION SITE PRURITUS (noticed in the IS itch), VACCINATION SITE INDURATION (Felt itch again, plus hard bump and redness in the IS) and VACCINATION SITE PRURITUS (Felt itch again, plus hard bump and redness in the IS) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Patient is using cream unknown generic name as a treatment for AEs.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Pain in extremity, Pruritus
Clinical narrative: huge red patch; Arm pain; itchy; Headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PRURITUS (itchy), HEADACHE (Headache) and INJECTION SITE ERYTHEMA (huge red patch) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A MSTDT and 023M20A) for COVID-19 vaccination.     Concomitant products included LETROZOLE for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), PRURITUS (itchy) and HEADACHE (Headache). On 09-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (huge red patch). On 28-Jan-2021, PAIN IN EXTREMITY (Arm pain) and HEADACHE (Headache) had resolved. At the time of the report, PRURITUS (itchy) and INJECTION SITE ERYTHEMA (huge red patch) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable patient took treatment medication with steroid ointment and concomitant medication   This case was linked to MOD-2021-101442 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Completed ADR Form
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Sluggishness
Clinical narrative: sluggish; Left arm still red; very itchy; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (sluggish), ERYTHEMA (Left arm still red) and PRURITUS (very itchy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No medical history was provided by the reporter.     On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (sluggish), ERYTHEMA (Left arm still red) and PRURITUS (very itchy). At the time of the report, SLUGGISHNESS (sluggish), ERYTHEMA (Left arm still red) and PRURITUS (very itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Influenza, Night sweats
Clinical narrative: night sweats/ sleeps in t shirts and shots and the t shirt is all sweat; felt with no energy; flu symptoms; tired; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats/ sleeps in t shirts and shots and the t shirt is all sweat), ASTHENIA (felt with no energy), INFLUENZA (flu symptoms) and FATIGUE (tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced FATIGUE (tired). On an unknown date, the patient experienced NIGHT SWEATS (night sweats/sleeps in t shirts and shots and the t shirt is all sweat), ASTHENIA (felt with no energy) and INFLUENZA (flu symptoms). At the time of the report, NIGHT SWEATS (night sweats/sleeps in t shirts and shots and the t shirt is all sweat), ASTHENIA (felt with no energy), INFLUENZA (flu symptoms) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient said that it felt fine but since it had the shot for the last 7 days was getting night sweats, it was not that the room was excessively hot and was felt fine. The patient mentioned that on the second day (Friday February 5th) itself and the spouse felt really tired. It lasted until Saturday February 6th and they felt with no energy but that didn't stopped them nor anything, and stated that was almost as flu symptoms.  Treatment information was not provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Joint swelling, Pruritus
Clinical narrative: bumps and itching across his body; major cluster on his ankle on the same side of his shot; fairly severe allergy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (bumps and itching across his body), JOINT SWELLING (major cluster on his ankle on the same side of his shot) and HYPERSENSITIVITY (fairly severe allergy) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) 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 PRURITUS (bumps and itching across his body), JOINT SWELLING (major cluster on his ankle on the same side of his shot) and HYPERSENSITIVITY (fairly severe allergy). At the time of the report, PRURITUS (bumps and itching across his body), JOINT SWELLING (major cluster on his ankle on the same side of his shot) and HYPERSENSITIVITY (fairly severe allergy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site reaction
Clinical narrative: COVID arm; Rash on the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm) and RASH (Rash on the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 VACCINATION SITE REACTION (COVID arm) and RASH (Rash on the arm). At the time of the report, VACCINATION SITE REACTION (COVID arm) and RASH (Rash on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided. Lab details were not provided.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Pain in extremity, Vaccination site pain
Clinical narrative: the bone her arm and hand is aching/pain described as in the bone; the bone her arm and hand is aching/pain on the arm of the injection, down to her hand; Vaccination site her arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (the bone her arm and hand is aching/pain described as in the bone), PAIN IN EXTREMITY (the bone her arm and hand is aching/pain on the arm of the injection, down to her hand) and VACCINATION SITE PAIN (Vaccination site her arm hurts) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced BONE PAIN (the bone her arm and hand is aching/pain described as in the bone), PAIN IN EXTREMITY (the bone her arm and hand is aching/pain on the arm of the injection, down to her hand) and VACCINATION SITE PAIN (Vaccination site her arm hurts). At the time of the report, BONE PAIN (the bone her arm and hand is aching/pain described as in the bone), PAIN IN EXTREMITY (the bone her arm and hand is aching/pain on the arm of the injection, down to her hand) and VACCINATION SITE PAIN (Vaccination site her arm hurts) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product includes Medication for Diabetes. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Patient is all better now
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site induration, Vaccination site rash, Vaccination site warmth
Clinical narrative: Vomiting; had spot on her arm near the injection site that was round, red, hard and hot to touch; had spot on her arm near the injection site that was round, red, hard and hot to touch; had spot on her arm near the injection site that was round, red, hard and hot to touch; had spot on her arm near the injection site that was round, red, hard and hot to touch; Slight Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (had spot on her arm near the injection site that was round, red, hard and hot to touch), VACCINATION SITE RASH (had spot on her arm near the injection site that was round, red, hard and hot to touch), VACCINATION SITE INDURATION (had spot on her arm near the injection site that was round, red, hard and hot to touch), VACCINATION SITE ERYTHEMA (had spot on her arm near the injection site that was round, red, hard and hot to touch) and HEADACHE (Slight Headache) in a 95-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.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE WARMTH (had spot on her arm near the injection site that was round, red, hard and hot to touch), VACCINATION SITE RASH (had spot on her arm near the injection site that was round, red, hard and hot to touch), VACCINATION SITE INDURATION (had spot on her arm near the injection site that was round, red, hard and hot to touch), VACCINATION SITE ERYTHEMA (had spot on her arm near the injection site that was round, red, hard and hot to touch) and HEADACHE (Slight Headache). On 09-Feb-2021, the patient experienced VOMITING (Vomiting). On 08-Feb-2021, HEADACHE (Slight Headache) had resolved. On 09-Feb-2021, VOMITING (Vomiting) had resolved. At the time of the report, VACCINATION SITE WARMTH (had spot on her arm near the injection site that was round, red, hard and hot to touch), VACCINATION SITE RASH (had spot on her arm near the injection site that was round, red, hard and hot to touch), VACCINATION SITE INDURATION (had spot on her arm near the injection site that was round, red, hard and hot to touch) and VACCINATION SITE ERYTHEMA (had spot on her arm near the injection site that was round, red, hard and hot to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; had spot on her arm near the injection site that was round, red, hard and hot to touch; had spot on her arm near the injection site that was round, red, hard and hot to touch; had spot on her arm near the injection site that was round, red, hard and hot to touch; had spot on her arm near the injection site that was round, red, hard and hot to touch; Slight Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (had spot on her arm near the injection site that was round, red, hard and hot to touch), VACCINATION SITE RASH (had spot on her arm near the injection site that was round, red, hard and hot to touch), VACCINATION SITE INDURATION (had spot on her arm near the injection site that was round, red, hard and hot to touch), VACCINATION SITE ERYTHEMA (had spot on her arm near the injection site that was round, red, hard and hot to touch) and HEADACHE (Slight Headache) in a 95-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.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE WARMTH (had spot on her arm near the injection site that was round, red, hard and hot to touch), VACCINATION SITE RASH (had spot on her arm near the injection site that was round, red, hard and hot to touch), VACCINATION SITE INDURATION (had spot on her arm near the injection site that was round, red, hard and hot to touch), VACCINATION SITE ERYTHEMA (had spot on her arm near the injection site that was round, red, hard and hot to touch) and HEADACHE (Slight Headache). On 09-Feb-2021, the patient experienced VOMITING (Vomiting). On 08-Feb-2021, HEADACHE (Slight Headache) had resolved. On 09-Feb-2021, VOMITING (Vomiting) had resolved. At the time of the report, VACCINATION SITE WARMTH (had spot on her arm near the injection site that was round, red, hard and hot to touch), VACCINATION SITE RASH (had spot on her arm near the injection site that was round, red, hard and hot to touch), VACCINATION SITE INDURATION (had spot on her arm near the injection site that was round, red, hard and hot to touch) and VACCINATION SITE ERYTHEMA (had spot on her arm near the injection site that was round, red, hard and hot to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye irritation, Eye pruritus, Eyelid ptosis, Headache
Clinical narrative: Burning Sensation in the Right Eye; Itchy around Right Eye; Swollen Face; Drooping Right Eye; Red Face; Headache; A spontaneous report was received from a consumer concerning a 52-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events burning sensation in the right eye, itchy around right eye, swollen face, red face, drooping right eye, headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 027L20A) Intramuscularly in left upper arm for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient experienced the event(s) burning sensation in the right eye, itchy around right eye, swollen face, red face, drooping right eye, headache. These symptoms started at her eye and migrated down half of her neck.  Treatment for events included 2 Benadryl (50 mg Total) and Elocon cream to relieve side effects.  On 14 JAN 2021, The symptoms seemed to get worsen, The patient spoke to her physician prescribed her medrol dose pack and Atarax. The medication seemed to help her symptoms, but she was still experiencing mild symptoms.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), burning sensation in the right eye, itchy around right eye, swollen face, red face, drooping right eye, headache was considered as not esolved.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Burning Sensation in the Right Eye; Itchy around Right Eye; Swollen Face; Drooping Right Eye; Red Face; Headache; A spontaneous report was received from a consumer concerning a 52-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events burning sensation in the right eye, itchy around right eye, swollen face, red face, drooping right eye, headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 027L20A) Intramuscularly in left upper arm for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient experienced the event(s) burning sensation in the right eye, itchy around right eye, swollen face, red face, drooping right eye, headache. These symptoms started at her eye and migrated down half of her neck.  Treatment for events included 2 Benadryl (50 mg Total) and Elocon cream to relieve side effects.  On 14 JAN 2021, The symptoms seemed to get worsen, The patient spoke to her physician prescribed her medrol dose pack and Atarax. The medication seemed to help her symptoms, but she was still experiencing mild symptoms.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), burning sensation in the right eye, itchy around right eye, swollen face, red face, drooping right eye, headache was considered as not esolved.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Feeling abnormal, Tremor
Clinical narrative: not feeling good; arms and legs were shaking; blood pressure got more elevated; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (blood pressure got more elevated), FEELING ABNORMAL (not feeling good) and TREMOR (arms and legs were shaking) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included thyroid medication and Pegasys interferon Injection                                   every for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (blood pressure got more elevated) and TREMOR (arms and legs were shaking). On 09-Feb-2021, the patient experienced FEELING ABNORMAL (not feeling good). At the time of the report, BLOOD PRESSURE INCREASED (blood pressure got more elevated), FEELING ABNORMAL (not feeling good) and TREMOR (arms and legs were shaking) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: muscle pain; soreness in her right arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain) and VACCINATION SITE PAIN (soreness in her right arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Lung cancer and Hypertension. Concomitant products included CLONIDINE, METOPROLOL, EZETIMIBE (ZETIA) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced MYALGIA (muscle pain) and VACCINATION SITE PAIN (soreness in her right arm). At the time of the report, MYALGIA (muscle pain) was resolving and VACCINATION SITE PAIN (soreness in her right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash, Vaccination complication
Clinical narrative: Sore/Pain on the Left Arm from shoulder to elbow; Covid arm; Itchy; Rash on the Left Arm from shoulder to elbow; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sore/Pain on the Left Arm from shoulder to elbow), VACCINATION COMPLICATION (Covid arm), PRURITUS (Itchy) and RASH (Rash on the Left Arm from shoulder to elbow) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PAIN (Sore/Pain on the Left Arm from shoulder to elbow), VACCINATION COMPLICATION (Covid arm), PRURITUS (Itchy) and RASH (Rash on the Left Arm from shoulder to elbow). On 21-Mar-2021, PAIN (Sore/Pain on the Left Arm from shoulder to elbow) and RASH (Rash on the Left Arm from shoulder to elbow) had resolved. At the time of the report, VACCINATION COMPLICATION (Covid arm) and PRURITUS (Itchy) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Additional information received included reporter details, suspect product details, update on initial adverse events and new adverse event.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Injection site warm to touch; Vaccination site knot; Itchy knot at injection site; Injection site a little sore; Injection site  pink; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site warm to touch), VACCINATION SITE MASS (Vaccination site knot), VACCINATION SITE PRURITUS (Itchy knot at injection site), VACCINATION SITE PAIN (Injection site a little sore) and VACCINATION SITE ERYTHEMA (Injection site  pink) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm to touch), VACCINATION SITE MASS (Vaccination site knot), VACCINATION SITE PRURITUS (Itchy knot at injection site), VACCINATION SITE PAIN (Injection site a little sore) and VACCINATION SITE ERYTHEMA (Injection site  pink). At the time of the report, VACCINATION SITE WARMTH (Injection site warm to touch), VACCINATION SITE MASS (Vaccination site knot), VACCINATION SITE PRURITUS (Itchy knot at injection site), VACCINATION SITE PAIN (Injection site a little sore) and VACCINATION SITE ERYTHEMA (Injection site  pink) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: sweating; fever; chills; headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and PAIN (body aches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 08-Feb-2021, the patient experienced HYPERHIDROSIS (sweating), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and PAIN (body aches). At the time of the report, HYPERHIDROSIS (sweating), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and PAIN (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site was a little swollen, red, itchy, and hard.; injection site was a little swollen, red, itchy, and hard.; injection site was a little swollen, red, itchy, and hard.; injection site was a little swollen, red, itchy, and hard.; injection site was a little swollen, red, itchy, and hard.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site was a little swollen, red, itchy, and hard.), VACCINATION SITE INDURATION (injection site was a little swollen, red, itchy, and hard.), VACCINATION SITE SWELLING (injection site was a little swollen, red, itchy, and hard.), VACCINATION SITE ERYTHEMA (injection site was a little swollen, red, itchy, and hard.) and VACCINATION SITE PAIN (injection site was a little swollen, red, itchy, and hard.) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (injection site was a little swollen, red, itchy, and hard.), VACCINATION SITE INDURATION (injection site was a little swollen, red, itchy, and hard.), VACCINATION SITE SWELLING (injection site was a little swollen, red, itchy, and hard.), VACCINATION SITE ERYTHEMA (injection site was a little swollen, red, itchy, and hard.) and VACCINATION SITE PAIN (injection site was a little swollen, red, itchy, and hard.). At the time of the report, VACCINATION SITE PRURITUS (injection site was a little swollen, red, itchy, and hard.), VACCINATION SITE INDURATION (injection site was a little swollen, red, itchy, and hard.), VACCINATION SITE SWELLING (injection site was a little swollen, red, itchy, and hard.), VACCINATION SITE ERYTHEMA (injection site was a little swollen, red, itchy, and hard.) and VACCINATION SITE PAIN (injection site was a little swollen, red, itchy, and hard.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Vaccination site erythema, Vaccination site rash
Clinical narrative: Itchy; Red; Bumps; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE RASH (Bumps) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE RASH (Bumps). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE RASH (Bumps) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Injection site feels hot; Weakness; Injection site redness; This spontaneous case was reported by an other health care professional and describes the occurrence of ASTHENIA (Weakness), VACCINATION SITE WARMTH (Injection site feels hot) and VACCINATION SITE ERYTHEMA (Injection site redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No medical history was provided by the reporter.     On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced ASTHENIA (Weakness), VACCINATION SITE WARMTH (Injection site feels hot) and VACCINATION SITE ERYTHEMA (Injection site redness). At the time of the report, ASTHENIA (Weakness), VACCINATION SITE WARMTH (Injection site feels hot) and VACCINATION SITE ERYTHEMA (Injection site redness) 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.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain in extremity, Pruritus
Clinical narrative: Itchy; Soreness in her arm; Headache; Nausea; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), PAIN IN EXTREMITY (Soreness in her arm), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) 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 reported).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PRURITUS (Itchy), PAIN IN EXTREMITY (Soreness in her arm), HEADACHE (Headache), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, PRURITUS (Itchy), PAIN IN EXTREMITY (Soreness in her arm), HEADACHE (Headache), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment details included none.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-027572 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-027572:linked case
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Itchy; Soreness in her arm; Headache; Nausea; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), PAIN IN EXTREMITY (Soreness in her arm), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) 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 reported).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PRURITUS (Itchy), PAIN IN EXTREMITY (Soreness in her arm), HEADACHE (Headache), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, PRURITUS (Itchy), PAIN IN EXTREMITY (Soreness in her arm), HEADACHE (Headache), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment details included none.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-027572 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-027572:linked case
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: hot circle; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot circle) and VACCINATION SITE ERYTHEMA (red) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Don't have that with her) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot circle) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE WARMTH (hot circle) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash from her mid back to her navel.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash from her mid back to her navel.) 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash from her mid back to her navel.). At the time of the report, RASH (rash from her mid back to her navel.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dyspnoea, Malaise, Oxygen saturation
Clinical narrative: Felt like they could not get enough air; Chest hurt; Every once in a while they feel like they need to take a deep breath; Coughed all night; A little sore arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (A little sore arm), COUGH (Coughed all night), DYSPNOEA (Felt like they could not get enough air), CHEST PAIN (Chest hurt) and MALAISE (Every once in a while they feel like they need to take a deep breath) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (A little sore arm). On 06-Feb-2021, the patient experienced COUGH (Coughed all night). On 07-Feb-2021, the patient experienced DYSPNOEA (Felt like they could not get enough air), CHEST PAIN (Chest hurt) and MALAISE (Every once in a while they feel like they need to take a deep breath). On 09-Feb-2021, DYSPNOEA (Felt like they could not get enough air) and CHEST PAIN (Chest hurt) had resolved. At the time of the report, PAIN IN EXTREMITY (A little sore arm), COUGH (Coughed all night) and MALAISE (Every once in a while they feel like they need to take a deep breath) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Oxygen saturation: 93 (normal) Then it went up to 95 and 96..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication use was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-160014 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Updated patient contact information. Updated Concomitant product use.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-160014:2nd dose case